Press releases

Stallergenes Greer Updates on the ANSM Injunction - Antony Site (France)

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Euronext:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today announced that the French National Agency for Medicines and Health Products Safety (ANSM) published today a partial extension of its injunction dated January 4, 2018.

The original injunction related to the quality management systems and processes at Stallergenes Greer’s facility in Antony (France) and primarily impacted the production of subcutaneous products. Sublingual products were not impacted.

In its 2019 decision, the ANSM noted the full resolution of four points among the seven raised in the January 2018 injunction. The ANSM decided to extend its injunction concerning the remaining three points: two related to the production of subcutaneous products and one related to pharmacist training as to batch releases. In accordance with the deadlines set by the ANSM, two of these points are expected to be concluded by the end of May 2019, the other by September 15, 2019.

ABOUT THE POTENTIAL FINANCIAL PENALTY

As announced in June 2018, the ANSM informed the Company that it may impose a financial penalty. The ANSM has not notified Stallergenes Greer of its decision in that regard.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION

Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as “believe,” “expects,” “project,” “estimated,” “forecast,” “should,” “plan,” “may,” “will” or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2018 annual report published on 21 March 2019 on the Company's website www.stallergenesgreer.com. Actual results may differ materially from those set forth in the forward-looking statements, due to these and other various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

 

Stallergenes Greer Reports Continued Sales Growth in the First Quarter 2019

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today published its unaudited net sales for the three-month period ended 31 March 2019.

Q1-19 unaudited net sales up 11% as a result of positive performance across main products and several regions

Unaudited   Reported Currency         Constant Currency  
FY-18 (3m)   FY-19 (3m)

Var %

FY-19 (3m)

Var %

In € million  

(€m)

 

% Sales

 

(€m)

 

% Sales

 

(€m)

 

% Sales

 
                               
Southern Europe   40.3   53%   44.8   53%   11% 44.9   54%   11%
Northern & Central Europe   10.9   14%   12.4   15%   14% 12.3   15%   13%
International markets   3.9   5%   5   6%   28% 5.1   6%   28%
United States   21.1   28%   22.5   26%   7% 20.8   25%   -1%
Net sales   76.2   100%   84.7   100%   11% 83   100%   9%
                       
Sublingual products   52   68%   59   70%   13%
Subcutaneous products   16.3   21%   18   21%   10%
Veterinary   2   3%   2.4   3%   20%
Other products   5.9   8%   5.3   6%   -10%
Net sales   76.2   100%   84.7   100%   11%

Net sales by region: Positive performance in Southern Europe (+11%) and in Northern & Central Europe (+14%) while net sales were slightly down in the United States at constant currency (-1% or +7% at reported currency)
The 11% increase year-over-year in Q1-19 net sales reflects positive growth in Southern Europe and in Northern & Central Europe. U.S. revenue was positively impacted by the foreign currency exchange rate in Q1-19. Net sales in the United States were slightly down (-1%) for the first quarter in local currency (US$).

Europe & International: Stallergenes Greer sales growth was primarily driven by France, for both Staloral and Oralair®. The company also increased its sales in Italy, Spain, Germany, Poland and Slovakia. Net sales increase in International markets (+28%) was primarily driven by Russia and Australia.

United States: In the United States, Stallergenes Greer net sales increased 7% in reported currency, delivering €22.5m in Q1-19, while being slightly down (-1%) at constant currency. The Group continued to strengthen its leadership position in the bulk allergen segment in this geography, while some of the adjacent businesses had a slower start to the year.

Net sales by category: Continued growth in the sublingual segment (+13%)
Staloral was Stallergenes Greer’s main growth driver in Q1-19, in particular in the French market. Additionally, Oralair net sales increased across all its major markets in Europe and International region, but had a slow start in the United States.

Sublingual products: in Q1-19, sublingual product sales increased by 13%, reaching €59.0 million, primarily driven by Staloral as a result of market share gains in priority markets, such as France. In parallel, in the tablet segment, the decline of the grass tablet market in the United States impacted Oralair’s performance in this geography.

Subcutaneous products: in the subcutaneous product category, the company reported Q1-19 net sales of €18.0 million, a 10% increase compared to Q1-18 thanks to a favorable US$ / Euro exchange rate, and despite a temporary shortage of injectable products in the Europe and International region as the Group pursued investments in major renovations and upgrades at its Antony facility.

Veterinary products: Q1-19 veterinary net sales grew 20% to €2.4 million compared to Q1-18, despite an increasingly competitive environment, through volume gains but also supported by a stronger US$ versus Euro foreign exchange rate.

Other products: net sales in the Other product line, which includes diagnostics and devices, declined by 10% quarter-over-quarter to €5.3 million in Q1-19, mostly due to a slower start of the adjacent businesses in the United States.

2019 FULL YEAR OUTLOOK
The Company confirms its full year outlook for 2019 disclosed on 21 March 2019 for net sales to be in the range of €290 million to €300 million and EBITDA2 to be in the range of €50 million to €60 million.

CORPORATE CALENDAR
Recommended cash acquisition of Stallergenes Greer plc by Ares Life Sciences I S.À.R.L.:
Court Meeting: 13 May 2019 at 2.00pm C.E.S.T. | General Meeting: 13 May 2019 at 2.15pm C.E.S.T.
Location: Maison de la Recherche, 54 rue de Varenne, 75 007 Paris, France

Annual General Meeting: 13 June 2019 at 2.00pm C.E.S.T.
Location: Maison de la Recherche, 54 rue de Varenne, 75 007 Paris, France

1H 2019 results: 29 August 2019

ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the USA) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

The financial information set out above does not constitute the Group’s financial statements for the period ended 31 March 2018 (unaudited) and 2019 (unaudited).

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking or that express management’s beliefs, expectations or estimates with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as “anticipate”, “target”, "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may," "will," or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events, or by the fact that such statements do not relate strictly to historical or current facts. These forward-looking statements are based on current expectations and are subject to risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, changes in regulation, government or intellectual property protection, changes in competitive factors and other risks inherent to the industries in which the Company operates. These and other factors are more fully described in the Company's 2018 annual report published on 21 March 2019 on the Company's website www.stallergenesgreer.com. Actual results may differ materially from those set forth in the forward-looking statements, due to these and other various factors. Nothing in this statement should be construed as a profit forecast. Save as required by applicable law (including under the Market Abuse Regulation, the UK Listing Rules and the Disclosure and Transparency Rules of the Financial Conduct Authority), neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update. The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files. All readers, wherever located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met, and investors are cautioned not to place undue reliance on the forward-looking statements.

This announcement does not constitute an invitation to underwrite, subscribe for or otherwise acquire or dispose of any shares in the Company, in the UK or in the US, or under the US Securities Act 1933 or in any jurisdiction.

1 Excluding one-off costs

2 Excluding one-off costs

Recommended Cash Acquisition of Stallergenes Greer plc ("Stallergenes Greer") by Ares Life Sciences I S.à r.l. ("Waypoint")

LONDON--(BUSINESS WIRE)-- Regulatory News:

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF THAT JURISDICTION

Highlights

  • The Scheme Document has been published today and is available on Stallergenes Greer's (Paris:STAGR) website at http://www.stallergenesgreer.com/
  • The Court Meeting and the General Meeting are scheduled to be held on 13 May 2019 starting at 14:00 and 14:15 C.E.S.T. respectively in Paris
  • The last date for lodging Voting Forms for the Court Meeting and General Meeting is 9 May 2019 at 14:15 C.E.S.T.
  • The Effective Date is expected to be on 16 May 2019
  • Shareholders are strongly encouraged to sign and return the Voting Forms for both the Court Meeting and the General Meeting as soon as possible
  • Payment of the cash consideration to the relevant paying agents by Waypoint is expected to be made by 23 May 2019

Publication of Scheme Document

On 21 March 2019, the special committee of independent directors of Stallergenes Greer (the "Special Committee") and Waypoint announced that they had agreed the terms of a recommended cash acquisition by Waypoint of the entire issued, and to be issued, ordinary share capital of Stallergenes Greer not already directly or indirectly owned by Waypoint (the "Acquisition"). The Acquisition is intended to be implemented by means of a scheme of arrangement under the U.K. Companies Act 2006 (the "Scheme").

The Special Committee is pleased to announce that the scheme document relating to the Acquisition (the "Scheme Document"), together with the Proxy Forms for the Court Meeting and the General Meeting, are being sent to Scheme Shareholders today. Copies of this announcement, the Scheme Document and the Voting Forms have been published on the Stallergenes Greer website at http://www.stallergenesgreer.com/ and the Scheme Document is being made available, for information only, to participants in the Share Schemes and persons with information rights. The Scheme Document and Voting Forms for the Court Meeting and the General Meeting will also be sent to Registered Shareholders shortly. Bearer Shareholders should contact their intermediary bank to request hard copies of the Scheme Document and Voting Forms. The Scheme Document sets out, amongst other things, a letter from the Chairman of the Special Commitee, an explanatory statement pursuant to section 897 of the U.K. Companies Act 2006, the full terms and conditions of the Scheme, an indicative timetable of principal events, notices of the shareholder meetings relating to the Scheme and details of the action to be taken by Shareholders.

Notices of the Court Meeting and General Meeting

As described in the Scheme Document, the Scheme will require the approval of the Scheme Shareholders at the Court Meeting, the passing of a special resolution at the General Meeting and then the sanction of the Court. The Court Meeting and the General Meeting are scheduled to be held at 14:00 and 14:15 C.E.S.T. respectively on 13 May 2019 at Maison de la Recherche, 54 Rue de Varenne, 75007 Paris, France.

It is important that, for the Court Meeting, as many votes as possible are cast so that the Court can be satisfied that there is a fair representation of Scheme Shareholder opinion. Shareholders are therefore strongly encouraged to sign and return the Voting Forms for both the Court Meeting and the General Meeting as soon as possible.

Timetable

The Scheme Document contains an expected timetable of principal events relating to the Scheme, which is copied below.

Event     Time/date
 
Publication of the Scheme Document 5 April 2019
 

Latest time for requesting copies of the Scheme Document,
Voting Forms and Proxy Forms

09:00 on 7 May 2019
 
Latest time for lodging Voting Forms for the:
 
Court Meeting (BLUE form) 14:15 on 9 May 2019(2)
 
General Meeting (WHITE form) 14:15 on 9 May 2019(2)
 
Voting Record Time 18:30 on 9 May 2019(3)
 
Latest time for lodging Proxy Forms for the:
 
Court Meeting (BLUE form) 14:15 on 10 May 2019(4)
 
General Meeting (WHITE form) 14:15 on 10 May 2019(4)
 
Court Meeting 14:00 on 13 May 2019
 
General Meeting 14:15 on 13 May 2019(5)
 
The following dates are subject to change (1)
 
Last day of dealings in Shares 10 May 2019
 
Suspension of listing of, and dealings in, Shares 09:00 on 13 May 2019
 
Court hearing to sanction the Scheme 15 May 2019
 
Scheme Record Time 19:00 on 15 May 2019
 
Scheme Effective Date 16 May 2019
 
De-listing of Shares 17 May 2019
 
Cancellation of book entries within the Euroclear system 20 May 2019
 

Payment of cash consideration to the Shareholder Paying Agent
and the Scheme Shareholder Paying Agent

by 23 May 2019(6)
 
Long Stop Date 30 June 2019(7)
 

The Court Meeting and the General Meeting will each be held at Maison de la Recherche, 54
Rue de Varenne, 75007 Paris, France.

(1) These times and dates are indicative only and will depend, amongst other things, on the date upon which the Court sanctions the Scheme. The timetable is also dependent on when the Court Order sanctioning the Scheme is delivered to the Registrar of Companies. Stallergenes Greer will give notice of any change(s) by issuing an announcement through Business Wire.

(2) It is requested that the Voting Forms for the Court Meeting and the General Meeting be lodged before 14:15 on 9 May 2019 or, if a Meeting is adjourned, not later than 72 hours (excluding any part of a day that is not a Business Day) before the time appointed for the holding of the adjourned Meeting. The completion and return of Voting Forms will not prevent you from attending the Court Meeting or the General Meeting and voting in person provided that: (i) if you are a Registered Shareholder, you attend the Meeting with your Attendance Card or, if not requested or not received on time, with valid identity papers; or (ii) if you are a Bearer Shareholder, you attend the Meeting with your Attendance Card or, if not requested or not received on time, with your Participating Certificate and valid identity papers.

(3) If either of the Meetings is adjourned, the Voting Record Time for the relevant adjourned Meeting will be 18:30 on the date two calendar days (excluding any part of a day that is not a Business Day) before the date set for the adjourned Meeting.

(4) It is requested that the Proxy Forms for the Court Meeting and the General Meeting be lodged before 14:15 on 10 May 2019 or, if a Meeting is adjourned, not later than 48 hours (excluding any part of a day that is not a Business Day) before the time appointed for the holding of the adjourned Meeting. The completion and return of Proxy Forms will not prevent you from attending the Court Meeting or the General Meeting and voting in person, if you so wish and are so entitled. Proxy Forms not so lodged may be handed to the Chairman of the Meeting before the taking of the poll at such Meeting.

(5) Or as soon thereafter as the Court Meeting has been concluded or adjourned.

(6) Shareholders and Scheme Shareholders will receive payment of the cash consideration from the Shareholder Paying Agent or the Scheme Shareholder Paying Agent (as applicable) in accordance with their respective normal procedures.

(7) This date may be extended to such date as Stallergenes Greer and Waypoint may agree and the Court (if required) may allow.

All times are C.E.S.T.

This section should be read in conjunction with the Scheme Document and, in particular, the notices of the Court Meeting and the General Meeting in Part 10 and Part 11 of the Scheme Document respectively.

Capitalised terms used but not defined in this announcement have the meanings set out in the Scheme Document.

Further Information

UBS AG London Branch is authorised and regulated by the Financial Market Supervisory Authority in Switzerland. It is authorised by the Prudential Regulation Authority and subject to regulation by the Financial Conduct Authority and limited regulation by the Prudential Regulation Authority in the United Kingdom. UBS AG London Branch is acting exclusively as financial adviser to Waypoint and no one else in connection with the Acquisition. In connection with such matters, UBS AG London Branch will not regard any other person as its client, nor will it be responsible to any other person for providing the protections afforded to its clients or for providing advice in relation to the Acquisition, the contents or subject matter of this announcement or any transaction, arrangement or other matter referred to herein.

Evercore Partners International LLP, which is authorised and regulated in the United Kingdom by the Financial Conduct Authority, is acting as financial adviser exclusively for the Special Committee and no one else in connection with the matters referred to in this announcement and will not regard any other person as its client in connection with the matters referred to in this announcement and will not be responsible to anyone other than the Special Committee for providing the protections afforded to clients of Evercore, nor for providing advice in relation to the matters referred to in this announcement, nor for the contents or subject matter of this announcement or any transaction, arrangement or other matter referred to herein.

This announcement has been prepared for the purpose of complying with English law and disclosure requirements under French law. Accordingly, the information disclosed may not be the same as that which would have been disclosed if this announcement had been prepared in accordance with the laws of jurisdictions outside of the United Kingdom and France (as applicable). The statements contained in this announcement are not to be construed as legal, business, financial or tax advice. If you are in any doubt about the contents of this announcement, you should consult your own legal adviser, tax adviser or financial adviser for legal, business, financial or tax advice.

The receipt of cash pursuant to the Acquisition by Shareholders and Scheme Shareholders may be a taxable transaction under applicable national, state and local, as well as foreign and other tax laws. Each Shareholder and Scheme Shareholder is urged to consult their independent professional adviser regarding the tax consequences of the Acquisition applicable to him or her.

No person has been authorised to make any representation on behalf of Stallergenes Greer or Waypoint concerning the Acquisition or the Scheme which is inconsistent with the statements contained in this announcement and any such representation, if made, may not be relied upon as having been so authorised.

The statements contained in this announcement are made as at the date of this announcement, unless some other time is specified in relation to them, and service of this announcement shall not give rise to any implication that there has been no change in the facts set out in this announcement since such date. Nothing contained in this announcement shall be deemed to be a forecast, projection or estimate of the future financial performance of Stallergenes Greer except where otherwise expressly stated. Neither Stallergenes Greer nor Waypoint intends, or undertakes any obligation, to update information contained in this announcement, except as required by applicable law or other regulation.

Information for Overseas Shareholders

Unless otherwise determined by Waypoint and Stallergenes Greer, and permitted by applicable law and regulation, the Acquisition will not be made, directly or indirectly, in, into or from any restricted jurisdiction where to do so would violate the laws of that jurisdiction and no person may vote in favour of the Acquisition by any such use, means, instrumentality or form within a restricted jurisdiction or any other jurisdiction if to do so would constitute a violation of the laws of that jurisdiction. Accordingly, copies of this announcement and any formal documents relating to the Acquisition are not being, and must not be, directly or indirectly, mailed or otherwise forwarded, distributed or sent in, into or from any restricted jurisdiction and persons receiving this announcement and all other documents relating to the Acquisition (including custodians, nominees and trustees) must not mail or otherwise forward, distribute or send them in, into or from any restricted jurisdiction. To the fullest extent permitted by applicable law, Waypoint, Stallergenes Greer and persons involved in the Acquisition disclaim any responsibility or liability for such violation by any person.

It is the responsibility of each Overseas Shareholder to satisfy himself as to the full observance of the laws of the relevant jurisdiction in connection with the Acquisition, including the obtaining of any governmental, exchange control or other consents which may be required, or the compliance with other necessary formalities which are required to be observed and the payment of any issue, transfer or other taxes due in such jurisdiction.

This announcement and the accompanying documents have been prepared for the purposes of complying with English law and disclosure requirements under French law. Accordingly, the information disclosed may not be the same as that which would have been disclosed if these documents had been prepared in accordance with the laws of jurisdictions outside the United Kingdom and France (as applicable). Nothing in this announcement or the accompanying documents should be relied upon for any other purpose.

The financial information included in, or incorporated by reference into, this announcement has been prepared in accordance with accounting standards that may not be comparable to the financial statements of U.S. companies. U.S. generally accepted accounting principles differ in certain respects from International Financial Reporting Standards. None of the financial information in, or incorporated by reference into, this announcement has been audited in accordance with auditing standards generally accepted in the U.S. or the auditing standards of the Public Company Accounting Oversight Board (United States). U.S. persons should note that the Scheme relates to shares of an English company trading on Euronext Paris that is a "foreign private issuer" as defined in Rule 3b-4 under the Securities Exchange Act of 1934, and the Scheme will be governed by English law. Neither the proxy solicitation rules nor the tender offer rules under the Securities Exchange Act of 1934 will apply to the Scheme. Moreover, the Scheme will be subject to the disclosure requirements and practices applicable in France, which differ from the disclosure requirements under U.S. securities laws.

It may be difficult for U.S. holders of Shares to enforce their rights and any claim arising out of the U.S. federal securities laws, since Stallergenes Greer and Waypoint are located in non-U.S. jurisdictions, and some of or all of their officers and directors may be residents of non-U.S. jurisdictions. U.S. holders of Shares may not be able to sue a non-U.S. company or its officer or directors in a non-U.S. court for violations of U.S. securities laws. Further, it may be difficult to compel a non-U.S. company and its affiliates to subject themselves to a U.S. court's judgment.

Neither the U.S. Securities and Exchange Commission nor any U.S. state securities commission has approved or disapproved of the Acquisition, or passed comment upon the adequacy or completeness of this announcement. Any representation to the contrary is a criminal offence.

Forward-Looking Statements

This announcement contains certain statements which are, or may be deemed to be, "forward-looking statements" which are prospective in nature. All statements other than statements of current or historical fact, are or may be deemed to be, forward-looking statements. Forward-looking statements are based on current expectations and projections about future events and are therefore subject to known and unknown risks and uncertainties which could cause actual results, performance or events to differ materially from the future results, performance or events expressed or implied by the forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of forward-looking words such as "plans", "expects", "is expected", "is subject to", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", "believes", "targets", "aims", "projects", "goal", "objective", "outlook", "risks", "seeks" or words or terms of similar substance or the negative thereof, as well as variations of such words and phrases or statements that certain actions, events or results "may", "could", "should", "would", "might", "probably" or "will" be taken, occur or be achieved. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding future expectations.

Such forward-looking statements involve risks and uncertainties that could significantly affect expected results and are based on certain key assumptions. Many factors could cause actual results to differ materially from those projected or implied in any forward-looking statements. Due to such uncertainties and risks, readers are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this announcement. Any forward-looking statements made in this announcement on behalf of Stallergenes Greer or Waypoint are made as of the date of this announcement based on the opinions and estimates of directors of Stallergenes Greer or Waypoint respectively and no assurance can be given that such opinions or estimates will prove to have been correct. Each of Stallergenes Greer and Waypoint and their respective members, directors, officers, employees, advisers and any person acting on behalf of one or more of them, expressly disclaims any intention or obligation to update or revise any forward-looking or other statements contained in this announcement, whether as a result of new information, future events or otherwise, except as required by applicable law. Neither Stallergenes Greer nor Waypoint nor their respective members, directors, officers or employees, advisers or any person acting on their behalf, provides any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward-looking statements in this announcement will actually occur.

No forward-looking or other statements have been reviewed by the auditors of Stallergenes Greer or Waypoint. All subsequent oral or written forward-looking statements attributable to Stallergenes Greer or Waypoint or their respective members, directors, officers, advisers or employees or any person acting on their behalf are expressly qualified in their entirety by the cautionary statement above.

Rounding

Certain figures included in this announcement have been subjected to rounding adjustments. Accordingly, figures shown for the same category presented in different tables may vary slightly and figures shown as totals in certain tables may not be an arithmetic aggregation of the figures that precede them.

No Profit Forecasts or Estimates

Nothing in this announcement is intended or shall be deemed to be a forecast, projection or estimate of the future financial performance of Stallergenes Greer or Waypoint for any period and no statement in this announcement should be interpreted to mean that cash flow from operations, earnings, or earnings per share or income of those persons (where relevant) for the current or future financial years would necessarily match or exceed the historical published cash flow from operations, earnings, earnings per share or income of those persons (as appropriate).

Publication on website and hard copies

A copy of this announcement will be available, subject to certain restrictions relating to persons resident in any jurisdiction where local laws or regulations may result in a significant risk of civil, regulatory or criminal exposure if information concerning the Acquisition is sent or made available to Shareholders in that jurisdiction, on Stallergenes Greer's website at http://www.stallergenesgreer.com/ promptly and in any event by no later than 12 noon (London time) on 6 April 2019. For the avoidance of doubt, the content of the website referred to in this announcement is not incorporated into and does not form part of this announcement.

If you are a Registered Shareholder, you will receive a hard copy of the Scheme Document and the Voting Forms from Société Générale. If you have not received such hard copies you may request such copies by contacting Société Générale with an address to which the hard copies may be sent.

If you are a Bearer Shareholder, you may request a hard copy of the Scheme Document and the Voting Forms by contacting your intermediary bank with an address to which the hard copies may be sent.

If you are a Scheme Shareholder, you may request a hard copy of the Scheme Document and the Proxy Forms by contacting Computershare, at #UKCSBRS.ExternalProxyQueries@computershare.co.uk or Computershare Investor Services PLC, The Pavilions, Bridgwater Road, Bristol, BS99 6ZY, United Kingdom with an address to which the hard copies may be sent.

Recommended Cash Acquisition of Stallergenes Greer plc – Publication of the Independent Exert Report

LONDON--(BUSINESS WIRE)-- Regulatory News:

Following the announcement of the recommended cash acquisition of Stallergenes Greer plc (Paris:STAGR) (“Stallergenes Greer” or the “Company”) on 21 March 2019, the special committee of independent directors of Stallergenes Greer (the "Special Committee") is pleased to announce that copies of the report from Finexsi Expert & Conseil Financier, the independent valuation expert (the “Independent Expert”) appointed by the Special Committee to deliver an opinion on the fairness of the acquisition price of €37.00 per Stallergenes Greer share (the “Acquisition Price”), are now available on the Company’s website in both French and English (https://www.stallergenesgreer.com/recommended-acquisition-of-the-shares-in-stallergenes-greer-by-waypoint?t=1).

The Independent Expert has opined that the Acquisition Price is fair from a financial point of view.

The Independent Expert report will also be published in the scheme document.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2018 annual report published on 21 March 2019 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

 

Recommended Cash Acquisition of Stallergenes Greer PLC by Ares Life Sciences I S.à r.l.

Regulatory News:

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

LONDON--(BUSINESS WIRE)-- For immediate release

21 March 2019

RECOMMENDED CASH ACQUISITION

of

STALLERGENES GREER PLC

by

ARES LIFE SCIENCES I S.À R.L.

(to be implemented by way of a scheme of arrangement under

Part 26 of the U.K. Companies Act 2006)

Summary

  • The special committee of independent directors of Stallergenes Greer (Paris:STAGR) (the "Special Committee") and Ares Life Sciences I S.à r.l. ("Waypoint") are pleased to announce that they have reached agreement on the terms of a recommended cash acquisition by Waypoint of the entire issued, and to be issued, ordinary share capital of Stallergenes Greer not held directly or indirectly by Waypoint (the "Acquisition").
  • The Acquisition will be implemented by way of an English law scheme of arrangement (the "Scheme") which requires, among other things, both the approval of SG Shareholders (other than Waypoint) and the approval of the High Court of Justice of England and Wales. Following the Acquisition, Stallergenes Greer will be de-listed from the regulated market of Euronext Paris.
  • Under the terms of the Scheme, Shareholders will be entitled to receive:

in respect of each Scheme Share: Euro 37.00 in cash

  • The Acquisition values the Existing Issued Share Capital at approximately Euro 730.1 million with an enterprise value of approximately Euro 678.5 million, and represents a premium of approximately:
  • 42.9 per cent. to the closing price per Share of Euro 25.90 (the "Closing Price") on the Last Practicable Date;
  • 33.5 per cent. to the volume weighted average Closing Price per Share of Euro 27.71 for the three months ended on the Last Practicable Date; and
  • 30.6 per cent. to the volume weighted average Closing Price per Share of Euro 28.33 for the twelve months ended on the Last Practicable Date.

Background to and reasons for the Acquisition

  • On 18 December 2018, Waypoint GP Limited, which manages Waypoint's immediate parent, Ares Life Sciences L.P., approached the Board to explore the possibility of Waypoint becoming the sole shareholder in Stallergenes Greer. Following this approach, the Board formed the Special Committee to evaluate and consider the proposal on behalf of Stallergenes Greer.
  • Waypoint has been Stallergenes Greer's majority shareholder since 2015 and on the Last Practicable Date held approximately 83.9 per cent. of the Existing Issued Share Capital. Waypoint continues to recognise and value Stallergenes Greer as a leader in the development and marketing of allergy immunotherapy treatments.
  • However, in light of Stallergenes Greer's limited public float, Waypoint has concluded that the benefits of having Shares publicly listed are limited, and the costs of maintaining such listing are not justified for Shareholders. In addition, de-listing Shares from the regulated market of Euronext Paris would allow Stallergenes Greer's management team to focus on the successful implementation of Stallergenes Greer's business objectives without the distraction of listing obligations. Enabling the management team to focus on the execution of Stallergenes Greer's business objectives without this distraction is particularly important as Stallergenes Greer continues to recover from the difficult operational challenges of recent years.
  • Waypoint believes that the Acquisition, in combination with an Acquisition Price that delivers a highly attractive valuation and full liquidity to Shareholders, represents the best alternative for all of Stallergenes Greer's stakeholders.

Implementation

  • The Acquisition will be implemented by way of the Scheme, on the terms and subject to the conditions set out in this Announcement and to be set out in a document to be dispatched to (among others) Shareholders, including, among other things, the full terms and conditions of the Scheme (the "Scheme Document").
  • To become Effective, the Scheme requires, among other things, the approval of a majority in number representing not less than 75 per cent. in value of the Scheme Shareholders present and voting in person or by proxy at a meeting of Scheme Shareholders, and the passing of the resolutions necessary to implement the Acquisition at a general meeting of SG Shareholders. After this, the Scheme must also be approved by the Court.
  • Stallergenes Greer will put in place arrangements similar to those which it has put in place for its previous shareholder meetings to allow Shareholders to vote (or direct the vote) of the Scheme Shares in which they are interested so that it is only Shareholders who determine whether the approval required at the Court Meeting of Scheme Shareholders is given.
  • Waypoint is not entitled to vote at the Court Meeting of Scheme Shareholders.
  • The Scheme will complete if the relevant resolutions are passed at the two shareholder meetings referred to above, the Court Order is obtained and the Court Order is filed at Companies House. If the Scheme completes, it will bind all of the Scheme Shareholders, even those who did not vote in favour of the Scheme, and Shareholders will receive the Acquisition Price in respect of each Scheme Share they hold. The Scheme will fail if the necessary majority does not approve the resolutions at the two shareholder meetings referred to above or if the Court does not then approve the Scheme. If the Scheme fails, Waypoint will not acquire any Scheme Shares pursuant to the Acquisition, even from Scheme Shareholders who voted in favour of the Scheme.
  • Waypoint intends to finance the aggregate price payable to Shareholders through a new debt facility to be entered into by Waypoint (or one of Waypoint's affiliates) before the Effective Date. Waypoint and Stallergenes Greer have also entered into the Funding Commitment Letter with certain affiliates of Waypoint, setting out arrangements for Waypoint to pay the aggregate price payable to Shareholders pursuant to the Scheme if the debt facility is not available.
  • It is expected that:
    • the Scheme Document will be dispatched to Shareholders and, for information only, to participants in Share Schemes within 28 days following the date of this Announcement; and
    • the Scheme will become Effective in May 2019, subject to the satisfaction of the Conditions and certain further terms set out in Appendix I to this Announcement.
  • If any dividend or other distribution is paid in respect of Shares on or after the date of this Announcement and before the Effective Date, Waypoint reserves the right to reduce the Acquisition Price by the aggregate per Share amount of such dividend or other distribution.

Regulation

  • The Scheme is not subject to the tender offer rules under the General Regulation of the Autorité des marchés financiers, the French Financial Markets Authority (the "AMF") or to authorisation by the AMF. However, the AMF has jurisdiction to enforce the provisions of the Market Abuse Regulation against Stallergenes Greer and to review public disclosures made by Stallergenes Greer in connection with the Acquisition under the Transparency Directive and applicable provisions of the General Regulation of the AMF.
  • The Scheme is not subject to the U.K. City Code on Takeovers and Mergers or the jurisdiction of the U.K. Panel on Takeovers and Mergers.

Recommendation

  • The Special Committee, which has been so advised by its financial adviser, Evercore Partners International LLP ("Evercore"), as to the financial terms of the Acquisition, considers the terms of the Acquisition to be fair and reasonable. In providing its advice to the Special Committee, Evercore has taken into account the commercial assessments of the members of the Special Committee.
  • Accordingly, the Special Committee: (i) believes that the terms of the Acquisition are in the best interests of Shareholders as a whole; and (ii) intends to unanimously recommend that Shareholders vote in favour (or procure or direct votes in favour) of the Acquisition at the Court Meeting and the General Meeting, as each member of the Special Committee who holds, or is otherwise beneficially interested in, Shares has irrevocably undertaken to do in respect of his or her entire beneficial holdings of, in aggregate, 1,150 Shares (representing 0.00583 per cent. of the Existing Issued Share Capital).

Independent Expert

  • In addition to appointing Evercore as its financial adviser, the Special Committee appointed Finexsi Expert & Conseil Financier as its independent valuation expert (the "Independent Expert") to deliver an opinion on the fairness of the Acquisition Price. The Independent Expert has opined that the Acquisition Price is fair from a financial point of view. Copies of the Independent Expert Report will be made available on Stallergenes Greer's website within one Business Day of being delivered in French and English in final form. The Independent Expert Report will also be published in the Scheme Document.

Comments on the Acquisition

  • Commenting on the Acquisition, Elmar Schnee, the Chairman of the Special Committee said: "The Special Committee has given careful consideration to the proposal by Waypoint and believes that the value proposed recognises the future potential of the business and the improved prospects of Stallergenes Greer following recent efforts by management. The proposal also represents an attractive cash premium to the current share price as well as a source of liquidity for Shareholders. As majority shareholder, Waypoint has been consistently and demonstrably supportive of Stallergenes Greer. We have confidence that with 100 per cent. ownership of Stallergenes Greer, Waypoint will develop the business into a successful future to the benefit of patients, employees and other stakeholders."

Further information

  • This summary should be read in conjunction with, and is subject to, the full text of this Announcement, including the Appendices.
  • The Acquisition is subject to the conditions and certain further terms set out in Appendix I and to the full terms and conditions to be set out in the Scheme Document.
  • Appendix II contains the sources and bases of certain information contained in this summary and the following Announcement.
  • Appendix III contains details of the irrevocable undertakings received by Waypoint to vote in favour of the Scheme.
  • Appendix IV contains the definitions of certain terms used in this summary and the following Announcement.

Investor and media calls

An investor slide deck is now available on the Investor Relations section of Stallergenes Greer's website at www.stallergenesgreer.com. Stallergenes Greer will hold an investor call and webcast at 10.30 a.m. (GMT) on 21 March 2019 to discuss this Announcement. Investors may dial in to the investor call on +44 (0) 20 7192 8000 (confirmation code: 9197292).

Enquiries:

Stallergenes Greer
Youssef Abbas, Investor Relations +33 1 55 59 78 43
Catherine Kress, Communications +33 1 55 59 26 05
 
Evercore +44 (0) 20 7653 6000
Financial adviser to the Special Committee
Edward Banks, Senior Managing Director
Simon Elliott, Senior Managing Director
Wladimir Wallaert, Managing Director
 
FTI Consulting +33 1 47 03 69 48
Investor and media relations adviser to Stallergenes Greer
Arnaud de Cheffontaines
 
Havas Worldwide Paris +33 06 13 54 38 91
Media relations adviser to Stallergenes Greer
Claire Olivieri
 
UBS +44 (0) 20 7567 8000
Financial adviser to Waypoint
Cailin McGurk, Managing Director

Sarantis Douropoulos, Executive Director

Nicolas Le Ray, Executive Director

 
Hirzel.Neef.Schmid.Counselors +41 43 344 42 42
Media relations adviser to Waypoint
Dr Jörg Neef

IMPORTANT NOTICES

Important Notices Relating to Financial Advisers

UBS AG London Branch is authorised and regulated by the Financial Market Supervisory Authority in Switzerland. It is authorised by the Prudential Regulation Authority and subject to regulation by the Financial Conduct Authority and limited regulation by the Prudential Regulation Authority in the United Kingdom. UBS AG London Branch is acting exclusively as financial adviser to Waypoint and no one else in connection with the Acquisition. In connection with such matters, UBS AG London Branch will not regard any other person as its client, nor will it be responsible to any other person for providing the protections afforded to its clients or for providing advice in relation to the Acquisition, the contents or subject matter of this Announcement or any transaction, arrangement or other matter referred to herein.

Evercore Partners International LLP, which is authorised and regulated in the United Kingdom by the Financial Conduct Authority, is acting as financial adviser exclusively for the Special Committee and no one else in connection with the matters referred to in this Announcement and will not regard any other person as its client in connection with the matters referred to in this Announcement and will not be responsible to anyone other than the Special Committee for providing the protections afforded to clients of Evercore, nor for providing advice in relation to the matters referred to in this Announcement.

Further Information

This Announcement is for information purposes only and is not intended to, and does not, constitute or form part of any offer, invitation, inducement or the solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of or exercise rights in respect of any securities, or the solicitation of any vote or approval of an offer to buy securities in any jurisdiction, pursuant to the Acquisition or otherwise nor shall there be any sale, issuance or transfer of any securities pursuant to the Acquisition in any jurisdiction in contravention of any applicable laws.

The Acquisition will be implemented solely pursuant to the terms of the Scheme Document, which will contain the full terms and conditions of the Acquisition, including details of how to vote in respect of the Scheme. Any decision, vote or other response in respect of the Acquisition should be made only on the basis of information contained in the Scheme Document. Shareholders are advised to read the formal documentation in relation to the Acquisition carefully once it has been dispatched.

This Announcement does not constitute a prospectus or prospectus-equivalent document.

This Announcement has been prepared for the purpose of complying with English law and disclosure requirements under French law. Accordingly, the information disclosed may not be the same as that which would have been disclosed if this Announcement had been prepared in accordance with the laws of jurisdictions outside of the United Kingdom and France (as applicable).

Overseas Jurisdictions

The release, publication or distribution of this Announcement in, and the availability of the Acquisition to persons who are residents, citizens or nationals of jurisdictions other than France may be restricted by laws and/or regulations of those jurisdictions. In particular, the ability of persons who are not resident in France or who are subject to the laws of another jurisdiction to direct voting of the Scheme Shares in which they are interested with respect to the Scheme at the Court Meeting, or to execute and deliver Forms of Proxy appointing another to vote at the Court Meeting on their behalf, may be affected by the laws of the relevant jurisdictions in which they are located.

Therefore, any persons not resident in France and/or who are subject to the laws and regulations of any jurisdiction other than France should inform themselves about, and observe, any applicable legal and regulatory requirements. Any failure to comply with the applicable requirements may constitute a violation of the laws and/or regulations of any such jurisdiction.

The Acquisition will not be made, directly or indirectly, in, into or from any restricted jurisdiction where to do so would violate the laws of that jurisdiction and no person may vote in favour of the Acquisition by any use, means, instrumentality or form within a restricted jurisdiction or any other jurisdiction if to do so would constitute a violation of the laws of that jurisdiction. Accordingly, copies of this Announcement and any formal documentation relating to the Acquisition are not being, and must not be, directly or indirectly, mailed or otherwise forwarded, distributed or sent in, into or from any restricted jurisdiction and persons receiving such documents (including custodians, nominees and trustees) must not mail or otherwise forward, distribute or send them in or into or from any restricted jurisdiction. To the fullest extent permitted by applicable law, Waypoint, Stallergenes Greer and persons involved in the Acquisition disclaim any responsibility or liability for such violation by any person.

The receipt of cash pursuant to the Acquisition by Shareholders may be a taxable transaction under applicable national, state and local, as well as foreign and other tax laws. Each Shareholder is urged to consult their independent professional adviser regarding the tax consequences of the Acquisition applicable to him or her.

Further details in relation to Shareholders in overseas jurisdictions will be contained in the Scheme Document.

Notice to U.S. Investors in Stallergenes Greer

The Acquisition relates to the shares of a company organised under the laws of England and Wales and listed on Euronext Paris and is proposed to be effected by means of a scheme of arrangement under the laws of England and Wales (Part 26 of the Companies Act). This Announcement, the Scheme Document and certain other documents relating to the Acquisition have been or will be prepared in accordance with English law and French law (in connection with disclosure only), all of which differ from the relevant laws in the United States of America. The Acquisition is not subject to the tender offer rules or the proxy solicitation rules under the U.S. Securities Exchange Act of 1934, as amended. Accordingly, the Acquisition is subject to the disclosure requirements of and practices applicable to a company listed on Euronext Paris which is subject to an English law scheme of arrangement, which differ from the disclosure requirements of the United States of America tender offer and proxy solicitation rules.

Stallergenes Greer's financial statements, and all financial information that is included in this Announcement or that may be included in the Scheme Document, or any other documents relating to the Acquisition, have been or will be prepared in accordance with non-U.S. accounting standards that may not be comparable to financial information of companies in the United States of America or other companies whose financial statements are prepared in accordance with U.S. generally accepted accounting principles.

Neither the United States Securities and Exchange Commission nor any U.S. state securities commission has approved or disapproved the Acquisition, passed upon the merits or fairness of the Acquisition or passed any opinion upon the accuracy, adequacy or completeness of this Announcement or the Scheme Document. Any representation to the contrary is a criminal offence in the United States of America.

Stallergenes Greer is incorporated under the laws of England and Wales and listed on Euronext Paris. Waypoint is incorporated under the laws of Luxembourg. In addition, some of Stallergenes Greer's and Waypoint's respective officers and directors reside outside the United States of America, and some or all of their respective assets are or may be located in jurisdictions outside the United States of America. Therefore, investors may have difficulty effecting service of process within the United States of America upon those persons or recovering against Stallergenes Greer, Waypoint or their respective officers or directors on judgments of United States of America courts, including judgments based upon the civil liability provisions of the United States of America federal securities laws. It may not be possible to sue Stallergenes Greer, Waypoint or their respective officers or directors in a non-U.S. court for violations of the U.S. securities laws.

The receipt of cash pursuant to the Acquisition by U.S. holders of Shares pursuant to the Scheme may be a taxable transaction for U.S. federal income tax purposes and under applicable U.S. state and local, as well as foreign and other, tax laws. Each U.S. holder of Shares is urged to consult his or her independent professional adviser immediately regarding the tax consequences of the Acquisition applicable to him or her.

Forward-Looking Statements

This Announcement contains certain statements which are, or may be deemed to be, "forward-looking statements" which are prospective in nature. All statements other than statements of current or historical fact, are or may be deemed to be, forward-looking statements. Forward-looking statements are based on current expectations and projections about future events and are therefore subject to known and unknown risks and uncertainties which could cause actual results, performance or events to differ materially from the future results, performance or events expressed or implied by the forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of forward-looking words such as "plans", "expects", "is expected", "is subject to", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", "believes", "targets", "aims", "projects", "goal", "objective", "outlook", "risks", "seeks" or words or terms of similar substance or the negative thereof, as well as variations of such words and phrases or statements that certain actions, events or results "may", "could", "should", "would", "might", "probably" or "will" be taken, occur or be achieved. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding future expectations.

Such forward-looking statements involve risks and uncertainties that could significantly affect expected results and are based on certain key assumptions. Many factors could cause actual results to differ materially from those projected or implied in any forward-looking statements. Due to such uncertainties and risks, readers are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this Announcement. Any forward-looking statements made in this Announcement on behalf of Stallergenes Greer or Waypoint are made as of the date of this Announcement based on the opinions and estimates of directors of Stallergenes Greer or Waypoint respectively and no assurance can be given that such opinions or estimates will prove to have been correct. Each of Stallergenes Greer and Waypoint and their respective members, directors, officers, employees, advisers and any person acting on behalf of one or more of them, expressly disclaims any intention or obligation to update or revise any forward-looking or other statements contained in this Announcement, whether as a result of new information, future events or otherwise, except as required by applicable law. Neither Stallergenes Greer or Waypoint or their respective members, directors, officers or employees, advisers or any person acting on their behalf, provides any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward-looking statements in this Announcement will actually occur.

No forward-looking or other statements have been reviewed by the auditors of Stallergenes Greer or Waypoint. All subsequent oral or written forward-looking statements attributable to Stallergenes Greer or Waypoint of their respective members, directors, officers, advisers or employees or any person acting on their behalf are expressly qualified in their entirety by the cautionary statement above.

Rounding

Certain figures included in this Announcement have been subjected to rounding adjustments. Accordingly, figures shown for the same category presented in different tables may vary slightly and figures shown as totals in certain tables may not be an arithmetic aggregation of the figures that precede them.

No Profit Forecasts or Estimates

Nothing in this Announcement is intended or shall be deemed to be a forecast, projection or estimate of the future financial performance of Stallergenes Greer or Waypoint for any period and no statement in this Announcement should be interpreted to mean that cash flow from operations, earnings, or earnings per share or income of those persons (where relevant) for the current or future financial years would necessarily match or exceed the historical published cash flow from operations, earnings, earnings per share or income of those persons (as appropriate).

General

If you are in any doubt about the contents of this Announcement or the action you should take, you are recommended to seek your own independent financial advice immediately from an appropriate authorised independent financial adviser.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

For immediate release

21 March 2019

RECOMMENDED CASH ACQUISITION

of

STALLERGENES GREER PLC

by

ARES LIFE SCIENCES I S.À R.L.

(to be implemented by way of a scheme of arrangement under

Part 26 of the U.K. Companies Act 2006)

1. Introduction

The Special Committee and Waypoint are pleased to announce that they have reached agreement on the terms of a recommended cash acquisition by Waypoint of the entire issued, and to be issued, ordinary share capital of Stallergenes Greer not held directly or indirectly by Waypoint.

It is intended that the Acquisition will be implemented by way of an English law scheme of arrangement pursuant to Part 26 of the Companies Act which requires, among other things, both the approval of the Scheme Shareholders and the approval of the Court. Following the Acquisition, Stallergenes Greer will be de-listed from the regulated market of Euronext Paris and re-registered as a private limited company.

2. The Acquisition

Under the terms of the Acquisition, which will be on the terms and subject to the Conditions set out in Appendix I to this Announcement and the full terms and conditions to be set out in the Scheme Document, Shareholders will be entitled to receive:

in respect of each Scheme Share: Euro 37.00 in cash

The Acquisition values the Existing Issued Share Capital at approximately Euro 730.1 million and at an enterprise value of approximately Euro 678.5 million, calculated on the basis described in paragraphs (b) and (c) of Appendix II.

The Acquisition Price represents a premium of approximately:

(a) 42.9 per cent. to the Closing Price per Share of Euro 25.90 on the Last Practicable Date;

(b) 33.5 per cent. to the volume weighted average Closing Price per Share of Euro 27.71 for the three months ended on the Last Practicable Date; and

(c) 30.6 per cent. to the volume weighted average Closing Price per Share of Euro 28.33 for the twelve months ended on the Last Practicable Date.

As of the Last Practicable Date, Waypoint held 16,550,910 Shares in aggregate (as a direct shareholder and indirectly through Euroclear as nominee), representing approximately 83.9 per cent. of the Existing Issued Share Capital. The Acquisition relates to all Shares not directly or indirectly owned or controlled by Waypoint, as well as 857,313 options to be cash settled under the Share Schemes.

3. Background to and reasons for the Acquisition

On 18 December 2018, Waypoint GP Limited, which manages Waypoint's Parent, approached the Board to explore the possibility of Waypoint becoming the sole shareholder in Stallergenes Greer. Following this approach, the Board formed the Special Committee to evaluate and consider the proposal on behalf of Stallergenes Greer.

Waypoint has been Stallergenes Greer's majority shareholder since 2015. Waypoint continues to recognise and value Stallergenes Greer as a leader in the development and marketing of AIT.

However, in light of Stallergenes Greer's limited public float, Waypoint has concluded that the benefits of having Shares publicly listed are limited, and the costs of maintaining such listing are not justified for Shareholders. In addition, de-listing Shares from the regulated market of Euronext Paris would allow Stallergenes Greer's management team to focus on the successful implementation of Stallergenes Greer's business objectives without the distraction of listing obligations. Enabling the management team to focus on the execution of Stallergenes Greer's business objectives without this distraction is particularly important as Stallergenes Greer continues to recover from the difficult operational challenges of recent years.

Waypoint believes that the Acquisition, in combination with an Acquisition Price that delivers a highly attractive valuation and full liquidity to the Shareholders, represents the best alternative for all of Stallergenes Greer's stakeholders.

4. Waypoint's intentions

Waypoint intends to support Stallergenes Greer in its ongoing process of recovery from the significant operational issues resulting from the ANSM's full suspension of production and distribution in Antony, France in 2015. Consistent with this current intent, Waypoint will support the CEO, Michele Antonelli, and the senior leadership team in their continuation of the restructuring programme previously announced by Stallergenes Greer, including: (i) taking all necessary actions in relation to the remaining ANSM injunction issued in January 2018 and resolving the ongoing operational issues at the Antony plant; (ii) continuing the operational efficiencies programme previously communicated by Stallergenes Greer; and (iii) consistent with the previously announced RESTART programme, refining and rebuilding Stallergenes Greer as a trusted leader in AIT. Waypoint believes that this previously announced programme has significant embedded risk and that the management team has a meaningfully better opportunity to successfully implement the programme as a private company. As noted above, Waypoint believes that the benefits of being a public company are not justified by the financial costs and the time and effort the management team must spend to comply with the requirements of being a public company. Waypoint, in particular, believes that the additional time and capacity to focus on these restructuring efforts afforded as a result of being a private company is critical to addressing the significant risks embedded in the implementation of the restructuring programme.

5. Share Schemes

The Acquisition will extend to any Scheme Shares which are unconditionally allotted, issued or transferred to satisfy the exercise of existing options under the Share Schemes. The Acquisition will not extend to Shares issued after the Scheme Record Time and, instead, any Shares issued after that time shall be automatically transferred to Waypoint (or as it directs) on the same terms as the Acquisition.

Stallergenes Greer and Waypoint will make proposals to the holders of options to acquire the Shares granted under the Share Schemes. Further details of these proposals will be set out in the Scheme Document. Full details of the effect of the Acquisition on participants' rights under the Share Schemes, and the actions they may take in respect of their options, will be communicated to participants in separate letters to be sent to them following publication of the Scheme Document.

6. Background to and reasons for the recommendation

The combination of Stallergenes S.A. and Greer Laboratories in 2015 made Stallergenes Greer a global biopharmaceutical leader in the development and marketing of AIT. The combination created a worldwide leader with a fully integrated manufacturing network underpinned by a diversified geographic footprint, the largest production capacity in AIT globally, strong international research and development presence, a broad portfolio of products in both Europe and the United States and an important global network supported by recognised brands and prime market access across target regions.

In December 2015, following a notification from the ANSM, as a result of certain technical problems encountered in the launch of its new IT business operations system, the production and distribution at Stallergenes Greer's plant in Antony (France) was temporarily suspended and products withdrawn in France according to a risk management plan agreed with the ANSM. The production resumed shortly after, but in January 2018, Stallergenes Greer received an injunction from the ANSM following the inspection of one of the production areas at Stallergenes Greer's facility in Antony. Addressing the operational issues at the Antony plant, which is the largest manufacturing facility for AIT globally and Stallergenes Greer's largest manufacturing facility, continues to be a key area of focus for management today, particularly given the increasingly competitive environment in which the SG Group is operating.

Since 2016, the leadership team of Stallergenes Greer, supported by Waypoint as its majority shareholder, has been implementing a significant turnaround plan to stabilise the organisation, improve production processes, deliver efficiencies, start to invest in the food allergy sector and leverage strategic alliances and partnerships to re-establish Stallergenes Greer's market leadership and bring the group back onto a path of profitable long-term growth. As part of the ongoing turnaround, Stallergenes Greer has seen improved financial performance in 2018, when compared to the turnaround initiatives reflected in 2017, with net sales increasing by 6 per cent. supported by positive performance in Stallergenes Greer's Europe and International region and in the United States, despite unfavourable foreign exchange effects, and solid growth in the sublingual route driven by Staloral®. EBITDA increased by 84 per cent. in 2018 driven by margin expansion resulting from strong operating efficiencies. As a result of the actions taken by management since 2016, the Special Committee is confident in the future prospects of Stallergenes Greer.

Waypoint first approached Stallergenes Greer with a proposal in relation to becoming Stallergenes Greer's sole shareholder in December 2018. Following this approach, the Board formed the Special Committee comprised of independent directors. The Special Committee engaged Evercore as financial adviser and Clifford Chance LLP as legal adviser in order to evaluate the approach and determine how to respond. Evercore has acted as the sole financial adviser to the Special Committee in relation to the financial terms of the Acquisition. After the approach by Waypoint, the Special Committee and its advisers held extensive discussions with Waypoint in relation to the terms and structure of the Acquisition. As a result of these discussions, in February 2019, Waypoint put forward an improved proposal to acquire the Existing Issued Share Capital not already held directly or indirectly by Waypoint for Euro 37.00 in cash per Scheme Share.

The Special Committee considered the Acquisition in the context of the fundamental value, future prospects and cash generation profile of Stallergenes Greer weighed against the operational, competitive and regulatory risks that are inherent to Stallergenes Greer and other businesses in this field. The Special Committee believes that the Acquisition represents an opportunity for Shareholders to realise the value of their holdings in cash at an attractive premium, particularly in the context of Stallergenes Greer's relative lack of liquidity and the control already exercised by Waypoint as the holder of approximately 83.9 per cent. of the Existing Issued Share Capital. The Acquisition will allow Shareholders to crystallise the value of their shareholdings at a premium of 42.9 per cent. to the Closing Price of Euro 25.90 per Share on the Last Practicable Date, and a premium of 33.5 per cent. to the volume weighted average Closing Price per Share of Euro 27.71 for the three months ended on the Last Practicable Date.

7. Recommendation

The Special Committee, which has been so advised by its financial adviser, Evercore, as to the financial terms of the Acquisition, considers the terms of the Acquisition to be fair and reasonable. In providing its advice to the Special Committee, Evercore has taken into account the commercial assessments of the members of the Special Committee.

Accordingly, the Special Committee: (i) believes that the terms of the Acquisition are in the best interests of Shareholders as a whole; and (ii) intends to unanimously recommend that Shareholders vote in favour (or procure or direct votes in favour) of the Acquisition at the Court Meeting and at the General Meeting, as each member of the Special Committee who holds, or is otherwise beneficially interested in, Scheme Shares has irrevocably undertaken to do in respect of his or her entire beneficial holdings of, in aggregate, 1,150 Scheme Shares (representing 0.00583 per cent. of the Existing Issued Share Capital).

8. Independent Expert

In addition to appointing Evercore as its financial adviser, the Special Committee appointed the Independent Expert to deliver an opinion on the fairness of the Acquisition Price. The Independent Expert has opined that the Acquisition Price is fair from a financial point of view. Copies of the Independent Expert Report will be made available on Stallergenes Greer's website within one Business Day of being delivered in French and English in final form. The Independent Expert Report will also be published in the Scheme Document.

9. Irrevocable undertakings

Irrevocable undertakings given by members of the Special Committee

Waypoint has received irrevocable undertakings from each member of the Special Committee to vote or procure votes in favour of the Scheme at the Court Meeting and the Special Resolution to be proposed at the General Meeting in respect of an aggregate of 1,150 Scheme Shares, in which they have an interest, representing approximately 0.00583 per cent. of the Existing Issued Share Capital.

Irrevocable undertakings given by Directors who are not members of the Special Committee

Waypoint has also received irrevocable undertakings from Stefan Meister and Rodolfo Bogni (being the other Directors who hold Shares) to vote or procure votes in favour of the Special Resolution to be proposed at the General Meeting in respect of an aggregate of 32 Shares, in which they have an interest, representing approximately 0.00016 per cent. of the Existing Issued Share Capital. Due to their relationship with Waypoint, neither Mr. Meister nor Mr. Bogni is entitled to vote or procure votes in favour of the Scheme at the Court Meeting.

Irrevocable undertaking given by Waypoint

Waypoint has undertaken in the Implementation Agreement to vote or procure votes in favour of the Special Resolution to be proposed at the General Meeting in respect of an aggregate of 16,550,910 Shares, representing approximately 83.9 per. cent of the Existing Issued Share Capital.

Further details of these irrevocable undertakings are set out in Appendix III to this Announcement.

10. Information relating to Waypoint

Waypoint is owned by a fund managed by the Waypoint Group.

Chaired and owned by Ernesto Bertarelli, the Waypoint Group and the businesses created by it manage investments in healthcare, medical technologies and asset management, including real estate. The Waypoint Group principally manages the investment funds associated with the Bertarelli family, which arise mainly from the $8.5 billion of capital realised by the 2007 sale of Serono, a global leader in biotech and healthcare developed by the Bertarelli family over three generations.

The Waypoint Group has grown to more than 160 employees across five global offices in Geneva, London, Jersey, Boston and Luxembourg.

Further details are available on the following website: www.waypointcapital.net.

11. Information relating to Stallergenes Greer

The combination of Stallergenes S.A. and Greer Laboratories in 2015 made Stallergenes Greer a global biopharmaceutical leader in the development and marketing of AIT. The combination created a group with a fully integrated manufacturing network underpinned by a diversified geographic footprint, the largest production capacity in AIT globally, strong international research and development presence, a broad portfolio of products in both Europe and the United States and an important global network supported by recognised brands and prime market access across target regions.

The SG Group:

(a) owns and operates five manufacturing sites in France, the United States and Canada;

(b) has a direct presence in 19 countries with distribution networks in a further 73 countries; and

(c) has approximately 1,240 employees in 19 countries.

The annual report and audited consolidated accounts of Stallergenes Greer and its group for the year ended 31 December 2018 are available on Stallergenes Greer's website at www.stallergenesgreer.com.

12. Financing the Acquisition

In connection with the financing of the aggregate price payable to the Shareholders pursuant to the Acquisition, Waypoint (or one of Waypoint's affiliates) intends to enter into a new debt facility.

Waypoint and Stallergenes Greer have also entered into the Funding Commitment Letter with certain affiliates of Waypoint, setting out arrangements for how these affiliates would finance Waypoint to allow Waypoint to pay the aggregate price payable to Shareholders pursuant to the Scheme if the debt facility is not available. Waypoint's payment obligation to Shareholders under the Scheme will not be guaranteed by a presenting bank.

A summary of the Funding Commitment Letter is set out in paragraph 17 below.

13. Structure of the Acquisition

Structure

It is intended that the Acquisition will be effected by means of a Court-approved scheme of arrangement between Stallergenes Greer and the Scheme Shareholders under Part 26 of the Companies Act. The Scheme is an arrangement between Stallergenes Greer and the Scheme Shareholders to which Waypoint will adhere.

The purpose of the Scheme is to enable Waypoint to become the holder of the entire issued ordinary share capital of Stallergenes Greer by the transfer to Waypoint by Scheme Shareholders of the Scheme Shares in consideration for which Shareholders will receive the Acquisition Price in respect of each Scheme Share.

Summary of Scheme Process

The key events relating to the Scheme are as follows:

(a) within 28 days of this Announcement, the Scheme Document including the notices of the Meetings will be sent to Shareholders;

(b) not less than 35 clear days after the service of the notices convening the Meetings, the Meetings will be held to vote on the Scheme Resolution and the Special Resolution. The General Meeting will take place immediately following the Court Meeting;

(c) provided the requisite majorities approve the Scheme Resolution and the Special Resolution, the Scheme will be considered at the Court Hearing. Shareholders, creditors and other interested parties may attend and object to the implementation of the Scheme on certain limited grounds (for example unfairness or procedural flaws);

(d) if the Court is satisfied that the correct procedures have been followed, that the Scheme Resolution and Special Resolution have been properly approved, that the terms of the Scheme are fair and that no valid objections have been raised, it will grant the Court Order approving the Scheme; and

(e) the Court Order will be delivered for registration to the Registrar of Companies and the Scheme will become binding on all Shareholders, whether or not they supported the Scheme.

Conditions

The Scheme is subject to the Conditions and certain further terms set out in Appendix I to this Announcement and to the full terms and conditions to be set out in the Scheme Document, and will only become Effective if, among other things, the following events occur on or before the Long Stop Date:

(a) a resolution to approve the Scheme is passed by a majority in number of the Scheme Shareholders present and voting (and entitled to vote) at the Court Meeting, either in person or by proxy, representing 75 per cent. or more in value of the Scheme Shares held by those Scheme Shareholders;

(b) the Special Resolution necessary to implement the Scheme is passed at the General Meeting of Stallergenes Greer (which will require the approval of SG Shareholders representing at least 75 per cent. of the votes cast at the General Meeting);

(c) following the Meetings, the Scheme is approved by the Court at the Court Hearing (with or without modification, on terms agreed by Waypoint and Stallergenes Greer in writing); and

(d) an office copy of the Court Order is delivered to the Registrar of Companies.

If any of the deadlines for the Conditions set out in paragraphs (a)(ii), (b)(ii) and (c)(ii) of Part A of Appendix I is not met, Stallergenes Greer shall make an announcement by 7.00 a.m. on the Business Day following such deadline confirming whether Waypoint has invoked the relevant Condition or agreed with Stallergenes Greer to extend the deadline in relation to the relevant Condition.

Scheme becoming Effective

Once the Conditions have been satisfied, the Scheme will become Effective upon delivery of the Court Order to the Registrar of Companies. The Scheme is expected to become Effective in May 2019.

Waypoint is not entitled to vote at the Court Meeting. If the Scheme becomes Effective, it will be binding on all Scheme Shareholders, whether or not they attended the Meetings and voted in favour of the Scheme Resolution and the Special Resolution.

Payment to Shareholders

The cash consideration payable under the Acquisition will be dispatched by (or on behalf of) Waypoint to the Paying Agent no later than five Business Days after the Effective Date. The Paying Agent will pay Shareholders following receipt of such consideration in accordance with its normal practice. Further details about payment to Shareholders will be set out in the Scheme Document.

Failure or lapse of Scheme

The Scheme will fail if the necessary majority does not approve the Scheme Resolution or the Special Resolution or if the Court does not approve it. The Scheme will also lapse if the Scheme does not become Effective by the Long Stop Date (provided that the deadline for the Scheme to become Effective may be extended by written agreement between Waypoint and Stallergenes Greer, with the consent of the Court (if required)). If the Scheme fails or lapses, Waypoint will not acquire any Scheme Shares pursuant to the Acquisition, even in respect of Shareholders who voted in favour of the Scheme.

Future issues of Shares

Any Shares issued before the Scheme Record Time will be subject to the terms of the Scheme. The Special Resolution will, amongst other matters, provide that the Articles be amended to incorporate provisions requiring any Shares issued after the Scheme Record Time (other than to Waypoint and/or its nominees) to be automatically transferred to Waypoint on the same terms as the Acquisition (other than terms as to timings and formalities). The provisions of the Articles (as amended) will prevent any person (other than Waypoint and its nominees) from holding shares in the capital of Stallergenes Greer after the Effective Date.

Scheme Document

The Scheme Document will include full details of the terms and conditions of the Scheme, together with notices of the Court Meeting and the General Meeting. The Scheme Document will also specify the necessary actions to be taken by Shareholders.

It is expected that the Scheme Document together with Forms of Proxy will be sent to Shareholders and, for information only, to persons with information rights and to holders of options and awards granted under the Share Schemes as soon as practicable and, in any event, within 28 days following the date of this Announcement (or such later date as is agreed in writing between Waypoint and Stallergenes Greer).

14. Regulation of the Acquisition

France

The Scheme is not subject to the tender offer rules under the General Regulation of the AMF or to authorisation by the AMF. However, the AMF has jurisdiction to enforce the provisions of the Market Abuse Regulation against Stallergenes Greer and to review public disclosures made by Stallergenes Greer in connection with the Acquisition under the Transparency Directive and applicable provisions of the General Regulation of the AMF.

United Kingdom

The Scheme is not subject to the U.K. City Code on Takeovers and Mergers or the jurisdiction of the Panel because it is a scheme of arrangement relating to a company subject to shared jurisdiction. Stallergenes Greer is a company subject to shared jurisdiction as it is a company incorporated in England and Wales with shares admitted to trading solely on the regulated market of Euronext Paris.

The Acquisition will be governed by English law and be subject to the jurisdiction of the courts of England and Wales.

15. Anticipated Scheme timetable

An expected timetable of principal events in connection with the Acquisition will be included in the Scheme Document. It is expected that the Scheme will become Effective in May 2019.

16. De-listing from Euronext Paris

Prior to the Scheme becoming Effective, Stallergenes Greer will make an application to Euronext Paris for the cancellation of the listing of Shares on Euronext Paris with effect as of or shortly following the Effective Date.

As soon as practicable after the Scheme is Effective and the de-listing of the Shares, Waypoint intends to re-register Stallergenes Greer as a private limited company under the relevant provisions of the Companies Act.

17. Acquisition related arrangements

Non-Disclosure Agreement

Waypoint and Stallergenes Greer have entered into the Non-Disclosure Agreement pursuant to which Waypoint and Stallergenes Greer have undertaken to each other to keep information provided to each other in connection with the Acquisition confidential and not to disclose it to third parties (other than to permitted recipients) unless required by law or regulation.

The Non-Disclosure Agreement sets out (among other things):

(a) an obligation on each party to keep information relating to the Acquisition and the other party confidential and not to disclose it to third parties unless permitted by the terms of the Non-Disclosure Agreement;

(b) a prohibition on each party from, at any time prior to the Effective Date, or the date on which the Scheme is abandoned or fails, having contact with any shareholder, member of management, director, employee, customer or supplier of, or lender to, any member of the other party's group (save for their respective representatives); and

(c) an obligation on each party, to the extent that it is: (i) reasonably practicable; (ii) not prohibited by law or regulation; and (iii) in relation to Stallergenes Greer, not likely to adversely affect the interests of Stallergenes Greer, to consult with the other party and its representatives and take into account the other party's reasonable comments prior to communicating with its regulator (including the Panel and the AMF, as applicable), and afford the other party a reasonable opportunity to participate in any such communications, in each case in connection with the Acquisition.

The obligations set out in the Non-Disclosure Agreement will expire one year from the date of the Non-Disclosure Agreement.

Implementation Agreement

Waypoint and Stallergenes Greer have entered into the Implementation Agreement, to record the steps that each has agreed to take in relation to the implementation of the Acquisition.

The Implementation Agreement sets out (among other things):

(a) undertakings given by Waypoint that it:

(i) has sufficient cash resources available, and which will remain available, to satisfy the cash consideration requirements under and in connection with the Acquisition, and will pay or procure the payment of the cash consideration to the Paying Agent in immediately available funds as soon as possible and in any case by no later than five Business Days following the Effective Date;

(ii) will vote in favour of the Special Resolution in respect of its entire beneficial holding of Shares;

(iii) will not, and will procure that each member of the Waypoint Group will not, deal in Shares prior to the Effective Date;

(iv) will not, and will procure that any person acting in concert with it does not, make any arrangements with SG Shareholders, or deal or enter into any arrangements to deal in Shares, or enter into arrangements which involve an acceptance of an offer for Shares on favourable terms including as to price that are not being extended to all SG Shareholders;

(v) will provide such collaboration and co-operation to Stallergenes Greer as it may reasonably request in connection with any discussions that Stallergenes Greer may have with any works council or other employee body in respect of the Acquisition; and

(vi) will provide Stallergenes Greer with information that is true, accurate and not misleading for the purposes of inclusion in the Scheme Document;

(b) undertakings given by Stallergenes Greer:

(i) to ensure that the conditions set out in the Scheme Document shall be the same as the Conditions and certain further terms set out in Appendix I to this Announcement;

(ii) to the extent reasonably practicable, to keep Waypoint informed of the number of proxy votes received in respect of the Scheme Resolution and Special Resolution;

(iii) to the extent reasonably practicable, to provide Waypoint with details of any material changes to the register of SG Shareholders (including beneficial owners of Shares) that occur prior to the Effective Date;

(iv) at Waypoint's cost, to provide, and procure that each member of the SG Group will provide, such collaboration and co-operation to Waypoint as it may reasonably request in connection with arranging the debt facility to finance the Acquisition in advance of the Effective Date, provided that compliance with this undertaking does not adversely affect Stallergenes Greer's ability to continue operating in the ordinary course of business;

(v) to co-operate with and provide such further details to Waypoint in relation to the Share Schemes as Waypoint may request and to communicate with participants of the Share Schemes as necessary to implement the Acquisition in the manner contemplated by the terms set out in the Implementation Agreement;

(vi) to promptly provide, and procure that each member of the SG Group promptly provides, to Waypoint such information, documentation and access to the management and employees of the SG Group as is reasonably necessary for the purposes of Waypoint's post-Acquisition planning and verifying of Stallergenes Greer's business plan, provided that compliance with this undertaking does not adversely affect Stallergenes Greer's ability to continue operating in the ordinary course of business; and

(vii) that it will not (without the prior approval of Waypoint) take any action which may result in the Acquisition being frustrated or in the Shareholders being denied the opportunity to decide on its merits; and

(c) the agreement by the parties to implement the Acquisition in accordance with, and subject to the terms of, the Implementation Agreement and this Announcement (including the Conditions);

(d) customary warranties given by Stallergenes Greer and Waypoint, together with a warranty given by Waypoint that it has not acquired any Shares in the three months prior to the date of the Implementation Agreement;

(e) the agreement by the parties to implement certain proposals in relation to the Share Schemes;

(f) the terms relating to the provision of directors' and officers' insurance and indemnification in respect of the current Directors; and

(g) the circumstances in which the Implementation Agreement may be terminated.

Funding Commitment Letter

Waypoint, the Funding Entity, the Waypoint Parent and Stallergenes Greer have entered into the Funding Commitment Letter, to record the manner in which the aggregate price payable to Shareholders pursuant to the Scheme will be funded.

The Funding Commitment Letter sets out (among other things):

(a) an obligation on the Funding Entity to transfer or cause to be transferred to Waypoint the aggregate price payable to Shareholders pursuant to the Scheme unless Waypoint has obtained this funding from another source;

(b) undertakings given by the Funding Entity that:

(i) it has sufficient cash resources available (whether in the form of liquid assets or amounts available for draw down under the Facilities Agreement, or a combination of these) and will ensure that such cash resources remain available to satisfy at least 125 per cent. of the aggregate price payable to Shareholders pursuant to the Scheme;

(ii) it will not take any action, or permit any action to be taken, to cancel, terminate or adversely amend the Facilities Agreement or which would allow UBS Switzerland AG to cancel or otherwise terminate the Facilities Agreement or not to advance any amount pursuant to the Facilities Agreement that is required by the Funding Entity to discharge its obligations under the Funding Commitment Letter; and

(iii) it will not take any action, or permit any action to be taken, which could reasonably be expected to cause it not to be able to discharge its obligations under the Funding Commitment Letter; and

(c) undertakings given by Waypoint that:

(i) it will not take on or assume liabilities in an aggregate amount greater than Euro 1,000,000, other than pursuant to the interest free loan agreements entered into between the Waypoint Parent and Waypoint on 18 December 2015 and 28 December 2017 (the "IFLAs") or in connection with the Acquisition; and

(ii) it will not take any action, or permit any action to be taken, which could reasonably be expected to cause it not to be able to discharge the aggregate price payable to Shareholders pursuant to the Scheme;

(d) undertakings given by the Waypoint Parent that it will not take any action, or permit any action to be taken, which would result in any amount being paid by Waypoint pursuant to the IFLAs or assign its rights under the IFLAs to any other person;

(e) customary warranties around existence, capacity and authority and the accuracy of information provided by Waypoint, the Funding Entity and the Waypoint Parent to Stallergenes Greer; and

(f) the circumstances in which the Funding Commitment Letter will be terminated.

18. Documents on display

Subject to certain restrictions relating to persons resident in certain restricted jurisdictions, copies of the following documents will, by no later than the Business Day after this Announcement, be made available on Stallergenes Greer's website at www.stallergenesgreer.com until the Effective Date:

(a) this Announcement;

(b) the irrevocable undertakings referred to in paragraph 9 above;

(c) the Funding Commitment Letter;

(d) the Non-Disclosure Agreement; and

(e) the Implementation Agreement.

Neither the contents of Stallergenes Greer's website, Waypoint's website, nor the content of any other website accessible from hyperlinks on such websites, is incorporated into or forms part of, this Announcement.

19. Restrictions concerning Shareholders

General

The availability of the Acquisition and the distribution of this Announcement to Shareholders who are not resident in France may be affected by the laws of their resident jurisdiction. Such persons should inform themselves of, and observe, any applicable legal or regulatory requirements of their jurisdiction. The Acquisition is not intended to be made available to persons directly or indirectly subject to such restrictions, and their participation cannot, in any way whatsoever, be accepted if originating from a jurisdiction in which the Acquisition is subject to such restrictions.

Shareholders who are in any doubt regarding such matters should consult an appropriate independent professional adviser in the relevant jurisdiction without delay. Any failure to comply with the applicable restrictions may constitute a violation of the securities laws of the relevant jurisdiction. To the fullest extent permitted by applicable law, Waypoint, Stallergenes Greer and persons involved in the Acquisition disclaim any responsibility or liability for the violation of such restrictions by any person.

This Announcement does not constitute an offer to purchase any securities. Shareholders are advised to carefully read the Scheme Document and related Forms of Proxy once these have been dispatched.

United States of America

The Acquisition relates to the shares of a company organised under the laws of England and Wales and listed on Euronext Paris and is proposed to be effected by means of a scheme of arrangement under the laws of England and Wales (Part 26 of the Companies Act). This Announcement, the Scheme Document and certain other documents relating to the Acquisition have been or will be prepared in accordance with English law and French law (in connection with disclosure only), all of which differ from the relevant laws in the United States of America. The Acquisition is not subject to the tender offer rules or the proxy solicitation rules under the U.S. Securities Exchange Act of 1934, as amended. Accordingly, the Acquisition is subject to the disclosure requirements of and practices applicable to a company listed on Euronext Paris which is subject to an English law scheme of arrangement, which differ from the disclosure requirements of the United States of America tender offer and proxy solicitation rules.

20. General

The information disclosed in connection with the Scheme may not be the same as that which would have been disclosed if this Announcement had been prepared in accordance with the laws of jurisdictions outside England and Wales and France.

The Acquisition is subject to the Conditions and certain further terms set out in Appendix I and the full terms and conditions to be set out in the Scheme Document when issued. Any voting decision or response in relation to the Acquisition should be made solely on the basis of the Scheme Document.

The bases and sources of certain financial information contained in this Announcement are set out in Appendix II. Appendix III contains details of the irrevocable undertakings received by Waypoint. Certain terms used in this Announcement are defined in Appendix IV.

UBS has given and has not withdrawn its written consent to the issue of this Announcement with the inclusion of references to its name in the form and context in which they appear herein.

Evercore has given and has not withdrawn its written consent to the issue of this Announcement with the inclusion of references to its name in the form and context in which they appear herein.

Finexsi Expert & Conseil Financier has given and has not withdrawn its written consent to the issue of this Announcement with the inclusion of references to its name in the form and context in which they appear herein.

Clifford Chance LLP has given and has not withdrawn its written consent to the issue of this Announcement with the inclusion of references to its name in the form and context in which they appear herein.

Enquiries:

Stallergenes Greer
Youssef Abbas, Investor Relations +33 1 55 59 78 43
Catherine Kress, Communications +33 1 55 59 26 05
 
Evercore +44 (0) 20 7653 6000
Financial adviser to the Special Committee
Edward Banks, Senior Managing Director
Simon Elliott, Senior Managing Director
Wladimir Wallaert, Managing Director
 
FTI Consulting +33 1 47 03 69 48
Investor and media relations adviser to Stallergenes Greer
Arnaud de Cheffontaines
 
Havas Worldwide Paris +33 06 13 54 38 91
Media relations adviser to Stallergenes Greer
Claire Olivieri
 
UBS +44 (0) 20 7567 8000
Financial adviser to Waypoint
Cailin McGurk, Managing Director

Sarantis Douropoulos, Executive Director

Nicolas Le Ray, Executive Director

 
Hirzel.Neef.Schmid.Counselors +41 43 344 42 42
Media relations adviser to Waypoint
Dr Jörg Neef

IMPORTANT NOTICES

Important Notices Relating to Financial Advisers

UBS AG London Branch is authorised and regulated by the Financial Market Supervisory Authority in Switzerland. It is authorised by the Prudential Regulation Authority and subject to regulation by the Financial Conduct Authority and limited regulation by the Prudential Regulation Authority in the United Kingdom. UBS AG London Branch is acting exclusively as financial adviser to Waypoint and no one else in connection with the Acquisition. In connection with such matters, UBS AG London Branch will not regard any other person as its client, nor will it be responsible to any other person for providing the protections afforded to its clients or for providing advice in relation to the Acquisition, the contents or subject matter of this Announcement or any transaction, arrangement or other matter referred to herein.

Evercore Partners International LLP, which is authorised and regulated in the United Kingdom by the Financial Conduct Authority, is acting as financial adviser exclusively for the Special Committee and no one else in connection with the matters referred to in this Announcement and will not regard any other person as its client in connection with the matters referred to in this Announcement and will not be responsible to anyone other than the Special Committee for providing the protections afforded to clients of Evercore, nor for providing advice in relation to the matters referred to in this Announcement.

Further Information

This Announcement is for information purposes only and is not intended to, and does not, constitute or form part of any offer, invitation, inducement or the solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of or exercise rights in respect of any securities, or the solicitation of any vote or approval of an offer to buy securities in any jurisdiction, pursuant to the Acquisition or otherwise nor shall there be any sale, issuance or transfer of any securities pursuant to the Acquisition in any jurisdiction in contravention of any applicable laws.

The Acquisition will be implemented solely pursuant to the terms of the Scheme Document, which will contain the full terms and conditions of the Acquisition, including details of how to vote in respect of the Scheme. Any decision, vote or other response in respect of the Acquisition should be made only on the basis of information contained in the Scheme Document. Shareholders are advised to read the formal documentation in relation to the Acquisition carefully once it has been dispatched.

This Announcement does not constitute a prospectus or prospectus-equivalent document.

This Announcement has been prepared for the purpose of complying with English law and disclosure requirements under French law. Accordingly, the information disclosed may not be the same as that which would have been disclosed if this Announcement had been prepared in accordance with the laws of jurisdictions outside of the United Kingdom and France (as applicable).

Overseas Jurisdictions

The release, publication or distribution of this Announcement in, and the availability of the Acquisition to persons who are residents, citizens or nationals of jurisdictions other than France may be restricted by laws and/or regulations of those jurisdictions. In particular, the ability of persons who are not resident in France or who are subject to the laws of another jurisdiction to direct voting of the Scheme Shares in which they are interested with respect to the Scheme at the Court Meeting, or to execute and deliver Forms of Proxy appointing another to vote at the Court Meeting on their behalf, may be affected by the laws of the relevant jurisdictions in which they are located.

Therefore, any persons not resident in France and/or who are subject to the laws and regulations of any jurisdiction other than France should inform themselves about, and observe, any applicable legal and regulatory requirements. Any failure to comply with the applicable requirements may constitute a violation of the laws and/or regulations of any such jurisdiction.

The Acquisition will not be made, directly or indirectly, in, into or from any restricted jurisdiction where to do so would violate the laws of that jurisdiction and no person may vote in favour of the Acquisition by any use, means, instrumentality or form within a restricted jurisdiction or any other jurisdiction if to do so would constitute a violation of the laws of that jurisdiction. Accordingly, copies of this Announcement and any formal documentation relating to the Acquisition are not being, and must not be, directly or indirectly, mailed or otherwise forwarded, distributed or sent in, into or from any restricted jurisdiction and persons receiving such documents (including custodians, nominees and trustees) must not mail or otherwise forward, distribute or send them in or into or from any restricted jurisdiction. To the fullest extent permitted by applicable law, Waypoint, Stallergenes Greer and persons involved in the Acquisition disclaim any responsibility or liability for such violation by any person.

The receipt of cash pursuant to the Acquisition by Shareholders may be a taxable transaction under applicable national, state and local, as well as foreign and other tax laws. Each Shareholder is urged to consult their independent professional adviser regarding the tax consequences of the Acquisition applicable to him or her.

Further details in relation to Shareholders in overseas jurisdictions will be contained in the Scheme Document.

Notice to U.S. Investors in Stallergenes Greer

The Acquisition relates to the shares of a company organised under the laws of England and Wales and listed on Euronext Paris and is proposed to be effected by means of a scheme of arrangement under the laws of England and Wales (Part 26 of the Companies Act). This Announcement, the Scheme Document and certain other documents relating to the Acquisition have been or will be prepared in accordance with English law and French law (in connection with disclosure only), all of which differ from the relevant laws in the United States of America. The Acquisition is not subject to the tender offer rules or the proxy solicitation rules under the U.S. Securities Exchange Act of 1934, as amended. Accordingly, the Acquisition is subject to the disclosure requirements of and practices applicable to a company listed on Euronext Paris which is subject to an English law scheme of arrangement, which differ from the disclosure requirements of the United States of America tender offer and proxy solicitation rules.

Stallergenes Greer's financial statements, and all financial information that is included in this Announcement or that may be included in the Scheme Document, or any other documents relating to the Acquisition, have been or will be prepared in accordance with non-U.S. accounting standards that may not be comparable to financial information of companies in the United States of America or other companies whose financial statements are prepared in accordance with U.S. generally accepted accounting principles.

Neither the United States Securities and Exchange Commission nor any U.S. state securities commission has approved or disapproved the Acquisition, passed upon the merits or fairness of the Acquisition or passed any opinion upon the accuracy, adequacy or completeness of this Announcement or the Scheme Document. Any representation to the contrary is a criminal offence in the United States of America.

Stallergenes Greer is incorporated under the laws of England and Wales and listed on Euronext Paris. Waypoint is incorporated under the laws of Luxembourg. In addition, some of Stallergenes Greer's and Waypoint's respective officers and directors reside outside the United States of America, and some or all of their respective assets are or may be located in jurisdictions outside the United States of America. Therefore, investors may have difficulty effecting service of process within the United States of America upon those persons or recovering against Stallergenes Greer, Waypoint or their respective officers or directors on judgments of United States of America courts, including judgments based upon the civil liability provisions of the United States of America federal securities laws. It may not be possible to sue Stallergenes Greer, Waypoint or their respective officers or directors in a non-U.S. court for violations of the U.S. securities laws.

The receipt of cash pursuant to the Acquisition by U.S. holders of Shares pursuant to the Scheme may be a taxable transaction for U.S. federal income tax purposes and under applicable U.S. state and local, as well as foreign and other, tax laws. Each U.S. holder of Shares is urged to consult his or her independent professional adviser immediately regarding the tax consequences of the Acquisition applicable to him or her.

Forward-Looking Statements

This Announcement contains certain statements which are, or may be deemed to be, "forward-looking statements" which are prospective in nature. All statements other than statements of current or historical fact, are or may be deemed to be, forward-looking statements. Forward-looking statements are based on current expectations and projections about future events and are therefore subject to known and unknown risks and uncertainties which could cause actual results, performance or events to differ materially from the future results, performance or events expressed or implied by the forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of forward-looking words such as "plans", "expects", "is expected", "is subject to", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", "believes", "targets", "aims", "projects", "goal", "objective", "outlook", "risks", "seeks" or words or terms of similar substance or the negative thereof, as well as variations of such words and phrases or statements that certain actions, events or results "may", "could", "should", "would", "might", "probably" or "will" be taken, occur or be achieved. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding future expectations.

Such forward-looking statements involve risks and uncertainties that could significantly affect expected results and are based on certain key assumptions. Many factors could cause actual results to differ materially from those projected or implied in any forward-looking statements. Due to such uncertainties and risks, readers are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this Announcement. Any forward-looking statements made in this Announcement on behalf of Stallergenes Greer or Waypoint are made as of the date of this Announcement based on the opinions and estimates of directors of Stallergenes Greer or Waypoint respectively and no assurance can be given that such opinions or estimates will prove to have been correct. Each of Stallergenes Greer and Waypoint and their respective members, directors, officers, employees, advisers and any person acting on behalf of one or more of them, expressly disclaims any intention or obligation to update or revise any forward-looking or other statements contained in this Announcement, whether as a result of new information, future events or otherwise, except as required by applicable law. Neither Stallergenes Greer or Waypoint or their respective members, directors, officers or employees, advisers or any person acting on their behalf, provides any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward-looking statements in this Announcement will actually occur.

No forward-looking or other statements have been reviewed by the auditors of Stallergenes Greer or Waypoint. All subsequent oral or written forward-looking statements attributable to Stallergenes Greer or Waypoint of their respective members, directors, officers, advisers or employees or any person acting on their behalf are expressly qualified in their entirety by the cautionary statement above.

Rounding

Certain figures included in this Announcement have been subjected to rounding adjustments. Accordingly, figures shown for the same category presented in different tables may vary slightly and figures shown as totals in certain tables may not be an arithmetic aggregation of the figures that precede them.

No Profit Forecasts or Estimates

Nothing in this Announcement is intended or shall be deemed to be a forecast, projection or estimate of the future financial performance of Stallergenes Greer or Waypoint for any period and no statement in this Announcement should be interpreted to mean that cash flow from operations, earnings, or earnings per share or income of those persons (where relevant) for the current or future financial years would necessarily match or exceed the historical published cash flow from operations, earnings, earnings per share or income of those persons (as appropriate).

General

If you are in any doubt about the contents of this Announcement or the action you should take, you are recommended to seek your own independent financial advice immediately from an appropriate authorised independent financial adviser.

APPENDIX I

CONDITIONS AND FURTHER TERMS OF THE ACQUISITION

Part A

Conditions to the Acquisition

The Acquisition will be subject to the following Conditions:

(a) (i) approval of the Scheme by a majority in number of the Scheme Shareholders present and voting, either in person or by proxy, representing three-quarters or more in value of the Scheme Shares held by those Scheme Shareholders at the Court Meeting; and (ii) the Court Meeting being held on or before the 36th clear day after the expected date of the Court Meeting to be set out in the Scheme Document in due course (or such later date as Stallergenes Greer and Waypoint may agree in writing and the Court may allow);

(b) (i) the Special Resolution being duly passed by the requisite majority or majorities at the General Meeting; and (ii) the General Meeting being held on or before the 36th clear day after the expected date of the General Meeting to be set out in the Scheme Document in due course (or such later date as Stallergenes Greer and Waypoint may agree in writing); and

(c) (i) the approval of the Scheme by the Court (with or without amendment as agreed by Waypoint and Stallergenes Greer) and the delivery of the office copy of the Court Order for registration to the Registrar of Companies; and (ii) the Court Hearing being held on or before the 36th clear day after the expected date of the Court Hearing to be set out in the Scheme Document in due course (or such later date as Stallergenes Greer and Waypoint may agree in writing and the Court may allow).

Part B

Extension and Invocation of the Conditions

The Scheme will not become Effective unless the Conditions have been fulfilled by no later than the Long Stop Date.

If any of the deadlines in the Conditions set out in paragraphs (a)(ii), (b)(ii) and (c)(ii) above are not met, Waypoint may extend such deadlines, with Stallergenes Greer's prior written consent. Stallergenes Greer shall make an announcement by 7.00 a.m. on the Business Day following such deadline confirming whether Waypoint has invoked the relevant Condition or agreed with Stallergenes Greer to extend the original deadline in relation to the relevant Condition.

Each of the Conditions shall be regarded as a separate Condition and shall not be limited by reference to any other Condition.

Part C

Certain Further Terms of the Acquisition

Scheme Shares will be acquired by Waypoint fully paid and free from all liens, equitable interests, options, charges, encumbrances, rights of pre-emption and other third party rights and interests of any nature whatsoever and together with all rights attaching to them as at the date of this Announcement or subsequently attaching or accruing to them, including voting rights and the right to receive and retain, in full, all dividends and other distributions (if any) declared, made, paid or payable, or any other return of capital made, on or after the date of this Announcement.

If any dividend or other distribution is paid in respect of Shares on or after the date of this Announcement, Waypoint reserves the right to reduce the Acquisition Price by the aggregate per Share amount of such dividend or other distribution, in which case any reference in this Announcement or in the Scheme Document to the consideration payable under the terms of the Acquisition will be deemed to be a reference to the consideration as so reduced. To the extent that any such dividend and/or distribution and/or other return of capital is declared, made or paid or is payable prior to the Court Hearing and it is: (i) transferred pursuant to the Acquisition on a basis which entitles Waypoint to receive the dividend or distribution and to retain it; or (ii) cancelled, the consideration payable under the terms of the Acquisition will not be subject to change in accordance with this paragraph. Any exercise by Waypoint of its rights referred to in this paragraph shall be the subject of an announcement and, for the avoidance of doubt, shall not be regarded as constituting any revision or variation of the Acquisition.

The Acquisition will be subject, inter alia, to the Conditions and certain further terms which are set out in this Appendix I and those terms and conditions which will be set out in the Scheme Document.

The availability of the Acquisition to persons not resident in the United Kingdom or France may be affected by the laws of the relevant jurisdiction. Persons who are resident in jurisdictions other than the United Kingdom or France should inform themselves of, and observe, any applicable requirements. Further information in relation to Shareholders not resident in the United Kingdom or France will be contained in the Scheme Document.

The Acquisition is not being made, directly or indirectly, in, into or from, or by use of the mails of, or by any means of instrumentality (including, but not limited to, facsimile, email or other electronic transmission, telex or telephone) of interstate or foreign commerce of, or of any facility of a national, state or other securities exchange of, any jurisdiction where to do so would violate the laws of that jurisdiction and will not be capable of acceptance by any such use, means, instrumentality or facility or from within any such jurisdiction.

This Announcement and any rights or liabilities arising hereunder, the Acquisition, the Scheme and any Forms of Proxy will be governed by English law and be subject to the jurisdiction of the courts of England and Wales. The Scheme will also be subject to certain public disclosure requirements under the General Regulation of the AMF.

APPENDIX II

SOURCES OF INFORMATION AND BASES OF CALCULATION

In this Announcement:

(a) unless otherwise stated, financial information concerning Stallergenes Greer has been extracted from Stallergenes Greer's 2018 annual report and audited consolidated financial statements;

(b) the equity value of the Acquisition of approximately Euro 730.1 million is based upon 19,733,323 Shares in issue as at the close of business on the Last Practicable Date (excluding 54,230 Treasury Shares);

(c) the enterprise value of approximately Euro 678.5 million is based upon the equity value of the Acquisition as set out in paragraph (b) above less Stallergenes Greer's net cash balance of Euro 55.2 million as at 31 December 2018, plus Euro 3.6 million in cash proceeds due to holders of 409,004 options which vested in September 2018 to be cash settled under the Share Schemes, but excluding the cash proceeds due to holders of 448,309 options which will be cash settled under the Share Schemes once they vest in September 2019;

(d) unless otherwise stated, all prices for Shares are the Closing Price (as derived from Bloomberg) on the relevant date;

(e) the three month and twelve month trading day volume weighted average Closing Prices of Shares have been derived from data provided by Bloomberg on the Last Practicable Date; and

(f) the International Securities Identification Number for Scheme Shares is GB00BZ21RF93.

APPENDIX III

DETAILS OF IRREVOCABLE UNDERTAKINGS

Irrevocable undertakings given by members of the Special Committee

The following members of the Special Committee have given irrevocable undertakings to vote (or direct the voting) in favour of the Scheme at the Court Meeting and the Special Resolution to be proposed at the General Meeting in relation to the following Scheme Shares:

Name Number of Scheme Shares Percentage of Existing Issued Share Capital
Jean-Luc Bélingard 20 0.00010 per cent.
Philip Broadley 100 0.00051 per cent.
Yvonne Schlaeppi 30 0.00015 per cent.
Elmar Schnee 1,000 0.00507 per cent.

The irrevocable undertakings given by the above listed members of the Special Committee will cease to be binding if the Implementation Agreement terminates in accordance with its terms.

Irrevocable undertakings given by Directors who are not members of the Special Committee

The following Directors who are not members of the Special Committee have given irrevocable undertakings to vote (or direct the voting) in favour of the Special Resolution to be proposed at the General Meeting in relation to the following Shares:

Name Number of Scheme Shares Percentage of Existing Issued Share Capital
Rodolfo Bogni 16 0.00008 per cent.
Stefan Meister 16 0.00008 per cent.

The irrevocable undertakings given by the above listed Directors will cease to be binding if the Implementation Agreement terminates in accordance with its terms.

Irrevocable undertaking given by Waypoint

Waypoint has undertaken in the Implementation Agreement to vote in favour of the Special Resolution to be proposed at the General Meeting in respect of an aggregate of 16,550,910 Shares, representing approximately 83.9 per. cent of the Existing Issued Share Capital.

APPENDIX IV

DEFINITIONS

"Acquisition" the proposed recommended cash acquisition by Waypoint of the entire issued and to be issued share capital of Stallergenes Greer not directly or indirectly held by Waypoint to be implemented by means of the Scheme, on the terms and subject to the conditions set out in this Announcement and to be set out in the Scheme Document

"Acquisition Price" Euro 37.00 in cash for each Scheme Share

"AIT" allergy immunotherapy treatments

"AMF" Autorité des marchés financiers, the French Financial Markets Authority

"Announcement" this announcement, together with its appendices

"ANSM" l'Agence Nationale de Sécurité du Médicament et des Produits de Santé, the French Health Authority

"Articles" the articles of association of Stallergenes Greer from time to time

"Board" the board of directors of Stallergenes Greer

"Business Day" a day (other than Saturdays, Sundays and public or bank holidays in the U.K. or France) on which banks are generally open for business in the City of London and Paris, including for the purposes of trading Euro in the international bank markets

"Closing Price" the closing middle market price per Share of Euro 25.90 on the Last Practicable Date

"Code" the City Code on Takeovers and Mergers issued from time to time by the Panel on Takeovers and Mergers

"Companies Act" the United Kingdom Companies Act 2006

"Conditions" the conditions set out in Part A of Appendix I to this Announcement and to be set out in the Scheme Document

"Court" the High Court of Justice of England and Wales

"Court Hearing" the hearing of the Court to sanction the Scheme

"Court Meeting" the meeting(s) of the Scheme Shareholders to be convened by order of the Court pursuant to section 896 of the Companies Act for the purpose of considering, and if thought fit, approving the Scheme (with or without amendment as approved by the Court and agreed by Waypoint and Stallergenes Greer) and any adjournment thereof

"Court Order" the order of the Court approving the Scheme under section 899 of the Companies Act

"Directors" the directors of Stallergenes Greer

"Effective" the Scheme having become effective in accordance with its terms, upon delivery of the Court Order to the Registrar of Companies

"Effective Date" the date upon which the Scheme becomes Effective

"Euroclear" Euroclear France S.A.

"Euronext Paris" Euronext Paris S.A.

"Evercore" Evercore Partners International LLP, financial advisers to the Special Committee

"Existing Issued Share Capital" the entire issued share capital of Stallergenes Greer as at the Last Practicable Date, other than any Treasury Shares

"Facilities Agreement" the facilities agreement entered into between the Funding Entity and UBS Switzerland AG on 11 May 2018

"Forms of Proxy" the voting instructions or proxy form in connection with each of the Meetings which will accompany the Scheme Document for use by Shareholders

"Funding Commitment Letter" the funding commitment letter entered into between Stallergenes Greer, Waypoint, the Waypoint Parent and the Funding Entity on 21 March 2019 in connection with the Acquisition

"Funding Entity" Waypoint Treasury Limited

"General Meeting" the general meeting of SG Shareholders (including any adjournment thereof) to be convened in connection with implementing the Scheme, notice of which will be set out in the Scheme Document

"IFLAs" the interest free loan agreements entered into between the Waypoint Parent and Waypoint on 18 December 2015 and 28 December 2017

"Implementation Agreement" the implementation agreement entered into between Stallergenes Greer and Waypoint on 21 March 2019 in connection with the Acquisition

"Independent Expert" Finexsi Expert & Conseil Financier, the independent expert appointed by the Special Committee

"Independent Expert Report" the report delivered by the Independent Expert to the Special Committee including an opinion on the fairness of the Acquisition Price

"Last Practicable Date" means 20 March 2019 (being the last practicable date prior the date of this Announcement)

"Long Stop Date" 11.59 p.m. on 30 June 2019, or such later date (if any) as Stallergenes Greer and Waypoint may agree and, if required, the Court may allow

"Market Abuse Regulation" Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014

"Meetings" the Court Meeting and the General Meeting

"Non-Disclosure Agreement" the non-disclosure agreement entered into between Stallergenes Greer and Waypoint on 27 February 2019

"Panel" the U.K. Panel on Takeovers and Mergers

"Paying Agent" Société Générale Securities Services or such other paying agent as is notified by Stallergenes Greer to Waypoint on or before the Effective Date

"Registrar of Companies" the Registrar of Companies in England and Wales

"Scheme" the proposed scheme of arrangement under Part 26 of the Companies Act between Stallergenes Greer and the Scheme Shareholders to implement the Acquisition with or subject to any modification, addition or condition approved or imposed by the Court and agreed by Stallergenes Greer and Waypoint

"Scheme Document" the document to be dispatched to (among others) Scheme Shareholders including, among other things, details of the Scheme required by section 897 of the Companies Act, the full terms and conditions of the Scheme and the notices of the Meetings

"Scheme Record Time" the time and date to be specified as such in the Scheme Document or such later time and/or date as Stallergenes Greer and Waypoint may agree

"Scheme Resolution" the resolution to approve the Scheme to be considered at the Court Meeting

"Scheme Shareholders" holders of Scheme Shares

"Scheme Shares" Shares:

(i) in issue at the date of the Scheme Document;

(ii) issued after the date of the Scheme Document and prior to the Voting Record Time; or

(iii) issued at or after the Voting Record Time and before the Scheme Record Time, in respect of which the original or any subsequent holders thereof are, or shall have agreed in writing to be, bound by the Scheme,

in each case which remain in issue at the Scheme Record Time but excluding any Treasury Shares or Shares legally or beneficially held by or on behalf of Waypoint or any of its affiliates

"SG Group" Stallergenes Greer and its subsidiaries and subsidiary undertakings from time to time

"SG Shareholders" registered holders of Shares

"Share Schemes" the option plan for the subscription of shares in Stallergenes S.A. with a date of grant of 12 November 2010 and the Stallergenes Greer long-term incentive plan adopted on 29 September 2016

"Shareholders" those persons (other than Waypoint) holding Shares through Euroclear, either in "bearer" or "registered" form and any Scheme Shareholder other than Euroclear

"Shares" the ordinary shares of Euro 1.00 each in the capital of Stallergenes Greer

"Special Committee" the special committee of independent directors of Stallergenes Greer formed by the Board to evaluate the terms of the Acquisition

"Special Resolution" the special resolution in connection with the implementation of the Scheme to be proposed at the General Meeting

"Stallergenes Greer" Stallergenes Greer plc

"Transparency Directive" Directive 2004/109/EC of the European Parliament and the Council of 15 December 2004

"Treasury Shares" the Shares held as treasury shares as provided for in section 734 of the Companies Act

"UBS" UBS AG London Branch, financial advisers to Waypoint

"U.K." the United Kingdom of Great Britain and Northern Ireland

"U.S." the United States of America

"Voting Record Time" the date and time specified in the Scheme Document to which entitlement to vote at the Court Meeting will be determined

"Waypoint" Ares Life Sciences I S.à r.l.

"Waypoint Group" Waypoint Group Holdings S.A. and its subsidiaries and subsidiary undertakings from time to time

"Waypoint Parent" Ares Life Sciences L.P. (acting through its General Partner, Waypoint GP Limited)

For the purposes of this Announcement, "subsidiary", and "subsidiary undertaking" have the respective meanings given thereto by the Companies Act.

All references to "Euro" are to the lawful currency of the European Union.

References to an enactment include references to that enactment as amended, replaced, consolidated or re-enacted by or under any other enactment before or after the date of this Announcement.

All the times and/or dates (other than references to Business Days) referred to in this Announcement are to those times and/or dates as determined by Greenwich Mean Time, unless otherwise stated.

References to the singular include the plural and vice versa.

Stallergenes Greer Delivers 2018 Sales and EBITDA in Line with Recent Outlook

LONDON--(BUSINESS WIRE)-- Regulatory News:

Paris:STAGR

Stallergenes Greer, a biopharmaceutical company specialising in treatments for respiratory allergies, today published its full-year results for the twelve-month period ended 31 December 2018.

FY 2018 Financial Highlights

     
(in € million)       Full Year (audited)      
      2017       2018       Var. (€m)       % change      
Net sales       260.2       277.0       + 16.8       + 6%      
Gross profit       165.8       179.1       + 13.3       + 8%      
Gross margin       64%       65%       n.a.       + 1 point      
EBITDA       21.9       40.2       + 18.3       + 84%      
EBITDA margin       8%       15%       n.a.       + 7 points      
EBIT (Operating Profit)       (5.4)       17.6       + 23.0       n.a.      
Net profit/(loss)       (9.9)       12.8       + 22.7       n.a.      

Michele Antonelli, Chief Executive Officer of Stallergenes Greer, commented:

“Stallergenes Greer sustained the ongoing recovery of its business in 2018 and we regained leading positions in many key markets.

We delivered meaningful growth and continue to invest in our product pipeline and manufacturing capabilities. Net sales and EBITDA were in line with our recent outlook and we showed steady growth across our main regions and products. We delivered substantial EBITDA margin expansion as a result of strong operating efficiencies.

Stallergenes Greer‘s business fundamentals are robust and provide the means and so confidence to continue enhancing our competitive profile, advancing our pipeline and further investing in technical operations and quality. Going forward, we will remain focused on providing patients and the medical community with a broader portfolio of innovative and high-quality allergy treatments and ultimately seek to deliver on our purpose of enabling people with allergies to live normal lives.”

FY18 net sales increased 6% as a result of continued growth across main products and regions, in line with outlook

Unaudited

 

In € million

      Reported Currency                       Constant Currency      
      FY-17 (12m)

(€m) % Sales

      FY-18 (12m)

(€m) % Sales

      Var %             FY-18 (12m)

(€m) % Sales

      Var %      
                                                                             
Southern Europe       119.0       46%       136.5       49%       15%             136.4       48%       15%      
Northern & Central Europe       33.7       13%       33.5       12%       0%             33.8       12%       0%      
International markets       19.6       8%       15.7       6%       -20%             16.5       6%       -16%      
United States       87.9       33%       91.3       33%       4%             95.5       34%       9%      
Net sales       260.2       100%       277.0       100%       6%             282.2       100%       8%      
                                                                             
Sublingual products       156.7       60%       172.9       63%       10%                                    
Subcutaneous products       70.4       27%       70.1       25%       0%                                    
Veterinary       10.2       4%       9.4       3%       -8%                                    
Other products       22.9       9%       24.6       9%       7%                                    
Net sales       260.2       100%       277.0       100%       6%                                    

The 6% increase year-over-year in full-year net sales reflects positive growth in Southern Europe and in the United States. U.S. revenue was negatively impacted by the foreign currency exchange rate in 2018. The region delivered 9% net sales growth year-over-year in local currency (US$). Staloral was Stallergenes Greer’s main growth driver in 2018 across all its major markets. In addition, the Company regained share with Oralair in the grass tablet segment in some of its key markets.

Operational efficiencies delivered margin improvement
The Group’s full-year 2018 gross margin of €179.1 million represented 65% of net sales, compared to 64% in 2017. The Group reported 2018 EBITDA of €40.2 million, compared to €21.9 million in 2017. Reported EBITDA increased overall by €18.3 million as a result of a €16.8 million increase in sales and a 8% decline in Selling, General and Administrative expenses, from €131.9 million in 2017 to €120.7 million in 2018. The Group benefited from the reduction of its operating expenditures and costs associated with its operations in the U.K., France and the United States in 2018.

Reported 2018 EBITDA came in near the low end of the outlook range, mostly due to a re-assessment of the research tax credits in France for fiscal years 2014-2017; non-recurring charges related to the change in leadership effective from January 2019 and costs associated with streamlining of the Company’s operations.

For the first time in three years, the Group generated a positive net profit and a positive cash flow. In 2018, net profit was €12.8 million compared to a net loss of €9.9 million in 2017. Free cash flow was positive € 23.1 million versus a negative €20.4 million in 2017.

As a result of the business performance and robust measures to contain costs, Stallergenes Greer continues to have a solid balance sheet. At 31 December 2018, the Group’s shareholders’ equity represented 82% of the balance sheet total. Cash balance stood at €74 million.

Continued investments in innovation translated into significant achievements in 2018
Stallergenes Greer is committed to developing innovative therapies for major respiratory allergies and invested €38.4 million in Research & Development in 2018, primarily to fund STAGR320, the Group’s phase III global multi-centre clinical trial for house dust mite (HDM)-induced allergic rhinitis. In November 2018, Stallergenes Greer announced that this phase III trial achieved its primary endpoint. The study also achieved all key secondary endpoints and showed a comparable safety profile to that observed in other clinical studies with STAGR320. The randomised, double-blind, placebo-controlled study, which recruited more than 1,600 patients from 231 participating investigative sites in 13 countries, was the largest phase III clinical trial conducted to evaluate the treatment of house dust mite allergy. Whilst certain hurdles remain, the results provide a basis for regulatory submissions in Europe and the United States and an assessment of the commercial viability of this new product.

In addition, Stallergenes Greer announced positive results from two real-world evidence studies regarding the use of allergy immunotherapy compared to the use of only symptomatic treatments in patients with respiratory allergies as part of the BREATH real-world evidence program designed to understand the real-world benefits of allergy immunotherapy outside of a clinical trial setting. These studies, conducted in France and Germany, further substantiated the long-term benefits of AIT to significantly reduce the need for allergic rhinitis and asthma medications in patients suffering from grass pollen and birch tree pollen-induced allergies.

Investments in Technical Operations and Quality to continue
Stallergenes Greer pursued investments in Technical and Quality Operations capabilities at all its manufacturing sites in 2018 to strengthen its quality culture across the organisation and to ensure product quality and patient safety for all released and distributed products.

Stallergenes Greer continues its ongoing improvements of the manufacturing facilities in France and closely collaborates with the French National Agency for Medicines and Health Products Safety (ANSM) to meet the requirements stated in its injunction dated 4 January 2018, in particular with respect to its injectable products.

In the United States, Stallergenes Greer continued to strengthen its quality system and introduced state-of-the-art manufacturing technologies and advanced initiatives to increase capacity.

2019 Business outlook
Stallergenes Greer anticipates further progress will be made in 2019. This includes investing in growth opportunities and delivering cost efficiencies across the organization. The Group expects:

  • Net sales to be in the range of €290 million and €300 million, and
  • EBITDA to be in the range of €50 million to €60 million (excluding one-off costs)

Stallergenes Greer plc recognised non-cash impairment with no impact on Group consolidated accounts
As part of its annual reviews, Stallergenes Greer plc has performed an impairment analysis of its “investments in subsidiary undertakings” on its statutory accounts based on the latest business plan and risks associated to it and an impairment of €47 million was recorded. The impairment in the statutory accounts for Stallergenes Greer plc has no impact on the Group consolidated accounts, its 2018 operating result, EBITDA or Equity1.

WEBCAST AND CONFERENCE CALL INFORMATION
Stallergenes Greer will host an Investors and Analysts meeting today, 21 March 2019. The event will be available via live webcast at 10:30 am GMT / 11:30 am CET / 5:30 am EST. The webcast will be available via the following link: https://edge.media-server.com/m6/p/vtdehysm and on the company’s website, http://stallergenesgreer.com/financial-calendar-events.

Participants UK / International : +44 (0) 2071 928000
Participants France: 0805103028
Participants United States: 18669661396
Conference ID: 9197292

Participants are asked to connect at least 15 minutes prior to the conference to register, download and install any necessary audio software.

FINANCIAL CALENDAR

  • 17 April 2019: First 2019 Quarter Sales Publication
  • 13 June 2019: Annual General Meeting
  • 29 August 2019: H1 2019 Results

ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2018 annual report published on 21 March 2019 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

TABLE OF CONTENTS

Consolidated income statement as of 31 December 2018

Consolidated balance sheet as of 31 December 2018

Consolidated cash flow statement as of 31 December 2018

Reconciliation of net income to EBITDA and adjusted EBITDA

The financial information set out above does not constitute the Group’s financial statements for the period-ended 31 December 2018 but are derived from those statements. The annual report for 2018 will be made public on 21 March 2019 and delivered to the UK Companies House on or before 30 June 2019. The auditor has reported on those statements. Their report was unqualified, did not draw attention to any matters by way of emphasis and did not contain statements under Section 498 (2) or (3) Companies Act 2006 or equivalent preceding legislation. While the financial information included in this preliminary announcement has been computed in accordance with International Financial Reporting Standards (IFRS), this announcement itself does not contain sufficient information to comply with IFRS.

The Group published full financial statements that comply with IFRS that are available on its website at http://stallergenesgreer.com/annual-report .

The financial statements were approved by the Board of Directors on 20 March 2019.

Consolidated income statement as of 31 December 2018

€ thousands   31/12/2018       31/12/2017
Net sales1   276,954       260,195
Other revenues   99       36
             
Total revenues   277,053       260,231
             
Cost of goods sold           (94,458)
    (97,917)        
Gross margin   179,136       165,773
             
Distribution costs   (10,806)       (11,413)
Selling and marketing expenses   (47,738)       (60,624)
Administrative expenses   (57,378)       (57,588)
Other general expenses   (4,768)       (2,281)
Selling, general and administrative expenses   (120,690)       (131,906)
             
Research and Development expenses (R&D)   (38,429)       (45,630)
R&D related income   865       6,412
Net R&D expenses   (37,564)       (39,218)
             
Operating profit / (loss) (EBIT) before transformation costs   20,882       (5,351)
             
Transformation costs   (3,322)      
             
Operating profit / (loss) (EBIT)   17,560       (5,351)
             
Financial income   109       20
Financial expenses   (1,000)       (1,817)
Net financial expense   (891)       (1,797)
             
Profit / (loss) before tax and associates   16,669       (7,148)
             
Income tax   (3,910)       (2,145)
Share of loss from associated companies         (578)
             
Profit / (loss) for the period attributable to:            
Owners of the parent   12,759       (9,871)
Non-controlling interest        
Group share of net profit / (loss)   12,759       (9,871)

1. The 2017 net sales figure includes a €5,112k unused reversal of the recall provision against sales.

Consolidated balance sheet as of 31 December 2018

€ thousands   31/12/2018       31/12/2017
Goodwill   202,723       195,187
Other intangible assets   65,093       70,913
Property, plant and equipment   76,148       69,138
Non-current financial assets   2,736       3,957
Deferred tax assets   27,276       26,754
Other non-current assets   237       237
Non-current assets   374,213       366,186
             
Inventories   58,453       56,793
Trade receivables   33,025       33,199
Current financial assets   772       684
Other current assets   9,192       9,231
Current income tax receivable   2,997       611
Research tax credit and subsidies receivable   21,704       22,708
Cash and cash equivalents   73,946       50,849
Current assets   200,089       174,075
Total assets   574,302       540,261
             
Share capital   19,788       19,788
Share premium   539       539
Merger and contribution premium   342,149       342,149
Revaluation reserve   (348)       (236)
Retained earnings   109,067       85,086
Group shareholders’ equity   471,195       447,326
Non-controlling interests        
Total shareholders’ equity   471,195       447,326
             
Provision for employee retirement obligations and related benefits   3,708       3,442
Non-current provisions   860       514
Non-current financial liabilities   6,318       6,318
Deferred tax liabilities   3,815       6,283
Non-current liabilities   14,701       16,557
             
Trade payables   21,680       19,793
Current provisions   1,264       2,115
Current financial liabilities   12,437       12,204
Income tax payable   2,566       1,313
Other current liabilities   50,459       40,953
Current liabilities   88,406       76,378
Total equity and liabilities   574,302       540,261

Consolidated cash flow statement as of 31 December 2018

€ thousands   31/12/2018       31/12/2017
Cash flow from operating activities            
             
Group share of net profit / (loss)   12,759       (9,871)
Share of loss from associated companies         578
Income tax   3,910       2,145
Net financial expense   891       1,798
             
Amortisation and depreciation charges   21,529       23,404
Change in provisions   (195)       (1,904)
Share-based compensation   2,363       2,429
Capital losses from disposal of assets   1,156       4,466
Financial losses excluding interests   (73)       (35)
             
Operating cash flow before changes in working capital   42,340       23,010
             
Current income tax paid   (5,722)       (3,768)
Change in subsidies and R&D tax credit receivables   (1,614)       (7,240)
Change in working capital of operating activities   6,731       (16,231)
Change in deferred income   (55)       11
             
Net cash flow from operating activities   41,680       (4,218)
             
Cash flow from investing activities            
             
Purchase of non-current assets   (24,863)       (12,643)
Acquisition of investments in consolidated undertakings, net of cash acquired   (123)       (1,403)
Proceeds from sale of non-current assets   5,652       5,269
Change in working capital of investment activities   816       (1,400)
             
Net cash flow from investing activities   (18,518)       (10,177)
             
Free cash flow after investing activities   23,162       (14,395)
             
Cash flow from financing activities            
             
Proceeds from issuance of ordinary shares        
Treasury shares transactions   169       (72)
Net financial interest paid   (822)       (1,407)
Use/(repayment) of bank overdrafts   (4)       (227)
Repayment of borrowings   (5,522)       (15,054)
Proceeds from borrowings   5,502       12,095
             
Net cash flow from financing activities   (677)       (4,665)
             
Change in cash and cash equivalents   22,485       (19,060)
             
+ cash and cash equivalents – opening balance   50,849       71,262
+/- effect of translation adjustment on foreign currency denominated cash   612       (1,353)
= cash and cash equivalents – closing balance   73,946       50,849

Reconciliation of net income to EBITDA and adjusted EBITDA

€ thousands 2018       2017
Group share of net loss 12,759       (9,871)
           
Add back:          
Tax expense 3,910       2,145
Net financial expense 891       1,798
Amortisation and depreciation 21,529       23,404
Capital losses and impairments 1,156       4,466
EBITDA 40,245       21,942
           
Transformation costs, not already considered in amortization, depreciation and capital losses 687      
Share-based compensation 2,363       2,429
Adjusted EBITDA 43,295       24,371

To supplement our financial information presented in accordance with IFRS we use the following financial measures to clarify and enhance an understanding of the company’s performance: EBITDA and adjusted EBITDA. We believe that the presentation of these financial measures enhances an investor’s understanding of our financial performance. We further believe that these financial measures are useful financial metrics to assess our operating performance from period-to-period by excluding certain items that we believe are not representative of our core business. We define our core business as those operations relating to the Group’s ongoing performance. We use these financial measures for business planning purposes and in measuring our performance relative to that of our competitors. We utilise both EBITDA and adjusted EBITDA as primary measures of performance.

EBITDA consists of net income before interest, taxes, depreciation and amortisation. Adjusted EBITDA consists of EBITDA adjusted for (i) certain non-cash items included within net income, specifically share-based compensation, (ii) items the Group does not believe are indicative of ongoing operating performance, specifically transformation and significant transaction costs. We believe that making such adjustments provides investors meaningful information to understand our operating results and ability to analyse financial and business trends on a period-to-period basis.

1 For more details please refer to the Group Financial Review and Stallergenes Greer plc. Financial statements

Stallergenes Greer to report full year financial results on 21 march 2019

London (UK), March 7, 2019 – Stallergenes Greer, a biopharmaceutical company specializing in treatments for respiratory allergies, today announced it will report financial results for the full fiscal year ended 31 December 2018 on 21 March 2019, before market hours. The Company’s management will host a live conference call and audio webcast at 10:30 am London / 11:30 am Paris / 6:30 am Boston that same day to discuss the FY 2018 results.

Members of the financial community may access the conference call through the dial-in information provided on the company’s website, at http://stallergenesgreer.com/financial-calendar-events. The live audio webcast will be accessible to the general public via the following link: https://edge.media-server.com/m6/p/vtdehysm. Participants are asked to connect at least 15 minutes prior to the conference call to register, download and install any necessary audio software. The webcast and conference call will be archived for one year.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION

Name: Stallergenes Greer

ISIN: GB00BZ21RF93 1 - Ticker: STAGR

ICB Classification: 4577

LEI: 213800CYVZA7GJQEME86

Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may," "will," or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2018 annual report published on 21 March 2019 on the Company's website www.stallergenesgreer.com. Actual results may differ materially from those set forth in the forward-looking statements, due to these and other various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer Delivers 2018 Sales in Line with Outlook

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today published its full-year unaudited net sales for the twelve-month period ended 31 December 2018.

Michele Antonelli, Chief Executive Officer of Stallergenes Greer, commented:

“Stallergenes Greer’s growth continued in 2018, with net sales up 6%. The Company’s commercial performance reflects the work accomplished to better serve our patients across all markets and all geographies, providing a broad portfolio of high-quality products to address their needs.”

FY18 unaudited net sales increased 6% as a result of continued growth across main products and regions, in line with objectives

                 
Unaudited for FY-18

 

In € million

  Reported Currency   Constant Currency    
  FY-17 (12m)

(€m) % Sales

  FY-18 (12m)

(€m) % Sales

  Var % FY-18 (12m)

(€m) % Sales

  Var %
                               
Southern Europe   119.0   46%   136.5   49%   15% 136.4   48%   15%
Northern & Central Europe   33.7   13%   33.5   12%   0% 33.8   12%   0%
International markets   19.6   8%   15.7   6%   -20% 16.5   6%   -16%
United States   87.9   33%   91.3   33%   4% 95.5   34%   9%
Net sales   260.2   100%   277.0   100%   6% 282.2   100%   8%
                         
Sublingual products   156.7   60%   172.9   63%   10%
Subcutaneous products   70.4   27%   70.1   25%   0%
Veterinary   10.2   4%   9.4   3%   -8%
Other products   22.9   9%   24.6   9%   7%
Net sales   260.2   100%   277.0   100%   6%

Net sales by region: Positive performance in Southern Europe (+15%) and in the United States (+4%, +9% at constant currency)

The 6% increase year-over-year in full-year net sales reflects positive growth in Southern Europe and in the United States. U.S. revenue was negatively impacted by the foreign currency exchange rate in 2018. The region delivered 9% net sales growth year-over-year in local currency (US$).

Europe & International: Stallergenes Greer sales growth was primarily driven by a strong performance in France, related largely to an increase in the number of Staloral patients experienced during the year. The company also increased its sales in Spain, Italy, Czech Republic, Slovakia. In Germany, Stallergenes Greer continued to gain market share in the birch tree segment with Staloral. Sales in international markets were impacted by a temporary shortage of injectable products at the Antony facility combined with a transition in a new distribution strategy in Australia.

United States: In the United States, Stallergenes Greer continued to strengthen its leadership position of the bulk allergen market and capitalised on market opportunities across the portfolio, delivering €91.3 million in net sales.

Net sales by category: Continued growth in the sublingual segment (+10%)

Staloral was Stallergenes Greer’s main growth driver in 2018 across all its major markets. In addition, the Company regained share with Oralair in the grass tablet segment in some of its key markets.

Sublingual products: In 2018, sublingual product sales increased by 10%, reaching €172.9 million, primarily driven by Staloral as a result of market share gains in priority markets, such as France, and the Company’s strength in the paediatric segment. This performance was delivered despite an increasingly competitive environment. In parallel, in the tablet segment, the decline of the grass tablet market in the United States has impacted Oralair’s performance in this country.

Subcutaneous products: In the subcutaneous product category, the company reported 2018 net sales of €70.1 million, in line with 2017 net sales, despite a temporary shortage of injectable products in the Europe and International region as the Company pursued investments in major renovations and upgrades at its Antony facility.

Veterinary products: 2018 veterinary net sales declined 8% to €9.4 million compared to 2017, due to increased competition in this segment, combined with an unfavourable foreign exchange rate.

Other products: Net sales in the Other product line, which includes diagnostics and devices, grew 7% year-over-year to €24.6 million in 2018 as a result of new market opportunities in the United States.

2018 FULL YEAR OUTLOOK

On August 30, 2018 the Company confirmed its full year outlook for 2018 for net sales to be in the range of €270 million to €280 million and EBITDA to be in the range of €40 million to €50 million.

While net sales are at the high end of the range provided in the outlook, EBITDA is expected to come in near the low end of the range, mostly due to an adjustment of the research tax credit in France for fiscal years 2014 – 2017 and non-recurring charges related to the change in leadership effective from January 2019 together with cost associated with streamlining of the Company’s operations.

OTHER INFORMATION

The Company pursues the improvement of its manufacturing facilities and is working to meet the requirements stated by the French National Agency for Medicines and Health Products Safety (ANSM) in its injunction dated 4 January 2018, in particular with respect to its injectable products. The Company continues to closely collaborate with the ANSM until a final decision is made.

FINANCIAL CALENDAR
21 March 2019: 2018 full year results | 2018 annual report publication

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the USA) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

The financial information set out above does not constitute the Group’s financial statements for the period ended 31 December 2017 (audited) and 2018 (unaudited). The audit process remains ongoing for the period ended 31 December 2018. While the financial information included in this preliminary announcement has been computed in accordance with International Financial Reporting Standards (IFRS), this announcement itself does not contain sufficient information to comply with IFRS.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may," "will," or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2017 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ materially from those set forth in the forward-looking statements, due to these and other various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer Confirms Appointments to the Board of Directors

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today announced that the following appointments to the Company’s corporate leadership and Board of Directors were confirmed and approved by the Company’s Board of Directors on 12 December 2018. Stefan Meister is appointed Chairman of the Board of Directors, Michele Antonelli is appointed member of the Board of Directors and Chief Executive Officer and Elmar Schnee is appointed Lead Independent Director.

The board of directors thanks Fereydoun Firouz, who will retire from his position as Chairman and Chief Executive Officer at the end of 2018, for his contribution to the company. Effective 4 January 2019, and as announced in August 2018, Stefan Meister will take over as Chairman of the board of Directors and Michele Antonelli as Chief Executive Officer.

Stefan Meister is Group Chief Operating Officer of the Waypoint Group, a business enterprise for the managers and advisers of the funds and investments associated with the Bertarelli family, which is also the indirect owner of Ares Life Sciences I S.a.r.l., Stallergenes Greer’s largest shareholder. Prior to his role at Waypoint Group, Mr Meister was Chief Financial Officer of the Haniel Group, before which he was a member of the Executive Management Board of Celesio Group. Mr Meister began his career in 1991 at Novartis AG (Switzerland), holding various positions including Head of Controlling for the Pharma Division. Until May 2016, Mr Meister was a Member of the Board of Directors of the Swiss group, Straumann. Mr Meister is Swiss and holds a degree in economics from Basel University.

Michele Antonelli has more than 20 years of international experience in the biopharmaceutical industry with extensive expertise in manufacturing, commercial and general management. Mr Antonelli joined Stallergenes Greer in November 2015 as Executive Vice President, Head of International Operations. In February 2016, Mr Antonelli was appointed Executive Vice President, Head of Europe and International, overseeing both commercial and technical operations for the Company’s Europe and International region. During the same period he also served as President of Stallergenes SAS. Prior to Stallergenes Greer, Mr Antonelli worked at UCB, the multinational biopharmaceutical company, as an Executive Committee Member where he held roles of various responsibility and scope in Belgium, Italy and France, most recently serving as Executive Vice President and Head of Immunology Europe, overseeing the region’s commercial, medical and market access activities. Prior to joining UCB, Mr Antonelli spent 16 years at Merck Serono, ultimately serving as Senior Vice President and Global Head of Biotech Manufacturing and Process Development. He is Swiss and Italian, and graduated as Doctor in Sciences from University of Bari. He trained in Biotechnology at Catholic University in Piacenza and at Iowa State University in Ames, Iowa.

Elmar Schnee has more than 25 years’ experience in the pharmaceutical industry. Mr Schnee is currently Board Secretary of Mindmaze SA and was, from 2016 to March 2017, Chief Operating Officer. Mr Schnee is Chairman of the Board of Directors of Santhera AG, a Swiss speciality pharmaceutical company developing medicines for rare diseases. He is also a Member of the Board of Directors of Jazz Pharmaceuticals. From November 2013 to August 2015, Mr Schnee served as a Non-Executive Director of Cardiorentis Ltd., a biopharmaceutical company, where he served as Chairman and Chief Executive Officer from October 2011 until November 2013. From 2003 to 2011, Mr Schnee held various positions at Merck KGaA, a global pharmaceutical and chemical group, having joined in 2003 as Managing Director of Merck Santé SAS. In 2004, Mr Schnee assumed responsibility for global commercial operations of the ethical pharmaceuticals division of Merck KGaA, and in November 2005, Mr Schnee was appointed as Deputy Member of the Executive Board responsible for the pharmaceuticals business. In 2006, he was appointed as a member of the Executive Board and General Partner of Merck KGaA, with responsibility for global pharmaceutical activities, and served in this position until 2011. Prior to Merck KGaA, Mr Schnee held senior positions in strategy, business development and marketing at UCB SA, Sanofi-Synthélabo SA, Migliara / Kaplan Associates, Inc. and Fisons Pharmaceuticals PLC. He currently serves on the Board of Directors of four privately held life sciences companies. Mr Schnee holds a BA in marketing and a masters in marketing and general management from the Swiss Institute of Business Administration in Zurich.

ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Further information disclosed pursuant to the AFEP-MEDEF Code can be found in the Investors section of our website.

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as “believe,” “expects,” “project,” “estimated,” “forecast,” “should,” “plan,” “may,” “will” or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2017 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ materially from those set forth in the forward-looking statements, due to these and other various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer Announces That the Phase III Trial for Its Sublingual Allergy Immunotherapy Tablet STAGR320 to Treat House Dust Mite-Induced Allergic Rhinitis Achieved Its Primary Endpoint

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced topline results for its phase III clinical trial to evaluate the efficacy and safety of its sublingual allergy immunotherapy tablet STAGR320 for the treatment of house dust mite (HDM)-induced allergic rhinitis. The study met its primary endpoint. Results indicated a statistically significant reduction of the Total Combined Score, the sum of the Rhinitis Total Symptom Score and the Rescue Medication Score, in patients treated with STAGR320 compared to patients on placebo. The study also reached key secondary endpoints, including overall quality of life, and showed that the treatment was generally well tolerated, confirming the favorable safety profile observed in previous studies.

This was the largest phase III study to evaluate the treatment of HDM-induced allergic rhinitis in adult and adolescent patients, recruiting more than 1,600 patients from 231 participating investigative sites in 13 countries.

“We are very pleased that the results from this confirmatory, double-blind and placebo controlled trial met its efficacy endpoints, demonstrated a favorable safety profile and validated previous clinical studies which showed that STAGR320 can bring relief to patients suffering from house dust mite-induced allergies,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “House dust mite allergy is one of the most common allergies, impacting the quality of life for patients across ages and geographies. The results of this study provide us with the confidence to seek further market registrations, including in Europe and the United States. We look forward to working with regulatory authorities around the world to make this therapy available to patients as part of our comprehensive portfolio of allergy immunotherapy products.”

Allergic rhinitis is a worldwide disease affecting more than 500 million people and the risk of developing asthma is about six times higher in patients with an allergy to house dust mites than those allergic to pollens1-4. Allergic rhinitis can include symptoms such as sneezing, runny or itchy nose, nasal congestion and watery or itchy eyes, among others1,2. Symptoms may be severe and can worsen over time with progression towards asthma, as well as have a significant impact patients’ quality of life1-3,5-8.

“Meeting the primary endpoint of this important study confirms the clinical value that STAGR320 is effective for the treatment of house dust mite allergies,” said Pascal Demoly, Professor at the Department of Pneumology and Addiction Heart Poumons Center at the University Hospital of Montpellier, France, President of the College of Allergology Teachers, President of the French Allergy Federation and a coordinating investigator. “In addition, these study results provide the physician community with compelling evidence that STAGR320 can address some of the most severe symptoms that patients experience, which ultimately has an impact on quality of life.”

“More than 500 million people globally are affected by allergic rhinitis, a condition that can be a factor of asthma onset and progress,” said Thomas Casale, MD, Professor of Medicine and Pediatrics at the University of South Florida and a coordinating investigator. “These study results demonstrate the clinical benefit that STAGR320 can offer to patients. By changing the immune response to the allergen and addressing the underlying cause of the allergy, patients have an alternative to treatment options that only affect the symptoms of the disease.”

The multi-center, randomized, double-blind and placebo-controlled study evaluated the efficacy and safety of STAGR320 at a daily dose of 300IR administered for approximately 12 months to adult and adolescent patients aged 12-65 with HDM-associated allergic rhinitis.

The study met its primary efficacy endpoint and demonstrated a statistically significant difference (p<0.0001) on the Total Combined Score (TCS) after one year of treatment in the treated group versus placebo. The TCS combined the Rhinitis Total Symptom Score (RTSS) and the Rescue Medication Score (RMS). In addition, all key secondary endpoints achieved statistical significance and, overall, the product was well tolerated.

A full assessment of the data is ongoing, with detailed results expected to be presented at future scientific congresses, including the annual European Academy of Allergy and Clinical Immunology (EAACI) Congress.

ABOUT THE STAGR320 PHASE III CLINICAL TRIAL

The phase III trial was a global, multi-center, randomized, double-blind and placebo controlled study. It evaluated the efficacy and safety of STAGR320 at a daily dose of 300IR administered to adult and adolescent patients aged 12-65 with HDM-induced allergic rhinitis. Patients who experienced HDM-associated allergic rhinitis for at least one year, who were sensitized to D. pteronyssinus and/or D. farinae mites as determined by a skin prick test and HDM-specific serum immunoglobulin E, were eligible for participation.

This was the largest phase III clinical trial conducted to evaluate the treatment of house dust mite allergy in adult and adolescent patients. The study recruited more than 1,600 patients from 231 participating investigative sites in 13 countries. International coordinating investigators were Pascal Demoly, Professor at the Department of Pneumology and Addiction Heart Poumons Center at the University Hospital of Montpellier, France, President of the College of Allergology Teachers and President of the French Allergy Federation, and Thomas Casale, MD, Professor of Medicine and Pediatrics at the University of South Florida.

ABOUT STAGR320

STAGR320 is Stallergenes Greer’s investigational sublingual allergy immunotherapy (AIT) tablet for the treatment of HDM-induced allergic rhinitis. AIT is a disease-modifying treatment that treats the underlying cause of allergy and can provide long-lasting reduction of allergy symptoms. STAGR320 is registered in Australia, Japan, New Zealand and South Korea. Results from the recent phase III trial, together with other clinical data, will form the clinical basis for the company’s potential submission of a Biologics License Application (BLA) in the United States, as well as for additional marketing authorizations in European and international markets.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014.

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as “believe,” “expects,” “project,” “estimated,” “forecast,” “should,” “plan,” “may,” “will” or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2017 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ materially from those set forth in the forward-looking statements, due to these and other various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

REFERENCES
1. Bousquet J, Khaltaev N, Cruz A, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160.
2. Brożek JL, Bousquet J, Agache I, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) Guidelines – 2016 Revision, Journal of Allergy and Clinical Immunology (2017), doi: 10.1016/j.jaci.2017.03.050.
3. Linneberg A., Henrik Nielsen N., Frolund L, et al. The link between allergic rhinitis and allergic asthma: a prospective population-based study. The Copenhagen Allergy Study. Allergy. 2002 Nov;57(11):1048-1052.
4. Calderon M. A., Linneberg A., Kleine-Tebbe J., De Blay F., Hernandez Fernandez de Rojas D., Virchow J. C., Demoly P. Respiratory allergy caused by house dust mites: What do we really know? J Allergy Clin Immunol. 2015 Jul;136(1):38-48.
5. Shin J-W, Sue J-H, Song T-W, et al. Atopy and house dust mite sensitization as risk factors for asthma in children. Yonsei Med J.2005;46:629-634
6. Leger D., Annesi-Maesano I., Carat F., et al. Allergic rhinitis and its consequences on quality of sleep: An unexplored area. Arch Intern Med. 2006 Sep 18;166(16):1744-1748.
7. Meltzer E. O. Quality of life in adults and children with allergic rhinitis. J Allergy Clin Immunol. 2001 Jul;108(1 Suppl):S45-53
8. Hankin C. S., Cox L., Lang D.,et al. Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a large-scale, retrospective, matched cohort study. Ann Allergy Asthma Immunol. 2010 2010 Jan;104(1):79-85.

Stallergenes Greer Announces U.S. FDA Approval of Pediatric Indication Extension for Oralair® Sublingual Immunotherapy Tablet for the Treatment of Grass Pollen Allergy

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the extension of the indication for Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract), an allergy immunotherapy sublingual tablet, to treat patients ages five to nine with grass pollen-induced allergic rhinitis. Oralair is the only allergy immunotherapy tablet that contains grass pollens from five of the most common grasses in the United States and received FDA approval in patients ages ten to 65 in 2014.

“We are very pleased to be able to make this effective and convenient treatment option with a demonstrated safety profile available for children ages five and over as well as adults,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “AIT can offer a valuable benefit to patients to help treat the underlying cause of allergies. Oralair provides an important option to patients who seek the relief of AIT but want the convenience of taking a tablet at home. We are committed to enabling physicians to determine the treatment method that best meets the disease and lifestyle needs of the patient.”

Allergic rhinitis affects approximately 40 to 60 million people in the U.S.1 and treatment options include allergy immunotherapy, a disease-modifying treatment that treats the underlying cause of allergy and can provide long-lasting improvements of allergy symptoms. In the U.S. AIT can be administered sublingually as a tablet, such as Oralair, or as an injectable formulation. Today, fewer than 3 million allergy sufferers (i.e., 5% of the U.S. allergic population), are treated with allergy immunotherapy.

ABOUT ORALAIR

Oralair is a sublingual tablet administration of allergy immunotherapy that contains a mix of five grass pollens: Kentucky Blue, Orchard, Perennial Rye, Sweet Vernal and Timothy. The five grass pollens contained in Oralair represent those to which most patients in the U.S. are exposed.

Oralair is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis for any of the five grass species contained in this product. Oralair has been approved based on results from an extensive clinical development program and has been studied in double-blind, placebo-controlled trials in Europe and the United States in over 2,500 adults and children. The results of these trials demonstrated that pre-seasonal and co-seasonal treatment reduces patients’ allergy symptoms and their need for symptom-relieving medication (Oralair is not indicated for immediate relief of allergy symptoms). In the clinical development program, the most common adverse reactions for Oralair (reported in ≥5% of patients) were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough and oropharyngeal pain.

1 https://acaai.org/allergies/types/hay-fever-rhinitis

To support administration of Oralair in the pediatric population, an open-label study was conducted to evaluate the 30-day safety profile of Oralair in 307 children five through nine years of age. Adverse reactions reported at an incidence of ≥2% were: throat irritation (22.1%), oral pruritus (11.7%), oral paresthesia (11.1%), tongue pruritus (8.1%), mouth edema (6.2%), cough (6.2%), oropharyngeal pain (4.2%), ear pruritus (5.2%), eye pruritus (4.6%), lip edema (3.3%), vomiting (2.6%), tongue edema (2.3%), abdominal pain (2.3%), oral discomfort (2.3%), and ocular hyperemia (2.0%).

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made, and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2017 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to those and other factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer Delivers Double Digit Growth and Solid Business Performance in the First Half of 2018; Announces Senior Leadership Succession Plan

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer, a biopharmaceutical company specialising in treatments for respiratory allergies, today announced its half-year results for the six-month period ended 30 June 2018.

H1 2018 Financial Highlights

(in € million)   H1 (unaudited)
  2018   2017   % change
Net sales   142.3   129.6   10%
Gross margin   96.9   83.4   16%
Gross margin as a % of sales   68%   64%    
EBIT   17.4   (3.5)   n.a.
Net income/(loss)   13.6   (8.9)   n.a.
EBITDA   27.6   8.3   n.a.
EBITDA as a % of sales   19%   6%    
   

Fereydoun Firouz, Chairman and Chief Executive Officer of Stallergenes Greer, commented:

“Our performance through the first half of 2018 reflects our continued focus on business fundamentals: grow our share in priority markets and strengthen profitability to sustain investments. We delivered double digit sales growth in a competitive global market, despite reimbursement and pricing challenges in European and International markets. At the same time, we reduced our operating expenses by 12% while investing in quality at each of our global manufacturing sites and advancing our clinical pipeline.

Our ability to drive growth while controlling our costs resulted in another important milestone in our recovery that is critical for the future of our company: positive net income at €13.6 million compared to a loss of €8.9 million in the first half of 2017. We also succeeded in generating positive cash flow. As a result of these important milestones being reached, we now have the organizational flexibility, balance sheet stability and internal capability to pursue our goals. We will continue to grow and expand our current business and be opportunistic to accelerate our future growth through external innovation.

In the second half of 2018, we will solidify our leadership position in priority markets and continue to grow our share strategically across our Europe/International and Americas regions. We also expect to release initial results from the phase III clinical trial for our house dust mite tablet candidate STAGR320 later this year. Most importantly, we will sustain our commitments to quality and technical operations to offer a complete range of high quality subcutaneous and sublingual AIT treatments that meet the current global market demand, to position ourselves for future growth and to deliver long-term value creation.”

Half-year net sales increased 10% because of continued growth across the product portfolio and regions

Net sales by region: Solid growth in Southern Europe and the United States

(in € million)   H1 (unaudited)
  2018   2017   % change
Southern Europe   72.1   53.7   34%
North & Central Europe   17.9   18.5   (3)%
International   6.9   11.8   (42)%
United States   45.4   45.6   (0)%
   

The 10% increase year-over-year in first half net sales reflects strong growth in Southern Europe and in the United States. However, results in the United States were negatively impacted by foreign currency exchange. While reported sales were stable compared to the same period in 2017, the region delivered 12% year-over-year sales growth in local currency (USD).

Stallergenes Greer continued to gain share in the European grass tablet market with Oralair®1 and in the German birch tree market with Staloral®2. In addition, the Company had a strong performance in France, Italy, Switzerland, the Benelux region, Slovakia and Russia. Sales in international markets were down due to a combination of effects from the application of the new revenue recognition standard from 1 January 20183 and a large shipment of products in the same period of 2017 to prepare for in-market launches.

In the United States, Stallergenes Greer has strengthened its leadership of the bulk allergen market by executing on a recalibrated marketing approach as well as by maximising production capabilities to meet the demand of a market-wide shortage of priority allergens during a high allergy season in the United States.

Net sales by product category: Sublingual sales grew in EU/International while United States strengthened leadership position in subcutaneous

(in € million)   H1 (unaudited)
  2018   2017   % change

Sublingual 4

  91.3   76.9   19%

Subcutaneous 5

  34.7   36.9   (6)%
Veterinary   4.3   5.0   (14)%

Other products 6

  12.0   10.8   11%
   

In the first half 2018, sublingual product sales increased 19% to €91.3 million from the first half of 2017, primarily driven by Staloral as a result of market share gains in priority markets, a strong performance in the paediatric market and, to some extent, the industry-wide shortage of subcutaneous immunotherapy treatments in Europe.

In the subcutaneous product category, the Company reported first half 2018 sales of €34.7 million, a 6% decrease compared to 2017. In Europe/International, sales decreased as a result of production delays at the Company’s Antony facility. In the U.S., solid sales growth was offset by the negative impact of foreign currency exchange.

First half 2018 veterinary sales declined 14% to €4.3 million compared to the same period of 2017, due to increased competition in this segment and the negative impact of foreign exchange. Sales from the other product category grew 11% year-over-year to €12.0 million in the first half of 2018 as a result of captured market opportunities in the U.S.

_______________
1 Source: IQVIA MIDAS
2 Source: Insight Health
3 IFRS15
4 Product category includes oral drops (Staloral) and tablets (Oralair and Actair®)
5 Product category includes Named Patient Prescription products and bulk allergens
6 Product category includes diagnostic and ancillary products

Operational efficiencies delivered margin improvement and return to positive net income

Stallergenes Greer’s first half 2018 gross margin of €96.9 million represented a margin of 68% of net sales, compared to 64% in the prior year first half. In addition, efficiency measures continued to deliver significant cost savings and the Company reported a positive first half 2018 EBIT of €17.4 million, compared to a loss of €3.5 million in the same period of 2017. First half 2018 EBITDA increased by €19.3 million to €27.6 million as a result of a €12.7 million increase in sales as well as a 12% decline in operating expenses, from €86.8 million in the first half of 2017 to €76.6 million in the same period of 2018. The Company reported a net income of €13.6 million in the first half of 2018, compared to a net loss of €8.9 million in the same period of 2017. As of 30 June 2018, the Company’s shareholders’ equity represented 83% of the balance sheet total.

Company continues to invest in innovation to fuel long-term growth

Stallergenes Greer is committed to developing innovative therapies for major respiratory allergies and invested €20.1 million in R&D in the first half of 2018, primarily to fund the phase III global multi-centre clinical trial for the Company’s tablet candidate STAGR320 for the treatment of house dust mite-induced allergic rhinitis. With more than 1,600 patients enrolled, this is the largest study conducted to assess the efficacy and safety of a sublingual immunotherapy tablet treatment. The Company expects to release top line results from the trial during the fourth quarter of 2018.

In addition, Stallergenes Greer announced positive results from two real-world evidence studies regarding the use of allergy immunotherapy (AIT) compared to the use of only symptomatic treatments to treat patients with respiratory allergies in June 2018. These studies were retrospective longitudinal analyses of French and German prescription databases and further substantiated the long-term benefits of AIT to significantly reduce the need for allergic rhinitis and asthma medication in patients suffering from grass pollen- and birch tree pollen-induced allergies. These studies are part of the BREATH real-world evidence program, which is designed to understand the real-world benefits of AIT outside of a clinical trial setting.

Investments in Quality and Technical Operations to continue

Stallergenes Greer continued investments in Technical and Quality Operations capabilities at all its manufacturing sites to comply with evolving regulatory requirements and the latest Good Manufacturing Practice (GMP) biological manufacturing standards; to strengthen its quality culture across the organisation; and to ensure product quality and patient safety for all released and distributed products.

During the first half of 2018, the Company successfully completed maintenance of its manufacturing operations with major renovations and upgrades. In France, the Company continued to progress on its remediation plan to address observations related to a 4 January 2018 injunction for its Antony facility from the National Agency for Medicines and Health Products Safety (ANSM), including renovation to key manufacturing areas, employee training and an enhanced quality system focused on consistency across operations. In the U.S., the Company continued to strengthen its quality system and introduced state-of-the-art manufacturing technologies and advanced initiatives to increase capacity.

The company also demonstrated its manufacturing flexibility to meet market demands during the first half of 2018. In France, the company increased production of sublingual products to partially offset the temporary shortage of injectable products in the European/International markets and sourced a new venom supply to meet a market shortage in Europe and Asia. In the U.S., the company increased its volume and delivered high priority allergens.

2018 Business Outlook unchanged

The Company expects 2018 net sales to be in the range of €270 million to €280 million and EBITDA to be in the range of €40 million to €50 million.

Senior Leadership Succession Plan

Fereydoun Firouz, currently Chairman & Chief Executive Officer, has informed the Board of his decision to retire from these positions at the end of 2018. He will be succeeded at that time as Chairman by Stefan Meister, a member of the Board since 2015, and as Chief Executive Officer by Michele Antonelli, currently Executive Vice President, Head of Europe & International & President of Stallergenes SAS. The announcement comes at the culmination of the successful turnaround of the Company led by Fereydoun Firouz. Stallergenes Greer is now well positioned to regain its global market leadership and continue its positive business momentum.

Fereydoun Firouz said “Stallergenes Greer is a special company with an inspiring purpose and highly dedicated people. By the end of 2018, I will have been Chairman and CEO for nearly four years and I believe this is the right time for a new leader to build upon what has been accomplished. I have been privileged to work with a passionate leadership team to successfully overcome some challenging phases and ultimately deliver the strong results we published today. These results demonstrate our achievements and the Company can now look to the future with great confidence. Michele has been an instrumental leader in the Company’s success over the past three years. He has the expertise and experience to take the lead as CEO and drive Stallergenes Greer to its next phase of growth.”

Fereydoun continued “I will leave the Company in very good hands and at a time when the strategy we devised and executed is showing through in our financial results and market performance. My colleagues on the Board of Directors and the management team have the knowledge and abilities to take the Company to new heights and capitalise on our product, manufacturing, and geographic opportunities. I would also like to thank the Board and our shareholders for their resolute support at all times and wish the very best success to the Company.”

“On behalf of the Board and our shareholders, I would like to recognise and thank Fereydoun for his remarkable contribution to the Company and its performance.” said Elmar Schnee, an Independent Director and the Chairman of the Remuneration and Appointment Committee. “Fereydoun oversaw the creation of the Company through the successful integration of Stallergenes and Greer Laboratories in 2015 and then led it through the resolution of significant problems from an earlier implementation of Enterprise Resource Planning software that unfortunately temporarily halted the supply of products in early 2016 to its major markets.”

He concluded by saying “Fereydoun combined a determination and relentless commitment to meeting challenges, with a penetrating vision to first develop and then implement a strategy to successfully bring the Company back to a path of growth and profitability. There is no doubt that the strength of the Company today is due to his leadership, of both the Company’s strategy and its great people. We recognise these achievements and are truly grateful for Fereydoun’s dedicated service and for assisting the process of transition until the end of 2019.”

The Chairman-designate, Stefan Meister, then welcomed Michele Antonelli to the role of Chief Executive Officer and said “In Michele we are fortunate to have ready the leader for the next phase of the Company’s development. His experience and insight, combined with his commitment and passion for the business, are the ideal combination of talent and motivation for the future of Stallergenes Greer. I look forward to serving as Chairman and join Elmar in thanking Fereydoun for his great service to the Company over the last four years.

Commenting on his appointment, Michele said today “I am honoured to have been invited to take on the role of CEO of Stallergenes Greer. This Company is a global leader in an important and growing market and makes a real difference to the lives of the patients it serves. The transformation driven by Fereydoun over the last four years leaves us in a remarkable place, ready to move forward and deliver even more outstanding results for all its stakeholders. I am delighted to accept this position at such an exciting time and look forward to working with the team of great professionals Fereydoun has attracted to the Company and build upon the strong foundations he has secured for this fantastic business.

Michele Antonelli has more than 20 years of international experience in the biopharmaceutical industry with extensive expertise in both manufacturing and commercial. He previously worked at UCB, the multinational biopharmaceutical Company, where he held roles of various responsibility and scope, most recently serving as Executive Vice President and Head of lmmunology Europe, overseeing the region’s commercial, medical, and market access activities. Prior to joining UCB, Michele spent 16 years at Merck Serono, ultimately serving as Senior Vice President and Global Head of Biotech Manufacturing and Process Development.

The Company and Fereydoun Firouz will enter into an agreement governing Fereydoun Firouz’s retirement from the Company that reflects the terms of his existing contract of employment. This agreement contemplates a one-year garden-leave period that will run through to the end of 2019, consistent with Fereydoun Firouz’s existing one year undertaking to not compete with the Company. During this one-year garden-leave period, Fereydoun will assist as needed with the transition to the Company’s new leadership, providing support as required to Michele Antonelli and to the Board and management team generally when requested. At the end of 2019, Fereydoun Firouz will leave the Company’s employment and be entitled to the severance terms set out in his existing contract.

Webcast and Conference Call Information

Stallergenes Greer will host an Investors and Analysts meeting tomorrow, 30 August 2018. The event will be available via live webcast at 10:30 am GMT / 11:30 am CET / 5:30 am EDT. The webcast will be available via the following link: https://edge.media-server.com/m6/go/STAGR_18HY and on the Company’s website,
http://stallergenesgreer.com/financial-calendar-events.

Participants are asked to connect at least 15 minutes prior to the conference call to register, download and install any necessary audio software.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION

Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made, and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2017 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

TABLE OF CONTENTS

Consolidated income statement as of 30 June 2018

Consolidated balance sheet as of 30 June 2018

Consolidated cash flow statement as of 30 June 2018

The financial information set out above does not constitute the Group’s financial statements for the period ended 30 June 2018 and 2017 but are derived from those statements. The annual report for 2017 have been delivered to the UK Companies House. The auditor has reported on those statements. Their report was unqualified, did not draw attention to any matters by way of emphasis and did not contain statements under Section 498 (2) or (3) Companies Act 2006 or equivalent preceding legislation. While the financial information included in this preliminary announcement has been computed in accordance with International Financial Reporting Standards (IFRS), this announcement itself does not contain sufficient information to comply with IFRS.

The Group published full financial statements that comply with IFRS that are available on its website at http://stallergenesgreer.com/half-year-report .

The financial statements were approved by the Board of Directors on 29 August 2018.

Consolidated income statement as of 30 June 2018

For the period ended 30 June 2018

€ thousands     30 June

2018

    30 June

2017

Net sales 142,327 129,615
Other revenue 57 10
 
Total revenues 142,384 129,625
 
Cost of goods sold (45,531) (46,265)
 
Gross margin 96,853   83,360
 
Distribution costs (5,439) (5,383)
Selling and marketing expenses (24,447) (29,894)
Administrative expenses (24,626) (28,807)
Other general expenses (3,168) (1,027)
Selling, general and administrative expenses (57,680) (65,111)
 
Research and development costs (R&D) (20,132) (24,947)
R&D-related income 1,189 3,225
Net R&D costs (18,943) (21,722)
 
Operating result (EBIT) before transformation costs 20,231 (3,473)
 

Transformation costs

(2,800)

-

 
Operating result (EBIT) 17,430 (3,473)
 
Financial income 3 20
Financial expenses (401) (847)
Net financial expense (398) (827)
 
Net income / (loss) before tax and associates 17,032 (4,300)
 
Income tax (3,394) (4,582)
Share of loss from associated companies - (8)
     
Net income / (loss) for the period 13,638 (8,890)
 

All the activities were in respect of continuing operations.
The basic profit and diluted net income per share for the six months to June 2018 was € 0.69 (June 2017: loss of € 0.45)

Consolidated balance sheet as of 30 June 2018

As at 30 June 2018

€ thousands     30 June

2018

  31 December

2017

Goodwill 199,711 195,187
Other intangible assets 67,878 70,913
Property, plant and equipment 66,768 69,138
Non-current financial assets 4,279 3,957
Deferred tax assets 26,717 26,754
Other non-current assets 237 237
Non-current assets 365,590 366,186
 
Inventories 60,828 56,793
Trade receivables 26,030 33,199
Current financial asset 732 684
Other current assets 10,888 9,231
Current income tax receivable 661 611
Research tax credit and subsidies receivable 26,151 22,708
Cash and cash equivalents 70,702 50,849
Current assets 195,991 174,075
Total assets 561,581 540,261
     
Share capital 19,788 19,788
Share premium 539 539
Merger and contribution premium 342,149 342,149
Revaluation reserve (236) (236)
Retained earnings 103,448 85,086
Group shareholders’ equity 465,688 447,326
Non-controlling interests

-

-
Total shareholders’ equity 465,688 447,326
 
Provision for employee retirement obligations and related benefits 3,560 3,442
Non-current provisions 526 514
Non-current financial liabilities 6,318 6,318
Deferred tax liabilities 6,432 6,283
Non-current liabilities 16,836 16,557
 
Trade payables 23,836 19,793
Current provisions 4,547 2,115
Current financial liabilities 12,378 12,204
Income tax payable 2,538 1,313
Other current liabilities 35,757 40,953
Current liabilities 79,057 76,378
Total equity and liabilities 561,581 540,261
 

Consolidated cash flow statement as of 30 June 2018

€ thousands     30 June

2018

  30 June

2017

Cash flow from operating activities
 
Group share of net income / (loss) 13,638 (8,890)
Share of earnings from equity accounted investments 8
Tax 3,394 4,582
Net financial result 398 827

Amortisation and depreciation charges

11,728 11,752
Change in provisions 2,620 (3,048)
Share-based compensation 976 1,391
Capital losses from disposal of assets 1,090 49
Financial (profits) / losses excluding interest (2) (385)
     
Operating cash flow before changes in working capital 33,842 6,286
 
Current income tax paid (2,418) (961)
Change in subsidies and R&D tax credit receivables (3,253) (3,585)
Change in working capital of operating activities (1,681) (13,375)
Change in deferred income 82 (315)
     
Net cash flow from operating activities 26,572 (11,950)
 
Cash flow from investing activities
 
Purchase of non-current assets (8,319) (4,653)
Acquisition of investments in consolidated undertakings, net of cash acquired
Proceeds from sale of non-current assets 2,363 2,274
Change in working capital of investment activities (906) (2,234)
     
Net cash flow from investing activities (6,862) (4,613)
 
Free cash flow after investing activities 19,710 (16,563)
 
Cash flow from financing activities
 
Treasury shares transactions 48 374
Net financial interest received / (paid) (396) (441)
Repayment of bank overdrafts (8) (238)
Repayment of borrowings (5,368) (15,704)
Proceeds from borrowings 5,393 9,766
     
Net cash flow from financing activities (331) (6,243)
 
Change in cash and cash equivalents 19,379 (22,806)
 
+ Cash and cash equivalents – opening balance 50,849 71,262
-/+ effect of translation adjustment on foreign currency - denominated cash 474 (811)
= Cash and cash equivalents – closing balance 70,702 47,645
 

Stallergenes Greer to Report First Half Financial Results on 29 August 2018

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced it will report financial results for the first half of its 2018 fiscal year after the market closes on 29 August 2018. The Company’s management will host a live audio webcast of its earnings conference call the following day, 30 August 2018, at 10:30 am London / 11:30am Paris / 5:30 am Boston to discuss the results.

Members of the financial community may access the conference through the dial-in information provided on the company’s website at http://stallergenesgreer.com/financial-calendar-events. The live audio webcast will be accessible to the general public via the following link: https://edge.media-server.com/m6/go/STAGR_18HY. Participants are asked to connect at least 15 minutes prior to the conference call to register, download and install any necessary audio software.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2017 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer Shareholders Approve All Resolutions Proposed by the Board of Directors at the Annual General Meeting

LONDON--(BUSINESS WIRE)-- Regulatory News:

The shareholders of Stallergenes Greer plc (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, announces that all resolutions proposed by the Board of Directors at the company’s Annual General Meeting (AGM) were duly passed today. All resolutions were set out in the Notice of Meeting posted to shareholders on 23 April 2017.

Notably, shareholders re-elected Chairman and CEO Fereydoun Firouz, and Directors, Jean-Luc Bélingard, Rodolfo Bogni, Stefan Meister, Yvonne Schlaeppi and Elmar Schnee – each for a further term of one year.

The terms of Patrick Langlois and Paolo Ricci have expired at the end of the AGM. The Board would like to thank both Patrick for his contributions to Stallergenes Greer as a Board member and Chair of the Audit Committee, and Paola for her contributions as a Board member.

In addition, Philip Broadley was elected as a Director with a one-year term. Mr Broadley has significant financial and international business experience, having previously been Group Finance Director of Prudential plc for eight years and Old Mutual plc for six years. He is currently a director of AstraZeneca plc and serves on their Audit Committee, and is also a director and the Audit Committee chairman of Legal & General Group plc. He is a member of the Oxford University Audit Committee, Treasurer of the London Library and Chairman of Governors at Eastbourne College. He is a Fellow of the Institute of Chartered Accountants in England and Wales. Mr Broadley started his career at Arthur Andersen where he was a partner for seven years. He is a past Chairman of the 100 Group of Finance Directors in the UK and served as a member of the Code Committee of the Takeover Panel. He graduated in Philosophy, Politics and Economics from St Edmund Hall, Oxford and has an MSc in Behavioural Science from the London School of Economics.

“2017 continued a transformation at Stallergenes Greer to improve our operations, serve our customers and deliver a strong performance. I would like to thank all of our Directors for their contributions and guidance, and our shareholders for their continued support. I would also like to welcome Philip Broadley to our Board of Directors. Philip has extensive experience in corporate finance and will be a valuable contribution to our Board and Audit Committee where he will serve as Chair,” said Chairman and CEO, Fereydoun Firouz, “We remain focused and committed to strengthening our leadership position, driving excellence across our business and positioning our company for long-term growth in order to deliver value to our shareholders, customers and employees.”

The full text of each resolution is set out in the Notice of Annual General Meeting, which is available on Stallergenes Greer's website at www.stallergenesgreer.com.

ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer Provides Business Update and Refines Its 2018 Financial Outlook

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today provided an update on its business performance and refined its 2018 business outlook. The revised outlook reflects a solid start to the year with company-wide operational efficiency improvements; market share gains across the portfolio and geographies; and improved clarity on market access in Europe.

“Our performance during the first months of 2018 confirm the strength of Stallergenes Greer’s business fundamentals. We have continued the momentum from 2017 and, we are executing on our commercial priorities,” said Fereydoun Firouz, Chairman and Chief Executive Officer. “With increased profitability, we can now confidently focus on our future, by sustaining our investments in both innovation and the upgrades of our manufacturing sites and quality systems.”

Performance through the first months of 2018 was driven by several factors:

  • Operational Efficiency: The company was able to effectively manage its expenses through a series of efficiency measures that resulted in earlier than expected cost savings. As the year progresses, the company will continue its commitment to operational efficiency while investing in manufacturing upgrades and innovation, including the completion of the phase III trial for the company’s House Dust Mite tablet candidate, STAGR320.
  • Commercial Excellence in Europe and International: Strong sales and marketing execution in Europe and International have continued to result in market share gains, especially in France, Italy and Eastern Europe. Staloral has consistently outpaced competition and Oralair has continued to gain shares in key markets. Data from the BREATH real-world evidence program presented last week at the European Academy of Allergy and Clinical Immunology Congress continue to strengthen the value proposition of these products.
  • Leadership in North America: Stallergenes Greer continues to lead the core bulk allergen business in the U.S. and Canada. While the U.S. grass tablet market has declined versus 2017, the recalibration of the commercial strategy has improved the profitability of the Oralair franchise and the company is building a sustainable platform to capture future growth in the tablet market.
  • Market access in Europe: The recent clarification of the reimbursement framework in France for Named Patient Products and the confirmation of the increase of governmental funding for Oralair in Italy have provided clarity and therefore better predictability into the business.

Investments in Quality and Technical Operations Continue

On the manufacturing front, Stallergenes Greer has made major investments in the quality systems and modernization of the manufacturing sites in Antony and Amilly, France and in Lenoir, in the U.S. In addition, the company increased the manufacturing and supply of sublingual products to meet market demand and partially offset the temporary shortage of injectable products in the European and International markets.

The company has continued to progress through its remediation plan in Antony, following the injunction received on 4 January 2018 from the French National Agency for Medicines and Health Products Safety (ANSM). Several actions are underway and the company is committed to addressing all the observations of the agency and strengthening its quality culture across the organization. For example, significant renovation work is underway and extensive training has been completed for the employees working on aseptic operations, traceability of pharmaceutical operations and deviations.

As part of the proceedings related to the injunction, the company received notification of potential financial penalties in the event of non-compliance with the agreed timelines. Stallergenes Greer is engaging with the ANSM regarding this notification and it would be premature to make any conclusion about the outcome. If sanction applied, the penalties are expected to be €1 million or less.

2018 Revised Financial Perspectives

With the current performance and clarity of market access in Europe, the company now expects 2018 net sales to be in the range of €270 million to €280 million and EBITDA to be in the range of €40 million to €50 million. This is updated from the outlook provided on 22 March 2018. At that time, the company expected mid-single digit revenue growth and EBITDA to be higher than 2017’s EBITDA of €21.9 million.

The financial data that support the statements presented in this press release are the company’s current and best estimates and have not been audited or reviewed by the statutory auditors. The company will provide an update to the market during its earnings call on 30 August 2018.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2017 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com . Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer plc: Two New Real-World Evidence Studies Show Long-Term Benefits of Sublingual Allergy Immunotherapy

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, announced positive results from two real-world evidence studies regarding the use of allergy immunotherapy (AIT) compared to the use of only symptomatic treatments to treat patients with respiratory allergies. These studies were retrospective longitudinal analyses of French and German prescription databases and further substantiated the long-term benefits of AIT to significantly reduce the need for allergic rhinitis and asthma medication in patients suffering from grass pollen- and birch tree pollen-induced allergies. These studies are part of the BREATH real-world evidence program, which is designed to understand the real-world benefits of allergy immunotherapy outside of a clinical trial setting.

“As a global leader in allergy immunotherapy, we are pleased to be able to provide further evidence into the real-world effectiveness of allergy immunotherapy for patients across Europe,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “The BREATH program has allowed us to deepen our knowledge and understanding of real-life patient outcomes. We look forward to bringing these outcomes to international forums to provide further evidence on the benefits that AIT can offer to a broader range of patients suffering from respiratory allergies. Today, less than 1% of patients are treated with allergy immunotherapy.1

Grass pollen tablets demonstrate effectiveness in reducing allergic rhinitis and asthma medication intake for allergic rhinitis patients in France 6,7,8
This retrospective analysis is based on four years’ worth of prescription data from 28,574 patients in France and demonstrated the statistically significant long-term benefit of grass pollen AIT sublingual tablets, including Stallergenes Greer’s Oralair®, on grass pollen-induced allergic rhinitis compared to only symptomatic treatments. The study included 1,099 patients treated with AIT sublingual tablets as well as symptomatic medications, and a non-AIT control group of 27,475 patients receiving only symptomatic medications. Study results showed that the number of symptomatic medication prescriptions per patient per year decreased by 50 percent in the post-treatment follow-up in the AIT group, compared to an increase of prescriptions (30 percent) for patients in the non-AIT group who were using only symptomatic treatments. In addition, the risk of new asthma medication onset in the AIT group during the follow-up period was 63 percent lower when compared to the non-AIT group (p=0.0025). Among patients who were already taking asthma medications at the onset of the study, AIT was associated with a 40 percent decrease in asthma medication prescriptions during post-treatment follow-up versus baseline, compared to a 20 percent increase of asthma medication prescriptions among the non-AIT group.

“The results from this study are significant and further demonstrate the positive impact allergy immunotherapy can bring to allergic patients,” said Professor Pascal Demoly, from Montpellier University’s Pneumology and Addiction Department and a member of the study’s scientific committee. “First, there is a clear benefit to AIT, showing that AIT reduced symptomatic medication prescriptions where patients who received only symptomatic treatments saw their need for medication increase. Second, these results are consistent with those obtained in Germany, confirming the scientific solidity of the methodology and suggesting transferability to other countries.”

Birch tree AIT demonstrates effectiveness in reducing allergic rhinitis and asthma medication intake for allergic patients in Germany 9,10,11
The retrospective analysis based on eight years’ worth of prescription data from 54,006 patients in Germany demonstrated the statistically significant long-term benefit of birch tree pollen AIT treatments, including Stallergenes Greer’s Staloral® sublingual drops, on birch tree-induced allergic rhinitis and asthma compared to only symptomatic treatments. The study included 9,001 patients treated with AIT (administered as either a sublingual or subcutaneous formulation) as well as symptomatic treatments, and a non-AIT control group of 45,005 patients receiving only symptomatic treatments. During the follow-up period, significantly more patients in the AIT group (65 percent) were free of allergic rhinitis symptomatic medications compared to the non-AIT group (47 percent). In addition, during the follow-up period, 49 percent of AIT patients using asthma therapy at baseline were asthma medication free compared to 35 percent of non-AIT patients. Finally, during treatment, new onset of asthma medication was significantly reduced in the AIT group compared to the non-AIT group (p=0.001)

“This data provides new insight on allergy immunotherapy benefits for asthmatic patients,” said Professor Ulrich Wahn, Department for Pediatric Pneumology and Immunology, Charité Medical University, Berlin and a member of the study’s scientific committee. “This study builds upon our understanding of AIT and will help health care providers around the globe to make more informed decisions about how to treat patients suffering from respiratory allergies.”

Data from both studies were presented this week at the annual European Academy of Allergy and Clinical Immunology (EAACI) Congress, held in Munich, Germany. The studies are part of the BREATH real-world evidence program. The first BREATH study to be released, Zielen, et. al12, followed a similar study design and analyzed prescription data from patients with grass pollen-induced allergic rhinitis in Germany. The study was published in the peer-reviewed journal Allergy in May 2017 and its results were consistent with those released today. The three studies, funded by Stallergenes Greer, were conducted in collaboration with IQVIA (formerly Quintiles IMS), a 3rd party clinical research organization, and designed by independent scientific committees.

ABOUT BREATH
The BREATH (Bringing Real-World Evidence to Allergy Treatment for Health) real-world evidence program, sponsored by Stallergenes Greer, is designed to gather real-world data about the benefits of allergy immunotherapy (AIT). Allergy Immunotherapy is a disease-modifying treatment that treats the underlying cause of allergy and can provide long-lasting improvements of allergy symptoms. AIT can be administered sublingually (oral drop, tablet) or as an injectable formulation.

Real world data has the potential to supplement randomized controlled trial data by providing additional information about how AIT performs in routine medical practice, nevertheless, they have several limitations and cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment.

The BREATH studies reviewed prescription data for a variety of AIT products, including Stallergenes Greer’s Oralair and Staloral. Oralair is a sublingual allergy immunotherapy tablet with a mix of five grass allergen extracts (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) currently authorized in more than 30 countries around the world, including most European countries, the United States, Canada, Australia, and Russia for the treatment of grass pollen allergic rhinitis. Staloral is a sublingual immunotherapy oral drop, currently available in more than 40 countries, including most European countries for the treatment of allergy involving rhinitis, conjunctivitis, rhino-conjunctivitis or asthma (mild to moderate) of a seasonal or perennial nature, in adults and children (from the age of 5 year). Staloral is not approved in the U.S.

ABOUT STALLERGENES GREER
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2017 annual report published on 30 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

REFERENCES

1. Ozdoganoglu T, Songu M. The burden of allergic rhinitis and asthma. Ther Adv Respir Dis. 2012;6(1):11-23.
2. Simons FE. Allergic rhinobronchitis: the asthma-allergic rhinitis link. J Allergy Clin Immunol. 1999;104(3 Pt 1):534-40.
3. Greiner AN, Hellings PW, Rotiroti G, Scadding GK. Allergic rhinitis. Lancet. 2011;378:2112-22.
4. Van Bever HP, Samuel ST, Lee BW. Halting the allergic march. World Allergy Organ J. 2008;1:57-62.
5. Shaker M. New insights into the allergic march. Curr Opin Pediatr. 2014;26:516-20.
6. Devillier P., Demoly P., Ansolabehere X., Coulombel N., Molimard M., Impact of grass pollen sublingual immunotherapy tablets on allergic rhinitis and asthma: methodological aspects of a real-life, retrospective database analysis performed in France, EAACI 2018
7. Demoly P., Devillier P., Ansolabehere X., Molimard M., A real-life, long-term, retrospective analysis evidencing slower progression of grass pollen allergic rhinitis in patients treated with sublingual immunotherapy tablets, EAACI 2018
8. Demoly P., Molimard M., Ansolabehere X., Maurel F., Devillier P., A real-life, retrospective analysis evidencing slower long-term progression of asthma in grass pollen allergy patients treated with sublingual immunotherapy tablets, EAACi 2018
9. Ulrich Wahn, Claus Bachert, Joachim Heinrich, Hartmut Richter and Stefan Zielen, AIT has long-term benefits for patients with allergic rhinitis and/or asthma induced by birch family pollen: refinement of real-world study methodology designed to increase robustness of findings, EAACI 2018
10. Claus Bachert, Ulrich Wahn, Joachim Heinrich, Hartmut Richter and Stefan Zielen, Allergy immunotherapy provides long-term relief of birch family pollen-associated allergic rhinitis up to 6 years following treatment cessation: a real-world dataset analysis, EAACI 2018
11. Stefan Zielen Ulrich Wahn, Claus Bachert, Hartmut Richter and Joachim Heinrich, AIT is associated with reduced risk of asthma medication initiation and evolution up to 6 years after stopping AIT in patients with birch family pollen-induced allergic rhinitis and/or asthma, EAACI 2018
12. Zielen, S., Devillier, P., Heinrich, J., Richter, H. and Wahn, U. Sublingual immunotherapy provides long-term relief in allergic rhinitis and reduces the risk of asthma: a retrospective, real-world database analysis. Allergy. May 2017. doi:10.1111/all.13213

 

Notification to Stallergenes Greer Shareholders of Annual General Meeting on 7 June 2018

LONDON--(BUSINESS WIRE)-- Regulatory News:

The shareholders of Stallergenes Greer plc (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, are hereby informed that they are invited to attend the Company’s Annual General Meeting at la Maison de la Recherche, 54 rue de Varenne, 75007 Paris, France, on 7 June 2018 at 2:00p.m. (CET).

Notice of the meeting is available in the “Investors” section of the Company website at www.stallergenesgreer.com. It contains the draft resolutions proposed by the Board of Directors, the explanatory notes and the main conditions under which shareholders may participate, vote and exercise their rights.

All documents are at the disposal of shareholders, as part of the Annual General Meeting, and are available at the registered office of the Company in London (40 Bernard Street, 3rd Floor, London WC1N 1LE, United Kingdom), in Antony (6 rue Alexis de Tocqueville, 92160 Antony, France), and also in the “Investors” section of the Company’s website (www.stallergenesgreer.com), in “Results & Presentations / Annual General Meeting / 2018”.

ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer Announces Publication of Its 2017 Annual Report

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced the publication of its 2017 Annual Report.

Approved by the Company’s Board of Directors on 13 April 2018, the report can be downloaded via the link below.

http://stallergenesgreer.com/sites/default/files/investors/documents/2017_annual_report.pdf

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer Reports Solid Growth and Continued Recovery in 2017, Delivering on Full Year Guidance

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced its full year results for the year ended 31 December 2017.

                   

FY 2017 Financial Highlights

                   
(in € million)     H1 (unaudited)     H2 (unaudited)     Full Year (audited)
    2017     2016     % change     2017     2016     % change     2017     2016     % change
Net sales     129.6     78.0     66%     130.6     108.2     21%     260.2     186.2     40%
Gross profit     83.4     34.7     140%     82.4     66.3     24%     165.8     101.1     64%
Gross margin     64%     45%     19 points     63%     61%     2 points     64%     54%     10 points
EBIT     (3.5)     (58.5)     n.a.     (1.9)     (37.5)     n.a.     (5.4)     (96.0)     n.a.
Net profit/(loss)     (8.9)     (39.0)     n.a.     (1.0)     (21.5)     n.a.     (9.9)     (60.5)     n.a.
EBITDA     6.3     (45.1)     n.a.     15.7     (22.9)     n.a.     21.9     (67.9)     n.a.
EBITDA margin     5%     n.a.     n.a.     12%     n.a.     n.a.     8%     n.a.     n.a.
                                                       

Fereydoun Firouz, Chairman and Chief Executive Officer of Stallergenes Greer, commented:

“2017 was a pivotal year and the results we delivered are evidence of the Group’s transformation which began two years ago. We met our financial guidance and returned to a positive EBITDA representing a €90 million swing over 2016. We reached key innovation milestones, including the completion of patient enrolment in a Phase III trial for our house-dust mite tablet candidate, STAGR320, and the publication of real-world data from the BREATH studies, which notably demonstrated that Oralair® improved control of allergic rhinitis and may have a preventive effect on allergic asthma onset and progression compared to symptomatic treatments.

We made significant progress commercially, delivering a 40% increase in net sales year-over-year as a result of recapturing market share across our product portfolio in all European geographies and continuing to hold market leadership in the U.S. subcutaneous treatment market.

In 2018, we will continue to focus on commercial execution, optimizing our current product portfolio to gain further market share, and developing new offerings to expand allergy immunotherapy penetration in market segments where we see growth opportunities. Our operational plan is focused on driving top line growth, improving profitability, continuing our innovation path and upgrading our technical operations capabilities.”

Full-year net sales increased 40% as a result of market share gains in European and International markets and sales growth of the sublingual product category

Net sales by region: Europe and International grew significantly; Leading position held in the U.S.

(in € million)     H1 (unaudited)     H2 (unaudited)     Full Year (audited)
    2017     2016     % change     2017     2016     % change     2017     2016     % change
Southern Europe     53.7     17.8     202%     65.3     44.3     47%     119.0     62.1     91%
North & Central Europe     18.5     10.7     73%     15.2     12.4     22%     33.7     23.1     45%
International     11.8     4.7     151%     7.8     7.4     6%     19.6     12.1     63%
United States     45.6     44.8     2%     42.3     44.1     (4)%     87.9     88.9     (1)%

The 40% increase year-over-year in net sales reflects the continued recapture of share in European markets and success in new international markets following the temporary suspension of production and distribution at our Antony site in late 2015, which impacted sales in 2016. As of 31 December 2017, Oralair holds 38% of the grass tablet market in France, a 13-percentage point gain over 2016, and 34% of the grass tablet market in Germany, a 3-percentage point gain over last year.2 In addition, the Group holds a market leadership position in Russia, Poland, the Balkans and the Middle East, and regained share in Czech Republic and Slovakia. Sales growth and market share gains were the result of a refocused commercial organization and improved product supply lead time.

In local currency (US$), revenue in the U.S. was up 1% in 2017. In the grass tablet market, Oralair nearly doubled its share from December 2016 while the overall market declined by 5% year-over-year3. In the subcutaneous immunotherapy market, Stallergenes Greer maintained its leading position with a strong demand that exceeded supply.

Net sales by product category: Staloral ® drove 83% growth in sublingual; Subcutaneous grew 3%

                   
(in € million)     H1 (unaudited)     H2 (unaudited)     Full Year (audited)
    2017     2016     % change     2017     2016     % change     2017     2016     % change

Sublingual 4

    76.9     27.3     182%     79.8     58.4     37%     156.7     85.7     83%

Subcutaneous 5

    36.9     34.2     8%     33.5     33.8     (1)%     70.4     68.0     3%

Other products 6

    10.8     11.1     (3)%     12.1     10.0     21%     22.9     21.1     9%
Veterinary     5.0     5.4     (7)%     5.2     6.0     (14)%     10.2     11.4     (11)%
                                                       

Full year 2017 sublingual product sales increased 83% to €156.7 million from full year 2016, primarily due to the performance of Staloral, which saw total sales increase 98%, or €61.7 million, compared to 2016. The growth was mainly driven by market share gains and, to some extent, by the industry-wide shortage of subcutaneous immunotherapy treatments in Europe, which resulted in switching of some patients to sublingual therapy. Within the sublingual category, total tablet sales in 2017 reached €30.5 million compared to €21.4 million in 2016, mainly driven by Oralair market share growth in established markets. In the U.S., Oralair market share gained 15 points from 16% in 2016 to 31% in 2017. However, the market is growing more slowly than expected.

In the subcutaneous product category, the Group reported 2017 sales of €70.4 million, a 3% increase compared to 2016, driven by growth in European and International markets while the U.S. market remains flat. Sales from the other product category grew 9% year-over-year to €22.9 million, and veterinary sales declined 11% to €10.2 million compared to 2016, due to increased competition in this segment.

Operational efficiencies delivered margin improvement

The Group’s full year 2017 gross margin of €165.8 million represented 64% of net sales, compared to 54% in full year 2016. The improvement is largely due to a global commitment to cost management and a result of ongoing operational efficiency initiatives. In addition, 2016 margins were impacted by costs incurred during the temporary suspension of production and distribution as well as the product recall in 2015.

The Group reduced its net loss from €60.5 million in 2016 to a net loss of €9.9 million in 2017, and reported a positive 2017 EBITDA of €21.9 million, compared to an EBITDA loss of €67.9 million in 2016. EBITDA increased overall by €89.8 million fuelled by a €74.0 million increase in sales and a decline in Selling, General and Administrative expenses of 11%, from €148.2 million in 2016 to €131.9 million in 2017. In 2018, the Group will continue to recalibrate operating expenditures and will further review areas where efficiencies can be made, including the Group’s footprint and overhead costs. This commitment resulted in a decision to reduce its administrative offices in the U.K., France and the U.S.

As a result of the business recovery and robust measures to contain costs, Stallergenes Greer continues to have a solid balance sheet. At 31 December 2017, the Group’s shareholders’ equity represented 83% of the balance sheet total.

As part of our annual reviews, the Group has performed an impairment analysis of its intangible assets and goodwill in accordance with IAS 36 (Impairment of Assets) for its cash-generating units (CGU’s). Based on our long range business plan and related sensitivity scenarios around it, the value-in-use of each CGU exceeds its carrying value and therefore no impairment of goodwill has been recorded in the consolidated Group accounts.

Group continues to invest in innovation to fuel long-term growth

Stallergenes Greer is committed to developing innovative therapies for major respiratory allergies and invested €45.6 million in R&D in 2017, primarily to fund STAGR320, the Group’s Phase III global multi-centre clinical trial for house dust mite (HDM)-induced allergic rhinitis. In July 2017, Stallergenes Greer announced completion of patient enrolment. With more than 1,600 patients enrolled, this study is the largest conducted study to assess the efficacy and safety of a sublingual immunotherapy tablet treatment.

This followed Stallergenes Greer’s announcement in January 2017 of positive top-line results from its Phase III study for paediatric HDM-induced allergic rhinitis in Japan. Results from this study supported the March 2017 submission of a new drug application for paediatric use of Actair (Stallergenes Greer’s commercial name for STAGR320 in registered markets) in Japan, which was approved post-period in February 2018.

In September 2017, the Group received market approval to commercialize STAGR320 in New Zealand under the Actair brand name and in October 2017, Health Canada accepted for review the New Drug Submission for STAGR320.

In addition to STAGR320, in June 2017, Stallergenes Greer published results from BREATH (Bringing Real-World Evidence to Allergy Treatment for Health), the first global, real-world evidence studies demonstrating the long-term benefits of sublingual immunotherapy to control allergic rhinitis and may reduce the risk of the onset and progression of allergic asthma.

Investments in Quality and Technical Operations to continue

The AIT industry’s manufacturing model is based on that of a compounding pharmacy, with processes that must be continuously updated to meet evolving regulatory requirements and comply with the latest Good Manufacturing Process (GMP) biological manufacturing standards. To address this and to ensure product quality and patient safety for all released and distributed products, Stallergenes Greer has made significant investments in its Technical Operations and Quality capabilities over the past two years, including modernizing manufacturing processes and facilities.

As a result of these efforts and the Group’s ongoing commitment to quality, Stallergenes Greer successfully completed three U.S. Food and Drug Administration (FDA) inspections in 2017 at its U.S. facilities. Investments in Lenoir and San Diego will continue in 2018.

In France, the Group made significant progress on operational systems upgrades at its Antony facility, resulting in the reduction of the average product lead time to less than seven days7 compared to the industry standard of two to three weeks. In addition, work has continued to enhance quality control methods used for product manufacturing and release. Meanwhile, an inspection conducted in the fourth quarter of 2017 by the National Agency for Medicines and Health Products Safety (ANSM) in France resulted in the issuance of an injunction received on 4 January 2018. The injunction was primarily related to the quality management system and processes at the Antony facility, mostly for the production of subcutaneous products. The remediation plan is well underway and the Group is committed to working with the French authorities. Shipment delays and temporary shortages of subcutaneous products are expected in European and International markets through 2018.

2018 Business outlook

Stallergenes Greer made substantial progress in 2017 and will continue to make strategic decisions in order to improve its competitiveness and solidify its business fundamentals. This includes investing in growth opportunities and delivering cost efficiencies across the organization. The Group expects continued progress in 2018, both through sales growth and strengthened profitability. Stallergenes Greer expects:

  • net sales to grow mid-single digit percent in constant currency, and
  • EBITDA to be higher than 2017

---------------------------------------------------------

Stallergenes Greer plc recognized non-cash impairment with no impact on Group consolidated accounts

As part of our annual reviews, Stallergenes Greer plc has performed an impairment analysis of its “investments in subsidiary undertakings” on its statutory accounts based on the latest long range business plan and related sensitivity scenarios around it and an impairment of €234 million was recorded. The impairment in the statutory accounts for Stallergenes Greer plc has no impact on the Group consolidated accounts, its 2017 operating result, EBITDA or Equity8.

Webcast and Conference Call Information

Stallergenes Greer will host an Investors and Analysts meeting today, 22 March 2018. The event will be available via live webcast at 10:30 am GMT / 11:30 am CET / 6:30 am EDT. The webcast will be available via the following link: https://edge.media-server.com/m6/p/ptqhwgnv and on the company’s website, http://stallergenesgreer.com/financial-calendar-events.

Please connect at least 15 minutes prior to the conference to register, download and install any necessary audio software.

Financial Calendar

  • 16 April 2018: 2017 Annual Report Publication
  • 7 June 2018: Annual General Meeting
  • 30 August 2018: H1 2018 Results

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION

Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

TABLE OF CONTENTS

Consolidated income statement as of 31 December 2017

Consolidated balance sheet as of 31 December 2017

Consolidated cash flow statement as of 31 December 2017

The financial information set out above does not constitute the Group’s financial statements for the period-ended 31 December 2017 but are derived from those statements. The annual report for 2017 will be made public on or before 30 April 2018 and delivered to the UK Companies House on or before 30 June 2018. The auditor has reported on those statements. Their report was unqualified, did not draw attention to any matters by way of emphasis and did not contain statements under Section 498 (2) or (3) Companies Act 2006 or equivalent preceding legislation. While the financial information included in this preliminary announcement has been computed in accordance with International Financial Reporting Standards (IFRS), this announcement itself does not contain sufficient information to comply with IFRS.

The Group published full financial statements that comply with IFRS that are available on its website at http://stallergenesgreer.com/annual-report .

The financial statements were approved by the Board of Directors on 21 March 2018.

Consolidated income statement as of 31 December 2017

         
€ thousands    

31 December
2017

31 December
2016

Net sales 1     260,195 186,247
Other revenues     36 141
         
Total revenues     260,231 186,388
         
Cost of goods sold     (94,458) (85,331)
         
Gross margin     165,773 101,057
         
Distribution costs     (11,413) (11,783)
Selling and marketing expenses     (60,624) (63,943)
Administrative expenses     (57,588) (67,316)
Other general expenses     (2,281) (5,154)
Selling, general and administrative expenses     (131,906) (148,196)
         
         
Research and Development expenses (R&D)     (45,630) (52,783)
R&D related income     6,412 7,379
Net R&D expenses     (39,218) (45,404)
         
Operating loss (EBIT) before transformation costs     (5,351) (92,543)
         
Transformation costs     (3,506)
         
Operating loss (EBIT)     (5,351) (96,049)
         
Financial income     20 609
Financial expenses     (1,817) (699)
Net financial expense     (1,797) (90)
         
Loss before tax and associates     (7,148) (96,139)
         
Income tax     (2,145) 35,773
Share of loss from associated companies     (578) (156)
         
Loss for the period attributable to:        
Owners of the parent     (9,871) (60,522)
Non-controlling interest    
Group share of net loss     (9,871) (60,522)
         
1.   The 2017 net sales figure includes a €5,112k unused reversal of the recall provision against sales.
     

Consolidated balance sheet as of 31 December 2017

€ thousands   31 December
2017
    31 December
2016
Goodwill   195,187     216,550
Other intangible assets   70,913     90,428
Property, plant and equipment   69,138     80,304
Non-current financial assets*   3,957     6,011
Deferred tax assets   26,754     35,377
Other non-current assets   237    
Non-current assets   366,186     428,670
           
Inventories   56,793     63,786
Trade receivables   33,199     41,826
Current financial assets*   684     13
Other current assets   9,231     8,810
Current income tax receivable   611     529
Research tax credit and subsidies receivable   22,708     15,468
Cash and cash equivalents   50,849     71,262
Current assets   174,075     201,694
Total assets   540,261     630,364
           
Share capital   19,788     19,788
Share premium   539     539
Merger and contribution premium   342,149     342,149
Revaluation reserve   (236)    
Retained earnings   85,086     126,733
Group shareholders’ equity   447,326     489,209
Non-controlling interests      
Total shareholders’ equity   447,326     489,209
           
Provision for employee retirement obligations and related benefits   3,442     4,488
Non-current provisions   514     1,651
Non-current financial liabilities   6,318     6,753
Deferred tax liabilities   6,283     17,750
Non-current liabilities   16,557     30,642
           
Trade payables   19,793     26,658
Current provisions   2,115     3,180
Current financial liabilities   12,204     16,366
Income tax payable   1,313     1,217
Other current liabilities   40,953     63,092
Current liabilities   76,378     110,513
Total equity and liabilities   540,261     630,364
           

*The liquidity contract of the Group for €670k at 31 December 2017 (31 December 2016: €742k) has been reclassified from non-current financial assets to current financial assets.

Consolidated cash flow statement as of 31 December 2017

             
€ thousands     31 December
2017
    31 December
2016
Cash flow from operating activities            
             
Group share of net loss     (9,871)     (60,522)
Share of undistributed earnings from investments accounted for using the equity method     578     156
Tax     2,145     (35,773)
Net financial result     1,798     90
             
Amortisation and depreciation charges     23,404     27,682
Change in provision     (1,904)     (1,096)
Share-based compensation     2,429     1,117
Capital losses from disposal of assets     4,466     578
Financial losses excluding interests     (35)     56
             
Operating cash flow before changes in working capital     23,010     (67,712)
             
Current income tax paid     (3,768)     4,612
Change in subsidies and R&D tax credit receivables     (7,240)     (7,066)
Change in working capital of operating activities     (16,231)     (7,244)
Change in deferred income     11     (675)
             
Net cash flow from operating activities     (4,218)     (78,085)
             
Cash flow from investing activities            
             
Purchase of non-current assets     (12,643)     (22,015)
Acquisition of investments in consolidated undertakings, net of cash acquired     (1,403)    
Proceeds from sale of non-current assets1     5,269     19,509
Change in working capital of investment activities     (1,400)     (2,547)
             
Net cash flow from investing activities     (10,177)     (5,053)
             
Free cash flow after investing activities     (14,395)     (83,138)
             
Cash flow from financing activities            
             
Proceeds from issuance of ordinary shares        
Treasury shares transactions     (72)     20
Net financial interest paid     (1,407)     (583)
Use / (repayment) of bank overdrafts     (227)     (133)
Repayment of borrowings     (15,054)     (17,018)
Proceeds from borrowings     12,095     22,115
             
Net cash flow from financing activities     (4,665)     4,401
             
Change in cash and cash equivalents     (19,060)     (78,737)
             
+ cash and cash equivalents – opening balance     71,262     150,183
+/- effect of translation adjustment on foreign currency denominated cash     (1,353)     (184)
= cash and cash equivalents – closing balance     50,849     71,262
             
1.   Included within proceeds from sale of non-current assets are the proceeds from sale of the DBV Technologies shares of €16,834k in 2016.
     
     
1   Guidance for 2017 was stated as “total revenue”; there is no material difference between “net sales” and “total revenue”. Net sales stated in “constant currency” were determined using the same exchange rates as the half-year 2017 results.
2   Source: IMS MIDAS
3   Source: Symphony Health Solutions and US Specialty Pharmacy aggregated data internal data audit
4   Product category includes oral drops (Staloral) and tablets (Oralair and Actair®)
5   Product category includes Named Patient Prescription products and bulk allergens
6   Product category includes diagnostic and ancillary products
7  

Not including backorders

8

 

For more information, please refer to note 4.5 in the Stallergenes Greer plc, Company financial statements - www.stallergenesgreer.com.

 

Stallergenes Greer to Report Full Year Financial Results on 22 March 2018

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced it will report financial results for the second half and full fiscal year ended 31 December 2017 on 22 March 2018. The Company’s management will host a live audio webcast of its earnings conference call at 10:30 am London / 11:30 am Paris / 6:30 am Boston that same day to discuss the results.

Members of the financial community may access the conference call through the dial-in information provided on the company’s website, at http://stallergenesgreer.com/financial-calendar-events. The live audio webcast will be accessible to the general public via the following link: https://edge.media-server.com/m6/p/ptqhwgnv. Participants are asked to connect at least 15 minutes prior to the conference call to register, download and install any necessary audio software.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

 

Stallergenes Greer Announces Approval in Japan of Pediatric Use for ACTAIR®, Sublingual Immunotherapy Tablet for the Treatment of House Dust Mite Allergy

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced that its partner in Japan, Shionogi & Co. Ltd., received approval for the extension of the indication for ACTAIR®, an allergy immunotherapy sublingual tablet for the treatment of house dust mite (HDM) induced allergic rhinitis, to treat patients under the age of 12. ACTAIR is already approved for the treatment of HDM-induced allergic rhinitis in patients 12 years of age and older in Japan since March 2015.

“The approval of ACTAIR for pediatric use in Japan will provide a valuable treatment option for patients under the age of 12 suffering from allergic rhinitis caused by an allergy to house dust mites. We are very pleased that this product will be available to even more patients in Japan,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer.

The New Drug Application submission was supported by data from Shionogi’s positive Phase III trial, which was announced in January 2017. The multi-center, randomized, double-blind, placebo-controlled study evaluated the efficacy of ACTAIR at a daily maintenance dose of 300IR administered for 12 months to children between 5 and 16 years old with HDM-associated allergic rhinitis. The active group demonstrated a statistically significant difference (p=0.0005) versus placebo on the Average Adjusted Symptom Score after one year of treatment, achieving the primary efficacy endpoint.

In addition to Japan, Stallergenes Greer’s HDM tablet is registered in Australia, New Zealand and South Korea under the brand name ACTAIR for the treatment of HDM-induced allergic rhinitis in patients 12 years of age and older.

Stallergenes Greer has exclusive partnership agreements with Shionogi for the clinical development, registration and commercialization of HDM and Japanese cedar pollen sublingual immunotherapy tablets in Japan.

ABOUT SHIONOGI’S PHASE 3 TRIAL IN CHILDREN 5 TO 11 YEARS OLD

The primary endpoint was the AAdSS over the last month of the one-year treatment period. The AAdSS is the average of the total score of four rhinitis symptoms (sneezing, rhinorrhea, nasal congestion and nasal pruritus) adjusted for rescue medication use. This was a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy of HDM sublingual immunotherapy tablets for the treatment of allergic rhinitis. Patients aged 5 to 16 years old with medical history consistent with HDM-induced allergic rhinitis were eligible. A total of 438 patients were randomized to receive 12 months of treatment with HDM sublingual immunotherapy tablets or placebo. The active group showed statistically significant difference (p=0.0005) compared to placebo. Local adverse reactions were observed, with most of them mild in nature with no marked safety concerns.

ABOUT RESPIRATORY ALLERGIES IN JAPAN IN PEDIATRIC PATIENTS

Allergic rhinitis affects 25% of Japan’s population. House dust mites and Japanese cedar pollen are the two main causes of respiratory allergies in the country. From early childhood, house dust mites can trigger allergic rhinitis, which worsens over time with a potential progression towards asthma. The symptoms may be severe, significantly impairing patients’ quality of life. With 32 million respiratory allergy sufferers, there is a strong, and as yet unmet, demand for allergy treatment in Japan.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

 

 

Stallergenes Greer comments on share price movement

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today noted a drop of its share price that may be related to the publication of an injunction received from the French National Agency for Medicines and Health Products Safety (ANSM) following the inspection of one production area at the company’s facility in Antony, France.

The company clarifies that the injunction published by the ANSM on January 9, 2018 does not impact supply and does not require a product recall. Stallergenes Greer will continue to supply the market with allergy immunotherapy treatments while it addresses the ANSM observations identified in the injunction.

The company also confirms that most of the observations noted by the agency either have been addressed or are in the process of being resolved as part of the ongoing upgrade of the manufacturing operations at the Antony facility. The current manufacturing upgrades and investments began two years ago in order to ensure that Stallergenes Greer meets the required quality standards.

“We are fully cooperating with the ANSM and we have already taken corrective actions voluntarily to upgrade our manufacturing operations. We are now focused on completing the remaining items identified by the agency within the agreed-upon timeline,” said Fereydoun Firouz, Chairman and Chief Executive Officer.

The injunction was issued following an ANSM inspection of one of the facility’s production areas. The observations relate to the quality management system and processes, such as the procedures to investigate and close manufacturing deviations from agreed manufacturing specifications, primarily for the production of subcutaneous immunotherapy (SCIT) products.

The company does not expect the ANSM injunction to have a material impact on its business and will provide an update on the progress of its manufacturing upgrade during its next earning call on March 22, 2018.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website www.stallergenesgreer.com . Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer invests in Adeo Health Science, a research-driven food company with a novel approach in food allergy

LONDON--(BUSINESS WIRE)-- Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, announces a strategic investment in Adeo Health Science (“Adeo”) as part of an early-stage funding round. Adeo, a research-driven food company based in Boston, has developed organic and non-GMO fruit purees containing potentially allergenic proteins that can help parents integrate early allergen introduction into their infant’s diet.

Adeo’s approach is rooted in the findings of landmark studies that were published in the New England Journal of Medicine. The LEAP study1 demonstrated that regular consumption of peanuts by infants who are at high-risk for developing peanut allergy prevents the subsequent development of allergy. The EAT study2 3 showed that the early introduction of potentially allergenic foods (such as peanut, sesame, fish and egg) into the infant diet from three months may prevent the development of food allergy and other allergic diseases (such as eczema) in childhood.

Many of the potentially allergenic foods are not in a form easily eaten by infants. Nuts and seeds, even as sticky nut butters, are choking hazards for infants. Adeo is changing this paradigm by creating simple formulations that make early allergen introduction more broadly accessible. Inspired Start®, launched recently in the United States, is the first baby food designed to introduce eight of the most common allergens (peanut, egg, tree nut, soy, wheat, sesame, shrimp and cod) into the infant’s diet. Estimated at two percent among children4, peanut allergy alone is a large market with a high unmet need in the United States.

“Food allergy in children can be life threatening and is a significant unmet need. Our minority investment in Adeo Health Science provides us with an external platform to get a grasp of the food allergy market while remaining focused on driving execution in our core allergy immunotherapy business,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “There is strong scientific rationale behind this investment as the LEAP and the EAT studies showed that the early introduction of allergens can reduce the risk of developing food allergies.”

“The partnership with Stallergenes Greer is a great way for us to bring minds together and deliver on our promise of helping the next generation,” said Clarence Friedman, founder and CEO of Adeo. “Stallergenes Greer has the scale and expertise to help us globally. We value their team’s entrepreneurial mindset and commitment to changing the allergy care paradigm.”

The financial impact of the transaction is not material to the company's finances. The amount of the investment was not disclosed. Stallergenes Greer will have a non-voting representative on Adeo’s Board of Directors.

ABOUT THE LEAP AND THE EAT STUDIES

The LEAP (Learning Early About Peanut Allergy) is a randomized controlled clinical trial designed and conducted by the Immune Tolerant Network (ITN) to determine the best strategy to prevent peanut allergy in young children. 640 children between 4 and 11 months of age who were identified as high risk for peanut allergy, based on an existing egg allergy and/or severe eczema, were enrolled in the study and randomized to either consume or avoid peanuts. Study results demonstrated that consumption of a peanut-containing snack by infants who are at high-risk for developing peanut allergy prevents the subsequent development of allergy. 17 percent of the children who avoided peanuts developed peanut allergies, while only three percent of the children who ate peanuts developed allergy by age 5.

The EAT (Enquiring About Tolerance) study is a randomized controlled intervention study that was contracted by Kings College London. It aimed to investigate whether the early introduction of six allergenic foods (milk, peanut, sesame, fish, egg and wheat) into the infant weaning diet, alongside breastfeeding, reduced the number of children developing food allergies and other allergic diseases such as eczema by three years of age. The study recruited 1,303 mothers and their infants. The study found that introducing allergenic foods into the infant diet from three months may be effective in food allergy prevention when sufficient amounts of allergenic foods are consumed.

Both studies were published in the New England Journal of Medicine.

ABOUT ADEO HEALTH SCIENCE

Adeo Health Science is a research-driven food company with the mission of translating the latest food allergy research into easy to use, trusted products for families. The company is based in Boston, Massachusetts. Adeo’s Inspired Start® was launched in October 2017 in the United States.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

REFERENCES

1.   George Du Toit, M.B., B.Ch., Graham Roberts, D.M., Peter H. Sayre, M.D., Ph.D., Henry T. Bahnson, M.P.H., Suzana Radulovic, M.D., Alexandra F. Santos, M.D., Helen A. Brough, M.B., B.S., Deborah Phippard, Ph.D., Monica Basting, M.A., Mary Feeney, M.Sc., R.D., Victor Turcanu, M.D., Ph.D., Michelle L. Sever, M.S.P.H., Ph.D., Margarita Gomez Lorenzo, M.D., Marshall Plaut, M.D., and Gideon Lack, M.B., B.Ch., for the LEAP Study Team* Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy. New England Journal of Medicine (2015). DOI: 10.1056/NEJMoa1414850.
2.   Michael R. Perkin, Ph.D., Kirsty Logan, Ph.D., Anna Tseng, R.D., Bunmi Raji, R.D., Salma Ayis, Ph.D., Janet Peacock, Ph.D., Helen Brough, Ph.D., Tom Marrs, B.M., B.S., Suzana Radulovic, M.D., Joanna Craven, M.P.H., Carsten Flohr, Ph.D., and Gideon Lack, M.B., B.Ch., for the EAT Study Team. Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants. New England Journal of Medicine (2016). 374:1733-1743. DOI: 10.1056/NEJMoa1514210.
3.  

EAT Study: Early Introduction of Allergenic Foods to Induce Tolerance. Food Standards Agency UK. March 4, 2016. https://www.food.gov.uk/science/research/allergy-research/t07051.

4.   Gupta RS, Springston EE, Warrier MR, Smith B, Kumar R, Pongracic J, et al. The Prevalence, Severity, and Distribution of Childhood Food Allergy in the United States. Pediatrics 2011;128:e9-17.

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
Market: Euronext Paris regulated market
Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website www.stallergenesgreer.com . Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

 

Stallergenes Greer’s 2017 Innovation Day

LONDON--(BUSINESS WIRE)-- Stallergenes Greer plc, a biopharmaceutical company specializing in treatments for respiratory allergies, will today host an Innovation Day for analysts and investors from 10:00am BST to 12.15pm BST at its headquarters, 40 Bernard Street, Bloomsbury, London WC1N 1LE.

The event will include presentations, providing a more detailed understanding of Stallergenes Greer's strategy and innovation, followed by a question and answer session. The company will notably present real-world evidence data about ORALAIR® and its strategic investment in Adeo Health Science, announced today.

The company will host a live webcast on Stallergenes Greer’s website available in the investor section at www.stallergenesgreer.com (http://edge.media-server.com/m6/go/STAGR_ID2017). Those attending via webcast will have the opportunity to submit questions, via the webcast tool, following the presentations.

Relevant documents and materials related to the Innovation Day will be available from the company website shortly after the event has concluded.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of Greer Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR - ICB Classification: 4577
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website www.stallergenesgreer.com . Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

Stallergenes Greer acquires Canadian Medic Savoure, strengthening presence in North America

 

Stallergenes Greer Acquires Canadian Medic Savoure, Strengthening Presence in North America

  • With a leading market share, Medic Savoure is a long-standing player in the Canadian allergy immunotherapy market.
  • The acquisition provides Stallergenes Greer with a commercial platform to grow its existing business and to expand its product portfolio in Canada, including ORALAIR®.

LONDON--(BUSINESS WIRE)--Stallergenes Greer plc (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today announced the acquisition of Medic Savoure Limited, a well-established allergy immunotherapy (AIT) leader in Canada. The acquisition strengthens Stallergenes Greer’s local presence and accelerates the company’s growth in Canada. It provides a positive cash flow allergy business that bolsters Stallergenes Greer’s North American operations.

Medic Savoure commercializes a full range of allergy immunotherapy products, including diagnostic and AIT treatment products throughout Canada. The company has distributed Stallergenes Greer’s allergen bulk products for subcutaneous treatments since the 1970s. Medic Savoure is also licensed to produce individual and customized patient treatments. Assets include the transfer of all employees and a lab facility certified by Health Canada.

“With the acquisition of Medic Savoure, Stallergenes Greer becomes a fully integrated business in Canada, executing against our strategy to strengthen our footprint in North America and to expand our global leadership in allergy immunotherapy," said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “We know the team well and are excited by the prospect of working together to bring innovation to the market, and better serve Canadian physicians and patients.”

“We are excited to join the Stallergenes Greer team. We will greatly benefit from their global regulatory, quality and marketing experience,” said John Wigle, Managing Partner at Medic Savoure. Scott Wigle, co-Managing Partner, also added, “We share the same passion for excellence and commitment to delivering the best products and the best service to patients and the medical community.”

AIT is a disease-modifying allergy treatment that changes the way the body reacts to allergens, and can be administered by physicians through subcutaneous injection or taken at home sublingually by liquid or tablet formulation. Canada has a population of 37 million, with an estimated 20%-25% suffering from allergic rhinitis.1

The Medic Savoure acquisition is not expected to have material impact on the Group’s financial performance in 2017. The purchase price of the transaction, which is effective as of October 1st 2017, was not disclosed. On August, 31st Stallergenes Greer announced a narrowed 2017 revenue guidance2 of €260-€270 million and continuing positive development of EBITDA.

ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of Greer Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR - ICB Classification: 4577
Market: Euronext Paris regulated market

Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

NOTES
1. Keith P.K, Desrosiers M., Laister T., Schellenberg R.R., Waserman S. The Burden of Allergic Rhinitis (AR) in Canada: Perspectives of Physicians and Patients. Allergy, Asthma & Clinical Immunology. 2012 June. 8:7. Available from [https://doi.org/10.1186/1710-1492-8-7]
2. Guidance in constant currency.

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