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