Press releases

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.

Communications and Investor Relations
Stallergenes Greer plc
Natacha Gassenbach, Tel: +1 (617) 225 8013
Email: natacha.gassenbach@stallergenesgreer.com
or
Investor Relations Agency
FTI Consulting
Arnaud de Cheffontaines, Tel: +33 1 47 03 68 10
Email: stalleregenesgreer@fticonsulting.com
or
Media Relations Agency
Havas Worldwide Paris (Europe)
Samuel Rousseau, Tel: +33 (0) 6 51 03 51 43
Email: samuel.rousseau@havas.com
or
Bloom (US)
Serra Saridereli, Tel: +1 (212) 715 1604
Email: Sariderelis@bloompr.com

 

Stallergenes Greer advances its house dust mite allergy pipeline with acceptance of regulatory submission and new market approval

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

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today announced that Health Canada accepted for review the company’s New Drug Submission (NDS) for STG320, an investigational sublingual immunotherapy tablet for the treatment of house dust mite (HDM) induced allergic rhinitis. Once a New Drug Submission is accepted for review it takes usually between nine to twelve months for Health Canada to issue the results of the evaluation.

Stallergenes Greer’s HDM tablet is already available in Japan, Australia and South Korea under the brand name Actair and was approved for commercialization in New Zealand on September 8, 2017.

“We continue to make progress on delivering on our pipeline and expanding our portfolio. We believe STG320 has the potential to be a very important allergy immunotherapy treatment option for patients suffering from allergic rhinitis.”, said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer.

In July 2017, Stallergenes Greer announced the completion of enrollment for the largest Phase III clinical trial to evaluate the safety and efficacy of STG320 in adult and adolescent patients with HDM-induced allergic rhinitis. The study recruited over 1,600 patients from 13 countries. Together with other clinical data, it will form the company’s clinical submission of a Biologics License Application (BLA) in the United States currently planned for 2019, as well as for additional marketing authorizations in European and international markets.

ABOUT HOUSE-DUST MITE INDUCED ALLERGIC RHINITIS IN CANADA

About 20-25 percent of the population in Canada is estimated to be suffering from allergic rhinitis1. Most common sources of allergens in Canada include pets, house dust mites, indoor/outdoor mold, trees (especially oak trees), and grasses and weeds2. Allergic rhinitis can include symptoms such as sneezing, runny nose, wheezing, cough, itching, and watery/itchy eyes, among others3,4. Symptoms may be severe and significantly impact the patient’s quality of life, as well as worsen over time with progression towards asthma3-5, 7-10.

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.

REFERENCES

  1. Keith, Paul K., Martin Desrosiers, Tina Laister, Robert R. Schellenberg, and Susan Waserman. "The burden of allergic rhinitis (AR) in Canada: perspectives of physicians and patients." Allergy, Asthma & Clinical Immunology, 2012.
  2. Richard, Joanne. "Canada's 10 most common seasonal allergies." The Weather Network. April 11, 2017. https://www.theweathernetwork.com/news/articles/canadas-10-most-common-seasonal-allergies/81059.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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
  8. 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.
  9. Meltzer E. O. Quality of life in adults and children with allergic rhinitis. J Allergy Clin Immunol. 2001 Jul;108(1 Suppl):S45-53
  10. 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 reports strong first half 2017 results and narrows 2017 financial guidance

LONDON--(BUSINESS WIRE)--

Stallergenes Greer plc (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today announces its half-year results for the six-month period ended 30 June 2017.

H1 2017 Financial Highlights

             
In € millions   H1 2017   H1 2016   Growth
  Unaudited   Unaudited   % change
Total revenues 129.6   78.1   +66%
Gross margin 83.4 34.7 +140%
as % of net sales 64% 45% +19 pts
EBIT (3.5) (58.5) +94%
EBITDA 6.3 (45.1) +114%
Net loss   (8.9)   (39.0)   +72%

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

“During the first half of 2017, Stallergenes Greer delivered strong revenue growth with diligent cost control. As a result of the actions we have taken, we have narrowed our loss and significantly improved our cash flow. With positive EBITDA at the end of first half, we are ahead of schedule. These financial results make us confident enough to narrow our revenue guidance1 to the high end of the range.

“This performance reflects the Company’s progress and transformation accomplished since the temporary suspension of production in late 2015 that affected one of our sites for several months. With steady market share gains across our portfolio month after month, we have been relentlessly focused on customer satisfaction and we are positioned to regain our global market leadership. We have upgraded our manufacturing processes and we can now see the impact of our new ERP system in our financial results. In most countries, we outperform the industry standard by delivering products in six days compared to ten to fifteen days standard practice.

“As part of our commitment to bring innovative solutions to patients suffering from allergies, we have also continued to advance science in allergy immunotherapy (AIT). At the EAACI2 congress in June 2017, we presented real-world evidence data that showed the long-term benefit of ORALAIR in controlling allergic rhinitis and potentially preventing asthma. Recently, we announced the completion of the enrolment for STG320, the largest phase III clinical trial for house dust mite induced allergy.

“We are at an exciting turning point for Stallergenes Greer and we are confident in the strength of our organisation to deliver on our operational plan and to keep up the momentum.”

First half 2017 financial highlights

The Group has continued to deliver consistent progress enabled by the RESTART (Restart Stallergenes Greer After Revalidation Task) program initiated early 2016 and a focus on excellence across the organisation. For the first half of 2017, total revenues increased 66% to €129.6 million reflecting the significant recovery of the business since operations gradually resumed following several months suspension of production in Antony, France, in late 2015.

Overall, the Group delivered 70% of the pro forma sales achieved in the first half of 2015, a peak year, paving the way for the Group to regain its leading position in Europe and International allergy immunotherapy markets.

Revenue growth has been fuelled by market share regained across the portfolio. In France, ORALAIR held a 38% market share, a 15-point increase compared to June 2016. In Germany, ORALAIR held a 39% market share for June 2017, a 6-point increase compared to June 2016.

The gross margin of €83.4 million represented 64% of net sales, compared to 45% in the first half of 2016 as the increase in net sales more than offset the increase in cost of goods sold.

EBITDA for the first half of 2017 was €6.3 million, a significant turnaround compared to the negative EBITDA of €45.1 million in the first half of 2016, reflecting improved sales and the positive impact of effective operating cost management. Accordingly, the current operating loss of €3.5 million has also improved compared to the operating loss of €58.5 million for the first half of 2016.

Selling, general and administration expenses were €65.1 million, down €6.2 million versus €71.3 million at 30 June 2016.

At 30 June 2017, the Group had "cash and cash equivalents" of €47.6 million. In addition, the Group has limited external debt with an outstanding debt balance of €16.0 million. This has resulted in a net cash position of €31.6 million.

Region highlights

H1 2017 Net Sales by Region

             
In € millions   H1 2017   H1 2016   Growth
  Unaudited   Unaudited   % change
Southern Europe 53.7   17.8   +202%
North & Central Europe 18.5 10.7 +73%
International markets 11.8 4.7 +151%
US 45.6 44.8 +2%
Net sales   129.6   78.0   +66%

Southern Europe first half 2017 net sales were €53.7 million, up €35.9 million or 202% over the prior-year period. The progress is mainly due to the positive impact of the RESTART program and the regain of the market share lost during the temporary production and distribution suspension at the site in Antony in late 2015.

North & Central Europe net sales were €18.5 million, up €7.8 million or 73% over the prior-year period.

International markets net sales were €11.8 million, up €7.1 million or 151% over the prior-year period with notable performance in Australia that successfully launched ACTAIR®, Stallergenes Greer’s tablet for house dust mite induced allergy.

In the US, first half 2017 net sales grew 2% to €45.6 million over the prior-year period. The slower growth is in part due to competitor pricing and discount strategy in the human bulk allergen business and in the veterinary product category. Despite this, the Group has maintained its leading market share in the human bulk allergen business while ORALAIR has continued to gain incremental market share.

Product highlights

H1 2017 Net Sales by Product Category

             
In € millions   H1 2017   H1 2016   Growth
  Unaudited   Unaudited   % change
Sublingual 76.9   27.3   +182%
Subcutaneous 36.9 34.2 +8%
Other products 10.8 11.1 -3%
Veterinary 5.0 5.4 -7%
Net sales   129.6   78.0   +66%

In the first half of 2017, the Group fulfilled 90% of the demand for all sublingual allergens, as well as the top three subcutaneous allergens (house dust mite, grass, birch) most needed by patients and physicians in Europe and International markets. Product lead time3 improved from three weeks to six days setting up new industry standards in delivering the right product to the right patient at the right time.

Sublingual sales increased by €49.6 million or 182% compared to €27.3 million from 30 June 2016. Sales reached 63% of the sales achieved in the first half of 2015, prior to the temporary suspension. The sublingual product category includes STALORAL sublingual liquid solution as well as ORALAIR and ACTAIR tablets.

Subcutaneous sales were €36.9 million for the period, up 8% or €2.7 million from €34.2 million at 30 June 2016. Sales reached 85% of the sales achieved in the first half of 2015, prior to the temporary suspension. The subcutaneous product category includes ALUSTAL® and PHOSTAL®.

Other sales, which include Diagnostics and Ancillary products, were €10.8 million, down €0.3 million or 3% from €11.1 million.

Veterinary sales in the US were €5.0 million for the period, down €0.4 million or 7% from €5.4 million of sales at 30 June 2016.

Innovation

In March, Shionogi & Co., Ltd., the Group’s partner for commercialisation in Japan, submitted its New Drug Application (NDA) for ACTAIR, an investigational allergy immunotherapy sublingual tablet for the treatment of HDM-induced allergic rhinitis in children from 5 through 11 years of age. ACTAIR is already approved for the treatment of HDM-induced allergic rhinitis in patients from 12 years old in Japan.

In June, a retrospective analysis from a prescription database in Germany including over 74,000 patients was presented at the EAACI2 Congress. The data showed that grass pollen SLIT (sublingual immunotherapy) treatment, including ORALAIR can help control allergic rhinitis and may reduce the risk of the onset and progression of allergic asthma. This is the first study of our BREATH program (Bringing Real-world Evidence for Allergy Treatment to Health), a comprehensive program to strengthen evidence of AIT benefits for patients and payers.

In July, the Group completed enrolment of its phase III clinical study to evaluate the safety and efficacy of its investigational sublingual immunotherapy tablet STG320 for the treatment of house dust mite (HDM) induced allergic rhinitis. The study recruited over 1,600 patients from 13 countries with 231 participating investigative sites and is the largest study of its kind. This phase III study, together with other clinical data, will form the company’s submission for a Biologics License Application (BLA) in the United States planned for 2019 and for additional marketing authorisations in European and International markets. To date, the product is already commercialised in Japan, Australia and South Korea.

Manufacturing

In December 2016, the Group received a three-year GMP (Good Manufacturing Practice) certificate for its site in Antony (France) that was impacted by a temporary production and distribution suspension late 2015.

In June 2017, the Group’s manufacturing sites in in San Diego (CA, United States) and in Lenoir (NC, United States) successfully completed a FDA (US Food and Drug Administration) inspection.

Business Outlook and Guidance1

The Group continues to deliver on its operations and commercial priorities with an increased focus on cost control. For the second half of the year, the Group is focusing on continuing to rebuild trust with all stakeholders, rightsizing the organisation including hiring for key positions, regaining global market leadership and investing wisely to support innovation and sustainable growth.

Considering the good start of the year with market share regain, operational successes and the positive EBITDA in the first half of 2017, Stallergenes Greer:

  • narrowed its 2017 revenue guidance1 to €260-€270m versus €240-€270m; and
  • continuing positive development of EBITDA

Webcast and Conference Call Information

The company will host an Investor and Analyst call today, Thursday 31 August 2017. The event will also be available via live webcast at 2.00 pm CEST / 1.00 pm BST / 8.00 am EDT. The webcast will be available via the following link: http://edge.media-server.com/m/go/STAGR_HY2017

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

Financial Calendar

  • 25 October 2017 – Strategy / R&D Day
  • March 2018 – FY 2017 Results

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 U.S.) and Stallergenes S.A.S. (whose registered office is in France).

1 Guidance in constant currency

2 European Academy of Allergy and Clinical Immunology (EAACI) Congress

3 Lead time: Number of days from sales order to shipment date

Trading information
Name: Stallergenes Greer Plc
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.

TABLE OF CONTENTS

Consolidated income statement as of 30 June 2017

Consolidated balance sheet as of 30 June 2017

Consolidated cash flow statement as of 30 June 2017

The financial information set out above does not constitute the Group’s financial statements for the period-ended 30 June 2017 and 2016 but are derived from those statements. Financial statements for 2016 have been delivered to the Registrar of Companies. 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 company 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 30 August 2017.

Consolidated income statement as of 30 June 2017

         
€ thousands 30 June 2017 30 June 2016
Net sales 129,615 78,018
Other revenue 10 93
 
Total revenues 129,625   78,111
 
Cost of goods sold (46,265) (43,378)
 
Gross margin 83,360   34,733
 
Distribution costs (5,383) (7,625)
Selling and marketing expenses (29,894) (31,364)
Administrative expenses (28,807) (29,857)
Other general expenses (1,027) (2,503)
Selling, general and administrative expenses (65,111) (71,349)
 
Loss before R&D 18,249 (36,616)
 
Research and development costs (R&D) (24,947) (25,072)
R&D-related income 3,225 4,612
Net R&D costs (21,722) (20,460)
 
Operating loss before transformation costs (3,473) (57,076)
 
Transformation costs

-

(1,465)
 
Operating loss (3,473) (58,541)
 
Financial income 20 44
Financial expenses (847) (284)
Net financial expense (827) (240)
 
Loss before tax and associates (4,300) (58,781)
 
Income tax (4,582) 19,844
Share of loss from associated companies (8) (92)
     
Group share of net loss (8,890) (39,029)

Consolidated balance sheet as of 30 June 2017

         
€ thousands

30 June
2017

31 December
2016

Goodwill 202,849 216,550
Other intangible assets 79,984 90,428
Property, plant and equipment 74,294 80,304
Non-current financial assets 4,986 6,011
Deferred tax assets 32,091 35,377
Non-current assets 394,204 428,670
 
Inventories 59,297 63,786
Trade receivables 28,058 41,826
Current financial asset 1,128 13
Other current assets 10,713 8,810
Income tax receivable 19,501 15,997
Cash and cash equivalents 47,645 71,262
Current assets 166,342 201,694
Total assets 560,546 630,364
     
Share capital 19,788 19,788
Share premium 539 539
Merger and contribution premium 342,149 342,149
Revaluation reserve

-

-
Retained earnings 98,301 126,733
Group shareholders’ equity 460,777 489,209
Non-controlling interests - -
Total shareholders’ equity 460,777 489,209
 
Provision for employee retirement obligations and related benefits 4,305 4,488
Non-current provisions 1,257 1,651
Non-current financial liabilities 6,753 6,753
Deferred tax liabilities 16,743 17,750
Non-current liabilities 29,058 30,642
 
Trade payables 19,750 26,658
Current provisions 417 3,180
Current financial liabilities 9,264 16,366
Income tax payable 1,356 1,217
Other current liabilities 39,924 63,092
Current liabilities 70,711 110,513
Total equity and liabilities 560,546 630,364

Consolidated cash flow statement as of 30 June 2017

         
€ thousands 30 June 2017 30 June 2016
Cash flow from operating activities
 
Operating loss (3,473) (58,541)
Amortisation and depreciation charges 11,752 12,786
Change in provisions (3,048) (12)
Share-based payments 1,391 247
Capital losses from disposal of assets 49 401
Financial losses excluding interests (385) 40
     
Gross operating result (EBITDA) 6,286 (45,079)
 
Income tax paid (961) 4,898
Change in working capital of operating activities (16,960) (9,397)
Change in deferred income (315) (338)
     
Net cash flow from operating activities (11,950) (49,916)
 
Cash flow from investing activities
 
Acquisition or increase in non-current assets (4,653) (8,712)
Cash acquired on combinations under common control
Proceeds from sale of non-current assets* 2,274 591
Change in working capital of investment activities (2,234) (4,477)
     
Net cash flow from investing activities (4,613) (12,598)
 
Free cash flow after investing activities (16,563) (62,514)
 
Cash flow from financing activities
 
Treasury shares transactions 374 (243)
Net financial interest received / (paid) (441) (281)
Repayment of bank overdrafts (238) (371)
Repayment of borrowings (15,704) (1,435)
Proceeds from borrowings 9,766 37
     
Net cash flow from financing activities (6,243) (2,293)
 
Change in cash and cash equivalents (22,806) (64,807)
 
+ cash and cash equivalents – opening balance 71,262 150,183
-/+ effect of translation adjustment on foreign currency denominated cash (811) (434)
= cash and cash equivalents – closing balance 47,645 84,942

Communications and Investor Relations
Stallergenes Greer plc
Natacha Gassenbach, +1-617-225-8013
natacha.gassenbach@stallergenesgreer.com
or
Investor Relations Agency
FTI Consulting
Arnaud de Cheffontaines, +33 1 47 03 68 10
stalleregenesgreer@fticonsulting.com
or
Media Relations Agency
Havas Worldwide Paris (Europe)
Samuel Rousseau, +33 (0) 6 51 03 51 43
samuel.rousseau@havas.com
or
Bloom (US)
Serra Saridereli, +1-212-715-1604
Sariderelis@bloompr.com

Stallergenes Greer announces completion of enrollment in largest phase III study to treat house dust mites allergy

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

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, announced today that it completed enrollment in a pivotal Phase III clinical study to evaluate the safety and efficacy of its investigational sublingual immunotherapy tablet STG320 for the treatment of house dust mite (HDM) induced allergic rhinitis. The study recruited over 1,600 patients from 13 countries with 231 participating investigative sites, and is the largest study of its kind. Principal investigators are Pascal Demoly, MD, from University Hospital of Montpellier, France, and the President of the French Allergy Federation, and Thomas Casale, MD, Professor of Medicine and Pediatrics at the University of South Florida.

“This is the largest study undertaken to measure the efficacy of sublingual immunotherapy (SLIT) treatment against HDM-induced allergic rhinitis and this study has the potential to bring more options for patients,” said Professor Casale. “In the United States, subcutaneous immunotherapy treatment for patients with allergic rhinitis is administered through injections at the doctor’s office; the tablet formulation offers an effective alternative treatment option for patients that may prefer oral administration at home.”

“Our aim is to bring innovation to patients suffering from HDM-induced allergic rhinitis, one of the most prevalent allergies in the world4. Completion of patient enrollment in this pivotal study is a significant milestone for Stallergenes Greer towards achieving this goal,” said Fereydoun Firouz, CEO of Stallergenes Greer. “We are committed to our purpose – to enable people with allergies to live normal lives – and continue to focus on developing evidence based solutions to prevent and treat all allergies.”

This Phase III study, together with other clinical data, will form the company’s submission for a Biologics License Application (BLA) in the United States planned for 2019 and for additional marketing authorizations in European and international markets. To date, the product is already approved for commercialisation in Japan, Australia and South Korea.

ABOUT THE STG320 STUDY
The study is global, multi-center, randomized, double-blind and placebo controlled. It evaluates the safety and efficacy of STG320 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 are sensitized to D. pteronyssinus and/or D. farinae mites as defined on a skin prick test and HDM-specific serum immunoglobulin E, were eligible for participation.

ABOUT HOUSE-DUST MITE INDUCED ALLERGIC RHINITIS
Allergic rhinitis is a worldwide disease affecting over 500 million people and the risk of developing asthma is about six times higher in patients with allergy to House Dust Mites (HDM) than those allergic to pollens1-4. Allergic rhinitis can include symptoms such as sneezing, runny nose, wheezing, cough, itching, and watery/itchy eyes, among others1,2. Symptoms may be severe and significantly impact the patient’s quality of life, as well as worsen over time with progression towards asthma1-3,5-8.

Symptomatic treatments such as antihistamines and nasal corticosteroids provide only temporary relief to patients1,8. The primary therapeutic goals of allergy immunotherapy (AIT) include reducing symptoms, reducing symptomatic medication use, and improving allergy-related quality of life. The evidence is strong that AIT achieves these goals and can alter the course of the disease, with benefits persisting in many patients for several years after treatment discontinuation1,2,10-16.

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 2015 annual report published on 29 April 2016 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. 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.
9. Nathan R. A. The burden of allergic rhinitis. Allergy and asthma proceedings : the official journal of regional and state allergy societies. 2007 Jan-Feb;28(1):3-9.
10. Abramson M., Puy R., Weiner J. Immunotherapy in asthma: an updated systematic review. Allergy. 1999 1999 Oct;54(10):1022-1041.
11. Durham S. R., Walker S. M., Varga E. M., et al. Long-term clinical efficacy of grass-pollen immunotherapy. The New England journal of medicine. 1999 Aug 12;341(7):468-475.
12. Abramson M. J., Puy R. M., Weiner J. M. Allergen immunotherapy for asthma. Cochrane database of systematic reviews. 2003(4):CD001186.
13. Calderon M. A., Alves B., Jacobson M., et al. Allergen injection immunotherapy for seasonal allergic rhinitis. Cochrane database of systematic reviews. 2007 2007(1):CD001936.
14. Nelson H. S. Allergen immunotherapy: where is it now? The Journal of allergy and clinical immunology. 2007 Apr;119(4):769-779.
15. Radulovic S., Calderon M. A., Wilson D., Durham S. Sublingual immunotherapy for allergic rhinitis. Cochrane database of systematic reviews. 2010(12):CD002893.
16. Lin S. Y., Erekosima N., Suarez-Cuervo C., Ramanathan M., Kim J. M., Ward D., Chelladurai Y., Segal J. B. Allergen-Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and/or Asthma: Comparative Effectiveness Review. Rockville (MD)2013.

Stallergenes Greer announces Matthias Vogt as Chief Financial Officer

LONDON--(BUSINESS WIRE)--

Stallergenes Greer plc (Paris:STAGR) (Euronext Paris: STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, announced today the appointment of Matthias Vogt as its Chief Financial Officer (CFO), effective as of October 1st. Matthias Vogt will lead Stallergenes Greer’s global Finance function. He will report directly to Fereydoun Firouz, Chairman and CEO of Stallergenes Greer, and will be based in London.

Matthias Vogt is joining Stallergenes Greer after working for Axalta Coating Systems, a +$4b global paint and coatings company, as Chief Financial Officer EMEA. Prior to Axalta, Matthias was Chief Financial Officer and a member of the Group Management Board at Merz Pharma, a leading healthcare group in Germany where he led the Group’s Finance, Legal and M&A functions. Before joining Merz, he held several country regional and global level financial roles at Novartis, including SVP and CFO of the global OTC Division and member of the Novartis Group Finance leadership team.

“I’m pleased to welcome Matthias to Stallergenes Greer. His broad knowledge across all areas of finance and his global experience will be very valuable as we complete the company’s turnaround and strengthen our leadership position,” said Fereydoun Firouz, Chairman and Chief Executive Officer.

“I am impressed by Stallergenes Greer’s focused, strategic direction and its aspiration to change the allergy immunotherapy treatment paradigm in order to provide access to more patients,” said Matthias Vogt. “It is exciting to join this dynamic global team at this stage of the Group’s transformation.”

Matthias Vogt, who holds an MA in Industrial Engineering and an MBA and Ph.D. in Finance, brings Group CFO experience and a broad corporate Finance background to Stallergenes Greer. He replaces Peter Bühler, who served as Stallergenes Greer’s CFO for the past two years.

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 Plc
Investor and Analyst Relations
Natacha Gassenbach
Head of Communications and Investor Relations
Tel: +1 617 225 80 13
Email: natacha.gassenbach@stallergenesgreer.com
or
Investor Relations Agency
FTI Consulting
Arnaud de Cheffontaines
Tel: +33 1 47 03 69 48
Email: arnaud.decheffontaines@fticonsulting.com
or
Media Relations Agency
Havas Paris
Samuel Rousseau
Tel: +33 6 51 03 51 43
Email: samuel.rousseau@havas.com

Stallergenes Greer announces change of auditor

LONDON--(BUSINESS WIRE)--

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, announces that following the completion of a formal audit tender process, conducted in accordance with the relevant requirements and led by the Company's Audit Committee, the Board has approved the appointment of EY LLP as the Company's auditor for the financial year commencing 1 January 2017. This appointment was approved by shareholders at the Company’s Annual General Meeting held on 8 June 2017.

The Board of extends its appreciation and thanks to PwC LLP for its past contributions.

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

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

Communications and Investor Relations
Natacha Gassenbach
Tel: +1 (617) 225 8013
Email: natacha.gassenbach@stallergenesgreer.com
or
Investor Relations Agency
FTI Consulting
Arnaud de Cheffontaines
Tel: +33 1 47 03 69 48
Email: arnaud.decheffontaines@fticonsulting.com
or
Media
Bloom
Serra Saridereli
Tel: +1 (212) 715 1604
Email: Sariderelis@bloompr.com
or
Havas Worldwide Paris
Samuel Rousseau
Tel: +33 (0) 6 51 03 51 43
Email: samuel.rousseau@havas.com

DISCLAIMER
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.

First real-world evidence shows long term benefits of sublingual immunotherapy to control allergic rhinitis and potentially prevent allergic asthma

LONDON--(BUSINESS WIRE)-- 

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, announced positive results from a real-world evidence (RWE) study on the long-term effectiveness of grass pollen sublingual immunotherapy (SLIT) treatment vs. symptomatic drugs. This is the first study that is based on eight years’ worth of data to demonstrate the long-term effectiveness of SLIT tablets including Stallergenes Greer’s tablet ORALAIR®. Study results showed that grass pollen SLIT tablets significantly improved control of allergic rhinitis and may have a preventive effect on allergic asthma onset and worsening compared to symptomatic treatments. Notably, SLIT treatment was associated with a ~30 percent relative reduction in the risk of developing asthma throughout the treatment period, and a ~40 percent relative risk reduction in the follow-up period.

The data were published in the peer-reviewed journal Allergy in May 2017 and presented this week at the annual European Academy of Allergy and Clinical Immunology (EAACI) Congress, held in Helsinki, Finland. The study, a retrospective analysis of a database of 74,126 patients in Germany, is the first of its kind in the SLIT grass therapeutic area, and adds to the body of evidence about the benefits of Allergy Immunotherapy (AIT) in controlling allergic rhinitis and potentially preventing allergic asthma. AIT is a disease-modifying allergy treatment that acts on the immune system by increasing tolerance to allergens, and can be administered by physicians through injection (subcutaneous) or taken at home through liquid formulation or tablets (sublingual).

“The study data further confirm the long-term benefits of allergy immunotherapy over symptomatic treatments such as antihistamines and corticosteroids that provide temporary relief for patients suffering from allergies,” said Professor Ulrich Wahn, Department for Pediatric Pneumology and Immunology, Charité Medical University, Berlin, who presented the data during the EAACI Congress. “The health impact of allergic rhinitis is often underestimated and can lead to allergic asthma. Taking the right course of treatment upfront can potentially prevent the onset and the development of the disease.”

“The study data provide further evidence that the tablet formulation is an effective allergy immunotherapy treatment option for the patients who may prefer oral administration over injections,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “As a global leader, we are engaged in a comprehensive program to gather real world data from diverse countries to deepen our knowledge and understand how real life practices may impact patient outcomes.”

“With over 74,000 patients in the data set, the design of this retrospective analysis is powered enough to drive meaningful conclusions about the use of allergy immunotherapy treatment over symptomatic treatments,” said Professor Stefan Zielen, Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic Fibrosis, Goethe University Hospital, Frankfurt, who co-presented the data with Professor Wahn during the EAACI Congress. “Germany is ahead of many other countries in the use of allergy immunotherapy and patient access. We look forward to additional data from other countries to further review the findings.”

STUDY RESULTS

After SLIT cessation, allergic rhinitis medication use in the SLIT group vs. the control group was 18.8 percentage points lower compared to before SLIT treatment (p<0.001). While the study was not designed to assess efficacy difference between the tablets (a five-grass pollen SLIT tablet and a timothy SLIT tablet), a subgroup sensitivity analysis showed that Stallergenes Greer’s ORALAIR® SLIT tablets controlled allergic rhinitis by 20 percent up to six years after treatment cessation, compared to the symptomatic treatment group (p<0.001).

Overall, SLIT tablets were associated with a lower risk of developing asthma in non-asthmatic patients by about 30 percentage points during treatment (p=0.013), and by about 40 percent after treatment cessation (p=0.013). In the ORALAIR® subgroup (1,466 patients), the risk of developing asthma in non-asthmatic allergic rhinitis patients was reduced by about 32 percent during the treatment period (p=0.033), and by about 44 percent following the cessation of treatment (p=0.051). In patients who already had asthma at the onset of the study, SLIT tablets were also associated with lower use of asthma medication by about 21 percentage points during treatment (p=0.005) and by about 17 percentage points after treatment cessation (p=0.004). For the ORALAIR® subgroup, the treatment was associated with lower use of asthma medication by 24.6 percentage points during treatment (p=0.013) and by 15.2 percentage points after treatment cessation (p=0.05), compared to the control group.

STUDY DESIGN

The objective of the study was to evaluate the real-world effectiveness of grass-pollen SLIT tablets in controlling allergic rhinitis, and their impact on asthma onset and progression, following a minimum treatment period of two years. The study was based on a real-world, retrospective analysis of data from a prescription database in Germany, which is the first European country to have authorized the marketing of grass pollen SLIT tablet formulations and therefore provided the longest time for the analysis. The study analyzed a data set related to 74,126 adult and pediatric patients with allergic rhinitis induced by grass pollen. Two groups of patients were compared. One group received grass pollen allergy immunotherapy treatment, either in the form of a five-grass pollen SLIT tablet (1,466 patients) or a timothy grass SLIT tablet (1,385 patients), and the other group received symptomatic treatments only (71,275 patients). The overall analysis period ran from January 2008 to February 2016. Changes in the use of symptomatic allergic rhinitis medication, asthma medication and time to asthma onset were compared between the two groups using multiple regression and logistic regression. The study, commissioned by Stallergenes Greer, was conducted by Quintiles IMS, a 3rd party clinical research organization (CRO) and designed by an independent Scientific Committee. The committee included Hartmut Richter (Quintiles IMS); Stefan Zielen, MD; Philippe Devillier, MD, PhD; Joachim Heinrich, PhD, Karel Kostev, MD, and Ulrich Wahn, MD. The study was published online in the May 2017 edition of Allergy.

There were some limitations to the study. The database only included reimbursed prescriptions and lacked direct clinical information, such as the diagnostic methodology and the patient’s sensitisation status. However, the sensitisation status would not impact the results of the study, as both the timothy grass tablet and the five-grass tablet showed a similar treatment effect regardless of the patient’s sensitisation status. To eliminate the risk of including patients without allergic rhinitis in the study, the researchers looked at INS prescription (nasal corticosteroids that are only indicated for the treatment of allergic rhinitis) data. The SLIT tablet formulations used in the study differed in composition and recommended regimen. The study was not designed to assess the efficacy difference between the SLIT tablets included in the study.

ABOUT ORALAIR®

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).

ORALAIR® is a treatment for grass pollen allergic rhinitis with or without conjunctivitis in adults, adolescents, and children (above the age of five except in the United States, where it is approved for use in persons 10 through 65 years of age) with clinically relevant symptoms, confirmed by a positive cutaneous test and/or a positive titre of the specific IgE to the grass pollen. ORALAIR® is not indicated for the immediate relief of allergy symptoms. ORALAIR® is not indicated for allergic asthma treatment.

ORALAIR® was originally approved in Europe in 2008 and is currently authorized in over 30 countries around the world, including most European countries, the United States, Canada, Australia, and Russia for the treatment of grass pollen allergic rhinitis. In United States, ORALAIR® was launched in May 2014, making it the first allergy immunotherapy tablet to be registered and marketed in United States. Worldwide post-marketing experience with ORALAIR® includes more than 50 million doses given to more than 290,000 patients.

ORALAIR® has been approved based on results from an extensive clinical development program. ORALAIR® has been studied in double-blind, placebo-controlled trials, in both Europe and the United States in over 2,800 adults and children.

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

Trading information

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

DISCLAIMER

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.

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. 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

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