Press releases

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

Communications and Investor Relations
Natacha Gassenbach
Tel: +1 (617) 225 8013
Email: natacha.gassenbach@stallergenesgreer.com
or
Media
Bloom
Serra Saridereli
Tel: +1 (212) 715 1604
Sariderelis@bloompr.com
or
Havas Worldwide Paris
Samuel Rousseau
Tel: +33 (0) 6 51 03 51 43
Email: samuel.rousseau@havas.com

Stallergenes Greer shareholders approve all resolutions proposed by the board of directors at the annual general meeting

LONDON--(BUSINESS WIRE)--

Stallergenes Greer Plc (Paris:STAGR) (Euronext 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 3 May 2017.

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

“2016 has been a turnaround year for Stallergenes Greer. I would like to thank our re-elected Directors for their contributions and guidance, and our shareholders for their continued support,” said Chairman and CEO, Fereydoun Firouz, “We are relentlessly focused on strengthening our leadership position and driving excellence across our business to capture new growth opportunities that create value for 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 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
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 Stallergenes Greer 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," "expect," "project," "estimate," "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 Stallergenes Greer’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
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 Relations Agency
Havas Worldwide Paris
Samuel Rousseau, Tel: +33 (0) 6 51 03 51 43
Email: samuel.rousseau@havas.com

Stallergenes Greer plc - AGM 8 June 2017 Convocation

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

The shareholders of Stallergenes Greer plc (the “Company”) (Paris:STAGR) (Euronext Paris: STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, are hereby informed that they are invited to attend the Annual General Meeting at Palais Brongniart, 28 Place de la Bourse, 75002 Paris, France, on 8 June 2017 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 / 2017.”

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
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 2016 annual report

LONDON--(BUSINESS WIRE)--

Stallergenes Greer (the “Company”) (Paris:STAGR) (Euronext Paris: STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today announces the publication of its 2016 Annual Report.

Approved by the Company’s Board of Directors on 27 April 2017, the report has been filed with the Autorités des Marchés Financiers (AMF) and can be downloaded via the link below.

http://stallergenesgreer.com/sites/default/files/investors/documents/2016_annual_report.pdf

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

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.

Stallergenes Greer plc
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 Relations Agency
Havas Worldwide Paris
Samuel Rousseau
Tel: +33 (0) 6 51 03 51 43
Email: samuel.rousseau@havas.com

 

Stallergenes Greer announces its 2016 full year results

LONDON--(BUSINESS WIRE)--

Stallergenes Greer plc (the “Company”) (Paris:STAGR) (Euronext Paris: STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced its full year results for the year ended 31 December 2016. The results were reviewed and agreed by the Company’s Board of Directors on 29 March 2017.

FY 2016 Financial Highlights

                     
In € millions   H1 2016   H2 2016   FY 2016   FY 2015   FY 2015
  Unaudited   Unaudited   Audited  

Pro forma (unaudited)1

  Audited
Net sales 78.0   108.2   186.2   272.9   81.7
Other revenue 0.1 0.1 0.2 0.2 0.1
Gross margin 34.7 66.4 101.1 182.9 43.8
EBIT before transformation costs (57.1) (35.4) (92.5) (19.4) (64.7)

EBITDA2

(45.1) (22.6) (67.7) n/a (53.4)
Net profit/(loss)   (39.0)   (21.5)   (60.5)   (8.8)   (49.3)

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

Stallergenes Greer progressed strongly in FY 2016, our first year as a consolidated Group, meeting the three strategic goals we set ourselves at the beginning of the period. Namely, we invested in our manufacturing and supply chain capabilities, generated increased demand for our comprehensive product portfolio and strengthened our R&D pipeline. Importantly, these were all achieved as a result of a committed, transformed and stronger organization.

Our European and International sales and market share recovered in H2 2016 demonstrating good execution of our RESTART programme. In the US, we are the leading Biopharmaceutical Company solely focused on allergy immunotherapy.

Our ambition in 2017 and beyond is clear: establishing global leadership in allergy immunotherapy and thus realising our purpose of enabling people to live a life beyond allergy.”

1 The unaudited pro forma consolidated income statement for the year ended 31 December 2015 has been prepared on the basis that the merger was effected on 1 January 2015.
2 EBITDA measure introduced in 2016 to provide a better view on the underlying business performance

H2 2016 and FY 2016 Financial Summary

For the fiscal year ended 31 December 2016, the net sales decrease of 32% compared to the 2015 unaudited pro forma reflects the significant impact of the temporary suspension of production and distribution of the Group’s manufacturing plant in Antony, France which ended on 1 February 2016. In the second half of 2016, Stallergenes Greer’s net sales increased by 21% to €108.2 million compared to H2 2015 unaudited pro forma sales. This growth was stimulated by the success of the RESTART programme in Europe and the ongoing, rapid development of Stallergenes Greer’s sales in North America, which were up 9% in H2 2016 compared to unaudited pro forma H2 2015. As of 31 December 2016, Stallergenes Greer was supplying more than 40 countries.

H2 2016 & FY 2016 Net Sales by Geography

                 
In € millions   H2 2016   FY 2016   H2 2015   FY 2015
  Unaudited   Audited   Pro forma (unaudited)   Pro forma (unaudited)
Southern Europe 44.3   62.1   28.0   127.2
North & Central Europe 12.4 23.1 14.8 47.2
International markets 7.4 12.1 6.2 17.5
US 44.1 88.9 40.2 81.0
Net sales   108.2   186.2   89.2   272.9

European Business

In FY 2016, Southern Europe and North & Central Europe were the most affected regions. Following the temporary suspension of production and distribution of the plant in Antony, France and the related voluntary recall of products originating from that facility, Stallergenes Greer initiated RESTART (Restart Stallergenes Greer After Revalidation Task), a programme designed to refine and rebuild the Company as a trusted leader in allergy immunotherapy (AIT), RESTART provided confirmation to patients, physicians and other stakeholders about the quality and reliability of the Group’s commercial, medical and technical operations capabilities; re-established supply of diagnostics and therapeutics; and shortened lead times for product delivery. Ultimately, in the ramp-up of the 2016/2017 allergy season, Stallergenes Greer achieved significant share gains translating quality, manufacturing and supply chain processes into customer value.

In H2 2016, net sales in Southern Europe more than doubled to €44.3 million compared to unaudited pro forma net sales of €17.8 million in H1 2016 and €28.0 million in H2 2015 (pro forma). The North and Central Europe region reported a sales decrease of 16% to €12.4 million in H2 2016 compared to unaudited pro forma net sales of €14.8m in the same period of 2015. Stallergenes Greer estimates that the Group regained in H2 2016 more than 15 points share gains in the European tablet market compared to the beginning of the year.

International Business

The FY 2016 International business performance was affected overall by the temporary suspension of production and distribution in Antony. In H2 2016, the Group’s International markets reported pro forma sales growth of 19% to €7.4 million due to the successful implementation of RESTART, a strong overall performance in Russia and the launch of ACTAIR® in Japan and Australia.

US Business

In the US, sales increased 10% driven across all product families including subcutaneous, sublingual, veterinary and other products. H2 2016 performance was strong with total reported sales up 10% to €44.1 million from H2 2015 unaudited pro forma sales of €40.2 million.

In more detail, subcutaneous therapies continue to be the largest source of revenue in the US – 73% of the region’s sales – in the period ended 31 December 2016. The Group invested substantially in the promotional efforts behind ORALAIR®. Results of this investment have shown a strong increase in market share during the year 2016 with ORALAIR exiting the year with 21% NRx share (new prescriptions), up from 14% at the end of 2015.

H2 2016 & FY 2016 Net Sales by Product Type

                 
In € millions   H2 2016   FY 2016   H2 2015   FY 2015
  Unaudited   Audited   Pro forma (unaudited)   Pro forma (unaudited)
Sublingual 58.4   85.7   37.5   159.4
Subcutaneous 33.8 68.0 34.0 77.3
Other products 10.0 21.1 11.5 24.9
Veterinary 6.0 11.4 6.2 11.3
Net sales   108.2   186.2   89.2   272.9

Sublingual Products

FY 2016 sublingual products sales declined 46% to €85.7 million from 2015 unaudited pro forma sales as ORALAIR became available to prescribers and patients from February 2016, whilst the liquid drop STALORAL® became available in late March in France and late April in other countries. In Europe and International markets, the sublingual product category was the most impacted by the events in Antony.

H2 2016 Stallergenes Greer’s sublingual products sales increased by 56% to €58.4 million compared to the unaudited pro forma H2 2015, including ORALAIR and ACTAIR tablets as well as STALORAL.

Subcutaneous Products

FY 2016 subcutaneous product sales, which include ALUSTAL®, PHOSTAL®, ALYOSTAL®, ALBEY® and GREER EXTRACTS®, were reported at €68.0 million, a 12% decrease from unaudited pro forma net sales of €77.3 million in FY 2015. In H2 2016, the sales of the division are stable compared to H2 2015.

In Europe and International markets, production and distribution of subcutaneous products resumed in Q4 2016 in a limited number of countries and product references. In the US, subcutaneous sales were strong and reinforced the Group’s leadership in this region with a 52% market share.

Other Products

Other products including diagnostics and ancillary products declined 15% in 2016 mainly related to a decrease of diagnostic products in the Europe and International region. The segment totalled sales of €10.0 million in H2 2016, compared to €11.5 million in H2 2015 on an unaudited pro forma basis.

Veterinary Products

In FY 2016, veterinary sales increased 1% to €11.4 million compared to unaudited pro forma 2015 as the Group is exploring opportunities to leverage bulk extracts to expand an attractive ancillary niche. Veterinary product sales reached €6.0 million in H2 2016, a decrease of 3% compared to H2 2015 on an unaudited pro forma basis.

Research and Development

Stallergenes Greer is committed to developing innovative therapies for major respiratory allergies and invested €52.8 million in R&D, principally funding STARG320, the Group’s Phase III global multi-center clinical trial for house dust mite (HDM) induced allergic rhinitis. Currently, more than 2,760 patients are enrolled in sublingual clinical studies worldwide.

In April 2016, Stallergenes Greer’s partner Shionogi & Co. Ltd. reported positive results for the Phase II clinical study of its sublingual immunotherapy tablet for the treatment of seasonal Japanese Cedar-induced allergic rhinitis (STAGR120). The study which was conducted in Japan achieved its primary efficacy endpoint with all treated groups demonstrating a positive, statistically significant difference on the Average Rhino conjunctivitis Total Symptom Score (ARTSS) versus the placebo group and the safety profiles were favourable overall.

In April 2016, Stallergenes Greer received the approval for ACTAIR, its immunotherapy tablet for the treatment of house dust mite (HDM) induced respiratory allergy, from the Australian health authorities (Therapeutic Goods Administration).

In November 2016, Stallergenes Greer announced collaboration with the Sean N. Parker Center for Allergy and Asthma Research at Stanford University to identify potential biomarkers of AIT efficacy. The primary goal of the collaboration is to assess the impact of peanut oral immunotherapy on biological parameters.

Operating and Financial Review

                     
In € millions   H1 2016   H2 2016   FY 2016   FY 2015   FY 2015
  Unaudited   Unaudited   Audited   Pro forma (unaudited)   Reported
Gross margin 34.7   66.4   101.1   182.9   43.8
as % of net sales 44% 61% 54% 67% 54%
EBIT before transformation (57.1) (35.4) (92.5) (19.4) (64.7)
EBITDA (45.1) (22.6) (67.7) n/a (53.4)
Net profit/(loss)   (39.0)   (21.5)   (60.5)   (8.8)   (49.3)

The Group’s FY 2016 gross margin of €101.1 million represented 54% of net sales, compared to 67% in FY 2015 unaudited pro forma, a direct consequence of the temporary suspension of production, distribution and the product recall, while costs continued to be incurred.

Stallergenes Greer published a FY 2016 operating loss (EBIT) before transformation costs of €92.5 million, in comparison with an unaudited pro forma operating loss before transformation costs of €19.4 million in FY 2015. This result includes investments in the resolution of the temporary production and distribution suspension and the voluntary product recall, the Group’s investment in the ORALAIR US opportunity and the establishment of the Group’s headquarters in London (United Kingdom) and Cambridge, Massachusetts (US).

In FY 2016, the Group’s transformation costs of €3.5 million (2015: €9.2 million) reflect those incurred as part of the restructuring of some subsidiaries, mainly in Europe, in response to the decrease in business following the temporary suspension of the activities.

The EBITDA for the second half of the year 2016 totalled €(22.6) million, a significant improvement compared to an EBITDA of €(45.1) million in the first half year of 2016, reflecting significantly improved sales and the positive impact of the effective operating cost management.

As of 31 December 2016, Group shareholder’s equity were €489.2 million (December 31, 2015: €540.0 million). This highlights that the Group remains in a strong position financially despite the challenges it has faced.

In November 2016, the Group signed a €50 million three-year multicurrency Revolving Loan Facility. As of 31 December 2016, the Group had drawn $17.0 million (€15.5 million) against this facility.

As of 31 December 2016, the Group had "cash and cash equivalents" of €71.3 million. In addition, the Group has limited external debt with an outstanding debt balance of €23.1 million.

Shareholder Remuneration

Stallergenes Greer aims to balance the appropriate cash returns to equity holders with the requirement of maintaining a balanced and sound financial position, while continuing to invest in its growth strategy. Accordingly the Board of Directors will not recommend at the Annual General Meeting of Shareholders on 8 June 2017 the distribution of a dividend for the financial year ended 31 December 2016.

Significant Events After the End of the 2016 Reporting Period

No significant events occurred after the end of the 2016 reporting period.

2017 Business Outlook and Guidance

FY 2016 financial results and year-end momentum confirmed that Stallergenes Greer’s turnaround is on course as the Group regained trust of patients, healthcare professionals and health authorities. This is a consequence of investments in 2016 in the Group’s organization, technical operations, quality and IT.

Stallergenes Greer’s ambitions are clear: regain market leadership and restore profitability. In 2017, the Group is focusing on finalizing the RESTART programme, realizing US ORALAIR market share gains, targeting key growth markets while continuing to right-size cost base, strengthening the balance sheet and efficiently manage cash.

Stallergenes Greer’s financial objectives for 2017 are as follows:

  • Total revenue growth of c.35-45% to €250-270m
  • EBITDA positive

Webcast and Conference Call Information

The company will host an Investors and Analysts meeting on 30 March 2017. The event will also be available via live webcast at 2.00 pm CET / 1.00 pm BST / 8.00 am EDT. The webcast will be available via the following link: http://edge.media-server.com/m/p/eucn8utk

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

Financial Calendar

  • 28 April 2017 - Annual Report Filing
  • 8 June 2017 - Annual General Meeting
  • 30 August 2017 - H1 2017 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 U.S.) and Stallergenes S.A.S. (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.

TABLE OF CONTENTS

Condensed consolidated income statement as of 31 December 2016

Condensed consolidated balance sheet as of 31 December 2016

Consolidated cash flow statement

Unaudited pro forma consolidated sales breakdown

Unaudited pro forma consolidated income statement

The financial information set out above does not constitute the Company’s financial statements for the years ended 31 December 2016 or 2015 but is derived from those statements. Financial statements for 2015 have been delivered to the Registrar of Companies and those for 2016 will be delivered following the Company’s annual general meeting. 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, on its internet site.

The financial statements were approved by the Board of Directors on 29 March 2017.

Condensed consolidated income statement as of 31 December

           
€ thousands 31 December 2016 31 December 2015*
Net sales 186,247 81,748
Other revenue 141 74
 
Total revenues 186,388   81,822
 
Cost of goods sold (85,331) (37,966)
 
Gross margin 101,057   43,856
 
Distribution costs (11,783) (8,561)
Selling and marketing expenses (63,943) (32,639)
Administrative expenses (67,316) (44,112)
Other general expenses (5,154) (3,568)
Selling, general and administrative expenses (148,196) (88,880)
 
Loss before R&D (47,139) (45,024)
 
Research and development costs (R&D) (52,783) (20,929)
R&D-related income 7,379 1,301
Net R&D costs (45,404) (19,628)
 
Operating loss before transformation costs (92,543) (64,652)
 
Transformation costs (3,506) (9,211)
 
Operating loss (96,049) (73,863)
 
Financial income 609 79
Financial expenses (699) (359)
Net financial expense (90) (280)
 
Loss before tax and associates (96,139) (74,143)
 
Income tax 35,773 24,889
Share of loss from associated companies (156) (27)
Loss for the period attributable to:
Owners of the parent (60,522) (49,281)
 
Non-controlling interest
Group share of net loss   (60,522)     (49,281)

* The result of the Group includes Stallergenes Greer Holdings Inc. Group from 8 May 2015 and the Stallergenes SA Group from 8 September 2015. Net sales in 2015 include the full impact of the temporary suspension and product recall including a provision against sales of 24 736 K€. The 2016 net sales figure includes a €595k reversal of this provision to cover credit notes issued.

Condensed consolidated balance sheet as of 31 December

         
€ thousands 31 December 2016 31 December 2015
Goodwill 216,550 210,844
Other intangible assets 90,428 101,716
Property, plant and equipment 80,304 78,059
Non-current financial assets 6,011 19,835
Deferred tax assets 35,377 4,447
Non-current assets 428,670 414,901
 
Inventories 63,786 59,362
Trade receivables 41,826 29,669
Current financial asset 13 2
Other current assets 8,810 14,034
Income tax receivable 15,997 17,608
Cash and cash equivalents 71,262 150,183
Current assets 201,694 270,858
Total assets 630,364 685,759
     
€ thousands 31 December 2016 31 December 2015
Share capital 19,788 19,788
Share premium 539 539
Merger and contribution premium 342,149 343,904
Revaluation reserve - (1,158)
Retained earnings 126,733 176,908
Group shareholders’ equity 489,209 539,981
Non-controlling interests - -
Total shareholders’ equity 489,209 539,981
 
Provision for employee retirement obligations and related benefits 4,488 5,333
Non-current provisions 1,651 758
Non-current financial liabilities 6,753
Deferred tax liabilities 17,750 25,692
Non-current liabilities 30,642 31,783
 
Trade payables 26,658 27,612
Current provisions 3,180 4,922
Current financial liabilities 16,366 17,669
Income tax payable 1,217 1,549
Other current liabilities 63,092 62,243
Current liabilities 110,513 113,995
Total equity and liabilities 630,364 685,759

Consolidated cash flow statement

         
€ thousands 31 December 2016 31 December 2015
Cash flow from operating activities
 
Operating result (96,049) (73,863)
Amortisation and depreciation charges 25,247 12,892
Allowance / (reversal) of impairment losses 2,435 (99)
Change in provisions (1,096) 3,390
Share-based payments 1,117 195
Capital losses from disposal of assets 578 3,980
Financial losses excluding interests 56 71
     
Gross operating result (EBITDA) (67,712) (53,434)
 
Income tax paid (2,454) (3,791)
Change in working capital of operating activities (7,244) 18,116
Change in deferred income (675) 882
     
Net cash flow from operating activities (78,085) (38,227)
 
Cash flow from investing activities
 
Acquisition or increase in non-current assets (22,015) (17,268)
Cash acquired on combinations under common control - 196,387
Proceeds from sale of non-current assets* 19,509 2,018
Change in working capital of investment activities (2,547) 6,420
     
Net cash flow from investing activities (5,053) 187,557
 
Free cash flow after investing activities (83,138) 149,330
 
Cash flow from financing activities
 
Proceeds from issuance of ordinary shares - 561
Treasury shares transactions 20 (1,279)
Net financial interest paid (583) (351)
Use / (repayment) of bank overdrafts (133) 357
Repayment of borrowings (17,018) (1,936)
Proceeds from borrowings 22,115 3,090
     
Net cash flow from financing activities 4,401 442
 
Change in cash and cash equivalents (78,737) 149,772
 
+ cash and cash equivalents – opening balance 150,183 58
-/+ effect of translation adjustment on foreign currency denominated cash (184) 353
= cash and cash equivalents – closing balance 71,262 150,183

* Included within proceeds from sale of non-current assets are the proceeds from sale of the DBV Technologies shares of €16,834k.

Unaudited pro forma consolidated sales breakdown

Net sales by product type

                     
 

6 months to 30 June1

6 months to 31 December1

Total2

€ millions 2016   2015   Pro forma 2016   2015   Pro forma 20163  

20153

  Pro forma
Sublingual route 27.3   0.1   121.9 58.4   21.0   37.5 85.7   21.1   159.4
Subcutaneous route 34.2 9.3 43.3 33.8 31.0 34.0 68.0 40.3 77.3
Other products 11.1 1.7 13.4 10.0 10.8 11.5 21.1 12.5 24.9
Veterinary 5.4   1.6   5.1 6.0   6.2   6.2 11.4   7.8   11.3
Net sales 78.0   12.7   183.7 108.2   69.0   89.2 186.2   81.7   272.9

Net sales by geographic segment

                     
  6 months to 30 June1 6 months to 31 December1 Total2
€ millions 2016   2015   Pro forma 2016   2015   Pro forma 20163   20153   Pro forma
Southern Europe (i) 17.8   0.6   99.2 44.3   15.4   28.0 62.1   16.0   127.2
Northern & Central Europe (ii) 10.7 0.2 32.4 12.4 9.7 14.8 23.1 9.9 47.2
International markets 4.7 0.3 11.3 7.4 3.4 6.2 12.1 3.7 17.5
United States 44.8   11.6   40.8 44.1   40.5   40.2 88.9   52.1   81.0
Net sales 78.0   12.7   183.7 108.2   69.0   89.2 186.2   81.7   272.9

(i) Portugal, Spain, France and Italy
(ii) Including Greece and Switzerland

1 The individual six-month results have not been audited
2 The results for 2016 and 2015 have been audited. Pro forma results are unaudited and are provided for illustrative purpose only.
3 The result of the Group includes the Stallergenes Greer Holdings, Inc. Group from 8 May 2015 and the Stallergenes SA Group from 8 September 2015. Net sales in 2015 include the full impact of the temporary suspension and product recall including a provision against sales of 24 736 K€.. The 2016 net sales figure includes a €0.6m utilisation of this provision to cover credit notes issued.

Unaudited pro forma consolidated income statement

             
 

6 months to 30 June1

6 months to 31 December1

Total2

In € millions 2016   2015   Pro forma 2016   2015   Pro forma

20163

  20153   Pro forma
Net sales 78.0   12.7   183.7 108.2   69.0   89.2 186.2   81.7   272.9
Other revenue 0.1 0.1 0.1 0.1 0.1 0.2 0.1 0.2
Total revenues 78.1   12.7   183.8 108.3   69.1   89.3 186.4   81.8   273.1
Cost of goods sold (43.4) (5.1) (46.7) (41.9) (32.9) (43.5) (85.3) (38.0) (90.2)
Gross margin 34.7   7.6   137.1 66.4   36.2   45.8 101.1   43.8   182.9
                               
Selling, general and administrative expenses (71.3) (8.4) (74.1) (76.9) (80.5) (95.3) (148.2) (88.9) (169.4)
Loss/(profit) before R&D (36.6) (0.8) 63.0 (10.5) (44.3) (49.5) (47.1) (45.1) 13.5
Research and development costs (R&D) (25.1) (0.7) (25.3) (27.7) (20.2) (27.1) (52.8) (20.9) (52.4)
R&D-related income 4.6     16.3 2.8   1.3   3.2 7.4   1.3   19.5
Net R&D costs (20.5) (0.7) (9.0) (24.9) (18.9) (23.9) (45.4) (19.6) (32.9)
Current operating (loss) / profit before transformation costs (57.1)   (1.5)   54.0 (35.4)   (63.2)   (73.4) (92.5)   (64.7)   (19.4)
Transformation costs (1.4) (6.6) (11.0) (2.1) (2.6) (1.4) (3.5) (9.2) (12.4)
Operating (loss) / profit (58.5)   (8.1)   43.0 (37.5)   (65.8)   (74.8) (96.0)   (73.9)   (31.8)
Financial income 0.9 0.6 0.1 0.6 0.1 0.9
Financial expenses (0.3)   (0.1)   (0.5) (0.4)   (0.3)   (0.2) (0.7)   (0.4)   (0.7)
Net financial (expense) / income (0.3) (0.1) 0.4 0.2 (0.2) (0.2) (0.1) (0.3) 0.2
(Loss) / profit before tax and associates (58.8)   (8.2)   43.4 (37.3)   (66.0)   (75.0) (96.1)   (74.2)   (31.6)
Income tax 19.8 0.5 (14.7) 16.0 24.4 37.6 35.8 24.9 22.9
Share of (loss) / profit from associated companies (0.1) (0.2) - (0.2) - (0.1)
 
Net (loss) / profit (39.0)   (7.7)   28.6 (21.5)   (41.6)   (37.4) (60.5)   (49.3)   (8.8)
Attributable to minority interests
Net (loss) / profit (39.0)   (7.7)   28.6 (21.5)   (41.6)   (37.4) (60.5)   (49.3)   (8.8)

1 The individual six-month results have not been audited.
2 The results for 2016 and 2015 have been audited. Pro forma results are unaudited and are provided for illustrative purpose only.
3 The result of the Group includes the Stallergenes Greer Holdings, Inc. Group from 8 May 2015 and the Stallergenes SA Group from 8 September 2015. Net sales in 2015 include the full impact of the temporary suspension and product recall including a provision against sales of 24 736 K€. The 2016 net sales figure includes a €0.6m utilisation of this provision to cover credit notes issued.

Investor and Analyst Relations
Peter Bühler, +33 1 55 59 23 22
Chief Financial Officer
investorrelations@aresallergyco.com
or
Investor Relations Agency
FTI Consulting
Arnaud de Cheffontaines, +33 1 47 03 69 48
arnaud.decheffontaines@fticonsulting.com
or
Media relations agency
Havas Worldwide Paris
Jean-Baptiste Froville, +33 1 58 47 95 39
jean-baptiste.froville@havasww.com

Stallergenes Greer announces submission of new drug application for pediatric use of Actair® in Japan

LONDON--(BUSINESS WIRE)--

Stallergenes Greer (the “Company”) (Paris:STAGR) (Euronext Paris: STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced that its commercialization partner in Japan, Shionogi & Co. Ltd. (Shionogi), submitted its New Drug Application (NDA) for ACTAIR®, an investigational allergy immunotherapy sublingual tablet for the treatment of house dust mite (HDM) induced allergic rhinitis in children 5 to 11 years old. ACTAIR is already approved for the treatment of HDM-induced allergic rhinitis in patients 12 years of age and older in Japan.

The NDA submission is 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. Having achieved the study’s primary efficacy endpoint, the active group demonstrated a statistically significant difference (p=0.0005) on the Average Adjusted Symptom Score (AAdSS) after one year of treatment versus placebo.

“Now on the cusp of providing access to this therapy for children living with HDM-induced allergies in Japan, we are pleased with the progress our partner, Shionogi, has made to bring this NDA filing to fruition,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “If approved, ACTAIR will be a valuable new treatment option for this pediatric patient population and their families.”

In September 2010, Stallergenes SA signed exclusive partnership agreements with Shionogi for the clinical development, registration and commercialization of sublingual HDM and Japanese cedar pollen immunotherapy tablets. As part of this, the Company is eligible for development, regulatory and sales milestones, as well as royalty payments on net sales.

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 this country. From early childhood, house dust mites can trigger allergic rhinitis, which worsens over time with a natural 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 where sublingual allergy immunotherapy tablets have not been available.

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.

Investor and Analyst Relations

Peter Bühler, +33 1 55 59 23 22

Chief Financial Officer

investorrelations@aresallergyco.com

or

Investor Relations Agency

FTI Consulting

Arnaud de Cheffontaines, +33 1 47 03 69 48

arnaud.decheffontaines@fticonsulting.com

or

Media Relations Agency

Havas Worldwide Paris

Jean-Baptiste Froville, +33 1 58 47 95 39

jean-baptiste.froville@havasww.com

Stallergenes Greer announces resignation of Chief Financial Officer

LONDON--(BUSINESS WIRE)--

Stallergenes Greer plc (the “Company”) (Paris:STAGR) (Euronext Paris: STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced that Peter Bühler has resigned as Chief Financial Officer. His last day will be April 28, 2017.

Mr. Bühler joined Stallergenes Greer in April 2013 and made the decision to leave the Company in order to move back to his home country of Switzerland to pursue other opportunities.

“I want to thank Peter for his contributions over the past four years. We wish him the best in his future endeavors," said Fereydoun Firouz, Chairman and Chief Executive Officer.

The Company has initiated an external search for a successor.

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.

Investor and Analyst Relations
Peter Bühler
Chief Financial Officer
Tel: +33 1 55 59 23 22
Email: investorrelations@aresallergyco.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 Worldwide Paris
Jean-Baptiste Froville
Tel: +33 1 58 47 95 39
Email: jean-baptiste.froville@havasww.com

Stallergenes Greer announces Positive top-line results of Phase 3 study for pediatric House Dust Mite-induced allergic rhinitis

LONDON--(BUSINESS WIRE)--

Stallergenes Greer (the “Company”) (Euronext Paris: STAGR) (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced positive topline results for a Phase 3 clinical study of its sublingual immunotherapy tablet (STG320) for the treatment of house dust mite (HDM) induced allergic rhinitis in the pediatric population, which was conducted in Japan by its partner Shionogi & Co. Ltd.

The multi-center, randomized, double-blind and placebo-controlled study evaluated the efficacy of STG320 at a daily dose of 300IR administered for 12 months to children between 5 and 16 years old with HDM-associated allergic rhinitis and achieved its primary efficacy endpoint. The active group demonstrated a statistically significant difference (p=0.0005) on the Average Adjusted Symptom Score (AAdSS) after one year of treatment versus placebo and the results will be used to obtain approval from Japan’s Pharmaceutical and Medical Device Agency (PMDA) in the pediatric population.

“We are pleased with the outcome of this study, which brings us another step closer to providing access to this therapy for children living with house dust mite-induced allergic rhinitis in Japan,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “This data increases our understanding of STG320’s clinical profile and will enable us, in the future, to generate appropriate evidence packages which support registration in those markets where ACTAIR® can provide a valuable new therapeutic option.”

In September 2010, Stallergenes SA signed exclusive partnership agreements with Shionogi & Co., Ltd. for the clinical development, registration and commercialization of sublingual house dust mite and Japanese cedar pollen immunotherapy tablets. As part of this, the Company is eligible for development, regulatory and sales milestones, as well as royalty payments on net sales.

ABOUT THE STG320 PHASE 3 TRIAL

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 and placebo-controlled study to assess the efficacy of house dust mite sublingual immunotherapy tablets for the treatment of perennial allergic rhinitis. Patients aged 5 to 16 years old with medical history consistent with house dust mite-induced allergic rhinitis were eligible. A total of 438 patients were randomized to receive 12 months of treatment with house dust mite 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

Allergic rhinitis affects 25% of Japan’s population. House dust mites and Japanese cedar pollen are the two main causes of respiratory allergies in this country. From early childhood, house dust mites can trigger allergic rhinitis, which worsens over time with a natural 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 where sublingual allergen immunotherapy tablets have not been available.

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.

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