Earnings Release • Mar 28, 2018
Earnings Release
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Press release
Paris (France), March 28 th , 2018, 8:00 am - BIOPHYTIS (Euronext Growth Paris: ALBPS), a biotechnology company specializing in the development of drug candidates for the treatment of degenerative age-related or genetic linked diseases, released its financial results today, and reviewed its activities.
"In 2017, significant progress has been realized in our two key clinical programs, as described in the development plan presented in 2016 : SARA in sarcopenia, and MACA in AMD ; we also have communicated preclinical results which allow us to consider a second clinical program for Sarconeos. The MYODA program will be developed in Duchenne Muscular Dystrophy, a degenerative disease of genetic origin. The company simultaneously raised the necessary capital to fund its clinical programs" stated Stanislas Veillet, Chairman and CEO of BIOPHYTIS, adding: "2018 will be a year of value creation, as the efficacy of our drug candidates will be tested for the first time in patients with age-related, disabling diseases for which no treatment exists. Sarconeos will be tested in sarcopenic patients in Europe and the United States, as part of the SARA-INT Phase 2b study. Macuneos will be tested in patients with Age-Related Macular Degeneration (dry AMD) in Europe as part of the MACA-PK Phase 1/2a study. In addition, we will prepare the clinical development plans of our drug candidates in orphan secondary indications, Sarconeos in Duchenne myopathy and Macuneos in Stargardt's disease."
In the continuity of its development plan, Biophtis has set three major objectives for the current year :
The Group's Income Statement, Consolidated Balance Sheet and Statement of Cash Flows have been drawn up in accordance with IFRS. The consolidated financial statements have been audited. The financial statements for the year ended December 31, 2017 were approved by the Board of Directors on March 26, 2018. The certification report has been issued on March 27, 2018.
The table below summarizes the key figures of the income statement:
| In € thousands | 2017 | 2016 |
|---|---|---|
| Net Research and Development Costs | (7,043) | (5,121) |
| Research and Development Costs | (9,593) | (6,788) |
| Grants | 2,550 | 1,667 |
| General and administrative expenses | (2,865) | (2,820) |
| Operating income | (9,908) | (7,942) |
| Financial income | (1,501) | (13) |
| Net Income | (11,409) | (7,954) |
The increase in development costs (launch and development of SARA-OBS, non-clinical regulatory studies for MACA) was the main reason for the significant increase in R&D expenses.
However, general and administrative expenses remain stable on the period.
Financial expenses are mainly due to the effect of the recognition at fair value of the Redeemable in Cash or New or Existing Shares with Subscription Warrants ("ORNANEBSA"), issued by the company in May 2017 and July 2017. This charge has no impact on the Company's cash position.
The table below summarizes the key figures for Company cash:
| in € thousands | 2017 | 2016 |
|---|---|---|
| Non-current financial assets (liquidity contract) | 190 | 98 |
| Cash and cash equivalents | 19,858 | 3,036 |
| Short-Term deposits | 9,857 | 2,001 |
| Bank accounts | 10,001 | 1,065 |
| Available Cash | 20,048 | 3,134 |
The company completed several private placements by issuing new shares generating a capital increase of €21.7 million, as follows:
In April 2017 :
In October 2017 :
In May and July 2017, the company issued two convertible bonds tranches ("ORNANEBSA") for €3 million each. The Company has the option to issue 900 additional bond warrants, which allows the company to draw a maximum additional amount of €9 million.
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Sarconeos is a first-in-class drug candidate based on the activation of the MAS receptor (major player of the renin-angiotensin system) restoring muscular anabolism, inhibiting myostatin, and that had demonstrated meaningful activity in animal models of muscular dystrophies. Sarconeos is developed in the treatment of sarcopenia, an age-related degeneration of skeletal muscle, leading to loss of mobility in elderly people. This condition, for which no medical treatment currently exists, was first described in 1993 and has entered the International Classification of Diseases (M62.84) in 2016. It affects more than 50 million people worldwide.
Macuneos is the first representative of a new class of drug candidates, agonists of nuclear receptor PPAR. Macuneos protects retinal pigment epithelium: Biophytis has shown in animal models a protection of retinal cells against phototoxic effects of A2E in the presence of blue light (oxidative stress), a reduction in accumulation of A2E, and eventually a slowdown of the degenerative process of the retina. Macuneos is a drug candidate against the dry form of AMD: AMD affects the central part of the retina, called the macula, causing severe visual impairment and irreversible loss of central vision beyond 60 years old. Macuneos is in tablet form (once per day), containing 100 mg or 350 mg of active Pharmaceutical Ingredient (API).
Biophytis SA (www.biophytis.com), founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, Biophytis has begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical needs. Specifically, the company is advancing two lead products into mid-stage clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD).
The business model of BIOPHYTIS is to ensure the conduct of the project until clinical activity in the patient is proven, then to license the technologies in order to continue the development in partnership with a pharmaceutical laboratory.
The company was founded in partnership with researchers at the UPMC (Pierre and Marie Curie University) and also collaborates with scientists at the Institute of Myology, and the Vision Institute.
BIOPHYTIS is listed on the Euronext Growth market of Euronext Paris (ALBPS; ISIN: FR0012816825).
For more information: http://www.biophytis.com
Follow us on Twitter @biophytis
BIOPHYTIS is eligible for the SMEs scheme
This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Listing Prospectus upon the admission of Company's shares for trading on the regulated market Euronext Growth of Euronext Paris filed with the AMF, which is available on the AMF website (www.amf- france.org) or on BIOPHYTIS' website (www.biophytis.com).
This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in BIOPHYTIS in any country. Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company's actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the Company's prospectus. This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall prevail.
BIOPHYTIS Stanislas VEILLET CEO [email protected] Tel: +33 (0) 1 44 27 23 00 Citigate Dewe Rogerson International media & Investors Laurence BAULT/Antoine DENRY
[email protected] [email protected] Tel: +33 (0)1 53 32 84 78 Mob: +33(0)6 64 12 53 61
LifeSci Advisors Chris MAGGOS Managing Director, Europe [email protected] Tel: +41 79 367 6254
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