Genfit, a French biopharmaceutical company focused on the discovery and development of therapeutic and diagnostic solutions in the field of hepatic and hepatobiliary diseases, has announced its intention to make a public offering of its common shares in the form of American Depositary Shares ( ADS) in the United States. It confidentially submitted a draft of the registration document (Form F-1) to the SEC.
Concurrently with the offering to the public in the United States, Genfit intends to proceed with the private placement of its common shares outside the United States, primarily in Europe, including France. The timing, number of new common shares and ADSs and the price of new common shares and ADSs to be issued under the proposed public offering and private placement have not yet been determined.
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– A biopharmaceutical company specializing in the early diagnosis, prevention and treatment of cardiometabolic diseases (diabetes, dyslipidemia, etc.), non-alcoholic steatotic hepatitis-like disorders (NASH) and diseases affecting the liver or intestines;
– Strong growth in the market for type 2 diabetic diseases, linked to obesity, and NASH diseases (2 O M of the adults in question in the United States);
– Portfolio divided into 5 main programs: GFT505 or elafibranor, NASH Phase III clinical trials, 2 biomarker programs for type 2 diabetes, circadian rhythm interruption program associated with type 2 diabetes, a program on immune system diseases affecting the liver and / or intestines, a program on the mechanisms of fibrosis affecting the liver and / or intestines: a set of targets is the subject of a pharmacological validation program;
– Patents and protection by the end of 2035 of the GFT505 against NASH and liver diseases in Europe and the United States, and obtaining FDA "accelerated review" status;
– A comfortable cash flow of € 274 million, able to finance developments through 2019, and financial agility strengthened by the Oceane issue of autumn 2017.
Weaknesses in value
– High value volatility, reinforced by the prospect of the end of phase III clinical trials of EAMFIBRANOR, expected by mid 2019;
– very competitive markers and drugs against diabetes;
– High cost of patient recruitment for elafibranor phase III;
– Very volatile value.
How to Follow the Value
– Molecules require many years of development before being marketed. They are therefore not immediately evaluated in the stock market. It is also necessary to assess the potential market for a developing molecule and whether it meets unmet medical needs;
– Market share sensitivity to the statements of competitors Intercept, Galmed and Tobira, also present at NASH, as well as mergers in the sector;
– Major catalysts in the market: the clinical results of elafibranor – which seem to confirm a preventative effect on NASH – and obtain the status of "accelerated review";
– Resumption of speculation on pharmaceutical partnerships for the industrialization of the Nash diagnosis and for the development of treatments against psoriasis and certain respiratory diseases;
– Reception of the health authorities in filing an IND request for the launch of a phase 2 fibrosis test;
– Capital exploded, between management and employees (13.99% of the capital and 23.01% of the voting rights), the Institut Pasteur de Lille (5.34% and 4.39%) and Lille 2 ( 5.25% and 8.64%).
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The environment is becoming increasingly favorable to the pharmaceutical industry. Large groups have been able to cope with the fall in the public domain of patents of their main drugs (blockbusters). They have generally been able to maintain their cash flow (cash flow). However, the consequences were important. For example, AstraZeneca's revenue was significantly reduced following the loss of Crestor, Nexium and Seroquel patents, which almost cost it its independence from Pfizer. And the actors are forced to adapt their strategy: the race for growth relays is launched. That is why in the industry, acquisitions are multiplying. Faced with the loss of its main company's patent, Lantus (15% of its turnover), Sanofi, recently acquired Bioverativ, a US biotechnology company specializing in hemophilia, for $ 11.6 billion. Preferred targets are biotechnology in key therapeutic areas, such as immuno-oncology. However, increased investment in venture capital funds in the industry generates valuations.