Press Releases

Formycon AG and its licensing partner Bioeq announce today, that the U.S. Food and Drug Administration (FDA) has requested additional data as part of the review process of the BLA for the Lucentis® biosimilar candidate FYB201, submitted by Bioeq in December 2019.

The company's group sales, including other earnings, as of September 30 of this year, amount to EUR 26.8 million while EBITDA was well-balanced and net result totaled around EUR -0.7 million. Formycon Group's stocks of liquid assets, including short-term receivables from deliveries and services as well as other assets are totaling EUR 29.2 million on the day of reporting.

Bioeq IP AG, the exclusive owner of the global commercialization rights of Formycon’s FYB201 has signed a license and development agreement with Coherus BioSciences, Inc. The US Biosimilar-specialist, headquartered in California, will exclusively market and distribute Formycon's biosimilar candidate to Lucentis® (FYB201) in the United States of America (US).

Formycon AG today announced the start of a Phase I clinical trial comparing the pharmacokinetics, safety, and tolerability of FYB202 and the reference product Stelara® (USA / EU). Dosing of study subjects started last week.

Formycon AG has today announced its financial results for the first half of 2019. With a Group turnover of Euro 17,2 million and a period result of Euro -0,7 million Formycon Group's commercial figures were as forcast.

Formycons shareholders followed the proposals of the Board of Management and the Supervisory Board and approved all resolutions proposed by the management with large majorities in each case.

With the agreement dated June 26, 2019, Wendeln & Cie. KG, an asset management company of Mr. Peter Wendeln (anchor shareholder and long-standing member of the Supervisory Board of Formycon AG), acquired all rights from the certificate of subscription as well as the 577,397 shares in Formycon AG from the cash capital increase.

The Group sales, including other earnings, as of March 31 of this year amount to EUR 9.5 million. Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR 0.5 million. The operating result (EBIT) as well as the quarterly result totaled around EUR 0.2 Million. The reported sales revenues result from reimbursements for development work in the licensed-out projects or projects developed in partnership. For the 2019 fiscal year, revenues in the amount of approximately EUR 35.0 million are expected at the group level.

As of today, totaling EUR 5,000,000.00, have been paid to the company’s capital increase account. The signatory's debt contribution amounting to EUR 12,264,170.30 is therefore still outstanding. The shares have so far not been delivered due to the as yet unsettled payment.

The Group's turnover rose compared to last year (Euro 29 million) by 48 percent to around Euro 43 million, exceeding forecasts. The earnings before interest, tax, depreciation and amortization on fixed and immaterial assets (EBITDA) were Euro 8 million (previous year Euro -0.8 million), which is significantly higher than last year’s figure.

Formycon has published news on its development portfolio. The FDA submission of FYB201 is expected for the beginning of the fourth quarter of this year. The submission to the European Medicines Agency (EMA) is scheduled for the first quarter of 2020. Also significant progress have been achieved with FYB202 and FYB203.

The Swiss company M&H Equity AG from Heerbrugg in the Canton of St. Gallen is a strategic investor with a long-term investment horizon. The funds acquired from the capital increase should be used primarily to develop the company’s own biosimilar products and further increase the value of the pipeline.

Strategic investor M&H Equity AG subscribes for a cash capital increase of € 17,264,170.30 million in the context of a private placement with an issue price of 29.90 EUR per share. The funds acquired from the capital increase will be used primarily to develop the company’s own biosimilar products, particularly FYB205.

For FYB201, new data from the recently completed COLUMBUS-AMD phase III trial in patients with neovascular age-related macular degeneration (nAMD) are available.

The turnover of the Formycon group increased significantly compared with the first nine months of 2017.