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Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its financial results for the first half of 2019.

On the day of reporting, June 30, 2019, the Formycon Group’s commercial figures were as forecast. During the first six months of 2019, turnover at the Group which, in addition to the joint-stock company also includes the two sub-holdings Formycon Project 201 GmbH and Formycon Project 203 GmbH, as well as the shareholding in FYB202 GmbH & Co. KG, stood at Euro 17.2 million (H1/2018 incl. a special effect of Euro 8.5 million: Euro 24.6 million).

During the company’s current phase, the Formycon Group is focusing on research and development activities for its own and licensed biosimilar projects. These development services are also the source of the current revenue returns. Following the successful approval of its products, Formycon is also involved in the various licensing partners’ subsequent marketing solutions. The company is currently focusing on three main projects for biosimilars, each targeting billion-dollar markets.

On the FYB201 project involving a biosimilar candidate to the reference drug Lucentis®¹⁾, the licensing partner Bioeq IP AG is about to submit the approval documents to the US Food and Drug Administration, the FDA. FYB202, a biosimilar candidate to the reference drug Stelara®²⁾, is imminently due to transition to clinical trials. The start of the clinical phase III for the FYB203 project, which involves a biosimilar candidate to the reference drug Eylea®³⁾, is planned for mid-2020.

The Group’s earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -0.2 million (H1/2018 incl. special effect: Euro 8.63 million). The operating result (EBIT) totaled Euro 0.7 million (H1/2018 incl. special effect: Euro 8.23 million). As of June 30, 2019, the Group period result was Euro -0.7 million compared to Euro 7.59 million in the same period last year.

For the whole of 2019 Formycon anticipates revenues of around Euro 35 million at group level. As in previous years, the Group’s financial position appears to be very solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 8 million on the day of reporting. Including short-term receivables and other assets worth Euro 19.8 million, the Formycon Group held liquid assets of around Euro 27.8 million in total.

The cash capital increase carried out in the first half of 2019 increased the company’s subscribed capital by Euro 577,397.00 by issuing an equal number of shares with a notional interest in the share capital of Euro 1.00 each to a total of EUR 10,000,000.00. The premium of Euro 16,686,773.30 was fully booked to the capital reserve. The Group’s equity ratio therefore increased to 92 per cent on the day of reporting.

Formycon AG, as the company’s central development and operational unit, achieved a turnover of Euro 11.3 million during the first half of 2019 (H1/2018 incl. special effect: Euro 18.9 million). The earnings for this period totaled Euro -0.7 million (H1/2018 incl. special effect: Euro 7.7 million).

During the reporting period, Formycon exceeded the 100-employee threshold for the first time in the company’s history. The total number of employees within the company rose during the first half of 2019 from 95 to a total of 103.

Dr. Nicolas Combé, Formycon’s CFO, was extremely satisfied with the developments of the first six months: “The half-year figures are as forecast and we have taken further key steps forward both on the development side and in the expansion of our organization. Our task continues to be developing our three key products successfully in collaboration with our partners and bringing them to approval stage so that we can then share in the future product sales. In this context, the submission of FYB201 to the FDA in the US represents an important interim goal.”

The full half-year report can be found on the Internet at
https://www.formycon.com/en/investor-relations/financial-reports/

¹⁾  Lucentis® is a registered trademark of Genentech Inc.
²⁾ Stelara® is a registered trademark of Johnson & Johnson
³⁾ Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.

Munich – The biosimilars company Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) held its Annual General Meeting on June 27, 2019.

At the Annual General Meeting, the shareholders represented 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. Both the members of the Board of Management and the Supervisory Board were given a vote of confidence by a majority of more than 95 percent each. Hermann Vogt, who had already been a member of the Supervisory Board since 2013 and acted as Deputy Chairman, was elected to the Supervisory Board with a large majority and for a further full term of office. In a subsequent constituent meeting, the Supervisory Board reappointed Dr. Olaf Stiller as Chairman and Mr. Hermann Vogt as Deputy Chairman.

At the time of the vote, around 4.4 million shares were represented, corresponding to 44.0% of the share capital. Detailed voting results and further information on the 2019 Annual General Meeting can be found at https://www.formycon.com/en/investor-relations/annual-general-meeting/.

Munich – The biosimilars company Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) presented the sales and earnings figures for the first quarter of 2019 today, showing a positivebusiness development.

As the company announced today, the group sales, including other earnings, as of March 31 of this year amount to EUR 9.5 million (previous year, including special effect, in the amount of EUR 8.5 million: EUR 13.7 million). Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR 0.5 million (previous year, including special effect: EUR 6.9 million). The operating result (EBIT) as well as the quarterly result totaled around EUR 0.2 million (previous year, including special effect: EUR 6.7 million).

The liquidity ratios of the Formycon Group in the first quarter of 2019 are as follows: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled EUR 9.2 million at the end of March. Including short-term receivables from deliveries and services worth approximately EUR 7.0 million, Formycon held liquid assets of EUR 16.2 million on the day of reporting. Within the capital increase announcement on March 22, 2019, to the present day EUR 577,397.00 nominal and EUR 4,422,603.00 as an additional payment under the law of obligations, i.e. a total of EUR 5,000,000.00, have been paid into the company’s capital increase account. In the first quarter of 2019, the previous inflow from the corporate action was offset by an additional contribution of EUR 5.1 million to the joint venture FYB 202 GmbH & Co. KG, the joint venture founded with Aristo Pharma. To date, Formycon has invested a total of around EUR 21.0 million in the development of FYB202.

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.

In the first three months of the year, Formycon AG as the company’s actual operational unit achieved a turnover of EUR 6.4 million (first quarter of 2018, including special effect: EUR 11.9 million). The three-month result of the joint stock company amounted to EUR 0.1 million compared to EUR 6.6 million in the same period last year (taking the special effect into consideration).

The number of employees increased as anticipated to 97 compared to 85 in the same period last year.

Chief financial officer Dr. Nicolas Combé is delighted: “In addition to the positive development of our biosimilars projects, in particular, the recently communicated successful conclusion of the pilot phase of the project FYB202, we are also very satisfied with our financial benchmarks. We are operating from a very solid financing position thanks to the current license agreements for our biosimilars projects FYB201 and FYB203 as well as the FYB202 joint venture. Our main focus is currently clearly on developing our three main projects as well as expanding our biosimilars pipeline.”

Munich – The biosimilars company Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published its 2018 Annual Report and has recorded a successful financial year.

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. The significant rise in the earnings with an annual surplus of Euro 7.1 million (previous year Euro -1.6 million) resulted from a one-off effect from the FYB202 development project which impacted turnover and earnings, but not liquidity.

As part of the joint venture founded in 2017 with Aristo Pharma GmbH, a company within the Strüngmann Group, Formycon is developing the FYB202 biosimilar candidate for the reference drug Stelara®* (ustekinumab). The amount posted by Formycon from 2013 to 2016 and therefore before the contribution to the FYB202 project was Euro 8.5 million, and this was taken into account in the first quarter of 2018 in the financial obligations committed to the joint venture. With the conclusion of the pilot phase, and with 24.9 percent of the shares in FYB 202 GmbH & Co. KG, Formycon will bear the previous and future development costs in accordance with its shareholding quota. To date, Formycon has invested around Euro 21 million in the development of FYB202.

As in previous years, turnover was essentially generated from ongoing remuneration for product development services which were delivered on behalf of licensing partners. The Group’s revenue, adjusted for the special effect of the joint venture, is Euro 34.5 million (previous year Euro 23.1 million), reflecting the advancing development of the biosimilar candidates FYB201 and FYB203.

The balance sheet total of the Formycon Group which, aside from the AG consists of both subsidiaries Formycon Project 201 GmbH and Formycon Project 203 GmbH, increased by 28.6% to around Euro 39.6 million (previous year: Euro 30.8 million). At the same time, the equity ratio rose to 83.9 percent (previous year 82.9 percent). Current assets are largely made up of cash and cash equivalents. Liquid assets, including securities, stood at Euro 12.3 million on the day of reporting (previous year Euro 15.5 million). Including short-term receivables from deliveries and services worth Euro 5.2 million and other assets, Formycon holds liquid assets of around Euro 17.5 million (previous year: Euro 26 million). The company has no financial liabilities.

Formycon AG, as the Group’s actual operational unit, achieved a turnover of Euro 29.6 million (previous year: Euro 16.4 million) and improved its EBITDA significantly to Euro 8.2 million (previous year: Euro -0.7 million). Accordingly, this resulted in highly positive earnings for the period of Euro 7.3 million (previous year Euro -1.5 million).

2018 was again shaped by a noticeable increase in staffing levels in several operational areas, with the number of employees rising from 83 to 95.

Dr. Nicolas Combé, Financial Director of Formycon AG, reflects on a successful 2018 financial year and had this to say about the results: “We can be very satisfied with the 2018 financial year. In terms of both operations and overall company development, we made good progress. One particular milestone in 2018 was the successful conclusion of the clinical phase III study for FYB201, which was conducted under the responsibility of Formycon’s licensing partner Bioeq IP AG. Thanks to the special effect of the joint venture, we have delivered a strongly positive year-end result. For the current financial year, we anticipate a turnover volume that will be within the framework of the revenue adjusted for the special effect. We believe we are confirmed in our business model and we look forward optimistically to the future which will mainly be marked by the further development of our existing and the initiation of new projects in order to broaden our pipeline.”

The 2018 Annual Report can be found on our website at https://www.formycon.com/en/investor-relations/financial-reports/

* Stelara® is a registered trademark of Johnson & Johnson

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published news on its development portfolio.

For FYB201, a biosimilar candidate for Lucentis®* (ranibizumab), Formycon and Bioeq IP AG successfully concluded a Type IV Pre-Submission Meeting in December 2018 with the US Food and Drug Administration (FDA). 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. If the submissions progress as planned, marketing authorization approvals in the US and the EU are expected in 2021. Formycon’s licensing partner Bioeq IP AG is responsible for the worldwide commercialization of FYB201. Formycon will receive sales dependent royalties after successful product launch. The overall market for the reference drug Lucentis®* (ranibizumab) has, according to the manufacturer, increased over the previous year by 9% to a total of US$ 3.7 billion, and this growth is continuing. This is also confirmed by the quarterly figures from Q1/2019. According to these figures, global sales of the ophthalmic drug grew by around 10% (USA +11%) compared to the first three months of 2018.

In the FYB202 program, a biosimilar candidate for Stelara®** (ustekinumab), which is developed in a joint venture with Aristo Pharma GmbH, the achievement of key milestones marked the successful conclusion of the pilot phase. During scientific advice meetings with the FDA and the EMA, further development steps up to submission of the marketing authorization dossier were discussed. The start of the phase I clinical trial is planned for mid of this year. Formycon holds a 24.9 percent share in the joint venture (FYB 202 GmbH & Co. KG). With the conclusion of the pilot phase, the previous and future development costs will be borne in accordance with the shareholding quota. To date, Formycon has invested around Euro 21 million in the development of FYB202. In 2018, total turnover for the reference drug Stelara® increased, according to the manufacturer, by 30 percentage points and stood at a total of US$ 5.2 billion. Global sales in the first quarter of 2019 also rose by a further 32% compared to Q1/2018.

With FYB203, a biosimilar candidate for Eylea®*** (aflibercept), also significant progress has been achieved. The preclinical study with FYB203 in an alternative formulation was able to demonstrate comparable intraocular pharmacokinetics to the reference product Eylea®. The next stage will focus on the preparation of the phase III clinical trial, which is scheduled to begin mid of 2020. Briefing documents for scientific advice are currently prepared in order to coordinate the future development strategy with the FDA and the EMA. Formycon’s global licensing partner for FYB203 is Santo Holding GmbH. Formycon receives sales-related royalties while successful course of the project. In 2018, the reference drug Eylea® significantly increased its global sales. According to the manufacturer, these stood at just under US$ 6.7 billion, equivalent to a rate of increase of around 13% compared to the previous year.

“Thanks to our team’s commitment and expertise, we were able to significantly advance our lead candidate FYB201 as well as FYB202 and FYB203, and achieve further key interim goals. The positive results from the Columbus AMD phase III study and the FDA pre-submission meeting support the product quality of FYB201 and illustrate that we are on the right path with our strategy. Together with our licensing partner Bioeq IP AG, we are in close consultation with the relevant medicines authorities, putting in place the necessary requirements for an approval and successful product launch of FYB201. This will take us closer to our goal of improving the global supply of important medicines to patients with serious conditions”, explains Dr. Stefan Glombitza, COO of Formycon AG.

A legal innovation to EU patent law, adopted by the European Parliament and expected to enter into force on July 1, 2019, strengthens European biosimilar manufacturers. Previously, the production of biosimilars and generic drugs in the European Union was prohibited while SPCs (Supplementary Protection Certificates) were still in force that effectively extend patents for medicines by up to 5 years, provided the reference drug was still protected by a SPC. Based on the SPC Waiver Program, European biosimilar manufacturers will now, from July 1, 2022, be able to commence production during the SPC period under certain conditions for export to third-party countries in which the relevant protective rights have already expired and manufacture six months before the SPC expiry to generate stocks for the market launch in Europe.

Dr. Carsten Brockmeyer, CEO of Formycon AG, welcomes this new ruling: “We are delighted that this hurdle, which significantly hampered the domestic production of medicines and therefore Europe’s competitiveness in this field, has now been removed. From mid-2022, this will make life significantly easier for Formycon, since production of the biosimilars will then no longer necessarily have to be outsourced to outside of the EU.”

* Lucentis® is a registered trademark of Genentech Inc.
** Stelara® is a registered trademark of Johnson & Johnson
*** Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announced on March 22, 2019 the private placement of a cash capital increase from the strategic Swiss investor M&H Equity AG. With the resolution by the Management Board and Supervisory Board, the company’s share capital of currently EUR 9,422,603.00 will be increased to a total of EUR 10,000,000.00 by partially utilizing approved capital of EUR 577,397.00 to issue 577,397 new bearer shares with a computational proportion of the share capital of EUR 1.00 each in return for a cash investment.

The inward flow of funds amounts to EUR 17,264,170.30 in total and corresponds to an issue price per share of EUR 29.90. 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. Oliver Fiechter, founder and Managing Partner of M&H Equity AG, commented on his involvement with Formycon as follows: “I’m very much looking forward to working with Formycon, and I see above-average growth potential in the company. Both the management and the business model impressed me, as did the fact that biosimilars will become increasing popular due to increasing cost pressure in global healthcare systems. When we are choosing our investments, the concept of sustainability most of all plays a very important role. The fact that Formycon AG, with its biosimilars, is keen to make access to important medicines easier for as many patients around the world as possible was an important investment criterion for us.”

The funds raised by the capital increase are primarily to be used to expand the pipeline and develop the company’s own biosimilar projects. “With Oliver Fiechter and M&H Equity AG, we have brought on board a strong strategic partner that fits very well with our company and from the support of which we will most certainly be able to benefit. We first and foremost want to advance the development of our projects with the acquired capital and, in so doing, further increase the value of the pipeline”, says Dr. Nicolas Combé, CFO of Formycon AG.

About M&H Equity AG:

The Mountains & Hills Investment Group is an international investment manager and advisor focusing on private markets and selected public holdings. The Group has its own investment approach that combines investments in value-driven companies with shareholdings in innovative technology firms. Within its group, Mountains & Hills combines its own investment fund, a VC company and a vehicle for direct investments in the healthcare market. Through its investments, Mountains & Hills creates added value by helping companies to implement the opportunities made possible by digital technologies in their day-to-day business. This allows them to achieve above-average value growth for their investors.

Munich – Today Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) published an update on development programs and key Milestones.

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 last patient in the trial, in which patients were investigated for a total of 48 weeks, has completed the study on June 06, 2018. In addition to the achievement of the primary efficacy endpoint reported in May 2018, the study showed comparable results with regard to efficacy, safety and immunogenicity between the investigational medicinal product FYB201 and the reference medicinal product Lucentis®* (ranibizumab). The final study report will be available in December 2018.

Formycon’s partner Bioeq IP AG, who is responsible for the COLUMBUS-AMD study and holds the exclusive global marketing rights for the product FYB201, has filed a request for a Type IV pre-submission meeting with the US Food and Drug Administration FDA to be held in December 2018. In addition to the data package for the technical and clinical development, the implementation of the commercial supply chain will be discussed. The filing of the Biologics License Application (BLA) under the 351 (k) pathway to the FDA is planned for the first half of 2019. A respective pre-submission meeting with the European Medicines Agency EMA is planned for the first quarter 2019.

FYB202 is a biosimilar candidate for Stelara®** (ustekinumab). The drug substance process development and manufacturing scale-up are at an advanced stage. A preclinical pharmacokinetic study has concluded the in-life phase and sample analysis is ongoing. Scientific advice briefing books have been sent to the US FDA for a Type II meeting and to the EMA for a scientific advice meeting. The advices are expected for November (EMA) and early 2019 (FDA). The initiation of the clinical testing of FYB202 is planned for mid-2019.

Significant progress has also been made in the development of FYB203, which is a biosimilar candidate for Eylea®*** (aflibercept). Similar to FYB202 drug substance process development and scale-up are at an advanced level. In preclinical development the in-life phase for a pharmacokinetic study has been completed and sample analysis is ongoing. Currently scientific advice briefing books are being prepared in order to align on the future development strategy with both regulatory authorities (FDA and EMA).

FYB205, for which Formycon has so far not published any details, is an early stage biosimilar project that has been progressed up to the initial cell line screening.

In addition, Formycon is exploring other biosimilar targets with the goal of optimizing the full potential of the development pipeline.

Dr. Carsten Brockmeyer, CEO of Formycon: “We believe FYB201 is the only Lucentis® biosimilar that has successfully completed phase III testing for the global market. The positive outcome of the FYB201 phase III study and the robust progress we have made in our partnered FYB202 and FYB203 programs underlines Formycon’s pioneering role in the development of global quality biosimilars in ophthalmology and immunology. I would like to thank the Formycon team and our licensing and cooperation partners for their great commitment and cooperation.”

Dr. Stefan Glombitza, COO of Formycon, completes: “Our teams are combining strong scientific skills with tremendous passion. This is a very powerful enabler to drive such complex development programs forward and the cross-functional teams can be proud of the achievements that have been made across all programs. We have expanded our organization by further skilled talents with focus on late stage experience and this will help us thrive our programs into further advanced stages.”

* Lucentis® is a registered trademark of Genentech Inc.
** Stelara® is a registered trademark of Johnson & Johnson
*** Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.