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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.

Munich – Today Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announced its financial result for the first nine months of the fiscal year 2018.

The turnover of the Formycon group, which, aside from the AG consists of both subsidiaries Formycon Project 201 GmbH and Formycon Project 203 GmbH, increased significantly compared with the first nine months of 2017. Thus revenues recorded an increase of 17.30 million euros to a total of 32.42 million euros (previous year: 15.12 million euros). This sales performance was driven by credit for the investments in the FYB202 project between 2013 and 2016. Taking these investments in the amount of 8.47 million euros into account for Formycon’s financing obligations for the joint venture FYB 202 GmbH & Co. KG led to a one-time effect on turnover and earnings to the same amount, however not on liquidity.

Formycon holds a 24.9 percent share in the joint venture with Aristo Pharma GmbH and on completion of a pilot stage, bears this amount of previous project investments and further development costs. On condition of a further successful development and approval Formycon will benefit at the same ratio from any potential future licensing and marketing revenues.

Total turnover, adjusted by this one-off effect, increased in the third quarter of 2018 by 8.83 million euros to a total of 23.95 million euros (previous year: 15.12 million euros). This means the Formycon group also records a clear growth in sales due to further development of both biosimilar candidates FYB201 and FYB203.

On the reporting date, earnings before interest, taxes and depreciation on fixed assets and intangible assets (EBITDA) amounted to 9.34 million euros (previous year: minus 4.25 million euros). Operational results (EBIT) amounted to 8.70 million euros (previous year: minus 4.84 million euros), net results totaled 8.06 million euros (previous year: minus 4.89 million euros).

For the whole of 2018 Formycon now anticipates a turnover of slightly over 40 million euros at group level. In addition, consolidated net earnings of 7.00 million euros are expected for the total year. On September 30 2018, stocks of liquid assets, which comprise cash, bank deposits and securities, totaled 12.01 million euros. Including short-term receivables from deliveries and services worth 6.24 million euros, liquid assets totaled around 18.25 million euros at the end of the third quarter.

In the first three quarters of 2018, Formycon AG as the actual operational unit, achieved a turnover of 23.72 million euros (previous year: 7.41 million euros). The EBITDA amounted to 9.08 million euros (previous year: minus 4.48 million euros), the operating result to 8.44 million euros (previous year: minus 5.07 million euros) and net earnings to 7.80 million euros (previous year: minus 5.11 million euros).

As planned, the number of employees at Formycon AG also increased. On the day of reporting in September the number was 93 (previous year: 75) and is expected to further increase slightly by the end of the year.

Dr. Nicolas Combé, member of the board and CFO of Formycon AG, gave the following statement with regard to the results: “We are pleased with the positive development of the business and are very happy with the figures of the first nine months of 2018. The key value driver for our company continues to be the development progress of our biosimilar candidates. The whole team is working very consistently towards this and we are optimistic about being able to give detailed information on the development state of our projects very soon.”

Munich – The biosimilars company Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has revealed impressive results for the first half of 2018 both in the development of its product candidates and its business figures. Key milestones were reached on project FYB201, a biosimilar candidate for Lucentis®* (ranibizumab). Following the achievement of the primary endpoint of the COLUMBUS-AMD phase III study under the licensing partner’s responsibility in the second quarter of 2018, which confirmed comparable efficacy of FYB201 and the reference product, treatment of the last patient has now also been completed. The final study results are expected during the course of the second half of 2018. Work is currently focused on the creation of a dossier for submission to the US medicines authority FDA, as well as the European agency EMA. In addition to the data package from the clinical and technical development, the implementation of the commercial supply chain represents a further key prerequisite for submission. Concepts to safeguard commercial market supplies will be implemented under the responsibility of the licensing partner.

FYB202, a biosimilar candidate for Stelara®** (ustekinumab) and FYB203, a biosimilar candidate for Eylea®*** (aflibercept), are currently at an advanced stage of preclinical development. Important development goals have been achieved on both projects over the last six months. Formycon will publish more details in due course.

Formycon’s economic performance parameters developed positively during the first half of 2018. Turnover at the Formycon 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 FYB 202 GmbH & Co. KG, grew compared to the first six months of 2017 from Euro 8.01 million to Euro 24.59 million. The earnings before interest, tax, depreciation and amortization (EBITDA) improved from Euro -2.50 million to Euro 8.63 million. The operating result (EBIT) totaled Euro 8.23 million (previous year: Euro -2.89 million). The group period result at the end of June 2018 stood at Euro 7.59 million compared to Euro -2.91 million during the same period last year.

This significant improvement in results was due primarily to the inclusion of investments in the FYB202 project from 2013 and 2016, which were charged to the company as a financial contribution for FYB 202 GmbH & Co. KG. At the end of 2017, Formycon transferred its rights in the FYB202 biosimilar project to this new company respectively to its subsidiary FYB 202 Project GmbH.

For the year as a whole, Formycon anticipates continued highly positive results, raising its turnover forecast from Euro 36 million to Euro 40 million.

The company’s financial resources remain as solid as ever, regardless of the increase in expenditure on development: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 11.82 million on the day of reporting. Including short-term receivables from deliveries and services worth Euro 8.42 million, Formycon’s liquid assets totaled around Euro 20.23 million. The Group’s equity ratio stands at 79 percent and is higher than industry average, as in previous years.

Formycon AG, as the company’s central development and operational unit, achieved a turnover of Euro 18.91 million during the first half of 2018 (previous year: Euro 4.80 million), with the result from this period being Euro 7.7 million (-2.88). Turnover was essentially generated, as in the past, from development services for proprietary projects.
The company’s workforce rose as planned during the first half of 2018 from 83 to 91.

Dr. Nicolas Combé, Chief Financial Officer of Formycon, is satisfied with developments over the first six months: “Through our licensing agreements and the newly founded joint venture with Aristo, Formycon is in a strong position. The funding of our ongoing projects is therefore extensively secured. It remains important for us during this phase to successfully and efficiently develop our biosimilar candidates. Their potential market launches promise very exciting market opportunities for our partners, from which we will participate.”

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

* 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 – The biosimilars company Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) is appointing Thomas Siklosi, a former board member of Rentschler Biopharma SE, to its Advisory Board. Siklosi is a renowned biotech manager and expert in the development and production of biologics and biosimilars with 34 years of professional experience in this field.

Thomas Siklosi studied chemistry at the Academy of Applied Sciences in Isny. He completed his thesis with distinction at the Institute of Radiochemistry at the Technical University of Munich. He gained his early professional experience in the field of biotechnology at Boehringer Mannheim in the laboratory led by Prof. Hans Ulrich Bergmeyer in Tutzing.

In 1984, he moved to the biotech pioneer Rentschler Arzneimittel in Laupheim and held various roles in the development and production of interferons, later being responsible at Rentschler Biotechnologie, a contract development and manufacturing organization (CDMO), for the provision of biopharmaceutical substances. In cooperation with a leading generic manufacturer, he was responsible as project manager for the technical development of the complex glycoprotein erythropoetin, which received approval as the first epoetin-alfa biosimilar in the EU in the fall of 2007.

In September 2012, Siklosi was appointed to the Board of Management at Rentschler Biopharma SE. As Chief Operating Officer, he was responsible for the Development, GMP Production, Technology, and Quality departments. Siklosi is a Member of the University Council of Biberach University and owns numerous patents in the field of biotechnology.

Dr. Carsten Brockmeyer, board member and CEO of Formycon, said of Siklosi’s appointment: “I’m delighted that we have been able to bring on board Thomas Siklosi, one of the world’s most experienced biotech managers. As a man who has been involved with biotechnology right from the start, he has managed numerous biotechnology drugs and biosimilars from cell line development to market maturity over the course of his career. With his many years of in-depth experience in the management of major development and production facilities, Mr. Siklosi will be advising and supporting Formycon AG on its ambitious future projects.”

Alongside Mr. Thomas Siklosi, the Advisory Board is also made up of Prof. Johannes Buchner, Dr. Bernhard Hampl and Dr. Gerhard Schaefer.