Formycon and Fresenius Kabi conclude global commercialization partnership for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara® (ustekinumab), announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”). Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.
Upon conclusion of the agreement Formycon receives an upfront payment as well as milestone payments contingent on the successful achievement of certain regulatory events which are expected to total in the mid double digit million Euro range. Post-commercialization value will be shared approximately equally by both companies. Semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA2 region and Latin America remain with Formycon.
Fresenius Kabi is a global healthcare company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions. In the field of biosimilars, Fresenius Kabi focuses on the development and marketing of biosimilars in the area of autoimmune diseases and oncology.
In August 2022, Formycon published positive interim results for efficacy for FYB202 from the clinical phase III study VESPUCCI. The randomized, double-blind multi-centric phase III study achieved the primary endpoint, demonstrating comparable efficacy of FYB202 and the reference medicine Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).
In the extended phase I pharmacokinetics study, the recruitment of study subjects was successfully completed in October 2022. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.
FYB202 is a proposed biosimilar referencing Johnson & Johnson’s Stelara®, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders. Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis with a global sales volume of more than USD 9.5 billion in 2022.
“We are delighted about the conclusion of the agreement and are looking forward to a successful commercialization of our Ustekinumab biosimilar after approval. The combination of Formycon’s development expertise and Fresenius Kabi’s global commercial competence offers an excellent basis for providing access to our highly efficacious product to many patients,” says Nicola Mikulcik, Chief Business Officer at Formycon AG.
“We welcome the potential of this agreement to build on the strengths of our companies across the value chain from development to commercialization. With the commercialization of the Ustekinumab biosimilar we are expanding our product portfolio with another autoimmune disease treatment option. In line with our Vision 2026, this is yet another key milestone for Fresenius Kabi in delivering on our strategic priority of providing access to biosimilars for patients worldwide,” says Dr. Michael Schönhofen, Fresenius Kabi’s Chief Operating Officer and Member of the Fresenius Kabi Management Board.
1) Stelara® is a registered trademark of Johnson & Johnson
2) Middle East and North Africa
Formycon AG announces result of private placement and sets placement price for the new shares from the capital increase
Munich – Management Board and Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Formycon” or “Company”) resolved to increase the Company’s share capital by EUR 910,000.00 from EUR 15,128,775.00 to EUR 16,038,775.00 by issuing 910,000 new shares (the “New Shares”). The 910,000 new no-par value bearer shares were placed with institutional investors by means of an accelerated bookbuilding and carry full dividend rights as of 1 January 2022.
The anchor shareholders ATHOS KG (26.4%) and Active Ownership Capital (6.6%) had agreed in advance to support the capital measure and participated in the capital increase. ATHOS KG was allocated 279,220 New Shares and Active Ownership Capital was allocated 67,532 New Shares.
On the basis of the bookbuilding procedure carried out as part of the private placement, the Management Board, with the approval of the Supervisory Board, set a placement price of EUR 77.00 per new share, resulting in gross proceeds from the offering of EUR 70,070,000.00 before commissions and costs. The shares issued correspond to approximately 6.02% of the Company’s currently issued share capital.
The New Shares were placed with selected investors in Germany and in other member states of the European Economic Area who are “Qualified Investors” within the meaning of Art. 2 lit. e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 and with selected investors in other selected jurisdictions. In the United States of America, the New Shares have been placed exclusively with “Qualified Institutional Buyers” as defined in Rule 144A under the Securities Act of 1933.
The New Shares are expected to be included in the existing listing on the “Scale” segment of the Frankfurt Stock Exchange on February 7, 2023 following registration of the implementation of the capital increase. Delivery of the New Shares is also scheduled for February 7, 2023.
The net proceeds from the capital increase will primarily be used to accelerate the ongoing development of Formycon’s proprietary biosimilar candidates (FYB202, FYB206, FYB208, FYB209) to regulatory approval, as well as to expand the biosimilar pipeline and support the organic growth strategy. In addition, Formycon is considering integrating further assets along the value chain into the Company in order to accelerate its development into a highly specialized and globally active company in the biosimilars market segment. The capital measure also serves to strengthen the balance sheet, including the repayment of the drawn amount under the loan facility granted by ATHOS and Active Ownership as part of the ATHOS transaction.
Formycon agreed to a lock-up obligation with market-standard exemptions for a period of six months.
Hauck Aufhäuser Lampe and Jefferies acted as joint global coordinators and First Berlin as selling agent in the private placement.
Formycon AG upsizes capital increase from authorized capital following strong demand
Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Formycon” or “Company”) announces that, following strong demand, the Company has decided to upsize their previously announced capital increase from authorized capital from approx. 5% to in total approx. 6% of the outstanding share capital. The share capital of the Company will be increased from currently EUR 15,128,775.00 to now up to EUR 16,038,775.00 through issuing up to 910,000 new shares, making partial use of the Authorized Capital.
The net proceeds from the capital increase will primarily be used to accelerate the ongoing development of Formycon’s proprietary biosimilar candidates (FYB202, FYB206, FYB208, FYB209) to regulatory approval, as well as to expand its biosimilar pipeline and support its organic growth strategy. In addition, Formycon is considering integrating further assets along the value chain into the Company in order to accelerate its development into a highly specialized and globally active company in the biosimilars market segment. The capital measure also serves to strengthen the balance sheet, including the repayment of the drawn amount under the loan facility granted by ATHOS and Active Ownership Capital as part of the ATHOS transaction.
The New Shares will be offered without a prospectus by way of a private placement to selected investors in Germany and in other member states of the European Economic Area who are “Qualified Investors” within the meaning of Article 2 lit. e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017. In addition, the New Shares may also be offered to institutional investors in other selected jurisdictions. In the United States of America, the New Shares will only be offered for purchase to “Qualified Institutional Buyers” as defined in Rule 144A under the Securities Act of 1933.
Books have opened earlier today and may close at short notice. Following the private placement, Formycon will be subject to a lock-up obligation with market-standard exemptions for a period of six months.
Formycon AG plans capital increase of approx. 5% of the share capital by way of an accelerated bookbuilding procedure to finance further growth
Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Formycon” or “Company”) intends to issue approx. 5% of the issued share capital of the Company, representing approx. 750,000 new shares (the “New Shares”). In this respect, the Management Board of the Company resolved, with the approval of the Supervisory Board of the Company, to increase the share capital of the Company against contributions in cash by partial use of the authorized capital of the Company. The Company’s existing shareholders’ subscription rights are excluded. The offering will be conducted by way of an accelerated bookbuilding procedure overnight. The New Shares will carry full dividend rights from 1 January 2022.
The anchor shareholders ATHOS KG (26.4%) and Active Ownership Capital (6.6%) have each agreed to support the capital measure and to subscribe for New Shares in the capital increase in proportion to their existing shareholding in the Company but committed to a combined minimum subscription of EUR 26.5 million.
The net proceeds from the capital increase will primarily be used to accelerate the ongoing development of Formycon’s proprietary biosimilar candidates (FYB202, FYB206, FYB208, FYB209) to regulatory approval, as well as to expand its biosimilar pipeline and support its organic growth strategy. In addition, Formycon is considering integrating further assets along the value chain into the Company in order to accelerate its development into a highly specialized and globally active company in the biosimilars market segment. The capital measure also serves to strengthen the balance sheet, including the repayment of the drawn amount under the loan facility granted by ATHOS and Active Ownership Capital as part of the ATHOS transaction.
The New Shares will be offered without a prospectus by way of a private placement to selected investors in Germany and in other member states of the European Economic Area who are “Qualified Investors” within the meaning of Article 2 lit. e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017. In addition, the New Shares may also be offered to institutional investors in other selected jurisdictions. In the United States of America, the New Shares will only be offered for purchase to “Qualified Institutional Buyers” as defined in Rule 144A under the Securities Act of 1933.
The accelerated bookbuilding process will commence with immediate effect and is expected to close tomorrow prior to the commencement of trading, possibly already as early as the late evening of February 1, 2023. Formycon will announce the results of the Offering, including the final number of New Shares and the Placement Price per New Share, before the start of trading on February 2, 2023. The inclusion of the New Shares in trading on the Stock Exchange and the delivery of the New Shares are scheduled for February 7, 2023.
Following the private placement, Formycon will be subject to a lock-up obligation with market-standard exemptions for a period of six months.
Hauck Aufhäuser Lampe and Jefferies are acting as joint global coordinators and First Berlin as selling agent in the private placement.
Formycon AG announces global license agreement with Fresenius Kabi for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara® (ustekinumab), today announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”). Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.
Upon conclusion of the agreement Formycon receives an upfront payment as well as milestone payments contingent on the successful achievement of certain regulatory events which are expected to total in the mid double digit million Euro range. Post-commercialization value will be shared approximately equally by both companies. Semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA2 region and Latin America remain with Formycon.
In August 2022, Formycon published positive interim results for efficacy for FYB202 from the clinical phase III study VESPUCCI. In the extended phase I pharmacokinetics study, the recruitment of study subjects was successfully completed in October 2022. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.
FYB202 is a proposed biosimilar referencing Johnson & Johnson’s Stelara®, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders. Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis.
1) Stelara® is a registered trademark of Johnson & Johnson
2) Middle East and North Africa
Formycon announces binding Term Sheet between Klinge Biopharma and Coherus BioSciences for the exclusive commercialization of FYB203, a biosimilar candidate to Eylea®1, in the United States
Munich – Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of FYB203, Formycon’s biosimilar candidate to Eylea® (aflibercept), informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today, that it has entered into a binding term sheet with Coherus BioSciences, Inc. (“Coherus”) for the exclusive commercialization of FYB203 in the United States (U.S.). The parties expect to complete the transaction in Q1 2023.
FYB203 is being evaluated in a Phase III clinical trial (MAGELLAN-AMD) and topline results are expected within the next few weeks. Coherus plans to file a Biologics License Application with the U.S. Food and Drug Administration (FDA) later this year and intends to launch the product at Eylea® biosimilar market formation, currently expected in 2025, if approved.
Under the binding term sheet, Coherus will make a total upfront payment to Klinge of approximately €30 million, comprised of cash and Coherus common stock, thirty days after the execution of the definitive agreements. Coherus will also make other regulatory and launch milestone payments and share profits approximately equally with Klinge in consideration for the commercialization rights to FYB203 in the United States. Formycon is entitled to participate in all Klinge income under the agreement with Coherus in the mid-single to low-double-digit-percentage range.
Coherus is already marketing Formycon’s ophthalmic Lucentis®2 biosimilar FYB201/CIMERLITM3 in the U.S. and can therefore leverage on established sales channels and an existing commercial infrastructure in the ophthalmic space for the commercialization of FYB203.
1)Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc.
2)Lucentis® is a registered trademark of Genentech, Inc.
3)CIMERLITM is a trademark of Coherus BioSciences, Inc.
Formycon Reports its Nine-month Figures for 2022
- Group turnover and other operating income totals Euro 28.2 million
- Group full-year sales forecast to be about Euro 40 million
- EBITDA of Euro -10.9 million and EBIT of Euro -12.1 million correspond to plans due to investments in the Group’s own projects
- Nine-month result of Euro 61.1 million continues to be affected by one-off and extraordinary effects on the financial result. These effects are transaction-related and do not have an effect on liquidity
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its results for the first nine months of the 2022 fiscal year. On the Group level, reporting is performed in accordance with IFRS (International Financial Reporting Standards).
At the end of the third quarter, the Formycon Group’s financial figures were as expected. The turnover of the Group, which, alongside Formycon AG, comprises the fully consolidated subsidiary companies Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH as well as a 50% stake in Bioeq AG, which is consolidated at equity, totaled Euro 28.2 million in the first nine months of the year 2022 (prior-year period IFRS: Euro 27.4 million). Formycon is forecasting revenues at Group level of around Euro 40 million for the whole year.
The Formycon Group focuses on research and development for its own, or out-licensed biosimilars projects as well as its own COVID-19 drug (FYB207). A large part of the revenue results from the development services for the out-licensed (FYB203) and partnered project (FYB201).
In July 2022 the commercialization of FYB201 in Great Britain started, through the distribution partner Teva Pharmaceutical Industries Ltd. (“Teva”) and in October, in the US, through Coherus BioSciences Inc. Additionally, in November, FYB201 was introduced onto the market in Germany by Teva. The nine-month figures included the first commercialization revenues from Great Britain since the introduction of FYB201 onto the market at the start of July. For the full year 2022, sales and earnings contributions from the marketing revenues in the additional territories are expected.
The Group’s earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -10.9 million (prior-year period IFRS: Euro -10.0 million), the operating result (EBIT) was Euro -12.1 million as of September 30, 2022, compared with -10.9 million in the prior-year period. The Group net period result amounted to Euro 61.1 million (prior-year period IFRS: Euro -11.1 million).
The period result is further affected by a one-off effect that influenced the result but not the liquidity. This resulted from the sale of the minority stake (24.9%) in FYB 202 in the course of the transaction with ATHOS KG (“ATHOS”). In the course of this, Formycon AG withdrew as a partner of FYB 202 GmbH & Co. KG. In parallel with this, the acquisition of 100% of the shares of FYB202 Project GmbH, in which the global assets and commercialization rights to FYB202 are located, took place.
After the acquisition of FYB202, as part of the transaction with ATHOS, the 50% stake ATHOS held in FYB201, a biosimilar for Lucentis®1, was also taken over, among others. For both financial assets (FYB201 and FYB202) there is a conditional liability (conditional purchase price components) towards ATHOS, the amount of which depends on the project-specific and actual realization of proceeds. The compounding of this liability, which must be adapted periodically, also influences the result but not liquidity and runs counter to the previously described effect.
The Formycon Group’s stocks of liquid assets, which comprise cash, checks, bank deposits and securities, remained solid at Euro 12.1 million as of September 30, 2022. Including short-term receivables from deliveries and services, as well as other assets, the Formycon Group held liquid assets totaling Euro 22.6 million on the day of reporting (prior year: Euro 33.7 million).
In the first nine months of the year, Formycon AG, as the Group’s central development and operational unit, continues to report according to the regulations of the Handelsgesetzbuch (HGB – German Commercial Code) and achieved a turnover of Euro 21.8 million (prior-year period: Euro 20.4 million). The company’s nine-month result was Euro 73.7 million compared to Euro -10.7 million last year.
“The nine-month result reflects our expectations. The global introduction onto the market of FYB201 under the trade name Ongavia®2 (UK) or Ranivisio®3 (EU) and CimerliTM4 (US) by our partners and the revenues anticipated due to this are an important milestone in our transformation to a commercial-stage company. At the same time, we continue our growth strategy with planned investments into our pipeline, in order to create sustainable value, explains Dr. Stefan Glombitza, CEO of Formycon AG.
1Lucentis® is a registered trademark of Genentech Inc.
2Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
3Ranivisio® is a registered trademark of Bioeq AG
4CimerliTM is a trademark of Coherus BioSciences, Inc.
Broad-acting antiviral SARS-CoV-2 drug FYB207 shows longer half-life and improved efficacy through optimized molecular design in preclinical studies
- Protein and glycoengineering improve pharmacokinetics and efficacy
- Half-life of more than 14 days comparable to the bioavailability of an antibody
- Reduction of viral load in the lung demonstrates neutralizing effect of FYB207 in preclinical in vivo models
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published preclinical in vivo results for the development of their COVID-19 drug FYB207.
In the course of preclinical in vivo studies, data on the pharmacokinetics and efficacy of various constructs of the ACE2-Fc fusion protein were collected in two different models, in order to select the most appropriate candidate for the human clinical trial.
The proprietary modifications of the molecular structure of the FYB207 lead candidate led to the desired effects and resulted in a significant extension of the half-life. By corresponding glyco optimizations and sequence modifications in the antibody part (Fc part), the lead candidate ACE2-IgG1-Fc (FYB207) achieved a half-life of more than 14 days, which is the order of magnitude of antibodies. As a result, FYB207 may not only have a broader application spectra for prophylaxis and treatment of COVID-19 but also in other indication areas.
Due to the high sialylation achieved within the context of glyco optimization, binding affinity to relevant receptors in the liver is reduced, which significantly slows down the elimination of the active substance and increases the bioavailability in the organism. In addition, sequence modifications have been introduced in the binding region of the antibody portion to the neonatal-receptor, enabling FYB207 to bind better to this receptor, thereby improving the recycling of the fusion protein in the body.
In the efficacy study, the in vivo preclinical models showed a significant reduction in viral load in the lungs, demonstrating the neutralizing effect of FYB207 also against the SARS-CoV-2 Delta variant in the organism. Thus, the FYB207 lead candidate, unlike vaccines and neutralizing antibodies, retains its full antiviral potential against SARS-CoV-2 variants of concern.
SARS-CoV-2 and other coronaviruses use the protein ACE2 on the surface of human cells as a portal of entry for respiratory infections. Biotechnologically produced ACE2 may compete for binding of the virus and thus prevent cell infection. Formycon has fused the human ACE2 protein to the constant part of human immunoglobulin G1 (IgG1) using computational structural design and thereby created FYB207, a highly effective SARS-CoV-2 blocker. By fusion with the optimized Fc part, ACE2 was stabilized and bioavailability significantly prolonged. ACE2 also has inherent enzymatic activity that may provide patients with additional protection for their lungs and cardiovascular system. In addition, FYB207 can potentially be used for all coronaviruses that use ACE2 as a port of entry.
The development strategy for an accelerated approval process has already been coordinated with the Paul Ehrlich Institute (“PEI”) and the FDA through Scientific Advices in 2021. In a follow-on Scientific Advice in May 2022, the PEI confirmed full support for the improved drug molecule for the accelerated development program. Another PEI meeting to align the clinical program is scheduled this year.
The GMP production of the study medication currently takes place for the start of the clinical trials. A toxicity study with the optimized molecular construct will be conducted at the beginning of next year. Entry into clinical trials is planned for 2023.
“The performed pre-clinical studies and the available data from the lead candidates form an important milestone in the development of our COVID-19 drug. The expanded in vivo study confirmed the intended objective – extending half-life – and showed that with FYB207 we are on track to develop a highly effective and long-lasting COVID-19 medication that is directed against all variants. In terms of efficacy, the study also showed the desired successes by demonstrating that viral load in the lungs of living organisms is significantly reduced,” explains Dr. Andreas Seidl, CSO of Formycon AG.
“The threat of viral mutations will continue in the future. With each successful mutation, SARS-CoV-2 evades vaccines and therapeutic antibodies a little bit more. Fusion proteins such as FYB207 can potentially make an important contribution here for the prevention and treatment of COVID-19,” adds Dr. Stefan Glombitza, CEO of Formycon AG.
Formycon will present the results of the completed in vivo preclinical studies at the Festival of Biologics in Basel (Switzerland) on November 4, 2022 and the Drug Discovery Summit in Madrid (Spain) on November 16/17, 2022.
Formycon reports final figures for the first half of 2022
- Consolidated reporting for the first time under IFRS (International Financial Reporting Standards)
- Group turnover of Euro 17.6 million (H1/2021 IFRS: Euro 20,1 million) as well as EBITDA of Euro -7,6 million (H1/2021 IFRS: Euro -9,7 million) and operating result (EBIT) of Euro -8,5 million (H1/2021 IFRS: Euro -10,5 million) confirmed against preliminary figures
- Operating figures reflect investments in fully-owned projects FYB202, FYB206 and FYB207 as well as in pipeline expansion with biosimilar projects FYB208 and FYB209
- Half-year result after preliminary purchase price allocation from ATHOS transaction of Euro 80.0 million (H1/2021 IFRS: Euro -10.6 million) impacted by transaction-related and non-cash extraordinary effect
- Significant balance sheet extension due to valuation of intangible assets acquired as part of the ATHOS transaction and due the purchase price recording of the acquired companies
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published its half-year report 2022, confirming the preliminary operating figures for the first half of 2022 already announced on September 06, 2022. In addition to this, the figures published today include purchase price allocation effects from the transaction with ATHOS KG closed in May where Formycon AG acquired 100% of the rights to FYB202, a biosimilar candidate for Stelara®1, the 50% stake of ATHOS KG in FYB201, a biosimilar for Lucentis®2, and the operational development unit Bioeq GmbH.
On the day of reporting, June 30, 2022, the financial figures of the Formycon Group were in line with Formycon’s expectations. Turnover within the Group, which alongside Formycon AG also includes the fully consolidated subsidiaries Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH and the 50% stake in Bioeq AG, which is consolidated at equity, totaled in Euro 17.6 million in the first six months of 2022 (H1/2021 IFRS: Euro 20.2 million).
With the market launch of FYB201 in the United Kingdom (UK) and the United States of America, as well as the launch in the EU by the respective commercialization partners, the first revenue and earnings contributions from commercialization proceeds are expected in the second half of 2022. For the full year of 2022, Formycon continues to forecast revenues above last year’s level for the entire Group (2021 IFRS: Euro 36.6 million).
Consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) stood at Euro -7.6 million (H1/2021 IFRS: Euro -9.7 million), while the operating result (EBIT) was around Euro -8.5 million as of June 30, 2022, compared with Euro -10.5 million in the prior-year period. The consolidated result for the period recorded a significant increase and amounted to Euro 80.0 million (H1/2021 IFRS: Euro -10.6 million).
Due to the sale of the minority stake (24.9%) in FYB 202 GmbH & Co. KG to Aristo Pharma GmbH as part of the transaction with ATHOS KG, the result for the period was dominated by an extraordinary effect, which had no impact on earnings or liquidity. In this context Formycon AG ceased to be a shareholder of FYB 202 GmbH & Co. KG. In parallel, the acquisition of 100% of the shares in FYB202 Project GmbH, in which the global assets and commercialization rights to FYB202 are located, was realized.
Extract of the Formycon Group balance sheet (IFRS, as of June 30, 2022)
| in thousand euros | End of period | |
| June 30, 2022 | December 31, 2021 | |
| Non-current Assets | 780,279 | 32,773 |
| Current Assets | 43,364 | 37,942 |
| Total Assets | 823,643 | 70,715 |
| Equity | 398,676 | 55,891 |
| Non-current liabilities | 404,465 | 4,406 |
| – of which liabilities from conditional purchase price payment | 291,502 | 0 |
| – of which deferred tax liabilities | 94,888 | 0 |
| – of which other non-current liabilities | 18,075 | 4,406 |
| Current Liabilities | 20,502 | 10,418 |
| Total equity and liabilities | 823,643 | 70,715 |
The increases in non-current assets, equity and non-current liabilities resulted mainly from the transaction with ATHOS KG and the subsequent purchase price allocation. Deferred tax liabilities reflect the tax effect of the intangible assets acquired and recorded. The liabilities from the conditional purchase price payment represent the component of the purchase price that is contingent on project-specific and factual revenue recognition in the acquired projects (FYB201 and FYB202). This purchase price component can assume values between 0 and the amount stated here.
The Group’s financial position continues to be solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 18.2 million on the day of reporting, compared to Euro 25.0 million as of December 31, 2021. In addition, as part of the ATHOS transaction, the company was provided with an on-demand line of credit amounting to Euro 50 million, of which Euro 40.0 million have not been utilized and could still be drawn down as of the reporting date.
Formycon AG, as the Group’s parent company and central development and operating unit, will continue to report in accordance with the rules of the German Commercial Code (HGB). Formycon AG achieved a turnover (HGB) of Euro 12.5 million in the first half of 2022 (H1/2021 HGB: Euro 12.4 million). The result (HGB) for this period amounted to Euro 82.6 million (H1/2021 HGB: Euro -10.0 million) which is also caused by the extraordinary effect described above.
“We look back on a successful half-year, which culminated in the transaction with ATHOS KG and the first approval of FYB201. The launch of FYB201, which has now taken place in the U.K. as well as in the US and is expected in the EU shortly, is another important milestone in our transformation into a company generating income from product commercialization,“ commented Dr. Stefan Glombitza, CEO of Formycon AG.
The full half-year report can be found at
https://www.formycon.com/en/investor-relations/financial-reports/
1) Stelara® is a registered trademark of Johnson & Johnson
2) Lucentis® is a registered trademark of Genentech Inc.
Formycon publishes details of a previously undisclosed pipeline project – FYB206 is a biosimilar candidate for Keytruda®* (pembrolizumab)
- Positioning in the field of immuno-oncology with the biosimilar candidate FYB206
- Addressable market size expected to be well above USD 20 billion after patent expiries from 2028 onwards
- With a patent application for a proprietary formulation important intellectual property (IP) has already been created
- Development of the manufacturing process is at an advanced stage and GMP manufacturing capacities have been secured
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced details of a previously undisclosed project in its development pipeline. FYB206 is a biosimilar candidate for Keytruda® (pembrolizumab) and the development is at an advanced preclinical stage. In addition to biosimilars in the field of ophthalmology (FYB201/FYB203), immunology (FYB202) and two further yet unpublished biosimilar candidates (FYB208/FYB209), Formycon is expanding its therapeutic range with FYB206 to the rapidly growing field of immuno-oncology.
The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is established in the treatment of a variety of tumors. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This helps the immune system activate the body’s own cellular anti-tumor immune response and kill e.g. melanoma cells.
Since 2015, Keytruda® has been established for the treatment of advanced melanoma, lung and other types of carcinoma. In 2021, the reference market for Keytruda® was reported at a size of more than USD 17 billion worldwide.[i] Expert analyses predict that Keytruda® will become the world’s top-selling drug in 2023, with annual revenue potential expected to be well over USD 20 billion as early as 2025.[ii]
The development and commercialization rights for FYB206 are fully owned by Formycon. Important IP has already been created and patent applications have been filed, with data from the development of alternative formulations. Following convincing results from the extensive analytical protein characterization as well as significant progress in the development of the manufacturing process, a comprehensive data package is currently being compiled in order to closely align further program steps in Scientific Advice Meetings with the EMA and FDA in the second half of the year. Adjusting the manufacturing process to commercial scale is planned for the end of 2022. For this purpose, Formycon has already secured GMP manufacturing capacities at a renowned contract manufacturer.
“Cancer, in its various forms, is still one of the most common and serious diseases of our time. The cost of effective cancer treatments has become a major challenge for healthcare systems around the globe. With the development of a Keytruda® biosimilar, we are pursuing the goal of facilitating access to this important medication for patients worldwide, while at the same time providing urgently needed savings for the healthcare systems,” says Dr. Stefan Glombitza, CEO of Formycon AG.
Formycon’s CSO, Dr. Andreas Seidl, adds: “With FYB206, we have a promising biosimilar candidate in the fast-growing field of immuno-oncology in our development portfolio. Keytruda® is a highly effective drug being successfully used as a breakthrough therapy for several types of cancer, including skin, lung and colorectal cancer.”
*Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
[i] Statista Revenue of Keytruda from 2014 to 2021 Keytruda revenue 2014-2021 | Statista. Retrieved September 2022
[ii] Best-selling drugs of the next 5 years The best-selling drugs of the next 5 years – Pharma Excipients; Merck, BMS, AbbVie blockbusters will rule pharma sales in 2025: report | Fierce Pharma. Retrieved September 2022
