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Munich – The Supervisory Board of the biosimilar company Formycon AG has extended the appointments of Dr. Carsten Brockmeyer, board member and CEO, and Dr. Nicolas Combé, board member and CFO, until June 30, 2022. With these contract extensions, the control committee is honoring the successful work carried out by the Formycon management team over recent years, and providing the continuity needed at the executive level of the company to allow further sustainable and successful development.

“Since its strategic focus on the development of biosimilars in 2013, Formycon’s development has been exceptionally pleasing. The extension of the executive board members’ contracts reflects not only the achievements of the entire Formycon team, but is also an expression of continuity within the company and the trusting cooperation between the Supervisory Board and Management Board”, says Dr. Olaf Stiller, Chairman of the Supervisory Board of Formycon AG. “We are delighted to be continuing this exceptional collaboration with our management.”

Dr. Brockmeyer has been with Formycon since 2013 and, as a renowned biosimilars expert, is responsible for the company’s corporate and development strategy. Dr. Combé was one of the co-founders of the present-day Formycon, starting out with the company back in 2008, and is responsible for the Finance, Controlling, Legal and HR departments. Dr. Stefan Glombitza joined the Formycon Management Board in October 2016 being in charge of Formycon’s operational development. His position on the Management Board continues until September 30, 2021.

Under the leadership of the current management team, Formycon has established itself as an internationally renowned developer of biosimilars. Since 2013, the company has launched four biosimilar projects, of which one is already in the advanced stages of a phase III clinical trial.

Munich – The biosimilars company Formycon AG has accomplished a successful first half year in 2017. Phase III of the clinical trial involving the furthest-advanced biosimilar candidate FYB201 is continuing to progress as planned. FYB201 is a biosimilar candidate for the ophthalmic agent Lucentis®* (ranibizumab) and is scheduled to be marketed in the US from mid-2020 under the responsibility of the licensing partner following successful approval and expiry of the reference product’s legal protection.

The development of FYB202, a biosimilar candidate for Stelara®** (ustekinumab), has also been pleasing during the first six months of 2017 and is set to continue in future as part of a development cooperation agreement. To this effect, a term sheet has since been signed for the joint development of FYB202 with Santo Holding (Deutschland) GmbH. The aim is to develop FYB202 through to market authorization. As already announced, under the terms of the co-investment agreement, Formycon will bear up to 30 percent of the development costs for FYB202 and in return will receive a share of up to 30 percent of the future global market revenues.

The development of FYB203, a biosimilar project for Eylea®*** (aflibercept), which is also already being licensed out, as well as of FYB205, is progressing in accordance with the project schedule.

Formycon’s economic results during the first half-year have been shaped considerably by the development expenses associated with FYB202. The group which, alongside the joint stock company also comprises the two sub-holdings Formycon Project 201 GmbH and Formycon Project 203 GmbH, therefore had a turnover of Euro 8.01 million (1st half year of 2016: 8.76 million). As in the past, the main source of income was the development of the two licensed-out biosimilar candidates FYB201 and FYB203. The group period result at the end of June 2017 stood at Euro -2.91 million compared to Euro -1.18 million during the same period last year.

The company’s financial resources remain solid, regardless of the increase in expenditure on development: On the day of reporting, Formycon held liquid assets of around Euro 14.4 million. Including short-term receivables from deliveries and services worth Euro 1.33 million, Formycon’s liquid assets totaled around Euro 15.7 million (20.7). The equity ratio has risen by 1.7 percentage points to 84.6 percent compared to the same period last year. The turnover forecast for the year as a whole remains unchanged at Euro 25 million.

The implementation of the term sheet for FYB202 in the intended contractual and company law structure is anticipated during the second half of the year and should make a significant contribution to improving the Formycon Group’s results for the 2017 financial year. The cash inflow from the capital increase worth around Euro 6 million at the start of the third quarter is not included in the figures stated.

Formycon AG, as the company’s central development and operational unit, achieved a turnover of Euro 4.80 million (previous year: 7.05 million) during the first six months, with the result from the first half-year being Euro -2.88 (-1.23) million. This change in turnover is essentially due to the shift of development activities to the respective project companies.

Dr. Nicolas Combé, Chief Financial Officer of Formycon, is satisfied with developments over the first six months: “The agreements on FYB202 will lead to an extremely valid development financing for this project too. Together with the licensing agreements for FYB201 and FYB203, development financing for our three main projects should therefore be assured. This puts us in a highly promising position for keeping the company on a healthy course for growth and being able to leverage the economic potential that will arise from our share of future product marketing revenue in particular.”

Dr. Carsten Brockmeyer, CEO of Formycon, says: “In the first half year of 2017, Formycon achieved significant progress on all of its projects. The global provision to patients of safe and effective biological medicines at affordable prices is a major commitment of ours. We are well on the way to achieving this objective.”

You will find the full half-year report 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 commercial performance of the biosimilars company Formycon has again advanced as planned in the first quarter of 2017. The development of its four biosimilar projects has progressed as expected and the company’s financial key performance indicators have developed as anticipated.

At group level, sales revenues and other earnings totaled Euro 3.38 million (previous year: Euro 6.34 million). During this phase of the company’s growth, sales revenues are directly linked to development expenditure in licensed projects, so this deviation is primarily a result of the reporting date. For the total year the company confirms the expected sales volume of around Euro 25 million. From January to March, the EBITDA was Euro -0.51 million (Euro -0.02 million) based on a quarterly result of Euro -0.71 million (Euro -0.19 million). Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 13.21 million at the end of March. Including short-term receivables from deliveries and services worth Euro 3.11 million, Formycon held liquid assets of Euro 16.32 million on the day of reporting.

Revenues from sales and other earnings at Formycon AG totaled Euro 2.16 million. The quarterly result stood at Euro -0.77 million.

Chief Financial Officer Dr. Nicolas Combé commented on the figures with these words: “The first quarter has again progressed in line with our expectations, and development costs are on budget, as outlined in our forecasts. What matters most here is that we have again made significant advances in our biosimilar projects. With the recently announced news that FYB202 is a biosimilar candidate for Stelara®*, we have once again highlighted the intrinsic value of our pipeline. We anticipate that we will reach further important milestones in our projects over the course of the year.”

* Stelara is registered trademark of Johnson & Johnson

Munich – The biosimilars company Formycon has today announced details of a further product from its development pipeline. FYB202 is a biosimilar candidate for Stelara®* (ustekinumab) which is currently in the pre-clinical testing phase. This means that Formycon’s development pipeline comprises FYB201 (biosimilar candidate for Lucentis®**), FYB203 (biosimilar candidate for Eylea®***) and FYB202 (biosimilar candidate for Stelara®), three of the highest-selling drugs from the third wave of biosimilars which addresses reference products set to lose their legal protection after 2020.

Stelara® (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and Interleukin-23. Since 2009, the drug has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its indications were extended, allowing Stelara® to also be used for the treatment of Crohn’s disease, a chronic inflammatory condition of the bowel.

In recent years, Stelara® has brought growing revenues and in 2016 achieved global sales of around US$ 3.2 billion. Further sales growth is also anticipated for the future. According to information from the US National Center for Biotechnology Information (NCBI) and the World Health Organization (WHO), the psoriasis market is set to increase by an average of 7.3 percent per year, reaching a volume of US$ 13.3 billion by 2024. For Crohn’s disease, an expansion of the market from its current level of US$ 3.5 billion to US$ 4.4 billion is expected over the same period. There may also be further potential for sales through the possible approval of Stelara® for additional indications, for example the treatment of other serious gastrointestinal conditions. Marketing of a biosimilar for Stelara® should become possible towards the end of 2023 in the USA and from the middle of 2024 in Europe once the legal protections expire.

Dr. Carsten Brockmeyer, board member and CEO of Formycon, regards the biosimilar candidate for Stelara® as a further important milestone on Formycon AG’s journey towards becoming a leading company in the promising biosimilar industry: “The costs of treating chronic conditions such as psoriasis and Crohn’s disease have become a major challenge for healthcare systems around the world. With the development of the Stelara® biosimilar, we are pursuing the goal of offering this treatment to doctors and patients at an affordable price, thereby increasing access to this important drug and at the same time allowing urgently needed savings to be made in healthcare systems.”

Dr. Stefan Glombitza, board member and COO of Formycon, adds: “For the sophisticated development of the biosimilar product FYB202, we will build on our first-class scientific expertise, strict development standards and efficient cooperation with renowned third-party manufacturers in order to achieve our milestones with the final goal of getting biosimilar approval from international authorities. Our team is highly motivated by the fact that through our product development we will be able to create broader access to high-quality medication for the many patients with psoriasis and Crohn’s disease.”

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

Munich – The biosimilars company Formycon from Martinsried near Munich has ended the 2016 financial year successfully and significantly advanced the development of its product candidates. The clinical phase III study of the most advanced biosimilar candidate FYB201 (ranibizumab), a follow-on drug to the successful ophthalmic agent Lucentis®*, is proceeding as planned. Formycon is therefore affirming its objective of marketing FYB201 as the first Lucentis® biosimilar under the responsibility of its licensing partner following the expiry of the Lucentis patent in the USA in 2020.

The development of FYB203 (aflibercept), a biosimilar candidate for Eylea®**, which is currently in its pre-clinical phase, is also advancing in line with expectations. With FYB201 and FYB203, Formycon’s development pipeline comprises the two most important and best-selling drugs for intraocular anti-VEGF treatments, one of the fastest-growing treatment sectors on the pharmaceutical market. Both projects are licensed out. Formycon is also working on the development of the two other biosimilar projects FYB202 and FYB205. The company will be releasing details of these products at a later date.

Formycon’s economic development also progressed as expected in 2016. The Group increased its turnover by more than 15 percent compared to the previous year to Euro 19.5 million (2015: 16.9 million). Sales were essentially generated from ongoing remunerations from licensing partners for the product development of FYB201 and FYB203.

In view of the expected higher expenditure on development caused by the on-plan project progress of the as yet un-licensed biosimilar developments, the Group’s earnings before interest, tax and depreciations (EBITDA) was Euro -3.37 million (2015: 1.47 million), with the net loss for the year being Euro -4.07 million (2015: 0.58 million). The Group’s equity ratio of 82.9 percent (2015: 91.6) is at an above-average level as in previous years. The company has no financial liabilities. Stocks of liquid assets, including securities, totaled Euro 14.0 million on the day of reporting. Including short-term receivables from deliveries and services worth Euro 5.2 million, Formycon held liquid assets of around Euro 19.2 million (2015: 23.1 million).

Formycon AG as the Group’s actual operational unit achieved a turnover of Euro 13.9 million (2015: 13.6 million) and had a net deficit of Euro -4.18 million (0.6) on a background of increased development expenditure.

The workforce has grown significantly from 53 to 70 over the past year. This reflects the increased demand for resources associated with the expansion and growing maturity of the product pipeline.

Dr. Nicolas Combé, Director and CFO of Formycon, believes that the company is on the right path: “By the year end, we anticipate that we will have achieved further major milestones in our development projects. These should include the clinical trial of our biosimilar candidate FYB201. We also expect news for FYB202, the marketing rights for which are still fully owned by Formycon. Given its solid financial foundations and ongoing revenue, Formycon is in excellent shape. For the 2017 financial year, we anticipate an annual turnover in the region of Euro 25 million.”

Dr. Stefan Glombitza, who has been responsible for operational business since October 2016 as the third member of the board, also believes the company is well positioned in relation to its operational divisions: “Over the last year we have significantly expanded Formycon’s development division and we will continue to do upgrades in accordance with our progress. Our significant scientific expertise, coupled with efficient processes in development will support our objective to gain on time marketing authorizations and achieve further important milestones while we are advancing our biosimilar product pipeline.”

The full annual report is available at www.formycon.com/investors/financial-reports. The English version will be published at the end of May.

* Lucentis is a registered trademark of Genentech Inc.
** Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.

Munich – The biosimilar company Formycon plans, with effect from March 1, 2017, to switch to Deutsche Börse AG’s new stock exchange segment “Scale” for small and medium-sized enterprises (SMEs). A corresponding request for inclusion in the SME segment has been lodged with Deutsche Börse AG. Formycon will be accompanied by its capital market partner Süddeutsche Aktienbank.

The new segment, which will be more strictly regulated in some areas both in terms of its inclusion and its follow-up requirements than the entry standard, will improve access to investors for small and medium-sized companies and place the emphasis on transparency and quality criteria. Deutsche Börse is therefore supporting the goals of the German government of sustaining innovation and growth in Germany and is keen, through this action, to make a contribution towards Germany’s sustainability as a business location.

“We welcome the new segment, and we anticipate further attention from investors and analysts as a result”, says Dr. Nicolas Combé, Chief Financial Officer at Formycon. “We also believe that the new SME segment represents a sensible further development of the entry standard. It should lead to more transparency on the market and could evolve into an indicator for small and medium-sized quality companies.”

Formycon shares have been listed in the curb segment entry standard since 2012. Formycon has already reported beyond the specified minimum standards that are imposed on corporate publicity in the past. The company communicates quarterly in German and English, for example, on the progress of its business and regularly updates investors and analysts. Formycon will continue to do so in the future.

Formycon develops follow-on versions of biopharmaceuticals, so-called biosimilars. Currently the company is working on four biosimilar projects, which are in different stages of pre-clinical and clinical development. Two of them have already been out-licensed.

Munich – The biosimilar company Formycon has been named “growth champion 2017” in the category “Chemistry and Pharma” by the news magazine Focus. Due to its significant growth in sales over recent years, Formycon was ranked first in this segment in a rating of the 500 companies in Germany with the largest growth in sales in the period from 2012 to 2015. In the overall ranking, Formycon took second place.

“We are very pleased with our excellent rankings in the Focus list,” said Dr. Carsten Brockmeyer, executive board member and CEO of Formycon. “They illustrate the rapid and successful achievements of our young company over the last few years with our biotechnological follow-on drugs and company growth. We owe this result to the great commitment of the entire Formycon team and the excellent support of our partners.”

Since the start of development activity in 2012, Formycon has continuously expanded its range of biosimilar projects, with four projects currently in the pipeline. In the current year, the company anticipates sales of EUR 20 million. In particular, Formycon expects a further substantial increase in revenues from the year 2020. From this point and given a successful development, it is planned to launch FYB201 – the first biosimilar developed by the company – on the market.

Biosimilars are follow-on products of biopharmaceutical drugs and are increasingly taking over the role of classical generics. In contrast to the latter, biosimilars are complex medical preparations whose development requires extensive know-how and considerable financial resources. Compared to original pharmaceutical products, which are usually expensive, biosimilars offer significant savings potential for healthcare systems and thus make a central contribution to the improvement of patient care in the form of highly effective, biopharmaceutical drugs.

Formycon’s most advanced development project (in partnership with Bioeq IP AG) is FYB201, a biosimilar candidate of the ophthalmic drug Lucentis®* (ranibizumab), for which patients have been enrolled in a global clinical phase III since the start of 2016. FYB201 is therefore the world’s only Lucentis® biosimilar to be in a phase III licensing study, the final stage of clinical development to gain marketing approval.

FYB203, which has been licensed out to Santo Holding Deutschland (GmbH), is a biosimilar candidate to Eylea®** (aflibercept) which, like Lucentis®, is used to treat neovascular, age-related macular degeneration (nAMD) and other serious eye conditions. Details of the FYB202 and FYB205 projects, which have not yet been partnered and the rights to which are still fully owned by Formycon, have so far not been published.

The Focus special “Growth Champions 2017” includes a list of the 500 German companies with the highest average percentage growth per year. Focus also subdivided the list into different industry sectors. The ranking was developed in cooperation with the statistical company Statista and takes into account both privately owned and listed companies. The prerequisites for inclusion were that the companies operate independently, are not subsidiaries, have their head office in Germany and generated at least EUR 100,000 in sales in 2012 and EUR 1.8 million or more in 2015.

* Lucentis is a registered trademark of Genentech Inc.
** Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.

Munich – In the first nine months of the 2016 financial year, the biosimilars company Formycon has further advanced the development of its drug candidates. Revenue from sales has primarily been generated through the development of the two partnered biosimilar product candidates FYB201 and FYB203. At the same time, Formycon has also invested heavily in both of its own development programs – FYB202 and FYB205 – thereby continuing its successful economic path as planned.

With a turnover of Euro 11.66 million, the Formycon Group achieved an overall performance of Euro 11.82 million after consideration of other operating income worth Euro 0.16 million. The nine-month earnings before interest, taxes, depreciation and amortizations (EBITDA) stood at Euro -2.06 million, with the operating result (EBIT) amounting to Euro -2.58 million. The result for the period totaled Euro -2.57 million.

As of September 30, 2016, the Formycon Group held liquid assets worth Euro 16 million. Including short-term receivables from deliveries and services worth around Euro 3 million, Formycon had liquid assets of around Euro 19 million at its disposal. As a result, the company continues to maintain a solid financial buffer which will enable it to advance the development of its biosimilar candidates.

For the full year, Formycon continues to anticipate group revenues in the range of Euro 20 million.

In the first three quarters of 2016, Formycon AG as the actual operational unit achieved sales of Euro 8.72 million, while the overall performance amounted to Euro 8.87 million. The EBITDA stood at Euro -2.30 million, the EBIT at Euro -2.82 million and earnings at Euro -2.81 million. On the day of review, Formycon employed 68 people.

Dr. Nicolas Combé, Director and CFO of Formycon, believes these results confirm that the company remains on the right path: “With the planned investments in our biosimilar projects, we are building up a valuable pipeline and positioning ourselves as a leading independent developer for biosimilars. Together with our licensing partners Santo Holding and Bioeq IP AG, our goal is to be the first to offer high-quality follow-on drugs after the expiry of patents on reference products. The progress this year shows us that we are on the right track.”

Formycon currently has four biosimilar projects in clinical and pre-clinical development. The furthest-advanced is FYB201, a biosimilar candidate of the ophthalmic drug Lucentis®* (ranibizumab), for which patients have been enrolling in a global clinical phase III since the start of 2016 in collaboration with Bioeq IP AG. FYB201 is therefore the world’s only Lucentis® biosimilar to be in the phase III licensing study, the final stage of clinical development to gain marketing approval.

FYB203, which has been licensed out to Santo Holding (Deutschland) GmbH, is a biosimilar candidate for Eylea®** (aflibercept) which, like Lucentis®, is used to treat neovascular, age-related macular degeneration (nAMD) and other serious eye conditions. Details of the FYB202 and FYB205 projects, which have not yet been partnered and the rights to which are still fully owned by Formycon, have so far not been published.

* Lucentis is a registered trademark of Genentech Inc.
** Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.

Research Seal awarded in recognition of particular dedication to biosimilar development

Munich – The biosimilar company Formycon has been awarded the Research Seal by the Stifterverband in recognition of its innovative research and development work. With this award, the organization is acknowledging the Munich company’s dedication to the development of biopharmaceutical follow-on drugs, known as biosimilars. According to the organization, the “Innovative Through Research” Seal is also intended to highlight the special responsibility that researching companies take on through their work on behalf of the state and society.

The Stifterverband points out that, although there are 3.5 million companies in Germany, less than one percent of them actually carries out research. This is an extremely important group. Only by researching can new things be discovered and innovation and growth created, says the organization.

Formycon is currently working on four biosimilar development projects (FYB201, FYB202, FYB203, FYB205), which are in various stages of pre-clinical and clinical development.

The most advanced development project is FYB201, a biosimilar candidate of the ophthalmic drug Lucentis®* (ranibizumab). It is the world’s only Lucentis® biosimilar to be in a phase III approval study. Formycon is pursuing the goal of marketing FYB201 via its licensing partner Bioeq IP AG as the first Lucentis® biosimilar following the expiry of the drug’s patent in the USA and Europe.

FYB203 is a biosimilar candidate for Eylea®** (aflibercept) which, like Lucentis®, is used to treat neovascular, age-related macular degeneration (nAMD) and other serious eye conditions. The project is licensed to Santo Holding Deutschland (GmbH).

Details of the biosimilar projects FYB202 and FYB205 have not yet been made public.

Dr. Carsten Brockmeyer, CEO of Formycon, is delighted by the award from the Stifterverband: “The award of the Research Seal is a major legitimation for us. It highlights the efforts that the entire Formycon team has been making for years in research and development to develop high-quality biosimilars. We will continue to work hard to ensure that as many patients as possible are able to receive high-quality medicines at affordable prices.”

The Stifterverband, a joint initiative between companies and foundations, is one of Germany’s largest private sponsors of science. Alongside its commitment to academic growth, first-class universities and cutting-edge research, the Stifterverband also regularly examines and evaluates the German research and innovation system on behalf of the German Ministry of Education and Research.

* Lucentis is a registered trademark of Genentech Inc.
** Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.