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Munich – The biosimilars company Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published its financial results for the first nine months of the 2019 fiscal year.

The company announced that group sales, including other earnings, as of September 30 of this year, amount to EUR 26.8 million (previous year, including special effect, in the amount of EUR 8.5 million: EUR 32.4 million). The earnings before interest, tax and depreciations and amortizations (EBITDA) was well-balanced (previous year, including special effect: EUR 9.3 million). The operating result (EBIT) as well as the net result totaled around EUR -0.7 million (previous year, including special effect: EUR 8.1 million) and therefore were in line with expectations.

The Formycon Group’s stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled EUR 9.6 million as of September 30, 2019. Including short-term receivables from deliveries and services as well as other assets worth approximately EUR 19.6 million, Formycon held liquid assets totaling EUR 29.2 million on the day of reporting.

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 group level.

In the first nine months of the year, Formycon AG – as the company’s actual operational unit – achieved a turnover of EUR 16.2 million (same period last year, including special effect: EUR 23.7 million). The nine-month result of the joint stock company amounted to EUR -0.8 million compared to EUR 7.8 million in the same period last year (taking the special effect into consideration).

CFO Dr. Nicolas Combé commented on the results as follows: “We are happy with the financial figures from the first nine months. As a result of sales revenue generated from development services and solid liquidity, we are operating from a stable financial position. For Formycon, advances in the development of our biosimilar candidates are our key value drivers. We are therefore delighted by the positive progress of 2019 so far, and by the fact that we have already achieved important milestones in our development projects.”

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the start of a Phase I clinical trial comparing the pharmacokinetics, safety, and tolerability of FYB202 and the reference product Stelara® (USA / EU). Dosing of study subjects started last week.

FYB202 is being developed in a joint venture by Aristo Pharma GmbH and Formycon AG in which Aristo Pharma GmbH holds 75.1% and Formycon AG 24.9%. Bioeq GmbH is the sponsor of the clinical trial and is also responsible for the study design and clinical operation.

Provided successful completion of clinical Phase I and subsequent Phase III testing and timely regulatory approval, FYB202 can be launched after patent expiry of Stelara® (USA 09/2023; EU 07/2024).

* Stelara® is a registered trademark of Johnson & Johnson.

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