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EQS-News: Formycon AG / Key word(s): Quarterly / Interim Statement/Quarter Results
Formycon reports on successful operating business and financial figures for the first quarter of 2024
2024-05-08 / 07:30 CET/CEST
The issuer is solely responsible for the content of this announcement.
Press Release // May 8, 2024
Formycon reports on successful operating business and financial figures for the first quarter of 2024
. Group revenue amounts to EUR 17.7 million and corresponds to plan
. Group EBITDA of EUR -5.5 million reflects investments in pipeline and corporate development
. Adjusted Group EBITDA of EUR -1.2 million shows strong at-equity result for FYB201 participation
. Gedeon Richter acquires a 9.1% stake as new strategic investor
. Working capital increases significantly to EUR 84.2 million including cash equivalents of EUR 56.9 million

. Invitation to today's conference call at 3:00 pm (CEST)
Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, "Formycon") today published figures for the first quarter of
financial year 2024.
Enno Spillner, CFO of Formycon AG, comments: "We have made a very good start to the new financial year in line with our
plans and are positive about the first three months. In March, Sandoz announced the acquisition of the CIMERLI^®
business including the Coherus ophthalmology sales team in the USA, which we very much welcome and are looking forward
to working together in the future. We can also report approvals and market launches in Saudi Arabia, Canada and
Switzerland and are pleased that our partners MS Pharma and Teva are providing many patients access to this treatment
for serious eye diseases.
In February, we completed a cash capital increase with the specialty pharmaceutical company Gedeon Richter with gross
proceeds of EUR 82.8 million. After many years of trustful cooperation in contract manufacturing, this strategic
investment by our partner opens up opportunities to jointly exploit long-term strategic opportunities in the areas of
development, manufacturing and commercial value creation. We are continuously investing in our pipeline and are well
positioned to capitalize on the potential of the rapidly growing biosimilar market and expand our position as one of
the few pure-play biosimilar developers."
Revenues are influenced by milestone payments from the FYB202 project as well as from revenue shares from FYB201 sales
In the first quarter of 2024, the Formycon Group generated revenues of EUR 17.7 million (Q1/2023: EUR 32.4 million)[i].
These are below the previous year's figure but are in line with planning. In the previous year's quarter of 2023, an
additional payment of EUR 10 million from the commercialization partnership with Fresenius Kabi for the FYB202 project,
as well as higher income from development services for the two partnered projects FYB201 and FYB203 led to a strong
revenue effect.
A significant share of revenue in the first quarter of 2024 was generated from development services for the partnered
projects FYB201 and FYB203 as well as from deferred success payments related to the commercialization partnership with
Fresenius Kabi from the FYB202 project. Revenue resulting from direct participation in the marketing of the Lucentis^®
[1] biosimilar FYB201 amounted to around EUR 1.9 million (Q1/2023: EUR 0.3 million). A further significant part of the
FYB201 revenue was realized as part of the 50% at equity investment in Bioeq AG and is therefore not shown directly in
the revenue but below EBITDA.
The consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -5.5 million and
is reflecting investments in the pipeline and further corporate development.
For the first quarter of 2024, the at equity result from the existing 50% stake in Bioeq AG amounted to EUR 4.3 million
(Q1/2023: EUR -6.4 million). This underscores the overall successful operating performance of the FYB201
commercialization. The at equity result is included in the new key financial figure "Adjusted Group EBITDA", which
amounted to EUR -1.2 million in the first quarter of 2024 (Q1/2023: EUR -0.4 million).
Strategic investment by Gedeon Richter leads to significant increase in working capital in the first quarter
In February 2024, the Hungarian specialty pharmaceutical company Gedeon Richter Plc ("Gedeon Richter") became a
strategic investor in Formycon with a 9.1% stake as part of a cash capital increase excluding subscription rights. The
rationale behind the transaction is the shared common interest in the development and production of future biosimilars
and in further potential operational cooperation. Formycon issued 1,603,877 new bearer shares with a pro rata amount of
the share capital of EUR 1.00 each against cash contribution at a placement price of EUR 51.65 per new share by partially
utilizing the authorized capital.
Through the transaction, Formycon generated gross proceeds of EUR 82.8 million, which will be used primarily for the
further development of the FYB206, FYB208 and FYB209 projects. In addition, the launch of FYB210, a new biosimilar
candidate, is planned for the second half of the year.
Formycon's net working capital increased significantly to EUR 84.2 million as of March 31, 2024 (December 31, 2023: EUR
38.9 million). It includes cash and cash equivalents of EUR 56.9 million (December 31, 2023: EUR 27.0 million). The
shareholder loan has now been repaid in full. The flexible shareholder credit line of up to EUR 48 million remains in
place.
Formycon confirms the financial guidance issued in April for the 2024 financial year. Assuming the expected approvals
and market launches as well as potential out-licensing of biosimilar candidates, Formycon is aiming for a positive
EBITDA in the medium term.
Operative milestones for FYB201 and FYB202 reached in the first quarter
In early March, the partner for the MENA region MS Pharma received marketing authorization for FYB201 from the Saudi
Food & Drug Authority and won the state NUPCO tender in Saudi Arabia. FYB201 is expected to be marketed under the trade
name Ravegza^®[2] in Saudi Arabia from the second quarter of 2024. In addition, following Jordan and Saudi Arabia,
market launches are also planned in Algeria and other Gulf Cooperation Council (GCC) countries in the course of 2024.
Subsequent to the end of the reporting period, the commercialization partner Teva announced the market launches of
FYB201 in Canada under the trade name Ranopto^TM[3] and in Switzerland under the trade name Ranivisio^®[4].
For FYB202, the biosimilar candidate for Stelara^®[5] (ustekinumab), Formycon and its commercialization partner
Fresenius Kabi have successfully concluded a settlement agreement for Europe and Canada with Johnson & Johnson. As
early as August last year, it was ensured that FYB202 can be launched on the US market no later than April 15, 2025,
following approval. The marketing authorization application for FYB202 was accepted for review by the European
Medicines Agency (EMA) in September 2023 and by the U.S. Food and Drug Administration (FDA) in November 2023.
Several approval decisions and the start of the next clinical program mark important milestones for the 2024 financial
year
Formycon is expecting important approval decisions for the biosimilar candidates FYB202 (ustekinumab) and FYB203
(aflibercept) in the USA and Europe in the course of 2024, which are expected to contribute to revenue growth from 2025
onwards, following the successful start of commercialization. The start of the clinical development program for FYB206,
the biosimilar candidate to Keytruda^®[6] (pembrolizumab), is planned with the treatment of the first patient (first
patient-in) in the course of 2024. Formycon continues to invest in the expansion of its biosimilar platform and further
extended its product pipeline with the two earlier biosimilar candidates FYB208 and FYB209. In addition, the plan is to
continue the expansion in 2024 with the initiation of the FYB210 project.
Conference call and dial-in data
The Management Board of Formycon AG will discuss the development of the company and the key financial figures for the
first quarter of the financial year 2024 in a conference call. The conference call, which will be broadcasted live on
the Internet on May 8, 2024 at 3:00 p.m. (CEST) in English.
To participate, please register at:
https://webcast.meetyoo.de/reg/f7ngieeBvHNo
You will then receive a confirmation e-mail with the telephone number, access code and PIN for the call.
The presentation and audio transmission can be accessed via the following link:
https://www.webcast-eqs.com/formycon-2024-q1
Following a short presentation, the Management Board will be available to answer analysts' questions. The conference
call will be recorded and will be available afterwards on the Formycon website at: https://www.formycon.com/en/
investor-relations/facts-figures/
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of
biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other
key disease areas, covering almost the entire value chain from technical development through clinical trials to
approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong,
well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the
market in Europe and the USA. Another five biosimilar candidates are currently in development. With its biosimilars,
Formycon is making an important contribution to providing as many patients as possible with access to highly effective
and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB /
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