Formycon reports on successful operating business and financial figures for
the first quarter of 2024

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

08.05.2024 / 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
RanoptoTM (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 / ISIN: DE000A1EWVY8 /
WKN: A1EWVY. Further information can be found at: https://www.formycon.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have
revolutionized the treatment of serious and chronic diseases. By 2032, many
of these drugs will lose their patent protection - including 45 blockbusters
with an estimated total annual global turnover of more than 200 billion US
dollars. Biosimilars are successor products to biopharmaceutical drugs for
which market exclusivity has expired. They are approved in highly regulated
markets such as the EU, the USA, Canada, Japan and Australia in accordance
with strict regulatory procedures. Biosimilars create competition and thus
give more patients access to biopharmaceutical therapies. At the same time,
they reduce costs for healthcare providers. Global sales of biosimilars
currently amount to around 21 billion US dollars. Analysts assume that sales
could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
Tel.: +49 (0) 89 - 86 46 67 149
Fax: + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information
which are based on Formycon's current expectations and certain assumptions.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, performance of the company, development of the products and the
estimates given here. Such known and unknown risks and uncertainties
comprise, among others, the research and development, the regulatory
approval process, the timing of the actions of regulatory bodies and other
governmental authorities, clinical results, changes in laws and regulations,
product quality, patient safety, patent litigation, contractual risks and
dependencies from third parties. With respect to pipeline products, Formycon
AG does not provide any representation, warranties or any other guarantees
that the products will receive the necessary regulatory approvals or that
they will prove to be commercially exploitable and/or successful. Formycon
AG assumes no obligation to update these forward-looking statements or to
correct them in case of developments which differ from those anticipated.
This document neither constitutes an offer to sell nor a solicitation of an
offer to buy or subscribe for securities of Formycon AG. No public offering
of securities of Formycon AG will be made nor is a public offering intended.
This document and the information contained therein may not be distributed
in or into the United States of America, Canada, Australia, Japan or any
other jurisdictions, in which such offer or such solicitation would be
prohibited. This document does not constitute an offer for the sale of
securities in the United States.

-----------------------------------------------------------------------------------------------------------------------

(1) Lucentis® is a registered trademark of Genentech Inc.

(2) Ravegza® is a registered Trademark of MS Pharma

(3) RanoptoTM is a Trademark of Teva Canada Ltd.

(4) Ranivisio® is a registered Trademark of Bioeq AG

(5) Stelara®is a registered Trademark of Johnson & Johnson

(6) Keytruda® is a registered Trademark of Merck Sharp & Dohme LLC

(i) For the Q1 2023 reporting the company preliminarily assumed that
revenues from the license agreement for FYB202, including upfront and
milestone payments would be realized at "point in time" when they were due
under IFRS 15. With further evaluation of revenue recognition of the
respective contract during the second quarter of 2023 it became evident that
revenues recognition has to be handled as following: Upfront payments,
relating to the at that point unfinished license, fulfilled the criteria of
IFRS 15 and thus to be realized at the respective point in time of the
payment, while revenues from milestone payments relating to development
milestones need to be realized over time based on the cost-to-cost method in
relation to the respective development expenditure. This also resulted in
the associated expenditure no longer falling under IAS 38 and therefore no
longer being capitalized as internally generated intangible asset but
recognized as cost of sales in the statement of comprehensive income.

After retrospective correction as of Feb. 1, 2023 the published key
performance indicators for 1Q 2023 change as follows, increasing Revenues as
well as Cost of Goods Sold and therefore being without significant impact on
EBITDA or Net Income:

    In EUR million  Q1/2023 as published  Correction  Q1/2023 after correction
    Revenue                       21.5        10.9                      32.4
    EBITDA                         4.5         1.5                       6.0
    EBIT                           4.1         1.5                       5.6
    Net Income                   -13.5         1.1                     -12.4

---------------------------------------------------------------------------

08.05.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

---------------------------------------------------------------------------

   Language:       English
   Company:        Formycon AG
                   Fraunhoferstraße 15
                   82152 Planegg-Martinsried
                   Germany
   Phone:          089 864667 100
   Fax:            089 864667 110
   Internet:       www.formycon.com
   ISIN:           DE000A1EWVY8
   WKN:            A1EWVY
   Indices:        Scale 30
   Listed:         Regulated Unofficial Market in Berlin, Dusseldorf,
                   Frankfurt (Scale), Hamburg, Munich, Stuttgart,
                   Tradegate Exchange
   EQS News ID:    1898085

End of News EQS News Service
---------------------------------------------------------------------------

1898085 08.05.2024 CET/CEST