COSMO ANNOUNCES FULL-YEAR RESULTS 2021; CONFIRMS BEATING GUIDANCE

Cosmo Pharmaceuticals N.V. / Key word(s): Annual Results

23-March-2022 / 06:00 GMT/BST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.

Ad hoc announcement pursuant to Art. 53 LR

Dublin, Ireland - 23 March 2022: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) ('Cosmo') reports full-year 2021 results for the year ended 31 December 2021, confirms beating guidance, and, as previously announced, proposes a dividend of €0.95 per share at the next AGM on 27 May 2022.

Business Highlights:

• FDA approved GI Genius(TM), the first-to-market device that uses artificial intelligence (AI) to assist clinicians in the detection of lesions in the colon in real time during a colonoscopy.
• DETECT study showed AI assistance using GI Genius(TM) reduces missed polyp rate by over 50% on initial colonoscopy.
• Signed licence and supply agreement between Cassiopea S.p.A. and Sun Pharmaceutical Industries for Winlevi(R) in the U.S. and Canada.
• Winlevi(R) launched by Sun Pharmaceutical Industries in the U.S. in November 2021.
• Cosmo launched and successfully closed public exchange offer to acquire Cassiopea S.p.A.
• Licensed EU rights (plus Switzerland, U.K., EEA countries and Mexico) for Lumeblue(R) to Alfasigma S.p.A.
• Announced successful outcome of phase II proof of concept (POC) clinical trial of Rifamycin SV MMX(R) 600 mg in irritable bowel syndrome with diarrhoea (IBS-D).

Financial Highlights:

• Revenue increased 6.9% to €65.1 million compared to €60.9 million in 2020.
• EBITDA increased 42.7% to €18.5 million compared to €12.9 million in 2020.
• Operating profit increased 60.9% to €11.1 million compared to €6.9 million in 2020.
• Profit after tax of €21.7 million, including share of Cassiopea gain €17.8 million, compared with a loss after tax of €7.9 million in 2020.
• Net cashflow from operating activities of €12.6 million compared to €13.0 million in 2020.
• Cash and fund investments of €222.2 million compared to €212.9 million at 31 December 2020.
• Equity attributable to owners of the Company €505.3m at 31 December 2021 vs €400.1m at 31 December 2020.
• A dividend of €0.95 per share will be proposed at the next AGM on May 27, 2022.   

Key figures:

Mauro Ajani, Chairman of Cosmo, said: 'I am very satisfied to see Cosmo's entering large markets while preserving its pioneering approach.' 

Alessandro Della Chà, Chief Executive Officer, said: 'We entered 2021 with high expectations and we are pleased to report remarkable business achievements during yet another challenging year. Most importantly, Cosmo has shifted from niche markets to very large markets, thereby significantly increasing our revenue potential. We now have two new and very innovative products, GI Genius(TM) and Winlevi(R), in two major markets. We are tackling these opportunities with two very strong partners, Medtronic and Sun Pharma. GI Genius(TM) addresses the worldwide colonoscopy market of an estimated 60 million annual colonoscopy procedures, of which an estimated 19 million are carried out in the US which, in terms of volume, is second only to the blood test. Winlevi(R) addresses the acne market with the first new mechanism of action for the treatment of this condition in almost 40 years. Acne affects an estimated 640 million people worldwide and the market in the US is worth an estimated USD 5bn per annum just for prescription drugs alone. In the meantime, we have seen our legacy products continue to perform well notwithstanding the difficult environment due to the pandemic. Our results reflect our capabilities, execution mindset and commitment to long term relationships. We are progressing the replenishment of our development pipeline and our performance in 2021 is reflected in a positive cashflow from operations and in our strong balance sheet. Our year-end cash balance of €222.2 million provides us with the necessary financial flexibility to execute on our strategic priorities. We are thus confident about our 2022 outlook.'

Cosmo provided the following 2022 financial outlook:

• Total revenues in the range of €90m - €100m vs €65.1m in 2021.
• Operating profit in the range of €20m - €25m vs €11.1m in 2021.

Management updates:

Effective April 1, 2022, Mr. Luigi Longo, currently Cosmo's R&D Operations Manager, will be promoted to the role of Chief Scientific Officer (CSO).Mr. Longo, Italian (born 1979), began his career as an analytical laboratory scientist in Cosmo S.p.A. in June 2005. He continued his career in the R&D laboratory department and was appointed Scientific Project Manager in 2014. In this role, he collaborated with the CSO of Cosmo in the management of several R&D projects and contributed to the successful completion of several R&D development programs. Mr. Longo has a degree in chemistry and pharmaceutical technology from 'La Sapienza' University in Rome.

Further, the Company has hired Mr. Stefano Alvergna as Chief Medical Officer, effective April 1, 2022. Mr. Alvergna, Italian (born 1958), has 30 years of experience in R&D and clinical research on drugs and medical devices covering different roles in CROs and pharmaceutical companies. Prior to joining Cosmo Mr. Alvergna was responsible for Scientific Service and Corporate Medical Affairs at Fidia Farmaceutici. In his career he has planned and managed more than 200 clinical trials, supervising scientific activities and medical aspects from phase I to III in different therapeutical areas. He has a degree in Medicine and Surgery from the University of Bologna, where he specialized in Toxicology. 

The Full-Year Report 2021 with further information was published today, 23 March 2022 at 07:00 am CET and is available for download at:

http://www.cosmopharmaceuticals.com/investor-relations/financial-reports

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About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of GI Genius(TM) its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo(R) to Red Hill Biopharma Ltd. for the US and has licensed Relafalk(R) to Dr. Falk Gmbh for the EU and other countries. For additional information on Cosmo and its products please visit the Company's website: www.cosmopharma.com

Disclaimer
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.

Contact
Hazel Winchester
Head of Investor Relations
Cosmo Pharmaceuticals N.V.                                  
Tel: +353 1 817 03 70
hwinchester@cosmopharma.com