Dublin, Ireland - 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 EUR0.95 per share at the next AGM on 27 May 2022.
Business Highlights:
FDA approved GI Genius, 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 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 in the U.S. and Canada.
Winlevi 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 to Alfasigma S.p.A.
Announced successful outcome of phase II proof of concept (POC) clinical trial of Rifamycin SV MMX 600 mg in irritable bowel syndrome with diarrhoea (IBS-D).
Financial Highlights:
Revenue increased 6.9% to EUR65.1 million compared to EUR60.9 million in 2020.
EBITDA increased 42.7% to EUR18.5 million compared to EUR12.9 million in 2020.
Operating profit increased 60.9% to EUR11.1 million compared to EUR6.9 million in 2020.
Profit after tax of EUR21.7 million, including share of Cassiopea gain EUR17.8 million, compared with a loss after tax of EUR7.9 million in 2020.
Net cashflow from operating activities of EUR12.6 million compared to EUR13.0 million in 2020.
Cash and fund investments of EUR222.2 million compared to EUR212.9 million at 31 December 2020.
Equity attributable to owners of the Company EUR505.3m at 31 December 2021 vs EUR400.1m at 31 December 2020.
A dividend of EUR0.95 per share will be proposed at the next AGM on May 27, 2022.
Alessandro Della Cha, 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 and Winlevi, in two major markets. We are tackling these opportunities with two very strong partners, Medtronic and Sun Pharma. GI Genius 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 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 EUR222.2 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 EUR90m - EUR100m vs EUR65.1m in 2021.
Operating profit in the range of EUR20m - EUR25m vs EUR11.1m 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.
About Cosmo
Cosmo is a pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders, to improve endoscopy quality measures through aiding the detection of colonic lesions and to treat selected dermatological conditions. Cosmo develops and manufactures products which are distributed globally including Lialda, Uceris/Cortiment and Winlevi. Cosmo has also developed medical devices for endoscopy and has a partnership with Medtronic for the global distribution of GI Genius which uses artificial intelligence to help detect potential signs of colon cancer. Cosmo has licensed Aemcolo to Red Hill Biopharma Ltd. for the US and has licensed Relafalk 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
E: hwinchester@cosmopharma.com
COSMO PHARMACEUTICALS N.V. 
