Corporate Presentation - June 2021 - Cosmo Pharmaceuticals
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Corporate Presentation
June 2021
Cosmo Pharmaceuticals Corporate Presentation June 2021
SAFE HARBOUR This presentation may include forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. The inclusion of forward-looking statements should not be regarded as a representation by Cosmo that any of its plans will be achieved. Actual results may differ materially from those set forth in this presentation due to the risks and uncertainties inherent in Cosmo’s ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialization of its product candidates and reduce costs (including staff costs), the market for drugs to treat IBD diseases, Cosmo’s anticipated future revenues, capital expenditures and financial resources and other similar statements, may be “forward-looking” and as such involve risks and uncertainties and risks related to the collaboration between Partners and Cosmo, including the potential for delays in the development programs for its products. No assurance can be given that the results anticipated in such forward-looking statements will occur. Actual events or results may differ materially from Cosmo’s expectations due to factors which include, but are not limited to, increased competition, Cosmo’s ability to finance expansion plans, the results of Cosmo’s research and development activities, the success of Cosmo’s products, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Cosmo assumes no responsibility to update forward-looking statements or to adapt them to future events or developments. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Cosmo undertakes no obligation to revise or update this presentation. Cosmo Pharmaceuticals 2 Corporate Presentation June 2021
Overview Cosmo Pharmaceuticals 3 Corporate Presentation June 2021
COSMO OVERVIEW
Two marketed medtech Three marketed Market Cap1
products therapeutics CHF 1,308.3 million
GI Genius™ Lialda® /Mezavant® Net Cash1
Uceris®/Cortiment® €207.9 million
Aemcolo®/RelaFalk®
One approved
therapeutic
(EU)
Rich development
pipeline
1 as at 31 May 2021
Cosmo Pharmaceuticals 4 Corporate Presentation June 2021COSMO’S OWN PRODUCTS DEVELOPMENT PIPELINE
PRODUCT INDICATION PH I PH II PH III
Aemcolo® IBS-D
Acute Uncomplicated
Diverticulitis*
Small Intestine BacteriaI
Overgrowth (SIBO)*
Minimal Hepatic
Encephalopathy*
Byfavo™ Procedural Sedation APPROVED
Lesion detection during
Methylene Blue MMX®
colonoscopy - European Union APPROVED
Lesion detection during
Methylene Blue MMX®
colonoscopy – U.S.
Oral AR antagonist against solid
CB-03-10
tumors
Lesion detection during
GI-Genius™
colonoscopy (US registration) APPROVED
* Investigator Initiated Studies
Cosmo Pharmaceuticals 5 Corporate Presentation June 2021COSMO’S STAKES IN OTHER COMPANIES AS A RESULT OF PARTNERSHIPS AND SPIN-OFFS
• As at 31st of May 2021 the market value of our stakes in other companies, cash, loans, investments and treasury
shares was €614.0 million.
€M 31 May 2021
Shareholding in Cassiopea 223.3
Shareholding in Acacia Pharma Group plc 45.1
Shareholding in RedHill Biopharma ltd. 41.0
Shareholding in PAION AG 9.0
Other investments 8.1
Loan to Acacia Pharma Group plc 25.0
Treasury shares 54.6
Cash, bonds and fund investments 207.9
Total 614.0
Cosmo Pharmaceuticals 6 Corporate Presentation June 2021FINANCIAL HIGHLIGHTS 2020
Revenue Operating profit Cash, bonds and fund
€60.9m €6.9m investments
2019: €62.5m 2019: Operating Loss €12.3m
€212.9m
2019: €268.2m
Manufacturing of own products and related services
Loss after tax
€32.8m €7.9m
Equity stakes in other
2019: €28.7m
2019: Loss after tax €24.5m companies
Manufacturing of generic products and related services €339.2m
€10.8m Cash inflow from operating 2019: €224.7m
2019: €9.6m activities Treasury shares and loans
Royalties €10.1m €72.5m
€8.5m 2019: Cash outflow from operating activities €17.6m
2019: €36.9m
2019: €10.4m
Equity
Licence fees, up-front fees and milestones
€7.4m €400.1m
2019: €393.7m
2019: €12.5m
Cosmo Pharmaceuticals 7 Corporate Presentation June 2021COMMERCIALISATION THOUGH PARTNERSHIPS Cosmo Pharmaceuticals 8 Corporate Presentation June 2021
COMMERCIALISATION THOUGH PARTNERSHIPS Cosmo Pharmaceuticals 9 Corporate Presentation June 2021
Recent Milestones Cosmo Pharmaceuticals 10 Corporate Presentation June 2021
RECENT MILESTONES • FDA approval of GI Genius™, April 2021 • EU rights (plus Switzerland, UK, EEA countries, Russia and Mexico) for Lumeblue™ (Methylene Blue MMX®) licensed to Alfasigma S.p.A., February 2021 • Successful outcome of Rifamycin 600mg phase II trial in IBS-D announced, January 2021 • License of Lumeblue™ (Methylene Blue MMX®) China rights to China Medical System Holdings Ltd, December 2020 • Cosmo’s associate Cassiopea receives FDA approval for Winlevi® (clascoterone cream 1%) for the treatment of acne, August 2020 • EU approval of Methylene Blue MMX®, August 2020 • Byfavo™ receives FDA approval for procedural sedation, July 2020 • ByFavo™ US rights licensed to Acacia Pharma and acquisition of equity stake in Acacia, January 2020 • Aemcolo® US rights licensed to RedHill Biopharma and acquisition of equity stake in RedHill, October 2019 • Worldwide A.I. distribution deal with Medtronic, April 2019 Cosmo Pharmaceuticals 11 Corporate Presentation June 2021
Products Update Cosmo Pharmaceuticals 12 Corporate Presentation June 2021
PRODUCTS UPDATE
GI Genius™
• In April 2021, GI Genius™ was approved by the FDA.
• The FDA assessed the safety and effectiveness of the GI Genius through a multicenter, prospective, randomized,
controlled study in Italy with 700 subjects 40-80 years old who were undergoing a colonoscopy for colorectal cancer
screening, surveillance, positive results from a previous fecal immunochemical (fecal occult blood) test for blood in
the stool or gastrointestinal symptoms of possible colorectal cancer.
• The primary endpoint of the study compared how often colonoscopy plus GI Genius identified a patient with at
least one lab-confirmed adenoma (precancerous tumor) or carcinoma (cancerous tumor).
• The study demonstrated that GI Genius™ can help to increased ADR.
14.4% 30% 46%
increase in relative increase increase in
absolute ADR1 in ADR1 relative APC1
1. Repici A, Badalamenti M, Maselli R, et al. Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Gastroenterology. 2020; 159:512–
520.e7.
Cosmo Pharmaceuticals 13 Corporate Presentation June 2021PRODUCTS UPDATE GI Genius™ - The global AI partnership with Medtronic • Now Approved in the US, Europe, Australia, Israel and the United Arab Emirates • Extensive marketing campaign by Medtronic underway • https://www.medtronic.com/us-en/c/digestive-gastrointestinal/gi-genius.html Cosmo Pharmaceuticals 14 Corporate Presentation June 2021
PRODUCTS UPDATE GI Genius™ Cosmo Pharmaceuticals 15 Corporate Presentation June 2021
PRODUCTS UPDATE GI Genius™ • In April 2021, GI Genius™ was launched by Medtronic in the US • The US market has approximately 32,000 endoscopy towers and GI Genius™ is compatible with all makes • The device is initially being marketed through an agreement lasting 3 years and providing for yearly subscription fee averaging > $ 40,000 Cosmo Pharmaceuticals 16 Corporate Presentation June 2021
PRODUCTS UPDATE Methylene Blue MMX® • In August 2020, the European Commission approved Methylene Blue MMX® for the visualization of colorectal lesions during colonoscopies • In December 2020, we licensed the Chinese rights for Lumeblue™ to China Medical System Holdings Ltd. (“CMS”) (SEHK: 867) • In February 2021, we licensed the EU rights (plus Switzerland, UK, EEA countries, Russia and Mexico) for Lumeblue™ to Alfasigma SpA • We are progressing our discussions with the FDA to prepare for the requested second phase III trial. We have now submitted the complete protocol and statistical analysis plan for final comment by the FDA • Subject to reaching agreement with the FDA on the final protocol, the trial is expected to start in 2021, ongoing pandemic permitting Cosmo Pharmaceuticals 17 Corporate Presentation June 2021
PRODUCTS UPDATE
Aemcolo™
• In January 2021, we announced the successful outcome of our Phase II Proof of Concept (POC) clinical trial of
Rifamycin-MMX 600mg in Irritable Bowel Syndrome with Diarrhea (IBS-D). Together with our licensees, we will
immediately commence discussions with the U.S. and EU regulatory agencies with a view to starting the Phase III
clinical studies required for marketing authorisation as soon as possible.
• Further clinical development with Investigator Initiated Studies:
Minimal Hepatic Encephalopathy
• IND and study protocol accepted by FDA
• Study underway
Small Intestine Bacterial Overgrowth (SIBO)
• IND approved
• Trial to start asap
Acute Uncomplicated Diverticulitis
• Protocol being finalized
Cosmo Pharmaceuticals 18 Corporate Presentation June 20212021 Key Priorities & Outlook Cosmo Pharmaceuticals 19 Corporate Presentation June 2021
KEY PRIORITIES FOR 2021 • Help Medtronic to maximise GI Genius™ sales • Finalize Cassiopea’s strategic deal to launch Winlevi® • Commence the Methylene Blue MMX® confirmatory phase III trial required for US approval • Together with our licensees RedHill and Dr. Falk, commence discussions with the US and EU regulatory agencies to start the Aemcolo™ phase III clinical studies • Complete the replenishment of our product pipeline and announce details • All milestones potentially influenced by the pandemic Cosmo Pharmaceuticals 20 Corporate Presentation June 2021
2021 GUIDANCE
• The coronavirus pandemic will likely continue to impact Aemcolo™ and Eleview® sales and delay our clinical trials
• Guidance is based on obtaining FDA approval for GI Genius™ in H1 2021 and assumes an increase in costs associated
with the deployment of GI Genius machines to Medtronic and into the market
- Revenue in the range of €60m - €64m
- Total expenses in the range of €57m - €59m (of which ESOP is €5.9m and Depreciation & Amortisation €6.2m)
- Operating profit in the range of €3m - €5m
• This guidance for operating profit does not take into account the outcome of any potential Cassiopea transaction on the
overall 2021 financial result
Cosmo Pharmaceuticals 21 Corporate Presentation June 2021COSMO AS SEEN BY EQUITY ANALYSTS
• Analyst – Peter Welford • Analyst – Barbora Blaha
• BUY Rating • OUTPERFORM Rating
• 12 month price target CHF 120 • 12 month price target CHF 95
• Analyst – Paul Verbraeken
• Analyst – Bob Pooler
• BUY Rating • Risk Adjusted NPV per share CHF 134
• 12 month price target CHF 110
Cosmo Pharmaceuticals 22 Corporate Presentation June 2021Thank You Cosmo Pharmaceuticals 23 Corporate Presentation June 2021
Cosmo Pharmaceuticals NV Riverside II Sir John Rogerson’s Quay Dublin 2, Ireland media@cosmopharma.com Mr. Alessandro Della Cha, CEO adellacha@cosmopharma.com Mr. Niall Donnelly, CFO ndonnelly@cosmopharma.com Cosmo Pharmaceuticals 24 Corporate Presentation June 2021
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