Cosmo Pharmaceuticals NV · SIX:COPN
Cosmo Pharmaceuticals NV — Investor Presentation (May 2022)
43 slides from Cosmo Pharmaceuticals NV's investor presentation, May 2022
Slide 1: Delivering Innovation + Improving Lives
DELIVERING INNOVATION + IMPROVING LIVES INVESTOR PRESENTATION MAY 2022
Slide 2: Safe harbour
Safe harbour This presentation may include forward-looking statements Cosmo’s business and risks following any potential for that are based on our management’s beliefs and delays in the development programs for its products. No assumptions and on information currently available to our assurance can
Slide 3: Who we are
Who we are Cosmo is a pharmaceutical company which develops and manufactures innovative products in the fields of: Gastroenterology HealthTech Dermatology Gastrointestinal (GI) diseases Artificial Intelligence applications in endoscopy Inflammatory Bowel Disease (IBD) Colorectal cancer (CRC) Colon –
Slide 4: Our business model
Our business model Innovative business model, based on three main pillars, with the aim to increase opportunities and decrease risks 01 DEVELOPMENT AND MANUFACTURING OF Maintain a OWN PRODUCTS Increase lean cost diversification 02 ALL PRODUCTS ARE structure DISTRIBUTED THROUGH This enables OUR SELEC
Slide 5: Overview: COPN, CHF 1.15bn market cap
Founded Listed on Six Mkt cap since 2007 CHF Overview1 1997 COPN 1.15bn Total employees Male Female Different nationalities 45 focussing on AI 290 59% 41% 14 14% 27% S,G&A R&D 59% Production & Logistics 1as at December, 2021 Cosmo Pharmaceuticals | May 2022 5
Slide 6: Impressive track record: drug products
Impressive track record: drug products one-of-a-kind to provide solutions to unmet needs 6 approved drugs: all distributed by our partners PRODUCT BRAND NAMES APPROVED DRUG SUBSTANCE AND INDICATION 01 Lialda®/Mezavant®/Mesavancol® US, JP, EU, Mesalamine with MMX® technology, once-daily oral tablet R
Slide 7: Impressive track record: medical devices
Impressive track record: medical devices one-of-a-kind to provide solutions to unmet needs 3 approved devices: all distributed by our partners PRODUCT BRAND NAMES APPROVED DRUG SUBSTANCE AND INDICATION 01 G.I. Genius™ US, EU, CAN First artificial intelligence (AI) based medical device for the real t
Slide 8: Established strong partnerships: products and medical devices
Established strong partnerships: products and medical devices Lialda (US/Japan) | Mezavant (EU/ROW) Winlevi (US) Uceris (US) | Cortiment (EU/ROW) Mesavancol (IT) G.I. Genius (US, EU, CAN) Eleview (US, EU, CAN) Cosmo Pharmaceuticals | May 2022 8
Slide 9: Established strong partnerships: products
Established strong partnerships: products Aemcolo (US) | RelaFalk (EU) LuMeBlue (EU, China) ByFavo (US) Cosmo Pharmaceuticals | May 2022 9
Slide 10: 2021 Key events
2021 Key events Announced successful outcome of phase DETECT study showed AI assistance II proof of concept (POC) clinical trial of using GI Genius™ reduces missed polyp Rifamycin SV MMX® 600mg in irritable rate by over 50% on initial colonoscopy. bowel syndrome with diarrhoea (IBS-D) Signed licence
Slide 11: EBITDA as a percentage of revenue to grow based on 2022 guidance
Cosmo EBITDA as a percentage of revenue to grow even further based on 2022 guidance €65.1m 70,0 €60.9m 60,0 50,0 40,0 30,0 20,0 28.4% 21.2% 10,0 €18.5m €12.9m - 2020 2021 EBITDA Revenue Cosmo Pharmaceuticals | May 2022 11
Slide 12: Legacy products on the market
LEGACY PRODUCTS ON THE MARKET Cosmo Pharmaceuticals | May 2022 12
Slide 13: Lialda/Mezavant/Mesavancol (Mesalamine)
Lialda® /Mezavant® /Mesavancol® (Mesalamine): With MMX® technology, for the treatment of mild to moderate Ulcerative Colitis (UC) TOTAL MESALAMINE CUMULATIVE TABLETS SUPPLIED1 3,289,777,874 TOTAL 2021 REVENUE €27.8M 1as at December 2021 Cosmo Pharmaceuticals | May 2022 13
Slide 14: Uceris/Cortiment (Budesonide)
Uceris® /Cortiment®(Budesonide): With MMX® technology, for the treatment of mild to moderate Ulcerative Colitis TOTAL BUDESONIDE CUMULATIVE TABLETS SUPPLIED1 80,627,882 TOTAL 2021 REVENUE1 €7.3M Potential to receive commercial milestones €57M ( €9M in 2022) Cortiment® Japan: 2nd largest IBD marke
Slide 15: New products on the market
NEW PRODUCTS ON THE MARKET Cosmo Pharmaceuticals | May 2022 15
Slide 16: Winlevi: first new mechanism of action in acne in 40 years
WINLEVI®: First new mechanism of action in acne launched in 40 years Approved for the topical $45 million upfront payment, will treatment of acne in patients 12 receive high double-digit royalties; years of age and older2 potential to receive up to $190 million in commercial milestones Tackles the a
Slide 17: Acne is the most prevalent skin condition in the US
Acne is the most prevalent skin condition in the US Yet the last new mechanism of action approved by the FDA was almost 40 years ago1,2 50 $5 Million sufferers in US3 Billion US gross market4 24 70% Million prescriptions4 Total Prescriptions written in the Dermatology Office4 1Thielitz A, Gollnick H
Slide 18: Winlevi: rapid TRx uptake
WINLEVI® : Rapid TRx uptake, one of the most successful launches in the topical acne space in the last 15 years TRx comparison of acne brand launches in first 5 months post launch Winlevi is the #1 most prescribed branded topical acne product 8525 unique prescribers Since launch 175,500 TRx have bee
Slide 19: GI Genius: Leading the AI race in GI
GI GENIUS™: Leading the AI race in GI The first-to-market computer-aided polyp detection system, powered by artificial intelligence (AI) In April 2021 GI Genius™ Assist clinicians in the detection of was approved by the FDA lesions in real time during colonoscopy HIGH ADENOMA DETECTION RATE CAN SIGN
Slide 20: GI Genius: Global AI partnership with Medtronic
GI GENIUS™: Global AI partnership with Medtronic Approved in the US, EU, Canada, Australia and selected markets in Asia and the Middle East Extensive marketing campaign by Medtronic underway https://www.medtronic.com/us-en/c/digestive-gastrointestinal/gi-genius.html https://www.medtronic.com/covidie
Slide 21: Douglas K. Rex video
Douglas K. Rex, M.D.,MASGE, President, American Society for Gastrointestinal Endoscopy Click to see the video Cosmo Pharmaceuticals | May 2022 21
Slide 22: Artificial intelligence aids doctors during colonoscopy screening
Artificial intelligence aids doctors during colonoscopy screening Click to see the video Cosmo Pharmaceuticals | May 2022 22
Slide 23: Introducing GI Genius intelligent endoscopy module
Introducing GI GENIUS™ intelligent endoscopy module Click to see the video Cosmo Pharmaceuticals | May 2022 23
Slide 24: GI Genius: compatible with all major endoscopic equipment
GI GENIUS™: Compatible with all major brands of endoscopic equipment World market >60m Detect the undetected annual colonoscopies GI Genius™ Intelligent Endoscopy US Module. Powered by artificial intelligence to help detect early >19m and treat early annual colonoscopies US Market potential 30,000 E
Slide 25: GI Genius: expanding our AI franchise
GI GENIUS™ Subsequent to the interest Expanding our AI franchise by investing in developing shown by the market new features and products 3,000 Among the top US hospitals who have already installed devices ordered by GI Genius™ Medtronic Beth Israel Stanford Cornell New York RUSH MD Anderson, (BIDMC
Slide 26: GI Genius: Switzerland and Germany
GI GENIUS™: Switzerland and Germany Sites who have already installed GI Genius™ Germany German sites Switzerland Universitätsklinikum Schleswig- Lübeck Universitätsklinikum Schleswig- Kiel 15 Barmherzige Brüder gemeinnützige CaritasKlinikum Saarbrücken Regensburg Saarbrücken 5 Gastroenterologie am E
Slide 27: Other products on the market
OTHER PRODUCTS ON THE MARKET Cosmo Pharmaceuticals | May 2022 27
Slide 28: LuMeBlue: commercial and development update
LuMeBlue® (Methylene Blue MMX®): Commercial & development update First drug to detect lesions during colonoscopy 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 L
Slide 29: Aemcolo: commercial and development update
Aemcolo® (Rifamycin): Commercial & development update Antibiotic for treatment of colonic infections • Excellent safety profile, both in toxicology and in clinical studies • Together with our licensees, we are commencing discussions with the U.S. and EU regulatory agencies with a view to starting th
Slide 30: Research and development pipeline
RESEARCH AND DEVELOPMENT PIPELINE Cosmo Pharmaceuticals | May 2022 30
Slide 31: Development pipeline
Development pipeline Product Indication Preclinical PH I PH II PH III Breezula® (Clascoterone solution) Androgenetic alopecia (AGA) Lesion detection during colonoscopy APPROVED BY FDA, ADDITIONAL FEATURES UNDER DEVELOPMENT GI Genius™ (US registration) Methylene Blue MMX® Lesion detection during colo
Slide 32: Breezula: potential new topical treatment for AGA
Breezula® (Clascoterone solution): Potential new topical treatment for AGA First drug with a new mechanism of action for the treatment of AGA in over two decades, if approved by FDA Phase 2 dose ranging study in males successful and most effective dose identified at 7.5% BID Expect to begin the Phas
Slide 33: CB-03-10: overview and development update
CB-03-10: Overview and development update CB-03-10 was selected from a compound library owned by Cosmo Pharmaceuticals Several Cosmo Pharmaceuticals compounds, derived from Cortexolone, were screened as potential treatment for diseases dependent on the Androgen receptor inhibition CB-03-01 (Clascote
Slide 34: CB-03-10: for the treatment of solid tumors
CB-03-10 (Cortexolone 17α-valerate-21-propionate): For the treatment of solid tumors • CB-03-10 is a highly potent AR1 and GR2 antagonist with impressive anti-tumor activity • Potential for first- and second-line therapy in Pancreatic and Colon cancers • Regulatory Toxicology shows oral dosing is sa
Slide 35: CB-01-33 (Colesevelam): for bile acid diarrhea
CB-01-33 (Colesevelam): For the treatment of bile acid diarrhea • Bile Acid Diarrhea (BAD) is reported in about 25%-33% of patients presenting with chronic diarrhea. Based on this data, BAD is estimated to affect approximately 1% of the population • Colesevelam is a bile acid sequestrant and was app
Slide 36: 2021 Financial review
2021 FINANCIAL REVIEW Cosmo Pharmaceuticals | May 2022 36
Slide 37: Growth in revenue, EBITDA and operating profit
Growth in revenue, EBITDA and operating profit, delivering positive cashflow from operations 2022 financial outlook1 FY21 Revenue Profit after tax €65.1m + 6.9% €21.7m (2020: €7.9m Loss after tax) FY21 EBITDA FY21 Net cashflow from operations €18.5m + 42.7% €12.6m (2020: €13.0m) FY21 Operating profi
Slide 38: FY21: delivered growth in revenue, EBITDA, operating profit and profit after tax
FY21: Delivered growth in revenue, EBITDA, operating profit & profit after tax Revenue Operating Profit\(Loss) 11,1 70,0 65,1 11,0 62,5 60,9 6,9 60,0 6,0 50,0 1,0 40,0 2019 2020 2021 30,0 (4,0) 20,0 (9,0) 10,0 2019 2020 2021 (14,0) (12,3) EBITDA Profit\(Loss) after Tax 18,5 25,0 21,7 20,0 16,0 12,9
Slide 39: Legacy products continue to deliver, new products generate revenue
Legacy products continue to deliver, new products starting to generate revenue €m 0,1 4,1 60,0 Cortiment; 6,0% Aemcolo/Relafalk; 4,1 4,5 2,1% Eleview; 3,1% 3,4 Uceris; 5,2% 0,7 7,1 0,7 50,0 3,4 2,0 1,4 Winlevi GI Genius; 10,9% 6,7 3,9 Lumeblue 40,0 4,9 3,4 Other Other; 7,0% GI Genius Eleview Lumeblu
Slide 40: Key priorities and outlook
KEY PRIORITIES & OUTLOOK 2022 Cosmo Pharmaceuticals | May 2022 40
Slide 41: Key priorities for 2022 and beyond
Key priorities for 2022 and beyond 01 02 ENSURE THAT GI GENIUS™ PERFORMS ENSURE THAT WINLEVI PERFORMS IN IN THE US MARKET BY PROVIDING THE US MARKET BY PROVIDING SUN MEDTRONIC WITH ALL THE WITH ALL THE NECESSARY SUPPLY NECESSARY SUPPLY AND SUPPORT AND SUPPORT 03 04 INITIATE BREEZULA PHASE III INITIA
Slide 42: 2022 financial outlook
2022 financial outlook Revenue and operating profit growth into 2022 Total Revenues driven by continued €90m – €100m performance of legacy products and increase in Operating Profit new product revenues €20m – €25m Cosmo Pharmaceuticals | May 2022 42
Slide 43: Thank you
THANK YOU Mr. Alessandro Della Chà, CEO adellacha@cosmopharma.com Mr. Niall Donnelly, CFO ndonnelly@cosmopharma.com Cosmo Pharmaceuticals N.V. Riverside II Sir John Rogerson’s Quay Ms. Hazel Winchester, Head of IR Dublin 2, Ireland hwinchester@cosmopharma.com investor.relations@cosmopharma.com
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