Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — Investor Presentation (June 2022)
51 slides from Cosmo Pharmaceuticals Nv's investor presentation, June 2022
Slide 1: Delivering Innovation + Improving Lives
DELIVERING INNOVATION + IMPROVING LIVES INVESTOR PRESENTATION JUNE 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 Pharmaceuticals | June 2022 3
Slide 4: 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 5: Overview
Founded Listed on Six Mkt cap (May 2022) since 2007 CHF Overview1 1997 COPN 923m Total employees Male Female Different nationalities 290 ∼ 45 focussing on AI 59% 41% 14 14% 27% S,G&A R&D 59% Production & Logistics 1as at December 2021 Cosmo Pharmaceuticals | June 2022 5
Slide 6: Our business model is based on 3 pillars
Our business model is based on 3 pillars to increase opportunities and I decrease risks + Development and manufacturing of Bear no cost Have a OWN PRODUCTS for a commercial lean and simple infrastructure cost base This enables Distributed through our selective Cosmo to STRONG PARTNERSHIPS Increase F
Slide 7: Overview of Approved Products and Partnerships
OVERVIEW OF APPROVED PRODUCTS AND PARTNERSHIPS Cosmo Pharmaceuticals | June 2022 7
Slide 8: Impressive track record: approved drug products distributed by partners
Impressive track record: 6 approved drug products distributed by partners one-of-a-kind to provide solutions to unmet needs PRODUCT BRAND NAMES APPROVED DRUG SUBSTANCE AND INDICATION 01 Lialda®/Mezavant®/Mesavancol® US, JP, EU, Mesalamine with MMX® technology, once-daily oral tablet ROW formulation
Slide 9: Impressive track record: approved medical devices distributed by partners
Impressive track record: 3 approved medical devices distributed by partners one-of-a-kind to provide solutions to unmet needs PRODUCT BRAND NAMES APPROVED DRUG SUBSTANCE AND INDICATION 01 GI Genius™ US, EU, CAN First artificial intelligence (AI) based medical device for the real time detection of le
Slide 10: 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 | June 2022 10
Slide 11: Established strong partnerships: products
Established strong partnerships: products Aemcolo (US) | RelaFalk (EU) (acquired June 2022) LuMeBlue (EU, China) ByFavo (US) Cosmo Pharmaceuticals | June 2022 11
Slide 12: A Solid & Growing Company
A SOLID & GROWING COMPANY Cosmo Pharmaceuticals | June 2022 12
Slide 13: 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 14: Delivering growth in revenue, EBITDA, operating profit & profit after tax
Delivering 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 15,0
Slide 15: Cosmo EBITDA as a percentage of revenue to grow further
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 | June 2022 15
Slide 16: Strong financial position as of 2021
Strong financial position as of 2021 €222.2m €46.4m Cash and fund investments Acacia, Red Hill & Paion stakes €53.1m €25m €348.4m Loan to Acacia pharma Total Treasury Shares Eagle Pharmaceuticals has acquired Acacia Pharma on June 2022 Cosmo Pharmaceuticals | June 2022 16
Slide 17: Legacy Business Providing Strong Foundation
LEGACY BUSINESS PROVIDING STRONG FOUNDATION Cosmo Pharmaceuticals | June 2022 17
Slide 18: Lialda/Mezavant/Mesavancol (Mesalamine) with MMX technology
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 18 Cosmo Pharmaceuticals | June 2022
Slide 19: Uceris/Cortiment (Budesonide) with MMX technology
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 20: Drug development and manufacturing on behalf of third parties
Drug development and manufacturing on behalf of third parties 14 €12.7m 12 €10.8m 10 8 6 4 2 0 2020 2021 20 Cosmo Pharmaceuticals | June 2022
Slide 21: Revenue breakdown 2021
Revenue breakdown 2021 Other 7% Third Party Manufactuing 16.4% Legacy Business 54% Approved Products 22.6% Cosmo Pharmaceuticals | June 2022 21
Slide 22: Legacy business growing, new products starting to generate revenue
Legacy business growing and continuing to deliver, new products starting to generate revenue €m 0,1 4,1 Cortiment; Aemcolo/Relafalk; Eleview; 60,0 6,0% 2,1% 3,1% 4,1 4,5 3,4 Winlevi Uceris; 5,2% 0,7 7,1 0,7 Lumeblue 50,0 3,4 2,0 1,4 Other GI Genius; 10,9% 6,7 3,9 GI Genius 40,0 4,9 3,4 Other; 7,0% E
Slide 23: New Products Tackling Large Markets
NEW PRODUCTS TACKLING LARGE MARKETS Cosmo Pharmaceuticals | June 2022 23
Slide 24: 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 25: 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 26: 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 9238 unique prescribers Since launch over 213,000 TRx hav
Slide 27: GI Genius AI-enhanced endoscopy aid device
GI GENIUS™ AI-enhanced endoscopy aid device Cosmo Pharmaceuticals | June 2022 27
Slide 28: 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™ was approved by the FDA 52.2% Assist clinicians in the detection of lesions in real time during colonoscopy HIGH ADENOMA DETECTION RATE CA
Slide 29: 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 30: Douglas K. Rex, President, American Society for Gastrointestinal Endoscopy
Douglas K. Rex, M.D.,MASGE, President, American Society for Gastrointestinal Endoscopy Click to see the video Cosmo Pharmaceuticals | May 2022 21
Slide 31: 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 32: Introducing GI Genius intelligent endoscopy module
Introducing GI GENIUS™ intelligent endoscopy module Click to see the video Cosmo Pharmaceuticals | May 2022 23
Slide 33: GI Genius: Compatible with all major brands of 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 >
Slide 34: GI Genius: Expanding our AI franchise
GI GENIUS™ Subsequent to the interest shown by the market Expanding our AI franchise by investing in developing 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 35: GI Genius: Switzerland and Germany
GI GENIUS™: Switzerland and Germany Sites who have already installed GI Genius™ Germany German sites Switzerland Universitätsklinikum Schleswig- Lübeck 15 5 Universitätsklinikum Schleswig- Kiel Barmherzige Brüder gemeinnützige Regensburg CaritasKlinikum Saarbrücken Saarbrücken Gastroenterologie am E
Slide 36: GI Genius: Italy
GI GENIUS™: Italy Sites who have already installed GI Genius™ Italy 9 Italian sites Ecas Spa Casa Di Cura Fornaca Torino Dimi - Università di Genova Genova Ospedale Fatebenefratelli Milano SNUPI - Sostegno Nuove Patologie Parma Presidio Ospedaliero Ariano Irpino Avellino Spedali Civili Di Brescia Br
Slide 37: Approved Products Starting to Perform
APPROVED PRODUCTS STARTING TO PERFORM Cosmo Pharmaceuticals | June 2022 37
Slide 38: LuMeBlue: Commercial & 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 39: Aemcolo/RelaFalk: Commercial & development update
Aemcolo®/RelaFalk® (Rifamycin SV MMX): 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 vi
Slide 40: Byfavo: Commercial & development update
Byfavo® (Remimazolam): Commercial & development update A novel sedation agent for procedural sedation Byfavo® (remimazolam) is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic for procedural sedation In-licensed from Paion in June 2016, was sub-licensed by Cosmo to Acacia Pharma
Slide 41: Eleview
Eleview® Approved medical device which enables the safer and faster removal of colonic lesions A submucosal injectable liquid composition, developed and patented by Cosmo The objective is to allow endoscopists with a faster and less risky excision of adenomas or polyps during endoscopy Approved in t
Slide 42: A Rich Development Pipeline
A RICH DEVELOPMENT PIPELINE Cosmo Pharmaceuticals | June 2022 42
Slide 43: 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 44: 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 45: 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 46: 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 47: CB-01-33 (Colesevelam): For the treatment of 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 48: Key Priorities & Outlook 2022
KEY PRIORITIES & OUTLOOK 2022 Cosmo Pharmaceuticals | June 2022 48
Slide 49: 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 50: 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 products revenues €20m – €25m Cosmo Pharmaceuticals | June 2022 50
Slide 51: Thank you
THANK YOU Mr. Alessandro Della Chà, CEO adellacha@cosmopharma.com Mr. Niall Donnelly, CFO Cosmo Pharmaceuticals N.V. ndonnelly@cosmopharma.com 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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