Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — FY2021 Earnings Presentation
44 slides from Cosmo Pharmaceuticals Nv's earnings presentation, Mar 23, 2022
Slide 1: Delivering Innovation + Improving Lives: Full Year Results 2021
DELIVERING INNOVATION + IMPROVING LIVES FULL YEAR RESULTS 2021 MARCH 23, 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: Agenda
01 Introduction Alessandro Della Chà, CEO 02 2021 Key Events & Products Update Alessandro Della Chà, CEO 03 2021 Financial Review Niall Donnelly, CFO Cosmo Pharmaceuticals | Full Year Results 2021 3
Slide 4: Introduction
INTRODUCTION ALESSANDRO DELLA CHÀ, CEO Cosmo Pharmaceuticals | Full Year Results 2021 4
Slide 5: 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 6: 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 7: Overview
Founded Listed on Six Mkt cap since 2007 CHF Overview1 1997 COPN 1.15bn Total employees Male Female Different nationalities 290 59% 41% 14 14% 27% S,G&A R&D 59% Production & Logistics 1as at December, 2021 Cosmo Pharmaceuticals | Full Year Results 2021 7
Slide 8: 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 9: 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 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 | Full Year Results 2021 10
Slide 11: Established strong partnerships: products
Established strong partnerships: products Aemcolo (US) | RelaFalk (EU) LuMeBlue (EU, China) ByFavo (US) Cosmo Pharmaceuticals | Full Year Results 2021 11
Slide 12: 2021 Key Events and Product Update
2021 KEY EVENTS AND PRODUCT UPDATE ALESSANDRO DELLA CHÀ, CEO Cosmo Pharmaceuticals | Full Year Results 2021 12
Slide 13: Key events
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 and
Slide 14: Cosmo EBITDA as a percentage of revenue
Cosmo EBITDA as a percentage of revenue €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 | Full Year Results 2021 14
Slide 15: Lialda/Mezavant/Mesavancol (Mesalamine)
Lialda® /Mezavant® /Mesavancol® (Mesalamine): With MMX® technology, for the treatment of mild Ulcerative Colitis (UC) TOTAL MESALAMINE CUMULATIVE TABLETS SUPPLIED1 3,289,777,874 TOTAL 2021 REVENUE €27.8M 1as at December 2021 Cosmo Pharmaceuticals | Full Year Results 2021 15
Slide 16: Uceris/Cortiment (Budesonide)
Uceris® /Cortiment®(Budesonide): With MMX® technology, for the treatment of severe Ulcerative Colitis TOTAL BUDESONIDE CUMULATIVE TABLETS SUPPLIED1 80,627,882 TOTAL 2021 REVENUE €7.3M 1as at December 2021 Cosmo Pharmaceuticals | Full Year Results 2021 16
Slide 17: 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 18: 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 market4 24 70% Million prescriptions4 Total Prescriptions written in the Dermatology Office4 1Thielitz A, Gollnick H. Am J
Slide 19: Winlevi: rapid TRx uptake
WINLEVI® : Rapid TRx uptake, one of the most successful launches in the topical acne space in the last 15 years 35,000 30,000 25,000 TRx 20,000 comparison of acne brand launches 15,000 in first 4 months post launch 10,000 5,000 - Month 1 Month 2 Month 3 Month 4 Epiduo FABIOR Aczone 7.5% Amzeeq Aklie
Slide 20: 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 21: 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 22: Introducing GI Genius intelligent endoscopy module
Introducing GI GENIUS™ intelligent endoscopy module Play Video ONE Cosmo Pharmaceuticals | Full Year Results 2021 22
Slide 23: Douglas K. Rex, President, ASGE
Douglas K. Rex, M.D.,MASGE, President, American Society for Gastrointestinal Endoscopy Play Video TWO Cosmo Pharmaceuticals | Full Year Results 2021 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 >USD 1bn
Slide 25: GI Genius: expanding our AI franchise
GI GENIUS™ Subsequent Expanding our AI franchise by investing in to the interest shown by the 3,000 developing new features and products market devices ordered by Medtronic Among the top US hospitals who have already installed GI Genius™ Delivered to Medtronic for placement as of today 1,062 458 MD
Slide 26: 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 27: Aemcolo: Commercial & 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 28: 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 29: 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 30: 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 31: 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 AR and GR antagonist with impressive anti-tumor activity • Potential for first- and second-line therapy in Pancreatic and Colon cancers • Regulatory Toxicology shows oral dosing is safe
Slide 32: CB-01-33 (Colesevelam): 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 33: 2021 Financial Review
2021 FINANCIAL REVIEW NIALL DONNELLY, CFO Cosmo Pharmaceuticals | Full Year Results 2021 33
Slide 34: 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 35: FY21: Delivered growth in revenue, EBITDA, operating profit & 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 36: Legacy products continue to deliver, new products starting to 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 0.7 7.1 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 37: Income statement
Income statement €m FY21 FY20 Change Revenue 65.1 60.9 4.2 Net operating expenses (54.0) (54.0) - Operating Profit 11.1 6.9 4.2 Net financial expenses (4.3) (8.9) 4.6 Share of result of associate 17.8 (4.9) 22.7 Loss of remeasurement to FV of pre-existing interest in acquiree (0.6) - (0.6) Profit/(l
Slide 38: Statement of financial position
Statement of financial position €m FY21 FY20 Change Property plant & equipment 30.5 29.3 1.2 Goodwill 24.0 1.4 22.6 Other intangible assets 372.7 26.6 346.1 Investment in associate - 136.1 (136.1) Financial assets 49.1 114.5 (65.4) Other non-current assets 53.4 35.3 18.1 Cash and cash equivalents &
Slide 39: Statement of financial position – continued
Statement of financial position – continued €m FY21 FY20 Change Interest bearing loans and borrowings 169.0 165.2 3.8 Deferred tax liabilities 99.7 6.3 93.4 Other non-current liabilities 3.0 2.7 0.3 Current liabilities 21.2 21.9 (0.7) Total liabilities 292.9 196.1 96.8 Total Equity 512.7 400.1 112.6
Slide 40: Cashflow
Cashflow €m FY21 FY20 Change Net cash flows from operating activities 12.6 13.0 (0.4) Capital expenditure (5.5) (4.1) (1.4) Capitalised development costs (3.0) (4.0) 1 Interest received 3.1 0.8 2.3 Net cash flow due to Cassiopea acquisition 26.0 - 26.0 Interest paid on convertible bonds (4.4) (4.4)
Slide 41: 2022 Priorities
2022 PRIORITIES ALESSANDRO DELLA CHÀ, CEO Cosmo Pharmaceuticals | Full Year Results 2021 41
Slide 42: 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 43: 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 | Full Year Results 2021 43
Slide 44: 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