Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — Investor Presentation (March 2022)
37 slides from Cosmo Pharmaceuticals Nv's investor presentation, March 2022
Slide 1: Delivering Innovation + Improving Lives
Delivering Innovation + Improving Lives Cosmo Pharmaceuticals Investor Presentation - March 2022
Slide 2: Safe Harbour
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 p
Slide 3: Executive Summary
Executive Summary Cosmo Pharmaceuticals 3 Investor Presentation - March 2022
Slide 4: Who We Are
WHO WE ARE Cosmo is a pharmaceutical company which develops and manufactures innovative products in the fields of: Gastroenterology Dermatology Gastrointestinal (GI) diseases • Acne • Inflammatory Bowel Disease (IBD) • Alopecia (Hair loss) • Irritable Bowel Syndrome - Diarrhea (IBS-D) • Colorectal c
Slide 5: 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 OWN Maintain a LEAN COST STRUCTURE PRODUCTS Increase DIVERSIFICATION 02 ALL PRODUCTS ARE DISTRIBUTED THROUGH OUR this enables SELEC
Slide 6: Overview
OVERVIEW1 Founded Listed on Six Mkt cap since 2007 CHF 1997 COPN 1.15bn 14% 27% 59% 41% 14 S,G&A R&D Male Female Different nationalities Total employees 290 59% Production & Logistics 1as at December, 2021 Cosmo Pharmaceuticals 6 Investor Presentation - March 2022
Slide 7: 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 8: 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 9: Established Strong Partnerships: Products and Medical Devices
E S TA B L I S H E D S T R O N G PA R T N E R S H I P S : P R O D U C T S A N D M E D I C A L D E V I C E S Winlevi G.I. Genius (US) (US,EU,CAN) Lialda / Mezavant / Mesavancol Eleview (US/Japan)(EU/ROW) (IT) (US, EU, CAN) Uceris / Cortiment (US) (EU/ROW) Cosmo Pharmaceuticals 9 Investor Presentation
Slide 10: Established Strong Partnerships: Products
E S TA B L I S H E D S T R O N G PA R T N E R S H I P S : P R O D U C T S Aemcolo/RelaFalk (US) (EU) LuMeBlue ByFavo (EU, China) (US) Cosmo Pharmaceuticals 10 Investor Presentation - March 2022
Slide 11: Legacy Products On The Market
Legacy Products On The Market Cosmo Pharmaceuticals 11 Investor Presentation - March 2022
Slide 12: Lialda/Mezavant/Mesavancol (Mesalamine)
L I A L D A ® / M E Z AVA N T ® / M E S AVA N C O L ® ( M E S A L A M I N E ) : with MMX® technology, for the treatment of mild Ulcerative Colitis (UC) TOTAL MESALAMINE CUMULATIVE TABLETS SUPPLIED1 3,289,777,874 TOTAL 2021 REVENUE2 €27.8M 1as at December 2021 2 preliminary unaudited results announce
Slide 13: Uceris/Cortiment (Budesonide)
U C E R I S ® / C O R T I M E N T ®( B U D E S O N I D E ) : with MMX® technology, for the treatment of severe Ulcerative Colitis TOTAL BUDESONIDE CUMULATIVE TABLETS SUPPLIED1 80,627,882 TOTAL 2021 REVENUE2 €7.3M 1as at December 2021 2 preliminary unaudited results announced 15 Feb. 2022 Cosmo Pharm
Slide 14: New Products On The Market
New Products On The Market Cosmo Pharmaceuticals 14 Investor Presentation - March 2022
Slide 15: Winlevi: First New Acne Product Launched in 40 Years
WINLEVI® FIRST NEW ACNE PRODUCT LAUNCHED IN 40 YEARS • Approved for the topical treatment of acne in patients 12 years of age and older² • Tackles the androgen hormone component of acne in both males & females² ³ • Launched in the US by Sun Pharma 1st Nov. 2021 • Rapid TRX uptake - One of the most s
Slide 16: Acne Is the Most Prevalent Skin Condition in the U.S.
A C N E I S T H E M O S T P R E VA L E N T S K I N C O N D I T I O N I N T H E U . S . . . Y E T THE LAST NEW MECHANISM OF ACTION APPROVED BY THE FDA WA S A L M O S T 4 0 Y E A R S A G O 1 , 2 50 $5 24 70% Million Billion US Million Total Prescriptions sufferers in US3 market4 prescriptions4 written
Slide 17: GI Genius: Leading the Race for AI in GI
GI GENIUS™: LEADING THE RACE FOR AI IN GI • The first-to-market computer-aided polyp detection system, powered by artificial intelligence (AI) • Assist clinicians in the detection of lesions in real time during colonoscopy • GI Genius increases ADR1 (adenoma detection rate) and decreases AMR2 (adeno
Slide 18: GI Genius: Global AI Partnership with Medtronic
G I G E N I U S ™ : G L O B A L A I PA R T N E R S H I P W I T H M E D T R O N I C • Approved in the US, EU, Canada, Australia, Israel, Singapore and the United Arab Emirates • Extensive marketing campaign by Medtronic underway https://www.medtronic.com/us-en/c/digestive-gastrointestinal/gi-genius.h
Slide 19: GI Genius
GI GENIUS™ Cosmo Pharmaceuticals 19 Investor Presentation - March 2022
Slide 20: GI Genius Compatible with All Major Brands of Endoscopic Equipment
G I G E N I U S ™ C O M PAT I B L E W I T H A L L M A J O R B R A N D S O F E N D O S C O P I C E Q U I P M E N T World market >30m annual colonoscopies US >19m annual colonoscopies DETECT THE UNDETECTED Market potential GI Genius™ Intelligent Endoscopy Module. >USD 1bn Powered by artificial intelli
Slide 21: GI Genius Update
G I G E N I U S ™ U P D AT E Subsequent to the interest shown • Expanding our AI franchise by investing in developing new features and by the market products • Among the top US hospitals who have already installed GI Genius™ 3,000 MD Anderson, Texas devices ordered Stanford University, Californi
Slide 22: Other Products On The Market & Development Update
Other Products On The Market & Development update Cosmo Pharmaceuticals 22 Investor Presentation - March 2022
Slide 23: Lumeblue (Methylene Blue MMX): Commercial & Development Update
L U M E B L U E ® ( M E T H Y L E N E B L U E M M X ® ) : C O M M E R C I A L & D E V E L O P M E N T U P D AT E FIRST DRUG TO DETECT LESIONS DURING COLONOSCOPIES • In August 2020, the European Commission approved Methylene Blue MMX for the visualization of colorectal lesions during colonoscopies •
Slide 24: Aemcolo (Rifamycin): Commercial & Development Update
A E M C O L O ® : ( R I FA M Y C I N ) : C O M M E R C I A L & D E V E L O P M E N T U P D AT E A N T I B I O T I C F O R T R E AT M E N T O F C O L O N I C I N F E C T I O N S W I T H O U T S I D E E F F E C T S • Excellent safety profile, both in toxicology and in clinical studies • Together with
Slide 25: R&D Pipeline Products Under Development
R&D Pipeline Products Under Development Cosmo Pharmaceuticals 25 Investor Presentation - March 2022
Slide 26: 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 colon
Slide 27: Clascoterone Solution 7.5%: Potential New Topical Treatment for AGA
C L A S C O T E R O N E S O L U T I O N 7 . 5 % : P O T E N T I A L N E W T O P I C A L T R E AT M E N T F O R A G A 7.5% Solution BID Baseline • 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 successfu
Slide 28: CB-03-10 Overview and Development Update
C B - 0 3 - 1 0 O V E R V I E W A N D D E V E L O P M E N T U P D AT E 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
Slide 29: CB-03-10 for the Treatment of Solid Tumors
C B - 0 3 - 1 0 ( C O R T E X O L O N E 1 7 Α - VA L E R AT E - 2 1 - P R O P I O N AT E ) F O R T H E T R E AT M E N T O F S O L I D T U M O R S • 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 Co
Slide 30: CB-01-25 (Rifamycin) Enema for Acute Pouchitis
C B - 0 1 - 2 5 ( R I FA M Y C I N ) E N E M A F O R R E C TA L A D M I N I S T R AT I O N F O R T H E T R E AT M E N T O F A C U T E P O U C H I T I S • A total proctocolectomy preserving the anal sphincters, followed by an ileal pouch-anal anastomosis (IPAA), which recreates a faecal reservoir, is
Slide 31: CB-01-33 (Colesevelam) for Bile Acid Diarrhea
CB-01-33 (COLESEVELAM) F O R T H E T R E AT M E N T O F B I L E A C I D D I A R R H E A • 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
Slide 32: Financials, Key Priorities for 2022 & beyond
Financials Key Priorities for 2022 & beyond Cosmo Pharmaceuticals 32 Investor Presentation - March 2022
Slide 33: 2021 Financial Position and 2022 Outlook
2021 FINANCI AL POSITION1 Strong balance sheet and positive cashflow from operations FY21 Prelim. Revenue FY21 Prelim Profit before Taxes Operating profit €65.1m €7m - €10m €20m - €23m 2022 FINANCI AL OUTLOOK1 Total Revenues Operating profit €90m - €100m €20m - €25m 1preliminary unaudited results an
Slide 34: Income Statement – Revenue
I N C O M E S TAT E M E N T – R E V E N U E 1 €65.1m vs €61.0m prior year Revenue by product/nature €millions FY21 Revenue % split 30.0 27.9 27.6 25.0 Licence fees, up-front fees 20.0 Eleview, 3% GI Genius, Generic and milestones, 15.2 11% Manufacturing 8% 15.0 13.0 and Other, 23% 10.0 7.1 7.4 6.7 4
Slide 35: Key Priorities for 2022 and Beyond
KEY PRIORITIES FOR 2022 AND BEYOND • Ensure that GI GeniusTM performs in the US market by providing Medtronic with all the necessary supply and support • Ensure that Winlevi performs in the US market by providing Sun with all the necessary supply and support • Initiate Breezula phase III studies in
Slide 36: Thank You
Thank You Cosmo Pharmaceuticals 36 Investor Presentation - March 2022
Slide 37: Cosmo Pharmaceuticals N.V.
Cosmo Pharmaceuticals N.V. Riverside II Sir John Rogerson’s Quay Dublin 2, Ireland [email protected] Mr. Alessandro Della Cha, CEO [email protected] Mr. Niall Donnelly, CFO [email protected] Ms. Hazel Winchester, Head of IR [email protected] Cosmo Pharmaceuticals 37 Inv
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