Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — Investor Presentation (September 2022)
47 slides from Cosmo Pharmaceuticals Nv's investor presentation, September 2022
Slide 1: Investor Presentation September 2022
S COSMO DELIVERING INNOVATION + IMPROVING LIVES INVESTOR PRESENTATION SEPTEMBER 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: Cosmo Pharmaceuticals | September 2022 3
Cosmo Pharmaceuticals | September 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 Inflammatory Bowel Disease (IBD) Colorectal cancer (CRC) Irritable Bowel Syndrome - Diarrhoea (IBS-D) Infectious diseases Cosmo Pharmaceuticals | September 2022 HealthTech Dermatology Sk
Slide 5: Our business model is based on pillars to increase opportunities and decrease risks
Our business model is based on 3 pillars to increase opportunities and decrease risks 01 Development and manufacturing of OWN PRODUCTS A. Gi 02 Distributed through our selective STRONG PARTNERSHIPS eS 03 Drug development and manufacturing on behalf of THIRD PARTIES A. Ce Cosmo Pharmaceuticals | Sept
Slide 6: Listed on SIX, market cap June 2022
Listed on Six Mkt cap (June 2022) since 2007 CHF ideal COPN 1821m Total employees Male Female Different nationalities 292 ~ 43 focusing on Al 61% Production & Logistics as at June 2022 Cosmo Pharmaceuticals | September 2022 6
Slide 7: 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 me €65.1m €60.9m 60.0 50.0 40.0 30.0 200 10.0 “EBITDA m Revenue Cosmo Pharmaceuticals | September 2022
Slide 8: Overview of approved products and partnerships
. )COSMO OVERVIEW OF APPROVED PRODUCTS AND PARTNERSHIPS
Slide 9: 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 o1 Lialda®/Mezavant®/Mesavancol® US, JP, EU, Mesalamine with MMX® technology, once-daily oral tablet ROW formulation
Slide 10: 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 o1 Gl Genius™ US, EU, CAN First artificial intelligence (Al) based medical device for the real time detection of le
Slide 11: Established strong partnerships: products and medical devices
Established strong partnerships: products and medical devices = Seale BAUSCH Health [FERRING O SUN 3SB10 429) PHARMACEUTICALS: Vv ® Ouceris CORTIMENT® Lialda (US/Japan) | Mezavant (EU/ROW) Mesavancol (IT) Uceris (US) | Cortiment (EU/ROW) Medtronic v Cosmo Pharmaceuticals | September 2022 al
Slide 12: Established strong partnerships: products
Established strong partnerships: products 2) hemcolo Relafalk Aemcolo (US) | RelaFalk (EU) ALFASIGMA™ cp sensamenes. E AGLE (acquired scocitatiis PHARMACEUTICALS June 2022) Cosmo Pharmaceuticals | September 2022 v ¥ LuMeBlue (EU, China) A2
Slide 13: HY 2022 Update & Financial Review
. )COSMO HY 2022 UPDATE & FINANCIAL REVIEW
Slide 14: Record best half year revenue performance
Delivered the record best half year revenue performance €41.5m HY 2022 €28.4m HY 2021 Revenue increase of 46.1% HY 2022 vs HY 2021 Cosmo Pharmaceuticals | September 2022 14
Slide 15: Solid performance in HY 2022
Solid performance in HY 2022 Ferring submitted the NDA for Cortiment®"" Japan. Application has been accepted by PMDA. Review is expected to last approximately a year US trial showed 50% reduction in missed colorectal polyps using GI Genius™ versus standard colonoscopy Agreement with Medtronic for di
Slide 16: HY 2022: Financial Highlights
HY 2022: Financial Highlights Growth in revenue, EBITDA and operating profit, delivering positive cashflow from operations HY 22 Revenue HY 22 Profit before tax €41.5m up 46.1% (HY 2021: €28.4m) €9.0m (HY 2021: €4.7m Loss before tax) HY 22 EBITDA HY 22 Net cashflow from operating activities €14.9m u
Slide 17: Product revenue distribution, new products generating revenue
Product revenue distribution, new products generating revenue Positive impact on our financial performance €m - Revenue by product HY 2021 vs. HY 2022 14.00 12.00 10.00 8,00 6.00 4.95.| y, 4 Cosmo Pharmaceuticals | September 2022 eye 207 0.70 4.00 ct <A 2.69 4 . 9 - sth oy, ad @HY 2022 @HY 2021 Reve
Slide 18: Strong financial position as of June 2022
Strong financial position as of 30 June 2022 Cosmo Pharmaceuticals | September 2022 €312.9m Total 18
Slide 19: Legacy business continues to grow
. )COSMO LEGACY BUSINESS CONTINUES TO GROW
Slide 20: Lialda — Mezavant — Mesavancol
Lialda® — Mezavant® — Mesavancol® /— Mesalamine \ fr Mesalamine Tablets Supplied (Millions) Revenue in Eur (Millions) (80 ta00 €13.0m t) 156.1m sono 11% growth 155.0 in revenues due to ‘eo increase in volumes — FY 42.40 in US and Japan NSN * 42.20 145.0 12.00 11.80 440.0 139.3m_ 11.60 41.40 135.0 11
Slide 21: Uceris — Cortiment
Uceris® — Cortiment® a Budesonide *y fr Budesonide Tablets Supplied (Millions) Revenue in Eur (Millions) 450 14.0 400 2am 12.0 3.50 & 10.0 Cortiment® $00 Major milestones received 250 80 a €8m 88 1.9m - : reaching cumulative net sales of €100m 1.50 40 400 Next €8m expected at reaching €200m 0.50 a0
Slide 22: Revenue from drug development and manufacturing on behalf of third parties
Revenue from drug development and manufacturing on behalf of third parties , M A SSSAES — wourenr ANGELINI H HELSINN Gohmcnafohmsen PHOENIX@LABS HELSINN STADA @ comps ——— BERLIN-CHEMIE @ATNAHS MENARINI Lmesenaeed GGIVUANI Cosmo Pharmaceuticals | September 2022 €5.8m €6.0m HY 2021 H1 2022
Slide 23: New products are delivering in large markets
. )COSMO NEW PRODUCTS ARE DELIVERING IN LARGE MARKETS
Slide 24: WINLEVI is the #1 most prescribed branded topical acne product in the U.S.
WINLEVI® is the #1 most prescribed branded topical acne product in the U.S. Unique prescribers 10,000 Launched in the U.S. by Sun Pharma in Nov. 2021 Strong U.S. launch resulting in demand from potential ex-U.S commercial partners Cosmo Pharmaceuticals | September 2022 U.S. gross market Prescription
Slide 25: Expanded partnership with Sun Pharma for Winlevi
Expanded partnership with Sun Pharma making Winlevi® available to more patients around the world US$ 7m Upfront paym Potential regulatory and sales milestones and customary double-digit royalties on net sales
Slide 26: New partnership for WINLEVI with 3SBio in Greater China
New partnership for WINLEVI® with 3SBio in Greater China US$ 6.5m Upfront payment US$ 63.5m aes Potential development and sales milestones and customary ascending high double-digit royalties on net sales
Slide 27: Huge market potential in Greater China
Huge market potential in Greater China Cosmo Pharmaceuticals | September 2022 27
Slide 28: GI Genius: Compatible with all major brands of endoscopic equipment
GI GENIUS™: Compatible with all major brands of endoscopic equipment World market >60m annual colonoscopies U.S >19m annual colonoscopies U.S. Market potential >USD 1bn Cosmo Pharmaceuticals | September 2022 In April 2021 GI Genius™ was approved by the FDA First U.S. Trial using GI genius™ intellige
Slide 29: Significant leap in signed contracts
Significant leap in signed contracts Commercial negotiations ongoing in US with potential clients representing 6,000 endoscopic towers (20% of the U.S. market) Contracted devices signed Endoscopic towers in the U.S. by Medtronic with clients in >30,000 Devices ordered by Medtronic for the U.S. 3,000
Slide 30: Top U.S. hospitals that have installed GI Genius
Some of the top U.S. hospitals who have already installed Gl Genius™ Beth Israel (BIDMC) Einstein Medical, Harvard, Boston Pennsylvania 02 | Speer Oe ae 03 pant 41 (0) mauere Affairs, 04 Pred ee University, 4 4 Hoge Wedical 05 | RUSH University 12 | eee _ Expanding our Al franchise by investing in d
Slide 31: Introducing GI Genius intelligent endoscopy module
Introducing GI GENIUS™ intelligent endoscopy module The better you train, the better you perform Source’ Medtronic Cosmo Pharmaceuticals | September 2022 31
Slide 32: AI-assisted colonoscopy is available today with the GI Genius system
Al-assisted colonoscopy is available today with the Gl Genius™ system Download the pdf to watch the video Cosmo Pharmaceuticals | September 2022 32
Slide 33: Other approved products update
. )COSMO OTHER APPROVED PRODUCTS UPDATE
Slide 34: 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 MM<X for the visualization of colorectal lesions during colonoscopies In December 2020, we licensed the Chinese rights for
Slide 35: 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 view t
Slide 36: Byfavo: Commercial & development update
Byfavo® (Remimazolam): Commercial & development update Anovel sedation agent for procedural sedation Byfavo® (remimazolam) is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic for procedural sedation 7 1 NDC71390.011-11 In-licensed from Paion in June 2016, was sub-licensed by Cosm
Slide 37: 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 a ™ excision of adenomas or polyps during endoscopy Eleview S
Slide 38: Development pipeline progress
. )COSMO DEVELOPMENT PIPELINE PROGRESS
Slide 39: Update on clinical development pipeline
Update on clinical development pipeline pistes a ai Breazuls® CB-01-33 ortexolone 17a-valerate- P Colesevelam Ns -propionate) (Clascoterone solution) ( ) Phase | study started in patients Preparing to start the Phase 3 trial in Completing formulation & IP protection with advanced refractory solid ma
Slide 40: Breezula: Potential new topical treatment for AGA
Breezula® (Clascoterone solution): Potential new topical treatment for AGA 2bn 50m estimated males estimated males Baseline Month 6 worldwide in the U.S affected by AGA affected by AGA
Slide 41: 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 "4 CB-03-01 (Clasc
Slide 42: CB-03-10: For the treatment of solid tumors
CB-03-10 (Cortexolone 17a-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 43: 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 44: Key priorities & outlook 2022
. )COSMO KEY PRIORITIES & OUTLOOK 2022
Slide 45: Key priorities for 2022 and beyond
Key priorities for 2022 and beyond 03 PROGRESS THE CB-03-10 PHASE | STUDY IN PATIENTS WITH ADVANCED REFRACTORY SOLID TUMORS Cosmo Pharmaceuticals | September 2022 02 ENSURE THAT WINLEVI® CONTINUES TO PERFORM IN THE US MARKET BY PROVIDING SUN WITH ALL THE NECESSARY SUPPLY AND SUPPORT 04 INITIATE BREE
Slide 46: FY 2022 financial guidance reaffirmed
FY 2022 financial guidance reaffirmed Total Revenue €90m — €100m Operating Profit €20m — €25m
Slide 47: Contact
COSMO Mr. Alessandro Della Cha, CEO adellacha@cosmopharma.com Mr. Niall Donnelly, CFO Cosmo Pharmaceuticals N.V. Soe P@cosmopharma.com Riverside || 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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