HALF YEAR REPORT 2021 - Cosmo Pharmaceuticals
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
HALF YEAR
REPORT
2021
Cosmo Pharmaceuticals Half Year Report 2021SAFE 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 plans will be achieved. Actual results may differ materially from those set forth in this presentation due to the risks and uncertainties inherent in Cosmo’s ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialization of its product candidates and reduce costs (including staff costs), the market for drugs to treat IBD diseases, Cosmo’s anticipated future revenues, capital expenditures and financial resources and other similar statements, may be “forward-looking” and as such involve risks and uncertainties and risks related to the collaboration between Partners and Cosmo, including the potential for delays in the development programs for its products. No assurance can be given that the results anticipated in such forward-looking statements will occur. Actual events or results may differ materially from Cosmo’s expectations due to factors which include, but are not limited to, increased competition, Cosmo’s ability to finance expansion plans, the results of Cosmo’s research and development activities, the success of Cosmo’s products, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Cosmo assumes no responsibility to update forward-looking statements or to adapt them to future events or developments. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Cosmo undertakes no obligation to revise or update this presentation. Cosmo Pharmaceuticals 2 Half Year Report 2021
AGENDA
01 Introduction
Alessandro Della Chà, CEO
02 H1 2021 Key Events & Products Update
Alessandro Della Chà, CEO
03 H1 2021 Financial Review
Niall Donnelly, CFO
04 2021 Key Priorities & Outlook
Alessandro Della Chà, CEO
Cosmo Pharmaceuticals 3 Half Year Report 2021Introduction Cosmo Pharmaceuticals 4 Half Year Report 2021
FINANCIAL HIGHLIGHTS
Revenue Operating profit Cash, bonds and fund
€28.4m €8k investments
H1 2020: €25.9m H1 2020: Operating Profit €2.7m
€203.1m
2020: €212.9m
Manufacturing of own products and related services
Loss after tax
€15.2m Equity stakes in other
€5.7m
H1 2020: €12.6m
H1 2020: €3.0m companies
Manufacturing of generic products and related services €299.1m
€5.8m Cash inflow from operating 2020: €339.2m
H1 2020: €6.0m activities Treasury shares and loans
Royalties €12.7m €79.8m
€2.4m H1 2020: €1.8m
2020: €72.5m
H1 2020: €4.4m
Equity
Licence fees, up-front fees and milestones
€4.0m €371.0m
2020: €400.1m
H1 2020: €2.2m
Cosmo Pharmaceuticals 5 Half Year Report 2021COSMO OVERVIEW
Two marketed medtech Three marketed Market Cap1
products therapeutics CHF 1,282.7 million
Eleview® Lialda® /Mezavant® Net Cash1
GI Genius™ Uceris®/Cortiment® €203.1 million
Aemcolo®/RelaFalk®
Equity stakes in other
One approved Rich development companies1
therapeutic pipeline €299.1 million
Methylene Blue MMX®(EU) Treasury shares and loans1
€79.8 million
1 as at 30 June 2021
Cosmo Pharmaceuticals 6 Half Year Report 2021Key Events & Update Cosmo Pharmaceuticals 7 Half Year Report 2021
H1 2021 UPDATE - KEY EVENTS • GI Genius™, the first device that uses artificial intelligence to assist clinicians in the detection lesions in the colon in real time during a colonoscopy, approved by the FDA • Successful outcome of our phase II Proof of Concept (POC) clinical trial of Rifamycin-MMX 600mg in Irritable Bowel Syndrome with Diarrhea (IBS-D) announced • EU rights (plus Switzerland, UK, EEA countries, Russia and Mexico) for Lumeblue ™ licenced to Alfasigma S.p.A. • Cosmo’s associate, Cassiopea S.p.A., announced the signing of license and supply agreements with Sun Pharmaceutical Industries for Winlevi ® in US and Canada in July • Agreement entered into with RedHill Biopharma Ltd. (Nasdaq: RDHL) to manufacture Movantik ®, RHB-204 and Opaganib Cosmo Pharmaceuticals 8 Half Year Report 2021
H1 2021 UPDATE GI Genius™ • In April 2021 the FDA approved GI Genius™ for lesion detection during colonoscopy • GI Genius™ uses artificial intelligence (AI) to assist clinicians in the detection lesions in the colon during a colonoscopy • The device is the first of its kind to obtain the FDA approval through the De Novo application • The FDA assessed the safety and effectiveness of GI Genius™ through a multicenter, prospective, randomized, controlled study in Italy with 700 subjects 40-80 years old who were undergoing a colonoscopy for colorectal cancer screening • In the study, the adenoma detection rate was 55.1% in colonoscopy plus GI Genius™ compared to 42.0% with standard colonoscopy Cosmo Pharmaceuticals 9 Half Year Report 2021
H1 2021 UPDATE GI Genius™ • We have delivered 261 devices for the US market to our partner Medtronic, sales are expected to commence in H2 • Europe, Australia, Israel and the United Arab Emirates regulatory approvals are also obtained so far • Sales in Europe commenced at the end of 2019, but the pandemic continues to impact sales Cosmo Pharmaceuticals 10 Half Year Report 2021
H1 2021 UPDATE GI Genius™ Video Clips Cosmo Pharmaceuticals 11 Half Year Report 2021
H1 2021 UPDATE
Cassiopea
• In July, our associate Cassiopea SpA (SIX: SKIN) announced it had signed license and supply agreements with Sun
Pharmaceutical Industries for Winlevi® in US and Canada
• Cassiopea will receive a $45 million upfront payment, high double-digit royalties and potential commercial
milestones up to $190 million
• Sun has committed to substantial promotional and marketing expenses according to an agreed commercialization
plan
• The license agreement will be effective once the parties have received HSR Antitrust Clearance, which is estimated
to occur by mid-September
• As a result of the agreements with Sun we estimate that Cosmo’s financial results will benefit significantly because
of Cosmo’s share of the overall Cassiopea FY21 financial result
Cosmo Pharmaceuticals 12 Half Year Report 2021H1 2021 UPDATE Aemcolo™ • In January 2021, we announced the successful outcome of our Phase II Proof of Concept (POC) clinical trial of Rifamycin-MMX 600mg in Irritable Bowel Syndrome with Diarrhea (IBS-D) • Together with our licensees, we will immediately commence discussions with the U.S. and EU regulatory agencies with a view to starting the Phase III clinical studies required for marketing authorisation as soon as possible • We have progressed the IBS-D phase II clinical program and two Investigator Initiated Studies have commenced in the U.S. for the treatment of Minimal Hepatic Encephalopathy and Small Intestine Bacterial Overgrowth (SIBO), while the trial on Uncomplicated Acute Diverticulitis has yet to start • As a consequence of travel restrictions and bans which have been put in place by most countries following the outbreak of the pandemic, Aemcolo™ sales continue to be adversely affected in 2021. Cosmo Pharmaceuticals 13 Half Year Report 2021
H1 2021 UPDATE Methylene Blue MMX® • In February 2021, we licensed the EU rights (plus Switzerland, UK, EEA countries, Russia and Mexico) for Lumeblue™ to Alfasigma SpA. We are expecting EU launch in Q1 2022. • Our partner CMS for China is progressing with regulatory activities • We have progressed our discussions with the FDA to prepare for the requested second phase III trial. Subject to reaching agreement with the FDA on the final protocol, we hope to commence the trial during 2021, pandemic permitting Cosmo Pharmaceuticals 14 Half Year Report 2021
H1 2021 Financial Review Cosmo Pharmaceuticals 15 Half Year Report 2021
H1 2021 FINANCIAL HIGHLIGHTS • Revenue €28.4m vs €25.9m last year • Net expenses increased by €5.2m to €28.4m because H1 2020 included a gain of €5.3m on the sub-licencing of BYFAVO™ and a break fee associated with a debt equity swap with Acacia, excluding this gain net expenses are in line with last year • Operating profit of €8k vs operating profit of €2.7m last year • Cashflows from operating activities €12.7m (H1 2020: €1.8m) • Net financial expenses of €1.9m vs net financial expenses of €5.8m last year • Includes imputed convertible bond interest €4.3m (€2.2m paid) • Loss after taxes for the period €5.7m (H1 2020: €3.0m) including share of Cassiopea loss €2.8m (H1 2020: €2.2m) Cosmo Pharmaceuticals 16 Half Year Report 2021
INCOME STATEMENT - REVENUE
• Revenue €28.4m vs €25.9m last year
• Lialda/Mesavant/Measvancol revenue increased by €0.06 million to €11.8m
• Uceris income was €1.8m (H1 2020: €2.5m), net sales by Bausch were US$13.6m (H1 2020:
US$16.3m)
• Cortiment income was €1.0m (H1 2020: €2.3m) net sales by Ferring were €9.8m (H1 2020: €8.9m)
Other revenues from sales, 4%
• GI Genius™ revenue was €2.1 (H1 2020: €0.1) Royalties , 9%
• Upfront fees and milestones represents the upfront payment of License fees of €4.0m in relation
to licensing out the EU rights (plus Switzerland, UK, EEA countries, Russia and Mexico) for
Lumeblue™ (Methelene Blue MMX) to Alfasigma S.p.A. Lumeblue™.
Manufacturing generic
16 15 products, speciality drugs
H1 2021
and related services, 22%
14 H1 2020
13 Licence fees , Up-
front fees &
12
milestones, 14%
10
8
6 6
6
4
4 Manufacturing of own Products
4
2 2 and related services, 52%
2 1 1
-
Manufacturing Manufacturing of Licence fees , Up- Royalties Other revenues
generic products, own Products and front fees & from sales
speciality drugs and related services milestones
related services
Cosmo Pharmaceuticals 17 Half Year Report 2021INCOME STATEMENT
EUR million H1 2021 H1 2020 Change
Revenue 28.4 25.9 2.5 • Revenue €28.4m vs €25.9m last year
Other income 0.2 5.5 (5.3)
• Expenses increased by €5.2m to €28.4m mainly as
Cost of sales (13.8) (12.8) (1.0) a result of gain booked in H1 2020 on the sub-
Research and development (7.4) (7.3) (0.1) licencing of BYFAVO™
S,G&A (7.4) (8.6) 1.2
• Operating profit €8k vs operating profit €2.7m last
Net operating expenses (28.4) (23.2) (5.2) year
Operating profit / (loss) 0.008 2.7 (2.7)
Net financial expense (1.9) (5.8) 3.9 • Net financial expenses €1.9m vs €5.8m last year
Share of result of associates (2.8) (2.2) (0.6) • Imputed convertible bond interest €4.3m (€2.2m paid),
net FX gain €0.9m (H1 2020: net FX loss €0.04m) and
Loss before taxes (4.7) (5.3) 0.6 net interest received €1.5m (H1 2020: €0.7m)
Income tax expenses (1.1) 2.3 (3.4)
• Loss after taxes for the period €5.7m (H1 2020:
Loss after taxes for the period (5.8) (3.0) (2.7) €3.0m) including share of Cassiopea loss €2.8m (H1
2020: €2.2m)
Cosmo Pharmaceuticals 18 Half Year Report 2021STATEMENT OF FINANCIAL POSITION - SUMMARY EUR million H1 2021 2020 Change Cash and cash equivalents and investments in funds 203.1 212.9 (9.8) Other current & non-current assets 359.6 383.2 (23.6) Liabilities (191.7) (196.0) 4.2 Total Equity 371.0 400.1 (29.2) • Cash and investments in funds €203.1m • Other current & non-current assets include shareholdings in Acacia Pharma, PAION AG and RedHill, and other companies €91.7m, investment in Cassiopea carried at €133.4m, intangible assets of €26.9m, property plant and equipment of €29.1m and trade and other receivables of €55.2m • Liabilities mainly consist of the liability component of the convertible bonds of €164.3m, deferred tax liabilities of €5.8m, lease liabilities of €2.9m, contingent consideration of €3.2m, trade payables of €7.1m and accruals of €2.8m Cosmo Pharmaceuticals 19 Half Year Report 2021
STATEMENT OF FINANCIAL POSITION - SUMMARY
Total Assets Total liabilities Equity
€562.8m €191.8m €371.0m
Cosmo Pharmaceuticals 20 Half Year Report 2021CASHFLOW EUR million H1 2021 Cashflow from operating activities 12.7 Disposal of investments 3.1 Payment of contingent consideration related to Linkverse acquisition in 2018/19 (2.6) Purchase of treasury shares (8.0) Convertible bond interest (2.2) Capital expenditure (1.9) Loan to Cassiopea (6.0) Capitalised development expenditure (1.6) Lease repayments (2.2) Tax paid (3.0) Other cashflows 2.0 Net cashflow (9.7) Opening cash and investment in funds 212.9 Net cashflow (9.7) Closing cash and investment in funds 203.1 Cosmo Pharmaceuticals 21 Half Year Report 2021
2021 Key Priorities & Outlook Cosmo Pharmaceuticals 22 Half Year Report 2021
KEY PRIORITIES FOR 2021 AND BEYOND • Ensure that GI Genius™ performs in the US market by providing Medtronic with all the necessary supply and support • Replenish our pipeline • Progress the development of Aemcolo™ in IBS-D • Commence the Methylene Blue MMX confirmatory phase III trial required for US approval Cosmo Pharmaceuticals 23 Half Year Report 2021
2021 GUIDANCE
• Guidance is maintained following FDA approval for GI Genius™ and assumes an increase in costs associated with the
deployment of GI Genius machines to Medtronic and into the market
- Revenue in the range of €60m - €64m
- Operating profit in the range of €3m - €5m
• In addition to the operating profit above, the agreement reached between Sun and Cassiopea in relation to Winlevi®,
which will close upon the expiration of the HSR waiting period, will result in Cassiopea delivering a profit in FY21.
Cosmo’s financial results will benefit in line with our stake in Cassiopea
• We are therefore expecting Cosmo to deliver a profit before tax in FY21 in the range of €4m to €6m
Cosmo Pharmaceuticals 24 Half Year Report 2021Thank You Cosmo Pharmaceuticals 25 Half Year Report 2021
Cosmo Pharmaceuticals NV Riverside II Sir John Rogerson’s Quay Dublin 2, Ireland media@cosmopharma.com Mr. Alessandro Della Cha, CEO adellacha@cosmopharma.com Mr. Niall Donnelly, CFO ndonnelly@cosmopharma.com Cosmo Pharmaceuticals 26 Half Year Report 2021
You can also read
