Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — H1 2020 Earnings Presentation
33 slides from Cosmo Pharmaceuticals Nv's earnings presentation, 2020
Slide 1: Half Year Report 2020
HALF YEAR REPORT 2020 Cosmo Pharmaceuticals
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: Agenda
A G E N DA 01 INTRODUCTION AND H1 2020 KEY EVENTS Alessandro Della Chà, CEO 02 H1 2020 FINANCIAL REVIEW Niall Donnelly, CFO 03 2020 OUTLOOK & KEY PRIORITIES Alessandro Della Chà, CEO 04 QUESTIONS AND ANSWERS Alessandro Della Chà, CEO Cosmo Pharmaceuticals 3 Half Year Report 2020
Slide 4: Introduction
I N T RO D U C T I O N • We are very pleased to report a series of positive developments in the year to date. • We are on track to return to operating profit in FY20 as a result of the actions we have taken over the last 18 months. • The EMA's CHMP adopted a positive opinion for Methylene Blue MMX.
Slide 5: Introduction
I N T RO D U C T I O N • Notwithstanding the coronavirus pandemic our production facilities continue to operate, we continue to ship our products and the inputs required for our operations continue to be received. • Measures remain in place to protect the health and welfare of our employees. • The p
Slide 6: Cosmo Pharmaceuticals N.V.
FY20 Revenue guidance CO S M O P H A R M A C E U T I C A L S N .V. €52 - €56 million FY20 Operating Profit guidance €2 - €8 million Market Cap1 CHF 1,303.7 million Net Cash1 €238.4 million Employees 46.56% Stake in 261 Cassiopea at IPO offer price & rights 19.6% stake in RedHill at cost $47.2m offer
Slide 7: Providing solutions for colon diseases
CO S M O P H A R M A C E U T I C A L S N .V. Providing solutions for colon diseases 3 marketed Stakes in other therapeutics pharma Lialda/Mezavant companies: Uceris/Cortiment Aemcolo/RelaFalk 2 marketed 46.56% Cassiopea medtech products 19.6% RedHill Eleview 24.03% Acacia Pharma GI Genius (EU) 7.91%
Slide 8: Introduction and Key Events
INTRODUCTION AND KEY EVENTS ALESSANDRO DELLA CHÀ, CEO Cosmo Pharmaceuticals 8 Half Year Report 2020
Slide 9: Key Events
KEY EVENTS • European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Methylene Blue MMX. • Progress made with the FDA in relation to the second Methylene Blue MMX phase III trial design and endpoints. Subject to reaching agreement with t
Slide 10: Key Events - continued
K E Y E V E N T S - CO N T I N U E D • In June Barhemsys® loan facility of €10m converted to equity and €1.1m break fee received in Acacia shares. • Byfavo™ approved by FDA in July, Cosmo’s stake in Acacia further increased. • Italian Agenzia del Farmaco (AIFA) grants Marketing Authorization to Stad
Slide 11: Key Events - continued
K E Y E V E N T S - CO N T I N U E D • GI Genius™ approved in Australia, Israel and the United Arab Emirates. • Associate Cassiopea completed a €23.25m rights offering, Cosmo participated and took up un-opted rights increasing our stake from 45.09% to 46.56%. We await the Winlevi® PDUFA date of 27 A
Slide 12: Acacia Pharma Deal
A C A C I A P H A R M A D EA L • Acacia Pharma is an English company with U.S. operations listed on Euronext (EURONEXT: ACPH) run by a management team highly experienced in U.S. hospital sales. • Sublicense of Byfavo™ for the U.S. In January, Acacia take over all marketing activities, development re
Slide 13: Acacia Pharma Deal
A C A C I A P H A R M A D EA L • On sub-licensing in Janaury down-payment of €10m in ACPH shares (listed on EURONEXT) plus €10m Cosmo direct investment in Acacia taking an intital stake of 14.1%. Additional €20m in Acacia Pharma shares due on approval of Byfavo™ by the FDA and first sales plus up to
Slide 14: Products Update: Methylene Blue MMX
P RO D U C T S U P DAT E Methylene Blue MMX • European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion for Methylene Blue MMX. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicine
Slide 15: Products Update: Aemcolo
P RO D U C T S U P DAT E Aemcolo™ • We have progressed the IBS-D phase II clinical program and three Investigator Initiated Studies have commenced in the U.S. for the treatment of Uncomplicated Acute Diverticulitis, Minimal Hepatic Encephalopathy and Small Intestine Bacterial Overgrowth (SIBO). • As
Slide 16: Products Update: GI Genius
P RO D U C T S U P DAT E GI Genius™ • Australia, Israel and the United Arab Emirates regulatory approvals obtained so far. • The U.S. trial required for FDA approval has commenced. • Sales in Europe commenced at the end of 2019 however the pandemic is impacting sales. • The trial required for U.S. r
Slide 17: Products Update: Eleview
P RO D U C T S U P DAT E Eleview® • Eleview® sales are being impacted by the ongoing pandemic as all promotion has either slowed down or moved on-line. Cosmo Pharmaceuticals 17 Half Year Report 2020
Slide 18: H1 2020 Financial Review
H1 2020 FINANCIAL REVIEW NIALL DONNELLY, CFO Cosmo Pharmaceuticals 18 Half Year Report 2020
Slide 19: H1 2020 Financial Highlights
H1 2020 FINANCIAL HIGHLIGHTS • Revenue €25.9m vs €21.5m last year • Net expenses reduced by 40.0% to €23.2m mainly as a result of the restructuring of our U.S. organisation in 2019 and other income recorded as a result of sub-license deal with Acacia • Operating profit of €2.7m vs operating loss of
Slide 20: Income Statement - Revenue
I N CO M E S TAT E M E N T - R E V E N U E • Revenue €25.9m vs €21.5m last year • Lialda/Mesavant/Measvancol revenue increased by €2.9 million to €11.7m mainly due to increase in U.S. sales • Uceris income was €2.5m (H1 2019: €4.6m), net sales by Bausch were US$16.3m (H1 2019: US$32.5m) • Cortiment
Slide 21: Income Statement
I N CO M E S TAT E M E N T EUR 1,000 H1 2020 H1 2019 Change Revenue • Revenue €25.9m vs €21.5m last year 25,883 21,507 4,376 Cost of sales (12,845) (11,029) (1,816) • Net expenses reduced by €15.5m to €22.2m mainly Gross Profit 13,038 10,478 2,560 due to the restructuring of our U.S. organisation an
Slide 22: Statement of Financial Position - Summary
S TAT E M E N T O F F I N A N C I A L P O S I T I O N – S U M M A RY EUR 1,000 30 Jun 20 31 Dec 19 Change Cash and cash equivalents and investments in funds 238,456 268,209 (29,753) Other current & non-current assets 358,161 316,951 41,210 Liabilities (191,177) (191,427) (250) Total Equity 405,440 3
Slide 23: Statement of Financial Position - Summary
S TAT E M E N T O F F I N A N C I A L P O S I T I O N – S U M M A RY Total Assets Total liabilities Equity €596.6m €191.1m €405.4m Cosmo Pharmaceuticals 23 Half Year Report 2020
Slide 24: Cash Flow
C A S H F LOW EUR 1,000 H1 2020 H1 2019 Loss for the period before tax (5,331) (22,619) Income taxes paid (net) 1,553 436 Adjustment for non-monetary item 10,090 11,583 Change in net working capital (2,960) (4,889) Net cash flows from operating activities 3,352 (15,489) Investments in property, plan
Slide 25: Cash Flow - continued
C A S H F LOW – CO N T I N U E D EUR 1,000 H1 2020 H1 2019 Interest paid on convertible bonds (2,188) (2,297) Repayments of interest-bearing loans and borrowings (107) (707) Proceeds from loans 1,223 - Purchase of treasury shares - net (3,427) (17,173) Acquisition of non-controlling interest – Linkv
Slide 26: 2020 Outlook & Key Priorities
2020 OUTLOOK & KEY PRIORITIES ALESSANDRO DELLA CH À , CEO Cosmo Pharmaceuticals 26 Half Year Report 2020
Slide 27: Strategy Going Forward
S T R AT EGY G O I N G FO RWA R D Following delay in approval of MB MMX in the U.S. Cosmo has decided to shift strategy to: 01 02 Enter into partnerships with selective players in exchange of Develop new product equity stake and/or opportunities with milestones/royalties or partners combination of b
Slide 28: Strategy Going Forward
S T R AT EGY G O I N G FO RWA R D Cosmo has no long-term strategic objectives for Cassiopea which is considered as a financial investment to be monetized in due course We will review our strategic options after the Winlevi® PDUFA date of 27 August 2020 Cosmo Pharmaceuticals 28 Half Year Report 2020
Slide 29: Development Pipeline
D E V E LO P M E N T P I P E L I N E PRODUCT INDICATION PH I PH II PH III Aemcolo™ IBS-D Acute Uncomplicated Diverticulitis* Small Intestine BacteriaI Overgrowth (SIBO)* Minimal Hepatic Encephalopathy* Byfavo™ Procedural Sedation APPROVED Lesion detection during Methylene Blue MMX colonoscopy - Euro
Slide 30: Upcoming Milestones
U P CO M I N G M I L ES TO N ES 2020 Q3 H2 ByFavo™ Key priorities for 2020 U.S. approval for procedural sedation • Complete the U.S. trial for GI Genius™ Cassiopea Winlevi® PDUFA date of 27 • Commence the Methylene Blue MMX August 2020 confirmatory Phase III trial Q4 • Conclude our Aemcolo™ phase II
Slide 31: 2020 Unchanged Guidance
2 0 2 0 U N C H A N G E D G U I DA N C E • The coronavirus pandemic is impacting Aemcolo™ and GI Genius™ sales and delaying our clinical trials • Notwithstanding the current circumstances we continue to operate our manufacturing facilities and ship products - Revenue in the range of €52m - €56m - To
Slide 32: Thank You
THANK YOU Cosmo Pharmaceuticals 32 Half Year Report 2020
Slide 33: Cosmo Pharmaceuticals NV contact details
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 +353 1 817 03 70 33 Half Year Report 2020
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