Paion AG · GETTEX:PA8
Paion — FY2020 Earnings Presentation
35 slides from Paion's earnings presentation, Mar 31, 2021
Slide 1: PAION Earnings Call Financial Results 2020
PAION Earnings Call Financial Results 2020 Dr. Jim Phillips, CEO | Abdelghani Omari, CFO Conference Call | 31 March 2021
Slide 2: Disclaimer
Disclaimer It is important to note that this information contains forward-looking statements which are based on the currently held beliefs and assumptions of the management of PAION AG, which are expressed in good faith and, in its opinion, reasonable. Forward-looking statements involve known and un
Slide 3: Agenda
AGENDA 1 Corporate Overview 2 Products 3 Financials 3 | www.paion.com
Slide 4: PAION Mission Statement
PAION Mission Statement “PAION’s mission is to be a leading specialty pharmaceutical company in the fields of anesthesia & critical care by bringing novel products to market to benefit patients, doctors & stakeholders in healthcare.” 4 | www.paion.com
Slide 5: Corporate overview
Corporate overview PAION AG is a specialty pharma company with a PAION has commercial partners for Byfavo® in the focus on anesthesia and critical care products U.S., China, South Korea, Southeast Asia, Canada, Russia + CIS, Turkey, Taiwan, Japan and the MENA region Byfavo® (Remimazolam), GIAPREZA®
Slide 6: PAION AG is listed on Frankfurt Stock Exchange
PAION AG is listed on Frankfurt Stock Exchange Listed on Frankfurt Stock Market capitalization: Liquidity (last six months) Exchange, Prime Standard cEUR150 m (Xetra, Tradegate & FRA stock markets): (FSE: PA8) c 30 million shares traded Stock Performance 2020 Market Data (price and volume in EUR) 3,
Slide 7: PAION Strategy
PAION Strategy Become a recognized innovative leader in Anesthesia & Critical Care within 3 years Create leading commercial capabilities in Europe in 2021-22 Launch Byfavo®, GIAPREZA® and XERAVA® in key EU markets over 2021-2 Drive rapid revenue growth & reach profitability end of 2023/begin
Slide 8: Highlights for 2020… a year of delivery of key value drivers
Highlights for 2020… a year of delivery of key value drivers Three product approvals in two indications – Japan / China / U.S. Two successful partner launches in H2 2020 in China & Japan and first royalties received Revenues of €19.7m Positive EBITDA of €1.9m Succesful completion of main E
Slide 9: Key targets and news flow for PAION in 2021
Key targets and news flow for PAION in 2021 Filing Byfavo® in GA until the end of 2021 Ongoing Byfavo® partners sales growth & launch activities Commercial launch for Byfavo®, GIAPREZA® & XERAVA® in Europe Market approval Byfavo® EU Procedural Sedation ✓ Byfavo® CHMP meeting EU Proceedural Sedation
Slide 10: Agenda
AGENDA 1 Corporate Overview 2 Products 3 Financials 10 | www.paion.com
Slide 11: Pipeline overview
Pipeline overview Status of Development Compound Indication PC Ph I Ph II Ph III NDA/ MA* Launch Byfavo® General Anesthesia Remimazolam Besylate Procedural Sedation ICU Sedation GIAPREZA® Blood pressure Angiotensin II management to treat EU / EEA / CH / UK septic shock XERAVA® Complicated Intra- EU
Slide 12: GIAPREZA, XERAVA & Byfavo: A portfolio to drive fast revenue growth
GIAPREZA®, XERAVA® & Byfavo®: A portfolio to drive fast revenue growth Potential Peak Revenues with the portfolio of >€300m c2028 : 250 Byfavo® EU Peak Sales c€150m Paion Projected €m Revenues by 2026 200 Byfavo® Royalties ex-EU c€60m 200 GIAPREZA® EU Peak Sales c€70m 150 150 XERAVA® EU Pe
Slide 13: Strong overlap in accounts and target groups
Strong overlap in accounts and target groups ICU/Theatre/ Intensivist/ Anesthetist/ Surgeon Theatre/ED/ ICU/Theatre Procedures/ /ED/Gastro- Anesthetist / surgeon/ Gastroente- Intensivist* rologists * Other specialties key for formulary listing, eg Inectious disease, Hospital antimicrobial stewardshi
Slide 14: Byfavo / Remimazolam
Byfavo® / Remimazolam 14 | www.paion.com
Slide 15: The ideal drug would combine “the best of both worlds”
The ideal drug would combine “the best of both worlds”* Propofol Remimazolam Midazolam CV/Respiratory Rapid onset/offset Lower safety issues Variable and depression Predictable Reversal agent prolonged periods No reversal agent recovery time of sedation Less resources Pain on injec
Slide 16: Procedural Sedation: EU Market Opportunity
Procedural Sedation: EU Market Opportunity 15-20 million ~8.7 million >90% procedures involving procedural Gastrointestinal procedures* Mean % GI procedures using sedation each year in EU5 procedural sedative ~1.2 million ~2.7 million ~2.7 million ~1.9 million Bronchoscopy* Cataract Surgery* Cardiac
Slide 17: Colonoscopies continue to increase in the EU
Colonoscopies continue to increase in the EU • Technical advances in diagnostic and therapeutic procedures have resulted in exponential growth of procedures in the last few decades, particularly in gastroenterology.1 • Procedural sedation plays an important role in increasing patient comfort and tol
Slide 18: Competitive Landscape
Competitive Landscape Standard of Care varies greatly between EU countries Standard of Care MIDAZOLAM PROPOFOL Midazolam Propofol 18 | www.paion.com IQVIA Market Prioritization Research 2019
Slide 19: Staggered launches of complete portfolio in 2021-22
Staggered launches of complete portfolio in 2021-22 Aligned with sales/profit expectations over time Q3/21-Q2/22* Q3/21-Q3/22* Q4/21-Q4/22* PAION will target nearly all mid- to large-sized accounts** *Timelines subject to successful Pricing & Reimbursement processes **Covering 100% of universe in Ne
Slide 20: GIAPREZA & XERAVA
GIAPREZA® & XERAVA® 20 | www.paion.com
Slide 21: GIAPREZA approved for Septic Shock in EU & U.S.
GIAPREZA® approved for Septic Shock in EU & U.S. GIAPREZA® is approved by the EMA as a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamine
Slide 22: About XERAVA
About XERAVA® XERAVA® (eravacycline) is approved by the European Commission for the treatment of complicated intra-abdominal infections in adults Novel broad-spectrum tetracycline initially developed by U.S.-based Tetraphase Potential to become a first line therapy prior to bacterial identific
Slide 23: PAION Commercial Structure
PAION Commercial Structure EU Head Office structure: 1. Corporate Management & Finance 4. Supply Chain 2. EU Marketing, Commercial & Market Access Support 5. Quality Assurance 3. Medical, Regulatory Affairs & PhV 6. Ongoing R&D European HQ United Kingdom France Netherlands Nordic Hub DACH Hub (DE/AT
Slide 24: Planned Structure of Field Based Teams with Syneos Health
Planned Structure of Field Based Teams together with contract Sales Force partner Syneos Health Targeted approach from KAMs/MSLs Country KAMs MSLs Total Netherlands 4 1 5 Denmark 2 1 3 Germany* 8 2 10 France* 8 2 10 UK 8 2 10 Italy* 8 2 10 Sweden 2 1 3 Norway 1 1 2 Finland 1 1 2 Austria* 2 1 3 Total
Slide 25: PAION in Europe
PAION in Europe Overview of Byfavo launch and Market Preparation 2020 – 2021 2020 – 2021 2021 – 2022 REGULATORY ORGANISATIONAL BUILD UP LAUNCHES Activity Date Local management established. 03/21 (UK/NL/Nordics) Jan 2021 CHMP Opinion Field force deployed 06/21 Supply Chain readiness 06/21 March 2021
Slide 26: Remimazolam – IP Status
Remimazolam (Byfavo® / Anerem® / Ruima®) – IP Status Besylate salt – Protection until at least 2031 in the U.S. Formulation Patent – Protection until at least 2033 in the EU IP Dosing Patent – Protection until at least 2033 in Japan Growing IP portfolio to secure attractive period of market
Slide 27: PAION's Partners Ex-EU
PAION‘s Partners Ex-EU U.S. – Acacia Pharma Japan – Mundipharma Taiwan – TTY BIOPHARM Lead indication: Procedural Sedation Lead indication: General Anesthesia License agreement signed in March 2021 Market approval received in July 2020 Market approval received in January 2020 Supply of d
Slide 28: Japan (Anerem) & China (Ruima): Combined sales of EUR 2.6 million in 2020
Japan (Anerem®) & China (Ruima®): Combined sales of EUR 2.6 million in 2020 JAPAN CHINA • NHI national reimbursed price of ¥2,218 per 50 mg vial • Pricing at launch RMB139 / Vial ( ~ €17) (~ €18) • Currently launched to hospitals in 31 provinces • Chinese KOLs supportive • 400 hospitals had product
Slide 29: USA (BYFAVO): Launch is proceeding extremely well
USA (BYFAVOTM): : „Launch is proceeding extremely well“ Commercial synergy with BARHEMSYS® (U.S. approved for treatment and prophylaxis of PONV) Target prescribers: anesthesiologists and proceduralists in hospitals and ambulatory surgery centers Substantial clinical data shows compelling effic
Slide 30: Agenda
AGENDA 1 Corporate Overview 2 Pipeline 3 Financials 33 | www.paion.com
Slide 31: Cash position and financing
Cash position and financing Cash of close to EUR 19.7m (as of 31 December 2020) EIB loan of EUR 20 million The first two tranches totalling EUR 12.5 million drawn in February 2021 Third tranche of EUR 7.5 million planned to be drawn shortly after rights issue Capital increase with subscrip
Slide 32: Consolidated statement of comprehensive income
Consolidated statement of comprehensive income In accordance with IFRS (all figures in EUR k) Revenues R&D Expenses 19.655 FY 2019 FY 2020 8.000 -10.288 FY 2019 FY 2020 -13.099 SG&A Expenses Net Result FY 2019 FY 2020 FY 2019 FY 2020 2.222 -5.023 -7.016 -7.523 R&D expenses mainly relate to EU Phas
Slide 33: Consolidated balance sheet and employees
Consolidated balance sheet and employees In accordance with IFRS (all figures in EUR k if not otherwise noted) Total assets Cash and cash equivalents 28.150 24.912 19.666 18.787 879 31 Dec. 2019 31 Dec. 2020 31 Dec. 2019 Total Cash Flow 31 Dec. 2020 Equity Employees (avg.) in the Group 21.290 44 43
Slide 34: Financial Outlook 2021
Financial Outlook 2021 Actual FY 2020 Plan FY 2021 Comments EUR million EUR million € 7.5m to € 9m from licensees - € 5m to € 6m from royalties and sale of remimazolam API Revenues € 19.7m € 8m – € 9.5m - € 2.5m to € 3m from milestones € 0.5m from own commercialization of Byfavo®, GIAPREZA® and XERA
Slide 35: Q&A Contact: PAION AG
Q&A Contact: PAION AG Heussstraße 25 52078 Aachen – Germany Phone +49 241 44 53-0 info@paion.com www.paion.com 38 | www.paion.com