Paion AG · GETTEX:PA8
Paion — H1 2021 Earnings Presentation
44 slides from Paion's earnings presentation, Aug 23, 2021
Slide 1: PAION Earnings Call Financial Results H1 2021
PAION Earnings Call Financial Results H1 2021 Dr. Jim Phillips, CEO | Abdelghani Omari, CFO Conference Call | 23 August 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 4 Conclusion 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 & other stakeholders in healthcare.” 4 | www.paion.com
Slide 5: 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 2021-22 Drive rapid revenue growth & reach profitability end of 2023/begi
Slide 6: 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 7: 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 cEUR130 m (Xetra, Tradegate & FRA stock markets): (FSE: PA8) c 30 million shares traded (c 45% of Free Float) Shareholder structure Market Data (Accord
Slide 8: Key targets and news flow for PAION in 2021
Key targets and news flow for PAION in 2021 Licensing of Byfavo ®, GIAPREZA ® & XERAVA ® in non-core EU markets Filing Byfavo® in GA until the end of 2021 Ongoing Byfavo® partners sales growth & launch activities Commercial launch of Byfavo® ✓, GIAPREZA®✓ & XERAVA® in Europe Market approval Byfavo®
Slide 9: Agenda
AGENDA 1 Corporate Overview 2 Products 3 Financials 4 Conclusion 9 | www.paion.com
Slide 10: 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 11: Byfavo / Remimazolam
Byfavo® / Remimazolam 11 | www.paion.com
Slide 12: 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 13: Broad Label for Byfavo provides ample opportunity
Broad Label for Byfavo® provides ample opportunity BYFAVO® (remimazolam besylate) is indicated in adults for procedural sedation TIME PROCEDURE INDEPENDENT INDEPENDENT Application does not require anaesthetist 13 | www.paion.com
Slide 14: 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 Dosing patent – Protection until at least 2033 in Japan Growing IP portfolio to secure attractive period of market exc
Slide 15: Commercialization strategy
Commercialization strategy Regions Western Europe Ex-EU + Southeast EU Strategy Own commercialization Partnering Rationale • Own commercialization as the • Search for local champions basis to develop the company to • “String of pearls” a specialty pharma company • Highest margin 15 | www.paion.com
Slide 16: Our Partnering strategy EX-EU
Our Partnering strategy EX-EU 16 | www.paion.com
Slide 17: PAION's partners – product revenues of EUR 2.7 million in H1 2021
PAION‘s partners – product revenues in the amount of EUR 2.7 million in H1 2021 U.S. – Acacia Pharma Japan – Mundipharma Taiwan – TTY BIOPHARM Lead indication: Procedural Sedation Lead indication: General Anesthesia License agreement signed in March 2021 Acacia launched BYFAVOTM in Jan 2021
Slide 18: Japan (Anerem) & China (Ruima)
Japan (Anerem®) & China (Ruima®) JAPAN CHINA • NHI national reimbursed price of ¥2,218 per 50 mg vial • Pricing at launch RMB139 / Vial ( ~ €17) (~ €17) • Currently the strongest market globally • Chinese KOLs supportive • 400 hospitals had product listed by year-end 2020 • “[…] four major advantage
Slide 19: BYFAVO U.S. launch
BYFAVOTM U.S. launch 47 accounts open (30 June 2021) including Mayor Clinics, against an FY 2021 expectation of 150; this represents an increase of 40 accounts since March 2021 A critical success factor was to avoid the necessity for administration by anesthesiologists or nurse anesthetists only
Slide 20: Report of early use in the USA – CRNA letter
Report of early use in the USA – CRNA letter 20 | www.paion.com
Slide 21: Paion commercial build up in Europe
Paion commercial build up in Europe 21 | www.paion.com
Slide 22: Early Partner launches provide education for EU launches
Early Partner launches provide education for EU launches Successful partner launches confirmed high market potential Targeted sales team approach has the highest risk/benefit ratio The launch comes at a time when COVID-19 has caused significant backlogs for elective surgeries and routine proce
Slide 23: 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 24: Commercial Organisation in Europe – investing for growth
Commercial Organisation in Europe – investing for growth 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 Netherla
Slide 25: Dedicated field-based commercial team structure
Dedicated field-based commercial team structure (green - in place) Targeted approach from Key Account Manager (KAM) and Medical Science Liaison (MSL) 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
Slide 26: Staggered launches of complete portfolio in 2021-22
Staggered launches of complete portfolio in 2021-22 Aligned with sales/profit expectations over time In July 2021, GIAPREZA® was launched in Germany In August 2021, Byfavo® was launched in UK Aug 21 - Q2/22* July 21- Q3/22* Q4/21-Q4/22* PAION will target nearly all mid- to large-sized accounts**
Slide 27: Overview of Byfavo launch and market preparation
Overview of Byfavo® launch and market preparation – Launched in UK in August 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
Slide 28: 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 EUROPE5 procedural sedative ~1.2 million ~2.7 million ~2.7 million ~1.9 million Bronchoscopy* Cataract Surgery* Car
Slide 29: Market Research
Market Research Suggests there is a high willingness to use Byfavo Regarding the potential use for procedural sedation by you, please select the option(s) that Willingness to use Byfavo for apply: procedural sedation: A. I would immediately start # of experts using it in some patients 45 B. I would
Slide 30: GIAPREZA & XERAVA
GIAPREZA® & XERAVA® 30 | www.paion.com
Slide 31: 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 32: Distributive shock as a result of sepsis remains a major unmet medical need
Distributive shock as a result of sepsis remains one of healthcare’s major unmet medical needs 32 | www.paion.com
Slide 33: Market Environment in septic shock
Market Environment in septic shock 1st Line Therapy • Catecholamine (dopamine, adrenaline, norepinephrine) • ~770k patients in EU 2nd line Therapy • Vasopressors (Argipressin [Brandname: Empressin], Vasopressin*) • ~ 300k patients in EU Patients who do not adequately respond to 1st/2nd line • GIAPRE
Slide 34: 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 company Tetraphase Potential to become a first line therapy prior to bacterial i
Slide 35: XERAVA effective against a wider range of AMR bacteria
XERAVA® effective against a wider range of AMR bacteria 35 | www.paion.com
Slide 36: Market environment in complicated Intra-Abdominal Infections (cIAI)
Market environment in complicated Intra-Abdominal Infections (cIAI) 1st line (empiric) therapy 2nd line (empiric) therapy • Carbapenems: • Combination therapy of generic 1st line antibiotics • Imipenem generic molecules • Ertapenem • Non-generic brands indicated in cIAI • Meropenem – indicated in cI
Slide 37: Agenda
AGENDA 1 Corporate Overview 2 Pipeline 3 Financials 4 Conclusion 37 | www.paion.com
Slide 38: Cash position and financing
Cash position and financing Cash of EUR 21.2 million (as of 30 June 2021) 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 drawn in June 2021 Capital increase with subscription rights with gross proceeds of
Slide 39: Consolidated statement of comprehensive income
Consolidated statement of comprehensive income In accordance with IFRS (all figures in EUR k) Revenues R&D Expenses 3.520 3.617 H1 2020 H1 2021 -2.912 H1 2020 H1 2021 -6.399 SG&A Expenses Earnings before interest and tax H1 2020 H1 2021 H1 2020 H1 2021 -3.610 -6.682 -8.706 -8.593 R&D expenses decr
Slide 40: 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 48.607 1,495 21.161 19.666 28.150 31 Dec. 2020 30 June 2021 31 Dec. 2020 Total Cash Flow 30 June 2021 Equity Employees (avg.) in the Group 21.290 47 1
Slide 41: Financial Outlook 2021
Financial Outlook 2021 Actual FY 2020 Plan FY 2021 Comments EUR million EUR million € 8m to € 9.5m from licensees (previous guidance: € 7.5m to € 9m) - € 4m to € 4.5m from royalties and sale of remimazolam API (previous guidance: € 5m to € 6m) - € 4m to € 5m from milestones and upfront payments Reve
Slide 42: Agenda
AGENDA 1 Corporate Overview 2 Products 3 Financials 4 Conclusion 42 | www.paion.com
Slide 43: Conclusion
Conclusion PAION is now a commercial stage specialty pharma company 3 strong products exhibiting market need & use all over the world First commercial & profitable year was 2020 Now investing for revenue growth in commercialization capabilities & launches We can become a high margin profit
Slide 44: 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 44 | www.paion.com