Paion AG · GETTEX:PA8
Paion — FY2021 Earnings Presentation
48 slides from Paion's earnings presentation, Mar 30, 2022
Slide 1: PAION Earnings Call Financial Results 2021
PAION Earnings Call Financial Results 2021 Dr. Jim Phillips, CEO | Abdelghani Omari, CFO Conference Call | 30 March 2022
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 Continue to launch remimazolam (brand name Byfavo®), Angiotensin II (brand name GIAPREZA®) and eravacycline (brand name XERAVA®) in key EU markets
Slide 6: Corporate overview
Corporate overview PAION AG is a specialty pharma company with a PAION has commercial partners for remimazolam focus on anesthesia and critical care products in the U.S., South Korea, Southeast Asia, Taiwan and Japan Remimazolam, angiotensin II & eravacycline are highly complementary fits for commer
Slide 7: PAION AG is listed on Frankfurt Stock Exchange
PAION AG is listed on Frankfurt Stock Exchange Listed on Frankfurt Stock Market capitalization: Shareholder structure Exchange, Prime Standard cEUR100 m (According to the latest notifications) (FSE: PA8) Above 3%: Cosmo Pharmaceuticals Liquidity (2021) Market Data 25 Millionen Capitalization (as of
Slide 8: Key targets and news flow for PAION in 2022
Key targets and news flow for PAION in 2022 Market approval remimazolam EU and UK General Anesthesia (2022/2023) Remimazolam CHMP meeting EU General Anesthesia Licensing of remimazolam, angiotensin II & eravacycline in non-core EU markets Ongoing remimazolam partners sales growth & launch activities
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 Remimazolam Besylate General Anesthesia Procedural Sedation ICU Sedation Angiotensin II Blood pressure management to treat EU / EEA / CH / UK septic shock Eravacycline Complicated Intra- EU / EEA / CH /
Slide 11: Remimazolam (Byfavo)
Remimazolam (Byfavo®) 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: The backbone of the remimazolam story
The backbone of the remimazolam story: Procedural success, Time to fully alert, safety profile Procedural success Time to fully alert Safety in ASA III/IV • Key benefit for patient and specialist alike • Significant time-saving enables higher • Reassures all about safety profile of • Eliminates stre
Slide 14: Broad Label for remimazolam provides ample opportunity
Broad Label for remimazolam provides ample opportunity remimazolam besylate is indicated in adults for procedural sedation TIME PROCEDURE INDEPENDENT INDEPENDENT Application does not require anaesthetist 14 | www.paion.com
Slide 15: Remimazolam – IP Status
Remimazolam – 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 exclusivity in major markets P
Slide 16: 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 16 | www.paion.com
Slide 17: Our Partnering strategy EX-EU
Our Partnering strategy EX-EU 17 | www.paion.com
Slide 18: PAION's partners – product revenues of EUR 7.5 million in 2021
PAION‘s partners – product revenues in the amount of EUR 7.5 million in 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 M
Slide 19: China (Ruima)
China (Ruima®) • In China good sales growth has been seen during 2021 for remimazolam (brand name Ruima®) • Beginning of 2022 PAION entered into a patent assignment agreement Humanwell • Under the agreement, PAION assigns all its Chinese remimazolam patents and sells the related future royalties for
Slide 20: Japan (Anerem)
Japan (Anerem®) JAPAN • NHI national reimbursed price of ¥2,218 per 50 mg vial (~ €17) • 400 hospitals had product listed by year-end 2020 • Strong market with growing sales • sales are expected to be back on track in 2022 (batch recall in 2021) 20 | www.paion.com
Slide 21: Remimazolam (Byfavo) U.S. launch
Remimazolam (BYFAVOTM) U.S. launch By the end of September 2021, remimazolam had been put on formulary in 95 accounts with a >90% win rate; Acacia expected a total of 150 accounts to put remimazolam on formulary by the end of 2021. A critical success factor was to avoid the necessity for adminis
Slide 22: Report of early use in the USA – CRNA letter
Report of early use in the USA – CRNA letter 22 | www.paion.com
Slide 23: PAION commercial build up in Europe
PAION commercial build up in Europe 23 | www.paion.com
Slide 24: 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 25: PAION Structure: Company Organizational Overview
PAION Structure: Company Organizational Overview European HQ Nordic Hub United Kingdom Netherlands DACH Hub (DE/AT) (DK/SE/NO/FI) London Amsterdam TBC Odense Country structure: Country Manager Non-commercial functions outsourced or centrally managed Country Admin Sales Manager* Marketing Manager Med
Slide 26: Structure of Field Based Teams
Structure of Field Based Teams Targeted approach from KAMs/MSLs Country KAMs MSLs Total Netherlands 4 1 5 Field personnel via Denmark 2 1 3 CSO (Syneos Health) Germany (tbc) 8 2 10 to mitigate risk with UK 8 2 10 the plan to internalise Sweden 2 1 3 field force 1-2 years after deployment Norway 1 1
Slide 27: 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 28: Market Research
Market Research Suggests there is a high willingness to use remimazolam Regarding the potential use for procedural sedation by you, please select the option(s) that Willingness to use remimazolam apply: for procedural sedation: A. I would immediately start # of experts using it in some patients 45 B
Slide 29: PAION's Key Account Framework
PAIONs Key Account Framework 29 | www.paion.com
Slide 30: KPI Tracking remimazolam
KPI Tracking remimazolam KPI Account Planning # Identification # Identification of all Key of key person Number of # Set-Up of Individuals/ championing # First order Accounts Account Plan Decision-making the formulary placed unit/decision submission Country process (plus back-up) Denmark 59 59 16 4
Slide 31: General anesthesia
General anesthesia DISPLACE PROPOFOL ASA III/IV PATIENTS • Phase III trial conducted in ASAIII and IV patients • Easier to displace propofol than • Integrated analysis shows volatile gases haemodynamic benefit more • Theatres already set up with pronounced in ill patients equipment needed for IV • U
Slide 32: Market
Market • The European market for General anesthesia (GA) in markets where PAION intends to become active is estimated to cover ~17m inpatient procedures annually • Procedures are expected to grow at a rate of ~0.7% due to an underlying population growth (~0.4%, 2020-301), an ageing population2 and a
Slide 33: Filing in General Anesthesia end of 2021
Filing in General Anesthesia end of 2021 Based on the positive results of the EU Phase III trial in general anesthesia, PAION has submitted an extension application to the marketing authorization for remimazolam in the indication of general anesthesia to the EMA end of 2021 A decision by the EMA
Slide 34: Angiotensin II (GIAPREZA) & eravacycline (XERAVA)
Angiotensin II (GIAPREZA®) & eravacycline (XERAVA®) 34 | www.paion.com
Slide 35: Angiotensin II (GIAPREZA) approved for septic shock in EU & U.S.
Angiotensin II (GIAPREZA®) approved for septic shock in EU & U.S. Angiotensin II 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 applic
Slide 36: 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 36 | www.paion.com
Slide 37: 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 • Angiot
Slide 38: About eravacycline (XERAVA)
About eravacycline (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 bacte
Slide 39: Eravacycline effective against a wider range of AMR bacteria
Eravacycline effective against a wider range of AMR bacteria 39 | www.paion.com
Slide 40: 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 41: Agenda
AGENDA 1 Corporate Overview 2 Pipeline 3 Financials 4 Conclusion 41 | www.paion.com
Slide 42: Cash position and financing
Cash position and financing Cash of EUR 6.4 million (as of 31 December 2021) Patent Assignment Agreement (Jan 2022) with Humanwell for EUR 20.5 million Additional funds are required Sufficient cash for the next 12 months cash at hand cash inflows from Humanwell Deal expected payments f
Slide 43: 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 2020 FY 2021 7.128 -5.249 -10.288 FY 2020 FY 2021 SG&A Expenses Net Result FY 2020 FY 2021 FY 2020 FY 2021 2.222 -7.523 -19.828 -21.786 SG&A expenses: Selling expenses incr
Slide 44: 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 36.785 28.150 19.666 13.226 6.440 31 Dec. 2020 31 Dec. 2021 31 Dec. 2019 Total Cash Flow 31 Dec. 2020 Equity Employees (avg.) in the Group 21.290 51 4
Slide 45: Financial Outlook 2022
Financial Outlook 2022 Actual FY 2021 Plan FY 2022 Comments EUR million EUR million € 25 - 27m from licensees - € 20.5m from Humanwell Revenues € 7.1m € 32m – € 35m - € 4,5m - € 6,5m from royalties and sale of remimazolam API € 2m - €3m from own commercialization in parts of Europe € 5m from outlice
Slide 46: Agenda
AGENDA 1 Corporate Overview 2 Products 3 Financials 4 Conclusion 46 | www.paion.com
Slide 47: Conclusion
Conclusion PAION is now a commercial stage specialty pharma company 3 strong products exhibiting market need & use all over the world Break-even expected in 2024 Now investing for revenue growth in commercialization capabilities & launches We can become a high margin profitable business in
Slide 48: 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 48 | www.paion.com