Slide 1: Conference Call | First Quarter 2023
Conference Call | First Quarter 2023 Gregor Siebert, CEO | Sebastian Werner, CFO 17 May 2023
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 | w w w.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 anaesthesia & critical care by bringing novel products to market to benefit patients, doctors & other stakeholders in healthcare. 4 | w w w.paion.com
Slide 5: PAION strategy
PAION strategy Explore additional outlicense and Establishment of professional distribution opportunities outside commercial hospital sales Europe for the lead drug remimazolam organizations in Europe Evaluate synergistic opportunities - for Anesthesia and Critical Care (lifecycle management) and in
Slide 6: PAION AG at a glance
PAION AG at a glance PAION AG is a specialty pharmaceutical company Approval for remimazolam in all major pharmaceutical markets, focusing on anesthesia and critical care products Market launch in Europe, Japan, South Korea, Taiwan and the USA, plus licensing in Latin America and Southeast Asia. 3 i
Slide 7: PAION's product portfolio and market access
PAION's product portfolio and market access Attractive Sales Target Group addressed by speciality portfolio in anesthesia and intensive care Market access and technical sales readiness achieved in main markets Long-term patent validity of +10 years, just at the beginning Gross margin potential, peak
Slide 8: Gregor Siebert appointed as CEO
Gregor Siebert appointed as CEO with more than 35 years of pharma & medical device industry experience Global Sales & Marketing Executive with proven track record of restructuring, building and driving sales organizations Key Expertise: Europe and Emerging Markets, Sales & Marketing Strategy and Exe
Slide 9: Sebastian Werner appointed as CFO
Sebastian Werner appointed as CFO with more than 20 years of pharma experience Finance Executive with proven track record in the pharma industry Key Expertise: Extensive experience in finance. Senior positions in the pharmaceutical and life science industry for over 20 years. He started this interna
Slide 10: Important events 2023
Important events 2023 EU approval of remimazolam in general anesthesia in the EU Extraordinary General Meeting approves capital reductions and creates scope for further corporate financing The CMS (Centers for Medicare & Medicaid Services) has established a „J-code“ for remimazolam in the U.S. that
Slide 11: Targets for PAION 2023
Targets for PAION 2023 Remimazolam launch in General Anesthesia in the EU Market access and launch implementations of Angiotensin II and Eravacycline in EU Growth in remimazolam sales in the key markets in Europe Market approval remimazolam EU General Anesthesia Remimazolam CHMP meeting EU General A
Slide 12: Agenda
AGENDA 1 Corporate Overview 2 Products 3 Financials 12 | w w w.paion.com
Slide 13: Lifecycle Management
Lifecycle Management 2021 '22 '23 '24 '25 '26 '27 '28 '29 '30 '31 '32 '33 '34 '35 '36 Adults 12y - 18y Procedural sedation 2y – 12y 0y – 2y March '36 Adults TCI General anesthesia 2y - 18y Adults Distributive shock Dec '34 2y - 18y Adults Complicated intra-abdominal Sep '33 2y - 18y infections Year
Slide 14: Three innovative products for acute care in Hospitals for Europe
Three innovative products for acute care in Hospitals for Europe Angiotensin II Remimazolam Eravacycline Indication: septic or other distributive shock*. Indication: procedural sedation for adults. Indication: treatment of complicated intra- abdominal infections (cIAI) in adults**. Leverages a sys
Slide 15: Lead drug Remimazolam (Byfavo)
Lead drug Remimazolam (Byfavo®) 15 | w w w.paion.com
Slide 16: 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 Less resources of sedation Pain on injec
Slide 17: Remimazolam launched worldwide – licensing and supply to regional experts
Remimazolam launched worldwide – licensing and supply of acute and specialty pharmaceuticals to regional experts Hana Pharm S. Korea launch 2021 Mundipharma Eagle Pharmaceutical Japan launch 2020 USA launch 2021 IP sold to Humanwell in 2022 Cristália Brazil TTY Biopharm launch expected Taiwan launch
Slide 18: PAION's partners
PAION's partners U.S. - Eagle Pharma Japan - Mundipharma Taiwan - TTY BIOPHARM Lead indication: procedural sedation Lead indication: general anesthesia License agreement signed in 2021 BYFAVOTM launched in 2021 Mundipharma launched Anerem ® in 2020 Approval received 2022 Royalties 20-2
Slide 19: Target groups: Physicians and judgements about remimazolam
Target groups: Physicians and judgements about remimazolam The sedation experts: Anesthetist Safety oriented & specialist skillset Key person for the introduction of a new sedation drug Decision-makers in favor of promoting remimazolam, very positive toward remimazolam The experts for interven
Slide 20: Three different innovative drugs in one commercial organization
Three different innovative drugs in one commercial organization Place of Usage OR ICU Endoscopy Decision Makers Anesthetist Microbiologist Gastroenterologist ICU –Specialist Pharmacist Strong overlap in accounts (decisionmakers) and target groups * Other specialties key for formulary listing, eg Ine
Slide 21: Sponsored angiotensin II symposium at ISICEM in Brussels
PAION hosted a sponsored angiotensin II symposium at ISICEM in Brussels Physician`s Comment: “We need to position Angiotensin II after epinephrine. We should stop increasing the dose of epinephrine and switch more quickly to second-line options.” 21 | w w w.paion.com
Slide 22: Sponsored remimazolam symposium at EUROANAESTHESIA in Glasgow
PAION will host a sponsored remimazolam symposium at EUROANAESTHESIA in Glasgow 22 | w w w.paion.com
Slide 23: General anesthesia launch of remimazolam
General anesthesia launch of remimazolam - target i.v. market and critically ill patients IV MARKET PATIENT FOCUS Concentration on the IV market Focus on ASA III and IV patients. Concentration on the IV market Phase III studies conducted Switching strategy from IV anesthetics (e.g., propof
Slide 24: Agenda
AGENDA 1 Corporate Overview 2 Products 3 Financials 24 | w w w.paion.com
Slide 25: Cash position and financing
Cash position and financing Cash of € 7.1m (as of 31 March 2023) Additional funds required Sufficient cash until end of 3rd Quarter 2023 Expected payments from revenues, potential financing and/or out-licensing PAION expects increasing revenues from licensing agreements and commercialization in
Slide 26: Consolidated statement of comprehensive income
Consolidated statement of comprehensive income In accordance with IFRS (unaudited figures in EUR k) Revenues R&D Expenses 800 Q1 2022 Q1 2023 Operative One Time 21’502 20,702 2’266 1,266 1,000 -916 -1,138 Q1 2022 Q1 2023 SG&A Expenses FY 2021 EBITDA FY 2022 Q1 2022 Q1 2023 15,006 -4,511 -3,714 -5,06
Slide 27: Cash and employees
Cash and employees In accordance with IFRS (unaudited figures in EUR k, if not otherwise noted) Employees (reporting date) in the Group Cash and cash equivalents 10,629 3,485 7,144 72 68 FY 2022 Q1 2023 31 Dec. 2022 Total Cash Flow 31 Mar. 2023 27 | w w w.paion.com
Slide 28: Financial Outlook 2023
Financial Outlook 2023 Revenues Low: 13 Mio. €; High: 19 Mio. € EBITDA Low: -15 Mio. €; High: -13 Mio. € 28 | w w w.paion.com
Slide 29: Suitable Financing Concept progressing
Suitable Financing Concept progressing Extraordinary General Meeting 2023 in January approved the proposed capital reductions by redemption and consolidation of shares EGM Resolutions were entered into the commercial register at the local court of Aachen on 14 March 2023 With regard to the option of
Slide 30: Contact
Contact: PAION AG Heussstraße 25 Phone: +49 241 44 53-0 52078 Aachen – info@paion.com Germany www.paion.com 30 | w w w.paion.com