Paion AG · GETTEX:PA8
Paion — H1 2023 Earnings Presentation
25 slides from Paion's earnings presentation, Sep 29, 2023
Slide 1: PAION Earnings Call - Financial Results H1 2023
PAION Earnings Call - Financial Results H1 2023 Tilmann Bur, CEO | Sebastian Werner, CFO 29 September 2023
Slide 2: Disclaimer
Disclaimer This presentation (the “Presentation”) is confidential. It contains information regarding PAION AG, a German stock corporation (Aktiengesellschaft) (the “Company”) and its direct or indirect subsidiaries (together “PAION”). It is being provided for informational purposes only and should n
Slide 3: Agenda
Agenda 01 Corporate Overview 02 Products 03 Financials 3 | www.paion.com
Slide 4: PAION AG at a glance
PAION AG at a glance PAION AG is a specialty 3 innovative products: Approval for lead drug Listed on the Frankfurt pharmaceutical company Lead drug Byfavo® Byfavo® in all major Stock Exchange headquartered in Aachen, (sedative/anesthetic) pharmaceutical markets, (since 2005) Germany, founded in GIAP
Slide 5: Management Board: Proven track record in the pharma industry
Management Board: Proven track record in the pharma industry Tilmann Bur, CEO Sebastian Werner, CFO Commercial Executive with international management Finance Executive with proven track record in the experience with a focus on sales and marketing. pharma industry Key Expertise: Extensive experience
Slide 6: PAION's Mission Statement
PAION’s Mission Statement “ Our mission is to be a leading specialty pharmaceutical company in the fields of anaesthesia & critical care by bringing our innovative products Byfavo®, GIAPREZA® & XERAVA® to market - to benefit patients, doctors & other stakeholders in healthcare. 6 | www.paion.com
Slide 7: PAION's strategy
PAION’s strategy Explore additional outlicense and distribution opportunities outside Developing a distribution platform Europe for the lead drug remimazolam for our products Evaluate synergistic opportunities Byfavo®, GIAPREZA® & XERAVA® (lifecycle management) and in- for Europe and worldwide (Byfa
Slide 8: PAION's commercial pathway
PAION’s commercial pathway Gross margin Market access Long-term Attractive High potential Strong partner potential, total (pricing patent validity sales target for product network: peak sales approval) and of 10+ years, group portfolio; Viatris potential at technical sales just at the addressed by
Slide 9: Important achievements in 2023
Important achievements in 2023 Submission Extraor- TTY Approval of The CMS Hana Pharm Pricing and Launch of of dinary Biopharm Byfavo® in (Centers for has received reimburse- Byfavo® in NDA for General (Taiwan) has general Medicare & market ment the Byfavo® by Meeting filed Byfavo® anesthesia Medica
Slide 10: Agenda
Agenda 01 Corporate Overview 02 Products 03 Financials 10 | www.paion.com
Slide 11: Three innovative products for acute care in hospitals worldwide
Three innovative products for acute care in hospitals worldwide PAION's IP rights Clinical status EU (peak sales potential p.a.) RoW (peak revenue potential p.a.) Byfavo® World wide Market approvals in € 40 to 50 million € 35 million (potential (without the US, EU, Japan, (procedural sedation) partn
Slide 12: Lifecycle Management: Patent term until 2036 – long term opportunity for all three products
Lifecycle Management: Patent term until 2036 – long term opportunity for all three products 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 - 1
Slide 13: PAION's commercialization strategy
PAION's commercialization strategy PAION's IP rights Commercialization Outlicensing Sales Royalties Byfavo® World wide DACH, NL, UK, SK (PAION) Japan (Mundipharma) (without Eastern Europe (Medis) Latin America (Cristália) China) Western/Southern Europe (Viatris) North America (Eagle Phar
Slide 14: PAION's partners – excellent partner network worldwide
PAION's partners – excellent partner network worldwide U.S. - Eagle Pharma Japan - Mundipharma South Korea + Southeast Asia Latin America (Cristália) BYFAVOTM launched in Mundipharma launched - Hana Pharm Exclusive license agreement procedural sedation 2021 Anerem® in general anesthesia Lead
Slide 15: Approval granted by European Medical Agency (EMA)
Approval granted by European Medical Agency (EMA) Regulatory hurdle passed 15 | www.paion.com
Slide 16: Market Access achieved in the Netherlands
Market Access achieved in the Netherlands In some countries, market access is easier than in others – PAION is currently focusing on the easier countries and has recently launched Byfavo in the Netherlands and UK in general anesthesia 16 | www.paion.com
Slide 17: Market Access Germany
Market Access Germany Additional benefit confirmed & Price User-Assessment of Pharmaceuticals in Germany negotiations completed a Challenge Since 2011, the Federal Joint Committee (G-BA) has had the task of conducting an (additional) benefit assessment for all newly approved drugs immediately afte
Slide 18: Agenda
Agenda 01 Corporate Overview 02 Products 03 Financials 18 | www.paion.com
Slide 19: Consolidated statement of comprehensive income H1 2023
Consolidated statement of comprehensive income H1 2023 In accordance with IFRS (unaudited figures in EUR k) Total Revenues (incl. one time effects) Revenues (Operative) 25’230 5.776 1.050 550% 24.180 1.050 6’790 5.776 1.014 H1 2022 H1 2023 H1 2022 H1 2023 One Time Operative H1 2022 revenues were dri
Slide 20: Consolidated statement of comprehensive income H1 2023
Consolidated statement of comprehensive income H1 2023 In accordance with IFRS (unaudited figures in EUR k) SG&A Expenses EBIT H1 2022 H1 2023 H1 2022 H1 2023 11.112 -10.294 -9.350 -7.957 SG&A expenses decreased due to rigorous cost management H1 2022 EBITDA driven by patent sale to Humanwell (€ 20.
Slide 21: Cash and employees H1 2023
Cash and employees H1 2023 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 5.982 4.647 72 64 FY 2022 H1 2023 31 Dec. 2022 Total Cash Flow 30 Jun. 2023 21 | www.paion.com
Slide 22: Financial Outlook 2023
Financial Outlook 2023 Revenues EBITDA € 13m € 19m € -15m € -13m 22 | www.paion.com
Slide 23: Financing concept up to break-even
Financing concept up to break-even (based on current planning) Source Intended use Cash of €4.6 million (as of June 30, 2023) Mid-term financing need of approx. € 30m until break even "Going Concern" until Q3 2024 Funds to be used for further commercialization & obligatory study execution Additi
Slide 24: PAION is executing its strategy
PAION is executing its strategy PAION is a commercial stage 3 strong innovative and specialty pharma company with a complementary products exhibiting distribution platform serving their market need & use all over worldwide network the world Funding Streamline supply chain, High profit margin busines
Slide 25: Contact
Contact PAION AG Heussstraße 25 52078 Aachen – Germany Phone: +49 241 44 53-0 info@paion.com www.paion.com 25 | www.paion.com