Xbrane Biopharma AB · OMXSTO:XBRANE
Xbrane Biopharma AB — Q3 2023 Earnings Presentation
19 slides from Xbrane Biopharma AB's earnings presentation, November 2023
Slide 1: Xbrane – a World-Leading Biosimilar Developer
STO: XBRANE November 2023 Xbrane – a World-Leading Biosimilar Developer 1
Slide 2: Disclaimer
You must read the following before continuing. The following applies to this document and the information provided in this presentation by Xbrane Biopharma AB (publ) (the “Company”) or any person on behalf of the Company and any other material distributed or statements made in connection with such p
Slide 3: Key Achievements in First Nine Months
Key Achievements in First Nine Months * Generated revenues of +170mSEK * Launch of Ximluci® late March, volume growth 20% q3 vs q2 2023, now available in 12 markets, on path with revised sales targets ¢ Filed Ximluci BLA to FDA in April, accepted for review in June ¢ Secured financing of 375mSEK in
Slide 4: Current Focus for Xbrane
Current Focus for Xbrane Reaching positive cash-flow as soon as possible and minimizing potential need for additional capital through: * Supporting Ximluci® Sales Uptake in Europe with improved margin (reducing manufacturing costs) and launching the pre-filled syringe * Engaging a US partner for Xim
Slide 5: Current portfolio of biosimilar candidates
Originator peak sales estimate 2026* (€ billion) Biosimilar Ximluci® BIIB801™ Xdivane™ Xdarzane™ Current portfolio candidate Branded biologics Therapeutic Ophthalmology Immunology Oncology Oncology area 2020 (US) 2024 (US) 2029 (US) 2029 (US) Patent expiry 2022 (EU) 2025 (EU) 2030 (EU) 2030 (EU) EU:
Slide 6: European countries where Ximluci is launched (Q3 2023)
European countries where Ximluci is launched (Q3 2023) Comments → → → → → → → → 6
Slide 7: Retinal anti-VEGF sales (ex US)
Retinal anti-VEGF sales (ex US) Comments € million Approx. € 200-300m / quarter additional 1400 market from off label Avastin1 → 1200 1000 → 800 → 600 → 400 → 200 0 → Q2 2022 Q3 2022 Q4 2022 q1 2023 q2 2023 q3 2023 Eylea Vabysmo Lucentis Beovu Ranivisio Ximluci Sources: Novartis, Roche and Regeneron
Slide 8: Regulatory process EU and US, production and launch timeline
2022 2023 2024 Regulatory process EU Production launch volume* Regulatory process US Drug substance process scale-up Pre-filled syringe development Q1 2025 H2 2024 June 2023 April 2024 Expected PFS Feb 2022 July 2022 March 2023 US launch FDA accepts Expected US launch Top-line data Lucentis® LoE EU
Slide 9: Retinal anti-VEGF sales (US)
Retinal anti-VEGF sales (US) Commentary on Q3 2023 USD million Approx. USD 150m / quarter additional → 2500 annual market from off label Avastin1 → 2000 → 1500 → 1000 → 500 → → 0 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 Eylea Vabysmo Lucentis Beovu Cimerli Byooviz Sources: Quarterly r
Slide 10: Commercial Focus of Development Portfolio
Commercial Focus of Development Portfolio 10 Focus on development of products that can generate revenues in the short-term Prioritize development of Xdivane™ (Opdivo ® biosimilar candidate) as immuno-oncology biosimilar * First PD1 inhibitor to go off patent with an estimated market of € 13 billion
Slide 11: Introduction of Cost-Savings Program
Introduction of Cost-Savings Program — Adjusting the Costume 11 Expected yearly savings estimated to SEK 50 million per annum Total reduction of 38 positions, of which 20 are consultants, 4 vacancies not to be filled Reduction of remaining 14 positions (permanent employees) Core team of 75 employees
Slide 12: Slide 12
Slide 13: Quarter by Quarter revenue
Quarter by Quarter SEK m Q3 '22 Q4 '22 Q1 '23 Q2 '23 Q3 '23 70,0 • 60,0 50,0 • Product sales (incl. Profit share) 40,0 47,7 Outlicensing of product Contract manufacturing 37,0 30,0 58,7 Other • 20,0 14,1 • 13,9 14,1 14,1 10,0 3,2 0,0 0… 13
Slide 14: Quarter by Quarter costs
Quarter by Quarter SEK m Q3 '22 Q4 '22 Q1 '23 Q2 '23 Q3 '23 0 -6,6 -8,2 -11 -12 -11,3 -20 -51,2 -40 -59,5 -57,9 -81,5 -87,3 -60 -80 -100 -120 55% G&A R&D 14
Slide 15: Cash and Cash Equivalents, Operating Cash Flow
Cash and Operating Cash Flow Cash Equivalents Quarter by Quarter Quarter by Quarter SEK m SEK m Q3 '22 Q4 '22 Q1 '23 Q2 '23 Q3 '23 350 316 0 300 -20 250 -40 194 200 -60 165 167 -57 -80 150 119 -75 -100 100 -120 50 -115 -140 -125 0 -160 -143 Q3 '22 Q4 '22 Q1 '23 Q2 '23 Q3 '23 15
Slide 16: Outstanding Convertible Bond Recap
Outstanding Convertible Bond Recap 16 Outstanding debt SEK 229 m (nominal amount) Conversion price 93 SEK Favorable terms with interest rate of 6% until FDA approval, thereafter 0% Remaining duration 44 months (counting q3, 2023) Generally, amortization in equal installments every second month (cert
Slide 17: Key Take-Aways
Key Take-Aways Generated revenues of +170mSEK q1-q3, 2023 Launched Ximluci® in Europe, volume growth 20% q3 vs q2 2023, now available in 12 markets, on path with revised sales targets Consolidated the portfolio, introduced a cost-saving program Key priorities for the foresee-able future 17 Reaching
Slide 18: Q/A – Business Concept, Vision, Objective
Q/A BUSINESS CONCEPT Xbrane develops and manufactures biosimilars of difficult-to-manufacture and often very expensive original drugs VISION To become a world-leading scientifically-based biosimilar developer of cost- effective drugs for which there is a significant medical need OBJECTIVE To contrib
Slide 19: Q&A