Slide 1: Corporate Presentation Q3 2024
Corporate Presentation Q3 2024 1
Slide 2: Disclaimer
Disclaimer References herein to this presentation (the “Presentation”) shall mean and include this document, any oral presentation accompanying this document provided by Advicenne SA (the “Company”) and any further information that may be made available in connection with the subject matter containe
Slide 3: Sibnayal / ADV7103 commercially available
Sibnayal® / ADV7103 commercially available • Commercial launch in EU and UK for the treatment of dRTA (distal Renal Tubular Acidosis) in pediatric (from one year of age) and adult patients • H1 2024 gross sales: 1.28M€ up 28% • Around 10 patients gain per month on average • Distribution partnerships
Slide 4: …and supported by an extended distribution platform
…and supported by an extended distribution platform Nordics & Baltics - Signing date: 01/2022 - Signing date: 02/2023 Germany Distribution by Distribution by FrostPharma Avanzanite CEE - Signing date: 12/2021 Distribution by France, UK ExCEEd Orphan Commercial op. Austria Distribution by - Signing d
Slide 5: ADV7103: a breakthrough alkalinizing asset for rare renal diseases
ADV7103: a breakthrough alkalinizing asset for rare renal diseases • Patented prolonged release combination of potassium citrate (CK) and potassium hydrogen carbonate (bicarbonate - BK) enabling twice-daily dosing • Only convenient chronic oral treatment (>6-year European follow-up data): o Sustaine
Slide 6: ADV 7103: Designed to Change Patient’s Lives
ADV 7103: Designed to Change Patient’s Lives • ADV7103: Fixed combination of potassium citrate(CK) and potassium bicarbonate(BK) • Sequential and prolonged release of CK and BK enabling 24 hour pH control from twice- daily dosing Dissolution curves for ADV7103 CK (Citrate) and BK Predicted plasma PK
Slide 7: ADV7103: Impactful on Long-Term Bone Growth
ADV7103: Impactful on Long-Term Bone Growth Spine bone mineral density z-score change over 48 Analysis of covariance of z-score months for kids and adults Statistically significant incremental improvement • Significant increase of z-score in spine BMD compared to baseline (ANCOVA) for both kids and
Slide 8: ADV7103: Strong Business Protection
ADV7103: Strong Business Protection • ADV7103 is protected by 3 family patents covering formulation, including the patent that covers the combination of potassium citrate and potassium bicarbonate in a delayed- release formulation • Initial patents expiration date: November 2031 in USA and Europe •
Slide 9: Advicenne Regulatory Strategy has led to early NDA Filing
Advicenne Regulatory Strategy has led to early NDA Filing Advicenne has convinced FDA of a possible filing by leveraging EU clinical data and KOL support Long term safety and efficacy data from EU ➢ B21: demonstrated long-term control of metabolic acidosis with very good safety and tolerability prof
Slide 10: Cystinuria: a rare and well documented genetic disease
Cystinuria: a rare and well documented genetic disease • Cystinuria is a rare genetic disease characterized by a build-up of undissolved cystine in the kidneys and bladder, leading to the formation of cystine crystals and/or stones which may block the urinary tract • Cystine stones are challenging a
Slide 11: Advicenne Regulatory Strategy for Cystinuria
Advicenne Regulatory Strategy for Cystinuria Advicenne strategy in cystinuria validated by grant of ODD Importance of achieving ODD ➢ Implicit agreement from FDA that this drug has a role in cystinuria – plausibility ➢ Opens door to discuss PIII registration study with urine pH primary endpoint FDA
Slide 12: H1 2024 P&L – current / non current
H1 2024 P&L – current / non current INCOME STATEMENT June 30, 2024 June 30, 2023 Variance (in thousands of euros) Revenues 1 658 1 581 77 • Gross sales: 2,462 KEUR, up +10% Income from partnerships 119 4 115 Other operating income 137 138 - -2 • Sibnayal® up 14%, incl. royalties. Total revenue and o
Slide 13: June 30, 2024 - Cashflow statement IFRS
June 30, 2024 - Cashflow statement IFRS CASH FLOW June 30, 2024 June 30, 2023 (in thousands of euros) Net result (loss) -5 533 -3 734 Amortisation, depreciation and provisions 1 659 102 H1 2024 Net cashburn: 3.3 MEUR vs 4.9 MEUR in H1 Share-based payments 79 164 Net financial costs 712 627 2023 Sale
Slide 14: Advicenne’s value proposition
Advicenne’s value proposition ▪ US footprint ▪ European organization - ADV7103 Orphan Drug Designation in - Operating platform in France and dRTA and cystinuria the UK - Low clinical risk / Pediatric indication / - Rare diseases expertise formulation - Sibnayal® (ADV7103) dRTA - Significant US marke
Slide 15: Shareholding structure
Shareholding structure bpifrance 21,6% Free Float 56% CEMAG Invest 18,0% IRDI SORiDEC GESTION 3,5% Management 0,9% Source: Company information 15 Corporate presentation- Q3 2024
Slide 16: Contact: Didier Laurens - CEO
Contact: Didier Laurens - CEO dlaurens@advicenne.com 16