Advicenne Sa · EURONEXT:ALDVI
Advicenne Sa — Investor Presentation (June 2025)
21 slides from Advicenne Sa's investor presentation, June 2025
Slide 1: Corporate presentation Q2 2025
Corporate presentation Q2 2025 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: Advicenne's value proposition
Advicenne’s value proposition • A revenue generating specialty pharma • A proprietary asset, Sibnayal® (ADV7103), marketed in Europe in rare renal disease • Significant US & EU market potential in two orphan indications • Major steps forward to market ADV7103 in the USA • Regulatory clarity for NDA
Slide 4: 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 • European End-Market 2024 sales: €6.0m up 135%. Strong performance in France and Germany • More than 450 patie
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 Current therapeutic options (1) ADV7103 Requires 3-6 intake per day √ 1 x Twice daily dosing (12h) Frequent gastrointestinal intolerance √ 3 x Satisfactory gastrointestinal tolerance Bad taste and less adapted to pediatric 4 x Tasteless and well adapted t
Slide 7: dRTA: a rare disease with life-long complications
dRTA: a rare disease with life-long complications ▪ distal Renal Tubular Acidosis (dRTA) is a rare and chronic serious renal disorder characterized by the ➢ Failure to thrive increase of acid ions in the blood leading to decreased bone mineral density ➢ Muscle weakness / paralysis ▪ 2 identified for
Slide 8: ADV7103: impact on LT bone growth consequences of dRTA
ADV7103: impact on LT bone growth consequences of dRTA 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 bot
Slide 9: 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 10: Cystinuria: a significant market opportunity
Cystinuria: a significant market opportunity American Urological Association Treatment options including ADV7103 Guidelines ▪ Diet ▪ Diet ▪ Adequate fluid intake ▪ Adequate fluid intake First-line conventional ▪ ADV7103 : Optimizing alkalinizing treatment therapy as part of conventional first-line ▪
Slide 11: Regulatory strategy leading to early NDA filing in dRTA
Regulatory strategy leading to early NDA filing in dRTA Advicenne has convinced FDA of a possible filing by leveraging EU clinical data and KOL support Well established safety and efficacy as approved by EMA ➢ B21: demonstrated control of metabolic acidosis with very good safety and tolerability pro
Slide 12: Update on dRTA 2025 regulatory activity
Update on dRTA 2025 regulatory activity Current situation Advicenne actively preparing for NDA submission ➢ Pre NDA meeting executed Q2 2025 – feedback from FDA positive, clarity provided on submission details ➢ All additional research projects completed on time, delivering data required for NDA; Ga
Slide 13: Update on Cystinuria regulatory activity
Update on Cystinuria regulatory activity Advicenne has agreed a pathway to approval via a PIII study with a biomarker endpoint Importance of achieving ODD ➢ Agreement from FDA that this drug has a role in cystinuria treatment Strategy in cystinuria ➢ Type C meeting Q4 2024 – FDA agreed PIII registra
Slide 14: Advicenne regulatory strategy for Cystinuria
Advicenne regulatory strategy for Cystinuria Advicenne strategy in cystinuria validated by grant of ODD ➢ Next Type C meeting planned to finalize the pivotal study design ➢ In partnership with KOLs, Advicenne is identifying the right measure for cystine solubility to use in the study Timelines ➢ Con
Slide 15: 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 16: ADV7103: strong business protection
ADV7103: strong business protection Orphan Drug Designation (ODD) • ADV7103 ODD for dRTA achieved December 2022 • Exclusivity period: 2033 in USA • ADV7103 ODD for Cystinuria achieved April 2024 • Exclusivity period: 2034 in USA • Reduced research costs due to tax breaks for all US R&D at higher lev
Slide 17: P&L – French GAAP
P&L – French GAAP Revenue and other income: €9.6m (vs. €5.0m in 2023, +92%) FR GAAP INCOME STATEMENT December 31, December 31, Sibnayal® +14%, +40% in France (in thousands of euros) 2024 2023 Partnership income: mostly royalties from Sibnayal® sales Other operating income: €3.5m from the Pri
Slide 18: P&L – Current / non current – French GAAP
P&L – Current / non current – French GAAP FR GAAP INCOME STATEMENT December 31, December 31, Variance 2024 non current items (in thousands of euros) 2024 2023 Revenues 4 877 4 458 419 Revenue from Primex deal (€3.5m) Income from partnerships 545 209 336 Other operating income 656 332 - 324 Clawb
Slide 19: Cash-flow statement
Cash-flow statement CASH FLOW December 31, December 31, (in thousands of euros) 2024 2023 Net result (loss) -6 464 -7 528 Amortisation, depreciation and provisions 2 584 73 Net financial costs 900 997 Sale of PPE and intangible assets Self-financing capacity -2 971 9 - -6 457 Cash consumption from
Slide 20: 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 20 Corporate presentation - Q2 2025
Slide 21: Contact: Didier Laurens - CEO
Contact: Didier Laurens - CEO dlaurens@advicenne.com 21