Advicenne Sa · EURONEXT:ALDVI
Advicenne Sa — Investor Presentation (May 2023)
21 slides from Advicenne Sa's investor presentation, May 2023
Slide 1: Corporate Presentation Q2 2023
Corporate Presentation Q2 2023 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 ▪ US footprint ▪ European organization - ADV7103 Orphan Drug Designation - Operating platform in France in dRTA and the UK - Low clinical risk / Pediatric - Rare diseases expertise indication / formulation - Sibnayal® (ADV7103) dRTA - Significant US market potential in
Slide 4: Sibnayal / ADV7103
Sibnayal® / ADV7103 • Approved in EU and UK in April 2021 for the treatment of dRTA (distal Renal Tubular Acidosis) in pediatric (from one year of age) and adult patients • Sibnayal® unique and patented prolonged-release formulation has been designed to deliver effective alkalizing therapy with twic
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: ADV7103: intellectual property
ADV7103: intellectual property • ADV7103 is protected by 3 family patents, including the patent that covers the combination of potassium citrate and potassium bicarbonate in a delayed-release formulation • Initial patents expiration date : November 2031 • Since the approval of ADV7103 in EU and the
Slide 7: ADV7103 manufacturing overview
ADV7103 manufacturing overview ▪ SIBNAYAL® / ADV7103: • Manufacturing fully outsourced to CDMOs • French-based Lündbeck facility, for API sourcing bulk granules manufacturing • Primary Packaging subcontracted to Ivers Lee (CH), and secondary packaging done by Lündbeck ▪ Lündbeck is cGMP EMA approved
Slide 8: 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 ➢ Muscle weakness / paralysis bone mineral density ➢ Rickets / Osteom
Slide 9: ADV7103 for treatment of dRTA: Compelling clinical efficacy
ADV7103 for treatment of dRTA: Compelling clinical efficacy Mean plasma bicarbonate level Gastro-intestinal adverse events GI treatment related AEs (dark colour GI AEs (full bar) of the bar) B21CS and B22CS are European clinical studies part of the ARENA-1 clinical program Sources: Bertholet-Thomas
Slide 10: ADV7103: increasing clinical efficacy over time
ADV7103: increasing clinical efficacy over time Spine bone mineral density z-score change over 48 Analysis of covariance of z-score months for kids and adults Statistical significance overall spine (ANCOVA) Corporate presentation- Q2 2023 • Significant increase of z-score in spine BMD compared to ba
Slide 11: ADV7103 for treatment of dRTA: Changing the treatment landscape
ADV7103 for treatment of dRTA: Changing the treatment landscape Current unapproved options (1) ADV7103 Requires 3-6 intake per day √ 1 x Twice daily dosing (12h) Need for additional potassium intakes √ 2 x Normalizes plasma potassium Frequent gastrointestinal intolerance √ 3 x Satisfactory gastroint
Slide 12: ADV7103 approved for the treatment of dRTA in the EU and the UK
ADV7103 approved for the treatment of dRTA in the EU and the UK… Approved since Q2 2021 for the treatment of dRTA for pediatric (from 1 year old) and adult patients, MA covers both primary (genetic) and secondary dRTA forms Successful ARENA-1 program (B21 and B22 studies) ➢ B21: multi-center, open l
Slide 13: Supported by a rejuvenated platform for its distribution
…and supported by a rejuvenated platform for its distribution Nordics & - Signing date: 01/2022 Baltics - 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 - Signing date: 0
Slide 14: Development status of ADV7103 for dRTA in the US
Development status of ADV7103 for dRTA in the US ODD status in December 2022 for the treatment of genetic dRTA Current ARENA-2 program (B23 and B24 studies) agreed with FDA and ready to be launched: ➢ B23: phase III pivotal safety and efficacy registration trial, 32-patient, multi-center, double-bli
Slide 15: 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 16: FY 2022 financial statements
FY 2022 financial statements 16
Slide 17: Consolidated P&L IFRS
Consolidated P&L IFRS • 2022 IFRS revenue (Gross sales net of rebates / tax): CONSOLIDATED INCOME STATEMENT December 31, December 31, 2.3 m€ in 2022 vs 2.7 m€ in 2021 (in thousands of euros) 2022 2021 • Income from partnerships: royalties from Ozalin’s sales by Primex Revenues 2 341 2 670 Pharmaceut
Slide 18: Consolidated balance sheet IFRS
Consolidated balance sheet IFRS ASSETS December 31, December 31, LIABILITIES and CAPITAL December 31, December 31, (in thousands of euros) 2022 2021 (in thousands of euros) 2022 2021 Intangible assets 135 167 Capital stock 1 991 1 990 Capital-related premiums 1 490 24 469 Property, Plant and Equipme
Slide 19: Cashflow Statement IFRS
Cashflow Statement IFRS Operations • Cash flows used in operating activities significantly improved at -9.1 m€ in 2022 vs -12.5 m€ in 2021, thanks to the growth of product sales and control of expenses • WCR favorably impacted by the payables decrease Investments • mainly in manufacturing project •
Slide 20: Shareholding structure
Shareholding structure1 bpifrance 22,6% Free Float 63,7% CEMAG Invest 7,5% IRDI SORiDEC GESTION 4,4% Management 1,8% 1: On a fully diluted basis as of December 31st, 2022 Source: Company information Corporate presentation- Q2 2023 20
Slide 21: Contact: Didier Laurens - CEO
Contact: Didier Laurens - CEO dlaurens@advicenne.com 21