Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — Q2 2023 Earnings Presentation
22 slides from Indivior Pharmaceuticals's earnings presentation, Jul 27, 2023
Slide 1: Q2/H1 2023 Results
Q2/H1 2023 Results July 27, 2023
Slide 2: Important cautionary statement regarding forward-looking statements
Important cautionary statement regarding forward-looking statements This presentation contains certain statements that are forward-looking. Forward-looking statements include, among other things, statements regarding: expectations regarding the cost to resolve the Group's legal proceedings and regul
Slide 3: Mark Crossley, Chief Executive Officer
Mark Crossley Chief Executive Officer
Slide 4: Today's agenda
Today’s agenda Overview & Strategic Priorities Update Mark Crossley, CEO R&D & Pipeline Update Christian Heidbreder, Ph.D., CSO Q2 / H1 Performance & FY 2023 Guidance Ryan Preblick, CFO Conclusion Mark Crossley, CEO Q&A All participants 4 4
Slide 5: Q2 / H1 2023 key messages
Q2 / H1 2023 key messages Strong Q2 results – total NR1 $276m, +25% YOY / SUBLOCADE®(buprenorphine extended-release) NR $155m, ( +58% YOY / reported op. profit -3% YOY (+18% adjusted2 basis) FY 2023 guidance raised – total NR ($1,060m mid-point, +18% YOY) / SUBLOCADE NR ($610m mid-point, +50% YOY) /
Slide 6: Executing clear strategies for value creation
Executing clear strategies for value creation 1 2 3 4 Grow Build & Optimize SUBLOCADE Diversify Progress Operating >$1.5bn Revenue Pipeline Model • SUBLOCADE Q2 2023 NR of $155m, +58% • PERSERIS® (risperidone for extended release) • AELIS AEF0117 (CUD3): Phase 2B positive • $782m of gross cash and Q
Slide 7: Anti-trust MDL update
Anti-trust MDL update • Settlement with 41 States and District of Columbia - $102.5m paid in June 2023 • $187.5m provision continues to be our best estimate for remaining classes • Trial date for remaining classes (end payors and direct purchasers) is scheduled for October 30, 2023 • The Group’s dis
Slide 8: Christian Heidbreder, Chief Scientific Officer
Christian Heidbreder Chief Scientific Officer
Slide 9: SUBLOCADE studies
SUBLOCADE® studies → 5 Phase IV studies: → 21 RWE studies rapid induction in the era of (1) health disparity; (2) recovery; (3) synthetics; alternate injection sites; harm reduction. long-term outcomes; treatment cessation; ROAD → 9 ESS → 4 Collaborations: (1) high-risk opioid overdose; (2) Criminal
Slide 10: OPVEE status
OPVEE® status → FDA approval granted May 22, 2023. → Post-marketing requirement studies to assess the potential effects of dodecyl → 28-month shelf life approved. maltoside (DDM – nasal absorption → Section 12 (Clinical Pharmacology) of enhancer) on development and the Prescribing Information shows
Slide 11: Pipeline status
Pipeline status MECHANISM OF PRODUCT NAME INDICATION PCL Ph1 Ph 2 Ph 3 APPROVAL LAUNCH ACTION OPIOID USE DISORDER (OUD) & RESCUE FROM OPIOID OVERDOSE Intranasal nalmefene Emergency treatment of known or OPVEE® (opioid receptor suspected overdose induced by antagonist) natural or synthetic opioids Se
Slide 12: AEF0117: Clinical Phase 1 & 2A Results Published in Nature Medicine
AEF0117: Clinical Phase 1 & 2A Results Published by Aelis Farma in Nature Medicine Accepted May 1, 2023 Published online June 8, 2023 https://www.nature.com/articles/s41591-023-02381-w 12
Slide 13: Ryan Preblick, Chief Financial Officer
Ryan Preblick Chief Financial Officer
Slide 14: Q2 2023 financial highlights
Q2 2023 financial highlights Takeaways (vs. Q2 2022) Operating Results – Reported and Adjusted2 Adjusted ➤ Top-line NR growth of 25% $ mil Q2 23 Q2 22 Change Net Revenue: 276 221 25% ✓ U.S. NR up 26% U.S. 226 179 26% ✓ ROW NR up 19% (up 20% excluding FX) ROW3 50 42 19% Q2 23 Q2 22 Change Gross Profi
Slide 15: Cash & borrowing position
Cash & borrowing position Cash & Borrowing Takeaways Total gross cash & investments of $782m1 ➤ Cash and investments primarily held in USD Q2 23 YE 22 ➤ Anti-trust settlement payment of $102.5m in Q2 '23 ($ in mil.) ➤ Opiant acquisition completed in Q1'23 for $124m Cash & Cash Equivalents $592 $774
Slide 16: FY 2023 guidance updated
FY 2023 guidance updated1 Additional Top-Line Assumptions ➤ Underlying BMAT market growth of mid- to high-single digits FY 2023 Revised Guidance2 ($ in mil.) ➤ OPVEE NR impact immaterial reflecting anticipated Q4 launch timing ➤ U.S. SUBOXONE (Buprenorphine/naloxone) Film • Accelerated share erosion
Slide 17: Q&A
Q&A
Slide 18: Appendix
Appendix 18
Slide 19: H2 2023 Capital Markets Calendar
H2 2023 Capital Markets Calendar Date Key Event Sept. (dates TBD) Northland Securities "Teach-in" and non-deal roadshow Sept. 11th – 12th Morgan Stanley Healthcare Conference (New York) Sept. 22nd Jefferies “Back to School” Event (virtual) Late Oct. / Early Nov. Q3 23 Results Earnings Call & Investo
Slide 20: Peer-Reviewed Publications & Conferences
Peer-Reviewed Publications & Conferences Peer-Reviewed Publications YTD → 6 published & 2 in press Conference Presentations YTD → Association of Military Surgeons of the United States (AMSUS); Academy of Managed Care Pharmacy (AMCP); American Society for Clinical Pharmacology & Therapeutics (ASCPT);
Slide 21: Financial Reconciliation: Adjusted Results
Financial Reconciliation: Adjusted Results Q2 Q2 H1 H1 2023 2022 2023 2022 For the three and six months ended June 30 $m $m $m $m Exceptional items and other adjustments within costof sales Amortization of acquired intangible assets 1 (2) — (2) — Total exceptional items and other adjustments within
Slide 22: Indivior
Nz ANS INDIVIOR
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