Slides
Page 1
Audiocast presentation 17 July 2025 Second quarter 2025 results
Page 2
2 Forward looking statements This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations, and it may cause any or allof our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements.
Page 3
3 Agenda • Business highlights • Financial performance • Commercial development • R&D pipeline update • Key take-aways • Q&A Company participants Fredrik Tiberg, PhD President & CEO, CSO Jon Garay Alonso CFO Anders Vadsholt Incoming CFO Richard Jameson Chief Commercial Officer
Page 4
Business highlights
Page 5
5 Commercial execution Advancing R&D pipeline Financial & corporate development Strong second quarter performance YoY – year-on-year; QoQ – quarter-on-quarter; CER – constant exchange rate; PLD – polycystic liver disease • Record revenues of SEK 676 million, up 52% YoY • Profit before tax of SEK 307 million, up 195% YoY • Cash position further strengthened • License agreement with Lilly for FluidCrystal® long-acting incretins • Increased market shares in opioid dependence treatment • Buvidal sales grew 26% YoY at CER to SEK 470 million • Brixadi growth regained momentum, royalties increased 32% QoQ at CER • Scientific evidence base expanded with new publications • Oczyesa® approved in the EU for the treatment of acromegaly • POSITANO study of CAM2029 met primary endpoint in PLD patients • Positive results from ACROINNNOVA 2 extension study • All patients dosed in Phase 1 study of monthly semaglutide
Page 6
Financial performance
Page 7
7 Cash position SEK 3.3 billion +30% vs Q2 2024 Robust revenue growth and record-high profitability from operations FY – Full year Q2 0 100 200 300 400 500 600 0 500 1000 1500 Revenue 674 958 1234 MSEK Q2 FY Q2 FY Q2 FY 2023 2024 2025 445 676 835 MSEK Profit before tax 381 457 201 104 307 561 One-time revenues Revenues excl. one-time revenues One-time revenues Profit excl. one-time-revenues +195% Q2 FY Q2 FY Q2 FY 2023 2024 2025 +48% +52% +179%
Page 8
8 Reported Q2 profit and loss YTD – year-to-date MSEK Apr – Jun 2025 Change vs. 2024 CER Change vs. 2024 YTD Jan – Jun 2025 Change YTD vs. 2024 CER Change YTD vs. 2024 Total revenues 676 +52% +65% 1,234 +48% +54% Gross margin 634 93.9% 106bps 146bps 1,153 93.0% 99bps 132bps Marketing and distribution costs -134 +2% +6% -259 +11% +13% Administrative expenses -52 +118% +125% -91 +134% +138% Research and development costs -151 -13% -14% -276 -20% -19% Other operating expenses -6 – – 3 – – Operating result 292 43.2% +254% +333% 531 43.0% +229% +281% Profit before tax 307 45.4% +195% +251% 561 45.5% +179% +214%
Page 9
9 349 126 27 -27 -5 2,878 3,347 Cash end Q1 25 Operating activities Stock Option program Working Capital Investing Activities Other Cash end Q2 25 Strong cash position and maintained guidance . MSEK Operating activities ESOP 22/26 Working Capital Other Cash end Q1 2025 Cash end Q4 2024 Investing activities Full year 2025 outlook maintained Revenue SEK 2.7 – 3.0 billion + 45 – 61% vs. 2024 Profit before tax SEK 0.9 – 1.2 billion + 63 – 117% vs. 2024
Page 10
Commercial development
Page 11
11 346 366 364 400 421 469 485 470 0 100 200 300 400 500 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Buvidal – strengthened LAI leadership position •Increased market shares ‒ Net sales Q2 2025 was SEK 470 million; +17% YoY • Sales at CER grew 26% YoY and 3% QoQ ‒ Estimated 65,000 patients in treatment with Buvidal end of June 2025 •Growth across regions ‒ Led by the Australia, Spain and the Nordics •Market expansion ‒ Buvidal launch in Portugal ‒ Four regulatory applications under review •Quarterly sales MSEK CER – constant exchange rate 2024 20252023 SalesQoQ at CER1 (and QoQ growth)
Page 12
12 Brixadi royalty by quarter Returning growth of Brixadi in the US •Brixadi revenue increased 100% YoY (131% at CER) ‒ +21% quarter-on-quarter (+32% at CER) •Easing headwinds ‒ Prescription authorizations and the winding down of the continuous enrollment provision ‒ Diminished impacts of previous federal budget cuts •Expanding and protecting access to treatment ‒ States allocating funding and introducing policy changes for expanding OUD treatment ‒ Federal Medical Assistance Percentage for Medicaid remains at current levels in budget bill ‒ The budget reconciliation bill exempts Medicaid substance use disorder patients from the work requirement CER – constant exchange rate 2024 2025 2023 Salesat CER1 (and QoQ growth)1 8 26 45 58 83 74 89 0 20 40 60 80 100 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 MSEK
Page 13
R&D update
Page 14
14 *Oczyesa®, octreotide subcutaneous depot, for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogs CHMP positive opinion for Oczyesa® 15 April 2025 European commission granted marketing authorization for Oczyesa® 30 June 2025* Preparation for launch in the first EU-markets early Q4 2025 Oczyesa® EU approval
Page 15
15 Dissemination of scientific results for CAM2029 •Pre-launch activities ‒ Meeting with acromegaly stakeholders ‒ National and regional advisory board meeting ‒ Payer engagement and submissions ‒ Commercial and medical affairs readiness •Scientific conferences in 2025 1Endocrine Society’s annual meeting ENDO 2025, 12-15 July in San Francisco Rapid fire presentation, educational program and posters of ACROINNOVA results at ENDO1 Q1 2025 Q2 2025 Q3 2025 Q4 2025 IPS 9-11 Jul San Francisco US ESPE/ESE 10-13 May Copenhagen DK NANETS 23-25 Oct Austin US ACRO NET AACE 15-17 May Orlando US ENETS 5-7 Mar Krakow PL ENDO 12-15 Jul San Francisco US ENEA 3-5 Dec Marseille FR DGE 19-21 Mar Baden-Baden DE
Page 16
16 Positive ACROINNOVA 2 extension study data Improved biochemical response for patients during treatment with CAM2029 TSQM – treatment satisfaction questionnaire for medication * Transferred to standard-of-care (SoC) – either octreotide LAR or lanreotide Autogel – after completion of ACROINNOVA 2 main part. When ACROINNOVA extension study started, patients were reinvited to join study for another year on CAM2029. Time on SoC between 15 to 95 weeks (median 35 weeks) Extension start Week 102/104 0 20 40 60 80 100 Baseline Week 50/52 Proportion of responders(% IGF-1≤1xULN) Patients continuously on CAM2029 for 2 yrs ACROINNOVA 2 main part ACROINNOVA 2 extension SoC baseline w50/52 Extension start w102/104 N=19 N=19 N=19 N=19 48 61 35 59 0 20 40 60 80 100 Baseline Week 50/52 Extension start Week 102/104 Proportion of responders(% IGF-1≤1xULN) Intermediate treatment with standard-of-care* SoC baseline w50/52 w102/104Extension start ACROINNOVA 2 main part ACROINNOVA 2 extension Reinvited patients after intermediate treatment with SoC* N=23 N=23 N=23 N=22
Page 17
17 CONFIDENTIAL •Polycystic liver disease is a rare, genetic, and chronic disorder characterized by progressive growth of cysts in the liver, which can cause severe symptoms and result in impaired quality of life for patients. Positive results from POSITANO in polycystic liver disease
Page 18
18 Polycystic liver disease •Disease characteristics and prevalence ‒ Progressive growth of liver cysts of various sizes ‒ Estimated 37,000 target patients with symptomatic polycystic liver disease (PLD) in US, EU4 and UK1 ‒ No available pharmacological treatment for PLD •Treatment options ‒ Somatostatin receptor ligands show promise in clinical studies: decreasing liver volume, symptoms, and improving quality of life in symptomatic patients PLD 2-4 ‒ CAM2029 has orphan drug designation for ADPLD in EU and the US and ongoing applications for PLD associated with AKPKD 1Globe Life Sciences report 2020; data on file ; 2Gevers TJ, et al., Liver Int. 2015 May;35(5):1607-14.; 3Pisani A, et al., Clin Gastroenterol Hepatol. 2016 Jul;14(7):1022-1030.; 4van Aerts R, et al., Gastroenterology. 2019 Aug;157(2):481-491; 5Bergmann et al., Polycystic kidney disease. Nat Rev Dis Primers. 2018;4(1):50.; 6Abu‐Wasel et al., World J Gastroenterol. 2013;19:5775‐86 Epidemiology1 ADPKD PLD Target patients 185,000 patients (US, EU4, UK) 80% of ADPKD patients5 ~20% of the total ADPKD patients are symtomatic6 37,000 patients (US, EU4, UK)
Page 19
19 •Primary endpoint ‒ Liver volume change from baseline to week 53 vs to placebo •Secondary endpoints ‒ Camurus’ developed PRO, PLD-S ‒ Total liver cyst volume ‒ Total kidney volume in ADPKD patients ‒ PLD symptoms and quality of life ‒ Safety ‒ PK and immunogenicity POSITANO – Phase 2b study in PLD •Trial design ‒ 53-week randomized, placebo-controlled, three-arm study ‒ Open label extension for 120 weeks •Key eligibility criteria ‒ Symptomatic PLD (isolated or associated with ADPKD) ‒ htTLV ≥1800ml/m at screening PLD – polycystic liver disease, ADPKD – autosomal dominant polycystic kidney disease; htTLV-height adjusted total liver volume; PRO – patient reported outcome; PLD-S – PLD symptoms, 1Globe Life Science 2020 Week 53 CAM2029 dose group 1 Placebo 0 Double-blind randomized period R N=71 1:1:1 CAM2029 dose group 2 Open label extension / Safety follow-up CAM2029 open label extensionScreening Week 181
Page 20
20 -12 -10 -8 -6 -4 -2 0 2 Difference vs placebo in change from baseline in htTLV (%, mean and 95% CI) Week 13 Week 25 Week 53Baseline POSITANO met the primary endpoint Reduction in height adjusted total liver volume change with CAM2029 vs baseline Primary endpoint Combined, analysis of covariance, multiple imputation, intention-to-treat Sensitivity analysis I Combined, last observation carried forward, analysis of covariance, intention-to-treat Sensitivity analysis II Combined, mixed model repeated measures, intention- to-treat Main and sensitivity analyses for the primary endpoint Week 53 -10 0 10 Favors CAM2029 Favors placebo p-value 0.044 0.032 0.015 Treatment difference between CAM2029 groups and placebo -4.3 (-8.4, -0.1) -4.0 (-7.5, -0.4) -4.8 (-8.5, -1.0)
Page 21
21 -15 -10 -5 0 5 10 15 TLC change from baseline (mean and 95% CI) CAM2029 Placebo Week 13 Week 25 Week 53Baseline CAM2029 reduces liver cyst volume vs placebo Total liver cyst volume change from baseline Difference CAM2029 vs placebo Change from baseline at week 53 (%, mean, 95% CI) CAM2029 2.1 (-1.9, 6.2) Placebo 11.9 (5.2, 19.0) -20 -15 -10 -5 0 5 Difference vs placebo in change from baseline in TLCV (%, mean and 95% CI) Week 13 Week 25 Week 53Baseline Treatment difference at week 53 (%, mean, 95% CI) -8.7 (-15.2, -1.8)
Page 22
22 POSITANO topline results summary for CAM2029 • Reduction of liver volume growth vs placebo ‒ Primary endpoint supported by sensitivity analyses • Reduction of total liver cyst volume growth vs placebo • Kidney volume reduction indicated in patients with PLD associated with ADPKD • Improved PLD symptoms ‒ Reduction of PLD-S score versus baseline ‒ Improved symptoms indicated in several additional PROs (PLD-Q, PGI-S, CGI-S) • Robust decrease of IGF-1 vs placebo • Treatment generally well tolerated • Safety profile consistent with that of other injectable SRLs • No new or unexpected safety issues were identified • High study and treatment retention • All eligible patients entered the extension phase Efficacy conclusions Safetyprofile PLD-S – PolycysticLiver Diseasesymtoms; PLD-Q – PolycysticDiseaseQuestionnaire; PGI-S – Patient Global Impression of Severity;, CGI-S – clinicalglobal impression of severity
Page 23
23 CAM2029 recent milestones and expected progress ahead *Planned after completion of a recently announced routine GMP inspection of a third-party manufacturer by a national authority * Positive results from ACROINNOVA 1 and 2 NDA acceptance in the US – CRL for manufacturer Positive CHMP opinion in April 2025 EC approval decision in June 2025 NDA resubmission planned for Q3* Further regulatory approvals SORENTO Phase 3 start Q4 2021 SORENTO fully enrolled Q4 2023 Target number of events for primary endpoint est. early 2026 POSITANO fully enrolled Q1 2024 Orphan drug designation in EU and US Positive clinical study results in June 2025 End-of-phase 2 meeting with FDA Polycystic liver Safety and efficacy TriAl with subcutaneous Octreotide Subcutaneous Octreotide Randomized Efficacy in Neuroendocrine TumOrs Pivotal randomized placebo controlled and long-term safety trials in acromegaly
Page 24
24 Early-stage programs Several early-stage programs advancing All patients dosed i Phase 1 study of monthly semaglutide (CAM2056) Topline clinical results in Q4 2005 New partnership entered with Eli Lilly for long-acting incretins
Page 25
25 License agreement with Lilly on long-acting incretins CONFIDENTIAL •Partnership focused on long-acting therapies based on FluidCrystal and Lilly’s proprietary drug compounds ‒ Lilly obtained license to research, develop, manufacture and commercialize long- acting incretin products based on FluidCrystal ‒ Includes up to four Lilly proprietary drug compounds within the exclusivity scope: • Dual GIP and GLP-1 receptor agonists • Triple GIP, glucagon and GLP-1 receptor agonists • An option to include amylin receptor agonists •Camurus eligible to receive: ‒ Up to $290 million in license fees, development and regulatory milestone payments ‒ Up to $580 million in sales-based milestone payments ‒ Tiered mid-single digit royalties on global net product sales
Page 26
26 Successful second quarter Record revenues Buvidal patient increase in Europe and RoW Regained momentum for Brixadi in the US EU approval of Oczyesa® in acromegaly Positive POSITANO results for CAM2029 in PLD Partnership with Lilly for long-acting incretins based on FluidCrystal®
Page 27
Camurus AB│Rydbergs torg 4, SE-224 84 Lund, Sweden P +46 46 286 57 30│info@camurus.com│camurus.com Q&A
Page 28
28 < Shareholders and analyst coverage Shareholders as of 30 June 2025 Number of shares % of capital % of votes Sandberg Development AB 18,280,692 30.6 30.6 Fourth Swedish National Pension Fund 2,808,776 4.7 4.7 Swedbank Robur Fonder 2,518,251 4.2 4.2 Fredrik Tiberg, CEO 1,615,000 2.7 2.7 Handelsbanken fonder 1,453,740 2.5 2.5 Vanguard 1,263,698 2.2 2.2 Avanza Pension 1,260,629 2.1 2.1 Capital Group 1,087,307 1.9 1.9 Afa Försäkring 1,008,883 1.7 1.7 SEB Funds 981,497 1.7 1.7 Norges bank 767,117 1.3 1.3 Carnegie Fonder 715,129 1.2 1.2 Länsförsäkringar Fonder 666,056 1.1 .1.1 Jupiter Asset Management 656,428 1.1 1.1 Baillie Gifford & Co 644,309 1.1 1.1 Other shareholders 23,933,072 40.0 40.0 In total 59,660,584 100.0 100.0 Analysts DNB Carnegie Erik Hultgård Handelsbanken Suzanna Queckbörner Jefferies Shan Hama Nordea Viktor Sundberg Pareto Dan Akschuti Stifel Oscar Haffen Lamm SEB Christopher Uhde ABG Sundal Collier Georg Tigalonov-Bjerke Source: Modular Finance, Monitor report
Page 29
29 Experienced and committed management team PSP units – Performance Share Plan units Markus Johnsson Senior VP R&D In Company since: 2003-2017, 2019- Holdings: 21,000 shares, 9,500 employee options and 2,918 PSP units Education: Ph.D. in physical chemistry and M.Sc. in chemistry from Uppsala University. Previous experience: More than 20 years of experience from pharmaceutical development and project management Fredrik Joabsson, PhD Chief Business Dev. Officer In Company since 2001 Holdings: 40,170 shares and 2,918 PSP units Education: M.Sc. in Chemistry, PhD in PhysicalChemistry, Lund University Previous experience: More than 20 years of experience in pharmaceutical R&D, business development, alliance management and investor relations. Richard Jameson Chief Commercial Officer In Company since: 2016 Holdings: 29,193 shares and 6,082 PSP units Education: B.Sc. in Applied Biological Sciences from University West of England Previous experience: General Manager, UK & Nordics for Reckitt Benckiser (2010 – 2013) and Area Director Europe, Middle East and Africa for Indivior (2013 – 2016). Behshad Sheldon President Camurus Inc. In Company since 2024 Holdings: 1,000 shares, 2,000 employee options and 2,918 PSP units Education: B.Sc. in Neuroscience from University of Rochester Previous experience: More than 25 years of experience from the international pharma industry, including President & CEO of Braeburn Pharmaceuticals and senior positions within Smithkline Beecham, Bristol-Myers Squibb and Otsuka Pharmaceuticals. Agneta Svedberg VP Clinical Dev. In Company since: 2015 Holdings: 22,987 shares, 16,000 employee options and 2,918 PSP units Education: M.Sc. In Radiophysicsand B.Sc. In Medicine from Lund University, ExecutiveMBA from ExecutiveFoundation Lund Previous experience: More than 25 years of experience in drug development, incl. as COO at Zealand Pharma, CEO of Cantargia, Senior VP Clinical Development at Genmab. Maria Lundqvist Head of Global HR In Company since 2021 Holdings: 4,000 employee options and 2,918 PSP units Education: B.Sc: in Business and Economics, Uppsala University. Previous experience: More than 20 years of experience of leadership roles within Human Resources, including HR Director Nordics at Teva Pharmaceuticals and HR positions at Tetra Pak, Vestas and AstraZeneca. Annette Mattsson VP Regulatory Affairs In Company since: 2017 Holdings: 2,004 shares and 2,918 PSP units Education: Bachelor of Pharmacy, Uppsala University and Business Economics, Lund University Previous experience: More than 25 years of experience within regulatory affairs, including European RA Director/Global RA Lead at AstraZeneca and Global RA Lead at LEO Pharma. Fredrik Tiberg, PhD President & CEO, CSO In Company since 2002 Holdings: 1,615,000 shares, 42,000 employee options and 13,500 PSP units Education: M.Sc. in Chem. Eng., Lund Institute of Technology, PhD and Assoc. Prof. Physical Chemistry, Lund University. Previous experience: More than 20 years executive leadership experience from the pharmaceutical industry. Prof Physical Chemistry, Lund University; Visiting Prof at Oxford University; Section Head, Inst. for Surface Chemistry. Jon Garay Alonso Chief Financial Officer In Company since: 2022 Holdings: 1,450 shares and 2,300 PSP units Education: Bachelor in Business Administration by Universidad Comercial de Deusto. Executive MBA by IESE Business School. Previous experience: More than 20 years experience from Finance within pharmaceutical and medtech companies, incl. Baxter, Gambro, Convatec, Bristol Myers Squibb. Alberto M. Pedroncelli Chief Medical Officer In Company since 2023 Holdings: 1,000 shares, 20,000 employee options and 1,500 PSP units Education: MD University of Milan. Ph. D. endocrinology post-graduate school University of London Previous experience: Head of Clinical Development and Medical Affairs Recordati, Senior Leadership positions Novartis, clinician and research fellow Dept. Endocrinology, University Hospital Bergamo, Italy Bo A. C. Tarras-Wahlberg VP Legal & Group General Councel In Company since 2024 Holdings: 2,918 PSP units Education: LLM from Lund University and studies at Queen Mary College Previous experience: More than 20 years of experience as lawyer and from international senior legal positions, incl. as Assoc. General Counsel at Baxter, Gambro, legal private practice and as law clerk at District Court. Susanne Lagerlund VP, Technical Operations In Company since 2023 Holdings: 250 shares, 9,500 employee options and 2,618 PSP units Education: M. Sc. Chemical Engineering and studies Business Econoics, Lund University Previous experience: More than 30 years of experience from pharmaceutical industry, including Global Regulatory CMC Director at AstraZeneca, VP Regulatory Affairs at Cantargia, and Global Portfolio Lead at LEO Pharma.
Page 30
30 Broad and diversified product portfolio and pipeline 1Licensed to Braeburn Pharmaceuticals in North America; 2GEP-NET – Gastroenteropancreativneuroendocrinetumors; 3Licensed to Rhythm Pharmaceuticals worldwide; 4PAH – Pulmonaryarterialhypertension; 5CINV – Chemotherapy-inducednauseaand vomiting CNS Rare diseases Oncology& supportivecare Other clinical stage programs include CAM2032 (prostate cancer), CAM2043 (PAH4), and CAM2047 (CINV5) CAM4072 Genetic obesity diseases3 CAM4071 Endocrine disorders CAM2056 Metabolic diseases (q4w semaglutide) CAM2038 Chronic pain CAM2029 Acromegaly CAM2029 GEP-NET2 CAM2029 Polycystic liver disease Key pipeline programs US Phase 1 Phase 2 Phase 3 Registration Market EU, AUS, MENA US Approved products Buvidal® Opioid dependence Brixadi® Opioid use disorder1 CAM2043 Raynaud’s phenomenon EUOczyesa® Acromegaly Approved30 June 2025