Slides
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J.P. Morgan Healthcare Conference J a n u a r y 1 5 , 2 0 2 5 N A S D A Q : O P K
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O P K O 2 Forward-Looking Statements This presentation contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding financial strength and anticipated financial performance, and expectations regarding the market for and sales of our products, whether our product development efforts will be successful and whether the expected benefits of our products will be realized, including whether the data for products in trial will be positive and whether efforts to develop a daily oral dual-agonist GLP-1/glucagon peptide will be successful and we can successfully progress the development of oxyntomodulin in both subcutaneous and oral formulations, whether we will continue to repurchase shares under a buyback program and whether we will continue to purchase convertible notes, whether NGENLA profits will be sufficient to provide long term upside after satisfying our obligations under the note purchase agreement, whether the relationships with our commercial and strategic partners will be successful, our ability to market and sell any of our products in development, whether we will continue to successfully advance products in our pipeline and whether they can be commercialized, whether BioReference will be able to streamline its laboratory services business and better position the division for sustained growth and profitability, whether BioReference’s attempts at returning its core business to profitability will be successful, whether our strategic efforts to grow the Company will ultimately be successful and create shareholder value, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading “Risk Factors” in our other filings with the Securities and Exchange Commission, as well as the continuation and success of our relationship with our commercial partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
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O P K O 3 2024 In Review: A Transformative Year OPKO is well -positioned for growth and value across its businesses Therapeutics Pipeline Progression + Expansion Novel Long-Acting Biologics Development Global Pharmaceutical Business Growth Enhanced Financial Strength Restructuring Clinical Diagnostics to Profitability
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O P K O 4 ModeX Proprietary Technologies MULTISPECIFIC ANTIBODIES MULTIVALENT NANOPARTICLE VACCINES IMMUNO - ONCOLOGY IMMUNOLOGY VIRAL DISEASES Since OPKO’s acquisition in May 2022, ModeX has further validated its core technologies and advanced 3 pipeline assets to clinical stages ▪ Designed to bind to 2 T cell antigens and 2 tumor antigens ▪ Offers greater specificity than existing I/O treatments ▪ Broad potential applications across I/O, immunology and viral diseases ▪ Nanoparticle vaccine technology targeting 4+ viral proteins ▪ Next-generation vaccines for cancer prevention
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O P K O 5 PRODUCT INDICATION EARLY STAGE PRE-IND PHASE 1 PHASE 2 PARTNER Immuno-Oncology CD3/CD28/cMET/Trop2 Tetraspecific T Cell Engager Treatment of Solid Tumors CD3/CD28/CD19/CD20 Tetraspecific T Cell Engager Treatment of Leukemia/Lymphoma Multispecific Immune Modulator Solid Tumors, Infectious Disease, Autoimmune Antibody-radionuclide Conjugate Solid Tumors, Diagnostics Antiviral HIV Trispecific CODV Antibody Treatment and Prevention of HIV EBV Nanoparticle Vaccine Prevention of EBV-related Diseases COVID Multispecific Antibodies Prevention of COVID-19 HIV Multispecific Antibody Treatment and Prevention of HIV Influenza Multispecific Antibody and Gene Delivery Prevention of Influenza ModeX Development Pipeline MDX2001 MDX2003 MDX2004 MDX2201 MDX2301, MDX2202 SAR441236 – Phase 1 Complete ModeX has promising portfolio assets with 3 in clinical stage and 2 pre -IND assets to enter clinic in 2025 Lead Generation Lead Generation Lead Generation
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O P K O 6 ModeX Partnerships and Business Development COVID -19 / FLU MULTISPECIFICS EBV NANOPARTICLE VACCINE PAYMENTS RECEIVED TO DATE1 $87.5M IN TOTAL MILESTONE PAYMENTS AND ROYALTIES ON GLOBAL SALES $872.5M ELIGIBLE FOR UP TO OPKO has formed productive partnerships to share development costs and leverage commercial capabilities ADDITIONAL PARTNERSHIPS ▪ Active business development discussions around several programs ▪ Non-dilutive collaborations support and accelerate development of assets while retaining value creation PH1 TRIAL COMMENCED DEC 2024 COMMITTED TO DATE2 $110M IN TOTAL FUNDING FOR VIRAL PROGRAMS $205M NOW ELIGIBLE FOR UP TO $51M ADDITIONAL FUNDING AWARDED IN Q4 2024 1) Through 12/31/24; includes milestone payments of $62.5M and expense reimbursements of ~$25M 2) As of 12/31/24
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O P K O 7 Advancement in Long-Acting Biologics OPKO Biologics has developed a robust technology and portfolio of long -acting therapeutic proteins and peptide drug candidates which have the potential to address large, high -need markets In Development: Oxyntomodulin Analog Injectable Oral Targeting treatment of diabetes, obesity and MASH Collaborating on development of oral GLP2 and dual -agonist GLP -1/GCGR ✓ Created NGENLATM (somatrogon), once-weekly injectable hGH molecule now marketed by Pfizer in over 40 countries ✓ Utilize novel technologies to develop next-generation, bio-better, long-acting biologics ✓ In-house expertise and state-of-the-art facilities in Israel support mission of developing new and better drugs
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O P K O 8 Growth of Pharmaceutical Product Sales Business lines across the globe generate durable, growing revenues Global Health Sales hGH Franchise Growth Sustained Sales of CKD Therapy Production Capabilities 5% local currency sales growth 1 19 % EBITDA margin 1 Organic and inorganic growth opportunities $19M YTD profit share payments earned 2 Expansion of indications to adult and other pediatric populations Commercial launch in Greater China by partner Nicoya in 2025 Recent scientific publications expected to increase physician awareness Utilize manufacturing expertise for OPKO and others 1) For 9 months ended 09/30/24; local currency growth compared to the same period in 2023 2) Profit share payments paid by Pfizer for 9 months from 01/01/24 to 09/30/24 3) Eirgen generics revenues for 9 months ended 09/30/24 compared to 9 months ended 09/30/23 in local currency 57 % Eirgen sales growth 3
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O P K O 9 Clinical Diagnostics Reset: A Streamlined BioReference Divestiture of Clinical and Women’s Health Assets Outside NY & NJ Overhead Expense Realignment $237.5M asset sale to Labcorp accounting for ~$100M in annual revenues Lab facilities closed in CA, TX, FL and MD Right-sized workforce to ~2,000 FTEs1 from ~3,300 Oncology & Urology specialty testing nationwide Clinical Diagnostics in NY & NJ ~$400M in annual revenues Focus on Core Areas of Strength A re -calibration of the organization and improved cost structure position BioReference for profitability in 2025 Continue strategic restructuring Best -in-class oncology and urology testing Grow share in attractive NY & NJ markets Achieve sustainable profitability 2025 GOALS 1) Full-time employees as of 01/06/25
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O P K O 10 Realignment of Capital Structure in 2024 1) Gross proceeds on the sale of ~3.19 million GeneDx shares between 07/01/24 to 01/10/25; 370,841 GeneDx shares held in remaining stake as of 01/10/25 2) Shares of common stock repurchased and retired between 01/01/2024 to 01/08/25; 671,550,270 shares of common stock outstanding as of 12/31/24 3) Amount spent to repurchase 3.75% Convertible Senior Notes due 2029 between 08/01/24 to 01/08/25; ~$20.5 in principal A series of transactions in 2024 to recapitalize the balance sheet provide flexibility to execute long -term plans Balance Sheet Reset Shareholder Value convertible note conversion from 2025 to 2029 maturity$300M NGENLA royalty monetization with retention of upside and milestone rights of $100M$250M sale of clinical diagnostics and women’s health assets outside NY & NJ to Labcorp$238M proceeds from selling partial stake in GeneDx (NASDAQ:WGS)1$189M to repurchase and retire 81M shares (avg. of $1.11 per share)2$90M to repurchase convertible notes3 $30M Strongly Positioned for 2025+ Enhanced Financial Position Return Capital to Shareholders R&D Investment
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O P K O 11 2025 Priorities to Generate Long-Term Value Focused on execution of strategic priorities to produce clinical and financial success ModeX Pipeline Progression Global Pharmaceutical Business BioReference Biologics Development Enhanced Financial Strength ✓ Produce safety and early efficacy data for Ph1 assets ✓ Prepare 2 additional assets to enter clinical development ✓ Extend growth in non-dilutive partnerships ✓ Advance 2 molecules to IND stages ✓ Explore potential partnerships ✓ Maintain and accelerate revenue growth ✓ Improve profitability ✓ Continued strategic restructuring ✓ Grow share in NY & NJ market ✓ Achieve profitability ✓ Recapitalized financials achieved in 2024 ensures sustained funding for R&D and commercial operations