Core Insights - The European Medicines Agency's CHMP has approved a label update for DARZALEX® (daratumumab) allowing self-administration by patients or caregivers from the fifth dose, marking it as the first oncology injectable approved for self-administration in Europe [1][12]. Group 1: Approval and Impact - The approval applies to all ten therapeutic indications of daratumumab SC for multiple myeloma, smouldering multiple myeloma, and light chain (AL) amyloidosis, providing greater flexibility in treatment administration [2][3]. - This decision is expected to reduce the burden on healthcare systems by allowing patients to receive treatment in a more convenient manner, thus enhancing their quality of life [3]. Group 2: Historical Context and Innovation - Daratumumab has been a foundational therapy in multiple myeloma treatment since its first approval nearly a decade ago, with over 748,000 patients treated worldwide [6][12]. - The drug utilizes Halozyme's ENHANZE® drug delivery technology, co-formulated with recombinant human hyaluronidase PH20, enabling subcutaneous administration [6]. Group 3: Patient Demographics and Disease Overview - In the European Union, over 35,000 new cases of multiple myeloma were diagnosed in 2022, with more than 22,700 deaths attributed to the disease [7][20]. - Multiple myeloma is characterized by the proliferation of malignant plasma cells in the bone marrow, leading to various complications such as bone destruction and anemia [7][20].

Core Viewpoint - Halozyme Therapeutics has appointed David Ramsay as Interim Chief Financial Officer, effective March 23, 2026, while the company searches for a permanent CFO [1] Group 1: Appointment Details - David Ramsay has over 30 years of strategic financial leadership experience in biotechnology and life sciences [1] - He previously served as Halozyme's CFO from 2003 to 2009 and again from 2013 to 2015, during which the company grew into a billion-dollar public biopharmaceutical entity [1] - Ramsay's prior experience includes serving as Senior Vice President and CFO of Bonti, Inc. until its acquisition by Allergan in October 2018 [1] Group 2: Executive Search - Halozyme is actively searching for a permanent CFO and has engaged a leading executive search firm to identify suitable candidates [1] - The search is focused on candidates with expertise in capital markets and strategic planning [1] Group 3: Company Overview - Halozyme is a biopharmaceutical company known for its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of drugs, improving patient convenience [1] - The technology has impacted over one million patients through ten commercialized products across more than 100 global markets [1] - Halozyme has expanded its technology portfolio with Hypercon™ and Surf Bio's hyperconcentration technology, enhancing the delivery of biologics [1]

March 10, 2026 2025 Q4 Financial Results & Business Update Nasdaq: SKYE © 2026 Skye Bioscience, Inc. Disclaimer and Important Information for Investors This presentation ("Presentation") has been prepared solely for general information purposes by or on behalf of Skye Bioscience, Inc. (together with its subsidiaries and affiliates, "Skye"). Any discussion of the potential use or expected success of our product candidates is subject to our product candidates being approved by regulatory authorities. Cautiona ...

Core Insights - The U.S. FDA has approved TECVAYLI® in combination with DARZALEX FASPRO® for the treatment of adults with relapsed or refractory multiple myeloma, based on Phase 3 data showing significant improvements in progression-free survival (PFS) and overall survival (OS) compared to standard care [1][2] Company Overview - Halozyme Therapeutics, Inc. is a biopharmaceutical company focused on improving patient experiences and outcomes through innovative drug delivery technologies, including the ENHANZE® platform [1] - The company has commercialized ten products using ENHANZE® technology, impacting over one million patients globally [1] Product Approval Details - The approval of TECVAYLI® plus DARZALEX FASPRO® is based on the MajesTEC-3 study, which demonstrated an 83% reduction in the risk of disease progression or death compared to standard regimens, with a hazard ratio of 0.17 [1] - The three-year PFS rate for patients treated with the combination was reported at 83%, indicating a durable benefit [1] Technological Advancements - Halozyme's ENHANZE® technology facilitates subcutaneous delivery of drugs, reducing treatment burden and improving convenience for patients [1] - The company is expanding its drug delivery technology portfolio with Hypercon™ and Surf Bio's hyperconcentration technology, which aims to enhance the delivery of biologics [1] Financial Performance - Halozyme reported a record revenue of $1.4 billion for the full year 2025 and reiterated strong financial guidance for 2026 [2]

Core Insights - The European Commission has approved subcutaneous (SC) amivantamab, allowing for administration in minutes rather than hours, with efficacy and safety consistent with intravenous (IV) amivantamab [1][2][3] - SC amivantamab is now authorized for all previously approved IV indications, including every-four-week (Q4W) and every-three-week (Q3W) dosing regimens for advanced non-small cell lung cancer (NSCLC) [1][2][3][4] - The new dosing options aim to reduce administration-related reactions and improve patient convenience [1][2][3][4] Company Developments - Johnson & Johnson announced the approval of SC amivantamab, which is expected to enhance the treatment experience for patients with EGFR-mutated NSCLC [1][2][3] - The approval is part of Johnson & Johnson's commitment to improving patient care and treatment flexibility [1][2][3] Clinical Study Results - The approval is supported by Phase 2 PALOMA-2 and Phase 1 PALOMA studies, which demonstrated that SC amivantamab has a response rate and safety profile similar to IV amivantamab, but with significantly fewer administration-related reactions [1][2][3][4] - Administration time for SC amivantamab is approximately five minutes, compared to five hours for the first IV infusion [1][2][3][4] Treatment Context - Amivantamab is a bispecific antibody targeting EGFR and MET mutations, which are prevalent in NSCLC [3][4] - The approval of SC amivantamab aligns with the growing need for more efficient treatment options in the context of lung cancer, which is the leading cause of cancer-related deaths in Europe [6][7]

Halozyme Therapeutics, Inc. 1 Forward-Looking Statements In addition to historical information, the statements set forth in this presentation include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance and growth rates (including the Company's 2026 financial guidance and longer term financial outlook through 2028 and the assumptions used in deriving such guidance and longer term financial outlook) including expectations for futu ...

Core Insights - Halozyme Therapeutics reported record total revenue of $1.4 billion for the full year 2025, representing a 38% year-over-year increase, driven by significant growth in royalty revenue and product sales [1][2][3] - The company reiterated its strong financial guidance for 2026, projecting total revenue between $1.710 billion and $1.810 billion, with year-over-year growth of 22% to 30% [1][3] - Halozyme expanded its drug delivery technology portfolio through acquisitions of Elektrofi and Surf Bio, enhancing its long-term royalty opportunities [1][2][3] Financial Performance - Full year 2025 royalty revenue reached a record $868 million, a 52% increase from 2024, primarily due to the success of ENHANZE-enabled products [1][2] - Fourth quarter 2025 total revenue was $451.8 million, up 52% from $298.0 million in the same quarter of 2024, with royalties contributing $258.0 million [2][5] - The company reported a net loss of $141.6 million in Q4 2025, compared to a net income of $137.0 million in Q4 2024, largely due to acquired in-process research and development expenses [2][5] 2026 Financial Guidance - Halozyme expects non-GAAP diluted earnings per share for 2026 to be between $7.75 and $8.25, reflecting growth of 87% to 99% over 2025 [1][3] - Adjusted EBITDA is projected to be between $1.125 billion and $1.205 billion, indicating growth of 71% to 83% over the previous year [1][3] - Royalty revenue for 2026 is anticipated to be between $1.130 billion and $1.170 billion, representing a growth of 30% to 35% compared to 2025 [3] Corporate Developments - In November 2025, Halozyme completed the acquisition of Elektrofi, enhancing its drug delivery technology portfolio [1][2] - The company also acquired Surf Bio in December 2025, further expanding its capabilities in drug delivery technologies [1][2] - Halozyme entered into multiple collaboration agreements with partners such as Takeda and Merus, broadening its market reach and product offerings [1][2]

Core Insights - Halozyme Therapeutics, Inc. will release its fourth quarter and full year 2025 financial and operating results on February 17, 2026, after market close [1] - A conference call will be held on the same day at 1:30 PM PT/4:30 PM ET to discuss these results [1] Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through innovative drug delivery solutions [1] - The company is known for its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 to facilitate subcutaneous delivery of drugs, impacting over one million patients globally [1] - Halozyme has partnered with major pharmaceutical companies such as Roche, Takeda, Pfizer, and others to commercialize its technology across more than 100 markets [1] Technology and Product Development - The company has expanded its drug delivery technology portfolio with Hyperconâ™ and Surf Bio's hyperconcentration technology, which aims to reduce injection volume while maintaining dosage [1] - Hyperconâ™ technology has been licensed to leading biopharmaceutical partners, enhancing the delivery of biologics subcutaneously [1] - Halozyme also develops drug-device combination products using advanced auto-injector technologies to improve patient comfort and adherence [1] Corporate Structure - Halozyme is headquartered in San Diego, California, with additional offices in Ewing, New Jersey; Minnetonka, Minnesota; and Boston, Massachusetts [1]

Core Insights - Halozyme Therapeutics has raised its revenue estimates for 2025 and provided updated financial guidance for 2026, reflecting strong growth in its core ENHANZE business and recent acquisitions [1] Financial Estimates for 2025 - Total revenue is estimated to be between $1,385 million and $1,400 million, representing a year-over-year growth of 36% to 38% [1] - Royalty revenue is projected to be between $865 million and $870 million, with a year-over-year growth of 51% to 52% [1] Financial Guidance for 2026 - Total revenue guidance has been increased to a range of $1,710 million to $1,810 million, indicating a year-over-year growth of 23% to 30% [1] - Royalty revenue guidance has been raised to between $1,130 million and $1,170 million, reflecting a growth of 30% to 35% compared to 2025 [1] - Adjusted EBITDA is expected to be between $1,125 million and $1,205 million [1] - Non-GAAP diluted EPS is projected to be between $7.75 and $8.25 [1] Strategic Acquisitions - The company acquired Surf Bio for an upfront payment of $300 million, with potential milestone payments of up to $100 million, totaling up to $400 million [1] - Surf Bio's hyperconcentration technology aims to enable high concentrations of therapeutics for subcutaneous delivery, enhancing patient experience [1] Business Development and Partnerships - In 2025, Halozyme signed three new ENHANZE collaboration and licensing agreements, along with one new auto-injector commercial licensing agreement and two development agreements [1] - The company anticipates having 15 partner programs in development by the end of 2026, further expanding its drug delivery portfolio [1]

Core Insights - Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) for an indication extension of TECVAYLI® (teclistamab) in combination with DARZALEX® (daratumumab SC) for treating adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy [1][2] Group 1: Clinical Study and Results - The application is supported by data from the Phase 3 MajesTEC-3 study, which showed a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared to standard treatment [1][2] - The MajesTEC-3 study enrolled 587 patients and demonstrated an 83.4% reduction in the risk of disease progression or death compared to standard regimens at nearly three years follow-up (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; P<0.0001) [2][4] - More than 90% of patients who remained progression-free at six months continued to be progression-free at three years [2] Group 2: Treatment Efficacy and Safety - Teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38, enhancing immune-mediated responses earlier in treatment [2] - The combination regimen showed similar rates of Grade 3/4 treatment-emergent adverse events (TEAE) compared to standard care (95.1% vs. 96.6%) [2] - The most common Grade 3/4 events were cytopenia and infection, with infections observed in 96.5% of patients receiving teclistamab and daratumumab SC [2] Group 3: Regulatory and Market Position - The FDA has granted Breakthrough Therapy Designation for the teclistamab and daratumumab SC combination, expediting its development and regulatory review [2] - Johnson & Johnson aims to redefine treatment possibilities in multiple myeloma by using the right medicines early and combining them for optimal outcomes [3] Group 4: Background on Multiple Myeloma - Multiple myeloma is an incurable blood cancer affecting plasma cells, with over 35,000 new diagnoses in the EU in 2022 [8] - Patients experience frequent relapses, and remissions become progressively shorter with each line of therapy [8]