A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants With Solid Tumours

The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).

Start Date31 Mar 2026

Sponsor / Collaborator

AstraZeneca PLC

NCT05671172

/ CompletedNot ApplicableIIT

Effect of Adding Two Different Doses of Hyaluronidase to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Post-cesarean Section Analgesia; A Randomized Controlled Double Blinded Study.

Since TAP block needs to affect several nerves in single tissue plane with a single prick, hyaluronidase is expected to aid greatly in the spread of the LA and help the block. However, there have not been adequate studies to establish the efficacy of adding hyaluronidase in lateral TAP after cesarean section. Hence, the present study was carried out to evaluate the efficacy of hyaluronidase in different concentrations added to bupivacaine in US-guided bilateral lateral TAP block.

Start Date15 May 2023

Sponsor / Collaborator

Benha University

NCT05625399

/ Active, not recruitingPhase 3

A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Start Date06 Mar 2023

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Hyaluronidase Recombinant Human

100 Translational Medicine associated with Hyaluronidase Recombinant Human

100 Patents (Medical) associated with Hyaluronidase Recombinant Human

126

Literatures (Medical) associated with Hyaluronidase Recombinant Human

01 Jan 2026·Drug Delivery and Translational Research

A phase I clinical study to evaluate rapid, high-volume, subcutaneous auto-injector tolerability with recombinant human hyaluronidase

Article

Author: Knowles, Stephen P ; Nekoroski, Tara ; Connor, Robert J ; Kindig, Susan K ; Kang, David W ; LaBarre, Michael J ; Bitsura, Jo Ann M

Abstract:

Until recently, approved handheld auto-injectors (AIs) have been limited to volumes ≤ 2 mL. A prototype rapid high-volume AI (HVAI) that can deliver 10 mL in 30 s was developed to administer therapeutics co-formulated with a proprietary recombinant human hyaluronidase PH20 (rHuPH20). This phase I, open-label study assessed the tolerability of subcutaneous (SC) injections of 10% (100 mg/mL) immunoglobulin G (IgG) solution co-administered with 4000 U/mL rHuPH20, delivered using a syringe pump at a target rate of 5 or 10 mL/30 seconds or the prototype HVAI at a target rate of 10 mL/30 seconds in healthy human subjects. Subjects received 5 mL (Cohort A, n = 12) or 10 mL (Cohort B, n = 12) of test solution via syringe pump (injection visit 1), and 10 mL of test solution via HVAI (Cohorts A & B; injection visit 2). Primary endpoints were tolerability and safety outcomes. Secondary endpoints included HVAI injection duration. All 24 subjects completed visit 1; 23/24 completed visit 2. All injections were tolerated, with no serious adverse events (AEs). Following syringe pump administration, 6/24 subjects (25%) reported eight treatment-emergent AEs (TEAEs); after HVAI administration, 4/23 (17%) reported four TEAEs, all mild in severity. Mean (± SEM) injection duration via HVAI was 27.9 ± 0.8 s. Most subjects (91%, 21/23) experienced no or mild injection-site pain following HVAI administration, and 96% (22/23) said they would be willing to have the HVAI injection again. SC injection of a 10% IgG solution in combination with rHuPH20 was well tolerated at an injection rate of 10 mL/~30 s using the prototype HVAI.

01 Nov 2025·OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY

Identifying Minimum Single Dose of Recombinant Human Hyaluronidase for In Vitro Dissolution of Twenty-Two Hyaluronic Acid Fillers

Article

Author: Saeedi, Nikta ; Zhang-Nunes, Sandy X. ; Foster, Jill A. ; Sudharshan, Rasika ; Woodward, Julie ; Lee, Wendy W. ; Shen, Alena J. ; Kherani, Femida ; Gupta, Shreya ; Davuluru, Shaili S.

Purpose::

As the use of hyaluronic acid fillers continues to increase for clinical and aesthetic purposes, associated complications continue to rise as well. Excess hyaluronidase is often used to dissolve filler, which has its own set of adverse effects. This study analyzes 22 commercially available fillers to delineate the lowest single dose of recombinant human hyaluronidase (RHH) required to fully dissolve each filler within 6 hours across 3 trials.

Methods::

Aliquots in 0.2 ml amounts of each of 22 hyaluronic acid fillers were placed in wells. A single dose of RHH, titrated to a minimum volume of 0.45 cc, was administered to the center of the aliquot, to a maximum of 140 units. RHH amounts were as follows: 0, 2.5, 5, 10, 20, 40, 60, 80, 100, 120, or 140 units RHH. Bird’s eye and lateral photographs were taken to monitor dissolution progress at several time points over the 6-hour period to monitor aliquot height and appearance changes. Filler aliquots were left undisturbed for 6 hours, after which dissolution was confirmed by stirring the aliquot on video recording. This process was repeated 3 times per filler to determine the minimum dose of RHH required to consistently dissolve each aliquot.

Results::

For each of the 22 fillers, the minimum dose of RHH required for dissolution was identified with consistent results across 3 trials, demonstrating reliability. Juvéderm Volbella, Juvéderm Vollure, Juvéderm Skinvive, Restylane-L, Restylane Lyft, and Restylane Silk were identified as the least resistant fillers, requiring ≤20 units to dissolve. Resilient hyaluronic acid (RHA) 2, RHA 3, RHA 4, Belotero Volume, Juvéderm Ultra XC, Juvéderm Volux, Restylane Kysse, and Revanesse Versa were classified as most resistant, requiring ≥120 units to dissolve.

Conclusions::

This study identifies the minimum single dose of RHH from 2.5 units/0.2 ml to 140 units/0.2 ml for dissolution of 22 different hyaluronic acid fillers over 6 hours. These results paired with previous studies help elucidate the dissolution profiles of each filler in the context of their rheological properties, further informing physicians on how to optimally dissolve different hyaluronic acid fillers in a clinical setting.

01 Oct 2025·Journal of Allergy and Clinical Immunology-In Practice

Facilitated Subcutaneous Immunoglobulin 10% Safety Among Pediatric Patients With Primary Immunodeficiency Diseases

Review

Author: Walter, Jolan E ; Patel, Niraj C

Immunoglobulin replacement therapy is a fundamental treatment option to protect against infection for most patients with a primary deficiency in antibody production. Facilitated subcutaneous immunoglobulin (fSCIG) 10% is an immunoglobulin replacement therapy that uses recombinant human hyaluronidase to enhance immunoglobulin dispersion and absorption. This review provides an overview of data published to date relating to the safety and tolerability of fSCIG 10% for the treatment of primary immunodeficiency diseases in pediatric patients. Eight studies (199 pediatric patients) were included for discussion. fSCIG 10% displays a low rate of treatment-related systemic adverse events, and the risk of treatment-related local adverse events diminishes with increased treatment exposure. The reduced number of needle sticks required for fSCIG 10% administration than for conventional subcutaneous immunoglobulin may offer advantages for patients with immune disorders that have compromised their skin integrity, and for those who experience needle phobia and treatment-associated anxiety. Studies evaluating prospective, patient-centric data collected on the experience of such patients may be a valuable addition to the evidence base. Discussion of fSCIG 10% as a potential treatment option between families and health care professionals will enhance individualized treatment plans and shared decision making, which are important considerations for patients with primary immunodeficiency diseases.

135

News (Medical) associated with Hyaluronidase Recombinant Human

26 Feb 2026

·www.biospace.com

argenx Announces Positive Topline Results from Phase 3 ADAPT OCULUS Trial of VYVGART in Ocular Myasthenia Gravis

Study met primary endpoint (p-value = 0.012) First registrational study to specifically evaluate a targeted treatment for patients living with ocular MG Results support planned Supplemental Biologics License Application (sBLA) submission to U.S. Food and Drug Administration (FDA) to expand label into oMG Regulated Information – Inside Information February 26, 2026, 6:30 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART® (efgartigimod alfa and hyaluronidase-qvfc) in adults with ocular myasthenia gravis (oMG). ADAPT OCULUS met its primary endpoint (p-value=0.012), showing that patients living with oMG and treated with VYVGART demonstrated statistically significant improvement from baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared to placebo. In the overall population, mean change from baseline in patients treated with VYVGART was a 4.04 point improvement in MGII PRO versus a mean change of 1.99 MGII PRO score in patients treated with placebo. Patients treated with VYVGART experienced a marked reduction of key ocular symptoms: diplopia (double vision) and ptosis (drooping of the upper eyelids). “Ocular myasthenia gravis significantly impacts patients’ daily lives, affecting vision, independence and the ability to do routine tasks, such as work or drive a car. Yet today, there are no approved targeted medicines for this disease,” said Carolina Barnett-Tapia, M.D., Ph.D., Associate Professor of Medicine (Neurology) at the University of Toronto. “The improvements observed with VYVGART in the OCULUS trial offer hope to the thousands of myasthenia gravis patients with ocular involvement.” VYVGART was well tolerated and had a favorable safety pro patients with oMG, consistent with prior studies. No new safety concerns were identified. “ADAPT OCULUS is the first registrational study specifically designed to evaluate a targeted therapy for ocular myasthenia gravis,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx. “Ocular MG has been historically under-studied and represents a significant unmet need in the MG community. These positive results deliver on our patient-centered approach to drug development and bring us one step closer to our vision of delivering a targeted, transformative treatment option to as many MG patients as possible and ensuring no patient is left behind.” Data from the ADAPT OCULUS study will be presented at an upcoming medical meeting. About the ADAPT OCULUS Study Design ADAPT OCULUS is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group design study evaluating the efficacy and safety of VYVGART SC administered by prefilled syringe in adult patients with ocular MG (MGFA Class I) (n=141) across North America, Europe and Asia-Pacific. In Part A, randomized participants (1:1) received four once-weekly injections of efgartigimod PH20 SC or placebo PH20 SC followed by a 4-week follow-up. In Part B, open-label extension, participants received 2 cycles of four once-weekly efgartigimod injections with a 4-week interval between cycles. Additional cycles from Cycle 3 onward could start ≥1 week after the last administration of the previous cycle, based on clinical status. The primary endpoint was the change from baseline in Myasthenia Gravis Impairment Index (MGII) (patient-reported outcome [PRO] subcomponent) ocular score at week 4 (day 29) compared to placebo in Part A. Enrolled participants were either seropositive or seronegative for AChR-Ab, and MGFA Class I with only ocular muscle weakness as determined by an MGII (PRO) ocular score of ≥6 with at least 2 ocular items with a score of ≥2. Participants were on a stable dose of gMG treatment prior to randomization, including acetylcholinesterase inhibitors, corticosteroids or nonsteroidal immunosuppressive drugs. MGII is a validated measure of disease severity based on the signs and symptoms of myasthenia gravis and includes an ocular-specific subdomain that evaluates the two key clinical symptoms of oMG: diplopia and ptosis. Important Safety Information What is VYVGART ® (efgartigimod alfa-fcab)? VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive). IMPORTANT SAFETY INFORMATION Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. VYVGART can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART may cause serious side effects, including: Infection.  VYVGART may increase the risk of infection. The most common infections were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. Allergic Reactions (hypersensitivity reactions).  VYVGART can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with VYVGART.  Infusion-Related Reactions.  VYVGART can cause infusion-related reactions. The most frequent symptoms and signs reported with VYVGART were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have received or are scheduled to receive a vaccine (immunization), or have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. What are the common side effects of VYVGART? The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection. These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART and talk to your doctor. Important Safety Information What is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc)? VYVGART HYTRULO is a prescription medicine used to treat adults with: generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. chronic inflammatory demyelinating polyneuropathy (CIDP). It is not known if VYVGART HYTRULO is safe and effective in children. IMPORTANT SAFETY INFORMATION Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting. Before taking VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever. have recently received or are scheduled to receive any vaccinations. have any history of allergic reactions. have kidney (renal) problems. are pregnant or plan to become pregnant. It is not known whether VYVGART HYTRULO will harm your unborn baby. Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com are breastfeeding or plan to breastfeed. It is not known if VYVGART HYTRULO passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VYVGART HYTRULO can cause side effects which can be serious, including: Infection. VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection: fever, chills, frequent and painful urination, cough, pain and blockage or nasal passages, wheezing, shortness, sore throat, excess phlegm, nasal discharge. Allergic reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction: rash, swelling of the face, lips, throat, or tongue, shortness of breath, hives, trouble breathing, low blood pressure, fainting. Infusion or injection-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction: high blood pressure, chills, shivering, chest, stomach, or back pain. The most common side effects of VYVGART HYTRULO include respiratory tract infection, headache, urinary tract infection, and injection site reactions. These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor. About VYVGART and VYVGART Hytrulo VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART® Hytrulo is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions. About Ocular Myasthenia Gravis (oMG) Ocular myasthenia gravis (oMG) is a rare and chronic autoimmune disease characterized by muscle weakness limited to the muscles controlling the eyes and eyelids. Symptoms commonly include ptosis (drooping eyelids), diplopia (double vision), and fluctuating visual disturbance that can impair daily activities. Approximately 80% of myasthenia gravis (MG) patients initially present with ocular symptoms, and up to 92% experience ocular involvement at some point during the course of disease. While many progress to generalized myasthenia gravis (gMG), in 15–25% of patients, weakness remains restricted to the ocular muscles. oMG is driven by pathogenic IgG autoantibodies that disrupt communication at the neuromuscular junction. Despite the functional and quality-of-life burden associated with persistent ocular symptoms, there are currently no approved targeted therapies specifically for oMG. Treatment approaches often rely on symptomatic therapies and generalized immunosuppression, underscoring the need for additional therapeutic options for this distinct MG population. About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn , Instagram , Facebook , and YouTube . This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014). Media: Colin McBean cmcbean@argenx.com Investors: Alexandra Roy aroy@argenx.com FORWARD LOOKING STATEMENTS The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “advance,” “commit,” “continue,” “develop,” “potential,” and “will” and include statements argenx makes concerning the potential of VYVGART for oMG patients; argenx’s vision of delivering a targeted, transformative treatment option to as many MG patients as possible; its expectation that it will submit a Supplemental Biologics License Application (sBLA) for VYVGART for oMG to the U.S. FDA by end of third quarter 2026; its commitment to improve the lives of people suffering from severe autoimmune diseases; its plan to present data from the ADAPT OCULUS study at an upcoming medical meeting; its aim to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines; its commercialization of the first approved neonatal Fc receptor (FcRn) blocker and evaluation of its broad potential in multiple serious autoimmune diseases; and its advancement of several earlier stage experimental medicines within its therapeutic franchises. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx’s clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

Clinical ResultPhase 3ImmunotherapyDrug Approval

17 Feb 2026

·www.prnewswire.com

HALOZYME REPORTS FULL YEAR 2025 RECORD REVENUE OF $1.4 BILLION AND REITERATES STRONG 2026 FINANCIAL GUIDANCE

Full Year 2025 Total Revenue Increased 38% YOY to Record $1.397 billion Full Year 2025 Royalty Revenue Increased 52% YOY to Record $868 million Completed Acquisitions of Elektrofi's Hypercon™ Technology and Surf Bio's Hyperconcentration Technology Reiterating 2026 Financial Guidance Ranges: Total Revenue of $1.710 - $1.810 billion, YOY Growth of 22% - 30% Adjusted EBITDA of $1.125 - $1.205 billion, YOY Growth of 71% - 83%1 Non-GAAP Diluted EPS of $7.75 - $8.25, YOY Growth of 87% - 99%1 SAN DIEGO, Feb. 17, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the full year and fourth quarter ended December 31, 2025, and provided an update on its recent corporate activities. "2025 was a pivotal year for Halozyme as we delivered record total revenue of $1.4 billion, which was the result of continued growth in our ENHANZE business. In addition, we expanded our drug delivery technology portfolio with two acquisitions. Three ENHANZE‑enabled blockbusters, DARZALEX SC, Phesgo and VYVGART Hytrulo, drove royalty revenue growth of 52%, reaching a record $868 million in 2025. In the year, we also expanded our ENHANZE opportunities, adding three new collaboration and licensing agreements with Takeda, Merus and Skye Bioscience and gained one new target nomination from Roche. Furthermore, Janssen expanded the global reach of ENHANZE with approvals in the U.S., China and Japan for Rybrevant SC and new indication approvals in front line settings for DARZALEX Faspro. In parallel, we broadened our drug delivery portfolio with the acquisitions of the Hypercon technology and Surf Bio's hyperconcentration technology, which meaningfully expand, diversify and extend our long‑term royalty opportunity into the mid-2040s," said Dr. Helen Torley, President and Chief Executive Officer. Dr. Torley continued, "As we look ahead, our long-term outlook reflects the strong momentum and opportunity we have built through a broader drug delivery portfolio and offering to the biopharma industry. With royalty revenue projected to exceed $1 billion in 2026 and a clear line of sight to more than $2 billion in total revenue by 2028, Halozyme is entering its next phase of growth with strong conviction. Our projected 22% to 30% total revenue growth in 2026, combined with an expanding development pipeline with six projected new ENHANZE and two Hypercon development program starts, plus plans to sign three or more ENHANZE and Hypercon partnerships in 2026, all reinforce the durability of our revenue. With our strong cash generation and a diversified set of high‑value royalty drivers, we remain focused on delivering sustained long‑term value for shareholders." Fourth Quarter and Recent Corporate Highlights: In December 2025, Halozyme completed the acquisition of Surf Bio, Inc. ("Surf Bio"), subsequently renamed Halozyme Surf Bio, Inc., resulting in an expansion of Halozyme's drug delivery technology portfolio and the potential for future growth through new collaboration agreements. In December 2025, Halozyme announced that a German court had granted Halozyme's request for a preliminary injunction ordering Merck Sharp & Dohme Corp. ("Merck") to refrain from distributing and offering Keytruda® SC in Germany. In November 2025, Halozyme completed the acquisition of Elektrofi Inc. ("Elektrofi"), subsequently renamed Halozyme Hypercon, Inc., resulting in an expansion of Halozyme's drug delivery technology portfolio and the potential for future growth through new collaboration agreements. In November 2025, Halozyme completed the sale of $750.0 million aggregate principal amount of the 2031 Convertible Notes and $750.0 million aggregate principal amount of the 2032 Convertible Notes. The Company used a portion of the net proceeds to fund the cost of entering into the 2031 Capped Call Transactions and the 2032 Capped Call Transactions. The Company also used a portion of the net proceeds to enter into privately negotiated agreements with certain holders of its outstanding 2027 Convertible Notes and 2028 Convertible Notes to repurchase their 2027 Convertible Notes and 2028 Convertible Notes for cash through privately negotiated transactions entered into concurrently with or shortly after the offering. In November 2025, Halozyme entered into an amendment to the Company's credit agreement that, among other things extended the maturity date and increased the borrowing capacity of the Company's existing revolving credit facility from $575.0 million to $750.0 million. Fourth Quarter and Recent Partner Highlights: In January 2026, Janssen announced the U.S. Food and Drug Administration ("FDA") approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone ("D-VRd") for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In December 2025, Halozyme and Skye Bioscience entered into a non-exclusive global collaboration and license agreement that provides Skye Bioscience access to ENHANZE® for the development and potential commercialization of an SC formulation of nimacimab for the treatment of obesity. In December 2025, Halozyme and Takeda entered into a new global collaboration and exclusive license agreement which provides Takeda with access to ENHANZE® for use with vedolizumab, marketed globally as ENTYVIO®, for the treatment of adults with moderately to severely active Crohns' disease or ulcerative colitis, which are the two main forms of inflammatory bowel disease. In December 2025, Roche nominated a new undisclosed non-exclusive target to be studied using ENHANZE®. In the fourth quarter of 2025, the ongoing argenx ARGX-121 Phase 1 program was expanded to include an SC-arm evaluating ARGX-121 with ENHANZE® in healthy adults. In December 2025, Janssen announced the FDA approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) for the treatment of patients with epidermal growth factor receptor ("EGFR")-mutated locally advanced or metastatic non-small cell lung cancer ("NSCLC"). In December 2025, Janssen received approval from the National Medical Products Administration in China for RYBREVANT™ FASPRO for the first-line treatment of adult patients with advanced NSCLC. In December 2025, Janssen received approval from the Ministry of Health, Labour and Welfare in Japan for RYBROFAZ® (amivantamab) with ENHANZE® for the first-line treatment of adult patients with advanced NSCLC. In December 2025, Halozyme entered into a commercial license and supply agreement with Viatris under which Halozyme licenses and supplies an auto-injector product for self-administered SC selatogrel for the treatment of acute myocardial infarction in adult patients. In November 2025, Janssen announced the FDA approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE®, as single treatment of adult patients with high-risk smoldering multiple myeloma. In November 2025, Halozyme and Merus entered into a non-exclusive global collaboration and license agreement that provides Merus access to ENHANZE® technology for a single target. Merus intends to explore development and potential commercialization of SC administration of petosemtamab, an EGFR and leucine-rich repeat-containing G-protein coupled receptor 5 bispecific antibody, for the treatment of head and neck cancer. Full Year and Fourth Quarter 2025 Financial Highlights: Total revenue for the full year was $1,396.6 million, compared to $1,015.3 million in 2024. The 38% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $867.8 million in royalties, an increase of 52% compared to $571.0 million in 2024, primarily driven by continued sales uptake of ENHANZE® partner products that have launched since 2020, predominantly by VYVGART® Hytrulo by argenx, DARZALEX® SC by Janssen and Phesgo® by Roche in all geographies. Cost of sales for the full year was $228.8 million, compared to $159.4 million in 2024. The increase in cost of sales was primarily due to an increase in product sales and labor allocation initiatives. Amortization of intangibles expense for the full year was $76.7 million, compared to $71.0 million in 2024. The increase in amortization of intangibles expense was due to the acquisition of Elektrofi in November 2025. Research and development expense for the full year was $81.5 million, compared to $79.0 million in 2024. The increase was primarily due to the acquisition of Elektrofi and Surf Bio, partially offset by lower compensation expense driven by resource optimization, labor allocation initiatives, and timing of planned investments in ENHANZE® related to the development of our new high-yield rHuPH20 manufacturing process. Selling, general and administrative expense for the full year was $207.1 million, compared to $154.3 million in 2024. The increase was primarily due to an increase in consulting and professional service fees, including litigation costs incurred in connection with a patent infringement litigation case, diligence and transaction-related costs incurred in support of the acquisition of Elektrofi and Surf Bio, and an increase in compensation expense. Net income for the full year was $316.9 million, compared to $444.1 million in 2024. Net Income included acquired in-process research and development ("IPR&D") expense of $284.9 million related to the Surf Bio acquisition in the fourth quarter of 2025. Adjusted EBITDA for the full year was $657.6 million, compared to $632.2 million in 2024.1,2 Adjusted EBITDA included acquired IPR&D expense of $284.9 million related to the Surf Bio acquisition in the fourth quarter of 2025. GAAP diluted earnings per share for the full year was $2.56, compared to $3.43 in 2024. Non-GAAP diluted earnings per share was $4.15, compared to $4.23 in 2024.1,2 GAAP and non-GAAP diluted earnings per share included an unfavorable impact of approximately $2.30 per share related to acquired IPR&D expense for the Surf Bio acquisition in the fourth quarter of 2025. Total revenue in the fourth quarter was $451.8 million, compared to $298.0 million in the fourth quarter of 2024. The 52% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $258.0 million in royalties, an increase of 51% compared to $170.4 million in the fourth quarter of 2024, primarily driven by continued sales uptake of ENHANZE® partner products that have launched since 2020, predominantly by VYVGART® Hytrulo by argenx, DARZALEX® SC by Janssen and Phesgo® by Roche in all geographies. Net loss in the fourth quarter was $141.6 million, compared to net income of $137.0 million in the fourth quarter of 2024. Net loss included acquired IPR&D expense of $284.9 million related to the Surf Bio acquisition in the fourth quarter of 2025. Adjusted EBITDA in the fourth quarter was $21.9 million, compared to $195.8 million in the fourth quarter of 2024.1,2 Adjusted EBITDA included acquired IPR&D expense of $284.9 million related to the Surf Bio acquisition in the fourth quarter of 2025. GAAP diluted loss per share in the fourth quarter was $1.20, compared to GAAP diluted earnings per share $1.06 in the fourth quarter of 2024. Non-GAAP diluted loss per share was $0.24 compared to Non-GAAP diluted earnings per share of $1.26 in the fourth quarter of 2024.1,2 GAAP and non-GAAP diluted loss per share in the fourth quarter of 2025 included an unfavorable impact of $2.42 per share related to acquired IPR&D expense for the Surf Bio acquisition in the fourth quarter of 2025. Cash, cash equivalents, restricted cash and marketable securities were $145.4 million on December 31, 2025, compared to $596.1 million on December 31, 2024. The decrease was primarily driven by cash used for the Elektrofi and Surf Bio acquisitions and share repurchases, partially offset by the net proceeds from issuance of convertible notes and cash generated from operations. Financial Outlook for 2026 The Company is reiterating its 2026 financial guidance ranges, which were last updated on January 28, 2026. For the full year 2026, the Company expects: Total revenue of $1.710 billion to $1.810 billion, representing growth of 22% to 30% over 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API. Revenue from royalties of $1.130 billion to $1.170 billion, representing growth of 30% to 35% over 2025. Adjusted EBITDA of $1.125 billion to $1.205 billion, representing growth of 71% to 83% over 2025, including new Hypercon™ and Surf Bio investment of approximately $60 million. Non-GAAP diluted earnings per share of $7.75 to $8.25, representing growth of 87% to 99% over 2025. The Company's earnings per share guidance includes new Hypercon™ and Surf Bio investment of approximately $60 million and does not consider the impact of potential future share repurchases. Table 1. 2026 Financial Guidance Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the fourth quarter and full year ended December 31, 2025 today, Tuesday, February 17, 2026, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, Merus N.V. and Skye Bioscience. Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon™ and the Surf Bio hyperconcentration technology. Hypercon™ is an innovative microparticle technology expected to set a new standard in hyperconcentration of drugs and biologics by reducing injection volume for the same dosage and enabling administration in at‑home and healthcare‑provider settings. The development of the Surf Bio polymer‑based hyperconcentration technology further broadens the range of biologics that can be delivered subcutaneously, meaningfully expanding the scope of opportunities across therapeutic modalities. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly and argenx. Halozyme also develops, manufactures and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility. For more information, visit and connect with us on LinkedIn. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain Non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA, Non-GAAP diluted earnings per share, Non-GAAP diluted shares, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates Non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, transaction costs for business combinations, severance and share-based compensation acceleration expenses, intellectual property litigation costs, inducement expenses related to convertible notes, and certain adjustments to income tax expense. The Company calculates Non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating Non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, transaction costs for business combinations, severance and share-based compensation acceleration expenses and intellectual property litigation costs. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The Company provides Non-GAAP financial measures that it believes will be achieved; however, it cannot accurately predict all of the components of the adjusted calculations and the GAAP measures may be materially different than the Non-GAAP measures. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These Non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. The Company considers these Non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The Non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses Non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's expected financial outlook for 2026) and expectations for future growth, profitability, revenue durability, total revenue, royalty revenue, royalty revenue duration, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share, and shareholder value. Forward-looking statements also include future plans, objectives, expectations and intentions related to the acquisitions of Elektrofi and Surf Bio, such acquisitions' expected impact and contributions to the Company's and combined group's operations and financial results (including potential development and commercialization of partnered products and timing related to these events), as well as the expected benefits of the acquisitions. Forward-looking statements related to Elektrofi's and Surf Bio's intellectual property include expectations for length of patent terms and patent expirations and the expected impact such patents may have on the duration, durability and amounts of future royalty payments the Company may receive from licensing such intellectual property. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and advancement of partnered development programs, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations and collaborative targets, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "preliminary," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including uncertainties concerning future matters such as market conditions, changes in domestic and foreign business, changes in the competitive environment in which the Company operates, the expected benefits of its acquisitions of Elektrofi and Surf Bio, unexpected early expiration or termination of the patent terms for the Company's drug delivery technologies, unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, including under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] SOURCE Halozyme Therapeutics, Inc. 21% more press release views with Request a Demo

Phase 1License out/inDrug ApprovalAcquisition

28 Jan 2026

·www.prnewswire.com

Halozyme Raises 2025 Revenue Estimates, Raises 2026 and Multi-Year Financial Guidance

Updates Preliminary Unaudited 2025 Estimates: - Total Revenue of $1,385 - $1,400 million, YoY Growth of 36% to 38%1 - Royalty Revenue of $865 - $870 million, YoY Growth of 51% to 52%1 Raises 2026 Financial Guidance Ranges: - Increases Total Revenue to $1,710 - $1,810 million, YoY Growth of 23% to 30%2 - Increases Royalty Revenue to $1,130 - $1,170 million, YoY Growth of 30% to 35%2 - Increases Adjusted EBITDA to $1,125 - $1,205 million3,4 - Increases non-GAAP Diluted EPS to $7.75 - $8.253,4 Expands Drug Delivery Opportunity with Acquisition of Surf Bio and its Hyperconcentration Technology Conference Call Scheduled Today at 5:30am PT/8:30am ET SAN DIEGO, Jan. 28, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") today provided a business update, including providing preliminary unaudited 2025 revenue estimates and raising full year 2026 and multi-year financial guidance. The Company also announced it acquired Surf Bio, Inc. ("Surf Bio"), a biopharmaceutical company with an innovative, biologic hyperconcentration technology seeking to transform the delivery of antibodies and biologics, in December 2025. "Our increased multi-year guidance reflects both the strength of our core ENHANZE business and the exceptional momentum we built in 2025. In 2025, we expect royalty revenue growth to exceed 50% year‑over‑year, a clear demonstration of the strength of our business model and the durable demand for ENHANZE‑enabled products globally. In parallel, we significantly expanded new partnerships, signing three new ENHANZE collaboration and licensing agreements, one new auto-injector commercial licensing and supply agreement and two auto-injector development agreements. In addition, our partner Janssen gained global approvals for Rybrevant Faspro, the tenth ENHANZE-approved product. During 2025, we advanced our strategic growth roadmap with the acquisitions of Elektrofi and their Hypercon technology and of Surf Bio and their hyperconcentration technology. Both hyperconcentration technologies have long-duration IP into the mid-2040s. Our operational accomplishments and acquisitions broaden our drug delivery portfolio and opportunity, amplify and extend our royalty horizons, and diversify the pathways through which we create value," said Dr. Helen Torley, President and Chief Executive Officer. Dr. Torley added, "In the near-term, our strong 2026 total revenue expectations of 23% to 30% year‑over‑year growth underscore the strength of our royalty revenue, which is projected to exceed $1 billion in 2026, growing at 30% to 35% versus prior year. This is one year earlier than previously projected. By the end of 2026, we project we will have 15 partner programs in development and have signed three or more new drug delivery licensing agreements, expanding the reach and growing our opportunity through our diversified drug delivery portfolio. Taken together, these drivers reinforce our confidence in delivering durable revenue growth well into the 2040s and support our conviction in Halozyme's long‑term growth profile which will deliver sustained value for shareholders." The Company acquired Surf Bio for an upfront payment of $300 million, subject to customary purchase price adjustments, and up to $100 million milestone payments contingent on product development and regulatory approval milestones, for a total consideration of up to $400 million. The Surf Bio hyperconcentration technology is being developed to enable high concentrations of up to 500 mg/mL across a wide range of therapeutics, including monoclonal antibodies and small molecules, for delivery in a single auto-injector shot for at-home or in-HCP office use. These high concentration formulations are achievable using Surf Bio's proprietary, protective excipient and spray dry approach, enabling accessible and patient-friendly subcutaneous delivery of antibodies and biologics. Table 1. 2025 Unaudited Preliminary Revenue Estimates for the Twelve Months Ended December 31, 2025 Financial Outlook for 2026 The Company is raising its financial guidance for 2026. For the full year 2026, the Company expects: Total revenue of $1,710 million to $1,810 million, representing growth of 23% to 30% over projected 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API. Revenue from royalties of $1,130 million to $1,170 million, representing growth of 30% to 35% over 2025. Adjusted EBITDA of $1,125 million to $1,205 million, including new Hypercon™ and Surf Bio investment of approximately $60 million, which was not included in prior 2026 guidance. Non-GAAP diluted earnings per share of $7.75 to $8.25. The Company's earnings per share guidance includes new Hypercon™ and Surf Bio investment of approximately $60 million not included in prior 2026 guidance and does not consider the impact of potential future share repurchases. Table 2. 2026 Financial Guidance Webcast and Conference Call Halozyme will host an Investor Conference Call today, Wednesday, January 28 at 5:30am PT/8:30am ET. Pre-registration of the live call can be accessed via link here: . A webcast of the live call and presentation materials will be available through the "Investors" section of Halozyme's corporate website at ir.halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, and Merus N.V. Halozyme is also developing partner products with Hypercon™ to expand the breadth of its drug delivery technology portfolio. Hypercon™ is an innovative microparticle technology that is expected to set a new standard in hyperconcentration of drugs and biologics that can reduce the injection volume for the same dosage and expands opportunities for at-home and health care provider administration. The addition of Hypercon™ enhances our ability to transform the patient treatment experience by enabling the creation and delivery of highly concentrated biologics, substantially broadening the scope of therapeutics that can be delivered subcutaneously. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly, and argenx. Halozyme also develops, manufactures, and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability, and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products, and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility. Note Regarding 2025 Preliminary Results The financial results presented herein are preliminary, estimated, and unaudited. They are subject to the completion and finalization of the Company's financial and accounting close procedures. They reflect management's estimates based solely upon information available to management as of the date of this press release. Further information learned during the completion and finalization of these procedures may alter the final results. These preliminary estimates should not be considered a substitute for the financial information to be filed with the Securities and Exchange Commission on the Company's Form 10-K for the year ended December 31, 2025 once it becomes available. There is a possibility that the Company's financial results for the twelve months ended December 31, 2025 could vary materially from these preliminary estimates. Accordingly, you should not place undue reliance upon this preliminary information. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release contains certain non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA, Non-GAAP diluted earnings per share and non-GAAP diluted shares and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time changes, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, and certain adjustments to income tax expense. The Company calculates non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items, if any such as changes in contingent liabilities, inventory adjustments and impairment charges. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. The Company considers these non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including preliminary results for the fiscal year ended December 31, 2025 and the Company's expected financial outlook for 2026) and expectations for future growth, profitability, revenue and product demand durability, total revenue, royalty revenue, royalty revenue duration, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share, and shareholder value. Forward-looking statements also include future plans, objectives, expectations and intentions related to the acquisitions of Elektrofi and Surf Bio, such acquisitions' expected impact and contributions to the Company's and combined group's operations and financial results (including potential development and commercialization of partnered products and timing related to these events), as well as the expected benefits of the acquisitions. Forward-looking statements related to Elektrofi's and Surf Bio's intellectual property include expectations for length of patent terms and patent expirations and the expected impact such patents may have on the duration, durability and amounts of future royalty payments the Company may receive from licensing such intellectual property. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and advancement of partnered development programs, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations and collaborative targets, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "preliminary," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including uncertainties concerning future matters such as market conditions, changes in domestic and foreign business, changes in the competitive environment in which the Company operates, the expected benefits of its acquisitions of Elektrofi and Surf Bio, unexpected early expiration or termination of the patent terms for the Company's drug delivery technologies, unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-359-3016 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] SOURCE Halozyme Therapeutics, Inc. 21% more press release views with Request a Demo

License out/inAcquisitionFinancial Statement

100 Deals associated with Hyaluronidase Recombinant Human

External Link

KEGG	Wiki	ATC	Drug Bank
D06604	-	-	DB06205

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Drug adjuvant	United States	Halozyme Therapeutics, Inc.	02 Dec 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pain	Phase 3	United States	Halozyme Therapeutics, Inc.	01 Jan 2006
Diabetes Mellitus, Type 2	Phase 2	United States	Halozyme Therapeutics, Inc.	01 Aug 2010
Dermatitis, Allergic Contact	Phase 2	United States	Halozyme Therapeutics, Inc.	23 Jun 2009
Non-Muscle Invasive Bladder Neoplasms	Phase 2	United States	Halozyme Therapeutics, Inc.	30 Mar 2006
Hypercholesterolemia	Phase 1	Belgium	Halozyme Therapeutics, Inc.	01 Feb 2016
Osteoporosis	Phase 1	United States	Halozyme Therapeutics, Inc.	01 Dec 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00928447 (CTgov)	Phase 2	Dermatitis, Allergic Contact	22	Placebo+rHuPH20	lfwngmilgs = mghpdpfkgk maavtpfoad (fdzfxuinue, lapczyitze - pcgxbrkdck) View more	-	17 Dec 2021
NCT00318643 (CTgov)	Phase 1/2	Non-Muscle Invasive Bladder Neoplasms	27	Mitomycin C+Chemophase (Cohort 5: MMC Plus Chemophase 800,000 U)	ryzofdntad = ehlywpxcys rjxotdvsjh (wvaqhgpxsf, irzyeplams - cwqxudpdut) View more	-	29 Oct 2021
				Mitomycin C+Chemophase (Cohort 1: MMC Plus Chemophase 20,000 U)	zhfblasthc = ulsvdjqivn rzdjbgktbb (kcvpquwenh, ocwvihkbdi - duptyzsnvl) View more
NCT03662334 (HALO-117-406, CTgov)	Phase 4	Diabetes Mellitus, Type 1	14	Sham injection	hnsvbutklt(rttjwaaoxz) = wygahgygnd azbmkrtlfi (hgfxrqqour, hpjmzudmcm - yobkiicjhn) View more	-	01 Feb 2019
NCT01928030 (CTgov)	Phase 1/2	Neoplasms \| Lymphedema	3	rHuPH20+Chemophase	itmgrvxcxb(lxfndtodaq) = zqlbubuibf slgmwrmauf (adpbotjopx, fnwdfkzffq - zurznborip) View more	-	07 Feb 2017
NCT01848990 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	456	Insulin glulisine+Insulin lispro+Insulin aspart (Standard Rapid-Acting Insulin CSII)	oihjutrkzb(ecbysxhuxp) = arqvandrot pifdiqtbvr (tagfulexts, 0.687) View more	-	29 Oct 2014
				Insulin glulisine+Insulin lispro+Insulin aspart (Standard Rapid-acting Insulin CSII)	ukliekxrcl = zkuliywyia pdayodauni (xjssjfykqs, wsfsutmtnz - wzstljayey) View more
NCT01526733 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	25	Recombinant Human Hyaluronidase PH20+Insulin lispro+Insulin aspart (Insulin (Aspart or Lispro)-rHuPH20)	nbsqfjynrb(wlunbimpop) = edzrklxzao gkwublpeye (xvorqoekau, 11.81) View more	-	29 Sep 2014
				Sham Injection+Insulin lispro+Insulin aspart (Insulin (Aspart or Lispro)-Sham)	nbsqfjynrb(wlunbimpop) = whpkrhfhst gkwublpeye (xvorqoekau, 8.24) View more
NCT01848990 (EASD2014)	Phase 4	Diabetes Mellitus, Type 1	456	Recombinant human hyaluronidaserHuPH20 hyaluronidase (CSII with rHuPH20 pretreatment)	ilvipmgfpl(htxqgakanh) = adgnjfpcey tqngrjklrr (hdpkbkfvld ) View more	Positive	18 Sep 2014
				Recombinant human hyaluronidase (Usual CSII)	ilvipmgfpl(htxqgakanh) = tuzygyjypx tqngrjklrr (hdpkbkfvld ) View more
NCT00883558 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	48	recombinant human insulin (INSULIN-PH20 NP)	nchjsolhxx(vcwhipsnja) = rwlvtunoif defwqwdczy (kbouuojzgq, 36.040) View more	-	08 Sep 2014
				Insulin Lispro (Insulin Lispro)	nchjsolhxx(vcwhipsnja) = huvrcdbjhu defwqwdczy (kbouuojzgq, 35.113) View more
NCT01194258 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	132	insulin+rHuPH20+insulin lispro+insulin aspart (Analog-PH20)	anjpqbmaqi(wynlmlgqvo) = hwjwxhncab pszhxsxvea (fnvstuzfcd, 0.590) View more	-	20 Aug 2014
				Insulin Lispro (Insulin Lispro)	anjpqbmaqi(wynlmlgqvo) = ijowcrgyeg pszhxsxvea (fnvstuzfcd, 0.571) View more
NCT00862849 (CTgov)	Phase 1	Diabetes Mellitus	22	rHuPH20+Insulin Lispro (Insulin Lispro + rHuPH20)	svhixalhda(chhbhisjbr) = kaxmizmxll goliaitfom (cmednsgsnk, 11.12) View more	-	11 Jul 2014
				Insulin+rHuPH20 (Regular Human Insulin + rHuPH20)	svhixalhda(chhbhisjbr) = wqxvzzxdqi goliaitfom (cmednsgsnk, 12.43) View more

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