On November 5, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the third quarter ended September 30, 2026, and provided an update on its recent corporate activities.

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"Halozyme delivered another exceptional quarter, with total revenue increasing 39% and royalty revenue growing 44% year-over-year to record levels," said Dr. Helen Torley, President and Chief Executive Officer. "In and post the quarter, we have achieved multiple milestones that expand our opportunity and diversify our revenue. During the quarter, we expanded our agreements with argenx and Incyte to include additional targets to be evaluated with ENHANZE. In October, we also signed an expanded agreement with Johnson & Johnson for one additional target. Three ENHANZE programs, one each with Pfizer, Incyte and argenx advanced into Phase 1 clinical development, bringing our total products in development to twelve."

Dr. Torley continued, "In October, we also achieved an important victory in protecting our intellectual property. The Dutch specialized patent court found that Merck is infringing one of our MDASE patents and granted an injunction prohibiting the launch of Keytruda Qlex in multiple European markets. Our commitment to protecting the value of our innovations, growing royalties, continued partner expansion and growing pipeline demonstrates the power of Halozyme’s compounding platform engine and positions us to deliver durable revenue well into the next decade."

"Based on our strong financial performance this quarter, we are pleased to be able to raise our guidance for the full year 2026," said Darren Snellgrove, Executive Vice President and Chief Financial Officer. "We also further strengthened our financial position with the successful completion of our $1.5 billion convertible notes, which enhances our flexibility to execute our disciplined capital allocation strategy. We completed $400 million in share repurchases this year while continuing to invest in our highest-return organic opportunities and maintaining a clear path to retire our remaining 2027 and
2028 notes at maturity. With our strong cash generation, we remain focused on capital deployment to maximize long-term value creation."

Recent and Third Quarter Corporate Highlights:
•In October 2026, the Company announced the specialized Dutch patent court of the Hague found Merck Sharp & Dohme B.V. ("MSD BV"), the central European Market Authorization holder for Merck & Co., Inc., to be infringing one of Halozyme’s MDASE patents and ordered MSD BV to refrain from manufacturing, having manufactured, offering, placing on the market and using, or importing or stocking for these purposes, Keytruda Qlex in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands. The injunction also forbids MSD BV to facilitate infringement by its affiliates in those countries, including by allowing the use of its European Marketing Authorization. The court also rejected MSD BV’s arguments that the patent is invalid.
•During the third quarter of 2026, Halozyme repurchased approximately 0.8 million shares for $67.2 million at an average price of $79.47 per share under the May 2026 share repurchase program, resulting in $400 million of share repurchases in 2026.

Recent Partner Highlights:
•In October 2026, Takeda announced a Biologics License Application was filed with the Food and Drug Administration ("FDA") for TAK-881 for the treatment of Primary Immunodeficiency Disease.
•In October 2026, Janssen expanded its collaboration and licensing agreement with us for an additional oncology target to be developed with ENHANZE.
•In October 2026, Roche announced the FDA has approved TECENTRIQ (atezolizumab) and TECENTRIQ HYBREZA (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair ("dMMR") colon cancer, a type of tumour characterized by high mutation rates. This approval marks the twelfth indication for TECENTRIQ in the U.S.

Third Quarter Partner Highlights:
•In the third quarter of 2026, argenx submitted a supplemental Biologics License Application for VYVGART in ocular myasthenia gravis to the FDA.
•In September 2026, argenx expanded its collaboration and licensing agreement by nominating two additional targets which provides exclusive access to ENHANZE for a total of eight targets.
•In September 2026, Pfizer initiated a Phase 1 study to evaluate the pharmacokinetics of a single SC dose of tilrekimig with ENHANZE in healthy adults. Tilrekimig is a trispecific monoclonal antibody being developed for the treatment of atopic dermatitis, asthma, and chronic obstructive pulmonary disease.
•In September 2026, Halozyme and Incyte expanded their collaboration to evaluate the SC formulation of axatilimab, a monoclonal antibody targeting colony-simulating factor-1 receptor, with ENHANZE. Under the terms of the new target agreement, Incyte agreed to make an upfront payment and potential future milestone payments and royalties on net sales of products developed with ENHANZE.
•In August 2026, GSK disclosed plans to initiate a Phase 1b study to evaluate the pharmacokinetics and safety of a SC belantamab formulation with ENHANZE versus IV belantamab in patients with multiple myeloma while treated with standard of care.
•The SC formulation of INCA033989, a first-in-class mutant calreticulin-targeted monoclonal antibody utilizing ENHANZE drug delivery technology is being evaluated in an ongoing Phase 1 study.

•In July 2026, Halozyme and Incyte entered into a global collaboration and license agreement to evaluate additional SC formulations of INCA033989, a first-in-class mutant calreticulin-targeted monoclonal antibody, in patients with mutant calreticulin expressing myeloproliferative neoplasms, utilizing Halozyme’s proprietary ENHANZE drug delivery technology. Under the collaboration, Incyte also has the option to nominate up to two additional targets for use with ENHANZE. Under the terms of the agreement, Incyte agreed to make an upfront payment and potential future milestone payments and royalties on net sales of products developed with ENHANZE.
•In July 2026, Janssen announced the FDA granted priority review of the supplemental Biologics License Application filing for SC amivantamab and hyaluronidase-lpuj in adults with head and neck squamous cell carcinoma.
•In the third quarter of 2026, the ongoing ARGX-119 adimanebart program was expanded to include a Phase 1 SC bioavailability study with ENHANZE.

Third Quarter 2026 Financial Highlights:
•Total revenue was $493.0 million, compared to $354.3 million in the third quarter of 2025. The 39% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $341.0 million in royalties, an increase of 44% compared to $236.0 million in the third quarter of 2025, 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 and contributions from other recently launched products.
•Cost of sales was $82.5 million, compared to $55.2 million in the third quarter of 2025. The increase in cost of sales was primarily due to an increase in bulk rHuPH20 sales.
•Amortization of intangibles expense was $29.5 million, compared to $17.8 million in the third quarter of 2025. The increase in amortization of intangibles expense was due to the acquisition of Elektrofi, Inc. ("Elektrofi") in November 2025.
•Research and development expense was $27.8 million, compared to $17.3 million in the third quarter of 2025. The increase was primarily due to the acquisition of Elektrofi and Surf Bio, Inc. in the fourth quarter of 2025.
•Selling, general and administrative expense was $58.2 million, compared to $46.1 million in the third quarter of 2025. 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, the acquisition of Elektrofi, and an increase in compensation expense.
•Operating income was $295.0 million, compared to $217.9 million in the third quarter of 2025.
•Net income was $247.0 million, compared to $175.2 million in the third quarter of 2025.
•EBITDA was $328.7 million, compared to $238.3 million in the third quarter of 2025. Adjusted EBITDA was $336.2 million, compared to $248.2 million in the third quarter of 2025.1
•GAAP diluted earnings per share was $2.01, compared to $1.43 in the third quarter of 2025. Non-GAAP diluted earnings per share was $2.39, compared to $1.72 in the third quarter of 2025.1
•Cash, cash equivalents, restricted cash and marketable securities were $1.08 billion on September 30, 2026, compared to $145.4 million on December 31, 2025. The increase was primarily driven by the issuance of convertible notes and cash generated from operations.

Financial Outlook for 2026
The Company is raising its 2026 financial guidance ranges, which were last updated on August 6, 2026.
For the full year 2026, the Company expects:
•Total revenue of $1.860 billion to $1.925 billion, representing growth of 33% to 38% over 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API.
•Revenue from royalties of $1.235 billion to $1.255 billion, representing growth of 42% to 45% over 2025.
•Adjusted EBITDA of $1.240 billion to $1.290 billion, representing growth of 89% to 96% over 2025, including new Hypercon and Aerocon investments of approximately $60 million.
•Non-GAAP diluted earnings per share of $8.75 to $9.05, representing growth of 111% to 118% over 2025. The Company’s earnings per share guidance includes new Hypercon and Aerocon investments of approximately $60 million and does not consider the impact of potential future share repurchases.
Table 1. 2026 Financial Guidance
Previous Guidance Range New Guidance Range
Total Revenue $1.835 to $1.910 billion $1.860 to $1.925 billion
Royalty Revenue $1.220 to $1.245 billion $1.235 to $1.255 billion
Adjusted EBITDA1
$1.225 to $1.280 billion $1.240 to $1.290 billion
Non-GAAP Diluted EPS1
$8.65 to $9.00 $8.75 to $9.05

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the third quarter ended September 30, 2026 today, Thursday, November 5, 2026, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link:View Source 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.

(Press release, Halozyme, NOV 5, 2026, View Source [SID1234674308])