Halozyme Therapeutics

Halozyme Therapeutics, Inc. is a biopharmaceutical company, which engages in research, development and commercialization of human enzymes and drug candidates. It focuses on novel oncology therapies that target the tumor microenvironment. The firm products include rHuPH20, and HYLENEX recombinant. The company was founded by Gregory Ian Frost on February 26, 1998 and is headquartered in San Diego, CA.

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Halozyme posts record revenue in 2022, eyes growth opportunities

Halozyme's strong financial performance in 2022 and positive revenue guidance for 2023 reflect a robust growth trajectory.
While facing integration challenges from acquisitions and potential competition, the company's strategic priorities and market engagement remain strong.
Exploring new collaborations, advancing product development, and maintaining a competitive edge present key opportunities for Halozyme.
Overall, Halozyme's proactive approach to growth and market dynamics positions it well for future success in the biopharmaceutical industry.

Halozyme reports robust Q1 earnings, poised for continued growth

Halozyme's strong Q1 performance and robust pipeline position them for continued revenue growth and leadership in subcutaneous drug delivery.
Challenges include regulatory impacts and legal uncertainties, but opportunities in new agreements, partnerships, and investments offer avenues for future growth.
Overall, Halozyme's strategic focus on innovation and revenue diversification bodes well for their long-term success and financial stability.

Halozyme reports robust Q2 growth, eyes new partnerships for revenue

Halozyme's Q2 2023 earnings call showcased strong financial performance, innovative product developments, and a positive outlook for revenue growth. The company's focus on expanding partnerships, maintaining revenue durability, and strategic capital allocation positions it well for future success in the biopharmaceutical market.

Halozyme excels in Q3, raises guidance, eyes market expansion

Halozyme's Q3 performance reflects financial strength and operational resilience, supported by strategic partnerships and revenue growth.
The company's focus on shareholder value through accelerated buybacks and commitment to innovation positions them for sustained success.
While challenges like market competition exist, Halozyme's opportunities in market expansion and revenue growth paint a positive outlook for the future.

Halozyme posts record earnings, eyes strategic growth opportunities ahead

Halozyme's strong financial results and positive outlook for 2024 position the company for continued growth and value creation.
Addressing challenges around market adoption and reimbursement processes will be key to unlocking the full potential of subcutaneous products.
Strategic partnerships, new product launches, and a focus on shareholder value enhancement underscore Halozyme's commitment to sustainable growth.

Halozyme reports robust Q1 growth, navigates biosimilar challenges

Halozyme's Q1 2024 performance demonstrated strong financial growth driven by royalties and milestone payments, supported by operational achievements and strategic capital allocation.
While facing challenges such as biosimilar competition and partnership complexities, the company remains well-positioned to capitalize on opportunities in subcutaneous delivery preferences and market expansion.
Overall, Halozyme's focus on revenue diversification, partnership expansion, and operational excellence sets a positive trajectory for sustained growth and resilience in the biopharmaceutical sector.

Halozyme posts strong Q3 results, raises guidance amid growth opportunities

Halozyme Therapeutics reported a stellar Q3 performance with significant revenue growth and raised guidance across key financial metrics. The company's partnerships, product portfolio, and strong financial position underscore its growth potential and market resilience. Halozyme is well-positioned to capitalize on opportunities for expansion and innovation in the biopharmaceutical sector.

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Halozyme Therapeutics, Inc. is a biopharmaceutical technology platform company. It engages in developing, manufacturing, and commercializing drug-device combination products using advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The company was founded by Gregory Ian Frost on February 26, 1998 and is headquartered in San Diego, CA.

Royalty Revenue Increased 15% YOY to Record $114.4 million Announces Acceleration into 2023 of Remaining $250M Share Repurchase through ASR GAAP Diluted EPS of $0.61 and Non-GAAP Diluted EPS of $0.75 1 Maintained Revenue Guidance and Raised 2023 EBITDA Guidance to $430-$445 million and Non-GAAP EPS Guidance to $2.70-$2.80     SAN DIEGO , Nov. 6, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the third quarter ended September 30, 2023 and provided an update on its recent corporate activities and outlook. "I am delighted that our strong operating performance and expense management throughout the year have resulted in an increase to EBITDA and non-GAAP EPS guidance.

HALOZYME REPORTS THIRD QUARTER 2023 FINANCIAL AND OPERATING RESULTS

Acumen represents thirteenth license partner for ENHANZE ® Alzheimer's disease is a large and expanding market opportunity SAN DIEGO , Nov. 6, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced a global collaboration and non-exclusive license agreement with Acumen Pharmaceuticals that provides Acumen access to Halozyme's ENHANZE® drug delivery technology, a proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20) for rapid subcutaneous drug delivery, for a single target. Acumen intends to explore the potential use of ENHANZE® for ACU193, Acumen's clinical-stage monoclonal antibody (mAb) candidate to target Amyloid-β Oligomers (AβOs) for the treatment of early Alzheimer's disease (AD).

Halozyme and Acumen Pharmaceuticals Enter Global Collaboration and Non-Exclusive License Agreement for the ENHANZE® Technology in Alzheimer's Disease

SAN DIEGO , Oct. 30, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced it will release its third quarter 2023 financial and operating results on Monday, November 6, 2023, following the close of trading. Halozyme will host a conference call on Monday, November 6, 2023 at 1:30 p.m.

Halozyme To Report Third Quarter 2023 Financial and Operating Results

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BMS in discussions with health authorities regarding next steps for submission and approval of subcutaneous nivolumab in multiple indications SAN DIEGO , Oct. 19, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Bristol Myers Squibb (BMS) reported positive topline results from the Phase 3 CheckMate-67T trial evaluating a subcutaneous (SC) formulation of Opdivo (nivolumab) with ENHANZE® in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. The study met its co-primary pharmacokinetics endpoints and key secondary endpoint.

Positive Topline Results Reported from Bristol Myers Squibb's Phase 3 CheckMate-67T Trial of Subcutaneous Nivolumab with Halozyme's ENHANZE® Drug Delivery Technology for Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Study met primary end point and demonstrated successful subcutaneous administration of a 10 mL biologic co-formulated with ENHANZE® in 30 seconds using Halozyme's proprietary high-volume auto-injector SAN DIEGO , Oct. 16, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") will present the positive results of a clinical study demonstrating subcutaneous administration of 10 mL of a representative biologic product co-formulated with its ENHANZE® drug delivery technology, in approximately 30 seconds, at the 13th Annual PODD: Partnership Opportunities in Drug Delivery Conference. In the study, the biologic was delivered with Halozyme's proprietary high-volume auto-injector (HVAI) in healthy volunteers.

Update: Halozyme Announces Presentation of Positive Clinical Data of its High-Volume Auto-Injector Demonstrating Successful Rapid Subcutaneous Drug Delivery at 13th Annual PODD: Partnership Opportunities in Drug Delivery Conference

Study met primary end point and demonstrated successful subcutaneous administration of a 10 mL biologic co-formulated with ENHANZE® in 30 seconds using Halozyme's proprietary high-volume auto-injector  SAN DIEGO , Oct. 16, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced positive results of a clinical study demonstrating subcutaneous administration of 10 mL of a representative biologic product co-formulated with its ENHANZE® drug delivery technology, in approximately 30 seconds. In the study, the biologic was delivered with Halozyme's proprietary high-volume auto-injector (HVAI) in healthy volunteers.

Halozyme Announces Positive Clinical Data of its High-Volume Auto-Injector Demonstrating Successful Rapid Subcutaneous Drug Delivery

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Halozyme Therapeutics, based in San Diego, has developed ENHANZE technology based around its proprietary enzyme, rHuPH20. The enzyme makes it possible for many intravenously administered drugs to be administered subcutaneously instead. Not only is the SC method of administration quicker and easier for patients, it can help drug manufacturers extend patent protections.

Halozyme: Intriguing Buy Prospect Despite This Week's PDUFA Setback

First subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain Tecentriq® subcutaneous formulation with ENHANZE® reduces treatment time to seven minutes compared to 30-60 minutes for standard intravenous infusion SAN DIEGO , Aug. 29, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the approval of Roche's Tecentriq® SC (atezolizumab), using Halozyme's ENHANZE® drug delivery technology, by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. Tecentriq® subcutaneous (SC) is co-formulated with Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, allowing for subcutaneous delivery, which takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion.

Halozyme Announces Approval of Roche's Tecentriq® Subcutaneous (SC) with ENHANZE® in Great Britain

Halozyme (HALO) shares rise 4% in the after-market trading hours on better-than-expected second-quarter 2023 results, boosted by collaboration and royalty revenues. Management raises its 2023 guidance.

Halozyme (HALO) Q2 Earnings & Revenues Beat, 2023 View Raised

Halozyme Therapeutics, Inc. (NASDAQ:HALO ) Q2 2023 Earnings Conference Call August 8, 2023 4:30 AM ET Company Participants Tram Bui - VP, IR and Corporate Communications Helen Torley - President and CEO Nicole LaBrosse - CFO Conference Call Participants Mohit Bansal - Wells Fargo Michael DiFiore - Evercore ISI David Risinger - Leerink Partners Jason Butler - JMP Securities Mitchell Kapoor - H.C. Wainwright Mack Chandler - Jefferies Caroline Palomeque - Berenberg Capital Markets Operator Good afternoon, my name is Chris and I'll be your conference operator today.

Halozyme Therapeutics, Inc. (HALO) Q2 2023 Earnings Call Transcript

Halozyme Therapeutics (HALO) came out with quarterly earnings of $0.74 per share, beating the Zacks Consensus Estimate of $0.63 per share. This compares to earnings of $0.53 per share a year ago.

Halozyme Therapeutics (HALO) Q2 Earnings and Revenues Top Estimates

Revenue Increased 45% YOY to $221.0 million; GAAP Diluted EPS of $0.56 and Non-GAAP Diluted EPS of $0.74 1  Royalty Revenue Increased 31% YOY to Record $111.7 million Raised 2023 Non-GAAP Diluted EPS Guidance to $2.65-$2.75 Updated Revenue Guidance to $825-$845 million, Representing 25-28% YOY Growth, and EBITDA Guidance to $420-$440 million, Representing >30% YOY Growth1     SAN DIEGO , Aug. 8, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the second quarter ended June 30, 2023 and provided an update on its recent corporate activities and outlook. "Our strong second quarter results with record revenue of $221 million and non-GAAP EPS of $0.74 were complemented with significant commercial and clinical advancements with our ENHANZE product pipeline," said Dr. Helen Torley, president and chief executive officer of Halozyme.

HALOZYME REPORTS SECOND QUARTER 2023 FINANCIAL AND OPERATING RESULTS

SAN DIEGO , July 25, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced it will release its second quarter 2023 financial and operating results on Tuesday, August 8, 2023, following the close of trading. Halozyme will host a conference call on Tuesday, August 8, 2023 at 4:30 p.m.

Halozyme To Report Second Quarter 2023 Financial and Operating Results

Halozyme Therapeutics (HALO) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

Halozyme Therapeutics (HALO) Soars 5.4%: Is Further Upside Left in the Stock?

SAN DIEGO , July 17, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx reported positive topline data from the ADHERE study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) with ENHANZE® in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The study met its primary endpoint (p=0.000039) demonstrating a significantly lower risk of relapse with VYVGART® Hytrulo compared to placebo.

Positive Topline Data Reported from argenx's ADHERE Study of VYVGART® Hytrulo with Halozyme's ENHANZE® Drug Delivery Technology in Patients with Chronic Inflammatory Demyelinating Polyneuropathy

Halozyme (HALO) rises 5% after Roche's late-stage multiple sclerosis study of subcutaneous co-formulation of Ocrevus developed with its Enhanze technology meets goals.

Halozyme (HALO) Rises 5% as Ocrevus SC Meets Goals in MS Study

SAN DIEGO , July 13, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche's Phase 3 OCARINA II trial evaluating OCREVUS® (ocrelizumab) with ENHANZE® as a twice a year 10-minute subcutaneous (SC) injection, met its primary and secondary endpoints in patients with relapsing forms of multiple sclerosis (MS) or primary progressive MS (RMS or PPMS). OCREVUS subcutaneous injection co-formulated with ENHANZE ® , Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, was shown to be non-inferior to OCREVUS given by intravenous infusion (IV) as measured by pharmacokinetics (levels in the blood) at 12 weeks.

Positive Results Announced from Phase 3 OCARINA II Trial Evaluating Roche's OCREVUS® (ocrelizumab) with Halozyme's ENHANZE® Drug Delivery Technology in Patients with Multiple Sclerosis

argenx's Vyvgart Hytrulo, a game-changer with its 1-minute SC formulation, opens a new revenue stream for Halozyme with sales expected to surpass $10Bn. Despite past headwinds, Vyvgart's SC approval and potential co-formulation patent disclosure could kick-start HALO's stock recovery. A plethora of 2023 catalysts including subcutaneous formulation data for Ocrevus and Opdivo, Tecentriq approval, and phase 3 efgartigimod CIDP readout may further elevate HALO's stock.

Halozyme: Inflection Point With argenx's Vyvgart SC Approval (Reiterating Buy)

VYVGART® Hytrulo is first FDA-approved subcutaneous (SC) injectable for generalized myasthenia gravis (gMG) SAN DIEGO , June 20, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx received U.S. Food and Drug Administration (FDA) approval for VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection with ENHANZE® for subcutaneous (SC) use for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. VYVGART® Hytrulo is a subcutaneous product combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous delivery of biologics.

Halozyme Announces argenx Receives FDA Approval for VYVGART® Hytrulo With ENHANZE® for Subcutaneous Use in Generalized Myasthenia Gravis

Halozyme Therapeutics' valuation has declined, providing a more attractive entry point for investors. The company has multiple royalty-producing products and two new ones awaiting approval in 2023. Halozyme has a strong pipeline of products in development and diverse revenue sources from various therapies.

Halozyme Therapeutics: Pharma With Growing Royalty Revenue And Product Income

Halozyme Therapeutics (HALO) reported earnings 30 days ago. What's next for the stock?

Halozyme Therapeutics (HALO) Up 0.7% Since Last Earnings Report: Can It Continue?

SAN DIEGO , June 6, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Dr. Helen Torley, president and chief executive officer, will present at the Goldman Sachs 44th Annual Global Healthcare Conference on Tuesday, June 13, 2023, at 8 a.m. PT / 11 a.m.

Halozyme to Present at the Goldman Sachs 44th Annual Global Healthcare Conference

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