HALO - NASDAQ
Halozyme Therapeutics, Inc.
HALO·NASDAQ
$69.82
+2.3%HealthcareBiotechnology
Halozyme Therapeutics, Inc. operates as a biopharma technology platform company in the United States, Switzerland, Ireland, Belgium, Japan, and internationally. The company's products are based on the ENHANZE drug delivery technology, a patented recombinant human hyaluronidase enzyme (rHuPH20) that enables the subcutaneous delivery of injectable biologics, such as monoclonal antibodies and other therapeutic molecules, as well as small molecules and fluids. Its flagship product is Hylenex recombinant, a formulation of rHuPH20 to facilitate subcutaneous fluid administration for achieving hydration to enhance the dispersion and absorption of other injected drugs in subcutaneous urography and to improve resorption of radiopaque agents. The company also develops Perjeta; RITUXAN HYCELA and MabThera SC for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia (CLL); RITUXAN SC for patients with CLL; and HYQVIA for the treatment of immunodeficiency disorders. In addition, it is developing Tecentriq for non-small cell lung cancer; OCREVUS for multiple sclerosis; DARZALEX for the treatment of patients with amyloidosis, smoldering myeloma, and multiple myeloma; nivolumab for the treatment of solid tumors; ARGX-113, a human neonatal Fc receptor; ARGX-117 to treat autoimmune diseases; and BMS-986179, an anti-CD-73 antibody. The company has collaborations with F. Hoffmann-La Roche, Ltd.; Hoffmann-La Roche, Inc.; Baxalta US Inc.; Baxalta GmbH; Pfizer Inc.; Janssen Biotech, Inc.; AbbVie, Inc.; Eli Lilly and Company; Bristol-Myers Squibb Company; Alexion Pharma Holding; ARGENX BVBA; Horizon Therapeutics plc; National Institute of Allergy and Infectious Diseases; Centre for the AIDS Programme of Research in South Africa; and ViiV Healthcare Limited for small and large molecule targets for the treatment and prevention of HIV. Halozyme Therapeutics, Inc. was founded in 1998 and is based in San Diego, California.
At a Glance
Live SnapshotMarket Cap$8.28B
EPS2.6400
P/E Ratio25.45
Earnings Date08/04/2026
Earnings Call Transcript
HALO • 2025 • Q4
Operator
Good afternoon. My name is Alexandra, and I will be your conference operator today. At this time, I would like to welcome everyone to Halozyme's Fourth Quarter and Full Year 2025 Financial and Operating Results Conference Call. [Operator Instructions] Please note this event is being recorded. I will now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations and Corporate Communications.
Tram Bui
Thank you, operator. Good afternoon, and welcome to our fourth quarter and full year 2025 financial and operating results conference call. In addition to the press release issued today after the market close, you can find a supplementary slide presentation that will be referenced during today's call in the Investor Relations section of our website. Leading the call will be Dr. Helen Torley, Halozyme's President and Chief Executive Officer, who will provide an update on our business; and Nicole LaBrosse, our Chief Financial Officer, will review our financial results as well as our outlook. On today's call, we will be making forward-looking statements as outlined on Slide 2. I would also refer you to our SEC filings for a full list of risks and uncertainties. During the call, both GAAP and non-GAAP financial measures will be discussed. Certain non-GAAP or adjusted financial measures are reconciled with the comparable GAAP financial measures in our earnings press release and slide presentation. I will now turn the call over to Dr. Helen Torley.
Helen Torley
Thank you, Tram, and good afternoon, everyone. As I look back in the past year, it is clear that 2025 was one of the most significant and value-creating years in Halozyme's history. We showcased our ability to execute across every dimension, strategically, operationally and financially. This level of execution has created a clear value inflection for Halozyme, unlocking multiple drivers of long-term durable and profitable revenue. I'm incredibly energized by the pace of progress and excited with the opportunities that are ahead of us. And today, I'm pleased to welcome Chris Wahl, our Chief Scientific Officer, to the call. Chris will be reviewing the new potential opportunity that is emerging on the uses of ENHAN
Nicole LaBrosse
Thank you, Helen. Let me start on Slide 5. 2025 marked a year of disciplined execution and financial strength for Halozyme, highlighted by robust top line growth, solid profitability and a strengthened balance sheet that positions us firmly to advance our long-term strategy. I'll begin with the full year 2025 results. Total revenue grew 38% to $1.4 billion, reflecting sustained ENHAN
Helen Torley
Thank you, Nicole. Let's move now to Slide 6. As we look ahead, I could not be more energized by the momentum we have built and more confident in the long-term trajectory of the company. We have multiple levers and drivers of revenue that will position Halozyme for royalty revenue durability and exceptional value creation well into the 2040s. At the foundation of this growth engine is ENHAN
Christopher Wahl
Thank you, Helen. I will begin on Slide 7. We recognize the potential for ENHAN
Helen Torley
Thank you, Chris. Let's move now to Slide 12 and review our goals for 2026. We project supporting 6 new ENHAN
Nicole LaBrosse
As we look ahead, we are pleased to reiterate our 2026 financial guidance shown here on Slide 13. We continue to expect total revenue of $1.71 billion to $1.81 billion, representing year-over-year growth of 22% to 30%, driven by royalty revenue and product sales from API. Royalty revenues of $1.13 billion to $1.17 billion, representing year-over-year growth of 30% to 35%. We continue to expect DAR
Helen Torley
Thank you, Nicole. Let me conclude with these final remarks. Across ENHAN
Operator
[Operator Instructions] Your first question comes from the line of Mohit Bansal with Wells Fargo.
Mohit Bansal
Royalties for the first time. Really appreciate it. I have a question regarding the mechanics of DAR
Helen Torley
Thanks, Mohit. Yes, we're very proud to partner with Johnson & Johnson on creating such an important brand for patients with multiple myeloma with $14.4 billion with the majority of that being powered by subcu with ENHAN
Operator
Your next question comes from the line of Jason Butler with Citizens.
Jason Butler
I had 2 questions on the ADC strategy. I guess the first one is one thing that is really increasing clarity and confidence is regulatory path with ENHAN
Helen Torley
Yes. Let me ask Chris to address both of those. And Chris, the first one was what we believe the regulatory pathway would be. Obviously, today, we are basing on PK non-inferiority. Will that be the path? And the second one was with regard to the treatment paradigm. Is this going to be one where it might be a short injection in the infusion suite as opposed to subcu? Or can it be given at home?
Christopher Wahl
And thank you for the question, Jason. So regarding the regulatory path, as per those companies that wish to convert from IV to subcu, as we've seen with our traditional monoclonal antibody products, we'd expect a traditional approach that we've seen with PK non-inferiority studies. To your point, to the extent that those partners are developing products that aren't approved are seeking additional benefits related to efficacy and safety, those benefits would need to be proven through appropriate phase trials beyond PK non-inferiority that include both efficacy and safety endpoints. In terms of the approved ADCs and the benefit that we can provide, as you likely know, a lot of ADCs were developed not as monotherapy, but as combo therapy. So there is the benefit there to reduce the infusion center time that those patients spend in those infusion centers. But we are seeing more movement of ADCs to first-line therapy. So to the extent that they aren't administered in combination therapy, there would be the potential for IV-free regimens. And also note that many of the ADCs are being used in combination with products that are subcu or going subcu in large part enabled by ENHAN
Operator
Your next question comes from the line of Michael DiFiore with Evercore ISI.
Michael DiFiore
Congrats on all the continued progress. Two questions for me. One regarding the IPR filed against Alteogen back in December. How might the outcome of this influence the outcome of the Merck District Court litigation? And then separately, with regards to Merus' petosemtamab, a new trial was listed on ct.gov back in January. It was a first-line non-small cell lung cancer study. I guess my question is, as development extends beyond head and neck, how should we think about the potential incremental ENHAN
Helen Torley
All right. Thank you. Mike, with regard to the IPR filed against Alteogen, I would think about it very separately from our infringement case that is being brought against Merck, where we have identified that Merck is infringing multiple of Halozyme's already filed patent. So it's a very different part of our IP strategy. Now with regard to the district court case, we're still awaiting a scheduling order from the judge for that. The judge has allowed for certain discovery for Halozyme, including access to the Merck Alteogen agreement and also access to KEYTRUDA SC to continue testing of that. And we do expect that both parties will appear before the District Court in June following the output of the PTAB to receive further information and instructions. But the PGR and Alteogen, very separate and distinct from the District Court case. With regard to Merus' terrific drug, as we looked at that and we looked at the potential, obviously, I think it's just at the beginning of its potential utility based on its mechanism of action. It's currently used in regimens including KEYTRUDA. And I do believe that it is possible that there are going to be an extensive number of indications explored over time where this mechanism is going to be relevant. For patients, and I think this is where we really enjoyed working with the Merus team with regard to the fact that they're recognizing that the PD-1s go subcutaneously, the benefit of having an all subcu regimen is going to be terrific for patients. And so I think that's where the puck is going and in terms of how treatment is going to be delivered. And we're excited to see additional work being done to expand the indications over time for the subcu version.
Operator
Your next question comes from the line of Corinne Johnson with Goldman Sachs.
Corinne Jenkins
Maybe you could provide just a quick update on the progress you're making towards the clinic with the Hypercon products and kind of what remains to be done before you can start testing that technology in patients? And on a related note, what should we anticipate with respect to any update on the products and the progress they're making in terms of Phase I study, et cetera?
Helen Torley
I'm sorry, Corinne, I caught most of that. But towards the end, you just -- unfortunately, I couldn't hear you. I got the progress for the Hypercon clinical testing and the second part to the question?
Corinne Jenkins
Is that better?
Helen Torley
That's much better.
Corinne Jenkins
Okay. The second part was just what should we anticipate with respect to updates through the year as you kind of get those drugs into the clinic? And should we anticipate getting a better understanding of what the products are and the development strategy once they're in Phase I?
Helen Torley
Yes. Thank you. So we are continuing with the Hypercon team to support 2 partners in advancing to Phase I clinical testing in 2026. And as a reminder, these are already approved blockbuster MOAs. The additional steps that are happening include completion of the clinical scale-up batches as an example. And then the companies will also be moving forward to file their IND packages, or protocols with the regulatory authorities, et cetera. But everything as of today is very much on track for these 2 clinical starts in the fourth quarter and before the end of the year. This is partner confidential information, Corinne, in terms of what updates will be available. So it will be very much driven by the partners. I will say if these clinical studies are being done in patient populations, it is very likely that they will be posted on clinicaltrials.gov as the studies are about to start. And I think that might be the first indication publicly of what the partners are and certainly a visibility into the design of the Phase I studies. I don't believe there'll be a lot of information available at that time with regard to the full development pathway. But I will say that from our perspective, the development pathway will be very familiar to you if you're familiar with ENHAN
Operator
Your next question comes from the line of Sean Laaman with Morgan Stanley.
Sean Laaman
Helen, just to double-click on the last question, just to clarify, the 2 Phase I starts with Hypercon, are they existing ENHAN
Helen Torley
Thanks, Sean. We -- because the targets are confidential for the partners, we really can't make any further comments other than to say that these are established blockbuster drugs with the approved mechanisms of action. So I'm afraid we're limited to talk about that. If we think about our ENHAN
Operator
[Operator Instructions] Your next question comes from the line of Brendan Smith with TD Cowen.
Brendan Smith
Congrats on all the great progress. I actually wanted to ask about the auto-injector part of the business a bit. I'm wondering what your expectations for new partnerships there look like and if we should expect maybe any overlap in the new ENHAN
Helen Torley
All right. Thanks for that question. Yes. For everybody, we -- I'll start with the high-volume auto-injector, which we've continued to advance readiness for clinical testing for our partners. As you know, we've got a development agreement that is advancing with one of our current partners. And our high-volume auto-injector, which is able to inject between 3 and 10 mL with 10 mL going in, in just 30 seconds. We are seeing interest in it from current partners. We're seeing interest in it from new potential partners who are coming to evaluate the opportunity of ENHAN
Nicole LaBrosse
Yes, Brendan. So from a revenue perspective, we do recognize product sales from selling the devices. So you can think about that as similar to the way we recognize revenue from the sale of API. And when there are associated royalties, then we would recognize those as royalty revenues. So think about a situation where we having a high-volume auto-injector that is licensed with our ENHAN
Transcript from February 17, 2026
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