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HALO

Halozyme TherapeuticsB
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Investor releaseQuarter not tagged2026-08-15

The Top 5 Analyst Questions From Halozyme Therapeutics’s Q2 Earnings Call

StockStory
Halozyme Therapeutics delivered a notably positive second quarter, as evidenced by the strong market reaction and management’s attribution of outperformance to surging royalty revenue and a wave of new collaboration agreements. CEO Helen Torley highlighted that the ENHANZE platform, now underpinning revenue from six different drugs, enabled a record 50% year-over-year royalty growth. The quarter also benefited from sizable milestone payments tied to newly signed licensing deals, with Torley emphasizing, “The ENHANZE value proposition is attracting new partners and additional products from our current partners at a cracking pace.” Is now the time to buy HALO? Find out in our full research report (it’s free). Revenue: $481 million vs analyst estimates of $404.3 million (47.7% year-on-year growth, 19% beat) Adjusted EPS: $2.28 vs analyst estimates of $1.82 (25.5% beat) Adjusted EBITDA: $328.8 million vs analyst estimates of $267.2 million (68.4% margin, 23.1% beat) The company lifted its revenue guidance for the full year to $1.87 billion at the midpoint from $1.76 billion, a 6.4% increase Management raised its full-year Adjusted EPS guidance to $8.83 at the midpoint, a 10.3% increase EBITDA guidance for the full year is $1.25 billion at the midpoint, above analyst estimates of $1.16 billion Operating Margin: 59.8%, down from 62.2% in the same quarter last year Market Capitalization: $11.55 billion While we enjoy listening to the management’s commentary, our favorite part of earnings calls is the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Natasha (Morgan Stanley) asked about the drivers behind the implied acceleration in royalty revenue for the second half of the year. CFO Darren Snellgrove explained that new product launches, such as Rybrevant subcutaneous, are expected to drive sequential growth, though not at the same steep pace as between Q1 and Q2. Jaya (Evercore ISI) inquired about the future of target exclusivity as patents expire and whether this opens new licensing opportunities. CEO Helen Torley clarified that deal structures are increasingly flexible, with a mix of exclusive and non-exclusive agreements tailored to partner needs. Brendan Smith (TD Cowen) pressed for more detail on the timing and scale…Read full document

Halozyme Therapeutics delivered a notably positive second quarter, as evidenced by the strong market reaction and management’s attribution of outperformance to surging royalty revenue and a wave of new collaboration agreements. CEO Helen Torley highlighted that the ENHANZE platform, now underpinning revenue from six different drugs, enabled a record 50% year-over-year royalty growth. The quarter also benefited from sizable milestone payments tied to newly signed licensing deals, with Torley emphasizing, “The ENHANZE value proposition is attracting new partners and additional products from our current partners at a cracking pace.” Is now the time to buy HALO? Find out in our full research report (it’s free). Revenue: $481 million vs analyst estimates of $404.3 million (47.7% year-on-year growth, 19% beat) Adjusted EPS: $2.28 vs analyst estimates of $1.82 (25.5% beat) Adjusted EBITDA: $328.8 million vs analyst estimates of $267.2 million (68.4% margin, 23.1% beat) The company lifted its revenue guidance for the full year to $1.87 billion at the midpoint from $1.76 billion, a 6.4% increase Management raised its full-year Adjusted EPS guidance to $8.83 at the midpoint, a 10.3% increase EBITDA guidance for the full year is $1.25 billion at the midpoint, above analyst estimates of $1.16 billion Operating Margin: 59.8%, down from 62.2% in the same quarter last year Market Capitalization: $11.55 billion While we enjoy listening to the management’s commentary, our favorite part of earnings calls is the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Natasha (Morgan Stanley) asked about the drivers behind the implied acceleration in royalty revenue for the second half of the year. CFO Darren Snellgrove explained that new product launches, such as Rybrevant subcutaneous, are expected to drive sequential growth, though not at the same steep pace as between Q1 and Q2. Jaya (Evercore ISI) inquired about the future of target exclusivity as patents expire and whether this opens new licensing opportunities. CEO Helen Torley clarified that deal structures are increasingly flexible, with a mix of exclusive and non-exclusive agreements tailored to partner needs. Brendan Smith (TD Cowen) pressed for more detail on the timing and scale of Hypercon pipeline launches and whether royalty projections include future partnerships. Torley responded that five to seven product launches by the mid-2030s underpin the $1 billion royalty target, with current and potential future deals contributing. Amit (H.C. Wainwright) asked how the mix of new versus follow-on partner nominations and the entry into ADCs and nucleic acids will shape future deal cadence. Torley emphasized that both new deals and nominations from existing partners are expected to drive pipeline growth. David Risinger (Leerink Partners) requested updates on Merck litigation, Alteogen competition, and M&A strategy. Torley outlined ongoing legal actions and stressed Halozyme’s competitive advantages, while Snellgrove reiterated disciplined but flexible capital allocation for future M&A. In the coming quarters, the StockStory team will focus on (1) the pace of new ENHANZE and Hypercon partnership agreements and whether these expand further into ADCs and nucleic acids, (2) the ramp-up of royalty revenue contributions from newly launched subcutaneous products, and (3) progress toward clinical milestones, especially the target of 13 ENHANZE development programs by year-end. We will also monitor developments in patent litigation and any updates on manufacturing investments for Hypercon. Halozyme Therapeutics currently trades at $102.10, up from $85.76 just before the earnings. Is the company at an inflection point that warrants a buy or sell? The answer lies in our full research report (it’s free for active Edge members). ALSO WORTH WATCHING: Top 5 Momentum Stocks. The best time to own a great stock is when the market is finally noticing it. These aren’t just high-quality businesses. Something is happening with them right now. Elite fundamentals meet near-term momentum — both boxes checked at the same time. Find out which stocks our AI platform is flagging this week. See this week’s Strong Momentum stocks — FREE. Get Our Strong Momentum Stocks for Free HERE. Stocks that have made our list include now familiar names such as Nvidia (+1,460% between June 2020 and June 2025) as well as under-the-radar businesses like the once-micro-cap company Tecnoglass (+1,552% between June 2020 and June 2025). Find your next big winner with StockStory today.

Investor releaseQuarter not tagged2026-08-13

Halozyme (HALO) Q2 2026 Earnings Call Transcript

Motley Fool
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Vice President of Investor Relations - Tram Bui President and Chief Executive Officer - Dr. Helen Torley Chief Financial Officer - Darren Snellgrove Operator: Good afternoon. My name is Joel, and I will be your conference operator today. At this time, I would like to welcome everyone to Halozyme's Second Quarter 2026 Financial and Operating Results Conference Call. Please note, this event is being recorded. I will now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations. Please go ahead. Tram Bui: Thank you, operator. Good afternoon, and welcome to our Second Quarter 2026 Financial and Operating Results Conference Call. In addition to the press release issued today after the market close, you could 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 Darren Snellgrove, 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, and we will start on Slide 3. Helen Torley: Thank you, Tram, and good afternoon, everyone. I am pleased to report our results from an exceptionally strong second quarter, led by ENHANZE royalty revenue growth and new deal momentum that resulted in meaningful upfront milestones. You've heard me say before that ENHANZE is a unique compounding platform engine. On this call, we will share multiple proof points demonstrating how ENHANZE is delivering on all of the attractive features of a compounding platform engine. I'm talking about the repeatability of success, the scalability and diversification and the durability of revenues that flow from this. The ENHANZE value proposition is attracting new partners and additional products from our current…Read full document

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Vice President of Investor Relations - Tram Bui President and Chief Executive Officer - Dr. Helen Torley Chief Financial Officer - Darren Snellgrove Operator: Good afternoon. My name is Joel, and I will be your conference operator today. At this time, I would like to welcome everyone to Halozyme's Second Quarter 2026 Financial and Operating Results Conference Call. Please note, this event is being recorded. I will now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations. Please go ahead. Tram Bui: Thank you, operator. Good afternoon, and welcome to our Second Quarter 2026 Financial and Operating Results Conference Call. In addition to the press release issued today after the market close, you could 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 Darren Snellgrove, 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, and we will start on Slide 3. Helen Torley: Thank you, Tram, and good afternoon, everyone. I am pleased to report our results from an exceptionally strong second quarter, led by ENHANZE royalty revenue growth and new deal momentum that resulted in meaningful upfront milestones. You've heard me say before that ENHANZE is a unique compounding platform engine. On this call, we will share multiple proof points demonstrating how ENHANZE is delivering on all of the attractive features of a compounding platform engine. I'm talking about the repeatability of success, the scalability and diversification and the durability of revenues that flow from this. The ENHANZE value proposition is attracting new partners and additional products from our current partners at a cracking pace. On top of this, Hypercon is already off and running as a second future compounding platform engine for Halozyme, showing the same features and, in fact, doing so even earlier in the life cycle than ENHANZE, as we apply the knowledge and learnings of the last decade. Let's look now at what's new in the quarter. I will start with the broadening diversification and record growth of our royalty revenue streams. We are reporting increasing contributions of our newer launch products, Opdivo SC, Ocrevus SC and Rybrevant SC to our royalty revenues, with 80% growth quarter-on-quarter. This is repeating and building on top of the success and continued growth and performance of DARZALEX SC, VYVGART Hytrulo and Phesgo. What I love about this is that over the last years, we have moved from all focus being on DARZALEX SC performance to then expanding to Phesgo and then to VYVGART Hytrulo as it was recognized just how much opportunity these products represented. Now we're expanding to six products to focus on. This is exactly what I meant by the compounding platform engine, multiple winners, creating revenue diversification and durability. This broadened launch portfolio resulted in record total royalty revenue growth of 50% year-over-year to $308 million, providing strong support to and conviction for the 2026 to 2028 financial guidance and for the revenues in 2029 and beyond. Let me now move to the second highlight, the significant expansion in new partnerships for ENHANZE and Hypercon in the quarter. In the second quarter, we signed four new collaboration and licensing agreements, and we signed a fifth agreement in July. We have never had this pace of new collaboration agreements in the history of Halozyme. And for those of you who asked, can they sign great new deals for ENHANZE? The answer is a resounding, emphatic and demonstrated yes, with three of these five agreements being for ENHANZE. This year, we have added new ENHANZE agreements with GSK, Incyte and a third confidential partner. And we added two new Hypercon agreements with Vertex and with Oruka. And I will add, not only did we broadly expand the number of partners, we also expand in use areas to beyond monoclonal antibodies into two new expanding and leading-edge modality areas, ADCs and nucleic acids. This means brand-new growth opportunity for ENHANZE. The new CLAs contributed $35.5 million in upfront collaboration revenue in the quarter, approximately evenly split across ENHANZE and Hypercon. This was also an important contributor to record total revenue in the quarter. This is how we said we would and how we are bending the curve in the 2029 plus period. The third area I want to highlight is development portfolio expansion and progress. In the second quarter, we advanced our pipeline of future potential royalty streams with two new Phase I study starts. It is our goal to have 13 ENHANZE development programs in 2026, which is also bending the curve in the 2029 plus period. Moving now to Slide 4. I'll highlight the second quarter financial results. For the second quarter, total revenue increased 48% year-over-year to $481 million. This was largely driven by robust royalty revenues of $308 million, a strong 50% year-over-year growth. The robust revenue performance resulted in adjusted EBITDA of $329 million, adjusted EBITDA margin of more than 65% and non-GAAP earnings per share of $2.28, highlighting the strength of our diversified royalty portfolio and the operating leverage that's inherent in our differentiated business model. Moving now to Slide 5. Based on the strong second quarter and, in particular, the robust royalty revenue growth, we are pleased to raise full year 2026 guidance. What I will highlight is the increase in total revenue guidance of $110 million (sic) [ $112.5 million ] at the midpoint. This is driven by the increased projected royalty revenues from established products and the new launch products that I discussed earlier and also by the upfront milestones resulting from what has already been a record year for new collaboration and licensing agreements. Let me move now to Slide 6, and I'll provide additional detail on the key business drivers in the quarter, beginning with the current ENHANZE portfolio. In the second quarter, the contribution from the more recently launched subcutaneous products with ENHANZE including OCREVUS ZUNOVO, OPDIVO Qvantig and RYBREVANT subcutaneous increased by approximately 80% quarter-on-quarter. OCREVUS ZUNOVO is demonstrating how ENHANZE-enabled subcutaneous delivery can compound the value for our partners' products by expanding the accessible patient population. On their second quarter call, Roche reported that the number of patients receiving the subcutaneous formulation increased to 44,000. Contrast that with the 17,500 patients at the end of the fourth quarter of 2025, and you can see just how many new patients have been added for this every 6-month subcutaneous treatment. ZUNOVO is now the fastest-growing anti-CD20 multiple sclerosis brand in the United States. Roche noted that approximately 60% of the U.S. OCREVUS ZUNOVO starts are coming from community practices, demonstrating how ENHANZE-enabled delivery can reach new sites of care, enabling access to Ocrevus for new patients. Bristol's OPDIVO Qvantig continued its strong launch trajectory with subcutaneous conversion reported to have increased to 15%, well on track for BMS' targeted 30% to 40% conversion rate. Moving now to Bristol Myers Squibb. Bristol's OPDIVO Qvantige continued its strong launch trajectory with subcutaneous conversion reported to have increased to 15%, well on track for BMS' targeted 30% to 40% conversion rate. This resulted in global sales growth of more than 200% year-over-year to $261 million in the second quarter. Based on this, OPDIVO Qvantig is projected to exceed $1 billion in annualized revenue. Johnson & Johnson's RYBREVANT FASPRO is another strong example of how ENHANZE creates value for our partners and for Halozyme. For the second quarter of 2026, J&J highlighted rapid uptake of RYBREVANT FASPRO, contributing to the strong 62% year-over-year growth. Supporting growth acceleration in the upcoming quarters, the permanent J-code was awarded on July 1. This has been a contributor to broadening adoption and growth in multiple prior subcutaneous launches. J&J also commented that they have submitted a filing to the FDA for head and neck cancer. We are pleased to note that the FDA recently granted priority review to the filing, meaning an FDA review time line of approximately 6 months. Upon approval, this new indication would expand the opportunity for RYBREVANT FASPRO beyond its existing lung cancer indications into this new area of high unmet need. It is certainly very exciting to see the growth and contribution of these three newer launch brands, where for these three brands alone, the total IV and subcutaneous opportunity based on total sales is projected to be $25 billion in 2028. This is resulting in a diversified set of six products contributing royalty revenues where the total opportunity now exceeds $55 billion. I'll move now to DARZALEX subcutaneous, VYVGART Hytrulo and Phesgo, beginning with DARZALEX. DARZALEX continued to demonstrate robust revenue growth, increasing approximately 18% year-over-year to over $4 billion in the quarter, with virtually all global sales being for DARZALEX subcutaneous with ENHANZE. J&J attributed the strong performance to continued market growth and share gains across all lines of therapy, including nearly 11 percentage points of share gain in the frontline setting. It's also worth noting that following the FDA approval in March, the all subcutaneous regimen of TECVAYLI plus DARZALEX FASPRO is bringing new hope to patients with relapsed and refractory multiple myeloma. I'll move now to argenx. Total VYVGART sales grew 60% year-over-year to $1.5 billion in the second quarter, driven by continued strong adoption of the ENHANZE-enabled VYVGART Hytrulo pre-filled syringe, which I will refer to as the PFS. The PFS is expanding the prescriber base and bringing more patients into therapy with approximately 80% of U.S. PFS patients in the quarter reported to be new to VYVGART. This demonstrates how ENHANZE, by supporting continued innovation and administration, can meaningfully broaden patient reach and support long-term product growth. Driving continued growth, recent regulatory and clinical milestones continue to expand the long-term opportunity for VYVGART Hytrulo. VYVGART is now the first and only therapy approved across all gMG serotypes, including seronegative patients. The U.S. approval in seronegative gMG in May expands the addressable opportunity by approximately 11,000 patients. Positive Phase 3 data in ocular myasthenia gravis further highlights the opportunity to expand the franchise and drive future growth upon approval. Moving now to Phesgo. Phesgo continues to demonstrate the value of ENHANZE-enabled subcutaneous delivery within Roche's HER2 franchise. During the first half of 2026, Phesgo delivered strong growth of 18%, with global conversion reaching 54% in the 85 launch countries. Roche reiterated its expectation for at least 60% conversion at peak and highlighted Phesgo is a key component of the franchise's long-term durability. I'll move now to Slide 7. Looking beyond the current decade, our future launch portfolio represents a significant source of long-term value with the potential to expand and further diversify our royalty revenue streams and deliver durable revenue for many years to come. Beginning in the 2029-plus time frame, we have three revenue engines. The first is our 10 currently approved ENHANZE products. The second are the multiple launches that are arising from our growing and robust ENHANZE development portfolio. And the third is Hypercon partner products. We project that by year-end of 2026, we will have up to 13 ENHANZE partner products in development with potential approvals beginning in the 2029-plus time frame. These programs represent the next generation of royalty-producing assets and extend our future opportunity beyond the currently approved portfolio. During the second quarter, two new ENHANZE targets initiated Phase 1 testing. This is resulting in nine development products and keeps us well on track for the 13 development products by year-end. This broad and growing portfolio of future potential launches clearly demonstrates why we're so confident that ENHANZE will be a significant long-term revenue driver for Halozyme. I will now move to Hypercon, which we intend to make into a second compounding platform engine and recreate the amazing success of ENHANZE. Hypercon is designed to address growing demand for lower volume subcutaneous administration, enabling highly concentrated formulations that can potentially support at-home and physician office administration. We made strong progress in the quarter, advancing preparations to provide clinical supply to support the first Hypercon clinical starts in the first half of 2027. Our projected first launch timing for these two new products is in the 2030, 2031 time frame, and we continue to expect Hypercon to launch multiple products and achieve approximately $1 billion in royalty revenue in the mid-2030s. Let me now turn to the new collaboration and licensing agreements, which are summarized on Slide 8. I mentioned at the start that this has been our most successful year ever with record performance for ENHANZE and for Hypercon. The pace of recent collaboration activity reflects the growing importance of subcutaneous delivery across the biopharmaceutical industry. Pharma and biotech companies are increasingly focused on improving the patient treatment experience, reducing treatment burden, expanding access across sites of care and differentiating their products. In the second quarter, we announced the new ENHANZE agreement with GSK, which included the opportunity to use ENHANZE in a new use area with antibody drug conjugates. In July, we announced a second agreement with Incyte, working with Incyte on a subcutaneous formulation of its first-in-class mutant calreticulin monoclonal antibody. Today, we are pleased to announce a third new agreement signed in the second quarter with an undisclosed partner to explore the use of ENHANZE with a nucleic acid therapeutic. This is the first of what we hope will be several collaborations in this emerging area where ENHANZE brings the potential to enable subcutaneous delivery of large volume nucleic acid conjugate formulations and LNPs while mitigating the inflammatory and immune response that can be otherwise generated from subcutaneous administration. We are excited to expand into these two new areas of ADCs and nucleic acids that represent brand-new growth market segments for ENHANZE and where we estimate that there are at least 100 commercial and development products that may benefit. Also in the second quarter, we signed two new Hypercon collaboration agreements, one with Vertex and one with Oruka. These agreements establish strategic platform relationships that have the potential to expand over time through additional targets and future development programs. When we combine the up to 13 ENHANZE development programs by year-end and this expanding opportunity that's created by the current and new ENHANZE, Hypercon agreements, we have created a substantial portfolio of new potential royalty opportunities extending well into the next decade. What you've heard me describe is the power of having an established compounding platform engine with ENHANZE, and we're creating just the same for Hypercon. We have demonstrated time and again the repeatability and diversification with now six separate and growing royalty streams delivering record revenue. We've demonstrated scalability with multiple waves of new launches now extending well into the 2030s. The durability is clear with 50% royalty revenue growth more than 12 years after our first launch. And we're very proud that our partner products are clinical breakthroughs that we have helped create into multiple blockbuster subcutaneous products. Our priority in 2026 remains executing on these significant organic growth opportunities. We are also continuing to evaluate selective M&A opportunities that can expand our drug delivery technology offering and royalty duration. But any external opportunity must meet our criteria of a strong strategic fit, durable value creation and attractive returns. With that, I'm pleased to turn the call over to Darren. Darren Snellgrove: Thank you, Helen. I am thrilled to be joining Halozyme at such an exciting point in the company's evolution. Over the past few months, I've had the opportunity to dive deeper into the business, and what has stood out to me is the strength of Halozyme's business model. It's rare to find a company that offers such outstanding current performance and future potential. Halozyme's combination of strong growth, exceptional profitability and robust free cash flow, coupled with disciplined capital allocation, positions the company well as we continue to accelerate innovation and provide significant returns to shareholders. Having spent nearly three decades in the industry, I was familiar with the value Halozyme creates for partners, patients and the health care system. After joining the company, I have an even greater appreciation for the opportunities ahead. One of the unique characteristics of the business is what I would call the halo effect. Every successful ENHANZE-enabled product does more than generate high-margin, scalable royalty revenue. We enable our partners and improve products for patients. Our platforms reinforce the clinical and commercial value of subcutaneous delivery and create additional opportunities for target nominations, platform expansions and new collaborations. This cycle continues to broaden our opportunities and increase the durability of our long-term diversified model. The strong second quarter results reinforce that view as the company delivered another record quarter, exceeding expectations for royalty revenue, driving strong EBITDA growth and, at the same time, investing in our future growth platforms. Let me start on Slide 9. Total revenue increased 48% to $481 million compared to $325.7 million in the prior year period. This performance was driven by robust royalty revenue growth and higher collaboration revenue, reflecting new deals signed during the quarter. Royalty revenue of $307.7 million increased 50% from $205.6 million in the prior year period and exceeded our expectations. These results reflect increasing contributions from more recently launched ENHANZE products as well as the continued commercial success of DARZALEX subcu and VYVGART Hytrulo. DARZALEX generated $4 billion in global sales for J&J in the second quarter, representing close to 18% operational growth, further demonstrating the strength, durability and continued momentum of the franchise. These strong sales translated into $152.2 million of royalty revenue to Halozyme, representing an increase of 27% year-over-year. Halozyme's royalties from VYVGART Hytrulo increased 143% to $72.6 million in the second quarter. Total VYVGART brand sales for the second quarter reached $1.5 billion, up 60% versus prior year, reflecting strong demand for the ENHANZE-enabled pre-filled syringe, which continues to broaden the prescriber base and support adoption across gMG and CIDP. Other royalty revenues grew 85% to $54.4 million, driven by increasing partner product sales of recently launched products, OCREVUS subcu, Opdivo Qvantig, RYBREVANT subcu and Tecentriq subcu. We are pleased with the early momentum and see a significant opportunity ahead given that estimates for the total brand growth of these four products is approximately $30 billion in 2028. Moving to Slide 10 for more detail on the quarterly results. Research and development expenses were $27.7 million compared to $17.5 million in the prior year period, reflecting the addition of Hypercon and SurfBio and our continued investment in advancing these technologies. Selling, general and administrative expenses were $57 million in the quarter compared to $41.6 million in the prior year period. Net income increased 39% to $229.9 million from $165.2 million in the prior year period. Adjusted EBITDA increased 46% to $328.8 million from $225.5 million in the prior year period, driven by continued strong royalty growth. GAAP diluted earnings per share was $1.90 compared to $1.33 in the prior year period, and non-GAAP diluted earnings per share was $2.28 compared to $1.54 in the second quarter of 2025. Moving to Slide 11. We generate substantial free cash flow from our asset-light model, and our strong financial position gives us the flexibility to execute a disciplined capital allocation strategy. Our priorities are straightforward: fund the highest return organic opportunities, maintain a strong balance sheet and return excess capital to shareholders through a disciplined buyback program. We view share repurchases as an attractive use of capital when we believe the stock does not fully reflect the durability and growth of our royalty streams. That is why we purchased $332.8 million worth of shares in the second quarter against our target of $400 million for the full year, while also investing in long-term growth and expanding the ENHANZE platform as more products launch and gain share. Turning now to Slide 12 and our updated 2026 outlook. As Helen mentioned earlier, we are pleased to raise the guidance for the remainder of the year. We now expect total revenue of $1.835 billion to $1.91 billion, representing year-over-year growth of 31% to 37%, driven by an increase in royalty revenue projections and product sales from API. Royalty revenues of $1.22 billion to $1.245 billion, representing year-over-year growth of 41% to 43%. We expect growing contributions from the recently launched ENHANZE products, while DARZALEX subcu, VYVGART Hytrulo and Phesgo remain the largest revenue contributors. We expect adjusted EBITDA of between $1.225 billion and $1.28 billion, which includes approximately $60 million of planned investment in Hypercon and SurfBio, and non-GAAP diluted EPS of $8.65 to $9. I will now turn the call back over to Helen. Helen Torley: Thank you, Darren. In closing, let me highlight that our record second quarter results reinforce our confidence in both the strength of our business today and in the opportunities ahead. The growing contributions of our recently launched ENHANZE products and the continued strong performance of DARZALEX subcutaneous and VYVGART give us confidence in the 2026 to '28 financial guidance and beyond. In the quarter, we demonstrated meaningful progress to add to this and will bend the curve, including through multiple new ENHANZE and Hypercon collaboration and licensing agreements and multiple new clinical study starts. Thank you for your attention today. And operator, you can now open the line for questions. Operator: Our first question is from Sean Laaman with Morgan Stanley. Unknown Analyst: This is Natasha on for Sean. So you raised royalty guide of $1.22 billion to $1.245 billion against the $548 million in the first half royalties, implies around $336 million to $348 million per quarter in the back half, which is a step-up from 2Q's $308 million. I just wanted to ask what's driving that implied acceleration from here? Is it primarily the newer launch cohort or the established products? Helen Torley: Thanks, Natasha. I'll turn that over to Darren. Darren Snellgrove: Yes. Thanks for the question. And as you noted, royalties were an important component of the beat in the first half. And I would say that we do expect royalty revenue to grow sequentially through the second half, probably won't have quite the same amount of royalty step-ups that were part of the Q1 to Q2 growth. But we do expect that to continue to ramp up in the second half. And a lot of it is driven by some of the new product launches that you've seen. So things like RYBREVANT subcu, which has started to pick up a little bit, and some of the other new products. Operator: Your next question is from Michael DiFiore with Evercore ISI. Speaker 5: This is [ Jaya ] on for Mike. Congrats on the strong quarter. I'd like to ask a question on target exclusivity. So you've talked about partners who work with other providers and often approach Halozyme first, where target was already exclusively licensed. So as we look forward to 2029, how should we think about the way target exclusivity works as the base patents flow out? And then does that open up targets you couldn't take on before? Helen Torley: Yes. Thanks for the question. In terms of the exclusivity, it's often very much driven by the partner company. And if they request exclusivity and they are willing to pay the enhanced economics that are associated with that, historically, in the past, we have agreed to that, and we also would still agree to that today. I will note, however, that as you've probably seen in the latest series of agreements that we've done, there are now a lot of companies who are very comfortable with gaining a nonexclusive license. And so you're going to see a mix of the two as you go forward. And I will also say, if you think about exclusivity, exclusivity is also done in different ways. It can be exclusivity to an entire target, as an example, like we did with PD-1. But in other cases, there can be exclusivity to a specific molecule uses a target or perhaps a target that is part of a combination. And so we are being able to be a lot more, if you like, creative and broad in what we're able to license both on an exclusive and a nonexclusive basis as we go forward. And that really is reflected in the five recent deals across those and the additional deals we anticipate signing this year and next. Operator: Your next question is from Brendan Smith with TD Cowen. Brendan Smith: Congrats on the great quarter. Maybe first, actually on Hypercon. I know we'll get confirmation of the first two assets by early next year. Just wondering if you can give us a little bit more of a sense of timing for, kind of, subsequent assets in that pipeline and just roughly when the next wave might be, if there are others that could reach Phase 1 next year? Is that more of a '28 event? And I guess, kind of related, I wanted to ask actually about that $1 billion in incremental Hypercon royalties by 2035 you've spoken to. I guess, how many different assets are you assuming would contribute to that by 2035? And I guess, are your assumptions largely just based on the current partnerships? Or are you assuming any additional ones? Helen Torley: Yes. Thanks. With regard to Hypercon and timing, there absolutely could be additional study starts in the second half of 2027, Brendan, based on the progress we're seeing with companies advancing through the preparatory stages before they're ready to advance to the clinic. And if you recall, while we've got five agreements, those partners have taken up to 20 targets. And so some of the companies are advancing more than one target at this point in time, and that is already creating a very nice pipeline of future clinical studies for 2027 and for 2028. So that's the great thing about the model we have with this ability to access multiple targets in one agreement. As we projected the $1 billion in the mid-2030s, we had assumed between five and seven launches by that time period. And I think a number of those will come from the already signed agreements, but it is also possible that agreements in the next 1 to 2 years could also be contributing to that based on what we estimate the development time line to be. So I commented on the call about -- it's very exciting to see Hypercon turning into another compounding platform engine for us, but able to do so faster and quicker in part because the market is just more receptive to subcu delivery, but we're also able to bring a lot of our learnings from how we've been able to commercialize and grow ENHANZE. Operator: Your next question is from Mitchell Kapoor with H.C. Wainwright. Unknown Analyst: This is Amit on for Mitchell. Congrats on a strong quarter. I guess, for both or all platform cadence, I guess, how are you thinking about the mix of new partner wins and follow-on nominations from existing partners? And how would that shape the future deal cadence? And on the ADC and nucleic acid therapeutics, there's a lot of excitement about that. And I was just wondering how are you thinking about the broader opportunity? And how are you prioritizing these modalities as you pursue additional deals? Helen Torley: Yes. Thank you. With regard to the -- I'll start with the ADCs and the nucleic acids, yes, very excited now to have signed a deal, one each for both of those, opening up a brand-new growth opportunity for ENHANZE. We have previously said that there's 50 ADCs we think could benefit from ENHANZE, and we said there are about 50 nucleic acid-based therapies that we think can benefit from ENHANZE. And so this really is an exciting opportunity. And I would say our business development team are agnostic to whether it's an monoclonal antibody, an ADC or a nucleic acid. But what it has done is broaden the number of companies that we are speaking to and approaching with ideas as to how the ENHANZE technology can help improve their risk-benefit profile or their competitive profile. And so it just has dramatically increased the number of conversations we're having, and that's exciting in terms of what that can mean for long-term growth and expansion of the ENHANZE number of agreements. You make a good point, and it's something I think that's often underrecognized is that signing new deals is a source of growth for us. But the number of targets that we already have under license that has not yet been nominated is a second, separate source of growth. And in the first half of this year, I will say we've had one current partner nominate a product, and I actually am expecting more in the second half. And so it's going to be a mix of both really in terms of what's going to cause the continued growth and expansion of our pipeline. We expect to have 13 development products in the clinic camp this year. That's going to continue both from these current deals we're signing, adding more nominations and moving into the clinic, but even our existing partners who've still got slots left. Now falling into the same mindset, I think, as many of the companies today of recognizing that subcu delivery means competitive differentiation, and they are advancing new nominations at a pace also that we've not necessarily seen in a long, long time. So it's an exciting time with both of those avenues for growth as well as growth coming from the ADCs and the nucleic acid new opportunity. Operator: Your next question is from Mohit Bansal with Wells Fargo. Unknown Analyst: This is [ Will Zhang ] on for Mohit. Congrats on the recent deals in the quarter. But I guess, I just want to understand now that some of the smaller companies are also partnering with you on ENHANZE, like is the deal structure for these smaller companies any different from your prior deals? And I guess, like, what conversations are you currently having with new or smaller partners? Helen Torley: Yes. We're excited to be continuing to be discussing ENHANZE with all size ranges of companies. If you think about just the last few months, we have GSK that certainly is a very large company. We've got Incyte that is a large company, and as you point out some smaller companies as well. I would say what is more a driver of exactly what the deal structure will be is based much more on exclusivity versus non-exclusivity. And so that is where there is some difference in the economics that's really driven by that the deal structure is shaped around exclusivity, not company size. Operator: The next question is from Dave Risinger with Leerink Partners. David Risinger: Thanks very much and congrats on the financial upside, and Darren, congrats on your new role. So I have a few questions, please. First, could you provide an update on the Merck litigation prospects? How -- that's the first question. Second, how you see Alteogen as a competitor today? And then third, your view on the acquisition landscape? Helen Torley: All right. I'll take the first two, and I'll turn the acquisition landscape over to Darren. With regard to the Merck litigation, let me start outside the U.S. We are currently actively pursuing injunctions in approximately eight countries outside the U.S. with the goal of stopping the Merck infringing use of our MDASE technology. This includes the launch in countries as well as manufacturing, distribution and supply of Qlex for worldwide use. These cases are moving forward rapidly. You may have seen we did have a preliminary injunction in Germany in December. And we do expect important decisions broadly impacting Merck launches of sales in Qlex in Europe before the end of this year. So very active in Europe. With regard to the United States, we're working through the U.S. patent office proceedings that were brought by Merck with regard to the PGRs. And we expect to have more clarity once that we're through all of those steps on when the U.S. District Court case is going to move forward once the final decisions are reached in those proceedings later this year. Now I will say that it's a very active on the PGRs as well. We're going to be appealing the four initial written decisions that we received earlier this year. And we expect to hear the PTAB's decision on the remaining 10 sometime this fall. And so a lot still happening in the U.S. case as well, David, with some clarity with regard to the PGRs at the end of this year, clarity on the timing of the district case, but certainly, our conviction and our confidence is absolutely unwavering that we will prevail in this case, and we will be appealing certainly the first four PGRs that based on our very strong conviction that the Alteogen product is infringing. The Merck product using the Alteogen technology, as you probably see better, is infringing. With regard to Alteogen, it still continues to be the case that from what is publicly available, it would appear that the people who are assigning deals at the moment with Alteogen are for targets that Halozyme has exclusively licensed, and I can say many of those companies have directly come to us, and we've had to unfortunately say we're unable to work with them. And so in light of that, obviously, while we're not finding that performance of Alteogen is directly competing with us. And I will also share that when companies come to us, what they see is they want to work with Halozyme because of our track record of success because our product is being used and we've got a safety database and over 1.3 million patients with 15 years history of reliability of supply. And our team have got the expertise to support very rapidly getting the partners into the clinic, innovative trial designs and a faster path to approval. And so the entire package that Halozyme brings is what has -- if you think about just in the last 7 or 8 months, six new ENHANZE deals, we are definitely performing incredibly well in the market, and it comes from that competitive moat that we've created from all of our years of expertise and performance. Let me turn it to Darren for acquisition landscape. Darren Snellgrove: Yes. Thanks. David, with regards to M&A, we definitely continue to see M&A as an important part of our capital allocation strategy. I would say, particularly when we can add differentiated technologies, new capabilities or create future growth platforms. But at the same time, I think you've heard the company say this before, we're very disciplined. We indicated last quarter that for '26, we're going to really focus on organic growth and M&A is unlikely. But what I would say, the good news is given the strength of our portfolio, the growing cash flows that we have and our improving leverage profile, we really do have flexibility. But again, we remain focused on really on long-term shareholder value. Operator: Your next question is from Mitchell Kapoor with H.C. Wainwright. Unknown Analyst: This is Amit again. But I was wondering, as you build out Hypercon manufacturing, how should we think about potential revenue beyond royalties and any incremental investment within the 2026-'28 margins? And for -- you show that you -- or you guide to 13 ENHANZE programs in development by end of 2026 and 13 launches in 2029. I'm just wondering how are you thinking about any potential attrition? Or is that, kind of, built into your assumptions? Helen Torley: Yes. Let me talk about the manufacturing first, and maybe I'll begin by sharing why we think it's such an exciting opportunity for us invest in the manufacturing. As you're already hearing, we've got five deals, multiple products are advancing. And we believe that Hypercon is going to become rapidly the same type of compounding platform engine that we have from ENHANZE. To speed that up, and to maximize the success of that, Halozyme investing to advance manufacturing is just the right thing to do. We'll be able to drive that, control that at our pace and with our expertise. We have not finalized the exact planning around that. So I can't share any details on the investment required or the exact business model. But what I can say is that this is going to be very exciting as we contemplate just how much more quickly Hypercon is going to grow to be that $1 billion opportunity compared to ENHANZE. So more to come on that as we finalize our plans. With regard to the additional launches, just to just clarify one thing. We anticipate having 13 products in the clinic by the end of this year. In terms of the 2029 number, what we said was we will begin in the launches in 2029, and those will be occurring between '29 and 2033 as an example. So there is a series of -- they're occurring over a period of time. Our development time lines generally are 4 to 5 years just to help with that. So not all 13 in 2029, but after that. In terms of the mix of products that we have in that 13 products and very exciting products in their mechanisms of action that some of the products are already commercial, which represent a very high probability of success based on our track record. Other products are new mechanisms of action, but the majority are antibodies, and we have just got tremendous experience with antibodies, which again, from many aspects gives us confidence in the fact that ENHANZE is going to be very successful in making them into successful subcutaneous products. So a broad range of products in there. Hard to give you specifics on them. But as a body, this ability to have up to 13 additional launches beginning in 2029 is clearly a very exciting additional growth driver that will layer on top of the already launched products. Operator: We have reached the end of the Q&A portion, which concludes today's call. Thank you so much for attending. You may now disconnect. Before you buy stock in Halozyme Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Halozyme Therapeutics wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Halozyme (HALO) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-08-08

Halozyme Therapeutics Inc (HALO) (Q2 2026) Earnings Call Highlights: Record Revenue and Royalty ...

GuruFocus.com
This article first appeared on GuruFocus. Total Revenue: Increased 48% year-over-year to $481 million. Royalty Revenue: Record growth of 50% year-over-year to $308 million. Adjusted EBITDA: Increased 46% to $328.8 million, with a margin of more than 65%. Net Income: Increased 39% to $229.9 million. GAAP Diluted EPS: $1.90, compared to $1.33 in the prior year period. Non-GAAP Diluted EPS: $2.28, compared to $1.54 in the second quarter of 2025. DARZALEX Royalty Revenue: Increased 27% year-over-year to $152.2 million, driven by global sales of over $4 billion. VYVGART Hytrulo Royalty Revenue: Increased 143% to $72.6 million, with total brand sales reaching $1.5 billion. Other Royalty Revenue: Grew 85% to $54.4 million, driven by recently launched products. R&D Expenses: $27.7 million, compared to $17.5 million in the prior year period. SG&A Expenses: $57 million, compared to $41.6 million in the prior year period. Share Repurchases: Purchased $332.8 million worth of shares in the second quarter. Upfront Collaboration Revenue: New CLAs contributed $35.5 million in the quarter. Warning! GuruFocus has detected 4 Warning Sign with HALO. Is HALO fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Record total revenue growth of 48% year-over-year to $481 million, driven by robust royalty revenue growth of 50% to $308 million. Exceptional pace of new partnerships, signing five new collaboration and licensing agreements (three for ENHANZE, two for Hypercon) in Q2 and July, expanding into new modalities like ADCs and nucleic acids. Strong performance from newer launch products (Opdivo SC, Ocrevus SC, Rybrevant SC), with their combined royalty revenue growing 80% quarter-on-quarter, diversifying the revenue stream. Raised full-year 2026 guidance for total revenue, royalty revenue, adjusted EBITDA, and non-GAAP EPS, reflecting confidence in continued growth. Hypercon platform is advancing rapidly, with preparations for first clinical starts in H1 2027 and a projected $1 billion in royalty revenue by the mid-2030s, creating a second growth engine. Continued strong performance from established products like DARZALEX SC (18% growth) and VYVGART Hytrulo (143% royalty growth), demonstrating durability. Strong financial position with adjus…Read full document

This article first appeared on GuruFocus. Total Revenue: Increased 48% year-over-year to $481 million. Royalty Revenue: Record growth of 50% year-over-year to $308 million. Adjusted EBITDA: Increased 46% to $328.8 million, with a margin of more than 65%. Net Income: Increased 39% to $229.9 million. GAAP Diluted EPS: $1.90, compared to $1.33 in the prior year period. Non-GAAP Diluted EPS: $2.28, compared to $1.54 in the second quarter of 2025. DARZALEX Royalty Revenue: Increased 27% year-over-year to $152.2 million, driven by global sales of over $4 billion. VYVGART Hytrulo Royalty Revenue: Increased 143% to $72.6 million, with total brand sales reaching $1.5 billion. Other Royalty Revenue: Grew 85% to $54.4 million, driven by recently launched products. R&D Expenses: $27.7 million, compared to $17.5 million in the prior year period. SG&A Expenses: $57 million, compared to $41.6 million in the prior year period. Share Repurchases: Purchased $332.8 million worth of shares in the second quarter. Upfront Collaboration Revenue: New CLAs contributed $35.5 million in the quarter. Warning! GuruFocus has detected 4 Warning Sign with HALO. Is HALO fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Record total revenue growth of 48% year-over-year to $481 million, driven by robust royalty revenue growth of 50% to $308 million. Exceptional pace of new partnerships, signing five new collaboration and licensing agreements (three for ENHANZE, two for Hypercon) in Q2 and July, expanding into new modalities like ADCs and nucleic acids. Strong performance from newer launch products (Opdivo SC, Ocrevus SC, Rybrevant SC), with their combined royalty revenue growing 80% quarter-on-quarter, diversifying the revenue stream. Raised full-year 2026 guidance for total revenue, royalty revenue, adjusted EBITDA, and non-GAAP EPS, reflecting confidence in continued growth. Hypercon platform is advancing rapidly, with preparations for first clinical starts in H1 2027 and a projected $1 billion in royalty revenue by the mid-2030s, creating a second growth engine. Continued strong performance from established products like DARZALEX SC (18% growth) and VYVGART Hytrulo (143% royalty growth), demonstrating durability. Strong financial position with adjusted EBITDA margin over 65% and significant free cash flow, enabling a disciplined capital allocation strategy including $332.8 million in share repurchases in Q2. Ongoing legal and patent litigation with Merck regarding the infringement of ENHANZE technology, with an uncertain timeline and outcome in the US. Increased R&D expenses (up 58% year-over-year) due to investments in Hypercon and SurfBio, which could pressure near-term margins. Potential competitive threat from Alteogen, although Halozyme notes that many companies seeking Alteogen deals have targets exclusively licensed to Halozyme. The company's future growth is heavily dependent on the success of partner products, which are subject to clinical trial risks, regulatory approvals, and commercial adoption. Guidance for the second half of 2026 implies a significant sequential step-up in royalty revenue, which may be challenging to achieve if new product launches underperform. The company is not currently pursuing M&A, focusing on organic growth, which may limit opportunities for external innovation or portfolio expansion in the near term. Q: You raised royalty guidance to $1.22 billion to $1.245 billion against the $548 million in the first half royalties, implying around $336 million to $348 million per quarter in the back half, a step-up from 2Q's $308 million. What's driving that implied acceleration? Is it primarily the newer launch cohort or the established products? A: Darren Snellgrove (CFO): We do expect royalty revenue to grow sequentially through the second half, although probably not with quite the same amount of step-ups that were part of the Q1 to Q2 growth. A lot of it is driven by some of the new product launches, such as RYBREVANT subcu, which has started to pick up, and some of the other new products. Q: As we look forward to 2029, how should we think about the way target exclusivity works as the base patents flow out? Does that open up targets you couldn't take on before? A: Helen Torley (CEO): Exclusivity is often driven by the partner company. If they request exclusivity and are willing to pay the enhanced economics, we have historically agreed and still would today. However, many companies are now comfortable with a nonexclusive license, so you will see a mix. Exclusivity can also be structured in different ways, such as for an entire target (like PD-1) or for a specific molecule or combination. This allows us to be more creative and broad in what we license, which is reflected in the five recent deals. Q: On Hypercon, can you give us a sense of timing for subsequent assets in the pipeline and when the next wave might reach Phase 1? Also, how many different assets are you assuming contribute to the $1 billion in incremental Hypercon royalties by 2035? A: Helen Torley (CEO): There could absolutely be additional study starts in the second half of 2027 based on progress. Our partners have taken up to 20 targets, and some are advancing more than one, creating a nice pipeline for 2027 and 2028. For the $1 billion projection in the mid-2030s, we assumed between five and seven launches. A number of those will come from already signed agreements, but it is possible that agreements signed in the next 1 to 2 years could also contribute. Q: How are you thinking about the mix of new partner wins and follow-on nominations from existing partners? And on the ADC and nucleic acid therapeutics, how are you prioritizing these modalities as you pursue additional deals? A: Helen Torley (CEO): We are excited to have signed a deal in both ADCs and nucleic acids, opening new growth opportunities. We estimate 50 ADCs and 50 nucleic acid-based therapies could benefit from ENHANZE. Our business development team is agnostic to modality, but this has broadened the number of companies we speak with. Signing new deals is a source of growth, but the number of targets already under license that haven't been nominated is a second, separate source. In the first half, one current partner nominated a product, and we expect more in the second half. Q: Now that some smaller companies are also partnering with you on ENHANZE, is the deal structure for these smaller companies any different from your prior deals? A: Helen Torley (CEO): We are excited to discuss ENHANZE with all size ranges of companies. In the last few months, we have GSK and Incyte, which are large companies, as well as some smaller ones. The driver of the deal structure is based much more on exclusivity versus non-exclusivity, which shapes the economics, rather than company size. Q: Could you provide an update on the Merck litigation prospects? How do you see Alteogen as a competitor today? And what is your view on the acquisition landscape? A: Helen Torley (CEO) & Darren Snellgrove (CFO): On Merck litigation, we are actively pursuing injunctions in approximately eight countries outside the US to stop the infringing use of our MDASE technology. We expect important decisions broadly impacting Merck launches in Europe before the end of this year. In the US, we are working through the patent office proceedings and expect clarity on the district court case timing later this year. Our conviction is unwavering. On Alteogen, companies assigning deals with them are for targets Halozyme has exclusively licensed, and many have come to us first. We are not finding Alteogen directly competing with us due to our track record, safety database of over 1.3 million patients, and expertise. On M&A, we continue to see it as an important part of capital allocation, but we are disciplined. For 2026, we are focused on organic growth, and M&A is unlikely, but we have flexibility given our strong cash flows. Q: As you build out Hypercon manufacturing, how should we think about potential revenue beyond royalties and any incremental investment within the 2026-'28 margins? And for the 13 ENHANZE programs in development by end of 2026, how are you thinking about potential attrition? A: Helen Torley (CEO): Investing in Hypercon manufacturing is exciting because we believe it will rapidly become a compounding platform engine like ENHANZE. We haven't finalized the exact planning, so I can't share details on investment or business model, but it will be exciting as we contemplate how much quicker Hypercon will grow to the $1 billion opportunity. On the 13 programs, we anticipate having 13 products in the clinic by year-end, with launches beginning in 2029 and occurring between 2029 and 2033. Development timelines are generally 4 to 5 years. The mix includes products with high probability of success based on our track record, and the majority are antibodies, giving us confidence in success. Q: Can you provide more detail on the drivers of the record second quarter results, specifically the royalty revenue growth and the new collaboration agreements? A: Helen Torley (CEO): The second quarter was exceptionally strong, led by ENHANZE royalty revenue growth and new deal momentum. Royalty revenue grew 50% year-over-year to $308 million, driven by increasing contributions from newer launch products like Opdivo SC, Ocrevus SC, and Rybrevant SC, which grew 80% quarter-on-quarter. We also signed four new collaboration agreements in Q2 and a fifth in July, including deals with GSK, Incyte, Vertex, and Oruka, contributing $35.5 million in upfront collaboration revenue. This demonstrates the repeatability, scalability, and diversification of the ENHANZE platform. Q For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-08

Is Halozyme Therapeutics (HALO) Fairly Valued As Earnings Beat And Guidance Rise?

Simply Wall St.
Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. Halozyme Therapeutics (HALO) just put fresh numbers on the table, reporting second quarter 2026 results, raising full year revenue guidance and updating progress on its share repurchase programs. For the quarter ended June 30, 2026, revenue was reported at US$481 million compared with US$325.72 million for the same period a year earlier. Net income for the quarter was US$229.91 million compared with US$165.16 million a year ago. Basic earnings per share from continuing operations for the second quarter were US$1.96 compared with US$1.36 a year earlier. Diluted earnings per share from continuing operations were US$1.90 compared with US$1.33 a year ago. Looking at the first half of 2026, Halozyme Therapeutics reported revenue of US$857.71 million compared with US$590.58 million for the first six months of the prior year. Net income for the six month period was US$379.96 million versus US$283.26 million a year earlier. Basic earnings per share from continuing operations over the six months were US$3.23 compared with US$2.32 a year ago. Diluted earnings per share from continuing operations over the same period were US$3.11 compared with US$2.26 a year earlier. Alongside these results, the company lifted its 2026 total revenue guidance to a range of US$1.835b to US$1.910b. This compares with a previous range of US$1.710b to US$1.810b. Halozyme Therapeutics also continued to buy back stock. From May 1, 2026 to June 30, 2026, the company repurchased 2,525,425 shares, or 2.13% of its shares, for US$175.01 million. This completed the repurchase announced on May 11, 2026. From April 1, 2026 to June 30, 2026, Halozyme repurchased a further 2,274,575 shares, or 1.92% of its shares, for US$157.63 million. With this, the company has completed the repurchase of 13,452,356 shares, or 10.91% of its shares, for US$750 million under the buyback program announced on February 20, 2024. These updates give you several moving parts to weigh with Halozyme stock. There is the reported revenue and earnings for both the quarter and the first half of the year, the higher full year revenue guidance range, and the reduction in share count from completed buyback programs. See our latest analysis for Halozyme Therapeutics. Halozyme Therapeutics stock has reacted sharply to the…Read full document

Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St's investing ideas for FREE. Halozyme Therapeutics (HALO) just put fresh numbers on the table, reporting second quarter 2026 results, raising full year revenue guidance and updating progress on its share repurchase programs. For the quarter ended June 30, 2026, revenue was reported at US$481 million compared with US$325.72 million for the same period a year earlier. Net income for the quarter was US$229.91 million compared with US$165.16 million a year ago. Basic earnings per share from continuing operations for the second quarter were US$1.96 compared with US$1.36 a year earlier. Diluted earnings per share from continuing operations were US$1.90 compared with US$1.33 a year ago. Looking at the first half of 2026, Halozyme Therapeutics reported revenue of US$857.71 million compared with US$590.58 million for the first six months of the prior year. Net income for the six month period was US$379.96 million versus US$283.26 million a year earlier. Basic earnings per share from continuing operations over the six months were US$3.23 compared with US$2.32 a year ago. Diluted earnings per share from continuing operations over the same period were US$3.11 compared with US$2.26 a year earlier. Alongside these results, the company lifted its 2026 total revenue guidance to a range of US$1.835b to US$1.910b. This compares with a previous range of US$1.710b to US$1.810b. Halozyme Therapeutics also continued to buy back stock. From May 1, 2026 to June 30, 2026, the company repurchased 2,525,425 shares, or 2.13% of its shares, for US$175.01 million. This completed the repurchase announced on May 11, 2026. From April 1, 2026 to June 30, 2026, Halozyme repurchased a further 2,274,575 shares, or 1.92% of its shares, for US$157.63 million. With this, the company has completed the repurchase of 13,452,356 shares, or 10.91% of its shares, for US$750 million under the buyback program announced on February 20, 2024. These updates give you several moving parts to weigh with Halozyme stock. There is the reported revenue and earnings for both the quarter and the first half of the year, the higher full year revenue guidance range, and the reduction in share count from completed buyback programs. See our latest analysis for Halozyme Therapeutics. Halozyme Therapeutics stock has reacted sharply to the Q2 earnings beat, higher full year revenue guidance and completed buybacks, with a 1 day share price return of 20.24% and a 90 day share price return of 60.82%. Total shareholder return sits at 63.94% over 1 year and 148.66% over 5 years, indicating momentum that has been building rather than fading. If Halozyme's recent move has you considering where growth focused healthcare stories might emerge next, it could be worth scanning 43 healthcare AI stocks After Halozyme Therapeutics jumped on the earnings beat, raised guidance and heavy buybacks, the challenge is simple: lean into the move now or wait and hope valuation offers a cleaner entry point. The most followed narrative on Halozyme Therapeutics pegs fair value at $86.89, which sits below the latest close at $103.12 and frames the current debate. Read the complete narrative. Want to understand why this narrative says Halozyme can support its current price even with earnings growth below the market and expanding margins built into the model? The key is how revenue growth, profitability and the future earnings multiple are connected to move from today’s profit base to that long term earnings target. Result: Fair Value of $86.89 (OVERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, Halozyme Therapeutics still faces real pressure points, including heavy reliance on a handful of royalty partners and ongoing patent disputes that could eventually unsettle the current valuation story. Find out about the key risks to this Halozyme Therapeutics narrative. The analyst narrative pegs Halozyme Therapeutics at $86.89, which suggests the stock is 18.7% overvalued versus the latest close at $103.12. Our SWS DCF model points in a very different direction, with an estimate of $388.52 per share that implies the stock trades well below that future cash flow value. Which framework aligns more closely with the growth and risk profile you see? Look into how the SWS DCF model arrives at its fair value. Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Halozyme Therapeutics for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 51 high quality undervalued stocks. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity. With Halozyme Therapeutics pulling strong numbers and mixed valuation signals, sentiment is clearly divided. It makes sense to move quickly and test the assumptions yourself by weighing the 2 key rewards and 3 important warning signs. If Halozyme's story has sharpened your focus, now is a good time to broaden your watchlist using other clear, data driven ideas on Simply Wall Street. Target potential mispricing opportunities by scanning 51 high quality undervalued stocks that combine quality fundamentals with attractive valuations. Strengthen your focus on balance sheet resilience by reviewing the solid balance sheet and fundamentals stocks screener (49 results) that may better handle financial pressure. Get ahead of the crowd by checking the screener containing 19 high quality undiscovered gems before they attract wider attention. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include HALO. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Investor releaseQuarter not tagged2026-08-07

Halozyme Therapeutics, Inc. Q2 2026 Earnings Call Summary

Moby
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Record royalty revenue growth of 50% year-over-year was driven by a broadening portfolio of six key products, reflecting the platform's compounding effect and revenue diversification. Management achieved a record pace of five new collaboration agreements, with four signed in the second quarter and a fifth signed in July., expanding the ENHANZE platform into high-growth modalities including Antibody Drug Conjugates (ADCs) and nucleic acids. The 'halo effect' of the business model is driving repeatability, where successful subcutaneous launches reinforce clinical value and attract both new partners and additional target nominations from existing ones. Operational leverage remains high, with an adjusted EBITDA margin exceeding 65%, supported by an asset-light model that scales efficiently as royalty streams mature. Strategic positioning in the subcutaneous market is being bolstered by reaching new sites of care, such as community practices, which expanded the accessible patient population for partners like Roche. The company is successfully transitioning from a single-product focus on DARZALEX SC to a diversified engine with multiple blockbuster contributors including VYVGART Hytrulo and Phesgo. Management raised full-year 2026 guidance based on robust royalty momentum and significant upfront milestones from recent record-breaking collaboration and licensing activity. The company targets having 13 ENHANZE development programs in the clinic by year-end 2026, which is expected to drive a new wave of approvals beginning in the 2029-plus timeframe. Hypercon is projected to reach approximately $1 billion in royalty revenue by the mid-2030s, assuming five to seven product launches starting in the 2030-2031 window. Future growth assumptions include a 'bending of the curve' in 2029 and beyond, supported by the current approved portfolio, the growing development pipeline, and new Hypercon partnerships. Capital allocation priorities focus on organic growth and share repurchases, with management indicating that large-scale M&A is unlikely for the remainder of 2026. Halozyme is actively pursuing legal injunctions in eight countries against Merck to stop alleged infringement of its MDASE technology, with key European decisi…Read full document

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Record royalty revenue growth of 50% year-over-year was driven by a broadening portfolio of six key products, reflecting the platform's compounding effect and revenue diversification. Management achieved a record pace of five new collaboration agreements, with four signed in the second quarter and a fifth signed in July., expanding the ENHANZE platform into high-growth modalities including Antibody Drug Conjugates (ADCs) and nucleic acids. The 'halo effect' of the business model is driving repeatability, where successful subcutaneous launches reinforce clinical value and attract both new partners and additional target nominations from existing ones. Operational leverage remains high, with an adjusted EBITDA margin exceeding 65%, supported by an asset-light model that scales efficiently as royalty streams mature. Strategic positioning in the subcutaneous market is being bolstered by reaching new sites of care, such as community practices, which expanded the accessible patient population for partners like Roche. The company is successfully transitioning from a single-product focus on DARZALEX SC to a diversified engine with multiple blockbuster contributors including VYVGART Hytrulo and Phesgo. Management raised full-year 2026 guidance based on robust royalty momentum and significant upfront milestones from recent record-breaking collaboration and licensing activity. The company targets having 13 ENHANZE development programs in the clinic by year-end 2026, which is expected to drive a new wave of approvals beginning in the 2029-plus timeframe. Hypercon is projected to reach approximately $1 billion in royalty revenue by the mid-2030s, assuming five to seven product launches starting in the 2030-2031 window. Future growth assumptions include a 'bending of the curve' in 2029 and beyond, supported by the current approved portfolio, the growing development pipeline, and new Hypercon partnerships. Capital allocation priorities focus on organic growth and share repurchases, with management indicating that large-scale M&A is unlikely for the remainder of 2026. Halozyme is actively pursuing legal injunctions in eight countries against Merck to stop alleged infringement of its MDASE technology, with key European decisions expected by year-end. The company is appealing initial U.S. Patent Office (PTAB) decisions regarding Merck's challenges, maintaining high conviction that it will ultimately prevail in protecting its intellectual property. Management addressed competition from Alteogen, noting that many partners choose Halozyme due to its 15-year safety database and established track record of 1.3 million treated patients. The company is investing approximately $60 million in 2026 to advance Hypercon and SurfBio technologies, prioritizing the development of a second compounding platform engine. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Growth will be driven by sequential ramps in recently launched products like RYBREVANT SC and OCREVUS ZUNOVO. Management expects royalty revenue to grow sequentially, though the specific step-up seen between Q1 and Q2 may not repeat in the same magnitude. Exclusivity is partner-driven; partners can secure exclusive rights by paying enhanced economics, but many are now opting for non-exclusive licenses. The company is becoming more creative with deal structures, offering exclusivity for specific molecules or combination uses rather than entire targets. First clinical starts for Hypercon are expected in the first half of 2027, with additional study starts possible in the second half of that year. The $1 billion royalty target for the mid-2030s assumes five to seven launches, which may come from both existing and future agreements signed in the next 1-2 years. Management identified a total addressable market of approximately 100 commercial and development products across ADCs and nucleic acids that could benefit from ENHANZE. These new modalities broaden the business development pipeline by increasing the number of companies Halozyme can approach to improve competitive profiles.

Investor releaseQuarter not tagged2026-08-07

Halozyme Therapeutics Q2 Earnings Call Highlights

MarketBeat
Interested in Halozyme Therapeutics, Inc.? Here are five stocks we like better. Record Q2 performance: Revenue rose 48% year over year to $481 million, while royalty revenue increased 50% to $307.7 million. Net income, adjusted EBITDA and non-GAAP EPS also grew strongly. Royalty growth is broadening: Established products DARZALEX SC and VYVGART Hytrulo continued to drive gains, while newer launches including OCREVUS ZUNOVO, Opdivo Qvantig and RYBREVANT SC contributed significantly. Halozyme also signed five collaboration agreements that generated $35.5 million in upfront revenue. Outlook raised: Halozyme now expects 2026 revenue of $1.835 billion to $1.91 billion and adjusted EBITDA of $1.225 billion to $1.28 billion. The company is investing in its Hypercon platform, with initial clinical studies expected in the first half of 2027 and potential launches beginning in 2030. Halozyme Therapeutics (NASDAQ:HALO) reported record second-quarter revenue and raised its full-year outlook, citing growth in royalty income from its ENHANZE drug-delivery platform, contributions from newer product launches and revenue from newly signed collaboration agreements. Total revenue rose 48% year over year to $481 million in the second quarter, while royalty revenue increased 50% to $307.7 million. Net income rose 39% to $229.9 million, and adjusted EBITDA increased 46% to $328.8 million. GAAP diluted earnings per share was $1.90, compared with $1.33 a year earlier, while non-GAAP diluted EPS was $2.28, up from $1.54. → 3 Drone Stocks That Should Soar After the Summer Slump “The growing contributions of our recently launched ENHANZE products and the continued strong performance of DARZALEX Subcutaneous and VYVGART give us confidence in the 2026 to 2028 financial guidance and beyond,” President and CEO Helen Torley said during the company’s earnings call. Halozyme said its royalty performance reflected continued sales growth from established ENHANZE-enabled products, including DARZALEX SC, VYVGART Hytrulo and PHESGO, along with rising contributions from newer launches including OCREVUS ZUNOVO, Opdivo Qvantig and RYBREVANT FASPRO. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Royalties from DARZALEX totaled $152.2 million, up 27% year over year. Johnson & Johnson’s DARZALEX global sales exceeded $4 billion in the quarter, according to Halozyme, with virtually a…Read full document

Interested in Halozyme Therapeutics, Inc.? Here are five stocks we like better. Record Q2 performance: Revenue rose 48% year over year to $481 million, while royalty revenue increased 50% to $307.7 million. Net income, adjusted EBITDA and non-GAAP EPS also grew strongly. Royalty growth is broadening: Established products DARZALEX SC and VYVGART Hytrulo continued to drive gains, while newer launches including OCREVUS ZUNOVO, Opdivo Qvantig and RYBREVANT SC contributed significantly. Halozyme also signed five collaboration agreements that generated $35.5 million in upfront revenue. Outlook raised: Halozyme now expects 2026 revenue of $1.835 billion to $1.91 billion and adjusted EBITDA of $1.225 billion to $1.28 billion. The company is investing in its Hypercon platform, with initial clinical studies expected in the first half of 2027 and potential launches beginning in 2030. Halozyme Therapeutics (NASDAQ:HALO) reported record second-quarter revenue and raised its full-year outlook, citing growth in royalty income from its ENHANZE drug-delivery platform, contributions from newer product launches and revenue from newly signed collaboration agreements. Total revenue rose 48% year over year to $481 million in the second quarter, while royalty revenue increased 50% to $307.7 million. Net income rose 39% to $229.9 million, and adjusted EBITDA increased 46% to $328.8 million. GAAP diluted earnings per share was $1.90, compared with $1.33 a year earlier, while non-GAAP diluted EPS was $2.28, up from $1.54. → 3 Drone Stocks That Should Soar After the Summer Slump “The growing contributions of our recently launched ENHANZE products and the continued strong performance of DARZALEX Subcutaneous and VYVGART give us confidence in the 2026 to 2028 financial guidance and beyond,” President and CEO Helen Torley said during the company’s earnings call. Halozyme said its royalty performance reflected continued sales growth from established ENHANZE-enabled products, including DARZALEX SC, VYVGART Hytrulo and PHESGO, along with rising contributions from newer launches including OCREVUS ZUNOVO, Opdivo Qvantig and RYBREVANT FASPRO. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Royalties from DARZALEX totaled $152.2 million, up 27% year over year. Johnson & Johnson’s DARZALEX global sales exceeded $4 billion in the quarter, according to Halozyme, with virtually all global sales coming from the subcutaneous formulation using ENHANZE. VYVGART Hytrulo royalty revenue rose 143% to $72.6 million. Total VYVGART brand sales reached $1.5 billion, an increase of 60% from the prior-year period. Halozyme said argenx reported that about 80% of U.S. patients using the VYVGART Hytrulo prefilled syringe during the quarter were new to the VYVGART franchise. → Jersey Mike's Serves Fresh Gains After IPO Stumble Other royalty revenue grew 85% to $54.4 million, driven by sales of recently launched products including OCREVUS SC, Opdivo Qvantig, RYBREVANT SC and TECENTRIQ subQ. Torley said royalties from OCREVUS ZUNOVO, Opdivo Qvantig and RYBREVANT SC increased about 80% sequentially. Roche reported that 44,000 patients were receiving OCREVUS ZUNOVO, compared with 17,500 at the end of the fourth quarter of 2025. Bristol Myers Squibb reported a 15% subcutaneous conversion rate for Opdivo Qvantig and global sales of $261 million for the product in the quarter, according to Halozyme. The company signed four collaboration and licensing agreements in the second quarter and a fifth agreement in July. Three of the agreements involved ENHANZE, with GSK, Incyte and an undisclosed partner, while Vertex and Oruka entered Hypercon agreements. The agreements generated $35.5 million of upfront collaboration revenue in the second quarter, approximately evenly divided between ENHANZE and Hypercon, Torley said. Halozyme’s agreement with GSK includes use of ENHANZE with antibody-drug conjugates, while the confidential agreement covers a nucleic acid therapeutic. Torley said the company estimates there are at least 100 commercial and development-stage products across antibody-drug conjugates and nucleic acid therapies that could potentially benefit from ENHANZE. Torley also said deal economics are driven more by whether a partner seeks exclusivity than by the size of the partner company. Halozyme expects both new partnership agreements and additional nominations by existing partners to support development-pipeline growth. Halozyme is positioning Hypercon as a second platform intended to support lower-volume subcutaneous administration through highly concentrated formulations. The company is preparing to supply clinical material for the first Hypercon clinical studies, which it expects to begin in the first half of 2027. Torley said additional Hypercon clinical study starts could occur in the second half of 2027, with further activity possible in 2028. The company’s five existing Hypercon agreements cover up to 20 targets, she said. Halozyme projects the first two potential Hypercon launches could occur in 2030 and 2031 and continues to target about $1 billion in Hypercon royalty revenue in the mid-2030s. That forecast assumes between five and seven launches by that period. The company is also evaluating investment in Hypercon manufacturing, although Torley said it has not finalized plans for the required investment or business model. For ENHANZE, Halozyme said two new targets entered Phase I testing during the second quarter, bringing the number of development products to nine. The company expects to have up to 13 ENHANZE partner products in development by year-end 2026, with launches potentially beginning in 2029 and continuing over subsequent years. Halozyme raised its 2026 guidance and now expects: Total revenue of $1.835 billion to $1.91 billion, representing 31% to 37% growth year over year. Royalty revenue of $1.22 billion to $1.245 billion, representing 41% to 43% growth. Adjusted EBITDA of $1.225 billion to $1.28 billion, including about $60 million of planned investment in Hypercon and Surf Bio. Non-GAAP diluted EPS of $8.65 to $9.00. Chief Financial Officer Darren Snellgrove said the company expects royalty revenue to increase sequentially in the second half, supported in part by newer product launches such as RYBREVANT SC. Halozyme repurchased $332.8 million of stock during the second quarter against its $400 million full-year target. On M&A, Snellgrove said the company continues to view acquisitions as part of its capital-allocation strategy when they add differentiated technology, new capabilities or future growth platforms. However, he said Halozyme is focused on organic growth in 2026 and that an acquisition is unlikely this year. Halozyme Therapeutics, Inc is a biopharmaceutical company headquartered in San Diego, California, that specializes in the development and commercialization of novel drug-delivery technologies. Founded in 1998, Halozyme focuses on enabling subcutaneous administration of biologic therapies through its proprietary platforms. The company's core mission is to improve patient access and convenience while maintaining efficacy and safety profiles comparable to or better than traditional routes of administration. The company's flagship technology, ENHANZE®, is based on recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that transiently degrades hyaluronan in the extracellular matrix. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Halozyme Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-06

Halozyme Therapeutics (HALO) Q2 Earnings and Revenues Surpass Estimates

Zacks
Halozyme Therapeutics (HALO) came out with quarterly earnings of $2.28 per share, beating the Zacks Consensus Estimate of $1.82 per share. This compares to earnings of $1.54 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +25.28%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.54 per share when it actually produced earnings of $1.6, delivering a surprise of +3.9%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Halozyme Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $481 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 17.44%. This compares to year-ago revenues of $325.72 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Halozyme Therapeutics shares have added about 24.2% since the beginning of the year versus the S&P 500's gain of 12.8%. While Halozyme Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Halozyme Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the nea…Read full document

Halozyme Therapeutics (HALO) came out with quarterly earnings of $2.28 per share, beating the Zacks Consensus Estimate of $1.82 per share. This compares to earnings of $1.54 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +25.28%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.54 per share when it actually produced earnings of $1.6, delivering a surprise of +3.9%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Halozyme Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $481 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 17.44%. This compares to year-ago revenues of $325.72 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Halozyme Therapeutics shares have added about 24.2% since the beginning of the year versus the S&P 500's gain of 12.8%. While Halozyme Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Halozyme Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.05 on $455.73 million in revenues for the coming quarter and $7.96 on $1.77 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Alpha Cognition Inc. (ACOG), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 13. This company is expected to post quarterly loss of $0.39 per share in its upcoming report, which represents a year-over-year change of +40%. The consensus EPS estimate for the quarter has been revised 11.5% lower over the last 30 days to the current level. Alpha Cognition Inc.'s revenues are expected to be $4.32 million, up 160.2% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report Alpha Cognition Inc. (ACOG) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-06

Halozyme Therapeutics Q2 Adjusted Earnings, Revenue Rise; Shares Gain After Hours

MT Newswires

Halozyme Therapeutics (HALO) reported Q2 non-GAAP earnings late Thursday of $2.28 per diluted share,

Investor releaseQuarter not tagged2026-08-06

HALOZYME REPORTS RECORD SECOND QUARTER 2026 RESULTS, BEATS ESTIMATES AND RAISES FULL YEAR 2026 FINANCIAL GUIDANCE

PR Newswire
Total Revenue Increased 48% YOY to $481 millionRoyalty Revenue Increased 50% YOY to $308 million Raises 2026 Financial Guidance Ranges:Total Revenue of $1.835 - $1.910 billion, YOY Growth of 31% - 37%Royalty Revenue of $1.220 - $1.245 billion, YOY Growth of 41% - 43%Adjusted EBITDA of $1.225 - $1.280 billion, YOY Growth of 86% - 95%1Non-GAAP Diluted EPS of $8.65 - $9.00, YOY Growth of 108% - 117%1 Signed Five New ENHANZE® and Hypercon™ Collaboration Agreements YTD 2026, Exceeding Goal of Three for Full Year 2026 SAN DIEGO, Aug. 6, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the second quarter ended June 30, 2026, and provided an update on its recent corporate activities. "We delivered another quarter of strong performance, with multiple proof points demonstrating the attractive features of ENHANZE as a compounding platform engine: repeatability of success, scalability, diversification and durability of revenues," said Dr. Helen Torley, President and Chief Executive Officer. "Total revenue increased 48% year-over-year to $481 million, royalty revenue increased 50% to $308 million and adjusted EBITDA grew 46% to $329 million, reflecting the strength of our differentiated royalty business. Based on these record results, we are raising our full year 2026 financial guidance." "Importantly, we are delivering on both our near-term and long-term growth objectives. The ENHANZE value proposition is attracting new partners and additional products from our current partners. We expanded our royalty revenue opportunity by signing five new ENHANZE and Hypercon collaborations through July, including agreements with Vertex, Oruka, GSK, Incyte and an undisclosed partner who is the first to license ENHANZE for a nucleic acid therapeutic. We have also demonstrated our commitment to returning significant capital to shareholders, repurchasing $333 million of shares in 2Q 2026, at an average price of $69.30. Overall, these results illustrate our continued ability to create multiple waves of revenue opportunities that will drive long-term shareholder value," concluded Dr. Torley. Second Quarter Corporate Highlight: In May 2026, the Company announced a new share repurchase program to repurchase up to $1.0 billion of its outstanding common stock by December 31, 2028, with an expec…Read full document

Total Revenue Increased 48% YOY to $481 millionRoyalty Revenue Increased 50% YOY to $308 million Raises 2026 Financial Guidance Ranges:Total Revenue of $1.835 - $1.910 billion, YOY Growth of 31% - 37%Royalty Revenue of $1.220 - $1.245 billion, YOY Growth of 41% - 43%Adjusted EBITDA of $1.225 - $1.280 billion, YOY Growth of 86% - 95%1Non-GAAP Diluted EPS of $8.65 - $9.00, YOY Growth of 108% - 117%1 Signed Five New ENHANZE® and Hypercon™ Collaboration Agreements YTD 2026, Exceeding Goal of Three for Full Year 2026 SAN DIEGO, Aug. 6, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the second quarter ended June 30, 2026, and provided an update on its recent corporate activities. "We delivered another quarter of strong performance, with multiple proof points demonstrating the attractive features of ENHANZE as a compounding platform engine: repeatability of success, scalability, diversification and durability of revenues," said Dr. Helen Torley, President and Chief Executive Officer. "Total revenue increased 48% year-over-year to $481 million, royalty revenue increased 50% to $308 million and adjusted EBITDA grew 46% to $329 million, reflecting the strength of our differentiated royalty business. Based on these record results, we are raising our full year 2026 financial guidance." "Importantly, we are delivering on both our near-term and long-term growth objectives. The ENHANZE value proposition is attracting new partners and additional products from our current partners. We expanded our royalty revenue opportunity by signing five new ENHANZE and Hypercon collaborations through July, including agreements with Vertex, Oruka, GSK, Incyte and an undisclosed partner who is the first to license ENHANZE for a nucleic acid therapeutic. We have also demonstrated our commitment to returning significant capital to shareholders, repurchasing $333 million of shares in 2Q 2026, at an average price of $69.30. Overall, these results illustrate our continued ability to create multiple waves of revenue opportunities that will drive long-term shareholder value," concluded Dr. Torley. Second Quarter Corporate Highlight: In May 2026, the Company announced a new share repurchase program to repurchase up to $1.0 billion of its outstanding common stock by December 31, 2028, with an expectation of buying back at least $400 million of shares in 2026. During the second quarter of 2026, the Company repurchased 4.8 million shares for $332.8 million at an average price of $69.30 per share under the May 2026 and February 2024 share repurchase programs. The February 2024 share repurchase program was completed in June 2026. Recent Partner Highlights: In July 2026, Halozyme and Incyte entered into a global collaboration and license agreement to evaluate additional subcutaneous formulations of INCA033989, a first-in-class mutant calreticulin ("mutCALR")-targeted monoclonal antibody, in patients with mutCALR-expressing myeloproliferative neoplasms ("MPNs"), 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 the third quarter of 2026, the ongoing ARGX-119 adimanebart program was expanded to include a Phase 1 SC bioavailability study with ENHANZE®. Second Quarter Partner Highlights: In May 2026, Halozyme and an undisclosed company entered into a global collaboration and license agreement that provides the company access to ENHANZE® to develop a nucleic acid therapeutic. In May 2026, Janssen announced pivotal results from the Phase 1b/2 OrigAMI-4 study showing that subcutaneous amivantamab and hyaluronidase-lpuj delivered durable responses in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy and submitted a supplemental Biologics License Application ("sBLA") to the U.S. Food and Drug Administration ("FDA"). In May 2026, Viatris initiated a Phase 1 study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of a single dose of selatogrel in Chinese adults with chronic coronary syndrome. In May 2026, argenx announced FDA approval of a sBLA for VYVGART® Hytrulo with ENHANZE® for the treatment of adult patients with generalized myasthenia gravis including all serotypes – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. In May 2026, Halozyme and GSK plc ("GSK") entered into a global collaboration and license agreement for ENHANZE® with multiple oncology targets, including the first potential application in antibody-drug conjugates. Under the terms of the agreement, GSK made an upfront payment and agreed to make potential future milestone payments and royalties on net sales of products developed with ENHANZE®. In May 2026, Halozyme and Oruka Therapeutics, Inc. ("Oruka") entered into a global exclusive collaboration and license agreement for Halozyme's Hypercon™ technology for use with ORKA-001, in development for psoriasis and related inflammatory diseases and one additional target. Under the terms of the agreement, Oruka made an upfront payment and agreed to make potential future milestone payments and mid-single digit royalties on net sales of products developed using the Hypercon™ technology. In May 2026, Takeda announced positive topline results from its pivotal Phase 2/3 trial of TAK-881 with ENHANZE® in Primary Immunodeficiency Disease. In April 2026, Halozyme and Vertex Pharmaceuticals Incorporated ("Vertex") entered into a global exclusive collaboration and license agreement that provides Vertex access to Halozyme's Hypercon™ technology for use in up to three targets. Under the terms of the agreement, Vertex made a $15 million upfront payment and agreed to make potential future milestone payments and royalties on net sales of products developed using the Hypercon™ technology. Second Quarter 2026 Financial Highlights: Total revenue was $481.0 million, compared to $325.7 million in the second quarter of 2025. The 48% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $307.7 million in royalties, an increase of 50% compared to $205.6 million in the second quarter of 2025, primarily driven by continued sales uptake of ENHANZE® partner products that have launched since 2020, predominantly by VYVGART® Hytrulo by argenx and DARZALEX® SC Janssen in all geographies and contributions from other recently launched products. Cost of sales was $79.2 million, compared to $46.4 million in the second 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 second 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 $27.7 million, compared to $17.5 million in the second quarter of 2025. The increase was primarily due to the acquisition of Elektrofi and Surf Bio, Inc. ("Surf Bio") in the fourth quarter of 2025. Selling, general and administrative expense was $57.0 million, compared to $41.6 million in the second quarter of 2025. The increase was primarily due to an increase in consulting and professional service fees, including litigation costs incurred in connection with patent infringement litigation, the acquisition of Elektrofi and Surf Bio, and an increase in compensation expense. Operating income was $287.7 million, compared to $202.4 million in the second quarter of 2025. Net income was $229.9 million, compared to $165.2 million in the second quarter of 2025. EBITDA was $321.9 million, compared to $222.9 million in the second quarter of 2025. Adjusted EBITDA was $328.8 million, compared to $225.5 million in the second quarter of 2025.1 GAAP diluted earnings per share was $1.90, compared to $1.33 in the second quarter of 2025. Non-GAAP diluted earnings per share was $2.28, compared to $1.54 in the second quarter of 2025.1 Cash, cash equivalents, restricted cash and marketable securities were $231.9 million on June 30, 2026, compared to $145.4 million on December 31, 2025. The increase was primarily driven by cash generated from operations. Financial Outlook for 2026 The Company is raising its 2026 financial guidance ranges, which were last provided on May 11, 2026. For the full year 2026, the Company expects: Total revenue of $1.835 billion to $1.910 billion, representing growth of 31% to 37% over 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API. Revenue from royalties of $1.220 billion to $1.245 billion, representing growth of 41% to 43% over 2025. Adjusted EBITDA of $1.225 billion to $1.280 billion, representing growth of 86% to 95% over 2025, including new Hypercon™ and Surf Bio investments of approximately $60 million. Non-GAAP diluted earnings per share of $8.65 to $9.00, representing growth of 108% to 117% over 2025. The Company's earnings per share guidance includes new Hypercon™ and Surf Bio investments 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 second quarter ended June 30, 2026 today, Thursday, August 6, 2026, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: https://events.q4inc.com/analyst/838122249?pwd=X5tkHKi. 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., Skye Bioscience, GSK and Incyte. Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon™ and Surf Bio's 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 addition of Surf Bio's polymer-based hyperconcentration technology further broadens the range of biologics that can be delivered subcutaneously, meaningfully expanding the scope of opportunities across therapeutic modalities. Together, Hypercon™ and Surf Bio's technology complement ENHANZE® by enabling creation and delivery of highly concentrated biologics. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly, argenx, Vertex Pharmaceuticals, and Oruka Therapeutics. 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 www.halozyme.com 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 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 per share. 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 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 for 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 and potential future share repurchases. These forward-looking statements also include statements regarding the Company's potential receipt of upfront payments and payments associated with achievement of certain development, regulatory and sales-based milestones, and royalties on sales of commercialized products from recent collaboration agreements. 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 including its potential application with antibody drug conjugates. Forward-looking statements regarding the Company's Hypercon™ and Surf Bio technologies include the possible benefits and attributes of these technologies, including the potential to reduce injection volume for the same dosage of drugs and biologics and possibly enabling administration in at‑home and healthcare‑provider settings and statements concerning certain other potential benefits of these technologies including facilitating administration of injectable medications through subcutaneous delivery by enabling creation and delivery of highly concentrated biologics and potentially lowering the treatment burden, easing treatment access and improving the treatment experience for patients. 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 unexpected results or delays in the Company's repurchases of the Company's shares under the share repurchase program, market conditions, changes in domestic and foreign business, changes in the competitive environment in which the Company operates, 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 Report on Form 10-Q 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 BuiVP, Investor Relations and Corporate [email protected] Sydney [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/halozyme-reports-record-second-quarter-2026-results-beats-estimates-and-raises-full-year-2026-financial-guidance-302845332.html

Investor releaseQuarter not tagged2026-08-06

Compared to Estimates, Halozyme Therapeutics (HALO) Q2 Earnings: A Look at Key Metrics

Zacks

For the quarter ended June 2026, Halozyme Therapeutics (HALO) reported revenue of $481 million, up 47.7% over the same period last year. EPS came in at $2.28, compared to $1.54 in the year-ago quarter. The reported revenue represents a surprise of +17.44% over the Zacks Consensus Estimate of $409.57 million. With the consensus EPS estimate being $1.82, the EPS surprise was +25.28%. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how Halozyme Therapeutics performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Product sales, net: $129.63 million compared to the $110.4 million average estimate based on four analysts. The reported number represents a change of +59% year over year. Revenues- Royalties: $307.7 million versus $274.03 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a +49.6% change. Revenues- Revenues under collaboration agreements: $43.67 million versus the four-analyst average estimate of $25.14 million. The reported number represents a year-over-year change of +13.2%. View all Key Company Metrics for Halozyme Therapeutics here>>> Shares of Halozyme Therapeutics have returned +4% over the past month versus the Zacks S&P 500 composite's +3.3% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-06

Halozyme Therapeutics: Q2 Earnings Snapshot

Associated Press

SAN DIEGO (AP) — SAN DIEGO (AP) — Halozyme Therapeutics Inc. (HALO) on Thursday reported earnings of $229.9 million in its second quarter. On a per-share basis, the San Diego-based company said it had net income of $1.90. Earnings, adjusted for one-time gains and costs, were $2.28 per share. The biopharmaceutical company posted revenue of $481 million in the period, beating Street forecasts. Four analysts surveyed by Zacks expected $409.6 million. Halozyme Therapeutics expects full-year earnings in the range of $8.65 to $9 per share, with revenue in the range of $1.84 billion to $1.91 billion. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on HALO at https://www.zacks.com/ap/HALO

TranscriptFY2026 Q22026-08-06

FY2026 Q2 earnings call transcript

Earnings source - 71 paragraphs
Operator

Good afternoon. My name is Joel, and I will be your conference operator today. At this time, I would like to welcome everyone to Halozyme's second quarter 2026 financial and operating results conference call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. Please note this event is being recorded. I will now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations. Please go ahead.

Tram Bui

Thank you, operator. Good afternoon and welcome to our second quarter 2026 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 Darren Snellgrove, 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 two. 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.

Tram Bui

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 and we will start on slide three.

Helen Torley

Thank you, Tram. Good afternoon, everyone. I am pleased to report our results from an exceptionally strong second quarter, led by ENHANZE royalty revenue growth and new deal momentum that resulted in meaningful upfront milestones. You've heard me say before that ENHANZE is a unique compounding platform engine. On this call, we will share multiple proof points demonstrating how ENHANZE is delivering on all of the attractive features of a compounding platform engine. I'm talking about the repeatability of success, the scalability and diversification, and the durability of revenues that result from this. The ENHANZE value proposition is attracting new partners and additional products from our current partners at a cracking pace.

Helen Torley

On top of this, Hypercon is already off and running as a second future combining platform engine for Halozyme, showing the same features and in fact doing so even earlier in the life cycle than ENHANZE as we apply the knowledge and learnings of the last decade. Let's look now at what's new in the quarter. I will start with the broadening diversification and record growth of our royalty revenue streams. We are reporting increasing contributions of our newer launch products, Opdivo SC, Ocrevus SC, and RYBREVANT SC, to our royalty revenues with 80% growth quarter-on-quarter. This is repeating and building on top of the success and continued growth and performance of DARZALEX SC, VYVGART Hytrulo, and PHESGO.

Helen Torley

What I love about this is that over the last years, we've moved from all focus being on DARZALEX SC performance to it then expanding to PHESGO and then to VYVGART Hytrulo as it was recognized just how much opportunity these products represented. Now we're expanding to six products to focus on. This is exactly what I meant by the compounding platform engine, multiple winners creating revenue diversification and durability. This broadened launch portfolio resulted in record total royalty revenue growth of 50% year-over-year to $308 million, providing strong support to and conviction for the 2026-2028 financial guidance and for the revenues in 2029 and beyond. Let me now move to the second highlight, the significant expansion in new partnerships for ENHANZE and Hypercon in the quarter.

Helen Torley

In the second quarter, we signed four new collaboration and licensing agreements, and we signed a fifth agreement in July. We have never had this pace of new collaboration agreements in the history of Halozyme. For those of you who asked, "Can they sign great new deals for ENHANZE?" The answer is a resounding, emphatic, and demonstrated yes, with three of these five agreements being for ENHANZE. This year, we have added new ENHANZE agreements with GSK, Incyte, and a third confidential partner. We added two new Hypercon agreements with Vertex and with Oruka. I will add, not only did we broadly expand the number of partners, we also expanded use areas to beyond monoclonal antibodies into two new expanding and leading-edge modality areas, ADCs and nucleic acids. This means brand-new growth opportunity for ENHANZE.

Helen Torley

The new CLAs contributed $35.5 million in upfront collaboration revenue in the quarter, approximately evenly split across ENHANZE and Hypercon. This was also an important contributor to record total revenue in the quarter. This is how we said we would and how we are bending the curve in the 2029+ period. The third area I want to highlight is development portfolio expansion and progress. In the second quarter, we advanced our pipeline of future potential royalty streams with two new phase I study starts. It is our goal to have 13 ENHANZE development programs in 2026, which is also bending the curve in the 2029+ period. Moving now to slide four, I'll highlight the second quarter financial results. For the second quarter, total revenue increased 48% year-over-year to $481 million.

Helen Torley

This was largely driven by robust royalty revenues of CHF $308 million, a strong 50% year-over-year growth. The robust revenue performance resulted in adjusted EBITDA of CHF 329 million, adjusted EBITDA margin of more than 65%, and non-GAAP earnings per share of CHF 2.28, highlighting the strength of our diversified royalty portfolio and the operating leverage that's inherent in our differentiated business model. Moving now to slide five. Based on the strong second quarter, and in particular, the robust royalty revenue growth, we are pleased to raise full-year 2026 guidance. What I will highlight is the increase in total revenue guidance of CHF 110 million at the midpoint. This is driven by the increased projected royalty revenues from established products and the new launch products that I discussed earlier, and also by the upfront milestones resulting from what has already been a record year for new collaboration and licensing agreements.

Helen Torley

Let me move now to slide six. I'll provide additional detail on the key business drivers in the quarter, beginning with the current ENHANZE portfolio. In the second quarter, the contribution from the more recently launched subcutaneous products with ENHANZE, including OCREVUS ZUNOVO, Opdivo Qvantig, and RYBREVANT SC, increased by approximately 80% quarter-over-quarter. OCREVUS ZUNOVO is demonstrating how ENHANZE-enabled subcutaneous delivery can compound the value for our partners' products by expanding the accessible patient population. On their second quarter call, Roche reported that the number of patients receiving the subcutaneous formulation increased to 44,000. Contrast that with the 17,500 patients at the end of the fourth quarter of 2025, and you can see just how many new patients have been added for this every six months subcutaneous treatment. ZUNOVO is now the fastest-growing anti-CD20 multiple sclerosis brand in the U.S.

Helen Torley

Roche noted that approximately 60% of the U.S. OCREVUS ZUNOVO starts are coming from community practices, demonstrating how an ENHANZE-enabled delivery can reach new sites of care, enabling access to Ocrevus for new patients. Reflecting this momentum, Roche reaffirmed its expectation for CHF 9 billion in peak Ocrevus IV and subcutaneous sales by 2029, including approximately CHF 2 billion in growth resulting from the expanded accessibility created by OCREVUS ZUNOVO. Moving now to Bristol Myers Squibb. Bristol's Opdivo Qvantig continued its strong launch trajectory, with subcutaneous conversion reported to have increased to 15%, well on track for BMS's targeted 30%-40% conversion rate. This resulted in global sales growth of more than 200% year-over-year to CHF $261 million in the second quarter. Based on this, Opdivo Qvantig is projected to exceed CHF $1 billion in annualized revenue.

Helen Torley

Johnson & Johnson's RYBREVANT FASPRO is another strong example of how ENHANZE creates value for our partners and for Halozyme. For the second quarter of 2026, J&J highlighted rapid uptake of RYBREVANT FASPRO, contributing to the strong 62% year-over-year growth. Supporting growth acceleration in the upcoming quarters, the permanent J-code was awarded on July 1st. This has been a contributor to broadening adoption and growth in multiple prior subcutaneous launches. J&J also commented that they have submitted a filing to the FDA for head and neck cancer. We're pleased to note that the FDA recently granted priority review to the filing, meaning an FDA review timeline of approximately six months. Upon approval, this new indication would expand the opportunity for RYBREVANT FASPRO beyond its existing lung cancer indications into this new area of high unmet need.

Helen Torley

It is certainly very exciting to see the growth and contribution of these three newer launch brands, where for these three brands alone, the total IV and subcutaneous opportunity based on total sales is projected to be $25 billion in 2028. This is resulting in a diversified set of six products contributing royalty revenues where the total opportunity now exceeds $55 billion. I'll move now to DARZALEX subcutaneous, VYVGART Hytrulo, and PHESGO, beginning with DARZALEX. DARZALEX continued to demonstrate robust revenue growth, increasing approximately 18% year-over-year to over $4 billion in the quarter, with virtually all global sales being for DARZALEX subcutaneous with ENHANZE. J&J attributed the strong performance to continued market growth and share gains across all lines of therapy, including nearly 11 percentage points of share gain in the frontline setting.

Helen Torley

It's also worth noting that following the FDA approval in March, the all-subcutaneous regimen of TECVAYLI plus DARZALEX FASPRO is bringing new hope to patients with relapse and refractory multiple myeloma. I'll move now to argenx. Total VYVGART sales grew 60% year-over-year to $1.5 billion in the second quarter, driven by continued strong adoption of the ENHANZE-enabled VYVGART Hytrulo pre-filled syringe, which I will refer to as the PFS. The PFS is expanding the prescriber base and bringing more patients into therapy, with approximately 80% of U.S. PFS patients in the quarter reported to be new to VYVGART. This demonstrates how ENHANZE, by supporting continued innovation and administration, can meaningfully broaden patient reach and support long-term product growth. Driving continued growth, recent regulatory and clinical milestones continue to expand the long-term opportunity for VYVGART Hytrulo.

Helen Torley

VYVGART is now the first and only therapy approved across all gMG serotypes, including seronegative patients. The U.S. approval in seronegative gMG in May expands the addressable opportunity by approximately 11,000 patients. Positive Phase III data in ocular myasthenia gravis further highlights the opportunity to expand the franchise and drive future growth upon approval. Moving now to PHESGO. PHESGO continues to demonstrate the value of ENHANZE-enabled subcutaneous delivery within Roche's HER2 franchise. During the first half of 2026, PHESGO delivered strong growth of 18%, with global conversion reaching 54% in the 85 launch countries. Roche reiterated its expectation for at least 60% conversion at peak and highlighted PHESGO is a key component of the franchise's long-term durability. I'll move now to slide seven.

Helen Torley

Looking beyond the current decade, our future launch portfolio represents a significant source of long-term value with the potential to expand and further diversify our royalty revenue streams and deliver durable revenue for many years to come. Beginning in the 2029-plus timeframe, we have three revenue engines. The first is our 10 currently approved ENHANZE products. The second are the multiple launches that are arising from our growing and robust ENHANZE development portfolio, and the third is Hypercon partner products. We project that by year-end of 2026, we will have up to 13 ENHANZE partner products in development, with potential approvals beginning in the 2029-plus timeframe. These programs represent the next generation of royalty-producing assets and extend our future opportunity beyond the currently approved portfolio. During the second quarter, two new ENHANZE targets initiated Phase I testing.

Helen Torley

This is resulting in nine development products and keeps us well on track for the 13 development products by year-end. This broad and growing portfolio of future potential launches clearly demonstrates why we're so confident that ENHANZE will be a significant long-term revenue driver for Halozyme. I will now move to HyperCon, which we intend to make into a second compounding platform engine and recreate the amazing success of ENHANZE. HyperCon is designed to address growing demand for lower-volume subcutaneous administration, enabling highly concentrated formulations that can potentially support at-home and physician office administration. We made strong progress in the quarter, advancing preparations to provide clinical supply to support the first HyperCon clinical starts in the first half of 2027.

Helen Torley

Our projected first launch timing for these two new products is in the 2030, 2031 timeframe. We continue to expect HyperCon to launch multiple products and achieve approximately $1 billion in royalty revenue in the mid-2030s. Let me now turn to the new collaboration and licensing agreements, which are summarized in Slide eight. I mentioned at the start that this has been our most successful year ever with record performance for ENHANZE and for HyperCon. The pace of recent collaboration activity reflects the growing importance of subcutaneous delivery across the biopharmaceutical industry. Pharma and biotech companies are increasingly focused on improving the patient treatment experience, reducing treatment burden, expanding access across sites of care, and differentiating their products. In the second quarter, we announced a new ENHANZE agreement with GSK, which included the opportunity to use ENHANZE in a new use area with Antibody-Drug Conjugates.

Helen Torley

In July, we announced a second agreement with Incyte, working with Incyte on a subcutaneous formulation of its first-in-class mutant calreticulin-targeted monoclonal antibody. Today, we are pleased to announce a third new agreement signed in the second quarter with an undisclosed partner to explore the use of ENHANZE with a nucleic acid therapeutic. This is the first of what we hope will be several collaborations in this emerging area where ENHANZE brings the potential to enable subcutaneous delivery of large-volume nucleic acid conjugate formulations and LNPs while mitigating the inflammatory and immune response that can be otherwise generated from subcutaneous administration. We are excited to expand into these two new areas of ADCs and nucleic acids that represent brand-new growth market segments for ENHANZE, where we estimate that there are at least 100 commercial and development products that may benefit.

Helen Torley

Also in the second quarter, we signed two new HyperCon collaboration agreements, one with Vertex and one with Oruka. These agreements establish strategic platform relationships that have the potential to expand over time through additional targets and future development programs. When we combine the up to 13 ENHANZE development programs by year-end and this expanding opportunity that's created by the current and new ENHANZE and HyperCon agreements, we have created a substantial portfolio of new potential royalty opportunities extending well into the next decade. What you've heard me describe is the power of having an established compounding platform engine with ENHANZE. We're creating just the same for HyperCon. We have demonstrated time and again the repeatability and diversification with now six separate and growing royalty streams delivering record revenue. We've demonstrated scalability with multiple waves of new launches now extending well into the 2030s.

Helen Torley

The durability is clear, with 50% royalty revenue growth more than 12 years after our first launch. We're very proud that our partner products are clinical breakthroughs that we have helped create into multiple blockbuster subcutaneous products. Our priority in 2026 remains executing on these significant organic growth opportunities. We're also continuing to evaluate selective M&A opportunities that can expand our drug delivery technology offering and royalty duration. Any external opportunity must meet our criteria of a strong strategic fit, durable value creation, and attractive returns. With that, I'm pleased to turn the call over to Darren.

Darren Snellgrove

Thank you, Helen. I am thrilled to be joining Halozyme at such an exciting point in the company's evolution. Over the past few months, I've had the opportunity to dive deeper into the business and what has stood out to me is the strength of Halozyme's business model. It's rare to find a company that offers such outstanding current performance and future potential. Halozyme's combination of strong growth, exceptional profitability, and robust free cash flow, coupled with disciplined capital allocation, positions the company well as we continue to accelerate innovation and provide significant returns to shareholders. Having spent nearly three decades in the industry, I was familiar with the value Halozyme creates for partners, patients, and the healthcare system. After joining the company, I have an even greater appreciation for the opportunities ahead. One of the unique characteristics of the business is what I would call the Halo Effect.

Darren Snellgrove

Every successful ENHANZE enabled product does more than generate high margin, scalable royalty revenue. We enable our partners and improve products for patients. Our platforms reinforce the clinical and commercial value of subcutaneous delivery and create additional opportunities for target nominations, platform expansions, and new collaborations. This cycle continues to broaden our opportunities and increase the durability of our long-term diversified model. The strong second quarter results reinforce that view as the company delivered another record quarter, exceeding expectations for royalty revenue, driving strong EBITDA growth, and at the same time investing in our future growth platforms. Let me start on slide nine. Total revenue increased 48% to $481 million compared to $325.7 million in the prior year period. This performance was driven by robust royalty revenue growth and higher collaboration revenue, reflecting new deals signed during the quarter.

Darren Snellgrove

Royalty revenue of $307.7 million increased 50% from $205.6 million in the prior year period and exceeded our expectations. These results reflect increasing contributions from more recently launched ENHANZE products, as well as the continued commercial success of DARZALEX SC and VYVGART Hytrulo. DARZALEX generated $4 billion in global sales for J&J in the second quarter, representing close to 18% operational growth, further demonstrating the strength, durability, and continued momentum of the franchise. These strong sales translated into $152.2 million of royalty revenue to Halozyme, representing an increase of 27% year-over-year. Halozyme's royalties from VYVGART Hytrulo increased 143% to $72.6 million in the second quarter. Total VYVGART brand sales for the second quarter reached $1.5 billion, up 60% versus prior year, reflecting strong demand for the ENHANZE enabled prefilled syringe, which continues to broaden the prescriber base and support adoption across gMG and CIDP.

Darren Snellgrove

Other royalty revenues grew 85% to $54.4 million, driven by increasing partner product sales of recently launched products OCREVUS SC, Opdivo Qvantig, RYBREVANT SC, and TECENTRIQ subQ. We are pleased with the early momentum and see a significant opportunity ahead, given that estimates for the total brand growth of these four products is approximately $30 billion in 2028. Moving to slide 10 for more detail on the quarterly results. Research and development expenses were $27.7 million compared to $17.5 million in the prior year period, reflecting the addition of Hypercon and Surf Bio and our continued investment in advancing these technologies. Selling, general and administrative expenses were $57 million in the quarter compared to $41.6 million in the prior year period. Net income increased 39% to $229.9 million from $165.2 million in the prior year period.

Darren Snellgrove

Adjusted EBITDA increased 46% to $328.8 million from $225.5 million in the prior year period, driven by continued strong royalty growth. GAAP diluted earnings per share was $1.90 compared to $1.33 in the prior year period. Non-GAAP diluted earnings per share was $2.28 compared to $1.54 in the second quarter of 2025. Moving to slide 11. We generate substantial free cash flow from our asset light model, and our strong financial position gives us the flexibility to execute a disciplined capital allocation strategy. Our priorities are straightforward: fund the highest return organic opportunities, maintain a strong balance sheet, and return excess capital to shareholders through a disciplined buyback program. We view share repurchases as an attractive use of capital when we believe the stock does not fully reflect the durability and growth of our royalty streams.

Darren Snellgrove

That is why we purchased $332.8 million worth of shares in the second quarter against our target of $400 million for the full year, while also investing in long-term growth and expanding the ENHANZE platform as more products launch and gain share. Turning now to Slide 12 and our updated 2026 outlook. As Helen mentioned earlier, we are pleased to raise the guidance for the remainder of the year. We now expect total revenue of $1.835 billion to $1.91 billion, representing year-over-year growth of 31%-37%, driven by an increase in royalty revenue projections and product sales from API. Royalty revenues of $1.22 billion to $1.245 billion, representing year-over-year growth of 41%-43%. We expect growing contributions from the recently launched ENHANZE products, while DARZALEX SC, VYVGART Hytrulo, and PHESGO remain the largest revenue contributors.

Darren Snellgrove

We expect adjusted EBITDA of between $1.225 billion and $1.28 billion, which includes approximately $60 million of planned investment in Hypercon and Surf Bio. Non-GAAP diluted EPS of $8.65 to $9. I will now turn the call back over to Helen.

Helen Torley

Thank you, Darren. In closing, let me highlight that our record second quarter results reinforce our confidence in both the strength of our business today and in the opportunities ahead. The growing contributions of our recently launched ENHANZE products and the continued strong performance of DARZALEX Subcutaneous and VYVGART give us confidence in the 2026 to 2028 financial guidance and beyond. In the quarter, we demonstrated meaningful progress to add to this and will bend the curve, including through multiple new ENHANZE and Hypercon collaboration and licensing agreements and multiple new clinical study starts. Thank you for your attention today, and operator, you can now open the line for questions.

Operator

We will now begin the question and answer session. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question is from Sean Laaman with Morgan Stanley. Your line is now open. Please go ahead.

Speaker 4

Hi, this is Natasha on for Sean. Thank you for taking our question. Your raised royalty guide of $1.22 billion-$1.245 billion against the $548 million in the first half royalties implies around $336 million-$348 million per quarter in the back half, which is a step up from 2Q's $308 million. I just wanted to ask what's driving that implied acceleration from here. Is it primarily the newer launch cohort or the established products? Thank you.

Helen Torley

Yeah. Thanks, Natasha. I'll turn that over to Darren.

Darren Snellgrove

Yeah. Thanks for the question. As you noted, royalties were an important component of the beat in the first half. I would say that we do expect royalty revenue to grow sequentially through the second half. Probably won't have quite the same amount of royalty step-ups that were part of the Q1 to Q2 growth, we do expect that to continue to ramp up in the second half. A lot of it is driven by some of the new product launches that you've seen. Things like RYBREVANT SC, which has started to pick up a little bit, and some of the other new products.

Speaker 4

Thank you.

Operator

Your next question is from Michael DiFiore with Evercore ISI. Your line is now open. Please go ahead.

Yue Yue

Hi, this is Yue Yue on for Mike. Congrats on the strong quarter. Thank you for taking our question. We'd like to ask a question on target exclusivity. You've talked about partners who work with other providers often approach Halozyme first, where target was already exclusively licensed. As we look forward to 2029, how should we think about the way target exclusivity works as the base patents roll off? Then does that open up targets you couldn't take on before?

Helen Torley

Yeah, thanks for the question. In terms of the exclusivity, it's often very much driven by the partner company. If they request exclusivity and they are willing to pay the enhanced economics that are associated with that, historically, in the past, we have agreed to that, and we also would still agree to that today. I will note, however, that as you've probably seen in the latest series of agreements we've done, there are now a lot of companies who are very comfortable with gaining a non-exclusive license. So you're going to see a mix of the two as you go forward. I will also say, if you think about exclusivity is also done in different ways. It can be exclusivity to an entire target, as an example, like we did with PD-1.

Helen Torley

In other cases, there can be exclusivity to a specific molecule that uses a target or perhaps a target that is part of a combination. So, we are being able to be a lot more, if you like, creative and broad in what we're able to license, both on an exclusive and a non-exclusive basis as we go forward. That really is reflected in the five recent deals across those and the additional deals we anticipate signing this year and next.

Yue Yue

Thank you.

Operator

Your next question is from Brendan Smith with TD Cowen. Your line is now open. Please go ahead.

Brendan Smith

Great. Thanks for taking the question, and congrats on the great quarter. Maybe first, actually, on HyperCon. I know we'll get confirmation of the first two assets by early next year. Just wondering if you can give us a little bit more of a sense of timing for subsequent assets in that pipeline and just roughly when the next wave might be. If there are others that could reach phase I next year, is that more of a 2028 event? I guess kind of related, wanted to ask actually about that $1 billion in incremental HyperCon royalties by 2035 you've spoken to. I guess, how many different assets are you assuming would contribute to that by 2035? I guess, are your assumptions largely just based on the current partnerships, or are you assuming any additional ones? Thanks, guys.

Helen Torley

Yes, thanks. With regard to HyperCon and timing, there absolutely could be additional study starts in the second half of 2027, Brendan, based on the progress we're seeing with companies advancing through the preparatory stages before they're ready to advance to the clinic. This, if you recall, while we've got 5 agreements, those partners have taken up to 20 targets. Some of the companies are advancing more than 1 target at this point in time, and that is already creating a very nice pipeline of future clinical studies for 2027 and for 2028. That's the great thing about the model we have with this ability to access multiple targets in 1 agreement. As we projected the $1 billion in the mid-2030s, we had assumed between 5 and 7 launches by that time period.

Helen Torley

I think a number of those will come from the already signed agreements, but it is also possible that agreements in the next 1 to 2 years could also be contributing to that based on what we estimate the development timeline to be. I commented on the call about it's very exciting to see HyperCon turning into another compounding platform engine for us, but able to do so faster and quicker, in part because the market is just more receptive to sub-Q delivery. We're also able to bring a lot of our learnings from how we've been able to commercialize and grow ENHANZE®.

Brendan Smith

That's great. Thanks, Helen. Thanks, guys.

Operator

Your next question is from Mitchell Kapoor with H.C. Wainwright. Your line is now open. Please go ahead.

Mitchell Kapoor

This is Mitchell. Congrats on a strong quarter, thank you for taking our questions. I guess for both or all platform cadence, how are you thinking about the mix of new partner wins and follow-on nominations from existing partners, how would that shape the future deal cadence? On the ADC and nucleic acid therapeutics, there is a lot of excitement about that. I was just wondering, how are you thinking about that broader opportunity, how are you prioritizing these modalities as you pursue additional deals? Thank you.

Helen Torley

Yeah, thank you. I will start with the ADCs and the nucleic acids. Yes, very excited now to have signed a deal, one each for both of those, opening up a brand-new growth opportunity for ENHANZE®. We have previously said that there is 50 ADCs we think could benefit from ENHANZE®, we said there are about 50 nucleic acid-based therapies that we think can benefit from ENHANZE®. This really is an exciting opportunity, I would say our business development team are agnostic to whether it is a monoclonal antibody, an ADC, or a nucleic acid. What it has done is broaden the number of companies that we are speaking to and approaching with ideas as to how the ENHANZE® technology can help improve their risk-benefit profile or their competitive profile.

Helen Torley

It just has dramatically increased the number of conversations we are having, that is exciting in terms of what that can mean for long-term growth and expansion of the ENHANZE® number of agreements. You make a good point, it is something I think that is often under-recognized, is that signing new deals is a source of growth for us. The number of targets that we already have under license that has not yet been nominated is a second separate source of growth. In the first half of this year, I will say we have had one current partner nominate a product, actually I am expecting more in the second half. It is going to be a mix of both, really, in terms of what is going to cause the continued growth and expansion of our pipeline. We expect to have 13 development products in the clinic this year.

Helen Torley

That's going to continue both from these current deals we're signing, adding more nominations and moving into the clinic. Even our existing partners who've still got slots left. Falling into the same mindset, I think, as many of the companies today of recognizing that sub-Q delivery means competitive differentiation, and they are advancing new nominations at a pace also that we've not necessarily seen in a long, long time. It's an exciting time with both of those avenues for growth, as well as growth coming from the ADCs and the nucleic acid new opportunity.

Mitchell Kapoor

Thank you.

Operator

Your next question is from Mohit Bansal with Wells Fargo. Your line is now open. Please go ahead.

Will Zang

Hi, this is Will Zang on for Mohit. Congrats on the recent deals in the quarter. I guess we just want to understand now that some of the smaller companies are also partnering with you on ENHANZE, is the deal structure for these smaller companies any different from your prior deals? I guess, what conversations are you currently having with newer, smaller partners?

Helen Torley

Yeah, we're excited to be continuing to be discussing ENHANZE with all size ranges of companies. If you think about just the last few months, we have GSK that certainly is a very large company. We've got Incyte that is a large company, and as you point out, some smaller companies as well. I would say what is more a driver of exactly what the deal structure will be is based much more on exclusivity versus non-exclusivity. That is where there is some difference in the economics that's really driven by that the deal structure is shaped around exclusivity, not company size.

Will Zang

Great. Thanks.

Operator

As a reminder, if you would like to ask a question, please press star one to raise your hand. To withdraw the question, simply press star one again. The next question is from David Risinger with Leerink Partners. Your line is now open. Please go ahead.

David Risinger

Thanks very much, congrats on the financial upside and Darren, congrats on your new role. I have a few questions, please. First, could you provide an update on the Merck litigation prospects? That's the first question. Second, how you see Alteogen as a competitor today, then, third, your view on the acquisition landscape. Thank you.

Helen Torley

All right. I'll take the first two, and I'll turn the acquisition landscape over to Darren. With regard to the Merck litigation, let me start outside the U.S. We are currently actively pursuing injunctions in approximately 8 countries outside the U.S. with the goal of stopping Merck infringing the use of our MDx technology. This includes the launch in countries as well as manufacturing, distribution, and supply of QLEX for worldwide use. These cases are moving forward rapidly. You may have seen we did have a preliminary injunction in Germany in December. We do expect important decisions broadly impacting Merck's launches of sales in QLEX in Europe before the end of this year, so very active in Europe. With regard to the United States, we're working through the U.S. Patent Office proceedings that were brought by Merck with regard to the PGRs.

Helen Torley

We expect to have more clarity once we're through all of those steps on when the U.S. District Court case is going to move forward, once the final decisions are reached in those proceedings later this year. Now, I will say that it's very active on the PGRs as well. We're going to be appealing the 4 initial written decisions that we received earlier this year, and we expect to hear the PTAB's decision on the remaining 10 sometime this fall.

Helen Torley

Lots still happening in the U.S. case as well, David, with some more clarity with regard to the PGRs at the end of this year, clarity on the timing of the district court case, but certainly, our conviction and our confidence is absolutely unwavering that we will prevail in this case and we will be appealing, certainly the first 4 PGRs based on our very strong conviction that the Alteogen product is infringing. The Merck product using the Alteogen technology, I should probably say better, is infringing. With regard to Alteogen, it still continues to be the case that from what is publicly available, it would appear that the people who are assigning deals at the moment with Alteogen are for targets that Halozyme has exclusively licensed.

Helen Torley

I can say many of those companies have directly come to us, and we've had to unfortunately say we're unable to work with them. In light of that, obviously, we're not finding that the performance of Alteogen is directly competing with us. I will also share that when companies come to us, what they say is they want to work with Halozyme because of our track record of success. Because our product's been used and we've got a safety database in over 1.3 million patients with 15 years' history of reliability of supply. Our team have got the expertise to support very rapidly getting the partners into the clinic, innovative trial designs, and a faster path to approval. So the entire package that Halozyme brings is what has, if you think about just in the last 7 or 8 months, 6 new ENHANZE deals.

Helen Torley

We are definitely performing incredibly well in the market. It comes from that competitive moat that we've created from all of our years of expertise and performance. Let me turn it to Darren for acquisition landscape.

Darren Snellgrove

Yes, thanks, and hi, David. With regards to M&A, we definitely continue to see M&A as an important part of our capital allocation strategy. I would say particularly when we can add differentiated technologies, new capabilities or create future growth platforms. At the same time, I think you've heard the company say this before, we're very disciplined.

Darren Snellgrove

We indicated last quarter that for 2026, we're going to really focus on organic growth and M&A is unlikely. What I would say the good news is, given the strength of our portfolio, the growing cash flows that we have, and our improving leverage profile, we really do have flexibility. Again, we remain focused on long-term shareholder value.

David Risinger

Great. Thank you.

Operator

Your next question is from Mitchell Kapoor with H.C. Wainwright. Your line is now open. Please go ahead.

Mitchell Kapoor

Hi, this is Mitchell again. Thank you for taking our second round of questions. I was wondering, as you build out Hypercon manufacturing, how should we think about potential revenue beyond royalties and any incremental investment within the 2026, 2028 margins? You showed that you got to 13 ENHANZE programs in development by end of 2026 and 13 launches in 2029. I'm just wondering, how are you thinking about any potential attrition or is that built into your assumptions? Thank you.

Helen Torley

Yeah. Let me talk about the manufacturing first, and maybe I'll begin by sharing why we think it's such an exciting opportunity for us to invest in the manufacturing. As you're already hearing, we've got five deals, multiple products are advancing. We believe that Hypercon is going to become rapidly the same type of compounding platform engine that we have from ENHANZE. To speed that up, and to maximize the success of that, Halozyme investing to advance manufacturing is just the right thing to do. We'll be able to drive that, control that at our pace and with our expertise. We have not finalized the exact planning around that, so I can't share any details on the investment required or the exact business model.

Helen Torley

What I can say is that this is going to be very exciting as we contemplate just how much more quickly Hypercon is going to grow to be that billion-dollar opportunity, compared to ENHANZE. More to come on that as we finalize our plans. With regard to the additional launches, just to clarify one thing, we anticipate having 13 products in the clinic by the end of this year. In terms of the 2029 number, what we said was we will begin the launches in 2029, and those will be occurring between 2029 and 2033, as an example. They're occurring over a period of time. Our development timelines generally are four to five years just to help with that. Not all 13 in 2029, but after that.

Helen Torley

In terms of the mix of products that we have in that 13 products, some very exciting products in their mechanisms of action. Some of the products are already commercial, which represent a very high probability of success based on our track record. Other products are new or mechanisms of action, but the majority are antibodies, and we have just got tremendous experience with antibodies, which again, from many aspects, gives us confidence in the fact that ENHANZE is going to be very successful in making them into successful subcutaneous products. A broad range of products in there. Hard to give you specifics on them, but as a body, this ability to have up to 13 additional launches beginning in 2029 is clearly a very exciting additional growth driver that will layer on top of the already launched products.

Mitchell Kapoor

Thank you.

Operator

We have reached the end of the Q&A portion, which concludes today's call. Thank you so much for attending. You may now disconnect.

As of 2026-08-22 • Updated weeklySource: Earnings sourceIngestion runbook