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Halozyme (HALO) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 6, 2026

Source: earnings call transcript

Executive summary

Halozyme Q2 FY26 — Record Royalty Growth and New Deal Momentum

Halozyme delivered an exceptionally strong second quarter, driven by record ENHANZE royalty revenue growth and significant new collaboration agreements for both ENHANZE and Hypercon. The company is successfully diversifying its revenue streams with multiple new product launches and expanding its platform into new therapeutic modalities like ADCs and nucleic acids, reinforcing its long-term growth trajectory and raising full-year guidance.

Highlights

5
  • Total revenue increased 48% year-over-year to $481 million, driven by robust royalty and collaboration revenue.

  • Record total royalty revenue growth of 50% year-over-year to $308 million, supported by new launch products.

  • Signed 4 new collaboration and licensing agreements in Q2, plus a fifth in July, contributing $35.5 million in upfront revenue.

  • Adjusted EBITDA increased 46% to $328.8 million, with an adjusted EBITDA margin of more than 65%.

  • Raised full-year 2026 guidance for total revenue by $110 million at the midpoint, and royalty revenue by $55 million at the midpoint.

Concerns

2
  • Merck infringing use of MDAs technology

  • U.S. patent office proceedings (PGRs) and District Court case related to Merck's infringing product

Guidance & targets

CategoryTargetConfidence
Full-year 2026 Total Revenue
$1.835 billion to $1.91 billion
high materiality
High
Full-year 2026 Royalty Revenue
$1.22 billion to $1.245 billion
high materiality
High
Full-year 2026 Adjusted EBITDA
$1.225 billion to $1.28 billion
high materiality
High
Full-year 2026 Non-GAAP Diluted EPS
$8.65 to $9.00
high materiality
High
ENHANZE Development Programs
13
medium materiality
High
Hypercon Royalty Revenue
approximately $1 billion
high materiality
High
OCREVUS IV and subcutaneous sales
CHF 9 billion
medium materiality
High
OPDIVO Qvantig subcutaneous conversion rate
30% to 40%
low materiality
Medium
PHESGO global conversion rate
at least 60%
low materiality
High

Segment performance

SegmentRevenueYoYQoQMargin
DARZALEX SC
Continued robust revenue growth, with strong performance attributed to market growth and share gains across all lines of therapy, including frontline.
Global sales: >$4 billionGlobal sales growth: ~18% operational growthGlobal sales for SC: virtually allShare gain in frontline setting: nearly 11 percentage points
$152.2 million27%——
VYVGART Hytrulo
Strong adoption of the ENHANZE-enabled prefilled syringe (PFS) expanding the prescriber base and bringing new patients into therapy, supporting long-term product growth.
Total VYVGART brand sales: $1.5 billionTotal VYVGART brand sales growth: 60% YoYU.S. PFS patients new to VYVGART: ~80%
$72.6 million143%——
OCREVUS SC
Demonstrating how ENHANZE-enabled delivery expands accessible patient population and reaches new sites of care. Fastest-growing anti-CD20 multiple sclerosis brand in the U.S.
Patients receiving SC formulation: 44,000Patients at end of Q4 2025: 17,500U.S. OCREVUS ZUNOVO starts from community practices: ~60%
————
OPDIVO Qvantig
Strong launch trajectory with increasing subcutaneous conversion and significant global sales growth.
Subcutaneous conversion: 15%Global sales: $261 millionGlobal sales growth: >200% YoYProjected annualized revenue: >$1 billion
————
RYBREVANT SC
Rapid uptake contributing to strong brand growth, with a permanent J code awarded to broaden adoption.
Total RYBREVANT brand growth: 62% YoY
————
PHESGO
Continues to demonstrate value of ENHANZE-enabled subcutaneous delivery within Roche's HER2 franchise, with strong growth and conversion.
Growth (H1 2026): 18%Global conversion: 54% (in 85 launch countries)
————
Other Royalty Revenues (Newer Launches)
Driven by increasing partner product sales of recently launched ENHANZE products, showing significant early momentum.
Quarter-on-quarter growth (OPDIVO SC, OCREVUS SC, RYBREVANT SC): 80%
$54.4 million85%——

Product announcements

ProductTypeDetails
RYBREVANT FASPRO J codemilestone
VYVGARTexpansion
DARZALEX Faspro all subcutaneous regimenexpansion

Deals & partnerships

GSK New ENHANZE agreement

Included the opportunity to use ENHANZE in a new use area with antibody drug conjugates.

Incyte New ENHANZE agreement

Working with Incyte on a subcutaneous formulation of its first-in-class mutant calorectulin targeted monoclonal antibody.

undisclosed partner New ENHANZE agreement

To explore the use of ENHANZE within nucleic acid therapeutic, the first collaboration in this emerging area.

Vertex New Hypercon collaboration agreement

Established a strategic platform relationship with potential to expand over time.

Oruka New Hypercon collaboration agreement

Established a strategic platform relationship with potential to expand over time.

Risks & headwinds

Merck infringing use of MDAs technology Before the end of this year (Europe)

Actively pursuing injunctions in 8 countries outside the U.S.

Mitigation:Seeking injunctions to stop Merck's launch, manufacturing, distribution, and supply of infringing products; preliminary injunction already granted in Germany.

U.S. patent office proceedings (PGRs) and District Court case related to Merck's infringing product This fall (PTAB decision), later this year (clarity on District Court timing)

Appealing initial PTAB written decisions; awaiting PTAB's decision on remaining 10 PGRs.

Mitigation:Appealing PTAB decisions; strong conviction that Merck's product is infringing; confident in prevailing.

What to watch in Q3 FY26

Merck Litigation Decisions (Europe)

Before the end of this year
Current Preliminary injunction in Germany in December; actively pursuing injunctions in 8 countries.
Target Important decisions broadly impacting Merck launches/sales in Europe.

Why it matters

These decisions could significantly impact Merck's ability to commercialize infringing products outside the U.S., affecting Halozyme's royalty streams and competitive landscape.

And we do expect important decisions broadly impacting Merck launches of sales in [indiscernible] in Europe before the end of this year.

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Q&A highlights

What is driving the implied sequential step-up in royalty revenue from Q2's $308 million to $336-$348 million per quarter in the back half, as per the raised full-year guidance? Is it primarily newer launches or established products?

Management expects royalty revenue to grow sequentially through H2, driven largely by newer product launches like RYBREVANT subcu, which are starting to pick up. While Q1 to Q2 had significant step-ups, the ramp-up will continue.

“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 in some of the other new products.”

asked by Natasha on for Sean Laaman, Morgan Stanley · answered by Darren Snellgrove

3 min read 7 chapters

Detailed narrative

ENHANZE Platform Performance and Diversification

Halozyme's ENHANZE platform continues to demonstrate repeatability, scalability, and durability, driving record royalty revenue growth. The company has successfully diversified its royalty streams from a focus on DARZALEX SC to now include PHESGO, VYVGART Hytrulo, and newer launches like OPDIVO SC, OCREVUS SC, and RYBREVANT SC, which collectively grew 80% quarter-on-quarter.

This broadened portfolio resulted in a 50% year-over-year increase in total royalty revenue to $308 million, supporting long-term financial guidance.

Hypercon as a Second Compounding Engine

Hypercon is emerging as a second platform engine, designed for lower volume subcutaneous administration and highly concentrated formulations. The company is advancing preparations for the first Hypercon clinical starts in H1 2027, with projected first product launches in 2030-2031. Halozyme expects Hypercon to achieve approximately $1 billion in royalty revenue by the mid-2030s, with 5 to 7 launches contributing to this target, potentially from both existing and future agreements.

Record New Collaboration Agreements

Halozyme signed 4 new collaboration and licensing agreements in Q2 and a fifth in July, marking its most successful year for new deals. These include three new ENHANZE agreements (with GSK, Incyte, and an undisclosed partner) and two new Hypercon agreements (with Vertex and Oruka).

Notably, ENHANZE expanded into new modality areas: Antibody Drug Conjugates (ADCs) and nucleic acids, representing new growth segments with an estimated 100 commercial and development products that could benefit. These new CLAs contributed $35.5 million in upfront collaboration revenue.

Pipeline Expansion and Future Royalty Streams

The company is actively expanding its pipeline of future royalty streams, with 2 new ENHANZE targets initiating Phase I testing in Q2, bringing the total to 9 development programs. Halozyme aims to have 13 ENHANZE development programs by year-end 2026, with potential approvals beginning in the 2029+ timeframe.

This growing portfolio of future launches is expected to extend revenue opportunities well into the next decade, layering on top of currently approved products.

Capital Allocation and M&A Strategy

Halozyme maintains a disciplined capital allocation strategy focused on funding high-return organic opportunities, maintaining a strong balance sheet, and returning excess capital through share repurchases. The company bought back $332.8 million worth of shares in Q2, targeting $400 million for the full year.

While M&A is considered an important part of the strategy for adding differentiated technologies, the focus for 2026 remains on organic growth, with M&A being unlikely this year due to the strong internal portfolio and growing cash flows.

Merck Litigation Update

Halozyme is actively pursuing injunctions in 8 countries outside the U.S. against Merck for infringing use of its technology, with important decisions expected in Europe before year-end. In the U.S., the company is appealing initial PTAB decisions on PGRs and awaiting clarity on the remaining 10 PTAB decisions this fall, which will inform the timing of the U.S.

District Court case. Halozyme expresses unwavering confidence in prevailing, citing the infringing nature of Merck's product.

Competitive Landscape and Moat

Management views Alteogen as not directly competing, as companies signing deals with Alteogen often target areas where Halozyme has exclusive licenses. Halozyme emphasizes its competitive moat, built on a track record of success, a large safety database (1.3 million patients, 15 years), reliability of supply, and expertise in supporting rapid clinical advancement and innovative trial designs, which continues to attract new partners.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.