Halozyme Therapeutics [HALO]
2026-07-29 · Catalyst Criteria: MEASURED — dated events that would confirm or refute the implied path. Blocks nothing.
Sourcing rule applied without exception: every entry is traceable to a filed document. Where a date is not disclosed, the entry says so. No date is inferred or invented.
Sources abbreviated as: - Q1-26 8-K = 8-K Ex-99.1 filed 2026-05-11 (Q1-2026 results) - FY25 8-K = 8-K Ex-99.1 filed 2026-02-17 (FY2025 results and 2026 guidance) - Gd 8-K = 8-K Ex-99.1 filed 2026-01-28 (2026 and multi-year guidance) - FY25 10-K = 10-K filed 2026-02-17 - Q1-26 10-Q = 10-Q filed 2026-05-11
| Date | Event | Why it matters | Source |
|---|---|---|---|
| 2026-05-11 (occurred) | Q1-2026 results: revenue $376.7m (+42%), royalties $240.7m (+43%). 2026 guidance reiterated. New $1 billion share-repurchase programme announced, authorised through 2028-12-31, with at least $400m projected in 2026. | Baseline for this memo. The buyback is ~4% of the share count and is the most reliable EPS driver in the 12-month window | Q1-26 8-K |
| 2026-05 (occurred) | argenx: FDA approval of the sBLA for VYVGART Hytrulo with ENHANZE in all serotypes of generalised myasthenia gravis (AChR+, MuSK+, LRP4+, triple seronegative) | Partner C is the fastest-growing royalty line (+444% FY2025). All-serotype expands the addressable pool | Q1-26 8-K |
| 2026-05 (occurred) | GSK global ENHANZE collaboration — multiple oncology targets, "first potential application with antibody drug conjugates." Upfront plus milestones and royalties | Wave-3 duration. First ADC application for ENHANZE | Q1-26 8-K |
| 2026-05 (occurred) | Oruka Therapeutics global exclusive Hypercon licence for ORKA-001 (psoriasis) plus one additional target; upfront, milestones, mid-single-digit royalties | Fifth Hypercon agreement | Q1-26 8-K |
| 2026-05 (occurred) | Takeda: positive topline Phase 2/3 for TAK-881 with ENHANZE in primary immunodeficiency — "creating the potential for the 11th ENHANZE product launch" | New royalty product | Q1-26 8-K |
| 2026-04 (occurred) | Vertex global exclusive Hypercon collaboration, up to three targets, $15m upfront plus milestones and royalties | Fourth Hypercon agreement. The upfront is a disclosed dollar figure, unusually | Q1-26 8-K |
| 2026-03 (occurred) | Janssen: EMA CHMP approval for self- or caregiver administration of DARZALEX SC from the fifth dose — the first oncology injectable approved for self-administration in Europe | Directly expands the SC value proposition on the 34.6%-of-revenue product | Q1-26 8-K |
| 2026-03 (occurred) | Janssen: FDA approved TECVAYLI in combination with DARZALEX FASPRO in relapsed/refractory multiple myeloma after ≥1 prior line | Indication expansion on the largest royalty line | Q1-26 8-K |
| 2026-03 (occurred) | Pfizer nominated a new undisclosed non-exclusive ENHANZE target | Pipeline addition | Q1-26 8-K |
| 2026-02 (occurred) | argenx: positive topline Phase 3 ADAPT oculus for VYVGART with ENHANZE in ocular myasthenia gravis. Management sizes it at +7,000 US patients | Second-largest royalty line, addressable-market expansion | Q1-26 8-K |
| 2026-01 (occurred) | Janssen: FDA approved DARZALEX FASPRO + VRd for newly diagnosed multiple myeloma patients ineligible for autologous stem-cell transplant — one of the two largest, longest-duration patient populations | Largest single royalty driver | FY25 10-K; Q1-26 8-K |
| 2026-01 (occurred) | argenx initiated a Phase 1 study of ARGX-124 with ENHANZE | Pipeline addition | Q1-26 8-K |
| 2025-12 (occurred) | German court granted HALO a preliminary injunction ordering Merck to refrain from distributing and offering Keytruda SC in Germany | The single largest undated optionality in the name | FY25 10-K |
| 2025-12 (occurred) | New global Takeda collaboration for ENHANZE with vedolizumab (ENTYVIO) in Crohn's disease and ulcerative colitis | New indication class for ENHANZE | FY25 10-K |
| 2025-12 (occurred) | Janssen: FDA approval of RYBREVANT FASPRO; Japan approval of RYBROFAZ; China approval of RYBREVANT FASPRO — all in EGFR-mutated NSCLC | Newest royalty product across three geographies in one month | FY25 10-K |
| 2025-11 (occurred) | Janssen: FDA approved DARZALEX FASPRO as monotherapy in high-risk smouldering multiple myeloma | Earliest-line indication yet | FY25 10-K |
| 2025-11-18 / 2025-12-22 (occurred) | Elektrofi acquisition ($810.4m purchase consideration incl. $23.0m contingent) and Surf Bio asset acquisition ($305m incl. $100m contingent; $284.9m expensed as acquired IPR&D) | The Hypercon platform, and the charge that distorts the FY2026 growth headline | Q1-26 10-Q; FY25 10-K |
| 2025-04 (occurred) | HALO filed a patent-infringement suit against Merck Sharp & Dohme in the US District Court for New Jersey, alleging SC Keytruda uses HALO's patented MDASE subcutaneous delivery technology. Damages and injunctive relief sought | Origin of the litigation line item ($16.7m of costs in FY2025) | FY25 10-K |
| Window | Event | Why it matters | Source |
|---|---|---|---|
| FY2026 | Total revenue $1,710–1,810m (+22–30%); royalty revenue $1,130–1,170m (+30–35%); adjusted EBITDA $1,125–1,205m; non-GAAP diluted EPS $7.75–8.25. Includes ~$60m of new Hypercon and Surf Bio investment. ENHANZE royalty revenue expected to exceed $1 billion. | The 12-month target rests on this. Read the adjusted-EBITDA and EPS growth rates against a base restated for the $284.9m IPR&D charge — see HALO_Research.md §4.2 |
FY25 8-K; Q1-26 8-K |
| 2026 | At least $400m of share repurchase under the $1bn authorisation | ~4% of the share count; the most reliable EPS driver in the window | Q1-26 8-K |
| year-end 2026 | 13 ENHANZE products in development (nine as of Q1-2026) | Wave-2 pipeline breadth | Q1-26 8-K |
| 2026 | Goal of three new SC-delivery-platform deals — already exceeded with Vertex, Oruka and GSK | Management now says there is "real potential to exceed our goal" | Q1-26 8-K |
| 2029+ | First approvals from the current ENHANZE development pipeline, "creating a new wave of royalty revenue" | Wave 2 monetisation | Q1-26 8-K |
| 2030/2031 | First approvals from the five signed Hypercon agreements (17 targets: Janssen, Lilly, argenx, Vertex, Oruka) | Wave 3. Sits at or beyond the 5-year exit year and is therefore largely excluded from the implied-path test | Q1-26 8-K |
| 2030s to at least the mid-2040s | Management's stated duration for the new royalty opportunity; corroborated by the 10-K's "foreign patents having expiration dates into the mid 2040's" | The company's answer to the durability question | Q1-26 8-K; FY25 10-K |
| Event | Expected timing | Basis | Status |
|---|---|---|---|
| Q2-2026 results | early August 2026 | Prior years: 2025-08-05, 2024-08-06, 2023-08-08 | EXPECTED — date not announced as of 2026-07-29. Not confirmed. |
| Q3-2026 results | early November 2026 | Prior years: 2025-11-03, 2024-10-31, 2023-11-06 | EXPECTED — not confirmed |
| FY2026 results and FY2027 guidance | February 2027 | Prior years: 2026-02-17, 2025-02-18, 2024-02-20 | EXPECTED — not confirmed. This is the most likely occasion for the 2027 rHuPH20 royalty step-down to be quantified, because the 2027 US expiry enters the guidance window |
| Preliminary/multi-year guidance update | January 2027 | Prior years: 2026-01-28, 2025-01-08, 2023-01-10 | EXPECTED — not confirmed. HALO has a habit of pre-announcing guidance in early January |
| Date | Item | Source |
|---|---|---|
| 2027 | US rHuPH20 patent expires. The 10-K states the royalty rate is reduced in a country upon expiry of the rHuPH20 patents where no collaboration-specific patent covers the product, and that "Janssen's patents covering DARZALEX SC do not impact the timing for this royalty reduction." DARZALEX is 34.6% of total revenue. The magnitude of the reduction is not disclosed. | FY25 10-K |
| 2027-03-01 | 0.25% convertible senior notes due 2027 mature — $209.6m principal, conversion price $77.17. Already reclassified to current liabilities at 2026-03-31 | FY25 10-K; Q1-26 10-Q |
| 2028 | 1.00% convertible senior notes due 2028 — $470.0m principal, conversion price $56.02 (deep in the money at $83.62) | FY25 10-K |
| 2028-12-31 | End date of the $1bn share-repurchase authorisation | Q1-26 8-K |
| 2029 | European rHuPH20 patent expires; additional rHuPH20 patents valid into 2029 | FY25 10-K |
| 2031 / 2032 | Convertible senior notes due 2031 and 2032 — $750.0m each, conversion price $87.20 (just out of the money) | FY25 10-K |
| 2032 – 2034 | MDASE patents expire (US 2032–2034; Europe and other foreign 2032). These are the patents at issue in the Merck litigation and the subject of the instituted USPTO post-grant reviews | FY25 10-K |
| 2026 / 2027 / 2028 | Scheduled intangible amortisation of $118.0m per year, then $83.3m (2029) and $60.6m (2030) | FY25 10-K |
| end of 2027 | The $265.8m of remaining performance obligations on unfulfilled product purchase orders disclosed at Q1-2026 are "estimated to be delivered by the end of 2027" | Q1-26 10-Q |
| Item | Status | Source |
|---|---|---|
| HALO v. Merck, US District Court for New Jersey, filed April 2025 | No trial date, no schedule, no hearing date is disclosed in HALO's filings, and none is asserted here. | FY25 10-K |
| USPTO post-grant reviews instituted at Merck's request, challenging the validity of certain HALO US patents | No decision date is disclosed and none is asserted. This is the single most consequential undated event in the name — an adverse outcome is the named cause of the permanent-loss case | FY25 10-K |
| German preliminary injunction appeal | No date disclosed | FY25 10-K |
| Partner termination rights — "generally upon 90 days prior written notice", terminable "for any reason", in whole or target-by-target | Live at all times; Partner A is 41% of revenue | FY25 10-K |
Omitted because no filed source supports a date:
The shape of this calendar is the finding. HALO has an unusually dense record of partner events — eleven in the last twelve months, every one of them a filed, dated approval or trial result — and no dated event whatsoever for the two things that determine its terminal value: the royalty step-down magnitude and the patent-validity proceedings. A book relying on catalysts here is relying on partner approvals to drive the next twelve months, which they plausibly will, while the five-year question stays undated.