Royalty Pharma reports first quarter 2026 results

On May 6, 2026 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the first quarter of 2026 and raised full year 2026 guidance for Portfolio Receipts.

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"Royalty Pharma has delivered a strong start to 2026 across multiple dimensions. We grew Royalty Receipts by 13% and announced up to $1.25 billion of royalty transactions in the first quarter," said Pablo Legorreta, Royalty Pharma’s Chief Executive Officer and Chairman of the Board. "Importantly, we continue to innovate our business and are very excited by the emergence of a significant opportunity in R&D co-funding with global biopharma companies. Our transactions this year included two such agreements – with Johnson & Johnson and Teva – underscoring the growing demand for this novel funding modality. We were also delighted by positive clinical and regulatory developments across our portfolio, notably the unprecedented overall survival benefit for daraxonrasib in pancreatic cancer. Lastly, we took major steps to strengthen our capabilities in the Asia-Pacific region, Partnering and AI with the addition of key leaders to our team. As a result, we are incredibly well positioned as a premier capital allocator in life sciences to deliver consistent, compounding growth."

Double-digit growth in Royalty Receipts and Portfolio Receipts
•Royalty Receipts grew 13% to $887 million in the first quarter of 2026 driven by Tremfya, Voranigo and Evrysdi.
•Portfolio Receipts increased by 10% to $925 million.
Strong transaction activity
•Acquired three royalties for $1.25 billion in announced value; Capital Deployment of $528 million in the first quarter.
•R&D co-funding collaborations in immunology announced with Johnson & Johnson on JNJ-4804 and Teva on TEV-’408.
Positive clinical and regulatory updates across royalty portfolio
•Positive Phase 3 results for Revolution Medicines’ daraxonrasib in pancreatic cancer and Cytokinetics’ Myqorzo in non-obstructive hypertrophic cardiomyopathy.
•Denali’s Avlayah (tividenofusp alfa) approved by FDA (Hunter syndrome); Nuvalent’s neladalkib (lung cancer) New Drug Application submitted to FDA.
Raising financial guidance for full year 2026 (excludes contribution from future transactions)
•Royalty Pharma now expects 2026 Portfolio Receipts to be between $3,325 million and $3,450 million (previously $3,275 million to $3,425 million), representing expected Royalty Receipts growth of 4% to 8%.

Financial & Liquidity Summary
Three Months Ended March 31,
($ and shares in millions; unaudited)
2026 2025 Change
Portfolio Receipts 925 839 10%
Net cash provided by operating activities 718 596 20%
Adjusted EBITDA (non-GAAP)* 889 738 21%
Portfolio Cash Flow (non-GAAP)* 722 611 18%
Weighted average Class A ordinary shares outstanding – diluted 557 578 (4)%

2026 Financial Outlook
Royalty Pharma has provided guidance for full year 2026, excluding new transactions and borrowings announced after the date of this release, as follows:
Provided May 6, 2026
Previous
Portfolio Receipts
$3,325 million to $3,450 million
$3,275 million to $3,425 million
Payments for operating and professional costs
5.5% to 6.5% of Portfolio Receipts
5.5% to 6.5% of Portfolio Receipts
Interest paid
$350 million to $360 million
$350 million to $360 million

Portfolio Receipts is defined as the sum of Royalty Receipts and Milestones and other contractual receipts. The above Portfolio Receipts guidance provided on May 6, 2026 includes expected Royalty Receipts growth of 4% to 8% in 2026.
Royalty Pharma’s full year 2026 guidance reflects an estimated foreign exchange impact of approximately +1% to Portfolio Receipts, assuming current foreign exchange rates prevail for the rest of 2026.
Payments for operating and professional costs in 2026 are expected to decrease as a percentage of Portfolio Receipts, compared to 8.9% in 2025, primarily due to extinguishment of the management fee following the completion of the internalization transaction on May 16, 2025.
Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and the quarterly interest payment schedule for the term loan assumed as part of the internalization transaction. In 2026, Royalty Pharma anticipates interest paid to be approximately $350 million to $360 million.(5) Interest paid in the third quarter of 2026 is anticipated to be approximately $175 million. De minimis amounts are anticipated in the second and fourth quarters of 2026. These projections assume no additional debt financing in 2026, including no drawdown on the revolving credit facility. In the first quarter of 2026, Royalty Pharma collected interest of $6 million on its cash and cash equivalents, which partially offset interest paid.
Royalty Pharma today provides this guidance based on its most up-to-date view of its prospects. This guidance assumes no major unforeseen adverse events or changes in foreign exchange rates and excludes the contributions from transactions announced subsequent to the date of this press release.

Portfolio Receipts Highlights
Three Months Ended March 31,
($ in millions; unaudited)
2026 2025 Change
Products: Marketers: Therapeutic Area:
Cystic fibrosis franchise Vertex Rare disease 253 250 1%
Trelegy GSK Respiratory 98 85 15%
Evrysdi Roche Rare disease 80 53 51%
Tremfya Johnson & Johnson Immunology 64 36 79%
Tysabri Biogen Neuroscience 59 61 (3)%
Xtandi Pfizer, Astellas Oncology 51 52 (3)%
Voranigo Servier Oncology 47 20 140%
Imbruvica AbbVie, Johnson & Johnson Oncology 38 46 (17)%
Cabometyx/Cometriq Exelixis, Ipsen, Takeda Oncology 23 21 9%
Promacta Novartis Hematology 17 44 (61)%
Imdelltra Amgen Oncology 17 — n/a
Trodelvy Gilead Oncology 13 13 7%
Spinraza Biogen Rare disease 12 13 (9)%
Amvuttra Alnylam Rare disease 8 — n/a
Other products(6)
108 96 12%
Royalty Receipts 887 788 13%
Milestones and other contractual receipts 38 51 (25)%
Portfolio Receipts 925 839 10%

Amounts shown in the table may not add due to rounding.
Royalty Receipts was $887 million in the first quarter of 2026, an increase of 13% compared to $788 million in the first quarter of 2025. The increase was primarily driven by Tremfya, Voranigo and Evrysdi, partially offset by a decline from Promacta due to U.S. generic competition. Royalty Receipts from Evrysdi included the benefit of the additional royalties acquired in December 2025.
Portfolio Receipts was $925 million in the first quarter of 2026, an increase of 10% compared to $839 million in the first quarter of 2025, primarily driven by the same Royalty Receipts increases noted above, partially offset by lower Milestones and other contractual receipts.

Liquidity and Capital Resources
Royalty Pharma’s liquidity and capital resources are summarized below:
As of March 31, 2026, Royalty Pharma had cash and cash equivalents of $586 million and total debt with principal value of $9.2 billion.
In the first quarter of 2026, Royalty Pharma paid a quarterly dividend of $0.235 per share, equating to $136 million in dividends and distributions.
In January 2025, Royalty Pharma announced a share repurchase program under which it may repurchase up to $3.0 billion of its Class A ordinary shares. Royalty Pharma repurchased approximately 1.1 million Class A ordinary shares for $50 million in the first quarter of 2026. The weighted-average number of diluted Class A ordinary shares outstanding for the first quarter of 2026 was 557 million, a decline of 4% as compared to 578 million for the first quarter of 2025.
Liquidity Summary
Three Months Ended March 31,
($ in millions; unaudited)
2026 2025
Portfolio Receipts 925 839
Payments for operating and professional costs (36) (102)
Adjusted EBITDA (non-GAAP) 889 738
Interest paid, net (167) (127)
Portfolio Cash Flow (non-GAAP) 722 611

Amounts may not add due to rounding.
•Adjusted EBITDA (non-GAAP) was $889 million in the first quarter of 2026. Adjusted EBITDA is calculated as Portfolio Receipts minus payments for operating and professional costs.
•Portfolio Cash Flow (non-GAAP) was $722 million in the first quarter of 2026. Portfolio Cash Flow is calculated as Adjusted EBITDA minus interest paid or received, net. This measure reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases, or utilized for other discretionary investments.
Refer to Table 4 for Royalty Pharma’s reconciliation of each non-GAAP measure to the most directly comparable GAAP financial measure, net cash provided by operating activities.
Capital Deployment reflects cash payments during the period for new and previously announced transactions. Capital Deployment was $528 million in the first quarter of 2026, consisting primarily of upfront payments for the Ziihera (see ‘Royalty Transactions’) and Avlayah (formerly known as tividenofusp alfa) transactions and a milestone payment related to Trelegy.
The table below details Capital Deployment by category:
Capital Deployment
Three Months Ended March 31,
($ in millions; unaudited)
2026 2025
Acquisitions of financial royalty assets (452) (1)
Development-stage funding payments (26) (51)
Milestone payments (50) (50)
Contributions from legacy non-controlling interests – R&D — 0
Capital Deployment (528) (101)

Royalty Transactions
During the first quarter of 2026, Royalty Pharma announced new transactions of up to $1.25 billion, which reflects the entire amount of potential capital committed for new transactions, including potential future milestones.
Recent transactions include:
•In March 2026, Royalty Pharma entered into an R&D co-funding arrangement with Johnson & Johnson to provide $500 million over two years for the development of JNJ‑4804, an investigational medicine for autoimmune diseases.
•In March 2026, Royalty Pharma acquired a royalty interest in Ziihera from Zymeworks Inc. for $250 million. Ziihera, which is marketed by Jazz Pharmaceuticals and BeOne Medicines, is approved for human epidermal growth factor receptor 2 (HER2)-positive metastatic biliary tract cancer and is in development for HER2-positive gastric cancer.
•In January 2026, Royalty Pharma announced a funding agreement with Teva Pharmaceuticals for TEV-’408 for up to $500 million. The agreement includes up to $75 million to co-fund a Phase 2b study for vitiligo targeted for 2026. Based on the results of this study, Royalty Pharma has the option to provide up to an additional $425 million to co-fund the Phase 3 development program.
The information in this section should be read together with Royalty Pharma’s reports and documents filed with the SEC at www.sec.gov and the reader is also encouraged to review all other press releases and information available in the Investors section of Royalty Pharma’s website at www.royaltypharma.com.

Key Developments Relating to the Portfolio
The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products.
Myqorzo
In May 2026, Cytokinetics announced positive topline results from ACACIA-HCM, the pivotal phase 3 clinical trial of Myqorzo in patients with non-obstructive hypertrophic cardiomyopathy. ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to week 36 compared to placebo.
In February 2026, Cytokinetics announced that the European Commission (EC) approved Myqorzo for the treatment of symptomatic obstructive hypertrophic cardiomyopathy in adult patients.
Ziihera
In April 2026, Jazz Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) accepted for filing, with Priority Review, a supplemental Biologics License Application for Ziihera in combination regimens for the first line treatment of adult patients with HER2-positive metastatic gastroesophageal adenocarcinoma. The FDA has set a Prescription Drug User Fee Act target action date of August 25, 2026.
daraxonrasib
In April 2026, Revolution Medicines announced positive Phase 3 results from the RASolute 302 trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic cancer. Based on these results, Revolution Medicines intends to submit the data to global regulatory authorities, including the FDA, as part of a future New Drug Application (NDA) under the Commissioner’s National Priority Voucher program.
neladalkib
In April 2026, Nuvalent announced the submission of an NDA to the FDA for neladalkib, an investigational anaplastic lymphoma kinase (ALK)‑selective inhibitor, for tyrosine kinase inhibitor pre‑treated advanced ALK‑positive non-small cell lung cancer.
Spinraza
In March 2026, Biogen announced that the FDA approved the high dose regimen of Spinraza for spinal muscular atrophy (SMA).
In January 2026, Biogen announced that the EC granted marketing authorization for a high dose regimen of Spinraza for SMA.
litifilimab
In March 2026, Biogen reported positive Phase 2 results from the AMETHYST Phase 2/3 study (Part A) of litifilimab in cutaneous lupus erythematosus (CLE), demonstrating reductions in skin disease activity through week 24.
In January 2026, Biogen announced that the FDA granted Breakthrough Therapy Designation for litifilimab for the treatment of CLE.
Avlayah
In March 2026, Denali Therapeutics announced that the FDA granted accelerated approval of Avlayah (tividenofusp alfa) for the treatment of Hunter syndrome. Avlayah is the first FDA-approved biologic specifically designed to cross the blood-brain barrier and reach the whole body, including the brain.
Tazverik
In March 2026, Ipsen announced that it was voluntarily withdrawing Tazverik from all Ipsen markets based on emerging data from the ongoing Phase Ib/III SYMPHONY-1 trial. In addition, Eisai announced plans to discontinue sales of Tazverik in Japan. In the first quarter of 2026, Royalty Pharma recorded $69 million of non-cash impairment charges related to Tazverik.
ampreloxetine
In March 2026, Theravance Biopharma reported that the Phase 3 CYPRESS study evaluating ampreloxetine in patients with symptomatic neurogenic orthostatic hypotension due to multiple system atrophy did not meet the primary endpoint. As a result, Theravance will wind down the ampreloxetine program.
TEV-’749
In February 2026, Teva Pharmaceuticals announced that the FDA accepted the NDA for olanzapine extended-release injectable suspension (TEV-‘749) for the treatment of schizophrenia in adults.
pelabresib
In January 2026, Novartis announced plans to submit a European Union regulatory filing for pelabresib in 2026, and that it would begin a new Phase 3 study in the United States, China and Japan.
obexelimab
In January 2026, Zenas BioPharma announced positive results from the Phase 3 INDIGO trial of obexelimab in Immunoglobulin G4-related disease (IgG4-RD), which met the primary endpoint demonstrating a clinically meaningful and highly statistically significant reduction in risk of IgG4-RD flare. Zenas anticipates submitting a Biologics License Application in Q2 2026 and a Marketing Authorization Application to the European Medicines Agency in the second half of 2026.

Financial Results Call
Royalty Pharma will host a conference call and simultaneous webcast to discuss its first quarter 2026 results today at 8:00 a.m., Eastern Time. Please visit the "Investors" page of the company’s website at View Source to obtain conference call information and to view the live webcast. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

(Press release, Royalty Pharma , MAY 6, 2026, View Source [SID1234665198])

Diakonos Oncology Awarded Fast Track Designation by FDA for DOC1021 (dubodencel) in Unresectable or Metastatic Cutaneous Melanoma

On May 6, 2026 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021, the Company’s first-in-class, patient-derived double-loaded dendritic cell investigational therapy, for the treatment of unresectable or metastatic cutaneous melanoma.

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Unresectable or metastatic cutaneous melanoma represents an advanced form of skin cancer in which the disease cannot be removed surgically or has spread to distant organs. While advances in targeted therapies and immune checkpoint inhibitors have improved outcomes for some patients, many individuals experience disease progression, limited durability of response, or treatment‑related toxicity, underscoring the continued need for novel therapeutic approaches that can generate durable anti‑tumor immune responses.

"Receiving Fast Track designation underscores the FDA’s recognition of the significant unmet need that remains for patients with advanced melanoma and the potential of DOC1021 to address this challenge," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "This designation supports our ongoing clinical development efforts and reflects the promise of DOC1021’s novel approach, which leverages a patient’s full complement of tumor antigens to drive meaningful anti-tumor immune responses."

Building on this regulatory milestone, Diakonos plans to advance DOC1021 through ongoing and upcoming clinical studies, including the Phase 1/2 trial in refractory melanoma, which is now recruiting. The Company remains focused on generating robust clinical data to further validate its platform and expand treatment options for patients with advanced cancers.

About DOC1021
DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double-loading approach, a physiologic mimic of viral infection, unlocks a synergistic and exponentially more powerful tumor killing response that permits complete targeting of the total cancer antigen pool. Moreover, the approach does not require any molecular modification or genetic engineering of the patient’s immune cells and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 is designed for outpatient administration and broad access via community cancer centers.

Diakonos currently has three actively enrolling clinical trials evaluating DOC1021, including a Phase 1 pancreatic cancer study (NCT04157127), a Phase 2 glioblastoma (GBM) study (NCT06805305) and a Phase 1/2 study in refractory melanoma (NCT07288112) supported by the Cancer Prevention and Research Institute of Texas (CPRIT). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021 for the treatment of pancreatic cancer, GBM, and unresectable or metastatic cutaneous melanoma, reflecting the significant unmet medical need across these indications. Diakonos also received Orphan Drug Designation for the GBM program in January 2024.

(Press release, Diakonos Oncology, MAY 6, 2026, View Source [SID1234665217])

Medicus Pharma Announces Results from Pre-Specified Expanded Phase 2 SKNJCT-003 Data Analysis Demonstrating Positive Dose-Response

On May 6, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported results from a pre-specified expanded dataset analysis demonstrating positive dose response from its Phase 2 SKNJCT-003 study evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to treat nodular basal cell carcinoma (BCC) of the skin, the most common type of skin cancer.

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These additional pre-specified analysis, build upon the previously reported positive topline results, provide expanded biological, histologic, and safety insights that further strengthen SkinJect’s therapeutic profile and future registrational discussions with the U.S. Food and Drug Administration (FDA). These additional findings are also consistent with prior Phase 1 clinical observations in the SKNJCT-001 study in March 2021, and interim analysis of SKNJCT-003 in March 2025, reinforcing reproducibility across studies.

SKNJCT-003 Study Design Overview (NCT06608238)::

The SKNJCT-003 (NCT06608238) clinical study was designed as a randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma. It was a multi-center study designed to enroll 90 participants presenting with nodular type basal cell carcinoma. The participants were randomized 1:1:1 into three groups:

Device-controlled group receiving P-MNA
Low-dose group receiving 100µg of D-MNA
High-dose group receiving 200µg of D-MNA

Expanded central pathology reconciliation demonstrated that 69 participants met intended nodular BCC inclusion criteria, while 21 participants were identified as superficial or mixed subtype lesions.

The Results from Pre-specified Expanded Analysis of 69 participants are summarized below:

Dose # of patients(n) Day 29 post-treatment # of patients(n) Day 57 post-treatment
35 Clinical Clearance Histological Clearance (CR) 34 Clinical Clearance Histological Clearance (CR)
Device-only 12 42 % 25 % 14 29 % 29 %
100ug D-MNA 12 42 % 25 % 9 44 % 33 %
200ug D-MNA 11 46 % 27 % 11 64 % 55 %

The expanded analysis demonstrates a progressive and dose-dependent improvement, with the strongest separation emerging at Day 57.

"We are encouraged by these additional findings in the expanded analysis, which we believe meaningfully strengthens the clinical and regulatory foundation of the SKNJCT-003 Program" stated Dr. Raza Bokhari, Chairman and CEO of Medicus. "We are confident that this dataset moves us from Proof-of-concept to a clear registrational path, and we believe Skinject has the potential to fundamentally change the current approach of treating patients with BCC, addressing a major un-met medical need".

From Positive Topline Dataset to Positive Dose-Response:

The Company previously reported topline results from the population of 90 randomized patients, which demonstrated a positive topline and decision-grade dataset. The 69-patient refined efficacy analysis further strengthens the regulatory alignment of the study as the Company advances toward End-of-Phase 2 (EOP2) discussions with the FDA.

The topline dataset showed that:

The 200µg cohort achieved the highest observed activity at Day 57
Clearance rates improved from Day 29 to Day 57, consistent with continued biological activity over time

The pre-specified expanded dataset analysis builds on this foundation by:

Revealing a clear and consistent dose-response relationship across endpoints
Demonstrating stronger separation between the 200µg cohort and control, particularly at Day 57
Strengthens differentiation between drug-driven efficacy and device-only biological activity

Importantly, this expanded central pathology verified dataset provides a more precise and clinically interpretable view of treatment effect, with the 200µg cohort at Day 57 emerging as the leading dose with the most robust and consistent efficacy signal.

These findings suggest that many treated lesions may in the future be able to avoid immediate surgical intervention, representing a potentially meaningful shift in the treatment paradigm for BCC. Given the short treatment and excision timeline evaluated, these results are particularly encouraging and may suggest clinically meaningful anti-tumor activity within a highly practical therapeutic window.

Collectively, this dataset may support future registration-intent or NDA-enabling development discussions, including optimized patient population, lesion subtype, dose regimen, and treatment-to-excision interval.

D-MNA continued to demonstrate a highly favorable safety and tolerability profile, was generally well tolerated with no drug-related serious adverse events, no evidence of systemic doxorubicin toxicity, and predominantly mild localized treatment-site reactions, supporting repeatable lesion-directed administration consistent with prior Phase 1 observations.

Reinforcing Drug-Driven Therapeutic Effect:

The device-only arm also demonstrated early biological activity consistent with microneedle-induced local immune response, but it did not show sustained or deepening efficacy over time. In contrast, the 200µg D-MNA cohort demonstrated progressive improvement from Day 29 to Day 57, resulting in clear separation across both clinical and histological endpoints. This pattern is consistent with drug-driven therapeutic effect, rather than a device-only response.

Independent Investigator Validation Supports Clinical and Regulatory Read-Through

These findings are further supported by independent investigator validation from a leading academic dermatologist and clinical investigator.

Dr. Babar K. Rao, MD, FAAD, Principal Investigator of the SKNJCT-003 study, is an internationally recognized academic dermatologist, dermatopathologist, and clinical investigator in skin oncology. He serves as Professor of Dermatology and Pathology at Rutgers Robert Wood Johnson Medical School and holds academic appointments at Weill Cornell Medical College.

Dr. Rao has evaluated the dataset and noted that he believes it demonstrates a clinically meaningful rapid onset efficacy, clear differentiation between drug and device effect and a profile that supports continued development and regulatory progress. Dr. Rao noted the consistency between visual, histologic, and central pathology findings is highly encouraging and provides growing confidence that SkinJect is producing meaningful biologic anti-tumor effects. Notably, clinically meaningful anti-tumor responses were observed within weeks, potentially differentiating D-MNA from many existing non-surgical therapies that often require substantially longer treatment durations. This analysis also improves the understanding of the patient populations and treatment parameters most likely to optimize future clinical outcomes.

The Company believes these findings further de-risk advancement of the 200µg regimen and informs the design of subsequent development studies, including assessment timing, lesion selection, and endpoint strategy.

(Press release, Skinject, MAY 6, 2026, View Source [SID1234665233])

BeOne Medicines Announces First Quarter 2026 Financial Results and Business Updates

On May 6, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the first quarter of 2026.

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John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:

"These strong first-quarter results reinforce BeOne’s continued growth as a global oncology leader, driven by disciplined commercial execution, and underpinned by our established hematology leadership, and an impressive, rapidly emerging solid tumor pipeline. The sustained competitive advantages of our global superhighway for clinical development and manufacturing are now clear. BRUKINSA has firmly established itself as the foundational, best-in-class BTK inhibitor with unmatched long-term efficacy and safety data for the treatment of CLL and as the only BTKi with proven efficacy superiority over ibrutinib which has resulted in clear global revenue leadership. The fixed-duration combination of sonrotoclax, a foundational, next-generation BCL2 inhibitor, and BRUKINSA represents a potential new standard-of-care in first-line CLL, with BTK CDAC BGB-16673 emerging as a potential first-in-class therapy in the relapsed or refractory setting. With more than 20 abstracts across our hematology and solid tumor pipeline accepted for presentation at ASCO (Free ASCO Whitepaper), BeOne has solidified its position as a leading oncology company."

(Amounts in thousands of U.S. dollars and unaudited)

Three Months Ended

March 31,

2026

2025

% Change

Net product revenues

$

1,487,329

$

1,108,530

34

%

Other revenue

$

26,109

$

8,749

198

%

Total revenue

$

1,513,438

$

1,117,279

35

%

GAAP income from operations

$

249,902

$

11,102

2,151

%

Adjusted income from operations*

$

414,394

$

139,357

197

%

GAAP net income

$

227,357

$

1,270

17,802

%

Adjusted net income*

$

375,042

$

136,137

175

%

GAAP basic EPS per ADS

$

2.05

$

0.01

20,400

%

Adjusted basic EPS per ADS*

$

3.38

$

1.27

166

%

GAAP diluted EPS per ADS

$

1.96

$

0.01

19,500

%

Adjusted diluted EPS per ADS*

$

3.24

$

1.22

166

%

Free Cash Flow*

$

160,547

$

(12,325

)

1,403

%

* For an explanation of our use of non-GAAP financial measures, refer to the "Note Regarding Use of Non-GAAP Financial Measures" section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.

First Quarter 2026 Financial Results

Product Revenue totaled $1.5 billion for the first quarter of 2026, representing growth of 34% compared to the prior-year period.

BRUKINSA: Global sales totaled $1.1 billion for the first quarter of 2026, representing growth of 38% compared to the prior-year period; U.S. sales of BRUKINSA totaled $761 million in the first quarter of 2026, representing growth of 35% compared to the prior-year period.
TEVIMBRA (tislelizumab): Global sales totaled $206 million in the first quarter of 2026, representing growth of 20% compared to the prior-year period.
Amgen in-licensed products: Global sales totaled $142 million in the first quarter of 2026, representing growth of 25% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the first quarter of 2026 was 89%, compared to 85% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA.

Operating Expenses

The following table summarizes operating expenses for the first quarter of 2026:

GAAP

Non-GAAP

(unaudited, in thousands, except percentages)

Q1 2026

Q1 2025

% Change

Q1 2026

Q1 2025

% Change

Research and development

$

541,224

$

481,887

12

%

$

465,904

$

421,195

11

%

Selling, general and administrative

$

555,097

$

459,288

21

%

$

471,993

$

395,511

19

%

Total operating expenses

$

1,096,321

$

941,175

16

%

$

937,897

$

816,706

15

%

Research and Development (R&D) Expenses increased for the first quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing preclinical programs into the clinic and early clinical programs into late stage.

Selling, General and Administrative (SG&A) Expenses increased for the first quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth. SG&A expenses as a percentage of product sales were 37% for the first quarter of 2026, compared to 41% in the prior-year period.

Net Income and Basic/Diluted Earnings Per Share

GAAP net income for the first quarter of 2026 was $227 million, an increase of $226 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage.

For the first quarter of 2026, basic and diluted earnings per share were $0.16 and $0.15 per share and $2.05 and $1.96 per American Depositary Share (ADS), compared to basic and diluted earnings per share of $0.00 per share and $0.01 per ADS in the prior-year period.

Free Cash Flow for the first quarter of 2026 was $161 million, representing an increase of $173 million over the prior-year period.

For further details on BeOne’s First Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the first quarter of 2026 filed with the U.S. Securities and Exchange Commission.

Updated Full Year 2026 Guidance

BeOne’s financial guidance is summarized below:

Prior FY 2026 Guidance

Current FY 2026 Guidance1

Total revenue

$6.2 – $6.4 billion

$6.3 – $6.5 billion

GAAP gross margin %

High-80% range

High-80% range

GAAP operating expenses2

(combined R&D and SG&A)

$4.7 – $4.9 billion

$4.7 – $4.9 billion

GAAP operating income2

$700 – $800 million

$750 – $850 million

Non-GAAP operating income2,3

$1.4 – $1.5 billion

$1.45 – $1.55 billion

1 Assumes May 1, 2026 foreign exchange rates.
2 Does not assume any potential new, material business development activity or unusual/non-recurring items.
3 Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth.

BeOne’s total revenue guidance for full year 2026 of $6.3 billion to $6.5 billion includes expectations for strong revenue growth driven by BRUKINSA’s leadership position in the U.S. and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and a full year of 2026 productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage.

The Company is providing the following additional guidance on items impacting net income and earnings per ADS:

Other income (expense): Estimated range of $25 million to $50 million in expense, includes interest amortization from Royalty Pharma arrangement.
Income tax outlook: Earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized; the timing and magnitude of a potential reversal is uncertain; prior to reversal, income tax expense should trend with earnings per historical relationship. See Form 10-Q for additional updates on income tax uncertainties.
Diluted ADS outstanding: The Company expects diluted ADSs outstanding of approximately 118 million.
First Quarter 2026 Business Highlights

Core Marketed Products

BRUKINSA (zanubrutinib)

Received Orphan Drug Designation in Japan for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL).
Submitted New Drug Application in Japan for R/R MZL and tablet formulation.
Sonrotoclax (BCL2 inhibitor)

Launched and commercially available in China for the treatment of adult patients with R/R mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Included in the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) guidelines as a recommended third-line treatment for R/R MCL patients.
TEVIMBRA (tislelizumab)

Received acceptance of a Supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) with Priority Review for the treatment of adult patients with first-line HER2-positive gastroesophageal adenocarcinoma (GEA) in combination with ZIIHERA (zanidatamab) and chemotherapy, based on results of the HERIZON-GEA-01 trial which demonstrated statistically significant and clinically meaningful improvement in overall survival versus trastuzumab plus chemotherapy.
Received acceptance of sBLA by the Center for Drug Evaluation (CDE) in China for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.
ZIIHERA (zanidatamab)

Received acceptance of sBLA by the CDE in China for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.
Select Clinical-Stage Programs

Hematology

BGB-16673 (BTK CDAC): Initiated Phase 2 cohorts in R/R MZL and Richter’s Transformation.
Breast and Gynecological Cancers

BGB-43395 (CDK4 inhibitor): Received acceptance of Phase 1 study data as a poster presentation at ASCO (Free ASCO Whitepaper).
BG-C9074 (B7-H4 ADC): Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO (Free ASCO Whitepaper).
Gastrointestinal Cancers

BGB-B2033 (GPC3x41BB bispecific antibody):
Received FDA Orphan Drug Designation for hepatocellular carcinoma (HCC).
Initiated potentially registrational study in patients with HCC.
Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO (Free ASCO Whitepaper).
Lung Cancer

BG-C0979 (ADAM9-targeting ADC): Initiated first-in-human study.
Inflammation and Immunology

BG-A3004 (KLRG1 mAb): Initiated first-in-human study.
Anticipated R&D Milestones

Programs

Milestones
Timing

BRUKINSA

Interim analysis in the Phase 3 MANGROVE study data in combination with rituximab versus bendamustine plus rituximab for the treatment of adult patients with first-line MCL.
1H 2026

Japan regulatory action for the treatment of adult patients with first-line gastric cancer.
1H 2026

U.S. FDA regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA.
2H 2026

TEVIMBRA

China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA.
1H 2027

Hematology

Sonrotoclax (BCL2 inhibitor):

FDA regulatory action on New Drug Application as monotherapy treatment of adult patients with R/R MCL.

1H 2026

Phase 3 study initiation for the treatment of adult patients with R/R multiple myeloma t(11;14).

2H 2026

BGB-16673 (BTK CDAC):

Phase 2 potential accelerated approval submission (if data support) for the treatment of adult patients with R/R CLL.

2H 2026

Breast/Gynecologic

BGB-43395 (CDK4 inhibitor):
Cancers

Phase 3 study initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer.

1H 2026

Lung Cancer

BON-110 (PD-1xVEGF-AxCTLA-4 trispecific antibody):

First-in-human study initiation.

1H 2026

Gastrointestinal

BGB-B2033 (GPC3x41BB bispecific antibody):

Cancers

Pivotal Phase 3 study initiation.

2H 2026

Inflammation and

BGB-16673 (BTK CDAC):
Immunology

Phase 2 study initiation for the treatment of adult patients with chronic spontaneous urticaria.

2H 2026

Corporate Updates

Entered into an exclusive option with Huahui Health to license worldwide rights to HH160 (BON-110), a novel trispecific antibody targeting PD-1, VEGF-A and CTLA-4.
BeOne’s Earnings Results Webcast

The Company’s earnings conference call for the first quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, May 6, 2026, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available.

(Press release, BeOne Medicines, MAY 6, 2026, View Source [SID1234665183])

AbbVie to Present at the Bank of America Securities Healthcare Conference

On May 6, 2026 AbbVie (NYSE: ABBV) reported it will participate in the Bank of America Securities Healthcare Conference on Wednesday, May 13, 2026. Management will participate in a fireside chat at 1:20 p.m. Central Time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

(Press release, AbbVie, MAY 6, 2026, View Source [SID1234665218])