On April 29, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the first quarter of 2026 and provided a business update.

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"In the first quarter of this year, we were able to achieve strong double-digit growth on both the top and bottom line while continuing to invest significant resources in our portfolio of nearly 50 product candidates in clinical development," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Additionally, we recently entered into an agreement with the U.S. government that aims to make progress toward lowering drug prices for American patients by promoting more balanced pricing with other wealthy nations — an approach for which Regeneron has long advocated."

Financial Highlights

($ in millions, except per share data) Q1 2026
Q1 2025
% Change
Total revenues $ 3,605 $ 3,029 19 %
GAAP net income $ 727 $ 809 (10 %)
GAAP net income per share – diluted $ 6.75 $ 7.27 (7 %)
Non-GAAP net income(a) $ 1,040 $ 928 12 %
Non-GAAP net income per share – diluted(a) $ 9.47 $ 8.22 15 %

"Regeneron delivered strong first quarter 2026 financial results, achieving total revenue and non‑GAAP net income per share growth of 19% and 15%, respectively," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "In addition to driving commercial execution, we remain focused on our balanced approach to capital allocation—investing in our internal innovation engine, returning capital to shareholders through dividends and share repurchases, expanding our R&D and manufacturing footprint to support long-term growth, and preserving financial flexibility to pursue strategic business development opportunities."

Business Highlights

Key Pipeline Progress
Regeneron has nearly 50 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

Dupixent (dupilumab)

In April 2026, the U.S. Food and Drug Administration (FDA) and European Commission approved Dupixent for the treatment of CSU in children aged 2 to 11 years who remain symptomatic despite antihistamine treatment. This expands the previous approvals in the United States and European Union (EU) for CSU in adults and adolescents aged 12 years and older.
In March 2026, the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Dupixent for the treatment of adults with moderate-to-severe bullous pemphigoid (BP). Dupixent was previously approved for the treatment of BP in the United States and a regulatory application is under review in the EU.
In February 2026, the FDA approved Dupixent as the first and only medicine for the treatment of adults and children aged 6 years and older with AFRS.

EYLEA HD (aflibercept) 8 mg

In April 2026, the FDA approved the extension of dosing intervals for EYLEA HD up to every 20 weeks (5 months) for patients with wAMD and DME following one year of successful response based on visual and anatomic outcomes. This further extends the widest range of dosing intervals of any approved injectable anti-VEGF product.
The Company resubmitted its application seeking FDA approval for filling of the EYLEA HD pre-filled syringe (PFS) at Catalent Indiana, where the FDA has recently conducted a site re-inspection. In addition, the FDA did not act by the April 2026 PDUFA date on the Company’s regulatory application for a second contract manufacturer for the PFS; therefore, this application remains pending. The Company and both third-party filling manufacturers are working closely with the FDA to resolve all outstanding issues, and the Company anticipates a regulatory decision on one or both applications during the second quarter of 2026.

Otarmeni (lunsotogene parvec)

In April 2026, the FDA granted accelerated approval for Otarmeni (lunsotogene parvec, formerly known as DB-OTO), the first gene therapy approved under the FDA Commissioner’s National Priority Voucher program. Otarmeni is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric and adult patients with severe-to-profound hearing loss associated with variants in the OTOF gene. Otarmeni is the first and only in vivo gene therapy for genetic hearing loss and will be made available by Regeneron for free in the United States.

Fianlimab (LAG-3 antibody)

The Company remains on track to report results from the Phase 3 study of fianlimab in combination with cemiplimab versus pembrolizumab in first-line metastatic melanoma in the second quarter of 2026.
Following the first interim analysis, an Independent Data Monitoring Committee recommended that the Phase 3 study of fianlimab in combination with cemiplimab in adjuvant melanoma continue as planned. A second interim analysis as well as the study’s final analysis, if necessary, are anticipated in the second half of 2026. Regeneron remains blinded to these data.
The Company determined that Phase 2 data evaluating fianlimab in combination with cemiplimab in first-line advanced non-small cell lung cancer (NSCLC) did not support advancement to Phase 3 development.

Other Programs

The Company submitted a New Drug Application (NDA) for cemdisiran (C5 siRNA therapy) in myasthenia gravis, and utilized an FDA Rare Pediatric Disease Priority Review Voucher. NDA acceptance is anticipated in the second quarter of 2026 with an FDA decision expected in the fourth quarter of 2026.
In February 2026, the FDA accepted for priority review the Biologics License Application (BLA) for garetosmab (an Activin A antibody) for the treatment of adults with fibrodysplasia ossificans progressiva (FOP), which has a target action date in August 2026. A regulatory application is also under review in the EU.
A Phase 3 study for REGN7508, an antibody to Factor XI (catalytic domain), was initiated in cancer-associated venous thromboembolism. In addition, a three-arm, placebo-controlled Phase 3 study was initiated to evaluate REGN7508 and REGN9933, an antibody to Factor XI (A2 domain), individually, in stroke prevention in patients with atrial fibrillation who are not candidates for daily oral anticoagulation therapy. Initiation of additional Phase 3 studies for these Factor XI antibodies is planned for later this year.
A Phase 3 study was initiated for mibavademab, an agonist antibody to leptin receptor (LEPR), in monogenic obesity.

Corporate Updates

In April 2026, the Company announced agreements with the U.S. government pursuant to which the Company will provide certain of its products to the Medicaid program at or below prices benchmarked against a defined group of other developed countries (Most-Favored-Nation Pricing), price certain future medicines in the United States at or below Most-Favored-Nation Pricing, offer Praluent for direct patient purchase, and continue its large investment in domestic R&D and manufacturing capacity. Furthermore, Regeneron will not be subject to future U.S. government pricing mandates and will receive tariff relief for three years.
In March 2026, the Company entered into a strategic collaboration with TriNetX to receive access to TriNetX’s current and future de-identified health data from approximately 300 million individuals, sourced directly from its global network of health system partners. This collaboration will enable expansion of the Company’s genomic and proteomic Electronic Health Record (EHR)-linked database.
In April 2026, the Company entered into a collaboration with Telix Pharmaceuticals Limited to jointly develop and commercialize next generation radiopharmaceutical therapies.
In February 2026, the Company announced the renewal of Regeneron’s title sponsorship of the Regeneron Science Talent Search (STS), the United States’ oldest and most prestigious science and mathematics competition for high school seniors. The Company is also increasing its commitment for the next 10 years, pledging an additional $150 million, and bringing its 20-year investment in STS to $250 million.
In February 2026, the Company reached resolution of its patent infringement litigation related to the Samsung EYLEA (aflibercept) Injection 2 mg biosimilar product. This settlement precludes Samsung from launching its biosimilar product in the United States until January 2027. All intellectual property-related litigation with Samsung in the United States has been dismissed.

First Quarter 2026 Financial Results

Revenues

($ in millions) Q1 2026
Q1 2025
% Change
Net product sales:
EYLEA HD – U.S. $ 468 $ 307 52 %
EYLEA – U.S. 473 736 (36 %)
Total EYLEA HD and EYLEA – U.S. 941 1,043 (10 %)
Libtayo – U.S. 286 192 49 %
Libtayo – ROW* 152 93 63 %
Total Libtayo – Global 438 285 54 %
Praluent – U.S. 67 57 18 %
Evkeeza – U.S. 46 31 48 %
Lynozyfic – Global 11 — **
Other products – Global 32 — **
Total net product sales 1,535 1,416 8 %

Collaboration revenue:
Sanofi 1,605 1,183 36 %
Bayer 287 344 (17 %)
Other 7 4 75 %
Other revenue 171 82 109 %
Total revenues $ 3,605 $ 3,029 19 %

* Rest of world (ROW)
** Percentage not meaningful

Net product sales of EYLEA HD increased in the first quarter of 2026, compared to the first quarter of 2025, due to higher sales volumes driven by increased demand, partly offset by a lower net selling price. In addition, EYLEA HD net product sales were negatively impacted by lower wholesaler inventory levels at the end of the first quarter of 2026 compared to the end of the fourth quarter of 2025. EYLEA HD net product sales decreased 7% on a sequential basis; however, physician unit demand increased sequentially by 10%.

Net product sales of EYLEA in the first quarter of 2026, compared to the first quarter of 2025, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

Sanofi collaboration revenue increased in the first quarter of 2026, compared to the first quarter of 2025, due to an increase in the Company’s share of profits from the commercialization of antibodies, which were $1.451 billion and $1.018 billion in the first quarter of 2026 and 2025, respectively. The change in the Company’s share of profits from commercialization of antibodies was driven by higher profits primarily associated with an increase in Dupixent sales.

Refer to Table 4 for a summary of collaboration revenue.

Operating Expenses

GAAP % Change
Non-GAAP(a) % Change
($ in millions) Q1 2026 Q1 2025 Q1 2026 Q1 2025
Research and development (R&D) $ 1,544 $ 1,327 16 % $ 1,408 $ 1,186 19 %
Acquired in-process research and development (IPR&D) $ 102 $ 12 ** * * n/a
Selling, general, and administrative (SG&A) $ 648 $ 633 2 % $ 560 $ 537 4 %
Cost of goods sold (COGS) $ 373 $ 266 40 % $ 209 $ 217 (4 %)
Gross margin on net product sales(b) 76% 81% 86% 85%
Cost of collaboration and contract manufacturing (COCM)(c) $ 296 $ 199 49 % $ 281 $ 199 41 %

* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded
** Percentage not meaningful

GAAP and non-GAAP R&D expenses increased in the first quarter of 2026, compared to the first quarter of 2025, driven by the advancement of the Company’s late-stage clinical pipeline, including programs in hematology-oncology, complement-mediated diseases, and anticoagulation.
Acquired IPR&D expenses for the first quarter of 2026 primarily related to the premium on equity securities purchased, as well as development milestone and up-front payments, in connection with collaboration and licensing agreements.
GAAP and non-GAAP SG&A expenses increased in the first quarter of 2026, compared to the first quarter of 2025, primarily due to an increase in commercialization-related expenses for EYLEA HD and Libtayo and higher headcount and headcount-related costs, partly offset by lower charitable contributions to an independent non-profit patient assistance organization.
GAAP gross margin on net product sales decreased in the first quarter of 2026, compared to the first quarter of 2025, primarily due to unabsorbed manufacturing costs and higher inventory write-offs and reserves as a result of a temporary interruption of bulk manufacturing production at the Company’s facility in Limerick, Ireland, due to unanticipated facility repairs that commenced during the first quarter of 2026. The Company resumed initial production at the facility in the second quarter of 2026; however, GAAP gross margin will continue to be negatively impacted until production returns to normal levels, which is expected by the end of the second quarter of 2026. The interruption has not impacted, nor is it expected to impact, the availability of any of the Company’s products.

Other Financial Information

GAAP other income (expense), net decreased in the first quarter of 2026, compared to the first quarter of 2025, primarily due to lower net gains on marketable and other securities.

In the first quarter of 2026, the Company’s GAAP effective tax rate (ETR) was 12.5%, compared to 10.6% in the first quarter of 2025. The GAAP ETR increased in the first quarter of 2026, compared to the first quarter of 2025, primarily due to lower tax benefits from cross-border tax laws and federal tax credits for research activities. In the first quarter of 2026, the non-GAAP ETR was 13.9%, compared to 11.6% in the first quarter of 2025.

A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

Capital Allocation

During the first quarter of 2026, the Company repurchased $803 million of its common stock. As of March 31, 2026, $688 million remained available for share repurchases under the Company’s share repurchase programs. In April 2026, the Company’s board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of the Company’s common stock. Repurchases may be made from time to time at management’s discretion through a variety of methods. The program has no time limit and can be discontinued at any time.

In April 2026, the Company’s board of directors declared a cash dividend of $0.94 per share on the Company’s common stock and Class A stock, payable on June 4, 2026 to shareholders of record as of May 20, 2026.

2026 Financial Guidance*

The Company’s full year 2026 financial guidance consists of the following components:

2026 Guidance
Prior Updated
GAAP R&D $6.450–$6.680 billion Unchanged
Non-GAAP R&D(a) $5.900–$6.100 billion Unchanged
GAAP SG&A $2.860–$3.040 billion Unchanged
Non-GAAP SG&A(a) $2.500–$2.650 billion Unchanged
GAAP gross margin on net product sales 79%–80% 77%–78%
Non-GAAP gross margin on net product sales(a) 83%–84% Unchanged
GAAP COCM $940 million–$1.020 billion $955 million–$1.035 billion
Non-GAAP COCM(a) $940 million–$1.020 billion Unchanged
Capital expenditures $1.100–$1.300 billion $1.100–$1.200 billion
GAAP effective tax rate 12%–14% Unchanged
Non-GAAP effective tax rate(a) 13%–15% Unchanged

(Press release, Regeneron, APR 29, 2026, View Source [SID1234664897])

On April 29, 2026 PharmaMar Group (MSE:PHM) reported the first quarter of 2026, with total revenue growing by 10% to €42.9 million over the same period in 2025. Recurring revenue, calculated by adding net sales to royalties received from our partners, increased by 7%, reaching €40.5 million. Meanwhile, non-recurring revenue grew by 137% to €2.4 million during the first quarter of 2026.

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As of March 31st, 2026, net sales increased by 2.5% to €23.7 million. This growth was driven by revenue from Zepzelca (lurbinectedin) in Europe, where revenue from compassionate use rose by 44.4%—primarily in France—to €11.5 million. Sales of raw materials to our partners, including both lurbinectedin and Yondelis (trabectedin), grew by 30.2% to €7.4 million.

At the end of the first quarter of 2026, oncology royalty revenue increased by 14.0% to €16.8 million compared to the same period last year. This amount corresponds primarily to royalties received from sales of lurbinectedin by our partner Jazz Pharmaceuticals totaling €13.3 million[1]. Royalty estimates for the first quarter of 2025 (€12.7 million) were €3 million higher than the royalties ultimately received. These €3 million were adjusted in this following quarter. If, for comparative purposes, we were to eliminate that excess, sales for the first quarter of 2026 would be 40% higher than those for the same period of the previous fiscal year. Meanwhile, royalties received from trabectedin sales in the U.S. increased by 72.7%, reaching €3.5 million during the first quarter of the year. These sales continue the upward trend that began following the inclusion of trabectedin in U.S. National Comprehensive Cancer Network (NCCN) treatment guidelines for first-line use in combination with doxorubicin, following the positive results of a Phase III trial presented at ESMO (Free ESMO Whitepaper) 2023.

Non-recurring revenue from licensing agreements increased by 137% as of March 31st, 2026, reaching €2.4 million.

At the end of the first quarter of 2026, the PharmaMar Group’s R&D investment totaled €20.9 million, compared with €21.3 million as of March 31st, 2025.

Of the total R&D investment, the oncology segment reached €20.2 million, compared to €19.8 million in March 2025. This 2.0% increase is primarily driven by investment in the Phase III SaLuDo trial of lurbinectedin in combination with doxorubicin for the first-line treatment of leiomyosarcoma. Patient enrollment for this trial is expected to be completed during the second quarter of 2026. Additionally, the Company continues to invest in the development of the other two compounds in earlier stages of development, PM54 and PM534, for the treatment of solid tumors.

As of March 31st, 2026, the PharmaMar Group’s EBITDA reached €2.7 million, compared with -€1.1 million in the same period of 2025.

As a result of all this, the PharmaMar Group increased its net profit to €1.5 million, compared with a loss of €3.9 million at the end of the first quarter of the previous year.

As of March 31st, 2026, the PharmaMar Group’s cash and cash equivalents increased by €0.7 million to €168.5 million. Meanwhile, total financial debt decreased by €1.9 million to €44.7 million. Consequently, the net cash position at the end of first quarter 2026 stood at €123.8 million.

[1] The reported royalties for Zepzelca (U.S.) for this first quarter are an estimate, as sales data from Jazz Pharmaceuticals is not available as of the date of this report. Any discrepancies will be corrected in the following quarter.

(Press release, PharmaMar, APR 29, 2026, View Source [SID1234664896])

On April 29, 2026 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) (the "Company") reported financial results and provided key updates for the first quarter ended March 31, 2026.

"Ionis’ strong performance in the first quarter of 2026 underscores the strength of our commercial and R&D engines. Our independent launches are increasingly contributing to revenue, driven by strong commercial execution, and we are on track for two additional groundbreaking independent launches in 2026 — olezarsen for severe hypertriglyceridemia, our first medicine for a broad patient population, and zilganersen for Alexander disease, the first launch from our leading neurology pipeline," said Brett P. Monia, Ph.D., chief executive officer of Ionis. "In addition, we look forward to multiple key value-driving events this year, including results from pivotal Phase 3 partnered programs. These include presentation of positive bepirovirsen data in chronic hepatitis B next month at EASL, as well as results from the landmark pelacarsen Lp(a) HORIZON and eplontersen CARDIO-TTRansform cardiovascular outcomes trials later this year."

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First Quarter 2026 Summary Financial Results(1):

Three months
ended
March 31,

2026

2025

(amounts in
millions)

Total revenue

$
246

$
132

Operating expenses

$
364

$
278

Operating expenses on a non-GAAP basis

$
321

$
249

Loss from operations

$
(118
)

$
(146
)
Loss from operations on a non-GAAP basis

$
(75
)

$
(117
)

(1)
Reconciliation of GAAP to non-GAAP basis contained later in this release.

First Quarter 2026 Financial Highlights

•
Revenue increased 87% in the first quarter of 2026 compared to the same period last year, driven by continued commercial success. In addition, Ionis earned substantial R&D revenue, including $95 million in payments from both clinical and regulatory milestones from multiple partnerships

•
Operating expenses for the quarter ended March 31, 2026 were in line with expectations and increased year over year primarily from investments related to the commercialization efforts for TRYNGOLZA and DAWNZERA as well as launch preparations for olezarsen in sHTG and zilganersen in Alexander disease

•
Cash and short-term investments were $1.9 billion as of March 31, 2026. The change in cash and short-term investments from year end 2025 was primarily related to the $633 million the Company used for the maturity of the 0% convertible notes due on April 1, 2026

•
Increasing annual olezarsen peak net sales guidance to >$3 billion from >$2 billion to reflect increasing confidence in the sHTG market opportunity for olezarsen

First Quarter 2026 Financial Results

"Ionis entered 2026 with strong momentum. We continued this momentum with the first quarter financial results reflecting increased commercial revenue from our independent launches and robust R&D revenue when compared to the same period last year," said Elizabeth L. Hougen, chief financial officer of Ionis. "Based on our strong year-to-date revenue performance, accelerating momentum and positive outlook for the rest of the year, we are improving our 2026 financial guidance. The strong performance we expect in 2026 will support substantial growth and long-term value creation and our goal of reaching cash-flow breakeven in 2028."

Recent Highlights – Wholly Owned Medicines

•
TRYNGOLZA (olezarsen), the first FDA-approved treatment for adults living with familial chylomicronemia syndrome (FCS) as an adjunct to diet

o
Generated U.S. net product sales of $27 million in the first quarter of 2026, reflecting continued strong demand, offset by a decrease in net price

2

o
Launch initiated in the European Union (EU) by Sobi

•
Olezarsen on track to launch this year as a transformational medicine for severe hypertriglyceridemia (sHTG), assuming approval

o
sNDA accepted by the FDA for Priority Review for the treatment of sHTG with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026

o
The European Medicines Agency (EMA) accepted an indication extension application in March for the treatment of adult patients with sHTG

•
DAWNZERA (donidalorsen), the first and only RNA-targeted prophylactic therapy for hereditary angioedema (HAE) in patients 12 years of age and older

o
Generated U.S. net product sales of $16 million in the first quarter of 2026, an increase of 125% versus the fourth quarter of 2025

o
Launch initiated in the EU by Otsuka

o
Positive one-year results from OASISplus open-label extension cohort published in the Journal of Asthma and Allergy

•
Zilganersen on track to launch this year as the first and only medicine to demonstrate clinically meaningful and disease-modifying benefit in children and adults with Alexander disease (AxD), assuming approval

o
New Drug Application (NDA) for AxD accepted by FDA for Priority Review with PDUFA target action date of September 22, 2026

o
Expanded access program (EAP) in U.S. underway

o
Positive additional results from the pivotal study presented at the American Academy of Neurology 2026 annual meeting

Recent Highlights – Partnered Medicines

•
SPINRAZA (nusinersen) for the treatment of spinal muscular atrophy (SMA) generated global sales of $374 million in the first quarter of 2026, resulting in royalty revenue of $44 million

o
SPINRAZA high dose regimen approved and launched in the U.S. and EU

•
WAINUA (eplontersen) (WAINZUA in EU) for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTRv-PN) generated global sales of $51 million in the first quarter of 2026, resulting in royalty revenue of $11 million

o
Launches underway in numerous regions, including the EU and China; submissions in progress to expand WAINUA access globally

o
Phase 3 CARDIO-TTRansform study design and baseline characteristics to be presented at the Annual Congress of the Heart Failure Association of the ESC 2026

•
Bepirovirsen, a potential first-in-class medicine for chronic hepatitis B (CHB), achieved the primary endpoint demonstrating a statistically significant and clinically meaningful functional cure rate in the B-Well 1 and B-Well 2 Phase 3 studies

o
GSK to present the positive Phase 3 data at the European Association for the Study of the Liver (EASL) Congress 2026

o
On track for a 2026 launch with global regulatory filings underway, assuming approval

■
NDA filing accepted by FDA for Priority Review with PDUFA date of October 26, 2026; granted Breakthrough Therapy designation

■
Accepted for regulatory review in EU, Japan, and China

(Press release, Ionis Pharmaceuticals, APR 29, 2026, View Source [SID1234664895])

On April 29, 2026 GSK reported strong Q1 performance and start to 2026.

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Strong Specialty Medicines performance drives sales and core operating profit growth
Total Q1 sales £7.6 billion +2% AER; +5% CER
Specialty Medicines sales £3.2 billion (+14%); Respiratory, Immunology & Inflammation £0.9 billion (+16%); Oncology £0.5 billion (+28%); HIV sales £1.8 billion (+10%)
Vaccines sales £2.1 billion (+4%); Shingrix £1.0 billion (+20%); Meningitis vaccines £0.3 billion (-3%); and Arexvy £0.1 billion (-18%)
General Medicines sales £2.3 billion (-6%); Trelegy £0.6 billion (stable)
Total operating profit +9% and Total EPS +15% driven by Core operating profit growth and higher other income from disposals, partly offset by higher CCL charges
Core operating profit +10% and Core EPS +9% reflecting higher sales, favourable product and regional mix, SG&A benefits and higher royalty income, partly offset by increased investment in R&D and new asset launches

Cash generated from operations of £1.4 billion with free cash flow of £0.8 billion
Q1 2026
£m % AER % CER
Turnover 7,629 2 5
Total operating profit 2,293 3 9
Total operating margin % 30.1% 0.6ppts 1.3ppts
Total EPS 43.2p 9 15
Core operating profit 2,650 5 10
Core operating margin % 34.7% 1.0ppts 1.8ppts
Core EPS 46.5p 4 9
Cash generated from operations 1,350 4

Pipeline progress and R&D acceleration:

New product approvals for: Exdensur (EU & China for severe asthma with an eosinophilic phenotype and nasal polyps); Nucala COPD (EU); Blenrep (China for multiple myeloma)
Bepirovirsen, potential functional cure for chronic hepatitis B, regulatory filings accepted in US, EU, China and Japan. Data to be presented at EASL in Q2
Efimosfermin (FGF21) granted US Breakthrough and EU PRIME designations for liver disease MASH
Phase I data for Mo-Rez ADC in difficult-to-treat endometrial and ovarian cancer supports initiation of 5 phase III trials in 2026
Further pivotal readouts expected in 2026: camlipixant (chronic cough); Jemperli (rectal cancer); 3x yearly (Q4M) HIV PrEP; and Exdensur for EGPA
Pipeline acquisitions completed for new high-potential best-in-class assets: ozureprubart for food allergies; and HS235, pulmonary hypertension

Continued commitment to shareholder returns

Q1 2026 dividend of 17p declared; 70p expected for full year 2026
£1.7 billion executed to date as part of the £2 billion share buyback programme announced at FY 2024
2026 guidance and 2031 sales outlook reaffirmed
Expect 2026 turnover growth of between 3% to 5%; Core operating profit growth of between 7% to 9%; Core EPS
growth of between 7% to 9%
2031 sales outlook of more than £40 billion

Luke Miels, Chief Executive Officer, GSK:
"GSK has made a strong start to 2026, with good performance from our key growth drivers. Alongside operational delivery, we are focused on execution and accelerating R&D. This is visible in filings we have achieved for bepirovirsen, our potential functional cure for hepatitis B; updated phase III plans for our oncology ADCs; and completed acquisitions for new pipeline assets: ozureprubart for food allergies, and HS235 for pulmonary hypertension."

(Press release, GlaxoSmithKline, APR 29, 2026, View Source [SID1234664894])

On April 29, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported financial results for the first quarter ended March 31, 2026 and recent business highlights.

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"Crescent’s execution on the advancement of our pipeline this quarter positions us for meaningful clinical data readouts in 2027 from CR-001, our potentially best-in-class PD-1 x VEGF bispecific antibody, as well as our differentiated ADC programs. The innovative design of our Phase 1/2 ASCEND study of CR-001 enables us to quickly generate comprehensive data for this next generation immuno-oncology backbone both as monotherapy and in combination with standard of care chemotherapy in multiple tumor types, and we’re also working with our partner, Kelun-Biotech, to deliver ADC combination data," said Joshua Brumm, chief executive officer of Crescent. "We are pleased that both our global ASCEND trial and the Phase 1/2 trial of CR-003 in China are progressing well. We are on track to initiate two more trials during the second half of 2026, with the first ADC combination study for CR-001 and planned clinic entry for CR-002. This continued momentum underscores our commitment to delivering transformative therapies for people living with cancer."

Recent Business Highlights & Anticipated Milestones

CR-001, PD-1 x VEGF bispecific antibody
•CR-001 is an investigational tetravalent bispecific antibody that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. Enrollment is ongoing in ASCEND, a global, open-label Phase 1/2 clinical trial evaluating CR-001 in multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological cancers, in both treatment-naïve and previously treated patients.
•A trial in progress abstract of the ASCEND study design has been accepted for poster presentation during the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 29-June 2, 2026 in Chicago: "ASCEND: A phase 1/2, dose-escalation, optimization, and dose-expansion study to evaluate the safety and antitumor activity of CR-001 in adults with locally advanced or metastatic solid tumors."

•Under its strategic collaboration, Crescent granted Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., ("Kelun-Biotech") exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118) in Greater China. Kelun-Biotech plans to initiate a Phase 1/2 trial of CR-001 (SKB118) in China in the first half of 2026.

•Crescent also plans to evaluate CR-001 in combination with multiple ADCs, including CR-002 and CR-003. Initiation of the first Phase 1/2 combination trial of CR-001 with a Kelun-Biotech ADC is expected in the second half of 2026 in China.
•Crescent anticipates reporting:
•Proof-of-concept clinical data from the ASCEND trial of CR-001 in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose escalation and backfill cohorts in first-line and previously treated patients in multiple solid tumor types. A backfill cohort of first-line NSCLC patients is planned as part of this readout.
•Initial data of CR-001 in combination with standard of care chemotherapy in first-line and previously treated patients by mid-2027 (Q2/Q3) utilizing the dose expansion part of the ASCEND trial.
•Initial data from the Phase 1/2 trial in China of CR-001 in combination with a Kelun-Biotech ADC in mid-2027 (Q2/Q3).
CR-002, topoisomerase inhibitor ADC targeting PD-L1
•CR-002 is a topoisomerase inhibitor ADC directed to PD-L1, a validated target known to have high expression in multiple solid tumors. CR-002 incorporates a PD-L1 antibody selected for high internalization to facilitate payload release in target cells and a linker designed for intracellular cleavage and high stability in circulation.
•Crescent is on track to submit an Investigational New Drug (IND) application to the FDA for CR-002 in mid-2026 to support the initiation of a Phase 1/2 trial in solid tumors in the second half of 2026, with proof-of-concept data expected in the second half of 2027.
CR-003, topoisomerase inhibitor ADC targeting integrin beta-6 (ITGB6)
•CR-003 is an investigational topoisomerase inhibitor ADC directed to ITGB6, which is overexpressed in many solid tumors with minimal expression in most normal tissues. CR-003 consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker.
•A Phase 1/2 trial of CR-003 (also known as SKB105) in participants with advanced solid tumors led by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027. A Phase 1/2 combination trial of CR-003 and CR-001 is expected to initiate in the first half of 2027, with initial data anticipated by year-end 2027. Under its strategic collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105) in the United States, Europe and all markets outside of Greater China.

First Quarter 2026 Financial Results

Cash position: Cash and cash equivalents were $189.2 million as of March 31, 2026, which is anticipated to fund operations into 2028.

Revenue: Revenue for the three months ended March 31, 2026 was $1.0 million compared to no revenue in 2025. The revenue recognized in 2026 is the result of the $20.0 million upfront payment received from Kelun-Biotech pursuant to the license agreement for CR-001.

Research and development (R&D) expenses: R&D expenses were $17.9 million and $10.6 million for the three months ended March 31, 2026 and 2025, respectively. The increase in R&D expenses is the result of continued development of CR-001 and CR-002.

General and administrative (G&A) expenses: G&A expenses were $7.9 million and $3.6 million for the three months ended March 31, 2026 and 2025, respectively. The increase in G&A expenses is the result of personnel costs, including share-based compensation, and professional services associated with operating as a public company.
Net loss: Net loss was $23.3 million and $15.1 million, or $0.70 and $19.63 per basic and diluted share, for the three months ended March 31, 2026 and 2025, respectively.

Shares outstanding: As of March 31, 2026, Crescent had approximately 33.4 million shares of the Company’s ordinary shares and ordinary share equivalents issued and outstanding, including ordinary shares underlying pre-funded warrants and non-voting convertible preferred stock.

(Press release, Crescent Biopharma, APR 29, 2026, View Source [SID1234664893])