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])

On April 29, 2026 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported financial results and updates for the first quarter ended March 31, 2026.

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"Our first-quarter performance reflects strong execution and significant progress against our 2026 strategic objectives," said Brian Goff, Chief Executive Officer, Agios. "The solid early momentum of our U.S. commercial launch of AQVESME in thalassemia highlights both the medicine’s clinical value and strong community reception. Additionally, following collaborative engagement with the FDA, we now plan to submit our mitapivat sNDA for sickle cell disease under the U.S. accelerated approval pathway in the second quarter. 2026 marks an important growth inflection point for Agios as we continue to build a sustainable rare disease company that is rooted in hematology and focused on delivering differentiated medicines that create meaningful long-term value for patients and shareholders."

First Quarter 2026 and Recent Corporate Highlights
Mitapivat (PYRUKYND and AQVESME) Commercial Performance and Update

$18.8 million in U.S. net revenue and $1.9 million in ex-U.S. net revenue in the first quarter of 2026.
U.S. net revenue was driven by the U.S. commercial launch of AQVESME (mitapivat) in thalassemia in late January 2026.
Ex-U.S. net revenue reflected demand for PYRUKYND (mitapivat) in thalassemia in Saudi Arabia.

242 AQVESME prescriptions for thalassemia were written by Risk Evaluation and Mitigation Strategy (REMS)-certified U.S. physicians as of March 31, 2026, driven by motivated prescribers and highly engaged patients.

R&D Highlights

Mitapivat
Thalassemia –
In March 2026, the Emirates Drug Establishment of the United Arab Emirates (UAE) approved PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. With this approval, PYRUKYND becomes the only medicine approved in the UAE for this broad patient population.
Mitapivat is now approved for adults with thalassemia in the U.S., Saudi Arabia, and the UAE. A marketing application for mitapivat in thalassemia is currently under review by the European Commission.
Sickle Cell Disease –
Agios confirmed plans to pursue U.S. accelerated approval for mitapivat in sickle cell disease, following completion of its pre-supplemental New Drug Application (sNDA) meeting with the U.S. Food and Drug Administration (FDA).
The FDA’s accelerated approval pathway expedites the availability of medicines that can fill a medical need for a serious condition, with the requirement of a confirmatory clinical trial to convert to a traditional approval.
The company now plans to submit an sNDA for mitapivat in sickle cell disease in the second quarter of 2026.
Tebapivat
Lower-Risk Myelodysplastic Syndromes (LR-MDS) –
Agios expects to report topline results from its Phase 2b trial in the first half of 2026. Based on findings from the Phase 2a trial, the Phase 2b open-label trial is evaluating three higher daily dose levels of tebapivat (10 mg, 15 mg, and 20 mg) over a 24-week period. The primary endpoint is the proportion of participants achieving transfusion independence, defined as being transfusion-free for at least 8 consecutive weeks during the 24-week period.

Sickle Cell Disease –
Agios expects to report topline results from its Phase 2 trial in the second half of 2026. This double-blind, randomized, placebo-controlled trial is evaluating three daily dose levels of tebapivat (2.5 mg, 5 mg, and 7.5 mg) versus matched placebo over a 12-week period. The primary endpoint is hemoglobin response, defined as a ≥1.0 g/dL increase in average hemoglobin concentration from Week 10 through Week 12 compared with baseline.
First Quarter 2026 Financial Results
For the quarter ended March 31, 2026, net loss was $99.1 million, compared to net loss of $89.3 million for the quarter ended March 31, 2025.

Net product revenue from U.S. sales of mitapivat (PYRUKYND and AQVESME) for the first quarter of 2026 was $18.8 million, compared to $8.7 million for the first quarter of 2025.

Net product revenue from ex-U.S. sales of mitapivat (PYRUKYND) for the first quarter of 2026 was $1.9 million.

Cost of sales for the first quarter of 2026 was $1.3 million.

Research and Development (R&D) Expenses were $81.1 million for the first quarter of 2026, compared to $72.7 million for the first quarter of 2025, due to workforce-related expenses supporting pipeline advancement efforts, as well as increased mitapivat process development expenses.

Selling, General and Administrative (SG&A) Expenses were $48.3 million for the first quarter of 2026, compared to $41.5 million for the first quarter of 2025, due to an increase in activities to support the U.S. commercial launch of AQVESME in thalassemia, as well as an increase in stock compensation expense.

Cash, cash equivalents and marketable securities were $1.0 billion as of March 31, 2026, compared to $1.2 billion as of December 31, 2025. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to execute the U.S. commercial launch of AQVESME in thalassemia, prepare for the potential U.S. commercial launch of mitapivat in sickle cell disease, advance the company’s existing clinical programs, and opportunistically expand its pipeline through both internally- and externally-discovered assets.

First Quarter 2026 Conference Call Information
Agios will host a conference call and live webcast today at 8:00 a.m. ET to discuss the company’s first quarter 2026 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

(Press release, Agios Pharmaceuticals, APR 29, 2026, View Source [SID1234664892])

On April 29, 2026 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2026.

"We are off to an excellent start in 2026, with first-quarter results exceeding our expectations. AbbVie’s key growth drivers continue to deliver strong performance and support our enhanced full-year outlook," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We are also generating exciting data and advancing numerous programs across all stages of development. Our pipeline progress and solid business fundamentals position AbbVie for robust long-term growth."

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First-Quarter Results

•Worldwide net revenues were $15.002 billion, an increase of 12.4 percent on a reported basis, or 10.3 percent on an operational basis.

•Global net revenues from the immunology portfolio were $7.290 billion, an increase of 16.4 percent on a reported basis, or 14.3 percent on an operational basis.
◦Global Skyrizi net revenues were $4.483 billion, an increase of 30.9 percent on a reported basis, or 29.2 percent on an operational basis.
◦Global Rinvoq net revenues were $2.119 billion, an increase of 23.3 percent on a reported basis, or 20.2 percent on an operational basis.
◦Global Humira net revenues were $688 million, a decrease of 38.6 percent on a reported basis, or 40.3 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $2.875 billion, an increase of 26.0 percent on a reported basis, or 24.3 percent on an operational basis.
◦Global Vraylar net revenues were $905 million, an increase of 18.4 percent.
◦Global Botox Therapeutic net revenues were $1.009 billion, an increase of 16.5 percent on a reported basis, or 14.9 percent on an operational basis.
◦Global Ubrelvy net revenues were $339 million, an increase of 41.4 percent on a reported basis, or 41.2 percent on an operational basis.
◦Global Qulipta net revenues were $296 million, an increase of 53.6 percent on a reported basis, or 51.3 percent on an operational basis.
◦Global Vyalev net revenues were $201 million.

•Global net revenues from the oncology portfolio were $1.631 billion, a decrease of 0.2 percent on a reported basis, or 3.0 percent on an operational basis.
◦Global Venclexta net revenues were $770 million, an increase of 15.7 percent on a reported basis, or 9.7 percent on an operational basis.
◦Global Imbruvica net revenues were $556 million, a decrease of 24.7 percent.
◦Global Elahere net revenues were $198 million, an increase of 10.7 percent on a reported basis, or 8.3 percent on an operational basis.

•Global net revenues from the aesthetics portfolio were $1.186 billion, an increase of 7.6 percent on a reported basis, or 5.1 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $668 million, an increase of 20.2 percent on a reported basis, or 17.0 percent on an operational basis.
◦Global Juvederm net revenues were $232 million, an increase of 0.4 percent on a reported basis, or a decrease of 2.9 percent on an operational basis.

•On a GAAP basis, the gross margin ratio in the first quarter was 71.9 percent. The adjusted gross margin ratio was 83.6 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 23.9 percent of net revenues. The adjusted SG&A expense was 22.7 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 16.5 percent of net revenues. The adjusted R&D expense was 15.1 percent of net revenues.

•Acquired IPR&D and milestones expense was 5.0 percent of net revenues.

•On a GAAP basis, the operating margin ratio in the first quarter was 26.6 percent. The adjusted operating margin ratio was 40.8 percent.

•Net interest expense was $645 million.

•On a GAAP basis, the tax rate in the quarter was 32.9 percent. The adjusted tax rate was 15.4 percent.

•Diluted earnings per share (EPS) in the first quarter was $0.39 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.65. These results include an unfavorable impact of $0.41 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie announced it submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for Skyrizi (risankizumab) for subcutaneous (SC) induction in the treatment of adult patients with moderately to severely active Crohn’s disease (CD). AbbVie expects an approval decision later this year, which would offer adult CD patients an additional option for induction of Skyrizi. The submission is supported by data from the Phase 3 AFFIRM study evaluating the efficacy and safety of Skyrizi SC induction in adult patients with moderately to severely active CD. In the study, Skyrizi achieved superiority for the co-primary and ranked secondary endpoints at week 12 for induction delivered by SC injection versus placebo. The safety profile of Skyrizi SC induction was consistent with its known profile in CD, with no new safety risks observed.

•AbbVie announced it submitted an application to the FDA for a new indication for Rinvoq (upadacitinib) in the treatment of adult and adolescent patients with severe alopecia areata (AA). The submission is supported by data from the Phase 3 UP-AA clinical program in which Rinvoq achieved the primary endpoint as well as key secondary endpoints.

•At the 2026 American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented key data reinforcing the company’s leadership in advancing standards of care across immune-mediated skin diseases. Presentations showcased the efficacy and safety of Skyrizi in psoriatic disease, real-world evidence of minimal disease activity and clinical long-term safety outcomes of Rinvoq in atopic dermatitis (AD), as well as Phase 3 data for Rinvoq in vitiligo and AA. The company also presented data highlighting the safety and efficacy of new and emerging products in AbbVie’s aesthetics portfolio, including trenibotulinumtoxinE.

•AbbVie announced the FDA approved a supplemental new drug application (sNDA) for the combination regimen of Venclexta (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). This approval establishes the Venclexta and acalabrutinib combination as the first all-oral, fixed-duration regimen for previously untreated CLL, offering patients the potential of time off treatment. The approval is supported by data from the Phase 3 AMPLIFY trial.

•At the Society of Gynecologic Oncology (SGO) Annual Meeting, AbbVie presented Phase 2 data for Elahere in platinum-sensitive ovarian cancer (PSOC). Results from the IMGN853-0420 trial showed a more than 60 percent objective response rate (ORR) and consistent safety findings with Elahere plus carboplatin followed by a continuation of Elahere monotherapy in patients with folate receptor alpha (FRα)-expressing PSOC. These findings highlight Elahere’s potential expanding role across the ovarian cancer treatment continuum.

•AbbVie announced it received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for trenibotulinumtoxinE (trenibotE), a first-in-class botulinum neurotoxin serotype E with a rapid onset of effect and short duration. In its letter, the FDA requested additional information about manufacturing processes. The CRL does not identify any safety or efficacy concerns for trenibotE and does not request additional clinical studies. AbbVie is confident that it can address the FDA’s comments promptly and expects to submit a thorough response in the coming months.

•AbbVie announced positive topline results from the multiple ascending dose (MAD) part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m2. In the study, ABBV-295 treatment showed clinically meaningful body weight reduction at week 12 (weekly dosing) and week 13 (every other week and monthly dosing after week 5). ABBV-295 also demonstrated a favorable tolerability profile at all evaluated dose levels, with no serious adverse events reported. Data support continued development of ABBV-295 as a potentially differentiated treatment for chronic weight management, with a non-incretin-based mechanism of action.

•AbbVie announced a $1.4 billion investment to build a 185-acre pharmaceutical manufacturing campus in Durham, North Carolina. The state-of-the-art campus will integrate advanced manufacturing and laboratory technologies with artificial intelligence (AI) to support the production of AbbVie’s immunology, neuroscience and oncology medicines.

Recent Events (Continued)

•AbbVie announced a $380 million investment to build two new active pharmaceutical ingredient (API) manufacturing facilities at its North Chicago, Illinois, campus. These state-of-the-art facilities will integrate advanced manufacturing technologies with AI to support the production of AbbVie’s next-generation neuroscience and obesity medications.

•AbbVie announced the opening of the Allergan Medical Institute (AMI) Training Center in Austin, Texas. This location marks the third U.S. AMI Training Center opened in the last year, reflecting AbbVie’s continued investment in aesthetics training and education.

Full-Year 2026 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2026 from $13.96 – $14.16 to $14.08 – $14.28, which includes an unfavorable impact of $0.41 per share related to acquired IPR&D and milestones expense incurred year-to-date through the first quarter 2026. The company’s 2026 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2026, as both cannot be reliably forecasted.

(Press release, AbbVie, APR 29, 2026, View Source [SID1234664891])