On April 29, 2026 Biogen Inc. (Nasdaq: BIIB) reported first quarter 2026 financial results. Commenting on the quarter, President and Chief Executive Officer Christopher A. Viehbacher said:

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"We significantly advanced our transformation into the New Biogen through strong commercial and pipeline execution and the announcement of our intent to acquire Apellis. We believe the planned acquisition of Apellis will bolster our revenue and earnings growth, adding two differentiated commercial medicines and deepening the foundation for felzartamab, our key Phase 3 asset in kidney disease. This acquisition and the acquired rights to felzartamab in China come while we also expanded sales of our growth products, demonstrated continued resilience in our MS portfolio and reported important positive new data that reinforce our confidence in the late‑stage pipeline."
Financial Highlights
Q1 ’26 Q1 ’25 △
r (CC*)
Total Revenue (in millions) $2,478 $2,431 2% (2)%
GAAP diluted EPS $2.15 $1.64 31% N/A
Non-GAAP diluted EPS $3.57 $3.02 18% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q1 ’26 Q1 ’25 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$958 $953 —% (3)%
Rare disease revenue(2)
$557 $563 (1)% (5)%
Biosimilars revenue $182 $181 1% (7)%
Other product revenue(3)
$55 $29 88% 87%
Total product revenue $1,752 $1,727 1% (3)%
Revenue from anti-CD20 therapeutic programs $419 $378 11% 11%
Alzheimer’s collaboration revenue(4)
$60 $33 80% 80%
Contract manufacturing, royalty and other revenue $247 $293 (16)% (20)%
Total revenue $2,478 $2,431 2% (2)%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY and TYSABRI.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.

•Within MS product revenue TYSABRI benefitted from approximately $40 million from a favorable adjustment to discounts and allowances and inventory timing in the U.S. and $19 million of favorable inventory timing outside the U.S.

•Contract manufacturing, royalty and other revenue benefitted from the acceleration of manufacturing activity in the first quarter.

Expense Summary
(in millions) Q1 ’26 Q1 ’25 △
GAAP cost of sales*
$661 $629 (5)%
% of Total Revenue 27% 26%
Non-GAAP cost of sales*
$610 $580 (5)%
% of Total Revenue 25% 24%
GAAP R&D expense $539 $434 (24)%
Non-GAAP R&D expense $480 $427 (13)%
GAAP SG&A expense $607 $573 (6)%
Non-GAAP SG&A expense $600 $572 (5)%
GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense $34 $201 NMF

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
IPR&D = in-process R&D; NMF = no meaningful figure.
* Excluding amortization and impairment of acquired intangible assets

•The increase in first quarter 2026 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix.

•The increase in first quarter 2026 GAAP R&D expense was primarily driven by approximately $57 million of step-up amortization related to SKYCLARYS inventory as well as increased investment in late-stage programs including litifilimab and felzartamab. The increase in first quarter 2026 Non-GAAP R&D expense was primarily driven by increased investment in late-stage programs including litifilimab and felzartamab.

•The increase in first quarter 2026 GAAP and Non-GAAP SG&A was primarily driven by investments to support product launches.

•First quarter 2026 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was $34 million.
Other Financial Highlights

•First quarter 2026 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $74 million, which includes approximately $57 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $17 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. for the commercialization of ZURZUVAE in the U.S.

•First quarter 2026 GAAP other expense was approximately $20 million driven by net interest expense partially offset by net unrealized gains on equity securities. First quarter 2026 Non-GAAP other expense was approximately $42 million primarily driven by net interest expense.

•First quarter 2026 GAAP and Non-GAAP effective tax rates were 15.4% and 15.3%, respectively. First quarter 2025 GAAP and Non-GAAP effective tax rates were 22.7% and 19.4%, respectively. The year over year decrease in the Non-GAAP effective tax rate was due to favorable impacts from a foreign tax settlement and vesting of certain share-based awards partly offset by the increase in U.S. taxation on foreign earnings in 2026 under the One Big Beautiful Bill Act.

Financial Position

•First quarter 2026 net cash flow from operations was approximately $646 million. Capital expenditures were approximately $51 million, and free cash flow, a Non-GAAP financial measure defined as net cash flow from operations less capital expenditures, was approximately $594 million.

•As of March 31, 2026, Biogen had cash and cash equivalents totaling approximately $4.7 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $1.5 billion.

•For the first quarter of 2026 the Company’s weighted average diluted shares were approximately 148 million.
Full Year 2026 Financial Guidance

Biogen is updating its guidance for full year 2026 to reflect an approximately $1.00 impact from acquired IPR&D charges resulting from ongoing business development activities to support Biogen’s growth strategy. This comprises approximately $0.20 recorded in the first quarter and approximately $0.80 expected in the second quarter. This updated guidance excludes the anticipated Apellis transaction. Full year 2026 Non-GAAP diluted EPS range is expected as follows:
Full Year 2026 Non-GAAP Diluted EPS
Prior Guidance (February 2026) $15.25 to $16.25
Approx. impact from acquired IPR&D charges recorded in Q1 and expected in Q2 2026*
(Excluding the Apellis transaction)
($1.00)
Updated Guidance $14.25 to $15.25

*Includes an expected approximately $0.55 Non-GAAP diluted EPS impact from the deal with TJ Biopharma for felzartamab Greater China region rights and an additional $0.25 Non-GAAP diluted EPS impact from a milestone expected to occur in the second quarter of 2026.

Total revenue is expected to decline by a mid-single digit percentage for 2026 as compared to 2025 as further declines in multiple sclerosis product revenue, excluding VUMERITY, are expected to be partially offset by increases in revenue from growth products.

For full year 2026 as compared to full year 2025, Biogen expects the gross margin percentage, and combined Non-GAAP R&D expense and Non-GAAP SG&A expense to be roughly consistent year-over-year. Biogen expects full year 2026 Non-GAAP effective tax rate to be between approximately 17% and 18%.

This guidance also assumes that foreign exchange rates as of April 24, 2026, will remain in effect for the remainder of the year, net of hedging activities.

Other than the acquired IPR&D impact expressly stated above, this financial guidance does not include any other potential future acquired IPR&D charges, impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential healthcare reform, as all are difficult to predict. Other important financial considerations will be provided on the conference call and webcast.

Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2026 that could cause any of these assumptions and expectations to change and/or actual results to vary from this financial guidance.

Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable without unreasonable effort to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future litigation. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Conference Call and Webcast

The Company’s earnings conference call for the first quarter will be broadcast via the internet at 8:00 a.m. ET on April 29, 2026 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

(Press release, Biogen, APR 29, 2026, View Source [SID1234664903])

On April 29, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported a business update on its myvac platform, and its individualized neoantigen therapeutic vaccine (INTV) TG4050, and upcoming plans, including its financial position as of March 31, 2026.

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TG4050, Transgene’s first INTV from its myvac platform continues to progress according to plan in the adjuvant treatment of head and neck cancer

TG4050 is designed to stimulate a strong and individualized immune response aimed at preventing relapse in HPV-negative head and neck cancer (HNSCC1) patients following surgery and adjuvant (chemo)radiotherapy. It is currently under evaluation in a randomized multicenter Phase 1/2 clinical trial (NCT04183166).

As a monotherapy, TG4050 met all trial endpoints in the Phase 1 part of the trial and induced long-lasting immune responses to individualized vaccine neoantigens that were sustained for up to two years after treatment initiation. All patients treated were disease-free at 2 years, providing robust clinical proof of principle.

A comprehensive analysis of these positive clinical and translational data from the Phase 1 part of the randomized Phase 1/2 trial of TG4050 was published on the preprint platform medRxiv, in January 2026 (see press release). The data suggest that individualized treatment with TG4050 has the potential to prevent cancer relapses. The article is under review by a peer-reviewed journal. These data have also been presented orally at the World Vaccine Congress (WVC) (see press release).

3-year disease-free survival (DFS) follow-up of Phase 1 patients is expected in Q2/Q3 2026.
Transgene announced that the randomization of the Phase 2 part of the Phase 1/2 trial for adjuvant treatment of HNSCC has been completed (see press release).

The primary endpoint of the trial is 2-year DFS. Transgene expects to communicate these top-line results by the end of Q1 2028.
Early April 2026, Transgene and NEC Bio signed a license agreement to advance the clinical development of TG4050 in head and neck cancer (see press release). Transgene secures access to NEC’s AI-based neoantigen prediction platform, as well as rights to enable TG4050’s further clinical development and to support commercialization and potential partnering of the program. Under this agreement, Transgene has paid a technology access fee of €2.5 million in Transgene shares as well as a first tranche of €0.5 million from a total payment of a total €2.5 million in cash that will be paid out in several instalments through early 2028. Additional development and milestone payments will be paid upon progress of the clinical development of TG4050 in head and neck cancer.

Expanding the value of the myvac platform

Transgene’s INTV platform, myvac, has the potential to generate INTVs that could be used to improve treatment across a range of solid tumors where in many cases a significant unmet medical need remains.

In parallel with the ongoing Phase 1/2 trial in HNSCC, Transgene is progressing with start-up activities for a new Phase 1 trial in a second indication in an early treatment setting, with the aim of initiating later in 2026, as soon as all conditions are met.
To further enhance value and unlock the full potential of the myvac platform, Transgene continues to invest in the optimization of the manufacturing of its INTV candidates, with the aim of reducing turnaround time, enabling scalability and increasing capacity.

Operating revenue and financial visibility

During the first quarter of 2026, operating revenue amounted to €1.4 million compared to €2.5 million for the same period in 2025. It mostly comprised the research tax credit of €1.1 million compared to €2.3 million for the same period in 2025. In Q1 2025, eligible activities against which research tax credit could be claimed comprised manufacturing for the patients in the Phase 2 part of the TG4050 trial in HNSCC; most of these manufacturing activities were completed in Q1 2026, explaining the decrease of the RTC.

As of March 31, 2026, Transgene had €103.8 million in cash, cash equivalents and other financial assets, compared to €111.9 million as of December 31, 2025. Over the first quarter of 2026, Transgene’s net cash burn2 was €8.1 million compared to €14.8 million for the same period in 2025.

Under current plans, the company has sufficient cash to ensure financial visibility until early 2028.

(Press release, Transgene, APR 29, 2026, View Source [SID1234664900])

On April 29, 2026 Teva reported Strong Q1 2026 Results Driven by Innovative Portfolio Growth and Disciplined Execution.

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Q1 2026 revenues of ~$4.0 billion increased by 2% in U.S. dollars year-over-year (YoY), and decreased by 3% in local currency terms (LC). Excluding the Japan business venture (BV) results, revenues decreased by 1% in LC. These strong first quarter results were driven by our innovative portfolio growth and disciplined execution, even with lower revenues from lenalidomide capsules (the generic version of Revlimid) due to increased generic competition in the U.S.
Key Innovative brands continued to drive growth and provide value for patients, while transforming Teva’s portfolio mix and financial profile:
AUSTEDO continued to show strong growth, with global revenues of $578 million, growing 41% YoY in LC.
AJOVY global revenues of $196 million, increased by 35% YoY in LC.
UZEDY revenues of $63 million, increased by 62% YoY in LC. Fastest growing long-acting injectable (LAI)1 has nearly doubled the overall risperidone market since launch.
Collectively these brands’ revenues grew by 41% YoY in LC.
Generics revenues are lower in Q1 2026 vs. Q1 2025, mainly due to lenalidomide capsules (the generic version of Revlimid) impact; Biosimilar portfolio increasingly important contributor to performance and on track to deliver $800 in revenues by 2027:
Global generics revenues decreased by 16% YoY in LC, mainly due to lower revenues from generic products in the U.S., primarily lenalidomide capsules (the generic version of Revlimid) due to increased generic competition in the U.S., and the divestment of the business venture in Japan in Q1 2025.
Biosimilar PONLIMSI, received FDA-approval across all indications of the reference product, Prolia (denosumab) and our biosimilar candidate to Xolair (omalizumab) was accepted for review by U.S. FDA and EU EMA (link).
Innovative late-stage pipeline continued to drive transformation:
Four innovative product submissions targeted over the next 5 years.
duvakitug (anti-TL1A) Phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis (UC) and Crohn’s disease (CD); Phase 2b induction data have been accepted for future publication in a leading journal; Phase 3 enrollment currently on target.
olanzapine LAI New Drug Application (NDA) accepted by the FDA in February 2026 for once-monthly treatment of schizophrenia in adults; preparing for the launch of olanzapine LAI in Q4 2026, subject to regulatory approval. EU marketing authorization application (MAA) acceptance expected in Q2 2026.
Teva to acquire Emalex Biosciences, adding NDA-Ready, first-in-class therapy to neuroscience pipeline and accelerating Teva’s Pivot to Growth strategy. The transaction is subject to customary closing conditions, including receipt of necessary regulatory approvals, and is currently anticipated to close by the third quarter of 2026 (link).
Continuing to transform and modernize our business through Teva Transformation programs – combined with innovative product growth, expected to achieve 30% non-GAAP operating income margin by 2027. On track to deliver ~$700 million of net savings by 2027.
Teva’s Board of Directors instructed management to plan for a share repurchase program that may be implemented, subject to meeting applicable legal requirements. Execution will be subject to certain factors, such as market conditions, share price and other opportunities to invest capital for growth in alignment with the Company’s Pivot to Growth strategy, and are subject to the approval by Teva’s Board of Directors.

Q1 2026 Highlights:

Revenues of $4.0 billion
GAAP diluted EPS of $0.31
Non-GAAP diluted EPS of $0.53
Cash flow used in operating activities of $40 million
Free cash flow of $188 million

2026 Business Outlook maintained; updated exclusively for Emalex transaction:

Revenues of $16.4 – $16.8 billion
Non-GAAP operating income of $3.80 – $4.0 billion ($4.55 – $4.8 billion stand-alone), impacted by an expected $700 million IPR&D charge and $75 million to reflect Emalex’s operating expenses and transaction-related expenses.
Adjusted EBITDA of $4.23 – $4.53 billion ($5.0 – $5.3 billion stand-alone)
Non-GAAP diluted EPS of $1.91 – $2.11 ($2.57 – $2.77 stand-alone)
Free cash flow of $2.0 – $2.4 billion
________________
1 IQVIA Monthly NPA, March 2026 MAT vs PY

TEL AVIV, Israel, April 29, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended March 31, 2026.

Mr. Richard Francis, Teva’s President and CEO, said: "Our first quarter results are driven by strong growth in our key innovative products, continuing to shift Teva’s portfolio mix and support improvement in its financial profile. These results reflect disciplined execution of our Pivot to Growth strategy, and our focus remains unchanged: growing our innovative portfolio, improving margins and advancing key value-unlocking portfolio milestones expected during 2026 and beyond.

Mr. Francis added, "In parallel, biosimilars are becoming an increasingly important growth contributor, alongside new product launches in generics, reinforcing the foundational importance of Teva’s generic powerhouse.

Pivot to Growth Strategy

In the first quarter of 2026, we continued to execute on the four key pillars of our "Pivot to Growth" strategy, announced in May 2023:

Delivering on our growth engines – Teva’s key innovative brands delivered strong performance. In Q1 2026, AUSTEDO, AJOVY, and UZEDY revenues collectively grew by 41% YoY in LC to $838 million compared to Q1 2025. Based on our 2026 Outlook, these products are expected to generate an annual 4-year compound growth rate of ~38% and comprise ~21% of Teva’s total revenues.
Stepping up innovation – We continued to advance our innovative late-stage pipeline. In February 2026, we shared topline results from the maintenance period of our Phase 2b study of duvakitug in UC and CD. The data demonstrated robust, durable efficacy over the course of 44 weeks, and positions duvakitug to potentially be the "best-in-class" anti-TL1A. Phase 3 enrollment is currently on target. Teva’s NDA for olanzapine LAI was accepted by the FDA in February 2026. Teva is preparing for the anticipated launch of olanzapine LAI in Q4 2026, subject to receiving regulatory approval. During the remainder of 2026, Teva expects meaningful data updates on five other key innovative programs, including: emrusolmin in MSA, IL-15 (TEV-‘408) in Celiac disease and vitiligo, DARI (Dual-action Asthma Rescue Inhaler) in asthma, and Anti-PD-1/IL-2 in oncology.
Sustaining our generics powerhouse – Recently launched biosimilars, including SELARSDI (ustekinumab-aekn) the biosimilar to Stelara and EPYSQLI(eculizumab-aagh) the biosimilar to Soliris, along with the rest of our biosimilar portfolio, showed continued strong growth in the Q1 2026. In March 2026, PONLIMSI (denosumab-adet) has been approved by the FDA as a biosimilar to Prolia, and Teva’s applications for a proposed biosimilar candidate to Xolair (omalizumab) have been accepted by both the U.S. FDA and the European Medicines Agency (EMA).
Focusing our business – We are actively transforming and modernizing our business through Teva Transformation programs. On May 7, 2025, we announced that these programs are expected to generate ~$700 million of net savings through 2027, and expect to realize two-thirds of the targeted savings in 2026. In April 2026, Teva entered into a definitive agreement to acquire Emalex Biosciences, including its lead asset ecopipam. Emalex has completed Phase 3 development of ecopipam for the treatment of Tourette syndrome in a pediatric population. The transaction is subject to customary closing conditions, including receipt of necessary regulatory approvals, and is currently anticipated to close by the third quarter of 2026 (link).

First Quarter 2026 Consolidated Results

Revenues in the first quarter of 2026 were $3,982 million, an increase of 2% in U.S. dollars, or a decrease of 3% in local currency terms compared to the first quarter of 2025. This decrease in local currency terms was mainly due to lower revenues from generic products, primarily lenalidomide capsules (the generic version of Revlimid) in our U.S. segment as well as the divestment of our business venture in Japan in our International Markets segment, partially offset by higher revenues from our key innovative products, primarily AUSTEDO.

Exchange rate movements during the first quarter of 2026, including hedging effects, positively impacted revenues by $219 million, compared to the first quarter of 2025.

Gross profit in the first quarter of 2026 was $1,972 million, an increase of 5% compared to $1,877 million in the first quarter of 2025. Gross profit margin was 49.5% in the first quarter of 2026, compared to 48.2% in the first quarter of 2025. Non-GAAP gross profit was $2,108 million in the first quarter of 2026, an increase of 3% compared to $2,054 million in the first quarter of 2025. Non-GAAP gross profit margin was 52.9% in the first quarter of 2026, compared to 52.8% in the first quarter of 2025. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to higher revenues from AUSTEDO, partially offset by lower revenues from generic products in our United States segment, primarily lenalidomide capsules (the generic version of Revlimid).

Research and Development (R&D) expenses, net in the first quarter of 2026, were $222 million, a decrease of 10% compared to $247 million in the first quarter of 2025. Our lower R&D expenses, net in the first quarter of 2026 compared to the first quarter of 2025, were mainly due to a decrease in our generics pipeline and in our late-stage innovative pipeline in neuroscience, partially offset by an increase in immunology projects. Our R&D expenses, net in the first quarter of 2026 and 2025, were also impacted by reimbursements and cost sharing from our strategic partnerships and collaborations entered into in recent years.

Selling and Marketing (S&M) expenses in the first quarter of 2026, were $696 million, an increase of 12% compared to the first quarter of 2025. This increase was mainly due to promotional activities related to our key innovative products in our US segment, primarily AUSTEDO, as well as a negative impact from exchange rate fluctuations.

General and Administrative (G&A) expenses in the first quarter of 2026 were $304 million, an increase of 2% compared to the first quarter of 2025.

Other Income (Loss) in the first quarter of 2026 was $9 million, compared to other loss of $5 million in the first quarter of 2025.

Operating Income in the first quarter of 2026 was $652 million, compared to $519 million in the first quarter of 2025. Operating income as a percentage of revenues was 16.4% in the first quarter of 2026, compared to 13.3% in the first quarter of 2025. This increase was mainly due to lower intangible assets impairments and higher gross profit, partially offset by higher S&M expenses. Non-GAAP operating income in the first quarter of 2026 was $956 million representing a non-GAAP operating margin of 24.0% compared to $946 million representing 24.3%, respectively, in the first quarter of 2025. The decrease in non-GAAP operating margin in the first quarter of 2026 was due to higher S&M expenses as a percentage of revenues, partially offset by higher gross profit margin, as discussed above.

Exchange rate movements in the first quarter of 2026, including hedging effects, had a positive impact of $71 million on our operating income and non-GAAP operating income compared to the first quarter of 2025.

Financial expenses, net in the first quarter of 2026, were $216 million, mainly comprised of net interest expenses of $201 million. In the first quarter of 2025, financial expenses, net were $225 million, mainly comprised of net interest expenses of $212 million.

In the first quarter of 2026, we recognized a tax expense of $67 million, on pre-tax income of $437 million. In the first quarter of 2025, we recognized a tax expense of $74 million, on pre-tax income of $294 million.

Tax rate in the first quarter of 2026 was 15.5% compared to a tax rate of 25.1% for the first quarter of 2025. Non-GAAP tax rate in the first quarter of 2026 was 17.5%, same as in the first quarter of 2025. Our tax rate and non-GAAP tax rate in the first quarter of 2026 was mainly affected by the generation of profits in various jurisdictions in which tax rates are different than the Israeli tax rate, infrequent or non-recurring items, including internal legal entities reorganization. Our tax rate and non-GAAP tax rate in the first quarter of 2025 was mainly affected by the generation of profits in various jurisdictions in which tax rates are different than the Israeli tax rate as well as infrequent or non-recurring items.

We expect our annual non-GAAP tax rate for 2026 to be between 20%-23% (16%-19% stand-alone), higher than our non-GAAP tax rate for 2025, which was 15.8%.

Net income attributable to Teva and diluted earnings per share in the first quarter of 2026 were $369 million and $0.31, respectively, compared to $214 million and $0.18, respectively, in the first quarter of 2025. This increase was mainly due to higher operating income as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the first quarter of 2026 were $621 million and $0.53, respectively, compared to $602 million and $0.52, respectively, in the first quarter of 2025.

Adjusted EBITDA was $1,055 million in the first quarter of 2026, an increase of 1%, compared to $1,041 million in the first quarter of 2025.

As of March 31, 2026 and 2025, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,192 million shares and 1,178 million shares, respectively.

Non-GAAP information: non-GAAP adjustments in the first quarter of 2026 were $252 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the first quarter of 2026 were adjusted to exclude the following items:

Amortization of purchased intangible assets of $137 million, of which $128 million is included in cost of sales and the remaining $9 million in S&M expenses;
Legal settlements and loss contingencies of $72 million;
Restructuring expenses of $25 million;
Impairment of long-lived assets of $9 million;
Contingent consideration expenses of $5 million;
Gain on sale of business of $5 million;
Equity compensation expenses of $43 million;
Financial expenses of $13 million;
Other non-GAAP items of $17 million; and
Corresponding tax effects and unusual tax items of $65 million.

We believe that excluding such items facilitates investors’ understanding of our business including underlying trends, thereby improving the comparability of our business performance results between reporting periods.

For a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and for additional information, see the tables below and the information included under "Non-GAAP Financial Measures." Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.

Cash flow used in operating activities during the first quarter of 2026 was $40 million compared to $105 million in the first quarter of 2025. The lower cash flow used in operating activities in the first quarter of 2026 was mainly due to favorable timing and mix of sales and collections in our U.S. segment as well as lower payments of interest, partially offset by higher performance incentive payments to employees.

During the first quarter of 2026, we generated free cash flow of $188 million, which we define as comprising $40 million in cash flow used in operating activities, $354 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $42 million of proceeds from sale of businesses and long-lived assets, partially offset by $168 million in cash used for capital investments. During the first quarter of 2025, we generated free cash flow of $107 million, which we define as comprising $105 million in cash flow used in operating activities, $322 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $17 million proceeds from sale of businesses and long-lived assets, partially offset by $127 million in cash used for capital investments. The increase in the first quarter of 2026 resulted mainly from lower cash flow used in operating activities, as discussed above.

As of March 31, 2026, our debt was $16,627 million, compared to $16,807 million as of December 31, 2025. This decrease was mainly due to $174 million of exchange rate fluctuations. The portion of total debt classified as short-term as of March 31, 2026 was 16% compared to 11% as of December 31, 2025. Our financial leverage, which is the ratio between our debt and the sum of our debt and equity, was 67% as of March 31, 2026, compared to 68% as of December 31, 2025. Our average debt maturity was approximately 5.4 years as of March 31, 2026, compared to 5.6 years as of December 31, 2025.

Segment Results for the First Quarter of 2026

United States Segment

In alignment with our Pivot to Growth strategy, commencing January 1, 2026, Anda is no longer reported under our United States segment. This shift allows the United States segment to continue to manage its entire product portfolio in the region, while strengthening focus on its biopharmaceutical business, growth engines and innovation. As a result, from that date, Anda is reported as part of the Company’s Other Activities. Prior period amounts have been recast to reflect this change.

The following table presents revenues, expenses and profit for our United States segment for the three months ended March 31, 2026 and 2025:

Three months ended March 31,
2026 2025
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 1,534 100% $ 1,536 100%
Cost of sales 496 32.3% 523 34.1%
Gross profit 1,038 67.7% 1,013 65.9%
R&D expenses 147 9.6% 154 10.1%
S&M expenses 298 19.4% 244 15.9%
G&A expenses 90 5.9% 95 6.2%
Other (4) § 3 §
Segment profit* $ 507 33.0% $ 518 33.7%

* Segment profit does not include amortization and certain other items.
§ Represents an amount less than 0.5%.

Revenues from our United States segment in the first quarter of 2026 were $1,534 million, flat compared to the first quarter of 2025, mainly due to lower revenues from our generic products, primarily lenalidomide capsules (the generic version of Revlimid), offset by higher revenues from our key innovative products, primarily AUSTEDO.

Revenues by Major Products and Activities

The following table presents revenues for our United States segment by major products and activities for the three months ended March 31, 2026 and 2025:

Three months ended
March 31, Percentage
Change
2026 2025 2026-2025
(U.S. $ in millions)
Generic products (including biosimilars) $ 612 $ 849 (28%)
AJOVY 87 53 64%
AUSTEDO 559 396 41%
BENDEKAand TREANDA 27 36 (26%)
COPAXONE 62 54 16%
UZEDY 63 39 62%
Other* 123 109 13%
Total $ 1,534 $ 1,536 §

*Other revenues in the first quarter of 2026 include the sale of certain product rights.
§ Represents an amount less than 0.5%.

Generic products (including biosimilar products) revenues in our United States segment in the first quarter of 2026 were $612 million, a decrease of 28% compared to the first quarter of 2025. This decrease was mainly driven by lower revenues from lenalidomide capsules (the generic version of Revlimid) due to increased generic competition in the U.S., partially offset by higher revenues from our portfolio of biosimilar products.

Among the most significant generic products we sold in the United States in the first quarter of 2026 were Truxima (the biosimilar to Rituxan), epinephrine injectable solution (the generic equivalent of EpiPen and EpiPen Jr) and SIMLANDI (the biosimilar to Humira). In the first quarter of 2026, our total prescriptions were approximately 246 million (based on trailing twelve months), representing 6.3% of total U.S. generic prescriptions, compared to approximately 273 million (based on trailing twelve months), representing 7.1% of total U.S. generic prescriptions in the first quarter of 2025, all according to IQVIA data.

AJOVY revenues in our United States segment in the first quarter of 2026 were $87 million, an increase of 64% compared to the first quarter of 2025, mainly due to a reduction in sales allowance. In the first quarter of 2026, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 32.0% out of the subcutaneous injectable anti- CGRP class, compared to 30.2% in the first quarter of 2025.

AUSTEDO revenues (which include AUSTEDO XR) in our United States segment in the first quarter of 2026 were $559 million, an increase of 41%, compared to in the first quarter of 2025. This increase was mainly due to growth in volume.

AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023 in three doses of 6, 12 and 24 mg, and became commercially available in the U.S. in May 2023. The FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg in May 2024 and in doses of 18 mg in July 2024. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, which is additional to the twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041.

UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the first quarter of 2026 were $63 million, an increase of 62% compared to the first quarter of 2025, mainly due to growth in volume.

BENDEKA and TREANDA combined revenues in our United States segment in the first quarter of 2026 were $27 million, a decrease of 26% compared to the first quarter of 2025, mainly due to competition from alternative therapies, as well as from generic bendamustine products.

COPAXONE revenues in our United States segment in the first quarter of 2026 were $62 million, an increase of 16% compared to the first quarter of 2025, mainly due to a reduction in sales allowance, partially offset by lower volumes. COPAXONE continues to face competition from existing alternative therapies, generic versions of COPAXONE, and generic treatments for multiple sclerosis, injectable products, as well as from monoclonal antibodies.

United States Gross Profit

Gross profit from our United States segment in the first quarter of 2026 was $1,038 million, an increase of 2%, compared to the first quarter of 2025.

Gross profit margin for our United States segment in the first quarter of 2026 increased to 67.7%, compared to 65.9% in the first quarter of 2025. This increase was mainly due to higher revenues from AUSTEDO, partially offset by lower revenues from generic products, primarily lenalidomide capsules (the generic version of Revlimid).

United States Profit

Profit from our United States segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our United States segment in the first quarter of 2026 was $507 million, a decrease of 2% compared to the first quarter of 2025. This decrease was mainly due to higher S&M expenses, partially offset by higher gross profit, as discussed above.

Europe Segment

Our Europe segment includes the European Union, the United Kingdom and certain other European countries.

The following table presents revenues, expenses and profit for our Europe segment for the three months ended March 31, 2026 and 2025:

Three months ended March 31,
2026 2025
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 1,340 100% $ 1,194 100%
Cost of sales 606 45.2% 536 44.9%
Gross profit 734 54.8% 658 55.1%
R&D expenses 45 3.4% 60 5.1%
S&M expenses 215 16.0% 199 16.7%
G&A expenses 73 5.4% 69 5.8%
Other § § § §
Segment profit* $ 401 29.9% $ 329 27.6%
* Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our Europe segment in the first quarter of 2026 were $1,340 million, an increase of 12%, compared to the first quarter of 2025. In local currency terms, revenues decreased by 1% compared to the first quarter of 2025, mainly due to lower revenues from generic products, partially offset by higher revenues from AJOVY.

In the first quarter of 2026, revenues were positively impacted by exchange rate fluctuations of $159 million, including hedging effects, compared to the first quarter of 2025. Revenues in the first quarter of 2026 included $10 million from a positive hedging impact, which is included in "Other" in the table below. Revenues in the first quarter of 2025 included $12 million from a negative hedging impact, which is included in "Other" in the table below.

Revenues by Major Products and Activities

The following table presents revenues for our Europe segment by major products and activities for the three months ended March 31, 2026 and 2025:

Three months ended
March 31, Percentage
Change
2026 2025 2026-2025
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 1,089 $ 989 10%
AJOVY 76 58 31%
COPAXONE 40 42 (4%)
Respiratory products 59 55 8%
Other* 76 50 52%
Total $ 1,340 $ 1,194 12%

* Other revenues in the first quarter of 2026 and 2025 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our Europe segment in the first quarter of 2026 were $1,089 million, an increase of 10% compared to the first quarter of 2025. In local currency terms, revenues decreased by 1%, mainly due to lower sales of seasonal OTC products, partially offset by higher revenues from recently launched products.

AJOVY revenues in our Europe segment in the first quarter of 2026 were $76 million, an increase of 31% compared to the first quarter of 2025. In local currency terms revenues increased by 17% due to growth in volume.

COPAXONE revenues in our Europe segment in the first quarter of 2026 were $40 million, a decrease of 4% compared to the first quarter of 2025. In local currency terms revenues decreased by 14%, mainly due to price reductions and lower volumes resulting from the availability of alternative therapies.

Respiratory products revenues in our Europe segment in the first quarter of 2026 were $59 million, an increase of 8% compared to the first quarter of 2025. In local currency terms, revenues decreased by 2%, mainly due to net price reductions and lower volumes.

Europe Gross Profit

Gross profit from our Europe segment in the first quarter of 2026 was $734 million, an increase of 12% compared to the first quarter of 2025.

Gross profit margin for our Europe segment in the first quarter of 2026 decreased to 54.8%, compared to 55.1% in the first quarter of 2025.

Europe Profit

Profit from our Europe segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our Europe segment in the first quarter of 2026 was $401 million, an increase of 22%, compared to the first quarter of 2025. This increase was mainly due to higher gross profit, as discussed above.

International Markets Segment

Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segment. The International Markets segment covers a substantial portion of the global pharmaceutical industry, including more than 35 countries. The countries in our International Markets segment include highly regulated, mainly generic markets, such as Canada and Israel, and branded generics-oriented markets, such as Russia and certain Latin America markets.

On March 31, 2025, we divested our Teva-Takeda business venture in Japan, which included generic products and legacy products. Since the establishment of the business venture and until the completion of its sale, Teva held 51% of the outstanding common stock of the business venture. On March 31, 2025, we deconsolidated the business venture from our financial statements.

The following table presents revenues, expenses and profit for our International Markets segment for the three months ended March 31, 2026 and 2025:

Three months ended March 31,
2026 2025
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 524 100% $ 582 100%
Cost of sales 280 53.6% 304 52.3%
Gross profit 243 46.4% 278 47.7%
R&D expenses 22 4.3% 25 4.3%
S&M expenses 117 22.3% 118 20.2%
G&A expenses 39 7.5% 39 6.7%
Other § § (1) §
Segment profit* $ 65 12.3% $ 97 16.7%

* Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our International Markets segment in the first quarter of 2026 were $524 million, a decrease of 10% compared to the first quarter of 2025. In local currency terms, revenues decreased by 19% compared to the first quarter of 2025, mainly due to the divestment of our business venture in Japan.

In the first quarter of 2026, revenues were positively impacted by exchange rate fluctuations of $50 million, including hedging effects, compared to the first quarter of 2025. Revenues in the first quarter of 2026 included $1 million from a positive hedging impact, compared to a negative hedging impact of $15 million in the first quarter of 2025, which are included in "Other" in the table below.

The following table presents revenues for our International Markets segment by major products and activities for the three months ended March 31, 2026 and 2025:

Three months ended
March 31, Percentage
Change
2026 2025 2026-2025
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 386 $ 468 (18%)
AJOVY 33 28 20%
AUSTEDO 19 15 30%
COPAXONE 6 10 (43%)
Other* 79 61 30%
Total $ 524 $ 582 (10%)

*Other revenues in the first quarter of 2026 and 2025 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our International Markets segment in the first quarter of 2026 were $386 million, a decrease of 18% compared to the first quarter of 2025. In local currency terms, revenues decreased by 23%, mainly due to the divestment of our business venture in Japan.

AJOVY revenues in our International Markets segment in the first quarter of 2026 were $33 million, an increase of 20%, compared to $28 million in the first quarter of 2025. In local currency terms, revenues increased by 15%, mainly due to growth in existing markets in which AJOVY was launched. AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. In April 2026, we announced a strategic partnership for the marketing and distribution of AJOVY in China with Neurogen (Zhuhai) Pharmaceutical Company Ltd.

AUSTEDO revenues in our International Markets segment in the first quarter of 2026 were $19 million an increase of 30%, compared to the first quarter of 2025. In local currency terms, revenues increased by 22% compared to the first quarter of 2025. AUSTEDO was launched in China and Israel in 2021 and in Brazil in 2022, for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. In February 2024, we announced a strategic partnership for the marketing and distribution of AUSTEDO in China with Jiangsu Nhwa Hexin Pharmaceutical Marketing Co., Ltd. In April 2025, AUSTEDO received marketing authorization in South Korea. We continue to evaluate additional submissions in various other markets.

COPAXONE revenues in our International Markets segment in the first quarter of 2026 were $6 million a decrease of 43% compared to the first quarter of 2025.

International Markets Gross Profit

Gross profit from our International Markets segment in the first quarter of 2026 was $243 million, a decrease of 12% compared to the first quarter of 2025.

Gross profit margin for our International Markets segment in the first quarter of 2026 decreased to 46.4%, compared to 47.7% in the first quarter of 2025. This decrease was mainly due to unfavorable mix of products, partially offset by a positive impact from hedging activities.

International Markets Profit

Profit from our International Markets segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our International Markets segment in the first quarter of 2026 was $65 million, a decrease of 33%, compared to the first quarter of 2025. This decrease was mainly due to lower gross profit, as discussed above.

Other Activities

We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our United States, Europe or International Markets segments described above.

In alignment with our Pivot to Growth strategy, commencing January 1, 2026, Anda is no longer reported under our United States segment. This shift allows the United States segment to continue to manage its entire product portfolio in the region, while strengthening focus on its biopharmaceutical business, growth engines and innovation. As a result, from that date, Anda is reported as part of the Company’s Other Activities. Prior period amounts were recast to reflect this change.

Our revenues from other activities in the first quarter of 2026 were $584 million, an increase of 1% compared to the first quarter of 2025. In local currency terms, revenues decreased by 1% compared to the first quarter of 2025.

Anda revenues from third-party products in the first quarter of 2026 were $378 million, an increase of 1%, compared to the first quarter of 2025. Anda, our distribution business in the United States operates independently and distributes generic and innovative medicines and OTC pharmaceutical products from various manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. Anda competes in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States.

API sales to third parties in the first quarter of 2026 were $109 million, a decrease of 17% in both U.S. dollars and local currency terms, compared to the first quarter of 2025. This decrease was mainly due to price reductions and lower demand due to market dynamics.

Revenues from additional other activities, mainly from Medis and certain contract manufacturing services, in the first quarter of 2026 were $97 million, an increase of 28% in U.S. dollars compared to the first quarter of 2025. In local currency terms, revenues increased by 16% compared to the first quarter of 2025, mainly due to higher demand.

2026 Financial Outlook

$ billions, except diluted
EPS or as noted Stand-Alone Outlook
(Jan. 2026) Emalex April 2026
Revenues 16.4 – 16.8 16.4 – 16.8
AUSTEDO ($m) 2,400 – 2,550 2,400 – 2,550
AJOVY ($m) 750 – 790 750 – 790
UZEDY ($m) 250 – 280 250 – 280
Operating Income* 4.55 – 4.8 (0.77) 3.8 – 4.0
Adjusted EBITDA* 5.0 – 5.3 (0.77) 4.23 – 4.53
Finance Expenses* ($m) ~800 ~800
Tax Rate* 16% – 19% (+400 bps to ETR) 20% – 23%
Diluted EPS* ($) 2.57 – 2.77 (0.66) 1.91 – 2.11
Free Cash Flow* 2.0 – 2.4 2.0 – 2.4
CAPEX 0.5 0.5
Foreign Exchange Volatile swings in FX can negatively impact revenue and income

*Certain items above are non-GAAP financial measures. For more information, see "Non-GAAP Financial Measures" below. Free Cash Flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables.

Conference Call

Teva will host a conference call and live webcast along with a slide presentation on Wednesday, April 29, 2026 at 8:00 a.m. ET to discuss its first quarter 2026 financial results and overall business environment.

A question & answer session will follow.

In order to participate, please register in advance here to obtain a local or toll‐free phone number and your personal pin.

A live webcast of the call will be available on Teva’s website at: www.tevapharm.com

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva’s website.

(Press release, Teva, APR 29, 2026, View Source [SID1234664899])

On April 29, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest") reported it will present its most recent clinical data from its lead dual-targeting chimeric antigen receptor T-cell ("CAR-T") therapy product candidate, TPST-2003, at the International Society for Cell & Gene Therapy ("ISCT") Scientific Annual Meeting in Dublin, May 6-9, 2026. Updates will include the latest data from the ongoing REDEEM-1 Phase 1/2a trial evaluating TPST-2003, as well as progress in Tempest’s other dual-targeting CAR-T pipeline programs.

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Earlier this year, Tempest announced positive interim data from REDEEM-1, including a 100% complete response rate among all six efficacy then-evaluable patients according to the International Myeloma Working Group (IMWG) uniform response criteria, as well as a favorable safety profile.

"We look forward to sharing the latest results from REDEEM-1 and updates on our other dual-targeting CAR-T programs at ISCT," said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "We believe that the results that we announced earlier this year suggest that TPST-2003 could offer a safe, effective option for patients with relapsed/refractory multiple myeloma ("rrMM"), and we continue to believe that replicating these results in the remainder of the REDEEM-1 trial and in a registrational trial would position TPST-2003 as a class-leading therapy for rrMM."

Presentation Details

REDEEM-1, a multicenter open-label Phase 1/2a study of a BCMA/CD19 dual-targeting CAR-T therapy in patients with relapsed/refractory multiple myeloma including those with extramedullary disease. Abstract #1268. Oral Presentation, May 6, 2026 (12:00-13:00 GMT) & Poster Reception, May 7, 2026 (18:00-19:30 GMT), Immunotherapy Session. Presenter: Dr. Matt Angel.

About TPST-2003

TPST-2003 is an autologous CD19/BCMA dual-targeting CAR-T therapy designed to improve response depth and durability in patients with relapsed/refractory multiple myeloma ("rrMM") through a parallel dual-targeting CAR structure designed to address tumor heterogeneity and antigen escape. TPST-2003 is being developed in China by Tempest’s partner, Novatim Immune Therapeutics ("Novatim"). Under its agreement with Novatim, Tempest has the exclusive right to develop TPST-2003 outside of China, India, Turkey, and Russia.

About REDEEM-1

REDEEM-1 (Study nos. CTR20233309/NCT06223646) is a Phase 1/2a clinical trial evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The REDEEM-1 trial has a targeted full enrollment of 29 patients. The REDEEM-1 trial is sponsored and being conducted by Tempest’s partner, Novatim Immune Therapeutics, with a total of eight clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), The First Affiliated Hospital of Nanchang University (Dr. Fei Li), Peking University First Hospital (Dr. Yujin Dong), Henan Cancer Hospital (Dr. Baijun Fang), Shanxi Provincial Cancer Hospital (Dr. Liping Su), The Second Xiangya Hospital of Central South University (Dr. Hongling Peng), The First Affiliated Hospital of China Medical University (Dr. Xiaojing Yan), and The Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College (Dr. Dehui Zou).

Additional Clinical Trials Evaluating TPST-2003

A Phase 1/2 IIT (Study no. NCT04714827) is evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The IIT is sponsored and being conducted by Tempest’s partner, Novatim, with a total of two clinical sites registered in China: Shanghai Fourth People’s Hospital (Dr. Weijun Fu; lead site) and Shanxi Provincial Cancer Hospital (Dr. Liping Su).

A Phase 1 trial (Study nos. CTR20242409/NCT06518876) is evaluating TPST-2003 in patients with POEMS, a rare blood disorder caused by abnormal plasma cells. The Phase 1 trial is sponsored and being conducted by Tempest’s partner, Novatim, with a total of three clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), Xuanwu Hospital Capital Medical University (Dr. Wanling Sun), and West China Hospital, Sichuan University (Dr. Yu Wu).

(Press release, Tempest Therapeutics, APR 29, 2026, View Source [SID1234664898])

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])