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TORONTO, May 07, 2025 (GLOBE NEWSWIRE) — Bitfarms Ltd. (NASDAQ/TSX: BITF), a global energy and compute infrastructure company, will report its first quarter 2025 financial results on Wednesday, May 14^th before the market opens. Management will host a conference call on the same day at 8:00 am ET. All Q1 2025 materials will be available before the call and can be accessed on the ‘Financial Results’ section of the Bitfarms investor site.

The live webcast and a webcast replay of the conference call can be accessed here. To access the call by telephone, register here to receive dial-in numbers and a unique PIN to join the call.

About Bitfarms Ltd.

Founded in 2017, Bitfarms is a global energy and compute infrastructure company that develops, owns, and operates vertically integrated HPC and Bitcoin mining data centers. Bitfarms currently has 15 operating Bitcoin data centers situated in four countries: the United States, Canada, Argentina and Paraguay.  

Powered primarily by environmentally friendly hydro-electric and long-term power contracts, Bitfarms is committed to using sustainable and often underutilized energy infrastructure. 
To learn more about Bitfarms’ events, developments, and online communities:  

To learn more about Bitfarms’ events, developments, and online communities:

www.bitfarms.com

https://www.facebook.com/bitfarms/

https://x.com/Bitfarms_io

https://www.instagram.com/bitfarms/



https://www.linkedin.com/company/bitfarms/

Investor Relations Contacts:

Tracy Krumme
SVP, Head of IR & Corp. Comms.
+1 786-671-5638
[email protected]

Media Contacts:

Caroline Brady Baker
Director, Communications and Marketing
[email protected]

— First quarter 2025 net product revenue from global sales of IMCIVREE

^®

 (setmelanotide) of $37.7 million —

— Setmelanotide pivotal Phase 3 TRANSCEND trial met primary endpoint with -19.8% placebo-adjusted BMI reduction in patients (N=120) with acquired hypothalamic obesity —

— U.S. and EU regulatory submissions for setmelanotide in acquired hypothalamic obesity on track to be completed in the third quarter of 2025
—

— Topline data from Phase 2 trial of oral MC4R agonist bivamelagon on track to be announced in third quarter of 2025 —

— Cash on-hand expected to support planned operations into 2027 —

— Management to host conference call today at 8:00
a.m.
ET —

BOSTON, May 07, 2025 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today reported financial results and provided a business update for the first quarter ended March 31, 2025.

“Following compelling topline results from our pivotal Phase 3 trial of setmelanotide in acquired hypothalamic obesity (HO), we look forward to completing U.S. and EU regulatory submissions in the third quarter of 2025 and, pending approval, bringing the first-ever known approved therapy for this serious disease to patients,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “In addition, we are advancing our next-generation MC4R agonists as we are on track to read out topline data from the Phase 2 trial evaluating the oral-daily bivamelagon in patients with HO in the third quarter of 2025.”

Dr. Meeker continued, “With BBS, we are pleased with the continued growth in the number of patients on reimbursed therapy with a steady increase in new physicians writing prescriptions in the United States along with the ongoing strong performance internationally. In addition, we believe Rhythm is well capitalized with cash runway into 2027, beyond multiple clinical and regulatory milestones expected this year and early next year.”

First Quarter and Recent Business Highlights

• Revenue from global sales of IMCIVREE (setmelanotide) was $37.7 million for the first quarter of 2025. The number of patients on reimbursed therapy increased 14% in the first quarter of 2025 compared to the fourth quarter of 2024, as patient demand for IMCIVREE remained strong. Revenue of $24.5 million, or 65% of product revenue, was generated in the United States. The number of patients on reimbursed therapy in the United States continued to increase during the quarter. U.S. revenue was affected by an $8.3 million decrease in inventory at the specialty pharmacy that dispenses IMCIVREE to patients and a $1.1 million increase in product dispensed to patients, resulting in a net decrease in U.S. product revenue of $7.2 million in the first quarter of 2025 compared to the fourth quarter of 2024. Revenue of $13.2 million, or 35% of product revenue, was generated outside the United States, an increase of $3.2 million quarter over quarter.
• On April 7, 2025, Rhythm announced its pivotal Phase 3 TRANSCEND trial met its primary endpoint with a -19.8% placebo-adjusted body mass index (BMI) reduction with setmelanotide in patients (N=120) with acquired HO;
  • Patients with acquired HO on setmelanotide therapy (n=81) achieved mean BMI change of -16.5% compared with +3.3% for placebo (n=39) at 52 weeks (p<0.0001);
  • -19.2% placebo-adjusted BMI reduction achieved in adult patients 18 years old and older (n=49) at 52 weeks;
  • -20.2% placebo-adjusted BMI reduction achieved in patients younger than 18 years old (n=71) at 52 weeks;
  • 80% of patients on setmelanotide achieved BMI reduction of 5% or greater at 52 weeks; and
  • No new safety signals with setmelanotide were observed, in line with setmelanotide’s well-established and well-understood safety profile.
• Today, Rhythm announced new data from the Phase 3 TRANSCEND trial that demonstrated a consistent and statistically significant mean BMI reduction across three stratified age groups:
  • -19.5% placebo-adjusted BMI reduction achieved in pediatric patients ages 4 to younger than 12 years old (n=31: 20 setmelanotide, 11 placebo) at 52 weeks (p<0.0001);
  • -21.0% placebo-adjusted BMI reduction achieved in adolescent patients ages 12 to younger than 18 years old (n=40: 28 setmelanotide, 12 placebo) at 52 weeks (p<0.0001); and
  • -19.2% placebo-adjusted BMI reduction achieved in adult patients ages 18 and older (n=49: 33 setmelanotide, 16 placebo) at 52 weeks (p<0.0001).
• On April 7, 2025, Rhythm announced it dosed the first patients with Prader-Willi syndrome (PWS) in a 26-week, open-label Phase 2 trial of setmelanotide. The trial will assess the safety and efficacy of a daily dose of subcutaneous setmelanotide in approximately 20 patients for up to 26 weeks;
• On March 20, 2025, Rhythm announced it reacquired the rights to IMCIVREE in China, including mainland China, Hong Kong and Macau, as the Company agreed to terminate its 2021 licensing agreement with RareStone Group Ltd.
• On March 19, 2025, Rhythm announced it received orphan drug designation from Japan’s Ministry of Health, Labour and Welfare (MHLW) for setmelanotide as a treatment for acquired hypothalamic obesity; and
• On March 18, 2025, Rhythm announced a new research collaboration with the Raymond A. Wood Foundation, a patient advocacy organization for survivors of craniopharyngioma and hypothalamic-pituitary brain tumors, to study the impact of fatigue on persons with craniopharyngioma.

Anticipated Upcoming Milestones

Rhythm expects to achieve the following near-term milestones:

• Submit a supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency for setmelanotide for the treatment of patients with acquired HO in the third quarter of 2025;
• Announce topline data from the bivamelagon Phase 2 trial in acquired HO in the third quarter of 2025;
• Complete enrollment in the setmelanotide Phase 2 trial in PWS in the second half of 2025;
• Complete enrollment in the Phase 1, Part C trial evaluating the weekly, MC4R agonist RM-718 in patients with acquired HO in the second half of 2025;
• Complete enrollment in the setmelanotide Phase 3 trial substudy in congenital HO in the second half of 2025;
• Announce topline data in the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired HO in the first quarter of 2026; and
• Announce topline data in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first quarter of 2026.

First Quarter 2025 Financial Results:

Cash Position: As of March 31, 2025, cash, cash equivalents and short-term investments were approximately $314.5 million, as compared to $320.6 million as of December 31, 2024.

Revenue: Net product revenues relating to global sales of IMCIVREE were $37.7 million for the first quarter of 2025, as compared to $26.0 million for the first quarter of 2024. License revenue for the first quarter of 2025 was ($5.0) million, a reduction entirely due to the termination of an exclusive license agreement with RareStone Group Ltd. and the repayment by Rhythm of a portion of previously-recognized license revenue.

R&D Expenses: R&D expenses were $37.0 million in the first quarter of 2025, as compared to $128.7 million in the first quarter of 2024. The decrease was primarily due to the R&D expenses incurred in the first quarter of 2024 related to in-process research and development costs totaling $92.4 million associated with the acquisition of LG Chem’s proprietary compound bivamelagon, which did not recur in 2025.

SG&A Expenses: SG&A expenses were $39.1 million for the first quarter of 2025, as compared to $34.4 million for the first quarter of 2024. The year-over-year increase was primarily due to increased headcount and an increase in marketing to support continued revenue growth.

Other expense, net: Other expense, net was $2.4 million for the first quarter of 2025, as compared to other expense, net of $1.2 million for the first quarter of 2024.

Net Loss: Net loss attributable to common stockholders was ($50.8) million for the first quarter of 2025, or a net loss per basic and diluted share of ($0.81), as compared to a net loss attributable to common stockholders of ($141.4) million for the first quarter of 2024, or a net loss per basic and diluted share of ($2.35).

Financial Guidance: For the year ending December 31, 2025, Rhythm anticipates approximately $285 million to $315 million in Non-GAAP Operating Expenses. Non-GAAP Operating Expenses are derived from:

• GAAP total operating expenses, inclusive of:
  • SG&A expenses of approximately $135 million to $145 million;
  • R&D expenses of approximately $150 million to $170 million; and
  • Excluding stock-based compensation.

Non-GAAP Operating Expenses is defined as GAAP operating expenses excluding stock-based compensation and fixed consideration related to in-licensing (see below under “Non-GAAP Financial Measures” for more details).

Based on its current operating plans, Rhythm expects that its existing cash, cash equivalents and short-term investments as of March 31, 2025, will be sufficient to fund its operating expenses and capital expenditure requirements into 2027.

Conference Call Information

Rhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET today to review its first quarter 2025 financial results and recent business activities. Participants may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled start.

A webcast of the call will also be available under “Events and Presentations” in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for 30 days following the call.

About Rhythm Pharmaceuticals

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE^® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

Setmelanotide Indication

In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Limitations of Use

Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:

• Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or
  LEPR variants classified as benign or likely benign
• Other types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity

Contraindication

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol preserved drugs.

ADVERSE REACTIONS
Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.

Please see the full Prescribing Information for additional Important Safety Information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the safety, efficacy, potential benefits of, and clinical design or progress of any of our products or product candidates at any dosage or in any indication, including, setmelanotide, bivamelagon, and RM-718; the potential use of setmelanotide in patients with acquired hypothalamic obesity; the commercial growth of IMCIVREE; our expectations surrounding potential regulatory submissions, progress, or approvals and timing thereof for any of our product candidates, including the anticipated supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency; the estimated market size and addressable population for our drug products, including setmelanotide for the treatment of hypothalamic obesity; the future announcement of data from our ongoing clinical trials, including the Japanese cohort of our Phase 3 trial evaluating setmelanotide for patients with acquired hypothalamic obesity, the substudy evaluating setmelanotide for patients with congenital hypothalamic obesity, the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases, and the Phase 2 trial evaluating the oral MC4R agonist bivamelagon in acquired hypothalamic obesity; Part C of the Phase 1 trial evaluating RM-718; the open-label Phase 2 trial evaluating setmelanotide in patients with Prader-Willi syndrome; the ongoing enrollment in our clinical trials; the Company’s business strategy and plans; our anticipated financial performance and financial position for any period of time, including estimated Non-GAAP Operating Expenses for the year ending December 31, 2025; and the sufficiency of our cash, cash equivalents and short-term investments to fund our operations; and the timing of any of the foregoing. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will”, “aim” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the ability to achieve necessary regulatory approvals, risks associated with data analysis and reporting, failure to identify and develop additional product candidates, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing our international operations and the costs of any related compliance programs, the impact of competition, risks relating to product liability lawsuits, inability to maintain collaborations, or the failure of these collaborations, our reliance on third parties, risks relating to intellectual property, our ability to hire and retain necessary personnel, general economic conditions, risks related to internal control over financial reporting, and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this press release or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise.

Non-GAAP Financial Measures

This press release includes Non-GAAP Operating Expenses, a supplemental measure of our performance that is not required by, or presented in accordance with, U.S. GAAP and should not be considered as an alternative to operating expenses or any other performance measure derived in accordance with GAAP.

We define Non-GAAP Operating Expenses as GAAP operating expenses excluding stock-based compensation and fixed consideration related to in-licensing.

We caution investors that amounts presented in accordance with our definition of Non-GAAP Operating Expenses may not be comparable to similar measures disclosed by our competitors because not all companies and analysts calculate this non-GAAP financial measure in the same manner. We present this non-GAAP financial measure because we consider it to be an important supplemental measure of our performance and believe it is frequently used by securities analysts, investors, and other interested parties in the evaluation of companies in our industry. Management believes that investors’ understanding of our performance is enhanced by including this non-GAAP financial measure as a reasonable basis for comparing our ongoing results of operations.

Management uses this non-GAAP financial measure for planning purposes, including the preparation of our internal annual operating budget and financial projections; to evaluate the performance and effectiveness of our operational strategies; and to evaluate our capacity to expand our business. This non-GAAP financial measure has limitations as an analytical tool, and should not be considered in isolation, or as an alternative to, or a substitute for operating expenses or other financial statement data presented in accordance with GAAP in our consolidated financial statements.

Rhythm has not provided a quantitative reconciliation of forecasted Non-GAAP Operating Expenses to forecasted GAAP operating expenses because the Company is unable, without making unreasonable efforts, to calculate the reconciling item, stock-based compensation expenses, with confidence. This item, which could materially affect the computation of forward-looking GAAP operating expenses, is inherently uncertain and depends on various factors, some of which are outside of Rhythm’s control.

Corporate Contact:

David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
[email protected]

Media Contact:

Sheryl Seapy
Real Chemistry
(949) 903-4750
[email protected]

Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (Unaudited)
		March 31,				December 31,
		2025				2024
Assets
Current assets:
Cash and cash equivalents		$	106,095			$	89,137
Short-term investments			208,393				231,428
Accounts receivable, net			17,825				18,512
Inventory			19,316				18,741
Prepaid expenses and other current assets			17,659				16,382
Total current assets			369,288				374,200
Property and equipment, net			462				632
Right-of-use asset			3,367				3,477
Intangible assets, net			5,960				6,174
Restricted cash			464				464
Other long-term assets			7,144				7,326
Total assets		$	386,685			$	392,273
Liabilities, Convertible Preferred Stock and Stockholders’ equity
Current liabilities:
Accounts payable		$	11,912			$	12,328
Accrued expenses and other current liabilities			59,314				62,658
Other current liability – LG Chem			38,783				37,704
Lease liability			224				—
Deferred revenue			—				1,286
Deferred royalty obligation, current			1,590				1,541
Total current liabilities			111,823				115,517
Long-term liabilities:
Deferred royalty obligation			107,934				108,269
Lease liability, non-current			3,839				3,938
Total liabilities			223,596				227,724
Commitments and contingencies (Note 13)
Series A convertible preferred stock, $0.001 par value: 150,000 shares authorized; 150,000 and 0 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively. Liquidation preference of $150,000 as of March 31, 2025.			144,142				142,820
Stockholders’ equity:
Preferred stock, $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2025 and December 31, 2024			—				—
Common stock, $0.001 par value: 120,000,000 shares authorized; 63,494,892 and 62,390,654 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively			62				61
Additional paid-in capital			1,223,772				1,177,045
Accumulated other comprehensive (loss)			(51	)			(39	)
Accumulated deficit			(1,204,836	)			(1,155,338	)
Total stockholders’ equity			18,947				21,729
Total liabilities, convertible preferred stock and stockholders’ equity		$	386,685			$	392,273

Rhythm Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (Unaudited)
		Three months ended March 31,
		2025				2024
Revenues:
Product revenue, net		$	37,718			$	25,967
License revenue			(5,014	)			—
Total revenues			32,704				25,967
Costs and expenses:
Cost of sales			3,648				2,807
Research and development			36,973				128,665
Selling, general, and administrative			39,087				34,382
Total costs and expenses			79,708				165,854
Loss from operations			(47,004	)			(139,887	)
Other income (expense):
Other income (expense), net			(644	)			524
Interest expense			(5,409	)			(4,755	)
Interest income			3,639				3,046
Total other (expense), net			(2,414	)			(1,185	)
Loss before income taxes			(49,418	)			(141,072	)
Provision for income taxes			80				300
Net loss		$	(49,498	)		$	(141,372	)
Accrued dividends on convertible preferred stock			(1,322	)			—
Net loss attributable to common stockholders		$	(50,820	)		$	(141,372	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.81	)		$	(2.35	)
Weighted-average common shares outstanding, basic and diluted			63,059,165				60,143,558
Other comprehensive loss:
Net loss attributable to common stockholders		$	(50,820	)		$	(141,372	)
Foreign currency translation adjustment			(2	)			(71	)
Unrealized (loss), net on marketable securities			(10	)			(244	)
Comprehensive loss		$	(50,832	)		$	(141,687	)

Singapore, May 07, 2025 (GLOBE NEWSWIRE) — YY Group Holding Limited (NASDAQ: YYGH) (“YY Group,” “YYGH,” or the “Company”) is thrilled to announce a significant milestone as its flagship on-demand job matching platform, YY Circle, continues to expand its footprint, meeting the surging global demand for innovative workforce solutions.

Driving Innovation Across Europe

In Europe, YY Circle is making significant strides:

• YY Circle UK, based in London, is gaining momentum, serving an impressive portfolio of clients and solidifying its position as a trusted partner for businesses in the region.
• YY Circle Netherlands is on track to go live by the end of this May, marking a pivotal step in expanding YY Circle’s presence in Northern Europe.
• YY Circle Germany is poised to launch within 6 to 8 weeks, reinforcing YY Group’s commitment to delivering innovative solutions across the continent.

Accelerating Growth in the Middle East and North Africa

YY Circle continues its rapid growth trajectory in the Middle East and North Africa:

• YY Circle United Arab Emirates is experiencing significant market share expansion as it responds to the demand for flexible workforce solutions and cutting-edge labor matching technology. This growth highlights the platform’s ability to empower businesses with dynamic and scalable tools tailored to the UAE’s vibrant market.
• YY Circle Egypt, currently under development, is set to go live by July 2025, further strengthening YY Group’s footprint in the region.

Expanding Success Across Asia Pacific

In Asia, YY Circle’s comprehensive presence in Singapore, Malaysia, Australia, Vietnam, Cambodia, Hong Kong and Korea showcases its robust performance and growing market influence.

Additionally, the full acquisition of YY Circle Thailand by May will streamline operations and boost growth in Southeast Asia.

A Unified Vision for Growth and Innovation

“YY Circle’s expansion reflects our unwavering commitment to delivering cutting-edge solutions tailored to the diverse needs of our clients,” said Mike Fu, Group CEO of YY Group Holding Limited. “We are excited to strengthen our presence across these dynamic regions and continue empowering businesses worldwide.”

YY Group’s strategic investments in technology, sustainability, and regional expertise underscore its dedication to redefining industry standards while addressing local and global challenges.

Safe Harbor Statement

This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about YY Group Holding Limited’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. These factors include but are not limited to (i) growth of the workforce market in Europe, the Middle East, Africa, and Asia, (ii) capital and credit market volatility, (iii) local and global economic conditions, (iv) our anticipated growth strategies, (v) governmental approvals and regulations, and (vi) our future business development, results of operations and financial condition. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. All information provided in this press release is as of the date of this press release, and YY Group Holding Limited undertakes no duty to update such information except as required under applicable law.

About YY Circle:

YY Circle is a leading provider of interactive social networking solutions, dedicated to connecting individuals through innovative technology. With a focus on user experience and community engagement, YY Circle aims to foster meaningful connections and empower individuals worldwide.

About YY Holdings Limited:

YY Group Holding Limited (Nasdaq: YYGH) is a Singapore-headquartered, technology-enabled platform providing flexible, scalable workforce solutions and integrated facility management (IFM) services across Asia and beyond. The Group operates through two core verticals: on-demand staffing and IFM, delivering agile, reliable support to industries such as hospitality, logistics, retail, and healthcare.

Leveraging proprietary digital platforms and IoT-driven systems, YY Group enables clients to meet fluctuating labor demands and maintain high-performance environments. In addition to its core operations in Singapore and Malaysia, the Group maintains a growing presence in Southeast Asia, Europe, and the Middle East

Listed on the Nasdaq Capital Market, YY Group is committed to service excellence, operational innovation, and long-term value creation for clients and shareholders.

For more information on the Company, please log on to https://yygroupholding.com/.

Investor Contact:

Phua Zhi Yong, Chief Financial Officer
YY Group
[email protected]

Mark Niu, Chief Strategy Officer,
YY Group
[email protected]

REHOVOT, Israel, and HOBOKEN, N.J., May 07, 2025 (GLOBE NEWSWIRE) — Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced that it will release financial results for the first quarter that ended March 31, 2025, prior to the open of the U.S. financial markets on Wednesday, May 14, 2025.

Kamada management will host an investment community conference call on Wednesday, May 14, at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the call by dialing 1-877-407-0792 (from within the U.S.), 1-809-406-247 (from Israel), or 1-201-689-8263 (International) using conference I.D. 1375314. The call will be webcast live on the internet at: https://viavid.webcasts.com/starthere.jsp?ei=1715006&tp_key=c9896a4811. 

About Kamada

Kamada Ltd. (the “Company”) is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived therapies field. The Company’s strategy is focused on driving profitable growth through four primary growth pillars: First, organic growth from its commercial activities, including continued investment in the commercialization and life cycle management of its proprietary products, which include six FDA-approved specialty plasma-derived products: KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG® and HEPAGAM B®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom products, and the products in the distribution segment portfolio, mainly through the launch of several biosimilar products in Israel. Second: the Company aims to secure significant new business development, in-licensing, collaboration and/or merger and acquisition opportunities, which are anticipated to enhance the Company’s marketed products portfolio and leverage its financial strength and existing commercial infrastructure to drive long-term growth. Third: the Company is expanding its plasma collection operations to support revenue growth through the sale of normal source plasma to other plasma-derived manufacturers, and to support its increasing demand for hyper-immune plasma. The Company currently owns three operating plasma collection centers in the United States, in Beaumont Texas, Houston Texas, and San Antonio, Texas. Lastly, the Company is leveraging its manufacturing, research and development expertise to advance the development and commercialization of additional product candidates, targeting areas of significant unmet medical need, with the lead product candidate Inhaled AAT, for which the Company is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares.

CONTACTS:

Chaime Orlev
Chief Financial Officer
[email protected]

Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
[email protected]

• Worldwide revenue of $372.8 million in the first quarter 2025
• GAAP fully diluted earnings per share of $1.02, compared to $1.87 in the first quarter of 2024; adjusted fully diluted earnings per share of $1.53, compared to $1.69 in the first quarter of 2024
• Free cash flow totaled $98.8 million for the first quarter 2025
• Closed acquisition of Evergreen Theragnostics early in the second quarter; expect to close on acquisition of Life Molecular Imaging in the coming weeks; and yesterday announced planned divestiture of SPECT business
• Recently announced positive data for two MK-6240 pivotal studies; plan to file NDA in the third quarter of 2025
• Provided updated interim corporate guidance for full year 2025 revenue and adjusted fully diluted earnings per share

BEDFORD, Mass., May 07, 2025 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. (Lantheus or the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today reported financial results for its first quarter ended March 31, 2025.

“We are laying the foundation for the next chapter of Lantheus’ business with the acquisition of Evergreen Theragnostics and planned acquisition of Life Molecular Imaging, both of which add growth drivers that complement our business and diversify our revenues. These transactions also add exciting new pipeline programs in both late- and early-stage development and key capabilities that enable Lantheus to progress novel programs from bench to clinic,” said Brian Markison, Chief Executive Officer at Lantheus. “With robust cash flow and a disciplined capital allocation strategy, we are advancing our position as the leading radiopharmaceutical-focused company. We remain dedicated to being the partner of choice for nuclear medicine departments and free-standing imaging centers, delivering sustainable growth, creating long-term value for our shareholders, and bringing innovative products to patients in need.”

Summary Financial Results

(in millions, except per share data – unaudited)		Three Months Ended March 31,
			2025			2024		% Change
Worldwide revenue		$	372.8		$	370.0		0.8	%
GAAP net income		$	72.9		$	131.1		(44.3)	%
GAAP fully diluted earnings per share		$	1.02		$	1.87		(45.5)	%
Adj. net income (non-GAAP)		$	109.5		$	118.3		(7.5)	%
Adj. fully diluted earnings per share (non-GAAP)		$	1.53		$	1.69		(9.5)	%

First Quarter 2025

• Sales of PYLARIFY were $257.7 million, a decrease of 0.5%.
• Sales of DEFINITY were $79.2 million, an increase of 3.5%.
• Operating income decreased 4.3% to $102.1 million. Adjusted operating income (non-GAAP) decreased 7.1% to $144.3 million.
• Fully diluted earnings per share decreased to $1.02, compared to $1.87 in the prior year period. Adjusted fully diluted earnings per share (non-GAAP) decreased 9.5% to $1.53, compared to $1.69 in the prior year period.
• Net cash provided by operating activities and free cash flow were $107.6 million and $98.8 million, respectively.

Balance Sheet

• At March 31, 2025, the Company’s cash and cash equivalents grew to $938.5 million, compared to $912.8 million at December 31, 2024, after prepaying a $50.0 million deposit related to our Evergreen Theragnostics, Inc. (Evergreen) acquisition, which closed early in the second quarter of 2025.
• The Company currently has access to up to $750.0 million from a revolving line of credit.

Recent Business Highlights

Business Development Updates

• In January, the Company announced an agreement to acquire Life Molecular Imaging Ltd. (Life Molecular), which is now expected to close in the second quarter of 2025, subject to customary closing conditions. The acquisition will provide Lantheus with Neuraceq^®, a globally approved beta-amyloid targeted radiodiagnostic for Alzheimer’s disease, along with a strong commercial footprint and infrastructure. The deal is complementary to Lantheus’ portfolio of late-stage neurology radiodiagnostics and builds on the acquisition of worldwide rights to LNTH-2401 (⁶⁸Ga-DOTA-RM2) and LNTH-2402 (¹⁷⁷Lu-DOTA-RM2) announced last year.
• Also in January, the Company announced an agreement to acquire Evergreen, a clinical-stage radiopharmaceutical company based in New Jersey. On April 1, we announced the completion of the acquisition. Through the transaction, Lantheus has acquired OCTEVY^™, a registrational-stage PET imaging agent targeting neuroendocrine tumors, which complements Lantheus’ therapeutic candidate PNT2003, as well as acquiring a portfolio of clinical and pre-clinical theranostic pairs. The acquisition also advances Lantheus’ capabilities with the addition of Evergreen’s radioligand therapy manufacturing infrastructure, including a revenue-generating CDMO business.
• On May 6, 2025, the Company announced the agreement to sell the Company’s SPECT business to Illuminated Holdings, Inc., the parent company of SHINE Technologies, LLC (SHINE). Under the terms of the agreement, SHINE will acquire Lantheus’ SPECT business, including its diagnostic agents (TechneLite, NEUROLITE, Xenon Xe-133 Gas, and Cardiolite), the portion of the North Billerica, MA campus that manufactures Lantheus’ SPECT products and the SPECT-related Canadian operations. The transaction allows Lantheus to focus on growing its commercial portfolio of innovative PET radiodiagnostics and microbubbles, while advancing its pipeline of radiopharmaceuticals. The transaction is expected to close by the end of the year, subject to customary closing conditions.

Radiopharmaceutical Pipeline Updates

• Lantheus recently announced that MK-6240, its next-generation tau imaging agent, met its primary endpoints in two pivotal clinical studies assessing the investigational asset’s sensitivity and specificity. The Company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2025.
• LNTH-2503, a potentially best- and first-in-class lutetium-177 theranostic pair targeting the cholecystokinin receptor (CCK2R) brought in by the Evergreen acquisition, has been authorized to proceed with a therapeutic Phase 1 study in patients with small cell lung cancer by the European Medicines Agency (EMA). The Company expects to initiate the Phase 1 therapeutic study in the United States later this year and continue its ongoing Phase 2 gallium-68 imaging study.
• The Phase 3 SPLASH study of PNT2002 recently reached 100% of prespecified overall survival events. The results were comparable to the previously reported 46% and 75% readouts and remain confounded by patient crossover within the study. The Company is working closely with partner, Eli Lilly and Company, to review the full dataset, however the Company does not plan to pursue an NDA or further invest in this asset.

Full Year 2025 Interim Corporate Financial Guidance

		Guidance Issued May 7, 2025	Guidance Issued February 26, 2025
FY 2025 Revenue		$1.550 billion – $1.585 billion	$1.545 billion – $1.610 billion
FY 2025 Adjusted fully diluted EPS		$6.60 – $6.70	$7.00 – $7.20

On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of GAAP income per common share to adjusted fully diluted EPS because the Company is unable to predict with reasonable certainty business development and acquisition related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.

Conference Call and Webcast

As previously announced, the Company will host a conference call and webcast on Wednesday, May 7, 2025, at 8:00 a.m. ET. To access the conference call or webcast, participants should register online at https://investor.lantheus.com/news-events/calendar-of-events.

A replay will be available approximately two hours after completion of the webcast and will be archived on the same web page for at least 30 days.

The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

About Lantheus Holdings, Inc.

Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com. 

Internet Posting of Information

The Company routinely posts information that may be important to investors in the “Investors” section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company. 

Non-GAAP Financial Measures

The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share – fully diluted; adjusted operating income and its line components, and free cash flow. The Company’s management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company’s operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company’s reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “advance,” “believe,” “continue,” “could,” “driving,” “expect,” “guidance,” “maintain,” “may,” “on track,” “plan,” “potential,” “predict,” “progress,” “should,” “target,” “will,” “would” and other similar terms. Such forward-looking statements include our guidance for the fiscal year 2025 and our plans to expand our portfolio of late-stage assets and high potential early-stage candidates, our acquisition of Evergreen, our potential acquisition of Life Molecular and our plans to divest our SPECT business to SHINE, and are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) continued market expansion and penetration for our established commercial products, particularly PYLARIFY and DEFINITY, in a competitive environment and our ability to clinically and commercially differentiate our products; (ii) our ability to have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility, in amounts and at the times needed; (iii) the availability of raw materials, key components, and equipment, either used in the production of our products and product candidates, or in the use by healthcare professionals of our products and product candidates, including, but not limited to positron emission tomography (“PET”) scanners for PYLARIFY, MK-6240 and NAV-4694; (iv) our ability to satisfy our obligations under our existing clinical development partnerships using MK-6240 or NAV-4694 as a research tool and under the license agreements through which we have rights to MK-6240 and NAV-4694, and to further develop and commercialize MK-6240 and NAV-4694 as approved products, including the timing for any potential regulatory submissions for these investigational assets; (v) our ability to successfully integrate acquisitions, including of Life Molecular, subject to completion of our acquisition thereof, and Evergreen, including the potential for unforeseen expenses related to integration activities, the accuracy of our financial models, the potential for unforeseen liabilities within those businesses, the ability to integrate disparate information technology systems, retain key talent and create a merged corporate culture that successfully realizes the full potential of the combined organization; (vi) our ability to complete the transaction with SHINE on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to securing the necessary regulatory approvals and satisfaction of other closing conditions to consummate the transaction, unforeseen expenses related to the divestiture, and failure to realize the expected benefits of the transaction; (vii) our ability to obtain FDA approval for LNTH-2501, our investigational kit for the preparation of Gallium-68 DOTATOC, which may be used in conjunction with a PET scan to stage and localize gastroenteropancreatic neuroendocrine tumors in adults and children, and approval for PNT2003, and to be successful in the patent litigation associated with PNT2003; (viii) the cost, efforts and timing for clinical development, regulatory approval, adequate coding, coverage and payment and successful commercialization of our product candidates and new clinical applications and territories for our products, in each case, that we or our strategic partners may undertake; (ix) our ability to identify opportunities to collaborate with strategic partners and to acquire or in-license additional diagnostic and therapeutic product opportunities in oncology, neurology and other strategic areas and continue to grow and advance our pipeline of products; and (x) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

– Tables Follow –

Lantheus Holdings, Inc. Consolidated Statements of Operations (in thousands, except per share data – unaudited)
		Three Months Ended March 31,
			2025				2024
Revenues		$	372,764			$	369,975
Cost of goods sold			135,064				128,129
Gross profit			237,700				241,846
Operating expenses
Sales and marketing			42,503				45,546
General and administrative			56,816				47,895
Research and development			36,314				48,024
Total operating expenses			135,633				141,465
Gain on sale of assets			—				6,254
Operating income			102,067				106,635
Interest expense			4,804				4,859
Investment in equity securities – unrealized loss (gain)			14,862				(60,704	)
Other income			(14,128	)			(8,788	)
Income before income taxes			96,529				171,268
Income tax expense			23,584				40,202
Net income		$	72,945			$	131,066
Net income per common share:
Basic		$	1.06			$	1.91
Diluted		$	1.02			$	1.87
Weighted-average common shares outstanding:
Basic			68,675				68,757
Diluted			71,461				70,095

Lantheus Holdings, Inc. Consolidated Revenues Analysis (in thousands – unaudited)
		Three Months Ended March 31,
			2025			2024		% Change
PYLARIFY		$	257,654		$	258,870		(0.5)	%
Other radiopharmaceutical oncology			—			384		(100.0)	%
Total radiopharmaceutical oncology			257,654			259,254		(0.6)	%
DEFINITY			79,211			76,564		3.5	%
TechneLite			19,711			21,714		(9.2)	%
Other precision diagnostics			5,441			5,932		(8.3)	%
Total precision diagnostics			104,363			104,210		0.1	%
Strategic partnerships and other revenue			10,747			6,511		65.1	%
Total revenues		$	372,764		$	369,975		0.8	%

Lantheus Holdings, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (in thousands, except per share and percent data – unaudited)
		Three Months Ended March 31,
			2025				2024
Net income		$	72,945			$	131,066
Stock and incentive plan compensation			21,198				15,384
Amortization of acquired intangible assets			8,016				9,932
Campus consolidation costs			60				19
Non-recurring fees			2,478				—
Gain on sale of assets			—				(6,254	)
Strategic collaboration and license costs			5,413				28,000
Investment in equity securities – unrealized loss (gain)			14,862				(60,704	)
Acquisition-related costs			4,751				788
Other			(4,452	)			789
Income tax effect of non-GAAP adjustments(a)			(15,796	)			(701	)
Adjusted net income		$	109,475			$	118,319
Adjusted net income, as a percentage of revenues			29.4	%			32.0	%

		Three Months Ended March 31,
			2025				2024
Net income per share – diluted		$	1.02			$	1.87
Stock and incentive plan compensation			0.30				0.22
Amortization of acquired intangible assets			0.11				0.14
Campus consolidation costs			—				—
Non-recurring fees			0.03				—
Gain on sale of assets			—				(0.09	)
Strategic collaboration and license costs			0.07				0.40
Investment in equity securities – unrealized loss (gain)			0.21				(0.86	)
Acquisition-related costs			0.07				0.01
Other			(0.06	)			0.01
Income tax effect of non-GAAP adjustments(a)			(0.22	)			(0.01	)
Adjusted net income per share – diluted		$	1.53			$	1.69
Weighted-average common shares outstanding – diluted			71,461				70,095

(a)	The income tax effect of the adjustments between GAAP net income and adjusted net income (non-GAAP) takes into account the tax treatment and related tax rate that apply to each adjustment in the applicable tax jurisdiction.

Lantheus Holdings, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Continued) (in thousands, except per share and percent data – unaudited)
		Three Months Ended March 31,
			2025				2024
Operating income		$	102,067			$	106,635
Stock and incentive plan compensation			21,198				15,384
Amortization of acquired intangible assets			8,016				9,932
Campus consolidation costs			60				19
Non-recurring fees			2,478				—
Gain on sale of assets			—				(6,254	)
Strategic collaboration and license costs			5,413				28,000
Acquisition-related costs			4,751				788
Other			275				789
Adjusted operating income		$	144,258			$	155,293
Adjusted operating income, as a percentage of revenues			38.7	%			42.0	%

Lantheus Holdings, Inc. Reconciliation of Free Cash Flow (in thousands – unaudited)
	Three Months Ended March 31,
		2025				2024
Net cash provided by operating activities	$	107,563			$	127,238
Capital expenditures		(8,718	)			(8,273	)
Free cash flow	$	98,845			$	118,965
Net cash used in investing activities	$	(63,718	)		$	(106,529	)
Net cash used in financing activities	$	(18,219	)		$	(16,845	)

Lantheus Holdings, Inc. Condensed Consolidated Balance Sheets (in thousands – unaudited)
	March 31, 2025				December 31, 2024
Assets
Current assets
Cash and cash equivalents	$	938,533			$	912,814
Accounts receivable, net		348,749				321,258
Inventory		69,126				68,025
Other current assets		67,372				24,536
Total current assets		1,423,780				1,326,633
Investment in equity securities		30,375				39,489
Property, plant and equipment, net		180,783				176,798
Intangibles, net		153,745				161,761
Goodwill		61,189				61,189
Deferred tax assets, net		168,885				170,233
Other long-term assets		36,467				44,237
Total assets	$	2,055,224			$	1,980,340
Liabilities and stockholders’ equity
Current liabilities
Current portion of long-term debt and other borrowings	$	747			$	974
Accounts payable		44,874				34,560
Accrued expenses and other liabilities		202,381				204,992
Total current liabilities		248,002				240,526
Asset retirement obligations		18,740				23,344
Long-term debt, net and other borrowings		566,098				565,279
Other long-term liabilities		58,190				63,180
Total liabilities		891,030				892,329
Commitments and contingencies
Stockholders’ equity
Preferred stock ($0.01 par value, 25,000 shares authorized; no shares issued and outstanding)		—				—
Common stock ($0.01 par value, 250,000 shares authorized; 71,607 and 70,905 shares issued as of March 31, 2025 and December 31, 2024, respectively)		716				709
Additional paid-in capital		821,346				817,972
Treasury Stock at cost – 2,455 shares as of March 31, 2025 and December 31, 2024		(175,000	)			(175,000	)
Retained earnings		518,890				445,945
Accumulated other comprehensive loss		(1,758	)			(1,615	)
Total stockholders’ equity		1,164,194				1,088,011
Total liabilities and stockholders’ equity	$	2,055,224			$	1,980,340

Contacts:

Mark Kinarney
Vice President, Investor Relations
978-671-8842
[email protected]

Melissa Downs
Executive Director, External Communications
646-975-2533
[email protected]

TEL AVIV, Israel, May 07, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will host Innovation & Strategy Day on Thursday, May 29, 2025 to discuss the acceleration phase of its strategy and portfolio priorities. The event will take place in New York, N.Y. Presentations will begin at 8:30 a.m. Eastern Time and are expected to conclude at 12:30 p.m. Eastern Time.

Richard Francis, Teva’s President and CEO, along with other members of the executive management team will discuss an update on the strategy and key priorities focusing on growth and innovation.

Due to limited capacity, in-person attendance is by invitation only. Analysts and institutional investors will be invited to pre-register and attend through an invite that will is distributed separately.

For questions regarding the event, please contact Teva’s Investor Relations team at [email protected].

A live webcast of the event and presentation materials will be available on Teva’s Investor Relations website at: https://ir.tevapharm.com/Events-and-Presentations.

An archived version of the webcast will be available within 24 hours after the end of the live discussion.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release and the conference call may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace including our ability to successfully execute our Pivot to Growth strategy; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in this press release, in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned “Risk Factors” and “Forward-looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

For an accessible version of this Press Release, please visit www.tevapharm.com

• On track for 30% operating profit margin by 2027 in line with our Pivot to Growth Strategy; Q1 2025 shows ninth consecutive quarter of revenue growth, excluding revenues recorded for Sanofi collaboration.
• Q1 2025 revenues of $3.9 billion, an increase of 5%; net of $100 million foreign exchange impact, reported revenues growth of 2%.
• AUSTEDO^® – shows continued strong growth, with worldwide revenues of $411 million in Q1 2025, an increase of 39% in local currency terms compared to Q1 2024; increasing 2025 full-year revenue outlook from ~$1.9-2.05 billion to $1.95-2.05 billion.
• AJOVY^® – global revenues of $139 million in Q1 2025, an increase of 26% in local currency terms compared to Q1 2024. Reaffirming $600M 2025 revenue outlook.
• UZEDY^® continues strong momentum – global revenues of $39 million in Q1 2025.
• The generics business grew across all regions – increased by 5% in the U.S., 1% in Europe and 2% in International Markets, all in local currency terms, as compared to Q1 2024.

• Duvakitug (Anti-TL1A) Phase 3 ready; program initiation expected in H2 2025; preparing for olanzapine LAI FDA NDA submission in H2 2025.
• Transforming Teva: Targeted programs to deliver~$700 million of net savings, after incremental reinvestment behind growth, to transform Teva into a modern biopharmaceutical company and achieving 30% operating margin target in 2027.
• Current, confirmed U.S. tariffs expected to have immaterial impact; absorbed in updated 2025 non-GAAP outlook.
• Teva to host Innovation & Strategy Day on Thursday, May 29 in New York, NY.

Q
1
202
5
Highlights:

• Revenues of $3.9 billion
• GAAP diluted EPSof $0.18
• Non-GAAP diluted EPS of $0.52, an increase of $0.04 or 8% year-over-year
• Cash flow used in operating activities of $105 million
• Free cash flow of $107 million
• Underlying full-year outlook increased, excluding the impact of the Japan BV divestiture which closed on March 31, 2025 full year 2025 business outlook⁽¹⁾⁽²⁾revised:
  • Revenues of $16.8 ‐ $17.2 billion (-$200 million impact from at the high-end)
  • Non‐GAAP operating income of $4.3‐$4.6 billion (+$200 million at the low-end; mid-point increased by $100 million)
  • Adjusted EBITDA of $4.7 ‐ $5.0 billion(+$200 million at the low-end; same as above)  
  • Non‐GAAP diluted EPS of $2.45 ‐ $2.65 (+$0.10 at the low-end, mid-point increased by $0.10)
  • Free cash flow of $1.6 ‐ $1.9 billion(unchanged)

(1) Revised 2025 outlook now includes no contribution from the Japan BV after Q1 and continues to include a full year contribution from Teva API, as well as exclude the expected income from development milestone payments from Sanofi in connection with the Phase 3 ulcerative colitis and Crohn’s Disease initiations for duvakitug.

(2) This outlook is based on the existing tariff and trade environment as of May 7, 2025, and does not reflect any policy shifts, including pharmaceutical sector tariffs, that could impact business.

TEL AVIV, May 07, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended March 31, 2025.

Mr. Richard Francis, Teva’s President and CEO, said, “Teva had a solid start to the year, with its ninth consecutive quarter of revenue growth, delivering global revenues of $3.9 billion, an increase of 5% in local currency terms compared to the first quarter of 2024. Our key innovative growth drivers continue to show strong momentum, collectively generating revenues of $589 million while each growing more than 25% year over year. We also achieved solid generics performance across all regions with biosimilars rounding out the portfolio.”

Mr. Francis continued, “Now entering the Acceleration Phase of our Pivot to Growth Strategy, we have a clear roadmap to continue Teva’s transformation into a leading biopharmaceutical company with an expected 30% operating margin and today have announced ~$700 million net savings by 2027. We’re accelerating innovative growth and strengthening our generics business, while streamlining our operations, sharpening our business and optimizing processes. With these results, we are revising our 2025 outlook and reaffirming our 2027 targets.”

Pivot to Growth Strategy

In Q1 2025, we continued to execute on the four key pillars of our Pivot to Growth strategy, which we announced in May 2023.

• Delivering on our Growth Engines – on the first pillar, we continued to demonstrate strong performance of our key innovative products – AUSTEDO, AJOVY, and UZEDY. Collectively, these products grew ~39% year-over-year in the first quarter. This growth is driven by the strength of their product profiles, continued investments to promote awareness and access, and focused execution by our sales and marketing teams globally.
• Stepping Up Innovation – on the second pillar, we accelerated the development of certain key pipeline assets, including the recent positive Phase 2b results for duvakitug (anti-TL1A) in Crohn’s Disease and ulcerative colitis. We anticipate upcoming milestones for olanzapine LAI (NDA filing in 2025) and for DARI (Dual-action Asthma Rescue Inhaler; Phase 3 full enrollment in 2025 and potential Phase 3 event-driven read-out in 2026), as well the announcement of the start of the Phase 3 IBD programs for duvakitug in H2 2025.
• Sustaining Our Generic
  s
  Powerhouse – under the third pillar, we remained focused on strengthening our position as a global leader in generic medicines with a streamlined portfolio, robust pipeline, integrated manufacturing and global commercial footprint. In the past few quarters, we achieved several successful launches of biosimilars and other high-value complex generics including liraglutide, octreotide, SIMLANDI^® (adalimumab-ryvk), SELARSDI^TM (ustekinumab-aekn) and Epysqli^® (eculizumab-aagh).
• Focusing
  our Business – Lastly, on our fourth pillar, to accelerate our growth we are actively transforming our business through portfolio and global manufacturing footprint optimization. Our ongoing efforts to allocate capital appropriately include debt repayment of $1.4 billion at maturity, our recently completed divestment of our business venture in Japan, our intention to divest our API business through a sale, and ongoing programs to improve working capital efficiency.
• Teva is moving into the second phase of our Pivot to Growth strategy – Acceleration. We will focus on growing our innovative portfolio, modernizing and simplifying our organization and operations, reinforcing our commitment to patents, and aligning capital allocation to invest in the highest value activities.

• Teva continues in its effort to sell its active-pharmaceutical ingredient (API) business and is engaged with prospective purchasers. The timing and structure of the planned transaction are subject to ongoing consideration and the consummation of the sale remains contingent on reaching a definitive agreement, subject to approval by Teva’s Board of Directors. On December 31, 2024, Teva classified its API business (including its R&D, manufacturing and commercial activities) as held for sale.

First
Quarter 2025 Consolidated Results

Revenues in the first quarter of 2025 were $3,891 million, an increase of 2% in U.S. dollars or 5% in local currency terms, compared to the first quarter of 2024. This increase was mainly due to higher revenues from AUSTEDO in our United States segment, from generic products in all our segments, from AJOVY in all our segments, as well as from UZEDY in our U.S. segment, partially offset by lower revenues from the sale of mature innovative product rights in 2024. Exchange rate movements during the first quarter of 2025, including hedging effects, negatively impacted revenues by $101 million, compared to the first quarter of 2024.

Exchange rate movements during the first quarter of 2025, including hedging effects, negatively impacted our operating income by $50 million and non-GAAP operating income by $51 million compared to the first quarter of 2024.

Gross profit in the first quarter of 2025 was $1,877 million, an increase of 6% compared to $1,771 million in the first quarter of 2024. Gross profit margin was 48.2% in the first quarter of 2025, compared to 46.4% in the first quarter of 2024. Non-GAAP gross profit was $2,054 million in the first quarter of 2025, an increase of 5% compared to $1,963 million in the first quarter of 2024. Non-GAAP gross profit margin was 52.8% in the first quarter of 2025, compared to 51.4% in the first quarter of 2024. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to a favorable mix of products, primarily driven by higher revenues from AUSTEDO, partially offset by a negative impact from foreign exchange rate movements including hedging effects.

Research and Development (R&D)
expenses, net in the first quarter of 2025 were $247 million, an increase of 2% compared to $242 million in the first quarter of 2024. Our higher R&D expenses, net in the first quarter of 2025 compared to the first quarter of 2024, were mainly due to an increase in immunology and in immuno-oncology projects, as well as in our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), partially offset by the non-recurrence of milestone payments related to certain biosimilar projects in the first quarter of 2025.

Selling and Marketing (S&M) expenses in the first quarter of 2025 were $622 million, an increase of 2% compared to the first quarter of 2024. This increase was mainly to support revenue growth.

General and Administrative (G&A) expenses in the first quarter of 2025 were $297 million, an increase of 7% compared to the first quarter of 2024.

Other
loss in the first quarter of 2025 was $5 million, compared to $1 million in the first quarter of 2024.

Operating I
ncome in the first quarter of 2025 was $519 million, compared to an operating loss of $218 million in the first quarter of 2024. Operating income as a percentage of revenues was 13.3% in the first quarter of 2025, compared to an operating loss as a percentage of revenues of 5.7% in the first quarter of 2024. This increase was mainly due to other asset impairments, restructuring and other items in the first quarter of 2024 as well as higher gross profit in the first quarter of 2025. Non-GAAP operating income in the first quarter of 2025 was $946 million representing a non-GAAP operating margin of 24.3% compared to non-GAAP operating income of $892 million representing a non-GAAP operating margin of 23.4% in the first quarter of 2024. The increase in non-GAAP operating margin in the first quarter of 2025 was due to higher gross profit margin, partially offset by an increase of operating expenses as a percentage of revenues.

Financial expenses, net in the first quarter of 2025, were $225 million, mainly comprised of net-interest expenses of $212 million. In the first quarter of 2024, financial expenses, net were $250 million, mainly comprised of net-interest expenses of $233 million.

In the first quarter of 2025, we recognized a tax expense of $74 million, on a pre-tax income of $294 million. In the first quarter of 2024, we recognized a tax benefit of $52 million, on a pre-tax loss of $467 million.

Non-GAAP
tax rate in the first quarter of 2025 was 17.5%, compared to 15.0% in the first quarter of 2024. Our 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. Our non-GAAP tax rate in the first quarter of 2024 was mainly affected by deferred tax benefits resulting from IP-related integration plans, the generation of profits in various jurisdictions with different tax rates, tax benefits in Israel and other countries, as well as infrequent or non-recurring items.

We expect our annual non-GAAP tax rate for 2025 to be between 15%-18%, slightly higher than our non-GAAP tax rate for 2024, which was 15.3%, mainly due to net tax benefit related to deferred tax assets resulting from intellectual property-related integration plans in 2024.

Net income attributable to Teva and diluted earnings per share in the first quarter of 2025 were $214 million and $0.18, respectively, compared to net loss attributable to Teva and loss per share of $139 million and $0.12, respectively, in the first quarter of 2024. This change was mainly due to higher operating income in the first quarter of 2025, partially offset by higher net loss attributable to redeemable and non-redeemable non-controlling interests in the first quarter of 2024 as well as higher income taxes in the first quarter of 2025, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the first quarter of 2025 were $602 million and $0.52, respectively, compared to $548 million and $0.48, respectively, in the first quarter of 2024.

Adjusted EBITDA was $1,041 million in the first quarter of 2025, an increase of 4%, compared to $1,005 million in the first quarter of 2024.

As of March 31, 2025 and 2024, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,178 million shares and 1,167 million shares, respectively.

Non-GAAP information: net non-GAAP adjustments in the first quarter of 2025 were $388 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the first quarter of 2025 were adjusted to exclude the following items:

• Amortization of purchased intangible assets of $145 million, of which $135 million is included in cost of sales and the remaining $10 million in S&M expenses;
• Impairment of long-lived assets in the amount of $77 million;
• Legal settlements and loss contingencies of $83 million;
• Contingent consideration expenses of $11 million;
• Equity compensation expenses of $34 million;
• Restructuring expenses of $14 million;
• Financial expenses of $14 million;
• Other non-GAAP items of $63 million;
• Items attributable to redeemable non-controlling interests of $2 million; and
• Corresponding tax effects and unusual tax items of $55 million;  

We believe that excluding such items facilitates investors’ understanding of our business including underlying performance 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 2025 was $105 million, compared to $124 million of cash flow used in operating activities in the first quarter of 2024. The lower cash flow used in operating activities in the first quarter of 2025 resulted mainly from higher profit in our U.S. segment, partially offset by higher tax payments. Net changes in working capital items were neutral.

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 divestitures of businesses and other assets, partially offset by $127 million in cash used for capital investment. During the first quarter of 2024, we generated free cash flow of $32 million, which we define as comprising $124 million in cash flow used in operating activities, $295 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program), partially offset by $124 million in cash used for capital investment and $15 million in cash used for acquisition of businesses, net of cash acquired. The increase in 2025 resulted mainly from higher proceeds from divestitures of businesses and other assets and lower cash used for acquisition of businesses, net of cash acquired, as well as from lower cash flow used in operating activities.

As of March 31, 2025, our debt was $16,651 million, compared to $17,783 million as of December 31, 2024. This decrease was mainly due to repayment at maturity of $1,368 million of our senior notes, partially offset by $233 million of exchange rate fluctuations. The portion of total debt classified as short-term as of March 31, 2025 was 3% compared to 10% as of December 31, 2024.

Our average debt maturity was approximately 5.7 years as of March 31, 2025, compared to 5.5 years as of December 31, 2024.

Segment Results for the First Quarter of 2025

United States Segment

The following table presents revenues, expenses and profit for our United States segment for the three months ended March 31, 2025 and 2024:

	Three months ended March 31,
	2025				2024
	(U.S. $ in millions / % of Segment Revenues)
Revenues	$	1,910	100%	$	1,725	100%
Cost of sales		851	44.6%		867	50.2%
Gross profit		1,058	55.4%		858	49.8%
R&D expenses		154	8.1%		154	8.9%
S&M expenses		273	14.3%		261	15.1%
G&A expenses		96	5.0%		93	5.4%
Other		3	§		1	§
Segment profit*	$	532	27.9%	$	350	20.3%
* 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 2025 were $1,910 million, an increase of $184 million, or 11%, compared to the first quarter of 2024. This increase was mainly due to higher revenues from our innovative products, mainly AUSTEDO and UZEDY, as well as higher revenues from generic products.

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, 2025 and 2024:

		Three months ended March 31,						Percentage Change
		2025			2024			2025-2024
		(U.S. $ in millions)
Generic products (including biosimilars)		$	849		$	808		5%
AJOVY			53			45		18%
AUSTEDO			396			282		40%
BENDEKA and TREANDA			36			46		(20%)
COPAXONE			54			30		79%
UZEDY			39			15		156%
Anda			373			381		(2%)
Other			109			117		(7%)
Total		$	1,910		$	1,725		11%

Generic products (including biosimilars) revenues in our United States segment in the first quarter of 2025 were $849 million, an increase of 5% compared to the first quarter of 2024. This increase was mainly driven by higher revenues from lenalidomide capsules (the generic version of Revlimid^®) and the launch of SIMLANDI (adalimumab-ryvk) injection (the biosimilar to Humira^®).

Among the most significant generic products we sold in the United States in the first quarter of 2025 were lenalidomide capsules (the generic version of Revlimid^®), Truxima^® (the biosimilar to Rituxan^®) and epinephrine injectable solution (the generic equivalent of EpiPen^® and EpiPen Jr^®). In the first quarter of 2025, our total prescriptions were approximately 273 million (based on trailing twelve months), representing 7.1% of total U.S. generic prescriptions, compared to approximately 314 million (based on trailing twelve months), representing 8.2% of total U.S. generic prescriptions in the first quarter of 2024, all according to IQVIA data.

On February 21, 2025, Teva launched SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara^®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six years and older. On May 5, 2025, Teva and Alvotech announced that the FDA has approved SELARSDI (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara^® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025.

AJOVY revenues in our United States segment in the first quarter of 2025 were $53 million, an increase of 18% compared to the first quarter of 2024, mainly due to growth in volume. In the first quarter of 2025, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 30.2% compared to 27.4% in the first quarter of 2024.

AUSTEDO revenues in our United States segment in the first quarter of 2025 increased by 40%, to $396 million, compared to $282 million in the first quarter of 2024. This increase was mainly due to growth in volume, including the approval of AUSTEDO XR one pill, once-daily treatment in May 2024.

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 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 currently marketed twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041.

On January 17, 2025, the Centers for Medicare and Medicaid Services (“CMS”) released a list of prescription medicines selected for price-setting discussions, which included AUSTEDO and AUSTEDO XR. The price-setting process has commenced, and the revised prices set by the government, which will apply to eligible Medicare patients, are expected to become effective on January 1, 2027. As the price-setting process is still in its early stages, the extent to which prices for AUSTEDO and AUSTEDO XR will change as a result of such discussions remains uncertain.

UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the first quarter of 2025 were $39 million, an increase of 156% compared to the first quarter of 2024, mainly due to growth in volume. UZEDY (risperidone) extended-release injectable suspension was approved by the FDA on April 28, 2023 for the treatment of schizophrenia in adults, and was launched in the U.S. in May 2023. UZEDY is a subcutaneous, long-acting formulation of risperidone that controls the steady release of risperidone. UZEDY is protected by four Orange Book patents expiring between 2027 and 2040. UZEDY is protected by regulatory exclusivity until April 28, 2026. We are moving forward with plans to launch UZEDY in other countries around the world. UZEDY faces competition from multiple other products.

BENDEKA and TREANDA combined revenues in our United States segment in the first quarter of 2025 were $36 million, a decrease of 20% compared to the first quarter of 2024, mainly due to competition from alternative therapies, as well as the entry of generic bendamustine products into the market. The orphan drug exclusivity that had attached to bendamustine products expired in December 2022.

COPAXONE revenues in our United States segment in the first quarter of 2025 were $54 million, an increase of 79% compared to the first quarter of 2024, mainly due to reduction in sales allowance, partially offset by market share erosion and competition.

Anda revenues from third-party products in our United States segment in the first quarter of 2025 were $373 million, a decrease of 2%, compared to $381 million in the first quarter of 2024. This decrease was mainly due to lower volumes. Anda, our distribution business in the United States, distributes generic and innovative medicines and OTC pharmaceutical products from Teva and various third-party manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. Anda is able to compete in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States.

United States Gross Profit

Gross profit
from our United States segment in the first quarter of 2025 was $1,058 million, an increase of 23%, compared to $858 million in the first quarter of 2024.

Gross profit margin for our United States segment in the first quarter of 2025 increased to 55.4%, compared to 49.8% in the first quarter of 2024. This increase was mainly due to a favorable mix of products primarily driven by higher revenues from AUSTEDO.

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 2025 was $532 million, an increase of 52% compared to $350 million in the first quarter of 2024. This increase was mainly due to 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, 2025 and 2024:

	Three months ended March 31,
	2025				2024
	(U.S. $ in millions / % of Segment Revenues)
Revenues	$	1,194	100%	$	1,272	100%
Cost of sales		536	44.9%		534	42.0%
Gross profit		658	55.1%		738	58.0%
R&D expenses		60	5.1%		56	4.4%
S&M expenses		199	16.7%		194	15.2%
G&A expenses		69	5.8%		65	5.1%
Other		§	§		1	§
Segment profit*	$	329	27.6%	$	423	33.2%
* 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 2025 were $1,194 million, a decrease of 6%, or $78 million, compared to the first quarter of 2024. In local currency terms, revenues decreased by 2% compared to the first quarter of 2024, mainly due to lower revenues from COPAXONE and from the sale of mature innovative product rights in 2024, partially offset by higher revenues from AJOVY.

In the first quarter of 2025, revenues were negatively impacted by exchange rate fluctuations of $55 million, including hedging effects, compared to the first quarter of 2024. 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 in the first quarter of 2024 included $8 million from a positive 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, 2025 and 2024:

		Three months ended March 31,								Percentage Change
		2025				2024				2025-2024
		(U.S. $ in millions)
Generic products (including OTC and biosimilars)		$	989				$	1,004			(1%)
AJOVY			58					51			14%
COPAXONE			42					57			(27%)
Respiratory products			55					66			(18%)
Other			50					94			(46%)
Total		$	1,194				$	1,272			(6%)

Generic products revenues (including OTC and biosimilar products) in our Europe segment in the first quarter of 2025, were $989 million, a decrease of 1% compared to the first quarter of 2024. In local currency terms, revenues increased by 1%, mainly due to higher volumes and price increases as a result of market conditions such as inflationary pressures in certain markets, as well as revenues from recently launched products.

AJOVY revenues in our Europe segment in the first quarter of 2025 increased by 14% to $58 million, compared to $51 million in the first quarter of 2024. In local currency terms revenues increased by 18% due to growth in volume.

COPAXONE revenues in our Europe segment in the first quarter of 2025 were $42 million, a decrease of 27% compared to the first quarter of 2024. In local currency terms revenues decreased by 24%, due to price reductions and a decline in volume resulting from the availability of alternative therapies and competing glatiramer acetate products.

In certain countries, Teva remains in litigation against generic companies regarding COPAXONE.

Respiratory products revenues in our Europe segment in the first quarter of 2025 were $55 million, a decrease of 18% compared to the first quarter of 2024. In local currency terms, revenues decreased by 16%, mainly due to net price reductions and lower volumes.

Europe Gross Profit

Gross profit from our Europe segment in the first quarter of 2025 was $658 million, a decrease of 11% compared to $738 million in the first quarter of 2024.

Gross profit margin for our Europe segment in the first quarter of 2025 decreased to 55.1%, compared to 58.0% in the first quarter of 2024. This decrease was mainly due to a negative impact from hedging activities and unfavorable mix of products.

Europe Profit

Profit of 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 2025 was $329 million, a decrease of 22%, compared to $423 million in the first quarter of 2024. This decrease was mainly due to lower 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, branded generics-oriented markets, such as Russia and certain Latin America markets and hybrid markets, such as Japan.

On March 31, 2025, we closed the sale of our Teva-Takeda business venture in Japan. The business venture included generic products and legacy products.

The following table presents revenues, expenses and profit for our International Markets segment for the three months ended March 31, 2025 and 2024:

	Three months ended March 31,
	2025				2024
	(U.S. $ in millions / % of Segment Revenues)
Revenues	$	582	100%	$	597	100%
Cost of sales		304	52.3%		300	50.3%
Gross profit		278	47.7%		297	49.7%
R&D expenses		25	4.3%		28	4.6%
S&M expenses		118	20.2%		118	19.8%
G&A expenses		39	6.7%		35	5.8%
Other		(1)	§		§	§
Segment profit*	$	97	16.7%	$	117	19.6%
* 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 International Markets segment in the first quarter of 2025 were $582 million, a decrease of 2% compared to the first quarter of 2024. In local currency terms, revenues increased by 5% compared to the first quarter of 2024. This decrease was mainly due to higher revenues from AJOVY as well as generic products in most markets, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.

In the first quarter of 2025, revenues were negatively impacted by exchange rate fluctuations of $44 million, including hedging effects, compared to the first quarter of 2024. Revenues in the first quarter of 2025 included $15 million from a negative hedging impact, compared to a positive hedging impact of $4 million in the first quarter of 2024, which are included in “Other” in the table below.

Revenues by Major Products and Activities

The following table presents revenues for our International Markets segment by major products and activities for the three months ended March 31, 2025 and 2024:

		Three months ended March 31,						Percentage Change
		2025			2024			2025-2024
		(U.S. $ in millions)
Generic products (including OTC and biosimilars)		$	468		$	477		(2%)
AJOVY			28			17		65%
AUSTEDO			15			14		4%
COPAXONE			10			12		(11%)
Other*			61			77		(21%)
Total		$	582		$	597		(2%)
* Other revenues in the first quarter of 2025 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our International Markets segment were $468 million in the first quarter of 2025, a decrease of 2% compared to the first quarter of 2024. In local currency terms, revenues increased by 2% compared to the first quarter of 2024, mainly due to higher revenues in most markets, largely driven by price increases as a result of higher costs due to inflationary pressure in certain markets and higher volumes, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.

AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. AJOVY revenues in our International Markets segment in the first quarter of 2025 were $28 million, compared to $17 million in the first quarter of 2024, due to growth in existing markets in which AJOVY was launched.

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. We continue to pursue additional submissions in various other markets.

AUSTEDO revenues in our International Markets segment in the first quarter of 2025 were $15 million compared to $14 million in the first quarter of 2024. In local currency terms, revenues increased by 6%, substantially due to the launch of a strategic partnership in China.

COPAXONE revenues in our International Markets segment in the first quarter of 2025 were $10 million compared to $12 million in the first quarter of 2024.

International Markets Gross Profit

Gross profit from our International Markets segment in the first quarter of 2025 was $278 million, a decrease of 6% compared to $297 million in the first quarter of 2024.

Gross profit margin for our International Markets segment in the first quarter of 2025 decreased to 47.7%, compared to 49.7% in the first quarter of 2024. This decrease was mainly due to a negative hedging impact, as well as regulatory price reductions and generic competition to off-patented products in Japan.

International Markets Profit

Profit of 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 2025 was $97 million, a decrease of 17%, compared to $117 million in the first quarter of 2024. 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.

On January 31, 2024, we announced that we intend to divest our API business (including its R&D, manufacturing and commercial activities) through a sale. The intention to divest is in alignment with our Pivot to Growth strategy. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be agreed or completed at all.

Revenues from other activities in the first quarter of 2025 were $206 million, a decrease of 9% in U.S. dollars or 8% in local currency terms, compared to the first quarter of 2024, mainly due to a decrease in revenues from contract manufacturing services in the first quarter of 2025.

API sales to third parties in the first quarter of 2025 were $130 million, reflecting an increase of 2% in both U.S. dollars and local currency terms, compared to the first quarter of 2024.

Outlook for 202
5
Non-GAAP Results

$ billions, except EPS or as noted				January 2025 Outlook				May 2025 Outlook
Revenues*			$16.8 – $17.4				$16.8 – $17.2
AUSTEDO ($m)*			1,900-2,050				1,950-2,050
AJOVY ($m)*			~600				~600
UZEDY ($m)*			~160				~160
COPAXONE ($m)*			~370				~370
Operating Income			4.1 – 4.6				4.3 – 4.6
Adjusted EBITDA			4.5 – 5.0				4.7 – 5.0
Tax Rate			15%-18%				15%-18%
Finance Expenses			~0.9				~0.9
Diluted EPS ($)			2.35 – 2.65				2.45 – 2.65
Free Cash Flow**			1.6 – 1.9				1.6 – 1.9
CAPEX*			~0.5				~0.5
Foreign Exchange			Volatile swings in FX can negatively impact revenue and income
* Revenues and CAPEX presented on a GAAP basis. ** 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, May 7, 2025 at 8:00 a.m. ET to discuss its first quarter 2025 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.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

Some amounts in this press release may not add up due to rounding. All percentages have been calculated using unrounded amounts.

Non-GAAP Financial Measures

This press release contains certain financial information that differs from what is reported under accounting principles generally accepted in the United States (“GAAP”). These non-GAAP financial measures, including, but not limited to, non-GAAP operating income, non-GAAP operating margin, non-GAAP gross profit, non-GAAP gross profit margin, Adjusted EBITDA, free cash flow, non-GAAP tax rate, non-GAAP net income (loss) attributable to Teva and non-GAAP diluted EPS, are presented in order to facilitate investors’ understanding of our business. We utilize certain non-GAAP financial measures to evaluate performance, in conjunction with other performance metrics. The following are examples of how we utilize the non-GAAP measures: our management and board of directors use the non-GAAP measures to evaluate our operational performance, to compare against work plans and budgets, and ultimately to evaluate the performance of management; our annual budgets are prepared on a non-GAAP basis; and senior management’s annual compensation is derived, in part, using these non-GAAP measures. See the attached tables for a reconciliation of the GAAP results to the adjusted non-GAAP measures. Investors should consider non-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. We are not providing forward looking guidance for GAAP reported financial measures or a quantitative reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP measure because we are unable to predict with reasonable certainty the ultimate outcome of certain significant items including, but not limited to, the amortization of purchased intangible assets, legal settlements and loss contingencies, impairment of long-lived assets and goodwill impairment, without unreasonable effort. These items are uncertain, depend on various factors, and could be material to our results computed in accordance with GAAP.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. These forward-looking statements include statements concerning our plans, strategies, objectives, future performance and financial and operating targets, and any other information that is not historical information. Important factors that could cause or contribute to such differences include risks relating to:

• our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; concentration of our customer base and commercial alliances among our customers; competition faced by our generic medicines from other pharmaceutical companies and changes in regulatory policy that may result in additional costs and delays; delays in launches of new generic products; our ability to develop and commercialize additional pharmaceutical products; competition for our innovative medicines; our ability to achieve expected results from investments in our product pipeline; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; and the effectiveness of our patents and other measures to protect our intellectual property rights, including any potential challenges to our Orange Book patent listings in the U.S.;
• our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and our potential need to raise additional funds in the future, which may not be available on acceptable terms or at all;
• our business and operations in general, including: the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto; the widespread outbreak of an illness or any other communicable disease, or any other public health crisis; effectiveness of our optimization efforts; significant disruptions of information technology systems, including cybersecurity attacks and breaches of our data security; interruptions in our supply chain or problems with internal or third party manufacturing; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism, such as the ongoing conflict between Russia and Ukraine and the state of war declared in Israel; our ability to attract, hire, integrate and retain highly skilled personnel; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets or business units and close or divest plants and facilities, as well as our ability to successfully and cost-effectively consummate such sales and divestitures, including our planned divestiture of our API business;
• compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; the effects of governmental and civil proceedings and litigation which we are, or in the future become, party to; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; increased legal and regulatory action in connection with public concern over the abuse of opioid medications; our ability to timely make payments required under our nationwide opioids settlement agreement and provide our generic version of Narcan^® (naloxone hydrochloride nasal spray) in the amounts and at the times required under the terms of such agreement; scrutiny from competition and pricing authorities around the world, including our ability to comply with and operate under our deferred prosecution agreement (“DPA”) with the U.S. Department of Justice (“DOJ”); potential liability for intellectual property right infringement; product liability claims; failure to comply with complex Medicare, Medicaid and other governmental programs reporting and payment obligations; compliance with sanctions and trade control laws; environmental risks; and the impact of ESG issues;
• the impact of the state of war declared in Israel and the military activity in the region, including the risk of disruptions to our operations and facilities, such as our manufacturing and R&D facilities, located in Israel, the impact of our employees who are military reservists being called to active military duty, and the impact of the war on the economic, social and political stability of Israel;
• other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our long-lived assets; the impact of geopolitical conflicts including the state of war declared in Israel and the conflict between Russia and Ukraine; potential significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; our exposure to changes in international trade policies, including the imposition of tariffs in the jurisdictions in which we operate, and the effects of such developments on sales of our products and the pricing and availability of our raw materials; and the impact of any future failure to establish and maintain effective internal control over our financial reporting;

and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Consolidated Statements of Income
(U.S. dollars in millions, except share and per share data)
(Unaudited)
		Three months ended
		March 31,
		2025			2024
Net revenues	$	3,891		$	3,819
Cost of sales		2,014			2,048
Gross profit		1,877			1,771
Research and development expenses		247			242
Selling and marketing expenses		622			608
General and administrative expenses		297			278
Intangible assets impairments		121			80
Other asset impairments, restructuring and other items		(22)			673
Legal settlements and loss contingencies		86			106
Other loss (income)		5			1
Operating income (loss)		519			(218)
Financial expenses, net		225			250
Income (loss) before income taxes		294			(467)
Income taxes (benefit)		74			(52)
Share in (profits) losses of associated companies, net		*			4
Net income (loss)		220			(419)
Net income (loss) attributable to redeemable and non-redeemable non-controlling interests		6			(280)
Net income (loss) attributable to Teva		214			(139)
Earnings (loss) per share attributable to Teva:	Basic ($)	0.19			(0.12)
	Diluted ($)	0.18			(0.12)
Weighted average number of shares (in millions):	Basic	1,138			1,123
	Diluted	1,159			1,123
Non-GAAP net income attributable to Teva for diluted earnings per share:*		602			548
Non-GAAP earnings per share attributable to Teva:*	Diluted ($)	0.52			0.48
Non-GAAP average number of shares (in millions):	Diluted	1,159			1,143
Amounts may not add up due to rounding
* Represents an amount less than $0.5 million.
** See reconciliation attached.

CONSOLIDATED BALANCE SHEETS
(U.S. dollars in millions, except for share data)
(Unaudited)
						March 31,			December 31,
					2025			2024
ASSETS
Current assets:
Cash and cash equivalents					$	1,697		$	3,300
Accounts receivables, net of allowance for credit losses of $80 million and $78 million as of March 31, 2025 and December 31, 2024, respectively						3,384			3,059
Inventories						3,247			3,007
Prepaid expenses						1,018			1,006
Other current assets						368			409
Assets held for sale						1,814			1,771
Total current assets						11,528			12,552
Deferred income taxes						1,762			1,799
Other non-current assets						464			462
Property, plant and equipment, net						4,631			4,581
Operating lease right-of-use assets, net						363			367
Identifiable intangible assets, net						4,189			4,418
Goodwill						15,477			15,147
Total assets					$	38,415		$	39,326
LIABILITIES AND EQUITY
Current liabilities:
Short-term debt					$	421		$	1,781
Sales reserves and allowances						3,696			3,678
Accounts payables						2,290			2,203
Employee-related obligations						474			624
Accrued expenses						2,952			2,792
Other current liabilities						964			1,020
Liabilities held for sale						358			698
Total current liabilities						11,157			12,796
Long-term liabilities:
Deferred income taxes						461			483
Other taxes and long-term liabilities						4,011			4,028
Senior notes and loans						16,230			16,002
Operating lease liabilities						288			296
Total long-term liabilities						20,990			20,809
Redeemable non-controlling interests						–			340
Equity:
Teva shareholders’ equity:						6,262			5,373
Non-controlling interests						7			7
Total equity						6,269			5,380
Total liabilities and equity					$	38,415		$	39,326
Amounts may not add up due to rounding

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in millions)
(Unaudited)
		Three months ended
		March 31,
	2025			2024
Operating activities:
Net income (loss)	$	220	$	(419)
Adjustments to reconcile net income (loss) to net cash provided by operations:
Depreciation and amortization		244		272
Impairment of long-lived assets and assets held for sale		77		679
Net change in operating assets and liabilities		(700)		(497)
Deferred income taxes – net and uncertain tax positions		28		(189)
Stock-based compensation		34		28
Other items		(8)		2
Net cash provided by (used in) operating activities		(105)		(124)
Investing activities:
Beneficial interest collected in exchange for securitized trade receivables		322		295
Purchases of property, plant and equipment and intangible assets		(127)		(124)
Proceeds from sale of business and long-lived assets, net		17		–
Acquisition of businesses, net of cash acquired		–		(15)
Purchases of investments and other assets .		(11)		(12)
Net cash provided by (used in) investing activities		201		144
Financing activities:
Repayment of senior notes and loans and other long-term liabilities		(1,368)		–
Purchase of shares from redeemable and non-redeemable non-controlling interests		(38)		(64)
Dividends paid to redeemable and non-redeemable non-controlling interests		(340)		(78)
Other financing activities		3		(9)
Net cash provided by (used in) financing activities		(1,744)		(151)
Translation adjustment on cash and cash equivalents		45		(104)
Net change in cash, cash equivalents and restricted cash		(1,603)		(236)
Balance of cash, cash equivalents at beginning of period		3,300		3,227
Balance of cash, cash equivalents at end of period	$	1,697	$	2,991
Non-cash financing and investing activities:
Beneficial interest obtained in exchange for securitized accounts receivables	$	311	$	312
Amounts may not add up due to rounding

Reconciliation of net income (loss) attributable to Teva
to Non-GAAP net income (loss) attributable to Teva
			Three months ended
			March 31,
($ in millions except per share amounts)			2025		2024
Net income (Loss) attributable to Teva		$	214	$	(139)
Increase (decrease) for excluded items:
	Amortization of purchased intangible assets		145		152
	Legal settlements and loss contingencies(1)		83		106
	Impairment of long-lived assets(2)		77		679
	Restructuring costs		14		13
	Equity compensation		34		28
	Contingent consideration(3)		11		79
	Financial expenses		14		12
	Redeemable and non-redeemable non-controlling interests(4)		2		(284)
	Other non-GAAP items(5)		63		53
	Corresponding tax effects and unusual tax items(6)		(55)		(150)
Non-GAAP net income attributable to Teva		$	602	$	548
Non-GAAP tax rate(7)			17.5%		15.0%
GAAP diluted earnings (loss) per share attributable to Teva		$	0.18	$	(0.12)
EPS difference(8)			0.33		0.60
Non-GAAP diluted EPS attributable to Teva(8)		$	0.52	$	0.48
Non-GAAP average number of shares (in millions)(8)			1,159		1,143
(1)	For the three months ended March 31, 2025 and March 31, 2024, adjustments for legal settlements and loss contingencies primarily consisted of $50 million and $64 million, respectively, attributable to an update to the estimated settlement provision for the Company’s opioid litigation (mainly the effect of the passage of time on the net present value of the discounted payments).
(2)	For the three months ended March 31, 2025, adjustments for impairment of long-lived assets consist of (a) $121 million impairment of long-lived intangible assets mainly related to products in the U.S. and Europe, (b) a favorable adjustment of $46 million related to the classification of the API business (including its R&D, manufacturing and commercial activities) as held for sale. For the three months ended March 31, 2024, adjustments for impairment of long-lived assets primarily consisted of $577 million related to the classification of our business venture in Japan as held for sale.
(3)	For the three months ended March 31, 2024, adjustments for contingent consideration primarily related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide capsules (generic version of Revlimid®) of $64 million.
(4)	For the three months ended March 31, 2024, related to non-controlling interests portion of long-lived assets impairment of $577 million related to the classification of our business venture in Japan as held for sale.
(5)	Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, primarily related to the rationalization of our plants, accelerated depreciation, certain inventory write-offs, material litigation fees and other unusual events.
(6)	For the three months ended March 31, 2025 and March 31, 2024, adjustments for corresponding tax effects and unusual tax items exclusively consisted of the tax impact directly attributable to the pre-tax items that are excluded from non-GAAP net income included in the other adjustments to this table.
(7)	Non-GAAP tax rate is tax expenses (benefit) excluding the impact of non-GAAP tax adjustments presented above as a percentage of income (loss) before income taxes excluding the impact of non-GAAP adjustments presented above.
(8)	EPS difference and diluted non-GAAP EPS are calculated by dividing our non-GAAP net income attributable to Teva by our non-GAAP diluted weighted average number of shares.

Reconciliation of gross profit to Non-GAAP gross profit
(Unaudited)
			Three months ended
			March 31,
($ in millions)			2025	2024
Gross profit		$	1,877	1,771
Gross profit margin			48.2%	46.4%
Increase (decrease) for excluded items: (1)
	Amortization of purchased intangible assets		135	137
	Equity compensation		6	5
	Other non-GAAP items		37	50
Non-GAAP gross profit		$	2,054	1,963
Non-GAAP gross profit margin (2)			52.8%	51.4%
(1) For further explanations, refer to the footnotes under the “Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva” table.
(2) Non-GAAP gross profit margin is non-GAAP gross profit as a percentage of revenue.

Reconciliation of operating income (loss) to Non-GAAP operating income (loss)
(Unaudited)
			Three months ended
			March 31,
($ in millions)			2025	2024
Operating income (loss)		$	519	(218)
Operating margin			13.3%	(5.7%)
Increase (decrease) for excluded items: (1)
	Amortization of purchased intangible assets		145	152
	Legal settlements and loss contingencies		83	106
	Impairment of long-lived assets		77	679
	Restructuring costs		14	13
	Equity compensation		34	28
	Contingent consideration		11	79
	Other non-GAAP items		63	53
Non-GAAP operating income (loss)		$	946	892
Non-GAAP operating margin (2)		$	24.3%	23.4%
(1) For further explanations, refer to the footnotes under the “Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva” table.
(2) Non-GAAP operating margin is Non-GAAP operating income as a percentage of revenues.

Reconciliation of net income (loss) to adjusted EBITDA
(Unaudited)
			Three months ended
			December 31,
($ in millions)			2025	2024
Net income (loss)		$	220	(419)
Increase (decrease) for excluded items:(1)
	Financial expenses		225	250
	Income taxes		74	(52)
	Share in profits (losses) of associated companies –net		§	4
	Depreciation		99	119
	Amortization		145	152
EBITDA		$	763	54
	Legal settlements and loss contingencies		83	106
	Impairment of long lived assets		77	679
	Restructuring costs		14	13
	Equity compensation		34	28
	Contingent consideration		11	79
	Other non-GAAP items		59	46
Adjusted EBITDA		$	1,041	1,005
	(1) For further explanations, refer to the footnotes under the “Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva” table.
	§ Represents an amount of less than $0.5 million.

	Segment Information
		(Unaudited)
	United States						Europe						International Markets
	Three months ended March 31,						Three months ended March 31,						Three months ended March 31,
	2025			2024			2025			2024			2025			2024
	(U.S. $ in millions)						(U.S. $ in millions)						(U.S. $ in millions)
Revenues	$	1,910		$	1,725		$	1,194		$	1,272		$	582		$	597
Cost of sales		851			867			536			534			304			300
Gross profit		1,058	–		858	–		658	–		738	–		278	–		297
R&D expenses		154			154			60			56			25			28
S&M expenses		273			261			199			194			118			118
G&A expenses		96			93			69			65			39			35
Other		3			1			§			1			(1)			§
Segment profit	$	532		$	350		$	329		$	423		$	97		$	117
§ Represents an amount less than $0.5 million.

Reconciliation of our segment profit
to consolidated income (loss) before income taxes
		Three months ended
		March 31,
		2025			2024
		(U.S.$ in millions)
United States profit		$	532		$	350
Europe profit			329			423
International Markets profit			97			117
Total reportable segment profit			958			890
Profit (loss) of other activities			(13)			2
			946			892
Amounts not allocated to segments:
Amortization			145			152
Other asset impairments, restructuring and other items			(22)			673
Intangible asset impairments			121			80
Legal settlements and loss contingencies			83			106
Other unallocated amounts			99			99
Consolidated operating income (loss)			519			(218)
Financial expenses – net			225			250
Consolidated income (loss) before income taxes		$	294		$	(467)

Segment revenues by major products and activities
(Unaudited)
		Three months ended
		March 31,						Percentage Change
		2025			2024			2024-2025
		(U.S.$ in millions)
United States segment
Generic products (including biosimilars)		$	849		$	808		5%
AJOVY			53			45		18%
AUSTEDO			396			282		40%
BENDEKA and TREANDA			36			46		(20%)
COPAXONE			54			30		79%
UZEDY			39			15		156%
Anda			373			381		(2%)
Other			109			117		(7%)
Total			1,910			1,725		11%
		Three months ended
		March 31,						Percentage Change
		2025			2024			2024-2025
		(U.S.$ in millions)
Europe segment
Generic products (including OTC and biosimilars)		$	989		$	1,004		(1%)
AJOVY			58			51		14%
COPAXONE			42			57		(27%)
Respiratory products			55			66		(18%)
Other			50			94		(46%)
Total			1,194			1,272		(6%)
		Three months ended
		March 31,						Percentage Change
		2025			2024			2024-2025
		(U.S.$ in millions)
International Markets segment
Generic products (including OT and biosimilars)		$	468		$	477		(2%)
AJOVY			28			17		65%
AUSTEDO			15			14		4%
COPAXONE			10			12		(11%)
Other*			61			77		(21%)
Total			582			597		(2%)
* Other revenues in the first quarter of 2025 include the sale of certain product rights.

Free cash flow reconciliation
(Unaudited)
	Three months ended March 31,
	2025			2024
	(U.S. $ in millions)
Net cash provided by (used in) operating activities		(105)			(124)
Beneficial interest collected in exchange for securitized accounts receivables		322			295
Capital investment		(127)			(124)
Acquisition of businesses, net of cash acquired		–			(15)
Proceeds from divestitures of businesses and other assets, net		17			–
Free cash flow	$	107		$	32

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A PDF accompanying this announcement is available at http://ml-eu.globenewswire.com/Resource/Download/d4898052-9a00-4a3e-a329-e519a3693b1e

MILAN and NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) — Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, today announced a collaboration with Anemocyte, a leading Biotech Manufacturing Organization (BMO) based in Italy. This strategic partnership marks a major milestone, encompassing the successful production of critical starting materials, including the establishment of Cell Banks and the manufacturing of Plasmids for viral vector production.

This collaboration represents a pivotal step in the advancement of immuno-oncology therapies, highlighting the powerful synergy between Genenta’s innovative platform and Anemocyte’s proven expertise in the production of high-quality starting materials.

“Thanks to Anemocyte, Genenta has achieved significant milestones in the progression of its clinical trials. The expertise and knowledge of Anemocyte’s team have been instrumental throughout the entire manufacturing process of these critical starting materials,” stated Carlo Russo, M.D., Chief Medical Officer & Head of Development of Genenta Science. “Further manufacturing steps confirmed our expectations with Anemocyte’s plasmid DNA in the production of high-quality therapeutic products. Such results confirmed the role of Anemocyte as a top-quality, cost-effective, and reliable partner.“

“Genenta’s status as the first Italian company listed on Nasdaq is a testament to its innovation and leadership in the immuno-oncology space. We are immensely proud of this collaboration with Genenta supporting its pioneering product and technology, facilitating further progress in the next phase of trials,” expressed Marco Ferrari, CEO of Anemocyte. “Genenta symbolizes the concerted efforts of the Italian industry and academia to accelerate advancements in the Cell and Gene therapeutic field. Moreover, this collaboration confirms the direction Anemocyte has taken as future steps which have been built around pillars of flexibility, quality, and sustainability.“

About Anemocyte:

Anemocyte is a Biotech Manufacturing Organization (BMO) based in Italy, offering comprehensive development and manufacturing services and providing innovative solutions from R&D to GMP. Specialized in the development and production of pDNA and mRNA, Anemocyte brings over 25 years of expertise in manufacturing innovative therapies and related starting materials.
For more information, visit www.anemocyte.com.

About Genenta

Genenta (Nasdaq: GNTA) is a clinical-stage immuno-oncology company developing a proprietary hematopoietic stem cell therapy for the treatment of a variety of solid tumor cancers. Genenta first-in-class product candidate is Temferon™, which is designed to allow the expression of immune-therapeutic payloads within the tumor microenvironment by bone marrow-derived myeloid cells and enable a durable and targeted response. Genenta has completed the Phase 1 trial for newly diagnosed Glioblastoma Multiforme patients with an unmethylated MGMT gene promoter, which suggests the potential reprogramming of the tumor microenvironment and inhibiting of myeloid-induced tolerance, while allowing the induction of T cell responses, potentially breaking immune tolerance. Genenta has initiated in Q4 2024 a Phase 1/2a metastatic Renal Cell Carcinoma study that will also include a combination with immune checkpoint inhibitors. Genenta’s treatments are designed as one-time monotherapies, but with the additional potential, when used in combination, to significantly enhance the efficacy of other approved therapeutics.

Forward-Looking Statements

Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the funding to be provided by the Mandatory Convertible Bond, the completion and timing of Genenta’s ongoing clinical trial for newly diagnosed GBM patients with uMGMT-GBM, its clinical trial for metastatic RCC or any related studies, as well as Genenta’s ability to fund its research and development plans. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Genenta’s Annual Report on Form 20-F for the year ended December 31, 2023 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of the date of this announcement, and Genenta undertakes no duty to update such information except as required under applicable law. This press release discusses product candidates that are under preclinical or clinical evaluation and that have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. Until finalized in a clinical study report, clinical trial data presented herein remain subject to adjustment as a result of clinical site audits and other review processes. No representation is made as to the safety or effectiveness of these product candidates or the use for which such product candidates are being studied. Temferon™ is an investigational product candidate for which the effectiveness and safety have not been established. In addition, Temferon™ is not approved for use in any jurisdiction.

Genenta Media
Tiziana Pollio, Mobile: +39 348 23 15 143
Email: [email protected]

Anemocyte Media
Telephone +39 0299372311
Email: [email protected]
www.anemocyte.com

Immunocore reports first quarter financial results and provides a business update

KIMMTRAK

^®

(tebentafusp-tebn) net revenues of $93.9 million in Q1 2025, growing by 33% year-over-year

On track for Phase 3 TEBE-AM trial to complete enrollment in 1H 2026

On track for dose selection in Phase 3 PRISM-MEL-301 trial in 2H 2025

Initial multiple ascending dose data for HIV functional cure candidate presented during oral session at CROI 2025; dose escalation ongoing

Cash, cash equivalents and marketable securities of $837 million as of March 31, 2025

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US, May 7, 2025) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announced its financial results for the first quarter ended March 31, 2025, and provided a business update.

“We are thrilled to have achieved strong revenue performance in Q1, marked by year-over-year growth of 33%. This reflects our unwavering dedication to making KIMMTRAK accessible to patients who need it,” said Bahija Jallal, Chief Executive Officer of Immunocore. “In R&D, we continue to be laser-focused on execution in our oncology franchise with three ongoing Phase 3 trials and a promising early pipeline. We are also excited to have presented the initial MAD data at CROI from our ongoing HIV trial, which, together with our progress in autoimmune, underscores the breadth of our platform.”

First Quarter 2025 Highlights (including post-period)

Financial Results


Total net product revenue (or “net sales”) arising from the sales of KIMMTRAK^® (tebentafusp) was $93.9 million in the first quarter of 2025, an increase of 33% over the first quarter of 2024, of which $56.6 million was generated in the United States, $32.8 million in Europe and $4.5 million in international regions.

Research & development expenses for the three months ended March 31, 2025, were $56.5 million, compared to $57.5 million for the same period in 2024. Selling, general and administrative (SG&A) expenses for the three months ended March 31, 2025, were $40.2 million, compared to $39.3 million in the same period in 2024.

Net income for the first quarter of 2025 was $5.0 million compared to a net loss of $24.4 million in the same period in 2024. The first quarter basic and diluted income/(loss) per share was $0.10, compared to $(0.49) for the first quarter of 2024.

Cash, cash equivalents and marketable securities at March 31, 2025, were $837.0 million.

KIMMTRAK


The Company’s lead product, KIMMTRAK

^®

(tebentafusp), is approved in 39 countries and has been launched in 26 countries globally to date for HLA-A*02:01 positive people with metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched.

The Company sees three key growth areas for KIMMTRAK including continued global expansion in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma.

Metastatic uveal melanoma

• In the first quarter of 2025, KIMMTRAK net product sales were $93.9 million.
• Now launched in two additional countries for a total of 26 globally.
• 13% year-over-year growth in the United States, with demand continuing to grow as outreach extends into the community setting.
• Growth in Europe and in international regions driven by increased demand, new country launches, and completion of price negotiations in France and Germany.

2L+ advanced cutaneous melanoma

• The Company is currently enrolling the TEBE-AM registrational Phase 3 trial and expects to complete enrollment in the first half of 2026.
• The Phase 3 trial is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator’s choice of therapy including options such as investigator’s choice of clinical trials, chemotherapy, or retreatment with anti-PD1 or BRAF therapy).
• There is great unmet need in second- and later-line cutaneous melanoma, with no therapy having shown an Overall Survival (OS) improvement post checkpoint inhibitors in a randomized clinical trial. The Company estimates that there is a potential to address up to 4,000 previously treated advanced CM patients.

Adjuvant uveal (or ocular) melanoma

• The European Organisation for Research and Treatment of Cancer (EORTC) is enrolling patients in the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).
• The Company estimates that the HLA-A*02:01 high-risk adjuvant uveal melanoma patient population could be up to 1,200 patients.

PRAME portfolio


Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line, advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple tumor types, including ovarian cancer and non-small cell lung cancer (NSCLC).

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma

• The Company is enrolling patients in the registrational Phase 3 clinical trial evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab for HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma.
• The trial is currently randomizing to three arms: two brenetafusp dose regimens (40 mcg and 160 mcg) and a control arm. The Company is on track for selection of the go-forward brenetafusp dose in the second half of 2025; this analysis will be conducted by an IDMC.
• Despite approved therapies, there remains a need for improved progression-free survival and overall survival, and there is the potential to address an estimated 10,000 patients.

Phase 1/2 clinical trial of brenetafusp in multiple solid tumors

• The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination with non-platinum chemotherapies in platinum-resistant ovarian cancer (PROC) and with bevacizumab or with platinum chemotherapy in earlier lines of platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection in metastatic non-small cell lung cancer (NSCLC) cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC.
• The Company estimates that, across all solid tumors, the annual number of patients worldwide who test positive for HLA-A*02:01 and can potentially benefit from this program is up to 150,000.

IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)

• The Company is enrolling patients in the Phase 1 dose escalation trial, in multiple solid tumors, with IMC-P115C.
• IMC-P115C is the Company’s first half-life extended ImmTAC therapy – targeting the same PRAME peptide and with the same CD3 effector and TCR specificity as brenetafusp. It is designed to improve patient convenience by reducing the frequency of treatment administration.

IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers

• The Company is enrolling patients in the Phase 1/2 dose escalation trial evaluating IMC-R117C in HLA-A*02:01 positive patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.
• PIWIL1 is believed to play a role in tumor progression and is expressed across a range of tumors, including colorectal cancer.

ImmTAV candidates for a functional cure in infectious diseases


The Company’s bispecific TCR technology platform has the potential to offer a new approach for the treatment of certain chronic infections and aims to eliminate evidence of remaining virus in circulation after the patient stops taking medication – known as a “functional cure.” Two investigational candidates are in Phase 1 or Phase 1/2 trials for people living with human immunodeficiency virus (HIV) and people with chronic hepatitis B infection (HBV).

Phase 1/2 trial of IMC-M113V (Gag-A02) for people living with HIV

• The Company presented data from the initial multiple ascending dose (MAD) portion of the Phase 1/2 dose escalation trial, including 16 people living with HIV (PLWH), at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI).
• All doses were well tolerated and no serious adverse events or dose limiting toxicities were observed. 
• In the 15 evaluable PLWH, delayed viral rebound and/or viremia control at any point during the analytical treatment interruption (ATI) was observed in 0 of 5 PLWH at 60 mcg, 1 of 5 at 120 mcg, and 2 of 5 at 300 mcg.
• The 3 PLWH with evidence of viral control had a viral load of approximately 200 copies/mL at week 8. The historical rate for this observation is 5%¹. Furthermore, 2 of these 3 PLWH remained off ART for the entire 12-week ATI period that was pre-specified in the protocol.
• Patient enrollment continues at higher doses in the multiple ascending dose part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.

Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV or HBV-positive hepatocellular carcinoma

• The Company plans to report data from the single ascending dose portion of the trial in the second half of 2025.

Tissue-specific down modulation of the immune system for autoimmune diseases


The key differentiator of the ImmTAAI platform is tissue-specific, down modulation of the immune system, as the candidates suppress pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.

IMC-S118AI (PPI-A02) for type 1 diabetes

• The Company is on track to file a CTA or investigational new drug application (IND) for IMC-S118AI (PPI x PD1) in the second half of 2025.
• IMC-S118AI is targeted specifically to the pancreatic beta-cell and intended as a disease-modifying treatment in type 1 diabetes. IMC-S118AI recognizes a peptide from pre-pro-insulin protein that is presented by HLA-A02 on beta cells and has a PD1 agonist effector arm.

IMC-U120AI (CD1a) for atopic dermatitis as the initial indication – first universal program

• The Company plans to file a CTA/IND for IMC-U120AI (CD1a x PD1) in 2026.
• IMC-U120AI is a non-HLA-restricted (i.e. universal for all populations) CD1a-tethered PD1 agonist ImmTAAI therapy. IMC-U120AI has a dual mechanism of action: blocking CD1a (which presents lipids) from activating CD1a-specific T cells and preventing HLA Class I/II (which presents peptides) from activating T cells via PD1 agonism on the T cell.

Financial Results


Basic and diluted income per share was $0.10 for the quarter ended March 31, 2025, as compared to a basic and diluted loss per share of ($0.49) for the same period in 2024. Net income for the quarter ended March 31, 2025, was $5.0 million, as compared to a net loss of $(24.4) million for the same period in 2024.

For the first quarter ended March 31, 2025, the Company generated net product sales of $93.9 million compared to $70.3 million for the same period in 2024, due to sales of KIMMTRAK, of which $56.6 million was in the United States, $32.8 million (including one-time favorable revenue adjustments recorded upon completion of price negotiations in France and Germany of $6.0M) was in Europe, and $4.5 million was in the international regions. The increase in net product sales was due to global country expansion and increased sales volume in the United States, as we continued our commercialization efforts.

For the first quarter ended March 31, 2025, research and development (R&D) expenses were $56.5 million compared to $57.5 million for the same period in 2024.

For the quarter ended March 31, 2025, SG&A expenses were $40.2 million compared to $39.3 million for the same period in 2024.

Cash, cash equivalents and marketable securities were $837.0 million as of March 31, 2025, as compared to $820.4 million as of December 31, 2024.

##

About ImmTAC^® molecules for cancer

Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumors.

About ImmTAV molecules and infectious diseases

ImmTAV (Immune mobilising monoclonal TCRs Against Virus) molecules are novel bispecifics that are designed to enable the immune system to recognize and eliminate virally infected cells.
Immunocore is advancing clinical candidates to cure patients with HIV and hepatitis B virus (HBV). The Company aims to achieve sustained control of HIV after patients stop anti-retroviral therapy (ART), without the risk of virological relapse or onward transmission. This is known as ‘functional cure’. For the treatment of HBV, the Company aims to achieve sustained loss of circulating viral antigens and markers of viral replication after stopping medication for people living with chronic HBV.

About ImmTAAI molecules and autoimmune diseases

ImmTAAI (Immune mobilizing monoclonal TCRs Against AutoImmune disease) molecules are novel bispecifics that are designed for tissue-specific down modulation of the immune system. When tethered to the tissue of interest, ImmTAAI candidates suppress pathogenic T cells via PD1 receptor agonism. The Company is currently advancing two candidates for autoimmune conditions, including Type 1 Diabetes and inflammatory dermatological diseases.

About PRISM-MEL301 (NCT06112314) – Phase 3 trial with brenetafusp (IMC-F106C, PRAME-A02) in 1L advanced cutaneous melanoma

The Phase 3 registrational trial is randomizing HLA-A*02:01-positive patients with previously untreated advanced melanoma to brenetafusp + nivolumab versus nivolumab or nivolumab + relatlimab, depending on the country where the patient is enrolled. The trial will initially randomize to three arms: two brenetafusp dose regimens (40 mcg and 160 mcg) and control arm. One of the two brenetafusp dose regimens will be discontinued after an initial review of the first 60 patients randomized to the two experimental arms (90 patients randomized total). The primary endpoint of the trial is progression free survival (PFS) by blinded independent central review (BICR), with secondary endpoints of overall survival (OS) and overall response rate (ORR).

About the IMC-F106C-101 Phase 1/2 trial

IMC-F106C-101 is a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumors including non-small cell lung and ovarian cancers. The Phase 1 dose escalation trial was designed to determine the maximum tolerated dose (MTD), as well as to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-F106C (brenetafusp), a bispecific protein built on Immunocore’s ImmTAC technology, and the Company’s first molecule to target the PRAME antigen. The Company is currently focusing on enrolling patients in combination arms with standards-of-care across multiple tumor types.

About TEBE-AM – Phase 2/3 trial with tebentafusp (gp100xCD3) in second-line or later cutaneous melanoma

The trial is randomizing patients with second-line or later advanced cutaneous melanoma who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor. Patients are randomized to one of three arms including tebentafusp, as monotherapy or in combination with an anti-PD1, and a control arm. The primary endpoint is overall survival.

About the ATOM Phase 3 trial

The EORTC-led Phase 3 clinical trial will include sites in 10 EU countries and the United States and is randomizing HLA-A*02:01-positive patients with high-risk primary uveal melanoma after definitive treatment, by surgery or radiotherapy, and no evidence of metastatic disease on imaging. The trial is expected to enroll a total of 290 patients who will be randomized 1:1 to one of two arms: tebentafusp as monotherapy or observation. The primary endpoint of the trial is relapse-free survival (RFS), with secondary objectives of overall survival and safety and tolerability of tebentafusp. Exploratory objectives include the comparison of the health-related quality of life between the treatment arms and the evaluation of the role of circulating tumor DNA (ctDNA) as a biomarker for the presence of residual disease.

About Uveal Melanoma

Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.

About Cutaneous Melanoma

Cutaneous melanoma (CM) is the most common form of melanoma. It is the most aggressive skin carcinoma and is associated with the vast majority of skin cancer-related mortality. The majority of patients with CM are diagnosed before metastasis but survival remains poor for the large proportion of patients with metastatic disease. Despite recent progress in advanced melanoma therapy, there is still an unmet need for new therapies that improve first-line response rates and duration of response as well as for patients who are refractory to first-line treatments.

About KIMMTRAK^®

KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

IMPORTANT SAFETY INFORMATION

Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.

Skin Reactions

Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.

Elevated Liver Enzymes

Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.

Embryo-Fetal Toxicity

KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.

The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.

For more information, please see full Summary of Product Characteristics (SmPC) or full U.S. Prescribing Information (including BOXED WARNING for CRS).

About KIMMTRAKConnect

Immunocore is committed to helping patients who need KIMMTRAK obtain access via our KIMMTRAKConnect program. The program provides services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and site of care coordination. To learn more, visit KIMMTRAKConnect.com or call 844-775-2273.

About Immunocore

Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune diseases and infectious diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including numerous active clinical and pre-clinical programs​ in oncology, infectious diseases, and autoimmune diseases. The Company’s most advanced oncology TCR therapeutic, KIMMTRAK, has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “believe”, “expect”, “plan”, “anticipate”, “aim”, “continue”, “target” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, statements regarding the Company’s ability to advance its clinical pipeline; the key growth areas for KIMMTRAK, including continued global expansion in mUM, the potential expansion into 2L+ advanced cutaneous melanoma, and into adjuvant uveal melanoma; the commercial performance of KIMMTRAK; the potential benefits and advantages that KIMMTRAK will provide for patients; expectations regarding the estimated size of the patient populations for the Company’s product candidates; expectations regarding the design, progress, timing, enrollment, randomization, scope, expansion, funding, and results of the Company’s existing and planned clinical trials, those of the Company’s collaboration partners or the combined clinical trials with the Company’s collaboration partners; the timing and sufficiency of clinical trial outcomes to support potential approval of any of the Company’s product candidates or those of, or combined with, its collaboration partners; the Company’s goals to develop and commercialize product candidates based on its KIMMTRAK platform alone or with collaboration partners; the expected submission of clinical trial applications; and the potential regulatory approval, expected clinical benefits and availability of the Company’s product candidates. Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company’s control. These risks and uncertainties include, but are not limited to, the impact of worsening macroeconomic conditions on the Company’s business, financial position, strategy and anticipated milestones, including Immunocore’s ability to conduct ongoing and planned clinical trials; Immunocore’s ability to obtain a clinical supply of current or future product candidates or commercial supply of KIMMTRAK or any future approved products; Immunocore’s ability to obtain and maintain regulatory approval of its product candidates, including KIMMTRAK; Immunocore’s ability and plans in continuing to establish and expand a commercial infrastructure and to successfully launch, market and sell KIMMTRAK and any future approved products; Immunocore’s ability to successfully expand the approved indications for KIMMTRAK or obtain marketing approval for KIMMTRAK in additional geographies in the future; the delay of any current or planned clinical trials, whether due to patient enrollment delays or otherwise; Immunocore’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or future regulatory approval; Immunocore’s need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions, including changes in inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the war in Ukraine, the conflict in the Middle East, and global geopolitical tension; Immunocore’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any of its product candidates it or its collaborators are developing; and the success of Immunocore’s current and future collaborations, partnerships or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section titled “Risk Factors” in Immunocore’s filings with the Securities and Exchange Commission, including Immunocore’s most recent Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission on February 26, 2025, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law.

Contact Information

Immunocore

Sébastien Desprez, VP Communications
T: +44 (0) 7458030732
E: [email protected]
Follow Immunocore on LinkedIn: @Immunocore

Investor Relations

Clayton Robertson / Morgan Warenius
T: +1 (215) 384-4781
E: [email protected]

Immunocore Holdings plc

Condensed Consolidated Statement of Operations

Quarter Ended
March 31, 2025
and
2024

(In thousands, except share and per share data)

(Unaudited)

	Quarter Ended
	March 31, 2025	March 31, 2024
Revenue from sale of therapies, net	$93,881	$70,342
Collaboration revenue	—	160
Total revenue	93,881	70,502
Cost of revenue from sale of therapies	(831)	(246)
Research and development expenses	(56,468)	(57,459)
Selling, general, & administrative expenses	(40,198)	(39,287)
Loss from operations	(3,616)	(26,490)
Interest income	4,176	8,246
Interest expense	(3,025)	(3,239)
Foreign currency gain (loss)	3,080	(2,406)
Other income (expense), net	5,469	(190)
Net income (loss) before income taxes	6,084	(24,079)
Income tax expense	(1,061)	(357)
Net income (loss)	$5,023	$(24,436)
Basic net income (loss) per share	$0.10	$(0.49)
Basic weighted-average number of shares outstanding	50,086,684	49,877,218
Diluted net income (loss) per share	$0.10	$(0.49)
Diluted weighted-average number of shares outstanding	51,949,798	49,877,218

Immunocore Holdings plc

Condensed Consolidated Balance Sheets

As of

(In thousands)

(Unaudited)

	March 31, 2025	December 31, 2024
ASSETS
Current assets
Cash and cash equivalents	$476,845	$455,731
Marketable securities	360,185	364,645
Accounts receivable, net	63,094	63,009
Prepaid expenses and other current assets	41,697	41,033
Inventory, net	6,804	5,446
Total current assets	948,625	929,864
Property and equipment, net	9,770	10,092
Operating lease right of use assets, net	38,126	37,643
Deferred tax assets, net	14,355	14,790
Other non-current assets	17,132	17,117
Total assets	$1,028,008	$1,009,506
Liabilities and shareholders’ equity
Current liabilities
Accounts payable	$29,105	$25,100
Accrued expenses and other current liabilities	118,341	185,534
Operating lease liabilities, current	1,717	1,547
Total current liabilities	149,163	212,181
Accrued expenses, non-current	62,476	—
Deferred revenue, non-current	5,612	5,434
Operating lease liabilities, non-current	40,748	40,162
Interest-bearing loans and borrowings	391,530	391,013
Total liabilities	$649,529	$648,790
Shareholders’ equity
Ordinary shares	135	135
Deferred shares	1	1
Additional paid-in capital	1,202,171	1,190,104
Accumulated deficit	(790,738)	(795,761)
Accumulated other comprehensive loss	(33,090)	(33,763)
Total shareholders’ equity	378,479	360,716
Total liabilities and shareholders’ equity	$1,028,008	$1,009,506

Immunocore Holdings plc

Summary Condensed Consolidated Statements of Cash Flows

For the Quarter Ended
March 31,

(In thousands)

(Unaudited)

	2025	2024
Cash and cash equivalents at beginning of period	$455,731	$442,626
Net cash provided by (used in) operating activities	435	(4,587)
Net cash provided by (used in) investing activities	9,702	(430)
Net cash provided by financing activities	2,551	396,012
Net foreign exchange difference on cash held	8,426	(800)
Cash and cash equivalents at end of period	$476,845	$832,821

---

¹ Gunst, J.D., Gohil, J., Li, J.Z. et al. Time to HIV viral rebound and frequency of post-treatment control after analytical interruption of antiretroviral therapy: an individual data-based meta-analysis of 24 prospective studies. Nat Commun 16, 906 (2025).

Dayforce® recurring revenue, excluding float, of $323 million, up 14%, or 16% on a constant currency basis

Total revenue of $482 million, up 12%, and excluding float, up 15%, or 17% on a constant currency basis

Net cash provided by operating activities of $50 million

MINNEAPOLIS and TORONTO, May 07, 2025 (GLOBE NEWSWIRE) — Dayforce, Inc. (“Dayforce” or the “Company”) (NYSE:DAY) (TSX:DAY), a global leader in human capital management (“HCM”) technology, today announced its financial results for the first quarter ended March 31, 2025.

“We kicked off the year with strong first quarter results and excellent sales momentum,” said David Ossip, Chair and CEO of Dayforce. “The Dayforce value proposition of consolidating multiple separate technologies into the single Dayforce platform continues to resonate with organizations across a broad range of industries and sizes. Our first quarter sales growth builds on our already strong fourth quarter sales performance, reinforcing our optimism for continued momentum through 2025 and beyond as we further our HCM leadership position.”

“Our plan to deliver durable top line growth alongside increasing profitability and cash flow is progressing well,” said Jeremy Johnson, CFO of Dayforce. “With cash from operating activities of nearly $50 million in the first quarter, we were able to repurchase approximately $30 million worth of shares during the quarter under our $500 million repurchase program. To date we have returned more than $66 million of capital to stockholders under this program.”

Financial Highlights for the First Quarter 2025

¹

• Total revenue was $481.8 million, an increase of 11.7%, or 13.6% on a constant currency basis. Excluding float, total revenue was $426.5 million, an increase of 15.0%, or 17.1% on a constant currency basis.
• Dayforce recurring revenue, excluding float, was $323.1 million, an increase of 14.4%, or 15.9% on a constant currency basis.
• Operating profit was $31.0 million, compared to $40.7 million. Adjusted operating profit was $132.3 million, compared to $109.1 million.
• Net income was $14.9 million, compared to $7.1 million and net profit margin was 3.1%, compared to 1.6%. Adjusted net income was $93.9 million, compared to $68.0 million.
• Adjusted EBITDA was $156.7 million, compared to $129.9 million. Adjusted EBITDA margin was 32.5%, compared to 30.1%.
• Diluted net income per share was $0.09, compared to $0.04. Adjusted diluted net income per share was $0.58, compared to $0.43.
• Net cash provided by operating activities was $49.6 million, compared to $9.1 million. Operating cash flow margin was 10.3%, compared to 2.1%.
• Free cash flow was $19.5 million, compared to $(18.8) million. Free cash flow margin was 4.0%, compared to (4.4)%.

Supplemental Detail

• 6,929 customers were live on the Dayforce platform as of March 31, 2025, an increase of 5.4% year-over-year.²
• Dayforce recurring revenue per customer was $167,600 for the trailing twelve months ended March 31, 2025, an increase of 11.5%.³
• The average float balance for Dayforce’s customer funds during the quarter was $5.86 billion and the average yield on Dayforce’s float balance was 3.8%. Float revenue from invested customer funds was $55.3 million for the three months ended March 31, 2025.

¹ The financial highlights are on a year-over-year basis, unless otherwise stated. All financial results are reported in United States (“U.S.”) dollars and in accordance with accounting principles generally accepted in the U.S. (“GAAP”), unless otherwise stated.
² Excluding Ascender, ADAM HCM, and eloomi.
³ Excluding float revenue, Ascender, ADAM HCM, and eloomi revenue, and on a constant currency basis. Please refer to the “Non-GAAP Financial Measures” section for discussion of percentage change in revenue on a constant currency basis.

Recent Highlights

• Announced an expanded partnership with Microsoft, making the Dayforce platform available in the Microsoft Azure Marketplace.
• Named a Leader in the IDC MarketScape Worldwide Talent Acquisition 2025 Vendor Assessment and the Nucleus Research Enterprise HCM Value Matrix 2025.
• Welcomed a large entertainment and leisure company that has chosen the complete Dayforce suite as its unified HCM solution to support 61,500 employees across North America. 
• Welcomed a leading uniform and workplace solutions provider that selected the full Dayforce suite to support its 22,000 employees across North America.
• Introduced Dayforce AI Assistant (formerly Dayforce Co-Pilot) on Mobile for support on iOS and Android; enhanced the Advanced Experience Hub with personalized updates; improved Dayforce Learning and Dayforce Recruiting workflows for intuitive, mobile-friendly talent management; launched new direct-to-bank capabilities for Dayforce Wallet, allowing employees to route their pay to any personal bank account, released Total Remuneration Package calculation for comprehensive compensation management; and delivered compliance enhancements for global statutory requirements in the United Kingdom, Singapore, Australia, and New Zealand.

Business Outlook

Based on information available as of May 7, 2025, Dayforce is issuing the following guidance for the second quarter and full year (“FY”) of 2025 as indicated below. Comparisons are on a year-over-year basis, unless stated otherwise.

Second Quarter 2025 Guidance

• Total revenue of $454 million to $460 million.
• Total revenue, excluding float, of $408 million to $414 million, an increase of approximately 8.9% to 10.6% on a GAAP basis, or approximately 10% to 11% on a constant currency basis.
• Float revenue of $46 million.
• Adjusted EBITDA margin of 30.5% to 31.5%.

Full Year 2025 Guidance

• Total revenue of $1,929 million to $1,944 million.
• Total revenue, excluding float, of $1,749 million to $1,764 million, an increase of approximately 12.1% to 13.1% on a GAAP basis, or approximately 14% to 15% on a constant currency basis.
• Dayforce recurring revenue, excluding float, of $1,317 million to $1,342 million, an increase of approximately 13.6% to 15.7% on a GAAP basis, or approximately 15% to 17% on a constant currency basis.
• Float revenue of $180 million.
• Adjusted EBITDA margin of 32%.
• Free cash flow margin of 12%.

Please refer to the “Reconciliation of GAAP to Non-GAAP Financial Measures” section for a reconciliation of Dayforce’s free cash flow margin guidance. Dayforce has not reconciled the Adjusted EBITDA margin ranges for the second quarter and full year of 2025 to the directly comparable GAAP financial measures because applicable information for the future period, on which these reconciliations would be based, is not available without unreasonable efforts due to uncertainty regarding, and the potential variability of, depreciation and amortization, share-based compensation expense and related employer taxes, changes in foreign currency exchange rates, and other items.

Foreign Exchange

For the second quarter and full year of 2025, Dayforce’s guidance assumes an average U.S. dollar to key foreign currencies as follows:

		% of 2024 total revenue		Foreign exchange rate assumed in Q2 2025 guidance		Foreign exchange rate assumed in FY 2025 guidance		Foreign exchange rate in Q2 2024		Foreign exchange rate in FY 2024
U.S. dollar to Canadian dollar		21%		1.40		1.43		1.37		1.37
U.S. dollar to Australian dollar		4%		1.59		1.60		1.51		1.52
U.S. dollar to Great British pound		3%		0.76		0.79		0.79		0.78

Conference Call Details

Dayforce will host a live webcast and conference call to discuss the first quarter 2025 earnings at 8:00 a.m. Eastern Time on May 7, 2025. Those wishing to participate via the webcast should access the call through the Investor Relations section of the Dayforce website. Those wishing to participate via the telephone may dial in at 877-497-9071 (USA) or 201-689-8727 (International). The webcast replay will be available through the Investor Relations section of the Dayforce website.

About Dayforce

Dayforce makes work life better. Everything we do as a global leader in HCM technology is focused on enabling thousands of customers and millions of employees around the world do the work they’re meant to do. With our single AI-powered people platform for HR, Pay, Time, Talent, and Analytics, organizations of all sizes and industries are benefiting from simplicity at scale with Dayforce to help unlock their full workforce potential, operate with confidence, and realize quantifiable value. To learn more, visit dayforce.com.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to risks and uncertainties. All statements other than statements of historical fact or relating to present facts or current conditions included in this press release are forward-looking statements. Forward-looking statements give Dayforce’s current expectations and projections relating to its financial condition, results of operations, plans, objectives, future performance, and business. Users can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Forward-looking statements in this press release include statements relating to the second quarter and full year of 2025, as well as those relating to future growth initiatives. These statements may include words such as “anticipate,” “estimate,” “expect,” “assume”, “project,” “seek,” “plan,” “intend,” “believe,” “will,” “may,” “could,” “continue,” “likely,” “should,” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events, but not all forward-looking statements contain these identifying words. The forward-looking statements contained in this press release are based on assumptions that Dayforce has made in light of its industry experience and its perceptions of historical trends, current conditions, expected future developments and other factors that it believes are appropriate under the circumstances. As users consider this press release, it should be understood that these statements are not guarantees of performance or results. These assumptions and Dayforce’s future performance or results involve risks and uncertainties (many of which are beyond its control). In particular:

• our ability to continue to sustain and grow revenue from our recurring services solutions;
• any information security breach of our systems or the loss of, or unauthorized access to, customer information or sensitive company information;
• disruptions to the movement of funds to initiate payroll-related transactions on behalf of our customers, or customer inability to provide funds sufficient to cover the amounts paid on their behalf, or funds advanced to them via our Dayforce Wallet product;
• our aging software infrastructure and technology;
• our ability to manage our growth effectively;
• our ability to compete effectively in the competitive markets in which we participate;
• our exposure to risks inherent to our international sales and operations;
• any failure to manage our technical operations infrastructure, or the impact of service outages or delays in the implementation of our applications, or the failure of our applications to perform properly;
• our reliance on strategic relationships with third parties to drive additional growth;
• any failure to offer high-quality support services;
• any dissatisfaction of our customers with the quality and pace of the implementation and professional services provided by us or our partners;
• any loss of key employees or the inability to attract and retain highly skilled employees;
• any loss of customer funds and wage funds of their employees that our trustees and third-party financial institution partners hold;
• our acquisition of other companies or technologies;
• the implementation of new accounting systems or other applications;
• any failure to protect our intellectual property rights or any lawsuits against us for alleged infringement of third-party proprietary rights;
• the use of open source software in our applications;
• our failure, or the failure of our third-party service providers, to comply with laws and regulations, or to update our solutions to reflect changes in applicable laws and regulations;
• additional regulatory requirements placed on our software and services;
• any litigation and regulatory investigations aimed at us;
• any actual or perceived failure to comply with evolving regulatory frameworks around the development and use of AI;
• our existing and future debt obligations;
• volatility in the price of our common stock or the issuance of additional common stock;
• our share repurchase program;
• any change in our intention to not pay cash dividends in the foreseeable future;
• provisions in our certificate of incorporation and bylaws and Delaware law that might discourage, delay or prevent a change of control of the Company or changes in our management;
• any failure to maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act;
• adverse economic and market conditions;
• fluctuations in our quarterly results;
• catastrophic events and our disclosures and ambitions related to sustainability matters;
• our being subject to taxation in multiple jurisdictions; and any changes in generally accepted accounting principles in the United States.

Although Dayforce has attempted to identify important risk factors, additional factors or events that could cause Dayforce’s actual performance to differ from these forward-looking statements may emerge from time to time, and it is not possible for Dayforce to predict all of them. Should one or more of these risks or uncertainties materialize, or should any of Dayforce’s assumptions prove incorrect, its actual financial condition, results of operations, future performance, and business may vary in material respects from the performance projected in these forward-looking statements. In addition to any factors and assumptions set forth above in this press release, the material factors and assumptions used to develop the forward-looking information include, but are not limited to: the general economy remains stable; the competitive environment in the HCM market remains stable; the demand environment for HCM solutions remains stable; Dayforce’s implementation capabilities and cycle times remain stable; foreign exchange rates, both current and those used in developing forward-looking statements, specifically U.S. dollar to Canadian dollar, remain stable at, or near, current rates; Dayforce will be able to maintain its relationships with its employees, customers, and partners; Dayforce will continue to attract qualified personnel to support its development requirements and the support of its new and existing customers; and that the risk factors noted above, individually or collectively, do not have a material impact on Dayforce. Any forward-looking statement made by Dayforce in this press release speaks only as of the date on which it is made. Dayforce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Dayforce, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

		March 31,				December 31,
		2025				2024
(In millions, except per share data)
Assets
Current assets:
Cash and equivalents		$	557.3			$	579.7
Trade and other receivables, net			294.4				264.8
Prepaid expenses and other current assets			143.6				137.5
Total current assets before customer funds			995.3				982.0
Customer funds			5,362.7				5,001.5
Total current assets			6,358.0				5,983.5
Right of use lease assets, net			13.1				12.3
Property, plant, and equipment, net			228.5				223.7
Goodwill			2,343.4				2,336.7
Other intangible assets, net			162.4				189.2
Deferred sales commissions			242.2				231.8
Other assets			151.9				139.8
Total assets		$	9,499.5			$	9,117.0
Liabilities and stockholders’ equity
Current liabilities:
Current portion of long-term debt		$	582.3			$	7.3
Current portion of long-term lease liabilities			6.0				5.7
Accounts payable			86.0				77.0
Deferred revenue			40.1				42.3
Employee compensation and benefits			114.4				126.8
Other accrued expenses			35.8				31.5
Total current liabilities before customer funds obligations			864.6				290.6
Customer funds obligations			5,361.8				5,024.2
Total current liabilities			6,226.4				5,314.8
Long-term debt, less current portion			632.4				1,209.1
Employee benefit plans			5.6				5.9
Long-term lease liabilities, less current portion			10.5				10.8
Other liabilities			32.5				30.1
Total liabilities			6,907.4				6,570.7
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.01 par, 500.0 shares authorized, 160.0 and 159.0 shares issued and outstanding, respectively			1.6				1.6
Additional paid in capital			3,391.4				3,363.2
Accumulated deficit			(351.3	)			(335.8	)
Accumulated other comprehensive loss			(449.6	)			(482.7	)
Total stockholders’ equity			2,592.1				2,546.3
Total liabilities and stockholders’ equity		$	9,499.5			$	9,117.0

Dayforce, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

		Three Months Ended March 31,
		2025				2024
(In millions, except per share data)
Revenue:
Recurring services		$	410.5			$	382.7
Professional services			71.3				48.8
Total revenue			481.8				431.5
Costs and expenses:
Costs of recurring services			98.4				88.4
Costs of professional services			81.3				66.1
Product development and management			59.3				53.1
Selling and marketing			86.8				78.4
General and administrative			71.1				56.0
Depreciation and amortization			53.9				48.8
Total costs and expenses			450.8				390.8
Operating profit			31.0				40.7
Interest expense, net			7.9				13.3
Other expense, net			4.0				9.0
Income before income taxes			19.1				18.4
Income tax expense			4.2				11.3
Net income		$	14.9			$	7.1
Net income per share:
Basic		$	0.09			$	0.05
Diluted		$	0.09			$	0.04
Weighted average shares outstanding:
Basic			159.4				156.9
Diluted			161.9				159.9

Dayforce, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

		Three Months Ended March 31,
		2025				2024
(In millions)
Cash flows from operating activities
Net income		$	14.9			$	7.1
Adjustments to reconcile net income to net cash provided by operating activities:
Deferred income tax benefit			(18.9	)			(11.8	)
Depreciation and amortization			53.9				48.8
Amortization of debt issuance costs and debt discount			1.1				1.1
Loss on debt extinguishment			—				4.3
Provision for doubtful accounts			3.8				0.8
Net periodic pension and postretirement cost			4.8				2.6
Share-based compensation expense			45.9				38.0
Other			(0.1	)			—
Changes in operating assets and liabilities, excluding effects of acquisitions:
Trade and other receivables			(35.4	)			(48.1	)
Prepaid expenses and other current assets			(17.1	)			(13.1	)
Deferred sales commissions			(9.6	)			(6.3	)
Accounts payable and other accrued expenses			6.6				(1.8	)
Deferred revenue			(2.6	)			(2.3	)
Employee compensation and benefits			(17.8	)			(27.8	)
Accrued taxes			18.9				17.8
Other assets and liabilities			1.2				(0.2	)
Net cash provided by operating activities			49.6				9.1
Cash flows from investing activities
Purchases of customer funds marketable securities			(180.0	)			(139.6	)
Proceeds from sale and maturity of customer funds marketable securities			86.9				49.6
Purchases of marketable securities			(3.7	)			(0.5	)
Proceeds from sale and maturity of marketable securities			6.8				1.0
Expenditures for property, plant, and equipment			(4.0	)			(3.5	)
Expenditures for software and technology			(26.1	)			(24.4	)
Acquisition costs, net of cash acquired			—				(173.3	)
Net cash used in investing activities			(120.1	)			(290.7	)
Cash flows from financing activities
Increase in customer funds obligations, net			334.4				1,763.5
Proceeds from issuance of common stock under share-based compensation plans			4.4				21.7
Taxes paid related to the net share settlement of awards under share-based compensation plans			(17.1	)			(6.4	)
Repurchases of common stock			(30.1	)			—
Proceeds from debt issuance			—				650.0
Repayment of long-term debt obligations			(1.8	)			(644.5	)
Payment of debt refinancing costs			(1.2	)			(11.4	)
Net cash provided by financing activities			288.6				1,772.9
Effect of exchange rate changes on cash, restricted cash, and equivalents			1.0				(13.5	)
Net increase in cash, restricted cash, and equivalents			219.1				1,477.8
Cash, restricted cash, and equivalents at beginning of period			3,253.9				3,421.4
Cash, restricted cash, and equivalents at end of period		$	3,473.0			$	4,899.2
Reconciliation of cash, restricted cash, and equivalents to the condensed consolidated balance sheets
Cash and equivalents		$	557.3			$	392.5
Restricted cash			—				0.8
Restricted cash and equivalents included in customer funds			2,915.7				4,505.9
Total cash, restricted cash, and equivalents		$	3,473.0			$	4,899.2

Dayforce, Inc.

Revenue Financial Measures

(Unaudited)

		Three Months Ended March 31,								Percentage change in revenue				Impact of changes in foreign currency (a)				Percentage change in revenue on a constant currency basis (a)
		2025				2024				2025 vs. 2024								2025 vs. 2024
		(In millions)
Revenue:
Recurring services:
Dayforce recurring		$	323.1			$	282.4				14.4	%			(1.5	)%			15.9	%
Powerpay recurring			19.0				20.5				(7.3	)%			(6.3	)%			(1.0	)%
Other recurring			13.1				19.1				(31.4	)%			(2.1	)%			(29.3	)%
Float			55.3				60.7				(8.9	)%			(1.3	)%			(7.6	)%
Total recurring services			410.5				382.7				7.3	%			(1.7	)%			9.0	%
Professional services			71.3				48.8				46.1	%			(3.7	)%			49.8	%
Total revenue		$	481.8			$	431.5				11.7	%			(1.9	)%			13.6	%
Total revenue, excluding float		$	426.5			$	370.8				15.0	%			(2.1	)%			17.1	%

a)    Dayforce has calculated the percentage change in revenue on a constant currency basis by applying the average foreign exchange rate in effect during the comparable prior period. Please refer to the “Non-GAAP Financial Measures” section for discussion of percentage change in revenue on a constant currency basis.

Dayforce, Inc.

Share-Based Compensation Expense and Related Employer Taxes

(Unaudited)

		Three Months Ended March 31,
		2025				2024
		(in millions)
Costs of recurring services		$	3.3			$	4.1
Costs of professional services			4.2				3.8
Product development and management			9.3				8.0
Selling and marketing			11.1				8.5
General and administrative			18.1				13.6
Total		$	46.0			$	38.0

Dayforce, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited)

The following tables reconcile Dayforce’s reported results to its non-GAAP financial measures:

		Three Months Ended March 31, 2025
		As reported				As reported margins (a)				Share-based compensation				Amortization				Other (b)				As adjusted (b)				As adjusted margins (a)
		(Dollars in millions, except per share data)
Operating profit		$	31.0				6.4	%		$	46.0			$	28.7			$	26.6			$	132.3				27.5	%
Net income		$	14.9				3.1	%		$	46.0			$	28.7			$	4.3			$	93.9				19.5	%
Interest expense, net			7.9								—				—				—				7.9
Income tax expense (c)			4.2								—				—				(25.5	)			29.7
Depreciation and amortization			53.9								—				28.7				—				25.2
EBITDA		$	80.9							$	46.0			$	—			$	29.8			$	156.7				32.5	%
Net income per share – diluted		$	0.09							$	0.28			$	0.18			$	0.03			$	0.58

		Three Months Ended March 31, 2024
		As reported				As reported margins (a)				Share-based compensation				Amortization				Other (b)				As adjusted (b)				As adjusted margins (a)
		(Dollars in millions, except per share data)
Operating profit		$	40.7				9.4	%		$	38.0			$	28.4			$	2.0			$	109.1				25.3	%
Net income		$	7.1				1.6	%		$	38.0			$	28.4			$	(5.5	)		$	68.0				15.8	%
Interest expense, net			13.3								—				—				—				13.3
Income tax expense (c)			11.3								—				—				(16.9	)			28.2
Depreciation and amortization			48.8								—				28.4				—				20.4
EBITDA		$	80.5							$	38.0			$	—			$	11.4			$	129.9				30.1	%
Net income per share – diluted		$	0.04							$	0.24			$	0.18			$	(0.03	)		$	0.43

a)    Operating profit margin and net profit margin are determined by calculating the percentage operating profit and net income are of total revenue. Please refer to the “Non-GAAP Financial Measures” section for additional information on the as adjusted margins.

b)    The as adjusted column is a non-GAAP financial measure, adjusted to exclude share-based compensation expense and related employer taxes, amortization of acquisition-related intangible assets, and certain other items. For the three months ended March 31, 2025, the adjustments to operating profit consist of $26.6 million of restructuring expenses and the adjustments to net income also include $5.3 million of costs associated with the planned termination of its frozen U.S. pension plan, $2.1 million of foreign exchange gain, and a $25.5 million net adjustment for the effect of income taxes related to these items. For the three months ended March 31, 2024, the adjustments to operating profit consist of $2.0 million of restructuring expenses and the adjustments to net income also include $6.2 million of foreign exchange loss, $3.2 million of costs associated with the planned termination of its frozen U.S. pension plan, and a $16.9 million net adjustment for the effect of income taxes related to these items. Please refer below for additional information on the as adjusted metrics.

c)    Income tax effects have been calculated based on the statutory tax rates in effect in the U.S. and foreign jurisdictions during the period.

Dayforce, Inc.

Reconciliation of Free Cash Flow

(Unaudited)

The following table reconciles Dayforce’s reported results to free cash flow and free cash flow margin:

		Three Months Ended March 31,
		2025				2024
		(In millions)
Net cash provided by operating activities		$	49.6			$	9.1
Capital expenditures			(30.1	)			(27.9	)
Free cash flow		$	19.5			$	(18.8	)
Operating cash flow margin (a)			10.3	%			2.1	%
Free cash flow margin (b)			4.0	%			(4.4	)%

The following table reconciles Dayforce’s free cash flow and free cash flow margin guidance:

		Twelve Months Ended December 31, 2025
		Low range				High range
		(In millions)
Net cash provided by operating activities		$	334			$	339
Capital expenditures			(105	)			(105	)
Free cash flow		$	229			$	234
Operating cash flow margin (a)			17.4	%			17.5	%
Free cash flow margin (b)			11.9	%			12.1	%

(a)    Operating cash flow margin is determined by calculating the percentage that operating cash flow is of total revenue.

(b)    Free cash flow margin is determined by calculating the percentage that free cash flow is of total revenue.

Dayforce, Inc.

Reconciliation of Reclassification of Depreciation and Amortization

(Unaudited)

Beginning in 2025, Dayforce reclassified depreciation and amortization in its condensed consolidated statements of operations into a single financial statement line item. Application of this change is being made on a retrospective basis. The following presents the line items in which depreciation and amortization were previously included for the periods presented:

		Three Months Ended
		March 31, 2024				June 30, 2024				September 30, 2024				December 31, 2024
		(In millions)
Cost of revenue		$	18.5			$	19.3			$	20.8			$	21.8
Selling and marketing			0.6				0.7				0.6				0.7
General and administrative			29.7				30.6				30.7				35.8
Total depreciation and amortization		$	48.8			$	50.6			$	52.1			$	58.3

		Three Months Ended
		March 31, 2023				June 30, 2023				September 30, 2023				December 31, 2023
		(In millions)
Cost of revenue		$	15.3			$	15.0			$	17.1			$	19.4
Selling and marketing			0.5				0.6				0.5				0.5
General and administrative			6.3				7.7				21.1				28.5
Total depreciation and amortization		$	22.1			$	23.3			$	38.7			$	48.4

Non-GAAP Financial Measures

Dayforce uses certain non-GAAP financial measures in this release including:

Non-GAAP Financial Measure		GAAP Financial Measure
EBITDA		Net income
Adjusted EBITDA		Net income
Adjusted EBITDA margin		Net profit margin
Adjusted operating profit		Operating profit
Adjusted operating profit margin		Operating profit margin
Adjusted net income		Net income
Adjusted net profit margin		Net profit margin
Adjusted diluted net income per share		Diluted net income per share
Free cash flow		Net cash provided by operating activities
Free cash flow margin		Operating cash flow margin
Percentage change in revenue, including total revenue and revenue by solution, on a constant currency basis		Percentage change in revenue, including total revenue and revenue by solution
Dayforce recurring revenue per customer		No directly comparable GAAP measure

Dayforce believes that these non-GAAP financial measures are useful to management and investors as supplemental measures to evaluate its overall operating performance including comparison across periods and with competitors. Dayforce’s management team uses these non-GAAP financial measures to assess operating performance because these financial measures exclude the results of decisions that are outside the normal course of its business operations, and are used for internal budgeting and forecasting purposes both for short- and long-term operating plans. Additionally, Adjusted operating profit, free cash flow, and free cash flow margin are components of certain management compensation plans. Additionally, Dayforce believes that the non-GAAP financial measures free cash flow and free cash flow margin are meaningful to investors because they are measures of liquidity that provides useful information in understanding and evaluating the strength of Dayforce’s liquidity and future ability to generate cash that can be used for strategic opportunities or investing in its business. The reduction of capital expenditures facilitates comparisons of Dayforce’s liquidity on a period-to-period basis and excludes items that management does not consider to be indicative of Dayforce’s liquidity.

These non-GAAP financial measures are not required by, defined under, or presented in accordance with, GAAP, and should not be considered as alternatives to Dayforce’s results as reported under GAAP, have important limitations as analytical tools, and its use of these terms may not be comparable to similarly titled measures of other companies in its industry. Dayforce’s presentation of non-GAAP financial measures should not be construed to imply that its future results will be unaffected by similar items to those eliminated in this presentation. Please refer to Dayforce’s full financial results, including further discussion of non-GAAP financial measures, on the Investor Relations portion of its website at investors.dayforce.com.

Dayforce defines its non-GAAP financial measures as follows:

• EBITDA is defined as net income before interest, taxes, depreciation, and amortization, and Adjusted EBITDA is EBITDA, as adjusted to exclude share-based compensation expense and related employer taxes, and certain other items.
• Adjusted EBITDA margin is determined by calculating the percentage Adjusted EBITDA is of total revenue.
• Adjusted Cloud recurring gross margin is defined as Cloud recurring gross margin, as adjusted to exclude share-based compensation and related employer taxes, and certain other items, as a percentage of total Cloud recurring revenue.
• Adjusted operating profit is defined as operating profit, as adjusted to exclude share-based compensation expense and related employer taxes, amortization of acquisition-related intangible assets, and certain other items.
• Adjusted operating profit margin is determined by calculating the percentage Adjusted operating profit is of total revenue.
• Adjusted net income is defined as net income, as adjusted to exclude share-based compensation expense and related employer taxes, amortization of acquisition-related intangible assets, and certain other items, all of which are adjusted for the effect of income taxes.
• Adjusted net profit margin is determined by calculating the percentage Adjusted net income is of total revenue.
• Adjusted diluted net income per share is calculated by dividing adjusted net income by diluted weighted average shares outstanding. When adjusted net income is positive, diluted weighted average shares outstanding incorporate the effect of dilutive equity instruments.
• Free cash flow is defined as net cash provided by operating activities, reduced by capital expenditures.
• Percentage change in revenue, including total revenue and revenue by solution, on a constant currency basis is calculated by applying the average foreign exchange rate in effect during the comparable prior period.
• Dayforce recurring revenue per customer is an indicator of the average size of Dayforce recurring revenue customers. To calculate Dayforce recurring revenue per customer, we start with Dayforce recurring revenue on a constant currency basis by applying the same exchange rate to all comparable periods for the trailing twelve months and excludes float revenue, and Ascender, ADAM HCM, and eloomi revenue. This amount is divided by the number of live Dayforce customers at the end of the trailing twelve month period, excluding Ascender, ADAM HCM, and eloomi. We have not reconciled the Dayforce recurring revenue per customer because there is no directly comparable GAAP financial measure.

Source: Dayforce, Inc.

For further information, please contact:

Investor Relations
1-844-829-9499
[email protected]

Public Relations
1-647-417-2117
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