Market Newsdesk

• On February 4—in Las Vegas, at the National Automobile Dealers Association (NADA) Show — FF will hold a final launch of its first EAI robotics products and begin sales.
• FX Super One will continue to expand its pre-order pipeline and extend its market coverage to ten key states, leading the First Class EAI-MPV era across the U.S. and the Middle East.
• FF will strive to achieve its 2026 market cap targets to maximize value for stockholders, with the goal to achieve dual growth in revenue and contribution margin, reach positive operating cash flow as early as possible, and move decisively toward a profitability inflection point.
• FF will further solidify its dual-public-company governance framework and continue building an AI-driven operating system for the company.

LOS ANGELES, Jan. 11, 2026 (GLOBE NEWSWIRE) — Faraday Future Intelligent Electric Inc. (NASDAQ: FFAI) (“Faraday Future”, “FF” or the “Company”), a California-based global shared intelligent electric mobility ecosystem company, today shared a weekly business update from YT Jia, Founder and Global Co-CEO of FF.

“Hello everyone, I’m speaking to you today right outside the CES exhibition halls here in Las Vegas. On January 7, just nearby, we held the FF Stockholders’ Day event, where we not only shared what our investors care about most—our plans for Super One’s mass production, sales, delivery, service, and capacity ramp-up, but also officially unveiled FF’s long-incubated Embodied AI, or EAI, Robotics strategy. We also hosted private preview sessions for our first batch of robotics products. And here comes another big announcement: On February 4—once again here in Las Vegas, at the NADA Show—we will hold a final launch of our first EAI robotics products and officially begin sales. We invite everyone to stay tuned and witness this with us.

Why are we choosing now to formally announce EAI robotics?
There are three major external drivers:

First, the exceptionally high labor costs in the United States have made it the world’s largest market with rigid demand for embodied AI robotics.

Second, EAI robotics is approaching a critical inflection point, moving rapidly from research in the lab to large-scale, real-world deployment. I believe that a breakout moment is imminent.

Third, embodied intelligence is fast becoming a national strategic capability, on par with AI and semiconductors.

There are also four internal drivers:

First, this move is a natural extension of the AI DNA that has been embedded in FF since day one. It is also the inevitable evolution of the vehicle-as-robot concept we proposed ten years ago.

Second, this replicates and upgrades our Auto Industry Bridge model, based on full compliance, we could integrate a global EAI supply chain to deliver robots with high price-performance ratio to fill a market void in the U.S.

Third, the AI robotics business features lighter investment, faster delivery, and could generate positive operating cash flow more quickly.

Fourth, EAI robotics and EAI vehicles act as twin engines driving FF forward. They work hand-in-hand across R&D, manufacturing, sales, and service. Combined with FF’s Dual-Flywheel, Dual-Bridge, and Dual–Public-Company structure, they could create a strong ecosystem synergy and open a new growth curve for the company.

As we mentioned last week, I would now like to announce Faraday Future’s outlook for 2026.

1. Strategic and Business Targets:

For EAI EV, FX Super One will continue to expand its pre-order pipeline and extend our market coverage to ten key states, leading the First Class EAI-MPV era across the U.S. and the Middle East. At the same time, we will continue to strengthen the influence of FF 91 among the world’s spire user communities. With EAI Robotics, we will execute against our established sales and delivery targets, become the first company in the U.S. to deliver humanoid robot products targeted with positive gross margins, and accelerate our potential entry into the ranks of leading U.S. embodied AI robotics providers.

2. Capital Targets:

We will strive to achieve our 2026 market cap targets to maximize value for stockholders. At the same time, we will actively seek to bring in strategic investors; continue to identify high-value and highly cost-effective AI technologies and potential acquisition opportunities to help build a world-class EAI ecosystem.

3. Financial Targets:

Our goal is to achieve dual growth in revenue and contribution margin, reach positive operating cash flow as early as possible, and move decisively toward a profitability inflection point. We will continue to enforce extreme cost discipline and operational efficiency, strengthen financial management and internal controls, and uphold compliance as an absolute baseline.

4. System Build-up Targets:

We will further solidify our dual-public-company governance framework and continue building an AI-driven operating system for the Company.

To achieve these targets, we will focus all our efforts on winning seven critical battles:

S1 battle on user ecosystem: We will continue to make breakthroughs in our Co-Creation Ecosystem Online Direct Sales system, complete phase 1 build-out of Super One’s charging and service network in Q2, while closing the loop for AI robotics sales, delivery, and service. At the same time, we will focus on building user power, brand power, and sales power.

S2 battle on product power: For both EAI EV and EAI Robotics products, we will stay focused on ongoing original innovation and on building the most powerful product momentum.

S3 battle on EAI R&D: We will continue advancing Super One’s intelligence and ensure high-quality delivery of EAI software and hardware. In parallel, we will deliver U.S. compliance-related technologies and products for EAI robotics.

S4 battle on compliance & certification, mass production and capacity ramp-up for Super One and AI Robotics products: Our goal is to complete all required regulatory certification and testing on schedule, ensuring mass-production and delivery milestones are met as planned. In parallel, we will continue to strengthen scalable assembly and quality assurance capabilities, while further upgrading our intelligent manufacturing systems.

S5 battle on value restoration: We will remain firmly committed to the principle of “stockholders first,” seeking to improve our capital structure, lower financing costs, actively bring in strategic investors, and unlock and realize intrinsic value.

S6 battle on high-value market expansion including the Middle East: We aim to build the Middle East into a replicable and fast-to-profit overseas model, while expanding into additional high-value regional markets and working toward earlier deliveries.

S7 battle on system building, efficient execution and corporate culture: We will stay results-driven, while strengthening process KPIs & leading indicators, and continue building a culture with a strong desire to win, ownership & collaboration, and relentless execution.

Looking at the Crypto flywheel: With a term sheet signed for $10 million worth of FFAI stock purchase, AIxC noted that if it completes the transaction, it will mark the start of its stock tokenization RWA business. In 2026, AIxC also announced that it will systematically implement its “three driving-force businesses” and speed up transitioning into profitability.

In 2026, we will continue to promote the mutual empowerment between our “EAI + Crypto” Dual-Flywheel, Dual-Bridge, and Dual-Public-Company structure, and particularly, deeply empower and enable delivery and ramp-up of EAI EV products and EAI Robotics products. 

In 2026, I will honor commitments through action, respond to expectations through continuous innovation and delivery, return value to our stockholders, and earn back even greater trust and confidence through results. I will see you next week.“

ABOUT FARADAY FUTURE 

Faraday Future is a California-based global shared intelligent electric mobility ecosystem company. Founded in 2014, the Company’s mission is to disrupt the automotive industry by creating a user-centric, technology-first, and smart driving experience. Faraday Future’s flagship model, the FF 91, exemplifies its vision for luxury, innovation, and performance. The FX strategy aims to introduce mass production models equipped with state-of-the-art luxury technology similar to the FF 91, targeting a broader market with middle-to-low price range offerings. FF is committed to redefining mobility through AI innovation. Join us in shaping the future of intelligent transportation. For more information, please visit https://www.ff.com/

FORWARD LOOKING STATEMENTS 

This press release includes “forward looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. When used in this press release, the words “plan to,” “can,” “will,” “should,” “future,” “potential,” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements, which include statements regarding the potential purchase of FFAI common stock by AIxC, FFAI’s 2026 financial targets, FX Super One production and delivery, and entry into the embodied AI robotics market involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the Company’s control, which could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements.  

Important factors, among others, that may affect actual results or outcomes include, among others: the Company’s ability to maintain its listing on Nasdaq; the availability of sufficient share capital to execute on its strategy, which the Company currently lacks; if AIxC and the Company are able to execute a binding agreement for the purchase of the Company’s Common Stock; the agreement of stockholders to substantially increase the Company’s share capital, which could result in substantial additional dilution; the Board’s approval of various production and sales plans and proposals, which the Company may fail to obtain; the Company’s ability to homologate FX vehicles for sale; the Company’s ability to secure the necessary funding to execute on the FX strategy, which will be substantial; the Company’s ability to enter into an engineering services agreement, which will be required for the Super One in the U.S.; the ability of B2B preorder companies to identify purchasers for the Super One; overall demand for the Super One; the ability to secure the necessary agreements to produce an FX 4 vehicle or any other planned future FX vehicles, none of which have been secured; the Company’s ability to secure an occupancy certificate for its Hanford facility; the Company’s ability to continue as a going concern and improve its liquidity and financial position; the Company’s ability to pay its outstanding obligations; the Company’s ability to remediate its material weaknesses in internal control over financial reporting and the risks related to the restatement of previously issued consolidated financial statements; the Company’s limited operating history and the significant barriers to growth it faces; the Company’s history of losses and expectation of continued losses; the success of the Company’s payroll expense reduction plan; the Company’s ability to execute on its plans to develop and market its vehicles and the timing of these development programs; the Company’s estimates of the size of the markets for its vehicles and cost to bring those vehicles to market; the rate and degree of market acceptance of the Company’s vehicles; the Company’s ability to cover future warranty claims; the success of other competing manufacturers; the performance and security of the Company’s vehicles; current and potential litigation involving the Company; the Company’s ability to receive funds from, satisfy the conditions precedent of and close on the various financings described elsewhere by the Company; the result of future financing efforts, the failure of any of which could result in the Company seeking protection under the Bankruptcy Code; the Company’s indebtedness; the Company’s ability to cover future warranty claims; the Company’s ability to use its “at-the-market” program; insurance coverage; general economic and market conditions impacting demand for the Company’s products; potential negative impacts of a reverse stock split; potential cost, headcount and salary reduction actions may not be sufficient or may not achieve their expected results; circumstances outside of the Company’s control, such as natural disasters, climate change, health epidemics and pandemics, terrorist attacks, and civil unrest; risks related to the Company’s operations in China; the success of the Company’s remedial measures taken in response to the Special Committee findings; the Company’s dependence on its suppliers and contract manufacturer; the Company’s ability to develop and protect its technologies; the Company’s ability to protect against cybersecurity risks; and the ability of the Company to attract and retain employees, any adverse developments in existing legal proceedings or the initiation of new legal proceedings, and volatility of the Company’s stock price. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the Company’s Form 10-K filed with the SEC on March 31, 2025, , and Form 10-Qs for the quarters ended June 30, 2025 and September 30, 2025 filed with the SEC on May 9, 2025, August 19, 2025 and November 21, 2025, respectively, and other documents filed by the Company from time to time with the SEC. 

CONTACTS: 
Investor Relations (English): [email protected]        
Investors (Chinese): [email protected]  
Media: [email protected] 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1e88c93a-2fd7-40b4-b08e-dcb6d8e6a97f

TEL AVIV, Israel, Jan. 11, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) will present its ongoing transformation and expected growth trajectory through 2030 at the 44^th Annual J.P. Morgan Healthcare Conference. Teva’s President and Chief Executive Officer, Richard Francis, will meet with investors and present the Company’s milestones achieved in 2025, transformative initiatives, and forward-looking outlook for 2026 and beyond.

Presentation Highlights:

• Pivot to Growth Strategy Progress: Teva is accelerating its Pivot to Growth strategy, focusing on transforming into a leading innovative biopharmaceutical company through late-stage innovative pipeline, fueled by its world-class generics business.
• Innovation at
  the
  Heart
  of Teva’s Transformation: Teva’s key innovative brands – AUSTEDO^®, AJOVY^® and UZEDY^® – are already driving its growth and reshaping Teva’s financial outlook. Teva’s clinical pipeline assets – olanzapine LAI, DARI (ICS/SABA), duvakitug (anti-TL1A), emrusolmin, and anti-IL-15 – are expected to drive Teva’s long-term growth trajectory and further Teva’s transformation.
• 2025 Performance: Teva to provide its expected 2025 financial performance.
• 2026 and
  B
  eyond: In addition, Teva to provide forward-looking outlook for 2026 and beyond, underlining disciplined capital allocation and a commitment to securing an investment-grade credit rating.

Expected 2025 Performance

$ billions, except EPS or as noted	2025 Outlook	Expected 2025 performance relative to Outlook (excl uding duv akitug milestones)	Additional contribution from e xpected duvakitug milestones
Revenues*	$16.8 – $17.0	Lower point of the range	$500M
Operating Margin	~26.2% – 27.1%	Mid to high point of the range	~80%-85%
Adjusted EBITDA	$4.8 – $5.0	Midpoint of the range	~$400M-$430M
Tax Rate	15%-18%	Lower point of the range
Diluted EPS ($)	2.55 – 2.65	Higher point of the range
Free Cash Flow**	$1.6 – $1.9	Higher point of the range	~$500M
Net leverage	~2.5x – 2.9x	Midpoint of the range	~2.5x

P
ath to achieving 2027 targets and additional 2030 targets

$ billions or as n oted	2026	2027	2030
Revenues*	Flat to slightly down vs. 2025	Low-single digit growth	Mid-single digit CAGR
Operating Profit	Growing vs. 2025	30%	>30%
Adjusted EBITDA		Growing vs. 2026	Growing
Free Cash Flow**	Growing vs. 2025	>$2.7	>$3.5
Net Leverage	~2.0-2.2x	<2x	<2x
Cumulative Transformation Programs Savings	~$450M-500M	~$700M

<sup>Note: 2026 commentary compared to 2025 results excluding duvakitug milestones, except for net debt leverage calculation.

* Revenues presented on a GAAP basis; all other metrics presented on a non-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.</sup>

To access a live webcast of the presentation, visit 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 and will be accessible for up to 30 days.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to better health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Non-GAAP Financial Measures

This press release includes certain non-GAAP financial measures as defined by SEC rules. Management believes that such non-GAAP financial measures provide useful information to investors to facilitate their understanding of our business because the non-GAAP financial measures are used by Teva’s management and board of directors, in conjunction with other performance metrics, to evaluate the operational performance of the company, to compare against the company’s work plans and budgets, and ultimately to evaluate the performance of management; the company’s annual budgets are prepared on a non-GAAP basis; and senior management’s annual compensation is derived, in part, using these non-GAAP measures. Investors should consider the non-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. In the case of the non-GAAP financial measures disclosed in this press release, we are not providing comparable forward looking guidance for GAAP 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.

Teva Cautionary Note Regarding Forward Looking Statements

This Press Release and the presentation at the conference may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding our financial guidance, 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 results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. 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. 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,” “outlook” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. 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; 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 on 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; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in this document, in our Quarterly Report on Form 10-Q for the third 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.

Teva Media Inquiries	[email protected]
Teva Investor Relations Inquiries	[email protected]

• Positive Phase 3 HERIZON-GEA-01 results for Ziihera^® (zanidatamab-hrii) in first-line HER2-positive (HER2+) 
  gastroesophageal adenocarcinoma (
  GEA) presented at ASCO GI
• Up to $440.0 million in milestone payments eligible to be earned related to regulatory approvals of Ziihera in GEA in the United States, Europe, Japan, and China
• Company well-positioned to execute new
  strategy compounding long-term value by integrating royalty growth, strategic acquisitions, and continued internal R&D innovation
• $125.0 million share repurchase plan announced in November 2025 available to reduce share count
• Cash, cash equivalents, and marketable securities of approximately $270.6 million (unaudited) as of December 31, 2025, combined with anticipated regulatory milestone payments related to potential approvals of Ziihera in GEA, expected to provide cash runway beyond 2028
• Company to present at the J.P. Morgan Annual Healthcare Conference on Wednesday, January 14, 2026 at 3:00 pm Pacific Time (PT)

VANCOUVER, British Columbia, Jan. 11, 2026 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today outlined its strategic priorities and key milestones for 2026. Following a year of significant clinical, operational and financial progress, Zymeworks is focused on executing a long-term strategy designed to maximize value creation for patients, partners, and shareholders.

“2025 was a pivotal and transformative year for Zymeworks,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “We strengthened our leadership capabilities with the addition of seasoned biotech executives and a refreshed Board, delivered strong execution across our preclinical, clinical and partnered programs, and demonstrated the value of our integrated business model. We enter 2026 with a solid financial foundation, visibility of substantial future cash flows from partnered programs and a clear strategy to compound long-term value through integrating royalty growth, disciplined internal R&D innovation, and strategic acquisitions.”

Key 2025 Accomplishments:

Zymeworks’ progress in 2025 included significant clinical advancement, strengthened leadership, and increased financial flexibility.

Partnered Programs:

• Positive results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera^® (zanidatamab-hrii) in combination with chemotherapy, with or without the PD-1 inhibitor Tevimbra^® (tislelizumab), as a first-line treatment for HER2+ locally advanced or metastatic GEA. Ziihera plus chemotherapy showed a clinically meaningful and statistically significant improvement in progression-free survival (PFS) versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for overall survival (OS) at the first OS interim analysis;
• Regulatory approvals of zanidatamab in China by the National Medical Products Administration (NMPA) and European Commission approval, in previously treated unresectable or metastatic HER2+ biliary tract cancer;
• Our partner, J&J Innovative Medicine (J&J), reported Phase 1 trial results at ASCO 2025 for pasritamig (JNJ-78278343), a first-in-class, T-cell engaging bispecific antibody targeting human kallikrein 2 (KLK2) expressed on the surface of prostate cancer cells. In September, J&J announced initiation of several Phase 3 trials evaluating pasritamig in both monotherapy and combination regimens; and,
• $69.6 million in milestone payments earned from BMS, GSK, J&J, Daiichi Sankyo, and BeOne Medicines from zanidatamab and legacy platform collaboration agreements.

Wholly-owned Pipeline:

• Initiation of first-in-human global studies for ZW251, a novel glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) incorporating Zymeworks’ proprietary topoisomerase 1 inhibitor payload, ZD06519, for the treatment of hepatocellular carcinoma (NCT07164313);
• Presentation of preliminary Phase 1 results for ZW191, an ADC targeting folate receptor-alpha, demonstrating responses across dose levels and supporting a wide therapeutic index of Zymeworks’ novel ADC platform, with 64% overall response rate in gynecological cancers at doses ≥6.4mg/kg. Dose optimization of ZW191 in ovarian cancer initiated in 4Q-2025;
• Presented preclinical data for ZW1528, a novel IL-4Rα x IL-33 bispecific molecule designed to address respiratory inflammation, and the first program from our ADVANCE research strategy; and,
• Through a series of scientific publications and presentations, outlined additional preclinical data supporting the potential therapeutic benefit of clinical programs and investigational new drug (IND) candidates in our solid tumor ADC portfolio (ZW191, ZW251, and ZW327) and our Trispecific T-cell Engager (TriTCE) Co-stim platform (ZW209).

Corporate:

• Strengthened our board of directors through the addition of three new members: Oleg Nodelman, Robert E. Landry, and Greg Ciongoli;
• Strengthened our leadership team through the addition of Dr. Sabeen Mekan as Senior Vice President, Clinical Development, Dr. Adam Schayowitz as Acting Chief Development Officer and Mr. Scott Platshon as Acting Chief Investment Officer;
• Successfully completed $60.0 million in share repurchases under the Company’s initial Share Repurchase Program announced in August 2024; and,
• Evolved our strategy to focus on building a diversified portfolio of revenue-generating healthcare assets and wholly-owned product candidates. The new strategy will combine internal innovation, licensing, and strategic acquisitions to drive sustainable value creation for shareholders.

2026 Milestones & Priorities Expected to Drive Long-Term Value Creation

Zymeworks’ evolving strategy is designed to compound long-term value by integrating royalty growth, strategic acquisitions, and internal R&D innovation, all supported by a strengthened financial foundation and thoughtful capital allocation. The Company expects meaningful, predictable and durable cash flows from its partnered programs, including Ziihera and pasritamig, as these therapeutics continue through late-stage development and commercialization. These projected revenues provide greater flexibility in capital allocation, enabling Zymeworks to balance reinvestment into its royalty and asset portfolio, to target investment in innovative internal R&D, and to continue returning excess capital to shareholders. The Company intends to pursue partnership and acquisition opportunities based on strategic fit and long-term value creation with time and optionality rather than near-term cash needs.

This evolution also formalizes Zymeworks’ integrated operating model, which pairs a robust internal R&D engine with a growing portfolio of revenue-generating licensed products. The Company’s proven ability to evaluate, prioritize, and advance its own pipeline, independently and through valuable partnerships, provides a framework for assessing potential acquisitions that may include cash-generating products, undervalued programs, or assets with attractive financial structures. By combining internal innovation with strategic asset aggregation, Zymeworks aims to scale a model that has historically driven its success, and seeks to maximize sustainable value creation and reinforce its differentiation from other healthcare royalty and asset aggregators.

“Our internal R&D engine has demonstrated the depth and breadth of novel programs and technologies it can develop, including Ziihera and pasritamig. As we evolve our strategy, we remain committed to disciplined, data-driven portfolio management and investment decisions designed to prioritize high internal rate of return opportunities,” said Galbraith. “Our global development capabilities enable us to rapidly generate high-quality clinical data, while our integrated model ensures helps us identify, partner, or acquire the right assets to build a durable and diversified portfolio. We believe this is the foundation for long-term sustainable value creation at Zymeworks.”

The transition to an integrated partnership strategy requires a change in scope and priorities for our R&D activities within the ADVANCE R&D strategy as follows:

• In our current ADC portfolio, we intend to continue to conduct our ongoing Phase 1 clinical studies for ZW191 and ZW251 during 2026;
• We intend to advance our other ongoing ADC research efforts, including future clinical development of ZW220, ZW327, and ZW418 (a biparatopic PTK7-targeting ADC incorporating a novel pan-RAS inhibitor payload) into clinical studies only with partnerships and collaborations and/or external funding becoming available; and,
• Beyond 2026, we intend to focus our future ADVANCE research efforts solely on multispecific antibody and engineered-cytokine platforms, funded partially with early-stage partnerships and collaborations. We expect ZW1528 to be the first of our ADVANCE R&D programs to enter clinical studies in 2026. We intend to continue actively sharing peer-reviewed publications and data across preclinical and clinical programs.

The Company anticipates the following clinical development milestones from its R&D pipeline:

• The global Phase 1 clinical trial investigating ZW191 in solid tumors is ongoing with dose optimization of ZW191 in ovarian cancer. Additional data from the Phase 1 trial is anticipated to be presented at a major medical meeting in 2026;
• The global Phase 1 clinical trial investigating ZW251 in solid tumors is actively recruiting. The Company presented a Trial-in-Progress poster for ZW251, at ASCO Gastrointestinal Cancers Symposium (ASCO GI) on January 9, 2026;
• INDs for multispecific programs, ZW209 and ZW1528, remain on track for submission in 2026, as we continue evaluating partnership opportunities before the commencement of clinical studies; and,
• Development of wholly-owned preclinical candidates from our multispecific antibody portfolio to provide for one planned IND filing per annum commencing in 2028.

Ziihera

^®

(zanidatamab-hrii)

• Late-breaking HERIZON-GEA-01 clinical data presented at ASCO GI by partner Jazz Pharmaceuticals on January 8, 2026. The study found:
  • Both investigational arms, Ziihera plus tislelizumab and chemotherapy and Ziihera plus chemotherapy, led to a statistically significant and clinically meaningful prolongation of progression-free survival (PFS) with approximately 35% reduction in the risk of disease progression or death versus trastuzumab plus chemotherapy. This resulted in a median PFS of more than one year, representing a greater than four month improvement compared to the control arm.
  • Ziihera plus tislelizumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of more than two years (26.4 months), the longest reported in a Phase 3 trial in GEA, representing a greater than seven-month improvement in median OS and a 28% reduction in the risk of death versus trastuzumab plus chemotherapy.
  • At this first interim analysis, Ziihera plus chemotherapy showed a median OS of more than two years, with a strong trend toward statistical significance, favoring Ziihera plus chemotherapy versus trastuzumab plus chemotherapy. An additional planned OS interim analysis for Ziihera plus chemotherapy is currently expected in mid-2026.
  • The OS and PFS benefits were generally consistent across major prespecified subgroups including geographic region and PD-L1 status for both investigational arms.
• Based on the topline results from HERIZON-GEA-01, Jazz plans to submit a supplemental Biologics License Application in 1H-2026 for zanidatamab in the U.S. as first-line treatment for HER2+ locally advanced or metastatic GEA; and,
• Zymeworks has the potential to receive substantial near-term milestone payments related to future anticipated regulatory approvals in GEA totaling $440.0 million, as follows: U.S. – $250.0 million; EU – $100.0 million; Japan – $75.0 million; China – $15.0 million.

Authorized Share Repurchase Program

In November 2025, the Board of Directors authorized a new share repurchase program providing the ability to repurchase up to $125.0 million in common stock. The program underscores our confidence in Zymeworks’ long-term growth prospects and helps enhance shareholder value by reducing share count, while maintaining cash resources for operations and growth investments and preserving financial flexibility for strategic opportunities.

To date, the Company has utilized approximately $19.0 million of this approved repurchase program to acquire 727,271 shares of the Company’s common stock at an average price of $26.07 (exclusive of commission expense and estimated excise tax).

Operational and Cash Runway Guidance

Our adjusted gross operating expense (non-GAAP) guidance for combined adjusted research and development (R&D) expense (non-GAAP) and adjusted general and administrative (G&A) expense (non-GAAP) (excluding stock compensation expense) outlines a disciplined framework of approximately $300.0 million in aggregate adjusted gross operating expenditures (non-GAAP) over a three-year period ending December 31, 2028. We expect a greater proportion of adjusted gross operating expense (non-GAAP) to be incurred in 2026 and decline in 2027 and 2028, reflecting a deliberate and measured investment across R&D and G&A aligned with clearly defined strategic priorities. This outlook reflects current expectations, underscores our continued focus on cost discipline and capital allocation rigor, and does not include any potential acquisition-related expenditures.

As of December 31, 2025, the Company had cash resources of approximately $270.6 million (unaudited), consisting of cash, cash equivalents, and marketable securities.

Based on current operating plans and our existing cash resources, and assuming full execution of the $125.0 million share repurchase plan and receipt of anticipated regulatory milestone payments of $440.0 million associated with potential regulatory approvals of Ziihera in GEA in the United States, Europe, Japan, and China, we believe we are positioned to fund planned operations beyond 2028. This anticipated cash runway does not take into account any contribution from additional future milestone payments or royalties related to Ziihera, other current licensed product candidates or contributions from future partnerships and collaborations.

J.P. Morgan Healthcare Conference Presentation and Webcast

Management will participate in the J.P. Morgan Annual Healthcare Conference taking place in San Francisco, California, from January 12-15, 2026, and present on January 14, 2026, at 3:00 pm PT. The presentation and webcast will be available on Zymeworks’ website.

Non-GAAP Information

In addition to reporting financial information in accordance with U.S. generally accepted accounting principles (GAAP) in this press release, we have elected to present selected non-GAAP, or adjusted, financial measures on a forward-looking basis. A reconciliation of anticipated adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense to the most directly comparable GAAP measures is not available without unreasonable effort due to the uncertainty of expenses that may be incurred in the future, and we are also unable to predict the probable significance of such adjusted measures. Accordingly, in reliance on the exception provided by Item 10(e)(1)(i)(B) of Regulation S-K, we have not provided a reconciliation for the adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense guidance provided in this press release. Zymeworks believes that estimated adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense, which are non-GAAP financial measures, may be helpful to investors because they provides consistency and comparability with financial performance across periods. These non-GAAP financial measures are not defined by GAAP and should not be considered as alternatives to operating expenses, research and development expenses, and general and administrative expenses or any other indicators of Zymeworks’ performance required to be reported under GAAP. In addition, other companies, including companies in Zymeworks’ industry, may calculate similarly titled non-GAAP or adjusted measures differently or may use other measures to evaluate their performance, all of which could the reduce the usefulness of adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense as financial measures. As defined by Zymeworks, adjusted gross operating expense represents the aggregate of adjusted research and development expense and adjusted general and administrative expense, each of which excludes stock-based compensation expense for equity- and liability-classified equity instruments.

About Zymeworks Inc.
Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company’s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera^® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the early-stage development of innovative medicines. Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including 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 in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities and the anticipated benefits thereof, including shareholder returns and the anticipated manner of such returns; implementation of its long-term strategy to maximize value creation; preliminary and unaudited estimates of its cash, cash equivalents, and marketable securities; anticipated sufficiency of existing cash resources, assuming full execution of the share repurchase plan and receipt of anticipated regulatory milestone payments associated with potential regulatory approvals of Ziihera in GEA in the United States, Europe, Japan, and China, to fund Zymeworks’ planned operations beyond 2028; expectations regarding cash flows from partnered programs, including Ziihera and pasritamig; Zymeworks’ ability to balance reinvestments into its royalty and asset portfolio and internal R&D and return to stockholders; implementation of its evolving asset aggregation strategy, including existing and potential future royalty streams and existing and potential new partnerships; the anticipated benefits of its collaboration agreements, including Zymeworks’ ability to receive any future milestone payments and royalties thereunder; statements relating to potential milestone payments upon regulatory approvals of Ziihera in GEA and the timing thereof; statements that relate to the expected contributions of personnel to Zymeworks’ strategic goals; statements that relate to Zymeworks’ ability to execute the share repurchase plan, in whole or in part; expected timing and amount of repurchases; Zymeworks’ ability to pursue its business objectives following repurchases under the share repurchase plan; anticipated capital allocation strategy; industry opportunities for acquisition of new revenue streams or collaborations; the timing of and results of interactions with regulators; Zymeworks’ clinical development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future studies and the related data; anticipated preclinical and clinical data presentations; expectations regarding future regulatory filings and approvals and the timing thereof; expected financial performance and future financial position, including anticipated adjusted gross operating expense (non-GAAP), adjusted research and development expense (non-GAAP) and adjusted general and administrative expense (non-GAAP) for the three-year period ending December 31, 2028, excluding any potential acquisition-related expenditures; the commercial potential of technology platforms and product candidates; Zymeworks’ ability to satisfy potential regulatory and commercial milestones with existing and future partners; the timing and status of ongoing and future studies and the release of data; anticipated continued receipt of revenue from existing and future partners; Zymeworks’ early-stage pipeline; Zymeworks’ ability to execute new collaborations and partnerships and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not be able to successfully execute the share repurchase plan; the anticipated benefits of the share repurchase plan may not be realized; Zymeworks may not achieve milestones or receive additional payments under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue-generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; data providing early validation of our antibody drug conjugate platform and next generation pipeline programs may not be replicated in future studies; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca).

Furthermore, we are in the process of finalizing our financial results for the fourth quarter and fiscal year 2025, and therefore our finalized and audited results and final analysis of those results are not yet available. The preliminary expectations regarding year-end cash, cash equivalents, and marketable securities are the responsibility of management, are subject to management’s review and actual results could differ from management’s expectations. The actual results are also subject to audit by our independent registered public accounting firm and no assurance is given by our independent registered public accounting firm on such preliminary expectations. You should not draw any conclusions as to any other financial results as of and for the year ended December 31, 2025, based on the foregoing estimates.

Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.

Investor inquiries:

Shrinal Inamdar
Senior Director, Investor Relations
(604) 678-1388
[email protected] 

Media inquiries:

Diana Papove
Senior Director, Corporate Communications
(604) 678-1388
[email protected] 

– Reports $156 to $160 Million in Preliminary* Full-Year 2025 U.S. Net Product Sales, a 35% to 38% Increase Compared With Full-Year 2024 –

–Total Preliminary* Revenue of $400 to $408 million, a 20% to 23% Increase Compared With Full-Year 2024, and ~55% to 59% Increase Excluding One-Time Milestones –

– Cash and Cash Equivalents of Approximately $168 Million* at Year-End 2025 –

– Q4 Retail Prescription Equivalents Grew 34% Y/Y and 11.3% Q/Q –

        
– Expects Operating Expenses of Between $210 Million and $245 Million for Full-Year 2026 –

– Introduces Vision 2040 Growth Strategy Focused on Global Growth of Cardiometabolic Franchise and Expansion of Pipeline into Rare Hepatic and Renal Diseases –

ANN ARBOR, Mich., Jan. 11, 2026 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today provides preliminary financial results for the full-year 2025, including U.S. net product sales, cash and cash equivalents and expectations for 2026 operating expenses.

“2025 marked the most successful year in Esperion’s history, driven by exceptional execution across our U.S. commercial strategy, expanded global reach and performance, and significant progress across our pipeline – all while delivering meaningful growth in our cardiovascular franchise and strengthening our financial position. These achievements set the stage for something far bigger: Vision 2040. This bold roadmap reflects our commitment to transform Esperion into a multi-product, sustainable, innovation-driven global pharmaceutical company that not only leads in cardiovascular disease prevention but also addresses a broader spectrum of unmet medical needs,” said Sheldon Koenig, Chief Executive Officer of Esperion.

“By 2040, we envision Esperion as a company with multiple blockbuster products on the market, a robust pipeline of next-generation therapies, and a proven commercial infrastructure that makes us a partner of choice. Our deep expertise in ACLY biology and our relentless focus on patient impact will fuel this evolution. Vision 2040 is more than a strategy—it’s a promise to patients, providers, and shareholders that Esperion will continue to lead with science, scale with purpose, and deliver enduring value for decades to come,” concluded Mr. Koenig.

Introducing Vision 2040

Esperion is pleased to introduce its Vision 2040 that outlines its long-term strategy to evolve into a sustainable, innovation-driven, global pharmaceutical company that is anchored by leadership in cardiometabolic indications including rare and orphan diseases. Esperion’s goal is to leverage the billion-dollar opportunity in its current cardiovascular disease prevention franchise to build a global pharmaceutical company with a growing product portfolio of at least five marketed products and a dynamic discovery engine producing a robust pipeline that addresses a variety of diseases of unmet medical need.

A central component of Vision 2040 is to expand our product portfolio and advance our next-generation development pipeline. The company plans to leverage its proven commercial infrastructure to become a partner-of-choice through acquisition, in-licensing, co-promotion, and revenue-share opportunities. At the same time, Esperion will build on its deep domain expertise in ACLY biology to diversify our therapeutic focus and advance a series of novel product candidates, each with the power to change lives and the potential to become blockbuster products.

Together, these pillars form the foundation for Vision 2040 – a roadmap designed to transform Esperion by uniting scientific leadership, strategic business development, and operational execution. Esperion is positioned to expand its reach, accelerate innovation, and deliver lasting benefits to patients, partners and shareholders.

Advancing the U.S. Commercial Strategy

NEXLETOL^® (bempedoic acid) and NEXLIZET^® (bempedoic acid and ezetimibe) are approved by the U.S. Food and Drug Administration to help prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use. The treatable population represents more than 70 million patients in the U.S. alone. Esperion is currently focusing its commercialization efforts on the statin intolerant or statin resistant market, which represents approximately 30% of the overall market. To address this key market segment, Esperion has ramped up its sales efforts, developed a powerful suite of new promotional materials, created a bold new consumer campaign, enhanced its patient support programs, and continued working with payers to ensure broad patient access.

Importantly, Esperion is undertaking a series of strategic initiatives aimed at reinforcing the long-term protection of the bempedoic acid franchise, including potential extensions of market exclusivity and the introduction of a triple combination product that could provide a level of efficacy with the potential to rival existing injectable and emerging oral therapies.

• Achieved $156 to $160 million in preliminary* full-year 2025 U.S. net product sales, representing a 35% to 38% increase compared with full-year 2024
• Q4 retail prescription equivalents showed 34% Y/Y and 11.3% sequential Q/Q growth.
• Reached settlement agreements with four key ANDA filers, including Dr. Reddy’s Laboratories, restricting generic entry by these parties until April 2040 and leaving no remaining challenges regarding the validity or infringement of U.S Patent No. 7,335,799 in the pending patent litigation. Certain of Esperion’s patents that remain subject to the pending patent litigation are scheduled to expire in March 2036, while others are scheduled to expire in June 2040.
• Significantly strengthened access and reimbursement support for NEXLETOL and NEXLIZET, now exceeding 90% of commercial lives and 90% of Medicare beneficiaries covered, with all national commercial and Medicare payers covering all indications.
• Introduced the “Can’t take a statin? Make NEXLIZET happen!” campaign, which has already increased brand awareness and improved healthcare providers’ perception of NEXLETOL and NEXLIZET among statin-intolerant or resistant patients.
• Enabled the expansion of healthcare providers prescribing NEXLETOL and NEXLIZET from 36,311 to 44,991, a 24% increase in 2025 with strengthened reimbursement and award-winning marketing and educational initiatives.
• Expect bempedoic acid products to be included in the upcoming U.S. Dyslipidemia Guidelines in Q1 2026, which would be a major catalyst to drive adoption and growth of the bempedoic franchise.
• To leverage the strengthened reimbursement, potential expanded timeline to generic entry, and anticipated U.S. guideline inclusion, the Company plans to expand its U.S. commercial efforts through enhanced sales and marketing investments.
• Plans to expand its revenue opportunity in the cardiovascular prevention market with the introduction of two triple combination products. The published literature suggests that the triple combination products can lower LDL-C in excess of 60%. This level of efficacy has the potential to rival existing injectable and emerging oral therapies, offering a valuable oral option for both patients and physicians. The company expanded its partnerships with regulatory experts and others in the field to advance this important work with a goal to complete the clinical requirements and commercialize triple combinations in 2027.

Global Expansion

Cardiovascular (CV) disease remains the leading cause of death worldwide, and Esperion continues to make meaningful progress delivering its bempedoic acids products to patients who are unable to achieve their low-density lipoprotein cholesterol (LDL-C) goals and remain at heightened risk of CV disease or a CV event, such as a heart attack. Together with our global partners, we have made significant advancements expanding access to bempedoic acid internationally, strengthening the global footprint of the franchise.

• Daiichi Sankyo Europe, Esperion’s strategic partner across Europe, continued to deliver double digit quarterly growth across key EU markets, and expanded availability of bempedoic acid therapies across 30 countries in the European Union, with more than 600,000 patients treated to date.
  • Bempedoic acid was included as a Class I, Level A recommendation in the 2025 ESC/EAS guidelines.
  • Secured regulatory and reimbursement approval for NILEMDO in France, one of the largest markets in Europe.
  • Announced the development of oral triple combination lipid-lowering tablets, with SANTORINI simulations showing improved LDL-C goal attainment aligned with the 2025 ESC/EAS guidelines.
• Otsuka Pharmaceutical Co., Ltd., Esperion’s strategic partner in Japan, received regulatory approval and favorable National Health Insurance price listing, which resulted in a $90 million total payment to Esperion.
  • Successful commercial launch in late 2025 sets the stage for meaningful growth in 2026.
  • Japan is the third largest global market for cardiovascular prevention, representing significant long-term growth opportunity for NEXLETOL.
• HLS Therapeutics, Esperion’s strategic partner in Canada, received regulatory approval for NILEMDO in late 2025, with approval for NEXLIZET expected in 2026.
• Esperion continues to expect its partner in Israel, Neopharm Israel, to receive regulatory approval to market NEXLETOL and NEXLIZET in the first half of 2026.
• CSL Seqirus, the Company’s partner in Australia and New Zealand, filed a marketing application in Australia for NEXLETOL and NEXLIZET in July 2025, and expects market approval in Q4 2026.

R&D Pipeline

Esperion plans to advance its promising ACLY-focused pipeline, leveraging its established leadership in ACLY biology to pursue new therapeutic opportunities and develop next-generation inhibitors designed to address multiple life-threatening diseases. ACLY is a critical metabolic enzyme positioned at the intersection of nutrient catabolism and cholesterol and fatty acid biosynthesis, making it an attractive target for broad therapeutic intervention.

• Nominated ESP-2001, a highly specific allosteric ATP-citrate lyase inhibitor, as preclinical development candidate for the treatment of primary sclerosing cholangitis (PSC).
• Initiated Investigational New Drug-enabling studies for ESP-2001, with the goal of submitting an IND to the U.S. Food and Drug Administration (FDA) to begin first-in-human clinical studies in 2026.
• With an estimated prevalence of approximately 76,000 diagnosed PSC patients across the U.S. and Europe, and with no approved treatment options, ESP-2001 – a wholly owned asset for which Esperion retains exclusive global development and commercialization rights – represents a potential blockbuster market opportunity of more than $1 billion annually.
• ESP-2001 has potential eligibility for Orphan Drug and Fast Track designations from the U.S. FDA, as well as PRIME designation from the European Medicines Agency.

Financials

Esperion completed a $75.0 million capital raise in 2025, enhancing financial flexibility to support continued commercial expansion and pipeline development.

Esperion introduces its expectations for full-year 2026 operating expenses to be in the range of $210 million to $245 million, including $15 million in non-cash expenses related to stock compensation.  

J.P. Morgan Healthcare Conference Presentation

Esperion will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2025, at 2:15 p.m. PT (5:15 p.m. ET).

The live webcast can be accessed on the investor and media section of the Esperion website. Access to the webcast replay will be available approximately two hours after the completion of the call and will be archived on the Company’s website for approximately 90 days.

* The preliminary selected financial results are unaudited, subject to adjustment, and provided as an approximation in advance of the Company’s announcement of complete financial results in March 2026.

INDICATION

NEXLIZET and NEXLETOL are indicated:

• The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin).
  • NEXLIZET, to reduce LDL-C in adults with hypercholesterolemia, including HeFH.
  • NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible to reduce LDL-C in adults with hypercholesterolemia, including HeFH.

IMPORTANT SAFETY INFORMATION

NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.

Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.

Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.

The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in ≥2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.

Adverse reactions reported in ≥2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.

In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥3% and greater than placebo) observed with NEXLIZET, but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.

The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.

Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.

Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.

Please see full Prescribing Information for NEXLIZET and NEXLETOL.

About Esperion Therapeutics

Esperion Therapeutics, Inc. is a commercial-stage biopharmaceutical company dedicated to developing and delivering innovative cardiometabolic and rare/orphan disease therapies. The Company leverages deep domain expertise in ACLY biology to develop and commercialize transformative medicines for patients worldwide. Esperion currently markets two oral, once-daily, non-statin therapies for patients struggling to maintain their low-density lipoprotein cholesterol (LDL-C) levels and are at risk of cardiovascular disease.

With a broad U.S. commercial infrastructure and global approvals across more than 40 countries, Esperion is well positioned to serve as a partner-of-choice for global innovators seeking U.S. market access through acquisition, in-license, co-promotion and revenue share opportunities. In tandem, the Company is advancing its leadership in ACLY biology to build a diversified pipeline of novel product candidates, including treatments for Primary Sclerosing Cholangitis and renal diseases. For more information, visit esperion.com and follow Esperion on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization and business development plans, current and planned operational expenses, expected profitability, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway and profitability, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, business development, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

Esperion Contact Information:

Investors:
Alina Venezia
[email protected]
(734) 887-3903

Media:
Tiffany Aldrich
[email protected]
(616) 443-8438

• Royalty Pharma to provide up to $500 million, including $75 million for Phase 2b funding and a Royalty Pharma option for an additional $425 million, to support Teva’s anti-IL-15 candidate, TEV-‘408 
• TEV-‘408 is currently in Phase 1b for treatment of vitiligo and in Phase 2a for celiac disease
• Funding agreement supports Teva’s Pivot to Growth strategy to accelerate its innovative pipeline and bring treatments to patients faster
  
  
  

NEW YORK and PARSIPPANY, N.J., Jan. 11, 2026 (GLOBE NEWSWIRE) — Royalty Pharma plc (Nasdaq: RPRX) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced a funding agreement of up to $500 million to accelerate the clinical development of Teva’s anti-IL-15 antibody, TEV-‘408. IL-15 is a key cytokine involved in multiple immune-mediated disease pathways. Emerging Phase 1b data from the ongoing TEV-‘408 vitiligo study provides preliminary support for IL-15 as a potential therapeutic target to treat a broad variety of autoimmune conditions. Teva anticipates sharing results from TEV-‘408 trials during 2026.

“We are delighted to enter into this second collaboration with Teva as they advance the development of TEV-‘408,” said Pablo Legorreta, Chief Executive Officer and Chairman of the Board of Royalty Pharma. “Vitiligo is a chronic autoimmune skin disease that can have a profound emotional and psychosocial burden, yet current treatment options are insufficient. Our continued collaboration underscores Royalty Pharma’s role as a long-term, trusted partner with a focus on funding innovation in potentially transformative and practice changing therapies.”

“Strategic collaborations fuel innovation. This agreement with Royalty Pharma enables us to advance our science more efficiently and accelerate our pipeline to deliver meaningful solutions for patients worldwide,” said Richard Francis, President, and CEO of Teva. “Vitiligo represents a significant unmet need, with only one approved topical treatment currently available and no systemic options. We are dedicated to driving scientific progress that brings new, effective therapies to people living with chronic autoimmune diseases.”

Transaction Terms

Under the terms of the agreement, Royalty Pharma will provide Teva up to $500 million to fund ongoing development costs for TEV-‘408 in vitiligo. This is comprised of $75 million in R&D co-funding to conduct a Phase 2b study targeted to start in 2026. Based on the future results from Phase 2b in vitiligo, Royalty Pharma will have an option to provide an additional $425 million to co-fund the Phase 3 development program. If approved and launched, Teva will pay a milestone to Royalty Pharma and a royalty on worldwide net sales of TEV-‘408.

About TEV-‘408

TEV-‘408 is an investigational human monoclonal antibody designed to inhibit interleukin-15 (IL-15), a cytokine involved in immune-mediated pathways. TEV-‘408 has a high affinity and potency (in vitro) as well as a prolonged half-life, with a planned convenient self-administration option for patients.

It is currently in Phase 1b (NCT06625177) for the treatment of vitiligo. The candidate is also being evaluated in a Phase 2a study (NCT06807463) for celiac disease and was granted Fast Track designation by the U.S. FDA in May 2025. By blocking IL-15 activity, TEV-‘408 aims to reduce the immune-mediated destruction of melanocytes (pigment producing cells) resulting in white patches on the skin characteristic of vitiligo or reduce the IL-15-driven intestinal inflammation and damage characteristic of celiac disease.

About Vitiligo

Vitiligo is a chronic autoimmune skin disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches that can appear anywhere on the body. Affecting people of all ages, skin types, and ethnicities, vitiligo has an estimated global prevalence of 0.5% to 2% though many individuals remain undiagnosed. Beyond its physical manifestations, vitiligo can impose a significant emotional and psychosocial burden, with many people experiencing anxiety, depression, and social isolation.

Current treatment options are limited. Only one topical therapy is approved, and its use is restricted to treating up to 10% of the body surface area. As a result, many people with vitiligo remain insufficiently treated, underscoring the need for a systemic durable, effective, and safe therapy that addresses both visible skin changes and overall quality of life.

About Royalty Pharma plc

Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly – directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta and Alyftrek, Johnson & Johnson’s Tremfya, GSK’s Trelegy, Roche’s Evrysdi, Servier’s Voranigo, Biogen’s Tysabri and Spinraza, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, Pfizer’s Nurtec ODT, and Gilead’s Trodelvy, among others, and 20 development-stage product candidates. For more information, visit www.royaltypharma.com.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Royalty Pharma Forward-Looking Statements

The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this document unless stated otherwise, and neither the delivery of this document at any time, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes available or changes occurring after the date hereof. This document contains statements that constitute “forward-looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of Royalty Pharma’s strategies, financing plans, growth opportunities, market growth, and plans for capital deployment. In some cases, you can identify such forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “target,” “forecast,” “guidance,” “goal,” “predicts,” “project,” “potential” or “continue,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of Royalty Pharma’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, and other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of Royalty Pharma’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this document are made only as of the date hereof. Royalty Pharma does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law. For further information, please reference Royalty Pharma’s reports and documents filed with the U.S. Securities and Exchange Commission (“SEC”) by visiting EDGAR on the SEC’s website at www.sec.gov.

Teva 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. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop our anti-IL-15 antibody (TEV-’408) for vitiligo and for Celiac disease; our ability to successfully execute the agreement with Royalty Pharma for the funding of anti-IL-15 development for vitiligo; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; 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, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third 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.

Royalty Pharma Investor Relations and Communications

+1 (212) 883-6637
[email protected]

Teva Media Inquiries

[email protected]

Teva Investor Relations Inquiries

[email protected]

• Royalty Pharma to provide up to $500 million, including $75 million for Phase 2b funding and a Royalty Pharma option for an additional $425 million to support Teva’s anti-IL-15 candidate TEV-‘408
• TEV-‘408 is currently in Phase 1b for treatment of vitiligo and in Phase 2a for celiac disease
• Funding agreement supports Teva’s Pivot to Growth strategy to accelerate its innovative pipeline and bring treatments to patients faster

PARSIPPANY, N.J., and NEW YORK, Jan. 11, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Royalty Pharma plc (Nasdaq: RPRX), today announced a funding agreement of up to $500 million to accelerate the clinical development of Teva’s anti-IL-15 antibody, TEV-’408. IL-15 is a key cytokine involved in multiple immune-mediated disease pathways. Emerging Phase 1b data from the ongoing TEV-‘408 vitiligo study provides preliminary support for IL-15 as a potential therapeutic target to treat a broad variety of autoimmune conditions. Teva anticipates sharing results from TEV-‘408 trials during 2026.

“Strategic collaborations fuel innovation. This agreement with Royalty Pharma enables us to advance our science more efficiently and accelerate our pipeline to deliver meaningful solutions for patients worldwide,” said Richard Francis, Teva’s President and CEO “. Vitiligo represents a significant unmet need, with only one approved topical treatment currently available and no systemic options. We are dedicated to driving scientific progress that brings new, effective therapies to people living with chronic autoimmune diseases.”

“We are delighted to enter into this second collaboration with Teva as they advance the development of TEV-‘408,” said Pablo Legorreta, Chief Executive Officer and Chairman of the Board of Royalty Pharma. “Vitiligo is a chronic autoimmune skin disease that can have a profound emotional and psychosocial burden, yet current treatment options are insufficient. Our continued collaboration underscores Royalty Pharma’s role as a long-term, trusted partner with a focus on funding innovation in potentially transformative and practice changing therapies.”

Transaction Terms

Under the terms of the agreement, Royalty Pharma will provide Teva up to $500 million to fund ongoing development costs for TEV-‘408 in vitiligo. This is comprised of $75 million in R&D co-funding to conduct a Phase 2b study targeted to start in 2026. Based on the future results from Phase 2b in vitiligo, Royalty Pharma will have an option to provide an additional $425 million to co-fund the Phase 3 development program. If approved and launched, Teva will pay a milestone to Royalty Pharma and a royalty on worldwide net sales of TEV-’408.

About TEV-‘408

TEV-‘408 is an investigational human monoclonal antibody designed to inhibit interleukin-15 (IL-15), a cytokine involved in immune-mediated pathways. TEV-’408 has a high affinity and potency (in vitro) as well as a prolonged half-life, with a planned convenient self-administration option for patients.

It is currently in Phase 1b (NCT06625177) for the treatment of vitiligo. The candidate is also being evaluated in a Phase 2a study (NCT06807463) for celiac disease and was granted Fast Track designation by the U.S. FDA in May 2025. By blocking IL-15 activity, TEV-‘408 aims to reduce the immune-mediated destruction of melanocytes (pigment producing cells) resulting in white patches on the skin characteristic of vitiligo or reduce the IL-15-driven intestinal inflammation and damage characteristic of celiac disease.

About Vitiligo

Vitiligo is a chronic autoimmune skin disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches that can appear anywhere on the body. Affecting people of all ages, skin types, and ethnicities, vitiligo has an estimated global prevalence of 0.5% to 2% though many individuals remain undiagnosed. Beyond its physical manifestations, vitiligo can impose a significant emotional and psychosocial burden, with many people experiencing anxiety, depression, and social isolation.

Current treatment options are limited. Only one topical therapy is approved, and its use is restricted to treating up to 10% of the body surface area. As a result, many people with vitiligo remain insufficiently treated, underscoring the need for a systemic, durable, effective, and safe therapy that addresses both visible skin changes and overall quality of life.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

About Royalty Pharma plc

Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly – directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta and Alyftrek, Johnson & Johnson’s Tremfya, GSK’s Trelegy, Roche’s Evrysdi, Servier’s Voranigo, Biogen’s Tysabri and Spinraza, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, Pfizer’s Nurtec ODT, and Gilead’s Trodelvy, among others, and 20 development-stage product candidates. For more information, visit www.royaltypharma.com.

Teva 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. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop our anti-IL-15 antibody (TEV-’408) for vitiligo and for Celiac disease; our ability to successfully execute the agreement with Royalty Pharma for the funding of anti-IL-15 development for vitiligo; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; 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, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third 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.

Royalty Pharma Forward-Looking Statements

The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this document unless stated otherwise, and neither the delivery of this document at any time, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes available or changes occurring after the date hereof. This document contains statements that constitute “forward-looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of Royalty Pharma’s strategies, financing plans, growth opportunities, market growth, and plans for capital deployment. In some cases, you can identify such forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “target,” “forecast,” “guidance,” “goal,” “predicts,” “project,” “potential” or “continue,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of Royalty Pharma’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, and other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of Royalty Pharma’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this document are made only as of the date hereof. Royalty Pharma does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law. For further information, please reference Royalty Pharma’s reports and documents filed with the U.S. Securities and Exchange Commission (“SEC”) by visiting EDGAR on the SEC’s website at www.sec.gov.

Teva Media Inquiries: [email protected]  

Teva Investor Relations Inquires:
[email protected]

Royalty Pharma Investor Relations and Communications

+1 (212) 883-6637


[email protected]

Preliminary 2025 net product revenue of $155.4 million, representing 172% year-over-year growth; OJEMDA 2026 U.S. net product revenue projected to be $225 – $250 million

Company to present on corporate progress and priorities for 2026 during J.P. Morgan Healthcare Conference, January 12th at 5:15 pm PT (8:15 pm ET)

BRISBANE, Calif., Jan. 11, 2026 (GLOBE NEWSWIRE) — Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the release of preliminary unaudited 2025 OJEMDA™ net product revenue, cash and investments at year-end and provided 2026 OJEMDA net product revenue guidance ahead of the company’s scheduled presentation tomorrow at the 44th Annual J.P. Morgan Healthcare Conference at 5:15 pm PT (8:15 pm ET).

“Following remarkable commercial and clinical progress in 2025 and the strategic acquisition of Mersana and our new pipeline program Emi-Le (emiltatug ledadotin), we’re entering 2026 poised to deliver on our mission and on our growth aspirations,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “I’m thrilled by the steady uptake of OJEMDA in relapsed or refractory pLGG, and by the opportunities for future patient impact we expect from the clinical data for OJEMDA in front line pLGG and for Emi-Le and DAY301. Our solid financial position will continue to enable us to invest in future programs that have strong potential to become important new medicines.”

2025 OJEMDA Commercial Performance

• OJEMDA net product revenue was approximately $52.8 million and $155.4 million for the fourth quarter and full year 2025, respectively (unaudited)
• ~37% QoQ growth compared to Q3 2025; ~172% YoY growth vs. 2024, driven by momentum in patient demand, with prescription volumes increasing to 1,394 during the fourth quarter
• 2026 OJEMDA U.S. net product revenue is projected to be between $225 million and $250 million, representing 53% year-over-year growth at the midpoint

2026 Corporate Priorities and Key Milestones

OJEMDA

• Deliver on 2026 OJEMDA net product revenue guidance, with a focus on increasing persistency and driving new patient starts to support continued OJEMDA adoption as standard of care (SOC) in 2L pediatric low-grade glioma (pLGG)
• Extend the OJEMDA commercial opportunity beyond the U.S. with global expansions via our partner
• Complete enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial in first-line pLGG in the first half of 2026, enabling a mid-2027 data readout and a potential approval in 2028

PIPELINE

• Advance Emi-Le program by delivering Phase 1 clinical data by mid-2026 and progressing toward registration
• Provide initial data from the Phase 1a clinical trial for DAY301, a PTK7-targeted antibody drug conjugate (ADC), in the second half of 2026

Corporate Update

As of December 31, 2025, prior to the acquisition of Mersana, Day One had approximately $441.1 million of cash, cash equivalents, and short-term investments (unaudited). The 2025 net product revenues and cash, cash equivalents and short-term investments position included in this release are preliminary and are therefore subject to adjustment. The preliminary net product revenue results are based on management’s initial analysis of operations for the year ended December 31, 2025. The Company expects to issue full financial results for the fourth-quarter and full-year 2025 in February 2026.

J.P. Morgan Presentation Details

Dr. Jeremy Bender, chief executive officer, will present during the 44^th Annual J.P. Morgan Healthcare Conference on Monday, January 12 at 5:15 pm PT (8:15 pm ET). A live audio webcast of the presentation will be available by visiting the Events & Presentations section of the Company’s website at www.dayonebio.com. An archived replay of the webcast will be available for 30 days following the live presentation.

About Day One Biopharmaceuticals

Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company that believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.

Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. The Company’s pipeline includes tovorafenib (OJEMDA™), DAY301, and following the recently announced acquisition of Mersana Therapeutics, Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate (ADC) targeting the B7-H4 protein in clinical development to treat the rare cancer adenoid cystic carcinoma (ACC).

Day One is based in Brisbane, California. For more information, please visit www.dayonebio.com or find the Company on LinkedIn or X.

Cautionary Note Regarding 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, including, but not limited to: Day One’s ability to grow revenue from OJEMDA, plans to develop and commercialize cancer therapies and its pipeline and the impact of Emi-Le and DAY301, and statements regarding its net product revenues, cash, cash equivalents and short-term investments. Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.

Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including risks related to the ability to realize the anticipated benefits of the Mersana acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of the consummation of the acquisition on the market price of Day One’s common stock and/or operating results; significant transaction costs; unknown liabilities, Day One’s ability to develop, obtain and retain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, government shutdowns, rising interest rates, instability in the global banking system, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

DAY ONE MEDIA

[email protected]

DAY ONE INVESTORS

LifeSci Advisors, PJ Kelleher
[email protected]

Alignment Reached with U.S. FDA on Potential Accelerated Approval Pathway for BEAM-302 in Alpha-1 Antitrypsin Deficiency (AATD) Based on Biomarker Endpoints

U.S. B
iologics Licensing Application (BLA) Submission for risto-cel (Previously Known as BEAM-101)
Expected as Early as Year-End 2026

Expansion of Liver-targeted Genetic Disease Franchise Underway with New Program to be Announced in First Half of 2026

  
Ended 2025 with Estimated $1.25 Billion in Cash, Cash Equivalents and Marketable Securities; Projected Operating Runway Extension into 2029 Supports Anticipated risto-cel Launch and Execution of BEAM-302 Pivotal Development Plan

CAMBRIDGE, Mass., Jan. 11, 2026 (GLOBE NEWSWIRE) — Beam Therapeutics Inc. (Nasdaq: BEAM) today announced continued progress toward its mission to build a sustainable, predictable model for the advancement of precision genetic medicines, highlighting recent updates for its liver-targeted genetic disease and hematology franchises and strategic priorities in 2026, supported by an extended anticipated operating runway.

“Over the past year, we have continued to demonstrate the power and consistency of our base editing platform as we work to redefine what is possible in genetic medicine,” said John Evans, chief executive officer of Beam Therapeutics. “Our approach is rooted in precision and predictability – designing one-time treatments to reverse genetic disease, executing against our portfolio priorities with discipline, and generating differentiated clinical data that compound across programs. As our science and company matures, each milestone strengthens the foundation for the next, enabling us to advance a growing pipeline of programs with increasing confidence and speed. We are now further extending this platform-driven rigor into regulatory execution, including alignment with the FDA on a potential path to accelerated approval for BEAM-302 and a planned BLA submission for risto-cel as early as the end of 2026. Backed by a strong balance sheet and expected cash runway into 2029, we believe we are uniquely positioned to translate scientific innovation into meaningful, lasting benefit for patients with serious diseases.”

Recent Pipeline Updates and 2026 Anticipated Milestones

Liver-targeted Genetic Disease Franchise

Beam is building a platform approach for single-course, precision gene editing therapies for liver-targeted genetic diseases by delivering base editors through intravenous infusion of lipid-nanoparticles (LNPs), a clinically validated technology for delivery of nucleic acid payloads to the liver.

BEAM-302: Beam’s lead genetic disease program is designed to be a best-in-class and first-in-class liver-targeting therapy for alpha-1 antitrypsin deficiency (AATD) that addresses the underlying pathophysiology of both liver and lung disease. In an open-label Phase 1/2 clinical trial, treatment with BEAM-302 demonstrated the first-ever clinical in vivo genetic correction of a disease-causing mutation and established clinical proof of concept in AATD.

• To date, more than 25 AATD patients with lung and/or liver disease have been treated in the dose-exploration portions of the trial.
• Beam has reached alignment with the U.S. Food and Drug Administration (FDA) on a potential accelerated approval pathway for BEAM-302 based on AAT biomarkers evaluated over 12 months. To support a future BLA submission, the company anticipates enrolling approximately 50 additional patients to be treated with the selected optimal biologic dose of BEAM-302 in an expansion of the ongoing Phase 1/2 study.
• BEAM-302 has also been accepted into the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program aimed at facilitating CMC development of products with expedited clinical development timeframes.
• Beam expects to report updated data from the Phase 1/2 trial and next steps for pivotal development by the end of the first quarter of 2026.

BEAM-301: BEAM-301 aims to correct the most common disease-causing mutation, R83C, in patients with glycogen storage disease type Ia (GSDIa). BEAM-301 has the potential to normalize blood glucose in these patients without continuous supplementation and improve key metabolic parameters.

• BEAM-301 is currently being evaluated in an open-label Phase 1/2 dose-exploration trial in patients with GSDIa. Dosing is complete in the first cohort and enrollment has been initiated in the second cohort.
• Beam expects to report initial clinical data in 2026.

Pipeline Expansion: Beam expects to disclose the next clinical program for its liver-targeted genetic disease franchise in the first half of 2026.

Hematology Franchise

Beam is pursuing a long-term, multi-wave development strategy for sickle cell disease (SCD), intended to progressively expand the reach of the company’s base editing approach to broader subsets of patients.

Risto-cel: Ristoglogene autogetemcel (risto-cel, formerly known as BEAM-101) is an investigational autologous cell therapy with a potential best-in-class profile for the treatment of SCD. The most recent data from the ongoing BEACON Phase 1/2 clinical trial presented at the 67^th American Society of Hematology (ASH) Annual Meeting and Exposition continue to show evidence of risto-cel’s differentiated treatment profile. Risto-cel has demonstrated a deeper resolution of SCD markers and reduced time in the hospital driven by a median of one cell collection cycle, rapid engraftment, and low number of neutropenic days. Importantly, risto-cel’s predictable, robust manufacturing process led to fewer mobilizations and rapid delivery from cell collection to dose, potentially improving patient experience as well as treatment center capacity.

• The adult and adolescent cohorts of the BEACON trial were fully enrolled in mid-2025.
• Manufacturing of all doses was completed as of December 2025.
• In addition, Beam completed interactions with the FDA on the anticipated BLA package for risto-cel, which is expected to align with regulatory precedent set by previously approved SCD gene therapies.
• Risto-cel has also been accepted into the FDA’s CDRP program.
• Beam expects to submit a BLA for risto-cel as early as year-end 2026.

Next-generation Programs in Sickle Cell Disease and Hematology: Beam continues to make significant investments in developing targeted LNPs for delivery of genetic payloads outside of the liver. Based on recent advances using this technique to deliver gene editing to hematopoietic stem cells (HSCs), Beam is now prioritizing in vivo delivery for its next wave approach in SCD, complementing risto-cel as a potential best-in-class ex vivo therapy. Beam’s long-term goal is to provide accessible, transformative genetic therapies for all patients with SCD. Beam is also continuing development of its proprietary ESCAPE platform, a powerful technology to potentially enable non-genotoxic treatment strategies that can be delivered either ex vivo or in vivo, including as part of any future in vivo program for SCD.

• The ongoing Phase 1 healthy volunteer clinical trial of BEAM-103, an anti-CD117 monoclonal antibody (mAb) that enables ESCAPE, is expected to complete dosing in the first half of 2026.
• Multiple targeted LNPs for HSC delivery have been identified and are in lead optimization.

Cash Position and Updated Operating Runway

Beam estimates that it had $1.25 billion in cash, cash equivalents and marketable securities as of December 31, 2025. This estimate is inclusive of the $255.1 million in closing cash consideration received from the acquisition of Orbital Therapeutics by Bristol-Myers Squibb. In addition, Beam has the right to receive up to approximately $26.3 million in additional cash consideration upon the release, if any, of certain escrows from the transaction. This estimate of cash on hand is preliminary, unaudited and subject to completion of Beam’s financial statement closing procedures. This estimate does not present all information necessary for an understanding of Beam’s financial condition as of December 31, 2025, and its results of operations for the three months and year ended December 31, 2025. Accordingly, undue reliance should not be placed on this preliminary estimate.

Beam now expects that its estimated cash, cash equivalents and marketable securities as of December 31, 2025, will enable the company to cover its anticipated operating expenses and capital expenditure requirements into 2029, funding the company through the anticipated launch of risto-cel in SCD and execution of the BEAM-302 pivotal development plan in AATD.

J.P. Morgan Healthcare Conference

Management will present and discuss Beam’s pipeline and business updates during a presentation at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 5:15 p.m. PT. A live webcast will be available in the investor section of the company’s website at www.beamtx.com and will be archived for 60 days following the presentation.

About Beam Therapeutics

Beam Therapeutics (Nasdaq: BEAM) is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

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. Investors are cautioned not to place undue reliance on these forward-looking statements, including, but not limited to, statements related to: our upcoming presentations at the 44th Annual J.P. Morgan Healthcare Conference; the therapeutic applications and potential of our technology, including with respect to SCD, AATD and GSDIa; our plans, and anticipated timing, to advance our programs and present data from ongoing clinical trials; the clinical trial designs and expectations for risto-cel, BEAM-103, BEAM-301 and BEAM-302; our anticipated regulatory interactions and filings; our estimated cash, cash equivalents and marketable securities as of December 31, 2025 and our expectations related thereto; our potential receipt of additional cash consideration upon the release, if any, of certain escrows relating to the acquisition of Orbital Therapeutics by Bristol-Myers Squibb; the sufficiency of our capital resources to fund operating expenses and capital expenditure requirements and the period in which such resources are expected to be available; and our ability to develop life-long, curative, precision genetic medicines for patients through base editing. Each forward-looking statement is subject to important risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including, without limitation, risks and uncertainties related to: our ability to develop, obtain regulatory approval for, and commercialize our product candidates, which may take longer or cost more than planned; our ability to raise additional funding, which may not be available; our ability to obtain, maintain and enforce patent and other intellectual property protection for our product candidates; the uncertainty that our product candidates will receive regulatory approval necessary to initiate or continue human clinical trials; that preclinical testing of our product candidates and preliminary or interim data from preclinical studies and clinical trials may not be predictive of the results or success of ongoing or later clinical trials; that initiation and enrollment of, and anticipated timing to advance, our clinical trials may take longer than expected; that our product candidates, including the delivery modalities we rely on to administer them, may cause serious adverse events; that our product candidates may experience manufacturing or supply interruptions or failures; risks related to competitive products; whether our actual audited results will be consistent with our estimated cash, cash equivalents and marketable securities as of December 31, 2025; and the other risks and uncertainties identified under the headings “Risk Factors Summary” and “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and in any subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.

Contacts:

Investors:
Holly Manning
Beam Therapeutics
[email protected]

Media:
Josie Butler
1AB
[email protected]