Market Newsdesk

GEELONG, Australia, March 19, 2025 (GLOBE NEWSWIRE) — Carbon Revolution plc (Nasdaq: CREV) (the “Company”), a Tier 1 automotive supplier and the world’s leading manufacturer of innovative, lightweight carbon fiber wheels, announced today that industry veteran Donnie Hampton, Jr. has joined the Company as Acting Chief Executive Officer and member of the Board of Directors.

With more than three decades of experience leading and working with a range of Tier 1 automotive suppliers, Mr. Hampton brings his deep executive and operational expertise to Carbon Revolution as the Company realizes the full industrialization of its plant in Geelong, Australia.

“Donnie knows wheels,” Bob Lutz, Chairman of the Carbon Revolution Board of Directors, said. “His broad experience leading global manufacturing operations at Maxion Wheels, and serving in CEO and leadership positions at other Tier 1 suppliers – coupled with having started his career on the factory floor – makes him exactly the right leader for Carbon Revolution in 2025 and beyond.”

Mr. Hampton, who will relocate to Australia, said: “I am indeed thankful for the opportunity to bring the culmination of my experience to bear at Carbon Revolution and help lead this truly innovative company into its next phase of growth. The transformative potential of Carbon Revolution’s breakthrough product is unlike anything I’ve seen in 30 years in the industry.”

Mr. Hampton’s experience managing production facilities across multiple geographies opens the door for Carbon Revolution’s broader expansion in the global automobile market, especially as the Company continues to strive for operational excellence, pursue new opportunities with existing customers, and expand its customer base.

In addition to having served as Vice President of Global Operations at Maxion Wheels, Mr. Hampton previously was President and Chief Executive Officer of Michigan-based Pace Industries; led the North America Interiors division at Tier 1 supplier Faurecia as President of the group; and held a series of increasingly senior roles at Rea Magnet Wire and Honeywell International / Allied Signal.

The Company is grateful to Jake Dingle for his years of visionary leadership as CEO. Under his watch, Carbon Revolution grew from an R&D-oriented, disruptive startup into the premier global supplier of carbon fiber wheels to the automotive industry.

“Today, Carbon Revolution is poised at the starting line for its next chapter – one that I know Donnie, the entire team, and our customers are eager to embrace,” Chris Leary, a member of the Company’s Board of Directors, said. “Thanks to the incredibly hard work that Jake Dingle and the entire team have put in over many years to bring our product to market, grow our customer base, and industrialize our operations, our acceleration is just beginning,” he added.

About Carbon Revolution plc

Carbon Revolution plc (Nasdaq: CREV) (the “Company” or “Carbon Revolution”) is the parent of Carbon Revolution Pty Ltd, an early-stage growth company which has successfully innovated, commercialized and industrialized the advanced manufacture of carbon fiber wheels for the global automotive industry. The Company has progressed from single prototypes to designing and manufacturing lightweight wheels for cars and SUVs in the high performance, premium and luxury segments, for the world’s most prestigious automotive brands. Carbon Revolution is creating a significant and sustainable advanced technology business that supplies its lightweight wheel technology to automotive manufacturers around the world.

For more information, visit carbonrev.com

Forward Looking Statements

All statements other than statements of historical facts contained in this communication are forward-looking statements. Forward-looking statements may generally be identified by the use of words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “project,” “forecast,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” “target” or other similar expressions (or the negative versions of such words or expressions) that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the expectation of continued listing of Carbon Revolution’s ordinary shares and warrants on Nasdaq, the Company’s ability to file its Annual Report and promptly regain compliance with Nasdaq Listing Rule 5250(c)(1), the future financial performance, business strategies, financings and expectations for the Company’s business. These statements are based on various assumptions, whether or not identified in this communication, and on the current expectations of Carbon Revolution’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from such assumptions, and such differences may be material. Many actual events and circumstances are beyond the control of Carbon Revolution.

These forward-looking statements are subject to a number of risks and uncertainties, including (i) the ability to maintain the listing of Carbon Revolution’s securities on Nasdaq or any other exchange on which such securities may be listed in the future; (ii) the failure to realize the benefits of being listed on a U.S. securities exchange and publicly-traded in the United States; (iii) Carbon Revolution’s liquidity, including its ability to pay its obligations and to issue equity, refinance its indebtedness or otherwise obtain financing at all or on acceptable terms, (iv) risks related to its ability to meet financial covenants and other key covenants under existing financing arrangements or to obtain waivers or forbearance from compliance with such covenants, which could result in the acceleration of outstanding indebtedness, (v) changes in domestic and foreign business, market, financial, political and legal conditions; (vi) risks related to the rollout of Carbon Revolution’s business strategy and the timing of expected business milestones; (vii) the effects of competition on Carbon Revolution’s future business and the ability of the combined company to grow and manage growth, establish and maintain relationships with customers and retain its management and key employees; (viii) risks related to domestic and international political and macroeconomic uncertainty, including the Russia-Ukraine and conflicts in the Middle East; (ix) the outcome of any legal proceedings that may be instituted against Carbon Revolution; (x) the impact of pandemic and governmental responses on any of the foregoing risks; (xi) risks related to Carbon Revolution’s industry; (xii) changes in laws and regulations; and (xiii) those factors discussed in the documents Carbon Revolution filed with the SEC, including the Shell Company Report on Form 20-F.

If any of these risks materialize or Carbon Revolution’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Carbon Revolution does not presently know or that Carbon Revolution currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Carbon Revolution’s expectations, plans or forecasts of future events and views as of the date of this communication. Carbon Revolution anticipates that subsequent events and developments will cause Carbon Revolution’s assessments to change. However, while Carbon Revolution may elect to update these forward-looking statements at some point in the future, Carbon Revolution specifically disclaims any obligation to do so, unless required by applicable law. These forward-looking statements should not be relied upon as representing Carbon Revolution’s assessments as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements.

For further information, please contact:
 

Investors
[email protected]

Media
[email protected]

NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the appointment of Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer. Dr. Baumgartner will serve as part of the Company’s executive leadership team and will be responsible for leading Applied’s global regulatory strategy.

Dr. Baumgartner joins Applied as an accomplished global drug development leader with over 35 years of experience in senior regulatory, clinical development, and medical affairs roles. He has held a diverse set of leadership roles over the course of his career, notably leading a total of 12 New Drug Applications and marketing authorizations through their approvals.

“We are delighted to welcome Todd to Applied as we continue to prepare for regulatory interactions regarding govorestat,” said John H. Johnson, Executive Chairman of Applied Therapeutics. “We believe that Todd’s wealth of development experience and strong track record with regulators will be valuable to Applied as we remain committed to our mission of addressing the unmet needs of patients with rare diseases.”

“I have been passionate about advancing important medical breakthroughs through clinical and regulatory development throughout my career, and I am excited to join Applied at this important time,” said Dr. Baumgartner. “I look forward to working with the Applied team as we seek to advance govorestat for the potential treatment of rare diseases.”

Prior to joining Applied, Dr. Baumgartner served as Senior Vice President of Global Regulatory Affairs, Pharmacovigilance and Biometrics at Ovid Therapeutics from 2020 through 2024, where he oversaw multiple development functions for several pipeline programs, including Regulatory Affairs, Pharmacovigilance, Biometrics, Program Management and Quality Assurance, and served briefly as acting Chief Medical Officer. Prior to that, Dr. Baumgartner served as Senior Vice President of Regulatory Affairs at Acorda Therapeutics, where he led the Regulatory Affairs and Clinical Operations organizations, heading up the regulatory development and garnering regulatory marketing approvals in the US and Europe for Inbrija™ for Parkinson’s OFF episodes. Previously, he served as Chief Medical Officer of Purdue Pharma and, earlier in his career, held various leadership positions of increasing responsibility at AstraZeneca Pharmaceuticals and Bristol-Myers Squibb. Dr. Baumgartner obtained an MPH from the University of California-Berkeley, an MD from the University of Missouri-Columbia, and a BA from Duke University.

About Applied Therapeutics

Applied Therapeutics is a clinical-stage biopharmaceutical company committed to the development of novel drug candidates against validated molecular targets in rare diseases. The Company’s lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Classic Galactosemia, Sorbitol Dehydrogenase (SORD) Deficiency and PMM2-congenital disorder glycosylation (CDG).

To learn more, please visit www.appliedtherapeutics.com.

Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding the strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” “predicts” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Contacts

Investors:

Maeve Conneighton / Andrew Vulis
(212) 600-1902 or
[email protected]

Media:


[email protected]

Initiated VALUE, a global Phase III pivotal trial of EscharEx^® for venous leg ulcers

Expanded strategic research collaborations with industry leaders, now including Kerecis

$20 million in revenue for 2024; $24 million projected for 2025; $44 million in cash as of Year-End 2024

Conference call today, March 19 at 8:30am Eastern Time

YAVNE, Israel, March 19, 2025 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate update.

“2024 was a pivotal year for MediWound, marked by strong execution, clinical progress, and strategic collaborations,” said Ofer Gonen, CEO of MediWound. “The initiation of the VALUE Phase III pivotal study is another major milestone, further reinforced by partnerships with industry leaders that highlight EscharEx’s clinical and commercial potential. At the same time, the global adoption of NexoBrid continues to accelerate, solidifying its critical role in modern burn care. With our innovative therapies advancing in wound and burn management and a solid financial foundation, we enter 2025 with momentum and a clear vision to drive meaningful impact for patients worldwide.”

2024 Highlights and Recent Developments:

EscharEx^®  

• Initiated VALUE, a global pivotal Phase III trial to evaluate EscharEx for the treatment of venous leg ulcers (VLUs), enrolling 216 patients across 40 sites in the U.S. and Europe. An interim sample size assessment will be conducted after 65% of patients complete treatments, enabling adaptive adjustments as needed. This interim analysis is expected in mid-2026.
• Submitted Phase II study protocol to the U.S. Food and Drug Administration (FDA) for a randomized, head-to-head Phase II study comparing EscharEx to collagenase in VLU patients. This trial, planned for 2025, is designed to support the U.S. Biologics License Application (BLA) submission and strengthen MediWound’s commercialization strategy.
• Obtained €16.5 million in European Innovation Council (EIC) funding to accelerate the development of EscharEx for treating diabetic foot ulcers (DFUs). A Phase II/III clinical trial is expected to begin in 2026.
• Expanded strategic research collaborations with leading wound care companies to enhance study execution and improve patient outcomes. In addition to Solventum, Mölnlycke, and MIMEDX, which support the VLU trials, Kerecis (Coloplast subsidiary) has joined as a collaborator in the Phase II/III DFU trial. Kerecis will provide its MariGen Fish-Skin graft as the designated skin substitute during the wound healing phase of the study.
• Completed a head-to-head comparative analysis of EscharEx vs. SANTYL^® from a Phase II trial, demonstrating EscharEx’s superiority in key clinical outcomes.
• Conducted third-party market research, assessing EscharEx’s total addressable market (TAM) in the U.S. at $2.5 billion. With a projected 22% market share upon approval, peak U.S. sales are expected to reach approximately $725 million.

NexoBrid^®

• Completed construction of a new, state-of-the-art GMP-compliant manufacturing facility, with commissioning underway. The facility is expected to reach full operational capacity by the end of 2025, increasing output sixfold. Commercial availability will depend on securing the necessary regulatory approvals.
• U.S. launch by Vericel continues to gain momentum, with NexoBrid hospital orders increasing by 42% in the fourth quarter compared to the previous quarter.
• Received FDA approval of NexoBrid for pediatric patients aged newborn through 18 with deep partial-thickness and/or full-thickness thermal burns. NexoBrid is now authorized for use in the U.S. for all age groups, aligning with its indications in the European Union and Japan.
• Reported positive results from the Expanded Access Protocol (NEXT), reinforcing NexoBrid’s clinical and real-world benefits across 29 burn centers in the U.S. The study included 239 patients (215 adults and 24 children) with deep partial and/or full-thickness thermal burns covering up to 30% of total body surface area (TBSA).

Corporate Developments

• Secured $25 million through a strategic private investment in public equity from a mix of new and existing investors. Mölnlycke Health Care, a global leader in innovative wound care solutions, led the PIPE investment and entered into a collaboration agreement with MediWound.

Fourth Quarter 2024 Financial Highlights

• Revenue: Fourth quarter revenue was $5.8 million, compared to $5.3 million in the fourth quarter of 2023.
• Gross Profit: Gross profit for the fourth quarter was $0.9 million, representing a gross margin of 15.5%, compared to $0.7 million and a 13.5% gross margin in the same period last year.
• Expenditures:
  • Research and development expenses were $3.0 million, up from $1.8 million in the fourth quarter of 2023, primarily due to costs associated with the EscharEx VALUE Phase III trial.
  • Selling, general, and administrative expenses totaled $4.0 million, compared to $2.8 million in the prior-year quarter, mainly reflecting increased share-based compensation expenses.
• Operating Loss: Operating loss was $6.1 million, compared to $3.9 million in the fourth quarter of 2023.
• Net Loss: Net loss was $3.9 million, or $0.36 per share, compared to a net loss of $1.7 million, or $0.19 per share, in the fourth quarter of 2023.
• Non-GAAP Adjusted EBITDA: Adjusted EBITDA loss was $4.9 million, compared to a loss of $3.2 million in the same period last year.

Full Year 2024 Financial Highlights

• Revenue: Full-year revenue was $20.2 million, up from $18.7 million in 2023, primarily driven by increased revenue from Vericel and new contracts with the U.S. Department of Defense.
• Gross Profit: Gross profit for the year was $2.6 million, with a gross margin of 13.0%, compared to $3.6 million and a 19.1% gross margin in 2023. The decline was mainly due to changes in the revenue mix and higher fixed costs associated with scaling production.
• Expenditures:
  • R&D expenses increased to $8.9 million from $7.5 million in 2023, primarily due to costs related to the EscharEx VALUE Phase III trial.
  • Selling, general, and administrative expenses were $13.1 million, compared to $11.6 million in 2023, mainly reflecting higher share-based compensation costs.
• Operating Loss: Operating loss was $19.4 million, compared to $15.3 million in 2023.
• Net Loss: Net loss for 2024 was $30.2 million, or $3.03 per share, compared to $6.7 million, or $0.75 per share, in 2023. The $23.5 million increase was primarily due to financial expenses, mainly from the revaluation of warrants following a 75% rise in the Company’s share price in 2024.
• Non-GAAP Adjusted EBITDA: Adjusted EBITDA loss was $14.8 million, compared to a loss of $12.3 million in 2023.

Balance Sheet Highlights

As of December 31, 2024, the Company had cash and cash equivalents and deposits totaling $43.6 million, compared to $42.1 million as of December 31, 2023. During 2024, the Company raised $25 million through a PIPE offering, received $1.2 million from the exercise of Series A warrants, secured a $1.2 million grant from the EIC and fully settled its liability with Teva. The Company used $22.9 million to fund operations in 2024, including $6.8 million allocated to capital expenditures primarily for facility scale-up.

Conference Call

MediWound management will host a conference call for investors on Wednesday, March 19, 2025, beginning at 8:30 a.m., Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-833-630-1956 (in the U.S.), 1-80-921-2373 (Israel), or 1-412-317-1837 (outside the U.S. & Israel). The call will be available via webcast by clicking HERE or on the Events & Presentations page of Company’s website.

A replay of the call will be available on the Company’s website at www.mediwound.com.

Non-IFRS Financial Measures

To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company’s performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.
Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management. However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company’s operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.

About MediWound

MediWound Ltd. (Nasdaq: MDWD) is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of innovative biologics that enhance existing standards of care and improve patient experiences while reducing healthcare costs and unnecessary surgeries.

MediWound’s first drug, NexoBrid^®, is an FDA- and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, significantly reducing the need for surgical interventions. Leveraging its proprietary enzymatic technology, MediWound is advancing EscharEx^®, a promising candidate currently in Phase III development for the debridement of chronic wounds. Phase II clinical trials have shown EscharEx has distinct advantages over the currently available $370+ million drug for wound debridement, presenting a unique opportunity for significant market growth.

For more information visit www.mediwound.com and follow us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx^® and NexoBrid^®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 19, 2025 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

Contacts:
Hani Luxenburg Chief Financial Officer MediWound Ltd. [email protected]				Daniel Ferry Managing Director, LifeSci Advisors 617-430-7576 [email protected]

Media Contact: 

Ellie Hanson
FINN Partners for MediWound
[email protected]
929-588-2008

MediWound, Ltd.
Audited Condensed Consolidated Statements of Financial Position
U.S. dollars in thousands
	Dec 31,
	2024		2023
CURRENT ASSETS:
Cash and cash equivalents and short-term deposits	43,161		41,708
Trade and other receivable	6,310		5,141
Inventories	2,692		2,846
Total current assets	52,163		49,695
NON-CURRENT ASSETS:
Other receivables and long-term restricted bank deposit	439		673
Property, plant and equipment	14,132		9,228
Right of use assets	6,663		6,698
Intangible assets	99		165
Total non-current assets	21,333		16,764
Total assets	73,496		66,459
CURRENT LIABILITIES:
Current maturities of long-term liabilities	612		1,410
Warrants	17,092		*7,296
Trade payables and accrued expenses	5,281		5,528
Other payables	3,556		3,891
Total current liabilities	26,541		18,125
NON-CURRENT LIABILITIES:
Grants received in advance	736		–
Liabilities in respect of IIA grants	8,149		7,677
Liability in respect of TEVA	–		2,256
Lease liabilities	6,513		6,350
Severance pay liability, net	404		456
Total non-current liabilities	15,802		16,739
Total liabilities	42,343		34,864
Shareholders’ equity	31,153		31,595
Total liabilities & equity	73,496		66,459

 * restated with respect to the implementation of the amendments of IAS 1

MediWound, Ltd.
Audited Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss
U.S. dollars in thousands (except of share and per share data)
		Twelve months ended						Three months ended
		Dec 31,						Dec 31,
		2024			2023			2024			2023
Total Revenues		20,222			18,686			5,840			5,338
Cost of revenues		17,588			15,108			4,937			4,619
Gross profit		2,634			3,578			903			719
Research and development		8,878			7,467			2,986			1,808
Selling and Marketing		4,936			4,844			1,470			1,209
General and administrative		8,202			6,768			2,530			1,583
Other (Income) expenses		18			(211	)		18			13
Operating loss		(19,400	)		(15,290	)		(6,101	)		(3,894	)
Financial income (expenses), net		(10,763	)		8,759			2,211			2,271
Taxes on income		(61	)		(185	)		(18	)		(120	)
Net loss		(30,224	)		(6,716	)		(3,908	)		(1,743	)
Foreign currency translation adjustments		7			(13	)		4			(11	)
Total comprehensive loss		(30,217	)		(6,729	)		(3,904	)		(1,754	)
Basic and diluted net loss per share		(3.03	)		(0.75	)		(0.36	)		(0.19	)
Number of shares used in calculating basic and diluted loss per share		9,959,723			9,013,144			10,790,959			9,219,923

MediWound, Ltd.
Audited Condensed Consolidated Statements of Cash Flows
U.S. dollars in thousands
	Twelve months ended						Three months ended
	Dec 31,						Dec 31,
	2024			2023			2024			2023
	Audited						Unaudited
Cash Flows from Operating Activities:
Net Loss	(30,224	)		(6,716	)		(3,908	)		(1,743	)
Adjustments to reconcile net loss to net cash used in operating activities:
Adjustments to profit and loss items:
Depreciation and amortization	1,483			1,303			397			346
Share-based compensation	3,138			1,940			822			298
Revaluation of warrants accounted at fair value	10,704			(8,310	)		(1,964	)		(1,605	)
Revaluation of liabilities in respect of IIA grants	752			427			41			(282	)
Revaluation of liabilities in respect of TEVA	770			468			–			111
Financing income and exchange differences of lease liability	487			257			249			463
Increase (decrease) in severance liability, net	(30	)		83			16			3
Other (income) expenses	18			(211	)		18			13
Financial income, net	(2,039	)		(2,231	)		(553	)		(836	)
Un-realized foreign currency loss (gain)	47			189			(27	)		(345	)
	15,330			(6,085	)		(1,001	)		(1, 834	)
Changes in assets and liability items:
Decrease (increase) in trade receivables	(1,141	)		5,658			(1,426	)		(528	)
Decrease (increase) in inventories	187			(906	)		348			782
Decrease (increase) in other receivables	120			(894	)		403			(696	)
Increase (decrease) in trade payables and accrued expenses	406			(594	)		2,354			1,093
Increase in grants received in advance	1,181			–			1,181			–
Increase (decrease) in other payables	517			(928	)		412			311
	1,270			2,336			3,272			962
Net cash used in operating activities	(13,624	)		(10,465	)		(1,637	)		(2, 615	)

MediWound, Ltd.
Audited Condensed Consolidated Statements of Cash Flows
U.S. dollars in thousands
	Twelve months ended						Three months ended
	Dec 31,						Dec 31,
	2024			2023			2024			2023
	Audited						Unaudited
Cash Flows from Investing Activities:
Purchase of property and equipment	(6,273	)		(6,464	)		(806	)		(2,209	)
Interest received	2,252			1,947			664			722
Proceeds from (Investment in) short term bank deposits, net	(4,376	)		(29,804	)		4,970			6,515
Net cash provided by (used in) investing activities	(8,397	)		(34,321	)		4,828			5,028
Cash Flows from Financing Activities:
Repayment of lease liabilities	(928	)		(778	)		(242	)		(204	)
Proceeds from exercise of options	1,210			–			–			–
Proceeds from issuance of shares and warrants, net	22,165			24,909			(271	)		–
Repayments of IIA grants, net	(219	)		(380	)		–			–
Repayment of liabilities in respect of TEVA	(2,834	)		(834	)		–			–
Net cash provided by (used in) financing activities	19,39 4			22,917			(51 3	)		(204	)
Exchange rate differences on cash and cash equivalent balances	(8 4	)		( 160	)		2			378
Increase (decrease) in cash and cash equivalents	(2,711	)		(22, 029	)		2,680			2,58 7
Balance of cash and cash equivalents at the beginning of the period	11,866			33,895			6,475			9,279
Balance of cash and cash equivalents at the end of the period	9,155			11,86 6			9,155			11,86 6

MediWound, Ltd.
Adjusted EBITDA
U.S. dollars in thousands
		Twelve months ended						Three months ended
		Dec 31,						Dec 31,
		2024			2023			2024			2023
Net loss		(30,224	)		(6,716	)		(3,908	)		(1,743	)
Adjustments:
Financial income (expenses), net		(10,763	)		8,759			2,211			2,271
Other income (expenses), net		(18	)		211			(18	)		(13	)
Taxes on income		(61	)		(185	)		(18	)		(120	)
Depreciation and amortization		(1,483	)		(1,303	)		(397	)		(346	)
Share-based compensation expenses		(3,138	)		(1,940	)		(822	)		(298	)
Total adjustments		(15,463	)		5,542			956			1,494
Adjusted EBITDA		(14,761	)		(12,258	)		(4,864	)		(3,237	)

● Type B Meeting Discussion to Accelerate XRx-026 for Gout to NDA ●

CALGARY, Alberta, March 19, 2025 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease and gout, is pleased to provide an update regarding communications with the US Food and Drug Administration (the “FDA”). At the request of the FDA a type B meeting package will be provided by the Company during the next week, and accompanying FDA communications are expected by April 26, 2025. The Company has prepared a broad Type B meeting review at the request of the FDA, including review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence regarding the Company’s XRx-026 program for the treatment of gout. Drug Development of XORLO^TM, the Company’s proprietary drug formulation of oxypurinol, has advanced substantially to a state where a Type B meeting and discussion with the FDA to confirm the developmental state of each element of the program is warranted. The purpose of this meeting will be to review the XRx-026 program and its readiness for submission of a New Drug Application (“NDA”) to gain marketing approval for XORLO^TM in the US using the FDA 505(b)2 development pathway. The Company believes that a Type B meeting will facilitate a broader discussion toward market approval.

Dr. Allen Davidoff, CEO of XORTX commented, “We look forward to FDA feedback the last week in April and advancing the XRx-026 program, thereafter. Many key elements of the XRx-026 program have advanced sufficiently to warrant this robust program review with the FDA to define any additional information needed to complete this marketing approval. We believe that the XRx-026 program provides a much needed therapeutic option for individuals with gout and that advancing with the XRx-026 program will transform XORTX to a revenue positive state.”

The Company will provide further updates following communications with the FDA when additional information is available.

About Hyperuricemia and Gout

In the US it is estimated that approximately 44 million individuals have circulating uric acid above the normal range⁽¹⁾. The prevalence of gout was 3.9% or 9.2 million individuals. Mean serum urate levels were 6.0 mg/dL among men and 4.8 mg/dL among women, with hyperuricemia prevalences of 20.2% and 20.0%, respectively. The prevalence of ULT use among patients with gout was 33% during 2007 to 2014 and remained stable over time (P for trend >0.05)⁽¹⁾. Gout is an inflammatory arthritis that is triggered by the crystallization of monosodium urate inside the joints and is preceded by hyperuricemia. Gout flares lead to substantial morbidity by causing severe pain, reduced quality of life⁽²⁾, decreased physical function^(2,3), increased healthcare costs⁽⁴⁾, and lost economic productivity⁽⁵⁾. Furthermore, gout is strongly associated with the metabolic syndrome⁽⁵⁾, and may contribute to myocardial infarction^(6,7), type 2 diabetes mellitus⁽⁸⁾, chronic kidney disease⁽⁹⁾, and premature mortality^(6,10,11).

About the XRx-026 Program and XORLO

^TM

The XRx-026 program is developing XORLO^TM, a proprietary formulation of oxypurinol to treat individuals suffering from gout. At present, oral xanthine oxidase inhibitors (“XOIs”) are the preferred therapeutic option used to inhibit the production of uric acid and decrease chronically high uric acid in the circulation. Allopurinol is the most commonly prescribed XOI, with approximately 3.3 million prescriptions written per year in North America, however 3 to 5% of patients cannot tolerate Allopurinol. An alternative XOI, Febuxostat, was launched in the US in 2009 with the hope of treating individuals with gout, however while Febuxostat achieved peak sales greater than US$450 million after its launch, a Black Box warning due to its associated risk of sudden cardiovascular death resulted in a decline in its use. XORLO^TM can address this unmet medical need and accelerating advancement of the XRx-026 program through an NDA filing is now a priority for XORTX.

About Type B Meetings with the FDA

Type B meetings for each potential application (e.g., investigational new drug application (IND), NDA, biologics license application (BLA)) or combination of closely related products developed by the same sponsor or applicant (e.g., same active ingredient but different dosage forms being developed concurrently). Typically, it may be appropriate to conduct more than one of some of the Type B meetings for concurrent development of a product for unrelated claims.

References:

(1)   Chen-Xu M_Prevalence of Gout and Hyperuricemia in the US_ArthritisRheumatol_71-6_991-999_2019_nihms-1002533
(2)   Singh JA. Quality of life and quality of care for patients with gout. Curr Rheumatol Rep. 2009 4;11(2):154–60. [PubMed: 19296889]
(3)   Burke BT, Köttgen A, Law A, Windham BG, Segev D, Baer AN, et al. Physical Function, Hyperuricemia, and Gout in Older Adults. Arthritis Care Res. 2015 12;67(12):1730–8.
(4)   Rai SK, Burns LC, De Vera MA, Haji A, Giustini D, Choi HK. The economic burden of gout: A systematic review. Semin Arthritis Rheum. 2015 8;45(1):75–80. [PubMed: 25912932]
(5)   Choi HK, Ford ES. Prevalence of the metabolic syndrome in individuals with hyperuricemia. Am J Med. 2007 5;120(5):442–7. [PubMed: 17466656]
(6)   Choi HK, Curhan G. Independent impact of gout on mortality and risk for coronary heart disease. Circulation. 2007 8 21;116(8):894–900. [PubMed: 17698728]
(7)   Liu S-C, Xia L, Zhang J, Lu X-H, Hu D-K, Zhang H-T, et al. Gout and Risk of Myocardial Infarction: A Systematic Review and Meta-Analysis of Cohort Studies. Pizzi C, editor. PLOS ONE. 2015 7 31;10(7):e0134088. [PubMed: 26230580]
(8)   Choi HK, De Vera MA, Krishnan E. Gout and the risk of type 2 diabetes among men with a high cardiovascular risk profile. Rheumatology. 2008 8 13;47(10):1567–70. [PubMed: 18710901]
(9)   Roughley MJ, Belcher J, Mallen CD, Roddy E. Gout and risk of chronic kidney disease and nephrolithiasis: meta-analysis of observational studies. Arthritis Res Ther. 2015 12;17(1).
(10)   Kuo C-F, See L-C, Luo S-F, Ko Y-S, Lin Y-S, Hwang J-S, et al. Gout: an independent risk factor for all-cause and cardiovascular mortality. Rheumatology. 2010 1;49(1):141–6. [PubMed: 19933595]
(11)   Fisher MC, Rai SK, Lu N, Zhang Y, Choi HK. The unclosing premature mortality gap in gout: a general population-based study. Ann Rheum Dis. 2017 7;76(7):1289–94. [PubMed: 28122760]

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead program XRx-026 program for the treatment of gout; 2) XRx-008 program for ADPKD; and 3) XRx-101 for acute kidney and other acute organ injury associated with respiratory virus infections. In addition, the Company is developing XRx-225, a pre-clinical stage program for Type 2 diabetic nephropathy. XORTX is working to advance products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases. Additional information on XORTX is available at www.xortx.com.

For more information, please contact:
Allen Davidoff, CEO [email protected] or +1 403 455 7727	Nick Rigopulos, Director of Communications [email protected] or +1 617 901 0785

Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Forward Looking Statements

This press release contains express or implied forward-looking statements pursuant to applicable securities laws. These forward-looking statements include, but are not limited to, the Company’s beliefs, plans, goals, objectives, expectations, assumptions, estimates, intentions, future performance, other statements that are not historical facts and statements identified by words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates” or words of similar meaning. These forward-looking statements and their implications are based on the current expectations of the management of XORTX only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks, uncertainties, and other factors include, but are not limited to, our ability to obtain additional financing; the accuracy of our estimates regarding expenses, future revenues and capital requirements; the success and timing of our preclinical studies and clinical trials; the performance of third-party manufacturers and contract research organizations; our plans to develop and commercialize our product candidates; our plans to advance research in other kidney disease applications; and, our ability to obtain and maintain intellectual property protection for our product candidates. Except as otherwise required by applicable law and stock exchange rules, XORTX undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting XORTX is contained under the heading “Risk Factors” in XORTX’s Annual Report on Form 20-F filed with the SEC, which is available on the SEC’s website, www.sec.gov (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada, which are available on www.sedarplus.ca.

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 19, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (HKEX:​13; Nasdaq/AIM:​HCM) today reports its financial results for the year ended December 31, 2024 and provides updates on key clinical and commercial developments.

HUTCHMED to host results webcasts

today
at 8:00 a.m. EDT / 12:00 noon GMT / 8:00 p.m. HKT

in English on Wednesday

, March 19, 2025, and tomorrow
at 8:30 a.m. HKT

in Chinese (Putonghua) on Thursday

, March 20, 2025. After registration, investors may access the live webcast via HUTCHMED’s website at

www.hutch-med.com/event

.

All amounts are expressed in US dollars unless otherwise stated.

Global commercial progress and delivery of sustainable growth

• FRUZAQLA
  
  ^®
  
  (fruquintinib) ex-China in-market sales
  
  ¹
  
  of $290.6 million in 2024 by Takeda, sustaining momentum in its first full year driven by rapid US patient uptake, and EU and Japan launches, triggering a sales milestone from Takeda². Totaloncology products in-market sales up 134% to $501.0 million.
• Consolidated revenue from oncology products of $271.5 million, up 65%.
• Net income of $37.7 million was achieved in 2024, with a cash balance of $836.1 million as of December 31, 2024, achieving financial self-reliance ahead of schedule.
• Agreed partial disposal of equity in SHPL³ joint venture for $608 million.

Pipeline progress and new technology platform

• Primary endpoint met in SACHI China Phase III interim analysis for savolitinib for EGFRm⁴ NSCLC⁵ with MET amplification, followed by swift NDA⁶ filing, acceptance and priority review granted by the NMPA⁷.
• Positive SAVANNAH global pivotal Phase II results for savolitinib in combination with TAGRISSO^® for EGFRm NSCLC patients that progressed on TAGRISSO^® treatment with MET overexpression or amplification, achieving high, clinically meaningful and durable response rate and shared with global regulatory authorities by AstraZeneca⁸.
• Positive FRUSICA-2 China Phase III results for fruquintinib with sintilimab in 2L⁹ RCC¹⁰.
• Presented ESLIM-01 China Phase III data at ASH
  
  ¹¹
  
  and EHA
  
  ¹²
  , highlighting strong, sustained, and long-term durable response rates of sovleplenib for ITP¹³ patients, with the NDA under review by the NMPA. Additional data were requested by CDE¹⁴ and subsequently submitted by HUTCHMED. Review of the supplementary data is currently under review by CDE.
• FRUSICA-1 Phase II results presented at ASCO
  
  ¹⁵
  , leading to NMPA approval of a second indication of ELUNATE^® (fruquintinib) for EMC¹⁶ with pMMR¹⁷ status.
• First candidates from new ATTC
  
  ¹⁸
  
  platform, starting development of a new wave of drug candidates potentially more selective and tolerable than previous generations of antibody drug conjugates.

Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, “The successful commercialization of FRUZAQLA^® outside of China by our partner Takeda and the resulting milestones achieved during the year were pivotal in helping HUTCHMED reach its profitability goals. I am proud that, at times of uncertainty in the global environment and in the capital markets, we have successfully established an independent ability to support our valuable discovery engine and development pipeline while mitigating operational risks. We expect to continue our global growth with further sales in the US and in other regions of the world, while continuing to develop our pipeline in new and promising directions. The long-term interests of our shareholders and benefits to patients around the world will always remain our top priorities.”

“At the end of 2024, we decided to dispose of our 45% equity interest in SHPL for $608 million, subject to closing conditions. I would like to take this opportunity to express my appreciation to the management team at SHPL for their contribution to its impressive growth over the last 20 years, which has delivered consistent benefits to consumers and shareholders alike. The commercial success and monetary contribution were important in supporting HUTCHMED’s novel drug R&D¹⁹, helping us to weather challenges in our industry as we developed innovative medicines for patients in need. As our innovative drugs business has become more self-reliant, we believe it is time for HUTCHMED to move on to our next phase of evolution, particularly as we focus on global clinical development of our ATTCs. The proceeds from the SHPL disposal, on top of the ongoing profits of our globally commercialized portfolio, enables us to expedite the roll-out of this differentiated platform, which will be key to our long-term value creation.”

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “We’ve had a highly successful year, delivering against our strategy, in the clinic and commercially with our transformational medicines. This has culminated in HUTCHMED reaching profitability, which has been a key focus of ours. I’d like to thank and congratulate the team for this milestone, as we turn our attention to further growth and cultivating HUTCHMED’s next wave of medicines through our ATTC platform.”

“Our pioneering ATTC platform turns a new page in HUTCHMED’s innovative drug development story, establishing a new frontier in antibody-drug conjugates. This new portfolio of molecules is well placed to target a wide range of oncology indications with sizable market potential, including in first-line combinations. With the expertise and the financial strength to execute global clinical trials, we plan to move expeditiously into clinical development this year.”

“Our commercial medicines hit new milestones and expanded clinical development, reaching more patients in need around the world. Fruquintinib is now treating colorectal cancer patients in over a dozen countries, with more to come. FRUZAQLA^® in-market sales exceeded $200 million within a year of launch, triggering the first sales milestone. In China, it was approved in second-line endometrial cancer, with average duration of treatment almost double that of fruquintinib’s first indication, and a third registrational study FRUSICA-2 has read out positively in kidney cancer.”

“For savolitinib, positive data from SACHI interim analysis in patients progressed on first line EGFR²⁰ TKI²¹ treatment with MET amplification led us to file a NDA in China, which was accepted and granted priority review. We are hopeful that SAVANNAH/SAFFRON trials will support bringing this innovative medicine to patients globally. With recent full approval in both first-line and second-line MET exon 14 skipping alteration lung cancer, savolitinib remains one of the best-in-class medicines. A registration-intent study in MET-amplified gastric cancer is currently enrolling in China. We look forward to potentially expanding its indication as the first medicine for MET amplified EGFRm NSCLC and gastric cancer. Our marketed medicines will continue to support the revenue and earnings growth of HUTCHMED.”

“ESLIM-01 data for sovleplenib was presented at EHA and ASH, with durable response rate of 51.4% and overall response rate of 81.0%, significantly better than many different modalities of ITP medicines under development. These clinical results of sovleplenib again illustrate HUTCHMED’s R&D competency in selectivity, resulting in desirable efficacy and safety. We are working closely with the NMPA and look forward to bringing this innovative medicine to patients in need. ESLIM-02 registration Phase III in warm AIHA²² patients is enrolling and on-track to read out next year. A NDA is under review in China for tazemetostat for recurrent/refractory follicular lymphoma and approval is expected by mid-2025. We look forward to being able to add sovleplenib and tazemetostat to our commercial portfolio and their contributions to HUTCHMED’s continued growth.”

2024 FULL YEAR RESULTS & BUSINESS UPDATES

I. COMMERCIAL OPERATIONS

Oncology product in-market sales were up 134% (136% at CER

²³

) to $501.0 million in 2024 (2023: $213.6m), leading to strong growth in oncology product consolidated revenue of 65% (67% at CER) to $271.5 million (2023: $164.2m).

• FRUZAQLA
  
  ^®
  
  (fruquintinib ex-China) in-market sales were $290.6 million in 2024 (2023: $15.1m) by Takeda, with strong performance reflecting rapid US patient uptake, as well as launches in over a dozen countries. Reaching $200.0 million sales triggered a $20 million milestone payment from Takeda.
• ELUNATE
  
  ^®
  
  (fruquintinib China) in-market sales increased 7% (9% at CER) to $115.0 million in 2024 (2023: $107.5m), maintaining its leading market share position in metastatic CRC²⁴ and demonstrating resilience against rising pressure from competing products and their generics. New indication for EMC was approved in December 2024.
• SULANDA
  
  ^®
  
  (surufatinib) in-market sales increased 12% (14% at CER) to $49.0 million in 2024 (2023: $43.9m), as increasing brand awareness amongst doctors and improving NET²⁵ diagnosis drives prescription growth and market share to 27% in 2024 (2023: 21%).
• ORPATHYS
  
  ^®
  
  (savolitinib) in-market sales approximated prior year (-2%, flat at CER) to $45.5 million in 2024 (2023: $46.1m), impacted by the launch and NRDL²⁶ inclusion of several competing same-class MET TKIs for 2L METex14²⁷ NSCLC. Results do not reflect full approval in 1L²⁸ setting received in January 2025.

Total Oncology/Immunology consolidated revenue was $363.4 million in 2024 (2023: $528.6m), within guidance of $300 million to $400 million.

• Oncology product consolidated revenue (royalties, manufacturing revenue, promotion and marketing services revenue and commercial milestone) increased 65% (67% at CER) to $271.5 million (2023: $164.2m), driven by FRUZAQLA^® and exceeding guidance of 30% to 50% growth.
• Takeda upfront, regulatory milestones and R&D services revenue were $67.0 million (2023: $345.9m), which included recognition of $48.1 million of the $450.0 million upfront and regulatory milestone payments achieved. This compared to recognition of $312.0 million in 2023.
• Other revenue was $24.9 million (2023: $18.5m), including milestone payment of $6.0 million from AstraZeneca following NDA acceptance in China for ORPATHYS^® combined with TAGRISSO^®.

$630.2 million total consolidated revenue (2023: $838.0m) including Other Ventures of $266.8 million (2023: $309.4m).

($ in USD millions)	In-market Sales*							Consolidated Revenue**
		2024		2023	%Δ		(CER)		2024		2023	%Δ		(CER)
FRUZAQLA®	$290.6		$15.1		+1,825	%	(+1,825%)	$110.8		$7.2		+1,450	%	(+1,450%)
ELUNATE®	$115.0		$107.5		+7	%	(+9%)	$86.3		$83.2		+4	%	(+6%)
SULANDA®	$49.0		$43.9		+12	%	(+14%)	$49.0		$43.9		+12	%	(+14%)
ORPATHYS®	$45.5		$46.1		-2	%	(+0%)	$24.5		$28.9		-15	%	(-13%)
TAZVERIK®	$0.9		$1.0		-8	%	(-7%)	$0.9		$1.0		-8	%	(-7%)
Oncology Products	$ 501.0		$ 213.6		+134	%	(+136%)	$ 271.5		$ 164.2		+65	%	(+67%)
Takeda upfront, regulatory milestones and R&D services								$67.0		$345.9		-81	%	(-81%)
Other revenue (R&D services and licensing)								$24.9		$18.5		+34	%	(+36%)
Total Oncology/Immunology								$ 363.4		$ 528.6		-31	%	(-31%)
Other Ventures								$266.8		$309.4		-14	%	(-12%)
Total Revenue								$ 630.2		$ 838.0		-25	%	(-24%)

* = FRUZAQLA

^®

, ELUNATE

^®

and ORPATHYS

^®

mainly represent total sales to third parties as provided by Takeda, Lilly

²⁹

and AstraZeneca, respectively.

** = FRUZAQLA

^®

represents manufacturing revenue, royalties and commercial milestone paid by Takeda; ELUNATE

^®

represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS

^®

represents manufacturing revenue and royalties paid by AstraZeneca and sales to other third parties invoiced by HUTCHMED; SULANDA

^®

and TAZVERIK

^®

represent the Company’s sales of the products to third parties.

II. REGULATORY UPDATES

China

• Savolitinib NDA
  accepted by the NMPA with Priority Review status and Breakthrough Therapy designation for 2L EGFRm NSCLC patients with MET amplification, in combination with TAGRISSO^® (osimertinib), in December 2024, triggering a milestone from AstraZeneca.
• Savolitinib sNDA
  
  ³⁰
  
  approved by the NMPA for 1L and 2L (converted from conditional to full approval) METex14 NSCLC in January 2025.
• Fruquintinib sNDA approved by the NMPA, in combination with TYVYT^® (sintilimab), for 2L EMC patients with pMMR status in December 2024.
• Fruquintinib approved in Hong Kong for 3L
  
  ³¹
  
  CRC under the new 1+ Mechanism in January 2024, and subsequently the first innovative oncology medicine enlisted with Full Subsidy under the Special Drug category in October 2024.
• Tazemetostat approved in Hong Kong for 3L R/R
  
  ³²
  
  EZH2m
  
  ³³
  
  follicular lymphoma in May 2024.
• Savolitinib approved in Hong Kong for METex14 NSCLC under the 1+ Mechanism in February 2025.
• Tazemetostat NDA accepted by the NMPA with Priority Review status for 3L R/R follicular lymphoma in July 2024.
• Fruquintinib sNDA voluntarily withdrawn
  for 2L gastric cancer, in combination with paclitaxel, in August 2024, in light of discussions with the NMPA and internal review of current data package.

Ex-China

• Fruquintinib approved in the EU for
  CRC in June 2024, followed by first European reimbursement in Spain in December 2024, triggering a $10.0 million milestone from Takeda.
• Fruquintinib approved in Japan for CRC in September 2024, followed by pricing approval and launch in November 2024, triggering a milestone from Takeda.
• Fruquintinib approved in Argentina and Switzerland in August 2024, in Canada (also with reimbursement) and the United Kingdom in September 2024, in Australia and Singapore in October 2024, in Israel and the United Arab Emirates in December 2024, and in South Korea in March 2025.

III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES

Savolitinib (ORPATHYS



^®



in China)

,
a highly selective oral inhibitor of MET

• Positive SAVANNAH global pivotal Phase II top-line results for 2L EGFRm NSCLC patients with MET amplification or overexpression, in combination with TAGRISSO^® (osimertinib), achieving high, clinically meaningful and durable response rate (NCT03778229).
• Primary endpoint met in SACHI China Phase III interim analysis for 2L EGFRm NSCLC patients with MET amplification (NCT05015608).
• Presented Phase II small randomized controlled study results at AACR³⁴ for 2L EGFRm NSCLC patients with high MET amplification, in combination with TAGRISSO^® (osimertinib), showing ORR³⁵ of 63% and median PFS³⁶ of 8.2 months (NCT04606771).
• Continued enrolling SAFFRON global Phase III study for 2L EGFRm NSCLC patients with MET amplification or overexpression (NCT05261399) supporting SAVANNAH; and SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression (NCT05009836).

  Potential upcoming clinical and regulatory milestones for savolitinib:

• Presentation of SAVANNAH and SACHI data at upcoming scientific conferences.
• Complete SACHI NMPA NDA review in late 2025.
• Complete SAFFRON enrollment in the second half of 2025.
• Complete enrollment and potential NDA submission for gastric cancer with MET amplification in the second half of 2025.

Fruquintinib (ELUNATE



^®



in China, FRUZAQLA



^®



outside of China)

,
a highly selective oral inhibitor of VEGFR

³⁷

• Presented FRUSICA-1 China pivotal Phase II results at ASCO, in combination with TYVYT^® (sintilimab), for previously treated EMC with pMMR status, showing IRC³⁸-assessed confirmed ORR of 35.6%, median PFS of 9.5 months and median OS³⁹ of 21.3 months with a manageable safety profile (NCT03903705). This indication was approved by the NMPA in December 2024.
• Presented FRESCO-2 subgroup analyses for CRC patients at ASCO, biomarker analysis at AACR and quality-of-lifeanalysis at ASCO GI⁴⁰, showing meaningful quality-adjusted survival benefit, efficacy regardless of prior therapy or sequence as well as CEA⁴¹ potentially a predictor of efficacy (NCT04322539).
• Published FRUTIGA China Phase III results in Nature Medicine for 2L gastric cancer, in combination with paclitaxel, and presentations at ASCO, showing statistically significant improvements in ORR and PFS, as well as OS benefits in sub-group without taking subsequent antitumor therapy (NCT03223376).
• Positive result of FRUSICA-2 China Phase III in 2L RCC in March 2025 (NCT05522231).

Sovleplenib (HMPL-523)

, an investigative and highly selective oral inhibitor of Syk


⁴²

• Published ESLIM-01 China Phase III results for adult patients with primary ITP in China in The Lancet Haematology concurrently with presentations at EHA, showing durable response rate of 48.4%, tolerable safety profile and improved quality of life regardless of prior lines of therapies (NCT05029635).
• Presented ESLIM-01 China Phase III long-term results at ASH, showing durable response rate of 51.4% and long-term durable response rate of 59.8% as well as consistent safety profile.
• Published China Phase II results in warm AIHA in China at EHA and in
  
  The Lancet Haematology
  
  in 2025, demonstrating overall response rate of 66.7% and a favorable safety profile (NCT05535933).
• Initiated ESLIM-02
  China
  Phase III stage in warm AIHA (NCT05535933).

  Potential upcoming clinical milestones for sovleplenib:

• Complete ESLIM-01 NMPA NDA review around end 2025 (NCT05029635).
• Complete enrollment of ESLIM-02 Phase III in the second half of 2025 (NCT05535933).

Surufatinib (SULANDA



^®



in China)

, an oral inhibitor of VEGFR, FGFR

⁴³

and CSF-1R

⁴⁴

• Completed enrollment of Phase II part of a China Phase II/III trial for 1L metastatic PDAC
  
  ⁴⁵
  patients, in combination with AiRuiKa^® (camrelizumab), nab-paclitaxel and gemcitabine (NCT06361888). This study was informed in part by an investigator-initiated trial presented at ASCO GI 2024 of a similar combination.

  Potential upcoming clinical milestone for surufatinib:

• Data readout of the PDAC Phase II trial in late 2025.

Tazemetostat (TAZVERIK



^®



in Hainan, Macau and Hong Kong)

, a first-in-class, oral inhibitor of EZH2

• Positive bridging study in 3L follicular lymphoma leading to NDA submission with Priority Review status (NCT05467943).
• Continued enrolling SYMPHONY-1 Phase III China portion of the global study, in combination with lenalidomide and rituximab, in follicular lymphoma patients (NCT04224493).

  Potential upcoming clinical milestone for tazemetostat:

• Complete NDA review in China in mid 2025.

Fanregratinib (HMPL-453)

, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3

• Completed enrollment of registrational China pivotal Phase II for IHCC⁴⁶ with FGFR2 fusion / rearrangement in March 2025 (NCT04353375).

Ranosidenib (HMPL-306)

,
an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2


⁴⁷


enzymes

• Presented and published results from China and US/European Phase I studies at EHA and the journal Med for R/R IDH1/2m⁴⁸ AML⁴⁹ patients (NCT04272957, NCT04764474).
• Initiated RAPHAEL China Phase III trial for 2L R/R IDH1/2m AML (NCT06387069).

Other early-stage investigational drug candidates

• Presented pre-clinical and Phase I results at AACR, ASCO and EHA for ERK1/2⁵⁰ inhibitor HMPL-295, third-generation BTK⁵¹ inhibitor HMPL-760, Menin inhibitor HMPL-506, and anti-CD38 HMPL-A067.
• Initiated Phase I trial for HMPL-506 in hematological malignancies in China (NCT06387082).

IV. ANTIBODY-TARGETED THERAPY CONJUGATE (ATTC) PLATFORM

New in-house created platform with multiple potential IND



⁵²



candidates

Our ATTC next-generation technology platform leverages over 20 years of expertise in targeted therapies with small molecules inhibitors. ATTC drug candidates enrich the next wave of clinical development with potential key advantages over traditional antibody-drug conjugates and/or small molecule medicines:

• Better efficacy through synergistic antibody-small molecule targeted therapy combinations that will target specific mutations; overcome drug resistance and potentially support combinations with other targeted therapies, chemotherapy and immunotherapy, in early-line patient settings.
• Improved safety and prolonged treatment given lower off-tumor or off-target toxicity than small molecules, less myelosuppression and better quality of life than cytotoxin-based conjugates.
• Attractive pharmacokinetics tackles difficult drug targets, enabled by antibody-guided delivery to target sites which will improve bioavailability and reduce drug-drug interactions when compared to oral small molecules inhibitors.

V. COLLABORATION UPDATES

Further progress by Inmagene



⁵³



with two candidates discovered by HUTCHMED

• HUTCHMED received 7.5% shareholding interest in Inmagene following the latter’s exercise of an option to exclusively develop, manufacture and commercialize IMG-007, a nondepleting anti-OX40 antibody, and IMG-004, a reversible, non-covalent, highly selective oral BTK inhibitor.
• Inmagene and Ikena Oncology, Inc. agreed to merge, which is expected to close in mid-2025, subject to closing conditions. HUTCHMED will have an interest in the merged company.
• Inmagene announced positive results of a Phase IIa trial with IMG-007 for atopic dermatitis, showing Week 16 mean change in EASI⁵⁴ of 77% and EASI-75 response of 54% (NCT05984784). A Phase IIb dose-finding study with a subcutaneous formulation in moderate-to-severe atopic dermatitis is planned.
• Inmagene enrolled a Phase IIa trial with IMG-007 for alopecia areata (NCT06060977), and announced results of a Phase I study with IMG-004, indicating once daily dosing potential (NCT05349097).

VI. OTHER VENTURES

• Other Ventures consolidated revenue is predominantly from the prescription drug distribution business⁵⁵ in China. It decreased by 14% (12% at CER) to $266.8 million (2023: $309.4m) primarily due to lower COVID-related prescription drug distribution sales in 2024.
• Share of equity in earnings of SHPL, a non-consolidated joint venture, slightly decreased by 2% (increased 1% at CER) to $46.5 million (2023: $47.4m) mainly due to increased clinical trial investment for new products.
• Consolidated net income attributable to HUTCHMED from Other Ventures decreased by 5% (2% at CER) to $47.7 million (2023: $50.3m), due to disposal of consumer products business in December 2023, lower COVID-related prescription drug distribution sales and fluctuation in net income contributed from SHPL.

SHPL Disposal: HUTCHMED entered into share purchase agreements to divest its 45.0% equity interest in SHPL for approximately $608 million in cash, retaining a 5.0% equity interest. It is estimated that HUTCHMED will record a pre-tax gain of approximately $477 million.

VII. SUSTAINABILITY

HUTCHMED is committed to progressively embedding sustainability into all aspects of its operations and creating long-term value for its stakeholders. Continued progress was made in 2024 including:

• Sustainability goals and targets: satisfactory progress made in 11 short- to long-term goals and targets; sustainability performance continued to be incorporated into management’s performance-based remuneration. To prepare for new targets setting, sustainability-related efforts were continually assessed and a target achievement roadmap focused on HUTCHMED’s five sustainability pillars is being developed.
• Enhanced climate actions: based on the 2022 climate risk assessment, HUTCHMED conducted another comprehensive assessment on the potential financial impacts of climate risks and opportunities for HUTCHMED with costs estimated under low-, mid-, and high-emission scenarios. This also prepares it for the latest climate-related disclosure requirements of the HKEX⁵⁶ and other international disclosure standards.
• Biodiversity assessment: a biodiversity assessment was conducted to understand HUTCHMED’s dependency and impact on nature. Based on the results of the assessment, a Biodiversity Policy was prepared and approved by the Board for public disclosure.
• Supplier ESG
  
  ⁵⁷
  
  assessment: this was conducted to understand the sustainability maturity of the supplier base and pave the way for a tailored supplier engagement program in 2025.
• Improvement on ESG ratings: MSCI ESG upgraded the rating of HUTCHMED from BBB to A. ISS ESG upgraded the rating of HUTCHMED from C to C+, which is classified as Prime. Its S&P Global ESG score continued to rise from 48 to 53, placing HUTCHMED in the 90^th percentile of the industry. Additionally, HUTCHMED achieved an A- rating and a top quartile score in the Hang Seng Corporate Sustainability Index Series rating, particularly in the areas of environment and governance.

In recognition of its marked improvement in sustainability efforts within the pharmaceutical industry, HUTCHMED was honored with multiple ESG awards in 2024. These efforts will continue to guide HUTCHMED towards a more sustainable future. The 2024 Sustainability Report will be published alongside the 2024 Annual Report in April 2025 and will include further information on sustainability initiatives and performance.

FINANCIAL HIGHLIGHTS

Foreign exchange impact: The RMB depreciated against the US dollar by approximately 3% during 2024 on average, which has impacted consolidated financial results as highlighted below.

Revenue for the year ended December 31, 2024 was $630.2 million compared to $838.0 million in 2023.

• Oncology/Immunology consolidated revenue amounted to $363.4 million (2023: $528.6m):
  • FRUZAQLA^® revenue was $110.8 million, reflecting its successful launch since November 2023 comprising royalties, manufacturing revenue and commercial milestone.
  • ELUNATE^®revenue increased 4% (6% at CER) to $86.3 million (2023: $83.2m) in its sixth year since launch, comprising of manufacturing revenue, promotion and marketing services revenue and royalties, maintaining its leading market share position while weathering greater market competition.
  • SULANDA^® revenue increased 12% (14% at CER) to $49.0 million (2023: $43.9m) due to continued sales growth after NRDL renewal as brand awareness amongst doctors continues to increase, leading to greater NET patient access and market share.
  • ORPATHYS^® revenue decreased 15% (13% at CER) to $24.5 million (2023: $28.9m), due to phasing of manufacturing revenue of $10.9 million (2023: $15.1m), and royalties of $13.6 million (2023: $13.8m).
  • TAZVERIK^®revenue was $0.9 million (2023: $1.0m) mainly from sales in Hainan and Hong Kong.
  • Takeda upfront, regulatory milestones and R&D services revenue decreased to $67.0 million (2023: $345.9m, of which $280.0m was the recognized portion of the $400.0 million upfront cash payment received from Takeda in April 2023).
  • Other revenue of $24.9 million (2023: $18.5m), primarily related to milestone payment of $6.0 million from AstraZeneca and fees from AstraZeneca and Lilly for development and regulatory activities.
• Other Ventures consolidated revenue decreased 14% (12% at CER) to $266.8 million (2023: $309.4m), primarily as a result of lower COVID-related prescription drug distribution sales in 2024. This excluded non-consolidated revenue at SHPL of $393.5 million (2023: $385.5m).

Net Expenses for 2024 were $592.5 million compared to $737.2 million in 2023, reflecting strong efforts on cost control.

• Cost of Revenue decreased by 9% to $348.9 million (2023: $384.4m), which was mainly due to lower revenue from Other Ventures. Cost of revenue as a percentage of oncology product revenue improved (from 56% in 2023 to 34% in 2024) due to favorable product mix and economies of scale.
• R&D Expenses reduced 30% to $212.1 million (2023: $302.0m), mainly due to restructuring of teams outside of China, with clinical and regulatory expenses in the US and Europe decreasing to $34.5 million (2023: $106.9m). China investment was $177.6 million (2023: $195.1m) which reflects both a decrease in cost for completed studies with NDAs under review and an ongoing commitment to key assets with global potential in our internal pipeline, including the development of the next-generation ATTC platform.
• S&A
  
  ⁵⁸
  
  Expenses were $112.9 million (2023: $133.2m), which decreased primarily due to tighter controls over administrative spending $64.3 million (2023: $79.8m) and lower selling expenses $48.6 million (2023: $53.4m) as we realized efficiencies from a salesforce already scaled to support revenue growth.
• Other Items mainly comprised of equity in earnings of SHPL, interest income and expense, FX and taxes, generated net income of $81.4 million (2023: $82.4m).

Net Income attributable to HUTCHMED for 2024 was $37.7 million compared to $100.8 million in 2023.

• The net income attributable to HUTCHMED in 2024 was $0.04 per ordinary share / $0.22 per ADS⁵⁹, (2023: $0.12 per ordinary share / $0.59 per ADS).

Cash, Cash Equivalents and Short-Term Investments were $836.1 million as of December 31, 2024 compared to $886.3 million as of December 31, 2023.

• Adjusted Group (non-GAAP⁶⁰) net cash flows excluding financing activities in 2024 were -$19.5 million mainly due to net income attributable to HUTCHMED of $37.7 million offset by changes in working capital of $62.2 million from partner milestones achieved and receivable at the end of 2024 and ongoing recognition of Takeda deferred revenue (2023: $206.7m due to the receipt of $435 million in upfront and milestone payments from Takeda).
• Net cash used in financing activities in 2024 totaled $30.7 million mainly due to purchases for equity awards of $36.1 million (2023: net cash generated from financing activities of $48.7m mainly due to drawdowns of bank borrowings).

FINANCIAL GUIDANCE

HUTCHMED provides full year 2025 guidance for Oncology/Immunology consolidated revenue of $350 million to $450 million. HUTCHMED’s work in 2025 and beyond will be supported by its strong balance sheet. The Company will continue to be financially self-reliant while supporting investments to bring innovative medicines to patients globally.

Shareholders and investors should note that:

• The Company does not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; and
• The Company has in the past revised its financial guidance and reference should be made to any announcements published by it regarding any updates to the financial guidance after the date of publication of this announcement.

Use of Non-GAAP Financial Measures and Reconciliation
– References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

FINANCIAL STATEMENTS

HUTCHMED will today file with the US Securities and Exchange Commission its Annual Report on Form 20-F.

FINANCIAL SUMMARY

Condensed Consolidated Balance Sheets Data

(in $’000)	As of December 31,
	2024		2023
Assets
Cash and cash equivalents and short-term investments	836,110		886,336
Accounts receivable	155,537		116,894
Other current assets	74,908		93,609
Property, plant and equipment	92,498		99,727
Investment in an equity investee	77,765		48,411
Other non-current assets	37,378		34,796
Total assets	1,274,196		1,279,773
Liabilities and shareholders’ equity
Accounts payable	42,521		36,327
Other payables, accruals and advance receipts	256,124		271,399
Deferred revenue	98,503		127,119
Bank borrowings	82,806		79,344
Other liabilities	22,389		22,197
Total liabilities	502,343		536,386
Company’s shareholders’ equity	759,929		730,541
Non-controlling interests	11,924		12,846
Total liabilities and shareholders’ equity	1,274,196		1,279,773

Condensed Consolidated Statements of Operations Data

(in $’000, except share and per share data)	Year Ended December 31,
	2024			2023
Revenue:
Oncology/Immunology – Marketed Products	271,534			164,165
Oncology/Immunology – R&D	91,831			364,451
Oncology/Immunology Consolidated Revenue	363,365			528,616
Other Ventures	266,836			309,383
Total revenue	630,201			837,999
Operating expenses:
Cost of revenue	(348,884	)		(384,447	)
Research and development expenses	(212,109	)		(302,001	)
Selling and administrative expenses	(112,913	)		(133,176	)
Total operating expenses	(673,906	)		(819,624	)
Other income, net	42,598			39,933
(Loss)/income before income taxes and equity in earnings of an equity investee	(1,107	)		58,308
Income tax expense	(7,192	)		(4,509	)
Equity in earnings of an equity investee, net of tax	46,469			47,295
Net income	38,170			101,094
Less: Net income attributable to non-controlling interests	(441	)		(314	)
Net income attributable to HUTCHMED	37,729			100,780
Earnings per share attributable to HUTCHMED (US$ per share)
– basic	0.04			0.12
– diluted	0.04			0.12
Number of shares used in per share calculation
– basic	855,351,683			849,654,296
– diluted	872,829,129			869,196,348
Earnings per ADS attributable to HUTCHMED (US$ per ADS)
– basic	0.22			0.59
– diluted	0.22			0.58
Number of ADSs used in per share calculation
– basic	171,070,337			169,930,859
– diluted	174,565,826			173,839,270

About HUTCHMED

HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, and the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Contacts

Investor Enquiries	+852 2121 8200 / [email protected]
Media Enquiries
FTI Consulting –	+44 20 3727 1030 / [email protected]
Ben Atwell / Alex Shaw	+44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Brunswick – Zhou Yi	+852 9783 6894 (Mobile) / [email protected]
Panmure Liberum	Nominated Advisor and Joint Broker
Atholl Tweedie / Freddy Crossley / Rupert Dearden	+44 20 7886 2500
HSBC	Joint Broker
Simon Alexander / Alina Vaskina / Arnav Kapoor	+44 20 7991 8888
Cavendish	Joint Broker
Geoff Nash / Nigel Birks	+44 20 7220 0500

References

Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context.

Past Performance and Forward-Looking Statements

The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which have been obtained will continue to remain valid and effective in the future, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, “HUTCHMED’s Products”) will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the delay or inability of a drug candidate to meet the primary or secondary endpoint of a study; the delay or inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED’s Products after obtaining regulatory approval; discovery, development and/or commercialization of competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED’s Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED’s Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains, including various third party services, for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED’s Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED’s Products; the ability to obtain additional funding when needed; the ability to obtain and maintain protection of intellectual property for HUTCHMED’s Products and drug candidates; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the successful disposition of its non-core business; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates, uncertainties in global interest rates, and geopolitical relations, sanctions and tariffs. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, on AIM and on HKEX. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.

Inside Information

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).

Medical Information

This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

This announcement in its entirety is available at:
http://ml.globenewswire.com/Resource/Download/3b541e3e-0c05-4065-810b-72732d8ea41b

_______________________

REFERENCES & ABBREVIATIONS
1	In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE ® ), Takeda (FRUZAQLA ® ), AstraZeneca (ORPATHYS ® ) and HUTCHMED (ELUNATE ® , SULANDA ® , ORPATHYS ® and TAZVERIK ® ).
2	Takeda = Takeda Pharmaceuticals International AG, a subsidiary of Takeda Pharmaceutical Company Limited.
3	SHPL = Shanghai Hutchison Pharmaceuticals Limited.
4	EGFRm = Epidermal growth factor receptor mutated.
5	NSCLC = Non-small cell lung cancer.
6	NDA = New Drug Application.
7	NMPA = China National Medical Products Administration.
8	AstraZeneca = AstraZeneca AB, a subsidiary of AstraZeneca plc.
9	2L = Second-line.
10	RCC = Renal cell carcinoma.
11	ASH = American Society of Hematology.
12	EHA = European Hematology Association.
13	ITP = immune thrombocytopenia purpura.
14	CDE = Centre for Drug Evaluation.
15	ASCO = American Society of Clinical Oncology.
16	EMC = Endometrial cancer.
17	pMMR = Proficient mismatch repair.
18	ATTC = antibody-targeted therapy conjugates.
19	R&D = Research and development.
20	EGFR = Epidermal growth factor receptor.
21	TKI = Tyrosine kinase inhibitor.
22	AIHA = Autoimmune hemolytic anemia.
23	CER = Constant exchange rate. We also report changes in performance at CER which is a non-GAAP measure. Please refer to “Use of Non-GAAP Financial Measures and Reconciliation” for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures.
24	CRC = Colorectal cancer.
25	NET = Neuroendocrine tumor.
26	NRDL = China National Reimbursement Drug List.
27	METex14 = MET exon 14 skipping alteration.
28	1L = First-line.
29	Lilly = Eli Lilly and Company.
30	sNDA = Supplemental New Drug Application.
31	3L = Third-line.
32	R/R = Relapsed and/or refractory.
33	EZH2m = Enhancer of zeste homolog 2 mutated.
34	AACR = American Association for Cancer Research.
35	ORR = Objective response rate.
36	PFS = Progression free survival.
37	VEGFR = Vascular endothelial growth factor receptor.
38	IRC = Independent review committee.
39	OS = Overall survival.
40	ASCO GI = ASCO Gastrointestinal Cancers Symposium.
41	CEA = Carcinoembryonic antigen.
42	Syk = Spleen tyrosine kinase.
43	FGFR = Fibroblast growth factor receptor.
44	CSF-1R = Colony-stimulating factor 1 receptor.
45	PDAC = Pancreatic ductal adenocarcinoma.
46	IHCC = Intrahepatic cholangiocarcinoma.
47	IDH1 and IDH2 = Isocitrate dehydrogenase-1 and isocitrate dehydrogenase-2.
48	IDH1/2m = Isocitrate dehydrogenase-1 OR isocitrate dehydrogenase-2 mutated.
49	AML = Acute myeloid leukemia.
50	ERK = Extracellular signal-regulated kinase.
51	BTK = Bruton’s tyrosine kinase.
52	IND = Investigational new drug application.
53	Inmagene = Inmagene Biopharmaceuticals.
54	EASI = Eczema area and severity index.
55	Distribution business = Shanghai Hutchison Whampoa Pharmaceuticals Sales Limited, formerly Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited.
56	HKEX = The Main Board of The Stock Exchange of Hong Kong Limited.
57	ESG = Environmental, Social and Governance.
58	S&A = Selling and administrative expenses.
59	ADS = American depositary share.
60	GAAP = Generally Accepted Accounting Principles.