On March 19, 2025 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported full year 2024 financial results and business updates (Press release, Precigen, MAR 19, 2025, View Source [SID1234651260]).

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"Last year, we achieved several milestones on our path to potentially bring our innovative PRGN-2012 therapy to RRP patients, including presentation of groundbreaking pivotal data and BLA submission to the FDA. Through prioritizing our portfolio and financing activities, we strengthened our financial position, enabling ongoing commercial and manufacturing readiness efforts for PRGN-2012 in anticipation of a potential 2025 launch. Our commercial organization has been working to scale up quickly, right-sizing the organization to rapidly capitalize on the immense demand from patients and treating physicians for a new treatment paradigm that may finally address the underlying cause of the disease," said Helen Sabzevari, PhD, President and CEO of Precigen. "Already this year, our BLA for PRGN-2012 received priority review from the FDA with an August 2025 PDUFA action date, bringing us a step closer to launching the first and only FDA-approved treatment to the approximately 27,000 adult RRP patients in the US. FDA approval for PRGN-2012 would fundamentally change Precigen, enabling the transition from clinical to commercial stage with the real and imminent potential to begin realizing product sales this year and providing financial tailwinds to enable potential expansion of PRGN-2012 to new indications and geographical markets."

"As a result of the preferred stock offering and sale of intellectual property and related royalty rights for a non-core asset, we extended our cash runway into 2026, beyond the potential commercial launch of PRGN-2012 this year. We are preparing for the transition to a commercial stage company and the potential to add product-related revenue," said Harry Thomasian Jr., CFO of Precigen.

Key Program Highlights

PRGN-2012 (nonproprietary name: zopapogene imadenovec†) AdenoVerse Gene Therapy in RRP

PRGN-2012 is an investigational off-the-shelf AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment of recurrent respiratory papillomatosis (RRP). PRGN-2012 received Breakthrough Therapy Designation, Orphan Drug Designation, and an accelerated approval pathway from the FDA, and Orphan Drug Designation from the European Commission.

· In February 2025, the US Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for PRGN-2012, and granted priority review to the BLA with a Prescription Drug User Fee Act (PDUFA) target action date set for August 27, 2025. The FDA has indicated that they are not currently planning to hold an advisory committee meeting to discuss the BLA.

· Results from the pivotal clinical study of PRGN-2012 for the treatment of RRP were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in a late-breaking oral presentation titled, "PRGN-2012, a novel gorilla adenovirus-based immunotherapy, provides the first treatment that leads to complete and durable responses in recurrent respiratory papillomatosis patients" and published in The Lancet Respiratory Medicine.

· Pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints.

· PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.

· 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012. Complete Responses have been durable beyond 12 months with median duration of follow up
of 24 months, with some complete responders surgery-free beyond three years as of the August 28, 2024 data cutoff.

· 86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 (range: 3-10) pre-treatment to 0 (range: 0-7) post-treatment.

· PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders.

· PRGN-2012 significantly (p < 0.0001) improved anatomical Derkay scores and VHI-10 scores in complete responders.

· Patient enrollment continues to advance in the confirmatory clinical trial of PRGN-2012 in accordance with the guidance from the FDA to initiate the study prior to submission of the BLA.

· The Company continues to rapidly advance its commercial and manufacturing readiness campaign in anticipation of a potential launch in 2025.

· Based on recently updated internal analysis derived from review of claims data, the market opportunity for PRGN-2012 in RRP is estimated to be approximately 27,000 adult patients in the US and more than 125,000 patients outside of the US.

PRGN-2009 AdenoVerse Gene Therapy in HPV-associated cancers

PRGN-2009 is an investigational off-the-shelf AdenoVerse gene therapy designed to activate the immune system to recognize and target HPV-associated cancers.

· PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer are ongoing.

PRGN-3006 UltraCAR-T in AML and MDS

PRGN-3006 is an investigational multigenic, autologous chimeric antigen receptor T cell (CAR-T) therapy engineered to simultaneously express a CAR specifically targeting CD33, membrane bound IL-15 (mbIL15), and a safety/kill switch. PRGN-3006 has been granted Orphan Drug Designation in patients with acute myeloid leukemia (AML) and Fast Track Designation in patients with relapsed/refractory (r/r) AML by the FDA.

· The Company has completed enrollment of the Phase 1b trial for PRGN-3006 in acute myeloid leukemia (AML), which received Fast Track designation from the FDA, and is preparing for an end of Phase 1b meeting with the FDA to discuss next steps.

Financial Highlights

· In December 2024, the Company raised $87.5 million, of which $79.0 million was from a private placement offering of convertible preferred stock, and an additional $8.5 million was from the sale of certain intellectual property and royalty rights related to a non-core asset.

· By year’s end 2024, cash, cash equivalents, and investments totaled $97.9 million.

Full Year 2024 Financial Results Compared to Prior Year Period

Total revenues decreased $2.3 million, or 37%, and cost of products and services decreased $1.8 million or 30% compared to the year ended December 31, 2023. These decreases were primarily related to reductions in product and service volumes at Exemplar.

Research and development expenses increased $4.5 million, or 9%, compared to the year ended December 31, 2023. This increase was primarily the result of $3.1 million of increased costs associated with the initiation of the PRGN-2012 confirmatory clinical trial, increased drug manufacturing material costs related to PRGN-2012 for potential commercial use, and professional fees incurred in conjunction with the Company’s completed BLA submission and commercial readiness planning as well as the design and implementation of our manufacturing facility. Additionally, employee-related expenses rose by $3.0 million primarily due to severance charges incurred as a result of the Precigen workforce reduction in 2024 and the suspension of ActoBio’s operations. These increases were partially offset by a $1.9 million reduction in depreciation and amortization expense as a result of the impairment of noncurrent assets related to the suspension of ActoBio’s operations during the second quarter of 2024 as well as a reduction in clinical study expenses associated with programs that were deprioritized during the third quarter of 2024.

SG&A expenses increased $0.9 million, or 2%, compared to the year ended December 31, 2023. As a result of the Company’s increased focus on PRGN-2012, commercial readiness costs increased in 2024 compared to the prior year. In addition, the second and third quarters of 2024 included higher severance costs associated with the suspension of ActoBio’s operations and the Precigen workforce reduction. These increases were partially offset by a decrease in stock compensation and insurance rates in 2024 compared to the same period in 2023.

The Company recorded a $5.8 million impairment charge in the fourth quarter of 2024 related to its Exemplar subsidiary as a result of the Company’s annual goodwill impairment test. Also, in conjunction with the suspension of ActoBio’s operations, the Company recorded $34.5 million of impairment charges related to goodwill ($1.6 million) and other noncurrent assets ($32.9 million) in the second quarter of 2024.

Total other income, net, increased $3.6 million, or 106% compared to the year ended December 31, 2023. This increase was primarily derived from an $8.5 million gain on the sale of intellectual property rights and royalty rights related to a non-core asset in December 2024 as well as a $0.5 million reduction in interest expense due to the final retirement of the Company Convertible Notes in the second quarter of 2023. This increase was partially offset by a reclassification of cumulative translation losses of $2.9 million, which resulted from the final closing of the ActoBio facilities in the third quarter of 2024, as well as a reduction of $1.8 million in interest income compared to the same period in 2023.

Net loss was $126.2 million, or $(0.47) per basic and diluted share, compared to net loss of $95.9 million, or $(0.39) per basic and diluted share, in year ended December 31, 2023.

On March 19, 2025 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported the successful completion of its inaugural Rated Public Bond of €500 million with a coupon of 3.875%, maturing in March 2032 (Press release, Ipsen, MAR 19, 2025, View Source [SID1234651259]).

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Following the disclosure of the Investment Grade ratings with BBB- from S&P and Baa3 from Moody’s, both with a stable outlook, this transaction was very well received and largely oversubscribed by a diversified and solid institutional investor base.

"We are pleased with the outcome of this inaugural Rated Public Bond that reinforces and demonstrates investor’s confidence in Ipsen’s Investment Grade credit profile and long-term strategy," said Aymeric Le Chatelier, Executive Vice President and Chief Financial Officer, Ipsen. "While we remain committed to a disciplined financial approach, this issuance will further support our ambition to deliver ongoing sustained growth, driven by our internal pipeline and external innovation."

This transaction is an important component of Ipsen’s refinancing plan which included the successful renewal of €1,5 billion syndicated Revolving Credit Facility completed earlier this month for a period of 5 years with two possible extensions of one year each, significantly extending Ipsen’s debt maturity profile.

On March 19, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported financial results for the full year ended December 31, 2024 and provided a business update (Press release, Immunome, MAR 19, 2025, View Source [SID1234651258]).

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"Immunome’s efficient execution in 2024 laid the foundation for a productive 2025," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "We are pleased with the progress of our pipeline and, with multiple programs now in clinical development, we expect that our recent financing will support multiple clinical milestones. We particularly look forward to topline data in the second half of 2025 for the RINGSIDE trial of varegacestat, which we believe will demonstrate significant benefits for patients with desmoid tumors."

"Our highly capable team is achieving our vision of a broad, differentiated portfolio of ADCs. We recently dosed the first patient in the Phase 1 clinical trial of IM-1021, our ROR1-targeted ADC. Three additional novel ADCs, IM-1617, IM-1335 and IM-1340, are in IND-enabling manufacturing, with additional discovery-stage programs under evaluation. We recently submitted the IND for IM-3050, our FAP radiotherapy, and anticipate initiating a Phase 1 clinical trial for that program later this year."

Pipeline Highlights

Varegacestat: Full enrollment for the Phase 3 RINGSIDE Part B study of varegacestat for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing the manufacturing and pharmacology work required to support a new drug application filing for varegacestat.

IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with the first patient dosed in February 2025. The Phase 1 trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors.

IM-3050: Immunome recently submitted an IND for IM-3050 and expects to initiate a clinical trial for the program in the second half of 2025.

Preclinical Pipeline – Immunome’s preclinical pipeline also includes three novel ADCs against solid tumor targets, IM-1617, IM-1340 and IM-1335, which are currently undergoing IND-enabling work, and additional, undisclosed ADCs in discovery and lead optimization.

Fourth Quarter and Recent Corporate Highlights

· Successfully completed an upsized underwritten public offering for gross proceeds of $172.5 million in January 2025, providing capital that is expected to support achievement of clinical milestones for varegacestat, IM-1021 and IM-3050 and the advancement Immunome’s preclinical pipeline.

· Nominated IM-1617, IM-1340 and IM-1335 as novel ADC candidates, with IND-enabling work initiated in late 2024.

· Presented data highlighting preclinical efficacy for IM-1021 and a differentiated profile for HC74, Immunome’s proprietary TOP1 ADC payload, at the 36th ORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in October 2024.

Full-year 2024 Financial Results

· As of December 31, 2024, cash, cash equivalents and marketable securities totaled $217.3 million, which does not include gross proceeds of $172.5 million from the January 2025 financing. Immunome’s current cash runway is expected to extend into 2027.

· Research and development expenses for the year ended December 31, 2024 were $129.5 million, including stock-based compensation costs of $5.1 million.

· In-process research and development expenses for the year ended December 31, 2024 were $152.3 million. These expenses were related to Immunome’s business development activity.

· General and administrative expenses for the year ended December 31, 2024 were $33.0 million, including stock-based compensation expense of $10.6 million.

· Immunome reported a net loss of $293.0 million for the year ended December 31, 2024.

On March 19, 2025 HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (HKEX: 13; Nasdaq/AIM: HCM) reported its financial results for the year ended December 31, 2024 and provides updates on key clinical and commercial developments (Press release, Hutchison China MediTech, MAR 19, 2025, View Source [SID1234651257]).

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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 sales1 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. Total oncology 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 (Free ASH Whitepaper)11 and EHA (Free EHA Whitepaper)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 (Free ASCO Whitepaper)15, leading to NMPA approval of a second indication of ELUNATE (fruquintinib) for EMC16 with pMMR17 status.

· First candidates from new ATTC18 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 (Free EHA Whitepaper) and ASH (Free ASH Whitepaper), 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 CER23) 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, Lilly29 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 sNDA30 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 3L31 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/R32 EZH2m33 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 AACR (Free AACR Whitepaper)34 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 VEGFR37

· Presented FRUSICA-1 China pivotal Phase II results at ASCO (Free ASCO Whitepaper), 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 (Free ASCO Whitepaper), biomarker analysis at AACR (Free AACR Whitepaper) and quality-of-life analysis at ASCO (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper), 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 Syk42

· Published ESLIM-01 China Phase III results for adult patients with primary ITP in China in The Lancet Haematology concurrently with presentations at EHA (Free EHA Whitepaper), 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 (Free ASH Whitepaper), 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 (Free EHA Whitepaper) 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, FGFR43 and CSF-1R44

· Completed enrollment of Phase II part of a China Phase II/III trial for 1L metastatic PDAC45 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 (Free ASCO Whitepaper) 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 IDH247 enzymes

· Presented and published results from China and US/European Phase I studies at EHA (Free EHA Whitepaper) 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 (Free AACR Whitepaper), ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) 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 IND52 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 Inmagene53 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. (Nasdaq: IKNA) 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 ESG57 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 90th 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&A58 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.

On March 19, 2025 Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, reported a €20 million ($21.9 million) financing through the issuance of a Mandatory Convertible Bond to ENEA Tech and Biomedical (ETB) to support the expansion of its pipeline by advancing Temferon in metastatic Renal Cell Cancer (mRCC) (Press release, Genenta Science, MAR 19, 2025, View Source [SID1234651255]). ETB is a leading private foundation, supervised by the Italian Ministry of Enterprises and Made in Italy, managing over €1,7 billion in assets under management through two funds. With deep expertise in the biomedical sector, ETB is an established authority in identifying and supporting high-potential biotech companies.

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"ETB conducted a deep and thorough scientific and legal due diligence before committing to this investment. We spent several months in negotiations," said Pierluigi Paracchi, CEO of Genenta. "We believe the mandatory convertible bond terms are indicative of the potential long-term value of Genenta’s shares. The bond will not result in immediate dilution to Genenta’s shareholders, and is expected to provide the necessary capital to achieve key milestones in the Company’s new mRCC trial. Conversion to equity is set for March 2028, followed by a two-year lock-up period. Naturally, the process will be accelerated in the event of a change of control of our Company. ETB is a trusted partner with strong financial backing, which will help ensure the financial stability required to advance the validation of the Temferon platform and our ability to pursue strategic collaborations."

The February data cutoff from the Phase 1/2a Glioblastoma Multiforme (GBM) uMGMT trial shows an increase in the percentage of patients surviving at two years, now reaching 29%, compared to 25% in October. Additionally, there is a marginal improvement in median overall survival, which now stands at 17 months. Historically reported data showed the overall survival of uMGMT patients undergoing standard of care to be approximately 14% at two years with a median overall survival of 13–15 months.

Notably, the Phase 1/2a trial in metastatic Renal Cell Carcinoma has recently begun enrolling patients, further strengthening the Company’s clinical pipeline for Temferon.

Prof. Luigi Naldini, Co-founder of Genenta, added: "We are continuing to demonstrate at pre-clinical and clinical levels Temferon’s ability to reprogram the tumor microenvironment, which in turn induces cell-mediated immune responses, as suggested by Genenta’s ongoing GBM trial and which will be under testing in the Company’s mRCC trial."

ETB Mandatory Convertible Bond Investment Terms:

Total Bond: €20 million ($21.9M), subscribed by ETB;
Maturity: three years, with mandatory conversion at maturity (March 2028);
Lock-up: two years following conversion (March 2030);
Funding Structure:
First Tranche: €7.5 million ($8.2M), which is expected to provide sufficient funding to assess safety in the ongoing Phase 1/2a trial for mRCC.
Second Tranche: €12.5 million ($13.7M), conditional upon achieving safety and tolerability in the ongoing Phase 1/2a trial for mRCC, among other conditions.
ETB equity in Genenta will be capped at 29%.
The maximum conversion price is $17.64 per share based on an Independent Evaluation conducted by ETB’s Advisor on Genenta.