On May 6, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the first quarter of 2025 and updated financial guidance for 2025 (Press release, Jazz Pharmaceuticals, MAY 6, 2025, View Source [SID1234652579]).

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"In the first quarter of 2025, our focus on commercial execution resulted in total revenues of $898 million, led by the strong performance of Xywav and Epidiolex. In addition, our team continues to receive positive feedback from healthcare providers on the launch of Ziihera in its first approved indication of 2L HER2+ BTC. We are affirming our 2025 total revenue guidance range of $4.15 – $4.40 billion, reflecting our confidence in our commercial portfolio delivering top-line growth this year," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. "We continue to make meaningful progress across our pipeline. We are pleased to report that we have submitted a supplemental New Drug Application for Zepzelca for maintenance therapy in first-line extensive-stage small cell lung cancer. In addition, we recently completed the acquisition of Chimerix, adding a near-term commercial opportunity to our late-stage pipeline that addresses a significant unmet need for patients with H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults. We also advanced multiple trials across our zanidatamab development program and expect top-line data readout from the HERIZON-GEA-01 trial in 1L GEA in the second half of 2025."

Key Highlights

•Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 2H25.
•Submitted sNDA for Zepzelca in combination with atezolizumab (Tecentriq ) as maintenance therapy in 1L ES-SCLC based on the potentially practice-changing results from the Phase 3 IMforte trial. Data from trial to be presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting in June 2025.
•Acquisition of Chimerix added dordaviprone to late-stage pipeline, representing near-term commercial opportunity; PDUFA target data of August 18, 2025.
•Top-line growth expected in 2025; affirmed 2025 total revenue guidance of $4.15 – $4.40 billion, representing 5% growth at the midpoint.
◦Total revenue guidance is underpinned by expected continued growth of Jazz’s diversified commercial portfolio.

Business Updates

Commercial Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 9% to $344.8 million in 1Q25 compared to 1Q24.
•Meaningful Xywav net patient adds in 1Q25 (approximately 450 patients) with approximately 14,600 active Xywav patients exiting 1Q25, comprised of:

◦Approximately 10,375 narcolepsy patients.
◦Approximately 4,225 idiopathic hypersomnia (IH) patients, with 325 net patient adds.
•Two presentations at the American Academy of Neurology Annual Meeting provided updated results from the open-label, single-arm, Phase 4 DUET trial of adults with narcolepsy or IH. The results demonstrated statistically significant improvements from baseline to end of treatment in Epworth Sleepiness Scale (ESS) scores, reduced sleep stage shifts, increased deep sleep and reduced number of awakenings among adults with narcolepsy treated with Xywav. In adults with IH, Xywav treatment showed improvements in ESS and IH Severity Scale scores.
•Xywav is the only low-sodium oxybate, the #1 branded treatment for narcolepsy1 and the only U.S. Food and Drug Administration (FDA)-approved therapy to treat IH.

Xyrem (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties:
•Xyrem net product sales decreased 42% to $37.2 million in 1Q25 compared to 1Q24.
•Royalties from high-sodium oxybate AGs were $48.9 million in 1Q25.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 10% to $217.7 million in 1Q25 compared to 1Q24.
•Outside of the U.S., Epidyolex is approved in more than 35 countries.
•Remain confident in achieving blockbuster status for Epidiolex/Epidyolex in 2025.

Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
•Rylaze/Enrylaze net product sales decreased 8% to $94.2 million in 1Q25 compared to 1Q24. This decrease was driven by headwinds from an update to Children’s Oncology Group (COG) pediatric treatment protocols for acute lymphoblastic leukemia made in mid-2024 that impacted timing of asparaginase administration.
•The impact to Rylaze net product sales due to COG protocol updates is expected to normalize during 2Q25.

Zepzelca (lurbinectedin):
•Zepzelca net product sales decreased 16% to $63.0 million in 1Q25 compared to 1Q24. This decrease was driven by increased competition in second-line (2L) small cell lung cancer (SCLC) and treatment protocol updates delaying progression in first-line (1L) limited-stage SCLC patients to the 2L setting.
•The Company submitted a supplemental New Drug Application (sNDA) for Zepzelca’s use in combination with atezolizumab as maintenance therapy in 1L extensive-stage (ES) SCLC for patients who have not progressed after induction chemotherapy.
•Potentially practice-changing data from the Phase 3 IMforte trial, which showed a statistically significant and clinically meaningful benefit in both progression-free survival (PFS) and overall survival for the Zepzelca and atezolizumab combination for ES-SCLC patients receiving this treatment in the first-line maintenance setting, was accepted for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. This is the first presentation of data from the IMforte trial.

Ziihera (zanidatamab-hrii):
•Ziihera net product sales were $2.0 million in 1Q25 following product launch in December 2024.
•On April 25, 2025, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab in 2L BTC (biliary tract cancer). The CHMP recommendation is being reviewed by the European Commission.

Corporate Development
Chimerix Acquisition:
•The Company completed its acquisition of Chimerix in April 2025, adding dordaviprone to its late-stage pipeline. Dordaviprone is a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults.

Key Pipeline Highlights
Zanidatamab:
•The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is expected to read out in 2H25 based on the most recent assessment of progression events. Recruitment for the trial has been completed.
•New data from an ongoing Phase 2 trial of zanidatamab in combination with chemotherapy for the first-line treatment of HER2-positive metastatic GEA, including more mature overall survival data, was accepted for a rapid oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.
•The Phase 3 EmpowHER-BC-303 trial to evaluate zanidatamab plus chemotherapy or trastuzumab plus chemotherapy in patients with HER2-positive breast cancer whose disease has progressed on previous T-DXd treatment continues to enroll patients.
•The Phase 2 pan-tumor trial to evaluate HER2-positive solid tumors continues to enroll patients.

Dordaviprone:
•A New Drug Application for accelerated approval of dordaviprone in recurrent H3 K27M-mutant diffuse glioma was accepted and granted Priority Review by FDA. FDA has set a target Prescription Drug User Fee Act (PDUFA) action date of August 18, 2025.
•The ongoing Phase 3 ACTION trial is evaluating dordaviprone in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting.
•Data on the efficacy and safety of dordaviprone from prospective clinical trials of adult and pediatric recurrent H3 K27M-mutant diffuse glioma patients was accepted for an oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.

Financial Highlights
Three Months Ended
March 31,
(In thousands, except per share amounts) 2025 2024
Total revenues $ 897,841 $ 901,983
GAAP net loss $ (92,541) $ (14,618)
Non-GAAP adjusted net income1
$ 105,233 $ 178,430
GAAP loss per share $ (1.52) $ (0.23)
Non-GAAP adjusted EPS1
$ 1.68 $ 2.63

____________________________
1.Commencing with the first quarter of 2025, we are no longer including an adjustment for non-cash interest expense in the Company’s non-GAAP adjusted financial measures and for the purposes of comparability, non-GAAP adjusted financial measures for the first quarter of 2024 have been updated to reflect this change. See "Non-GAAP Financial Measures" below.

GAAP net loss for 1Q25 was $(92.5) million, or $(1.52) per diluted share, compared to $(14.6) million, or $(0.23) per diluted share, for 1Q24.
Non-GAAP adjusted net income for 1Q25 was $105.2 million, or $1.68 per diluted share, compared to $178.4 million, or $2.63 per diluted share, for 1Q24.
The GAAP net loss and non-GAAP adjusted net income for 1Q25 included an expense of $172.0 million related to certain Xyrem antitrust litigation settlements, which impacted our GAAP and non-GAAP results by $146.3 million (net of tax of $25.7 million) or $2.38 per share on a GAAP basis and $2.34 per share on a non-GAAP adjusted basis.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total Revenues
Three Months Ended
March 31,
(In thousands) 2025 2024
Xywav $ 344,804 $ 315,300
Xyrem 37,241 64,232
Epidiolex/Epidyolex 217,737 198,716
Sativex 5,407 2,735
Total Neuroscience 605,189 580,983
Rylaze/Enrylaze 94,233 102,750
Zepzelca 63,033 75,100
Defitelio/defibrotide 40,662 47,676
Vyxeos 29,544 32,023
Ziihera 1,975 —
Total Oncology 229,447 257,549
Other 4,782 3,570
Product sales, net 839,418 842,102
High-sodium oxybate AG royalty revenue 48,946 49,947
Other royalty and contract revenues 9,477 9,934
Total revenues $ 897,841 $ 901,983

Total revenues for 1Q25 were in line with 1Q24.
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $654.1 million in 1Q25, an increase of 4% compared to $630.9 million in 1Q24. The increase in 1Q25 was due to higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales.
Oncology net product sales were $229.4 million in 1Q25, a decrease of 11% compared to $257.5 million in 1Q24. The decrease in 1Q25 was primarily due to lower net product sales of Zepzelca, Rylaze/Enrylaze and Defitelio/defibrotide. In 1Q25, Rylaze net product sales were negatively impacted due to an update to the COG pediatric treatment protocols for ALL, which impacts the timing of asparaginase administration.

On May 6, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported that data from the company’s Phase 1/2 OVATION 2 trial evaluating intraperitoneal IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian cancer will be published in the peer-reviewed journal Gynecologic Oncology (Press release, IMUNON, MAY 6, 2025, View Source [SID1234652578]).

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The review of full data, entitled: OVATION-2: A Randomized Phase I/II study Evaluating the Safety and Efficacy of IMNN-001 (IL-12 gene therapy) with Neo/Adjuvant Chemotherapy in Patients Newly- Diagnosed with Advanced Epithelial Ovarian Cancer, is scheduled for publication on June 3, 2025.

As previously announced, data from the OVATION 2 study will also be reviewed in an oral presentation during the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3, 2025 in Chicago, Illinois. Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, is lead author on the publication and will lead the discussion in the oral presentation at the ASCO (Free ASCO Whitepaper) meeting.

"We are very pleased that the data from our OVATION 2 study will be presented in the highly esteemed peer-reviewed journal Gynecologic Oncology and in an oral presentation at the ASCO (Free ASCO Whitepaper) meeting," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "Having our data presented in two of the premier global platforms in gynecologic oncology underscores both the critical need to develop new therapies to treat ovarian cancer and the strength and potential of IMUNON’s TheraPlas platform technology."

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On May 6, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported a business update and announced financial results for the first quarter that ended March 31, 2025 (Press release, Ideaya Biosciences, MAY 6, 2025, View Source [SID1234652577]).

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"We have provided an updated cash runway guidance into 2029, and this past quarter we made significant progress on the darovasertib program, including receiving U.S. FDA breakthrough therapy designation, and enrollment is ahead of schedule with over 300 patients in the 1L HLA-A2-negative MUM registrational trial for a targeted median PFS readout by year-end to enable a potential accelerated approval filing next year. We also advanced a broad clinical pipeline of potential first-in-class programs to continue to drive forward our growth strategy, including DLL3 TOP1 ADC IDE849 in lung cancer, Werner Helicase inhibitor IDE275 in MSI-high colorectal and endometrial cancer, and MAT2A inhibitor IDE397 in MTAP-deletion lung and urothelial cancer," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Recent Key Developments and Upcoming Milestones

Research and Clinical Development

Darovasertib: a potential first-in-class PKC inhibitor in Phase 2/3 clinical testing for the treatment of metastatic uveal melanoma (MUM) and as neoadjuvant treatment for primary uveal melanoma (UM).

•
MUM
•
Part 2b with the selected optimal dose for the potential registration-enabling trial evaluating darovasertib and crizotinib in first line (1L) HLA-A2-negative MUM continues enrolling.
•
Median progression-free survival (PFS) readout for Phase 2/3 registration-enabling trial of the darovasertib and crizotinib combination in 1L HLA-A2-negative MUM targeted by year-end 2025. Rapid enrollment in the trial continues with over 300 patients as of May 5, 2025.
•
Phase 2 median overall survival (OS) readout from study IDE196-001 in over 40 1L MUM patients targeted at a medical conference in the second half of 2025. The readout will include both 1L HLA-A2-negative and HLA-A2-positive MUM patients. We continue to enroll additional HLA-A2-positive MUM patients in the IDE196-001 trial.
•
Neoadjuvant UM
•
Successfully completed a Type D meeting with the FDA on Phase 3 registrational trial design for darovasertib as neoadjuvant therapy for primary UM. The Phase 3 study is expected to enroll approximately 520 patients randomized 2:1 to receive darovasertib or control. Two cohorts include enucleation-eligible UM patients (n=120) and plaque brachytherapy (PB)-eligible UM patients (n=400). Primary endpoints, which are supportive of full approval based on the FDA Type D Meeting, include eye preservation rate for enucleation patients and proportion of patients with best corrected visual acuity 15-letter loss from time of randomization and time of completion of PB for the PB cohort, with event-free survival (EFS) as a required secondary endpoint for both cohorts. Commencement of the Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM is targeted for the first half of 2025.
•
U.S. FDA granted breakthrough therapy designation for single agent darovasertib for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM) for whom enucleation has been recommended.
•
Two clinical updates from the Company-sponsored Phase 2 trial targeted at medical conferences in mid-2025 and the second half of 2025. The mid-2025 update will be focused on vision data and the plaque brachytherapy patients, and the update in second half of 2025 will include over 90 UM patients from both the enucleation and plaque brachytherapy eligible cohorts.

IDE397: a potential first-in-class Phase 2 MAT2A inhibitor for the treatment of MTAP-deletion solid tumors.

•
Entered into an additional clinical study collaboration and supply agreement with Gilead to evaluate IDE397, IDEAYA’s MAT2A inhibitor, in combination with Trodelvy (sacituzimab govitecan-hziy), Gilead’s Trop-2 directed ADC, in MTAP-deletion NSCLC.
•
IDEAYA plans to enable the wholly-owned IDE397 and IDE892 (PRMT5MTA) combination in patients with MTAP-deletion non-small cell lung cancer (NSCLC) in the second half of 2025.
IDE849 (SHR-4849): a potential first-in-class Phase 1 DLL3 TOP1i antibody drug conjugate (ADC) targeting small cell lung cancer (SCLC) and neuroendocrine tumors (NETs).

•
U.S. IND clearance obtained for IDE849 Phase 1 study in small cell lung cancer (SCLC).
•
IDE849 currently being evaluated by Hengrui Pharma in an ongoing Phase 1 trial in China in SCLC patients. In January 2025, partner Hengrui Pharma selected expansion doses for the study. Clinical efficacy and safety data from over 40 SCLC patients in the multi-site open label Phase 1 trial, including the dose escalation and multiple expansion doses, will be presented at a medical conference in Q3 2025.
•
Initiation of evaluation of IDE849 and IDE161 combination targeted in the second half of 2025.
IDE275 (GSK959): a potential first-in-class and best-in-class Phase 1 Werner Helicase inhibitor for the treatment of high microsatellite instability (MSI-High) tumors.

•
Phase 1 dose escalation trial ongoing in MSI-H solid tumors with GSK.
•
IDE275 highlighted in an oral presentation in the New Drugs on the Horizon series, and three poster presentations, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting. The preclinical data demonstrated the molecule’s selectivity to treat MSI-H solid tumors and potential to be developed clinically as both a monotherapy agent and in combination with anti-PD1. A Trial in Progress poster for the ongoing SYLVER Phase 1/2 study (NCT06710847) was also presented at AACR (Free AACR Whitepaper) 2025.
IDE161: a potential first-in-class Phase 1 PARG inhibitor for the treatment of solid tumors.
•
Phase 1 monotherapy dose optimization is ongoing. The clinical focus for the IDE161 program moving forward will be on enrollment with combination with IDE849.
•
Preclinical data on immune checkpoint inhibitor (ICI)-driven anti-tumor immunity was presented at AACR (Free AACR Whitepaper) 2025
•
Targeting to present preclinical combination mechanism and synergy efficacy data of IDE161 with TOP1-payload based ADCs at a medical conference in the third quarter of 2025
IDE705 (GSK101): a potential first-in-class Phase 1 Pol Theta Helicase Inhibitor in combination with PARP inhibitor for the treatment of HRD solid tumors.

•
Targeting Phase 2 expansion in HRD solid tumors, which would trigger a potential $10 million milestone payment from GSK.
IDE892: a potential best-in-class MTA-cooperative PRMT5 inhibitor to enable wholly-owned combination with IDE397.

•
IND filing targeted for mid-year 2025.
•
Preclinical data providing insights into metabolite kinetics and PRMT5 dysregulation in MTAP-deficient cancers was presented at AACR (Free AACR Whitepaper) 2025.
IDE034: a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC with combination potential with IDE161.

•
IND filing targeted for the second half of 2025.
IDE574: a potential first-in-class KAT6/7 dual inhibitor development candidate with combination opportunities with multiple programs in the Company’s pipeline.

•
IND filing targeted for the second half of 2025.
•
Preclinical data on dual inhibition’s impact on epigenetics and adaptive drug resistance was presented at AACR (Free AACR Whitepaper) 2025.
Corporate Development and Operations

•
Formed a research collaboration with ATTMOS to develop a physics-based computational platform for small molecule discovery, aimed at swiftly unlocking oncology targets traditionally considered undruggable. The collaboration will integrate IDEAYA’s differentiated and proven capabilities in structural biology and pharmaceutical drug discovery across multiple first-in-class oncology targets with ATTMOS’s capabilities in computational chemistry method development, high performance computing, and software development.

•
Joshua Bleharski, Ph.D., joined IDEAYA as Chief Financial Officer. Dr. Bleharski joins from J.P. Morgan, serving most recently as Managing Director and Global Co-Head of Biopharma in the Healthcare Investment Banking group. Josh spent nearly 17 years at J.P. Morgan advising clients in the biopharma sector on capital markets transactions, corporate strategy and other investment banking services representing more than $65 billion of value for biotechnology companies worldwide.
•
Shanthakumar Tyavanagimatt, Ph.D., joined IDEAYA as Senior Vice President, Technical Operations, where he will lead IDEAYA’s darovasertib global commercial supply chain readiness activities, as well as the technical operations activities across IDEAYA’s preclinical and clinical-stage pipeline. Prior to IDEAYA, Shanthakumar brings over 20-years of technical operations experience to IDEAYA, including approximately 9-years at CTI Biopharma (acquired by SOBI, Inc.) where he led the technical operations function for multiple commercial product launches.
•
Updated cash runway guidance into 2029 based on current operating plan.
Financial Results

As of March 31, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.05 billion. This compared to cash, cash equivalents and marketable securities of approximately $1.08 billion as of December 31, 2024 The decrease in the balance as of March 31, 2025 was primarily driven by net cash used in operations which was offset by $25.0 million in net proceeds from the sale of common stock shares through at-the-market financings during the quarter.

IDEAYA projects that the $1.05 billion in cash, cash equivalent and marketable securities balance as of March 31, 2025 will be sufficient to fund its planned operations into 2029 based on its current operating plan. We have updated our operating plan costs with further pipeline prioritization, including focusing: 1) the IDE161 clinical program on the combination study with DLL3 TOP1 ADC IDE849, 2) the IDE397 and PRMT5 mechanism clinical combination activities to wholly-owned PRMT5 inhibitor IDE892 (PRMT5MTA), and 3) the clinical dose escalation and expansion data for the IDE397 and Trodelvy combination in MTAP-deletion UC, to be utilized for the MTAP-deletion NSCLC indication clinical expansion activities.

There was no collaboration revenue for the three months ended March 31, 2025, compared to $7.0 million in collaboration for the three months ended December 31, 2024. Collaboration revenue for the three months ended December 31, 2024 was related to a milestone payment from GSK that was earned for the IND clearance of IDE275 (GSK959) in October 2024.

Research and development (R&D) expenses for the three months ended March 31, 2025, totaled $70.9 million compared to $140.2 million for the three months ended December 31,2024. The decrease was primarily due to a one-time $75.0 million upfront payment under the license agreement for IDE849 with Hengrui Pharma that occurred in December 2024, offset by higher clinical trial, consulting and personnel-related expenses to support our pipeline.

General and administrative (G&A) expenses for the three months ended March 31, 2025 totaled $13.5 million compared to $11.0 million for the three months ended December 31, 2024. The increase was primarily due to higher personnel-related, consulting and legal patent expenses to support our growth.

The net loss for the three months ended March 31, 2025, was $72.2 million compared to the net loss of $130.3 million for the three months ended December 31, 2024. Total stock compensation expense for the three months ended March 31, 2025, was $10.2 million compared to $9.5 million for the three months ended December 31, 2024.

On May 6, 2025 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three months ended March 31, 2025, and highlighted recent corporate updates (Press release, Heron Therapeutics, MAY 6, 2025, View Source [SID1234652576]).

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"We are off to a strong start in 2025, achieving record adjusted EBITDA for the first quarter. Building on our efforts to strengthen our financial foundation, we are well positioned for future growth, with strong tailwinds for our lead product, ZYNRELEF. These include the expanded label indications, the approval of the NOPAIN Act, the launch of the VAN, and the partnership with Crosslink Network, LLC," said Craig Collard, Chief Executive Officer.

Financial Guidance for 2025

Item

2025 Full-Year Guidance for Net Revenue and Adjusted EBITDA
(in millions)

Original

Q1 Updated Guidance

Net Revenue

$153.0 to $163.0

Adjusted EBITDA

$0.0 to $8.0

$4.0 to $12.0

Business Highlights

Net Revenue growth of 12.2% Q1 2025 over Q1 2024, primarily driven by the acute care franchise which increased revenue by 89.4%; ZYNRELEF grew 60.4%.
Settlement reached with Mylan Pharmaceuticals, Inc. ("Mylan"), wherein the Company has granted Mylan a license to market generic versions of CINVANTI and APONVIE in the United States beginning June 1, 2032, or earlier under certain customary circumstances.
Non-Opioid Policy for Pain Relief took effect April 1, providing separate payment for non-opioids like ZYNRELEF by the Centers for Medicare & Medicaid Services with significant awareness among health care providers being recognized.
Successful launch of the VAN for ZYNRELEF continues to progress, offering a more efficient aseptic preparation, streamlining operations within the surgical setting.
Cash, cash equivalents, and short-term investments were $50.7 million as of March 31, 2025.
ZYNRELEF device transition for product preparation for use from the Vented Vial Spike ("VVS") to the Vial Access Needle ("VAN") proceeds smoothly with an orderly and efficient draw down of the VVS inventory.
ZYNRELEF development of the ready to use Prefilled Syringe ("PFS") continues with a projected early 2027 launch.
Net Revenue Performance – Quarter Ended March 31

2025

2024

Dollar Change

Percentage Change

Acute Care

$10,302

$5,438

$4,864

89.4 %

APONVIE

$2,260

$425

$1,835

431.8 %

ZYNRELEF

$8,042

$5,013

$3,029

60.4 %

Oncology

$28,601

$29,232

($631)

(2.2 %)

CINVANTI

$25,742

$25,617

$125

0.5 %

SUSTOL

$2,859

$3,615

($756)

(20.9 %)

Total Net Revenue

$38,903

$34,670

$4,233

12.2 %

Conference Call and Webcast

Heron will host a conference call and live webcast on Tuesday, May 6, 2025, at 8:00 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for sixty days following the call.

On May 6, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the first quarter ended March 31, 2025, provided an update on its recent corporate activities and raised its 2025 financial guidance (Press release, Halozyme, MAY 6, 2025, View Source [SID1234652575]).

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"2025 is off to a strong start with our current three blockbuster brands, Darzalex SC, Phesgo and VYVGART Hytrulo, continuing to demonstrate strong growth in their currently approved indications. Our four recently launched products, Ocrevus Zunovo in U.S. and Europe, Tecentriq Hybreza in U.S. and Europe, Opdivo Qvantig in U.S. and Rybrevant SC in Europe are just beginning their contributions as our partners focus on gaining and expanding coverage and reimbursement. This broadened portfolio is resulting in an unprecedented set of 11 additional growth catalysts that have happened recently or are expected to happen in the coming months. These opportunities include multiple new European and U.S. product approvals, multiple new indication approvals and multiple key reimbursement milestones supporting access for an even greater number of patients, all creating new near and longer-term growth opportunity. As a result of this momentum, I am pleased to announce we are increasing our full year 2025 financial guidance ranges and a new $250 million share buyback," said Dr. Helen Torley, president and chief executive officer, of Halozyme.

"In addition, our long-term growth prospects have never been better with additional growth opportunities projected to result from our pipeline, where two products, BMS’ nivolumab plus relatlimab SC and Takeda’s 20% immune globulin SC, continue in Phase 3 and where ViiV and Acumen announced development progress and data in the quarter. I am also pleased to announce that we have signed our first HVAI development agreement with a current ENHANZE partner and that a different ENHANZE partner is now moving our SVAI into clinical testing," concluded Dr. Torley.

First Quarter and Recent Corporate Highlights:
•On May 6, Halozyme announced a second $250 million share repurchase under the $750 million approved program from February 2024.
•In April 2025, Halozyme filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. ("Merck") in the U.S. District Court in New Jersey alleging that Merck is using Halozyme’s patented MDASE subcutaneous drug delivery technology to develop Subcutaneous ("SC") Keytruda. Halozyme is seeking damages and injunctive relief to stop Merck’s infringement of Halozyme’s MDASE intellectual property.
•In March 2025, Halozyme completed the first $250 million Accelerated Share Repurchase of its common stock under the $750 million approved program from February 2024.

First Quarter and Recent Partner Highlights:
•In April 2025, Roche received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use ("CHMP") recommending an update to the European Union ("EU") label for Phesgo for human epidermal growth factor receptor 2 ("HER2")-positive breast cancer. Administration of Phesgo outside of a clinical setting (such as in a person’s home) by a healthcare professional will be possible, once safely established in a clinical setting.
•In April 2025, argenx received a positive opinion from the CHMP recommending European Commission approval of VYVGART 1000mg (efgartigimod alfa) developed with ENHANZE for SC injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy ("CIDP") after prior treatment with corticosteroids or immunoglobulins.
•In April 2025, argenx received U.S. Food and Drug Administration ("FDA") approval of VYVGART Hytrulo prefilled syringe for self-injection for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adult patients with CIDP.
•In April 2025, Janssen received European Commission marketing authorization of the SC formulation of RYBREVANT (amivantamab) with ENHANZE, in combination with LAZCLUZE (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer ("NSCLC") with epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 L858R substitution mutations. Additionally, RYBREVANT (amivantamab) is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy. This represents the 10th partner product with ENHANZE to be commercialized.
•In April 2025, Janssen received European Commission approval for an indication extension of DARZALEX SC in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma regardless of transplant eligibility.
•In March 2025, Bristol Myers Squibb received a positive CHMP opinion recommending approval of Opdivo (nivolumab) with ENHANZE across multiple solid tumor indications.
•In March 2025, Acumen announced top-line results from a Phase 1 study of sabirnetug (ACU193) with ENHANZE comparing the pharmacokinetics between SC and intravenous administrations in healthy volunteers that demonstrated weekly SC administration of sabirnetug was well-tolerated with systematic exposure supporting further clinical development.
•In March 2025, ViiV announced results from a Phase 2b study demonstrated N6LS administered every four months SC with ENHANZE in combination with cabotegravir successfully maintained viral suppression in adults living with HIV who were already stable on treatment.

•In March 2025, Takeda announced Health Canada expanded the marketing authorization for HYQVIA to include CIDP as a maintenance therapy after stabilization with intravenous immunoglobulin to prevent relapse of neuromuscular disability and impairment in adults.

First Quarter 2025 Financial Highlights:
•Revenue was $264.9 million, compared to $195.9 million in the first quarter of 2024. The 35% year-over-year increase was primarily driven by royalty revenue growth and an increase in sales of bulk rHuPH20. Revenue for the quarter included $168.2 million in royalties, an increase of 39% compared to $120.6 million in the first quarter of 2024, primarily attributable to increases in revenue of VYVGART Hytrulo, DARZALEX SC, and Phesgo.
•Cost of sales was $48.4 million, compared to $28.3 million in the first quarter of 2024. The increase in cost of sales was primarily due to an increase in product sales.
•Amortization of intangibles expense remained flat at $17.8 million, compared to the first quarter of 2024.
•Research and development expense was $14.8 million, compared to $19.1 million in the first quarter of 2024. The decrease in research and development expense was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives, and timing of planned investments in ENHANZE related to the development of our new high-yield rHuPH20 manufacturing process.
•Selling, general and administrative expense was $42.4 million, compared to $35.1 million in the first quarter of 2024. The increase was primarily due to an increase in consulting and professional service fees and compensation expense.
•Operating income was $141.5 million, compared to $95.5 million in the first quarter of 2024.
•Net income was $118.1 million, compared to $76.8 million in the first quarter of 2024.
•EBITDA and Adjusted EBITDA were $162.0 million, compared to $115.7 million in the first quarter of 2024.1
•GAAP diluted earnings per share was $0.93, compared to $0.60 in the first quarter of 2024. Non-GAAP diluted earnings per share was $1.11, compared to $0.79 in the first quarter of 2024.1
•Cash, cash equivalents and marketable securities were $747.9 million on March 31, 2025, compared to $596.1 million on December 31, 2024. The increase was primarily a result of cash generated from operations.

Financial Outlook for 2025
The Company is raising its financial guidance for 2025. Note that the guidance reflects tariffs that are currently implemented.
For the full year 2025, the Company expects:

•Total revenue of $1,200 million to $1,280 million, representing growth of 18% to 26% over 2024 total revenue, primarily driven by increases in royalty revenue. Revenue from royalties of $750 million to $785 million, representing growth of 31% to 37% over 2024.
•Adjusted EBITDA of $790 million to $840 million, representing growth of 25% to 33% over 2024.
•Non-GAAP diluted earnings per share of $5.30 to $5.70, representing growth of 25% to 35% over 2024. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

Table 1. 2025 Financial Guidance

Previous Guidance Range
New Guidance Range
Total Revenue
$1,150 to $1,225 million
$1,200 to $1,280 million
Royalty Revenue
$725 to $750 million
$750 to $785 million
Adjusted EBITDA
$755 to $805 million
$790 to $840 million
Non-GAAP Diluted EPS
$4.95 to $5.35
$5.30 to $5.70

1 Adjusted EBITDA and non-GAAP Diluted EPS are non-GAAP financial measures. See "Note Regarding Use of Non-GAAP Financial Measures" below for an explanation of these measures.

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the first quarter ended March 31, 2025 today, Tuesday, May 6, 2025, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: View Source The call will also be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com.