On February 24, 2025 CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, reported the publication of the GEMSTONE-303 study results for sugemalimab (brand name: Cejemly) in the prestigious Journal of the American Medical Association (JAMA) (Press release, CStone Pharmaceauticals, FEB 24, 2025, View Source [SID1234650487]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

GEMSTONE-303 is a Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of sugemalimab in combination with capecitabine and oxaliplatin (CAPOX) compared to placebo plus CAPOX as first-line treatment for patients with unresectable locally advanced or metastatic G/GEJ adenocarcinoma with PD-L1 CPS ≥5. The dual primary endpoints were OS and investigator-assessed PFS. Key secondary endpoints included PFS assessed by the Blinded Independent Central Review Committee (BICR), objective response rate (ORR), and duration of response (DoR).

The GEMSTONE-303 article published in JAMA highlights the following key efficacy and safety findings:

In patients with PD-L1 CPS ≥5, the sugemalimab group showed statistically significant and clinically meaningful improvements in both OS and PFS compared with the control group.
Median OS was 15.6 months in the sugemalimab group compared with 12.6 months in the control group, with a hazard ratio (HR) of 0.75 (95% CI, 0.61-0.92), P=0.006, indicating that sugemalimab plus CAPOX could reduce the risk of death by 25%.
Median PFS was 7.6 months in the sugemalimab group versus 6.1 months in the control group, with a HR of 0.66 (95% CI, 0.54-0.81), P<0.001.
Grade ≥3 treatment-related adverse events (TRAE) occurred in 53.9% of patients in the sugemalimab group and 50.6% in the control group, indicating that the safety of this combination regimen was manageable.
Subgroup analyses demonstrated consistent clinical benefits across all pre-defined subgroups, including patients with varying PD-L1 expression levels:

Sugemalimab plus CAPOX significantly prolonged OS in patients with PD-L1 CPS ≥10; median OS was 17.8 months in the sugemalimab group compared with 12.5 months in the control group, with a HR of 0.64 (95% CI, 0.48-0.85), P=0.002.
In patients with PD-L1 CPS ≥10, median PFS was 7.8 months in the sugemalimab group compared with 5.5 months in the control group, with a HR of 0.58 (95% CI, 0.43-0.77), P<0.001.
In patients with PD-L1 CPS ≥10, ORR was 71.4% in the sugemalimab group compared with 48.6% in the control group.
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated: "We are honored to see the GEMSTONE-303 study results published in JAMA. This study establishes sugemalimab in combination with chemotherapy as the new standard first-line treatment for patients with PD-L1 CPS ≥5 G/GEJ adenocarcinoma. To date, sugemalimab has been approved for five indications in China. Internationally, we have expanded its regulatory pathways and forged commercialization partnerships in various global markets. The compelling clinical data from GEMSTONE-303 reinforce our confidence in advancing the global registration and commercialization of sugemalimab. We are committed to unlocking its full clinical potential and providing greater survival benefits to patients worldwide."

Professor Lin Shen, Peking University Cancer Hospital, the leading principal investigator of the GEMSTONE-303 study, said: "Before the availability of PD-1 monoclonal antibodies, chemotherapy was the standard first-line treatment for unresectable, locally advanced or metastatic G/GEJ adenocarcinoma, with median OS rarely exceeding one year. The combination of anti-PD-1 antibodies and chemotherapy has significantly extended survival for these patients. The GEMSTONE-303 study builds on this progress. As the first anti-PD-L1 antibody approved for this patient population, sugemalimab specifically targeted the PD-L1-expressing population in its pivotal study, achieving significant efficacy with a manageable safety profile. The acceptance and publication of these results in JAMA affirm the innovation of GEMSTONE-303 and the valuable contributions of all researchers and participants involved."

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:

In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5.
The European Commission (EC) has approved sugemalimab (brand name: Cejemly) in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.

The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has approved the marketing authorization application for sugemalimab in combination with platinum-based chemotherapy for first-line treatment of metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.

On February 24, 2025 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported its financial results and provides an update on operational progress for the fourth quarter and year-ended December 31, 2024 (Press release, Summit Therapeutics, FEB 24, 2025, View Source [SID1234650486]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Operational & Corporate Updates

Operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:

In January 2023, we closed our Collaboration and License Agreement with Akeso Inc. (Akeso, HKEX Code: 9926.HK) for ivonescimab (SMT112), with which over 2,300 patients have been treated in clinical studies globally. Summit has rights to develop and commercialize ivonescimab in the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa while Akeso retains development and commercialization rights for the rest of the world, including China.
Since in-licensing ivonescimab, we have begun our development for ivonescimab in non-small cell lung cancer ("NSCLC"), specifically launching Phase III clinical trials in the following proposed indications:
HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI)
HARMONi-3: Ivonescimab combined with chemotherapy in first-line metastatic NSCLC patients
In addition, we have begun to activate clinical trial sites in the United States for a Phase III clinical study in the following proposed indication:
HARMONi-7: Ivonescimab monotherapy in first-line metastatic NSCLC patients with high PD-L1 expression
In October 2024, we completed enrollment in our HARMONi clinical trial. We expect to disclose topline results from HARMONi in mid-2025, depending upon maturation of the data per the protocol.
The U.S. Food and Drug Administration ("FDA") has granted Fast Track designation for the proposed use of ivonescimab in combination with platinum-based chemotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR mutation, who have experienced disease progression following EGFR-TKI therapy.
In the fourth quarter of 2024, we amended the HARMONi-3 protocol to, amongst other changes, include patients with both squamous and non-squamous histologies, significantly increasing the population of patients eligible for treatment in the proposed indication. Enrollment has begun in all regions for patients with squamous tumors; the protocol amendment is effective and enrollment has begun in United States for patients with non-squamous tumors.
Recently, we announced a clinical trial collaboration with Pfizer in which Pfizer will contribute multiple antibody drug conjugates (ADCs) to be evaluated in combination with ivonescimab in unique solid tumor settings. The goal of the collaboration is to accelerate the advancement of potentially landscape-changing therapeutic combinations, which seek to improve the standards of care for patients facing serious unmet needs.
Under the terms of the agreement, Summit will provide ivonescimab for use in the proposed studies, and Pfizer will be responsible for conducting the operations of the studies, including associated costs. The studies will be overseen by both Summit and Pfizer. Both parties retain their respective rights to their products. The studies combining ivonescimab with Pfizer’s vedotin ADCs are planned to begin in the middle of this year. Further details on the clinical trials will be announced at a later date.
We intend to explore further clinical development of ivonescimab in solid tumor settings outside of metastatic non-small cell lung cancer, Additionally, institutions with whom we have collaborated have begun opening investigator-sponsored trials across multiple oncology settings. We plan to review the data generated from these clinical trials as a part of our consideration for advancing our clinical development for ivonescimab beyond non-small cell lung cancer.
Financial Highlights

Cash and Cash Equivalents & Short-term Investments

Aggregate cash and cash equivalents and short-term investments were $412.3 million and $186.2 million at December 31, 2024 and December 31, 2023, respectively.
GAAP and Non-GAAP Research and Development (R&D) Expenses

GAAP R&D expenses according to generally accepted accounting principles in the U.S. ("GAAP") were $150.8 million for the full year of 2024, compared to $59.4 million for the full year of 2023.
Non-GAAP R&D expenses were $134.8 million for the full year of 2024, compared to $55.0 million for the full year of 2023.
GAAP and Non-GAAP General and Administrative (G&A) Expenses

GAAP G&A expenses were $60.5 million for the full year of 2024, compared to $30.3 million for the full year of 2023.
Non-GAAP G&A expenses were $25.5 million for the full year of 2024, compared to $20.6 million for the full year of 2023.
GAAP and Non-GAAP Operating Expenses

GAAP operating expenses were $226.3 million for the full year of 2024, compared to $610.6 million for the full year of 2023.
Non-GAAP operating expenses were $175.3 million for the full year of 2024, compared to $596.5 million for the full year of 2023. The decrease is primarily related to the decrease in acquired in-process R&D expenses of $505.9 million, offset by the increase in R&D expenses due to expansion of clinical studies and development costs related to ivonescimab and increases in people costs as we continue to build out our team.
GAAP and Non-GAAP Net Loss

GAAP net loss in the full year of 2024 and 2023 was $221.3 million or $(0.31) per basic and diluted share, and $614.9 million or $(0.99) per basic and diluted share, respectively.
Non-GAAP net loss in the full year of 2024 and 2023 was $170.3 million or $(0.24) per basic and diluted share, and $600.8 million or $(0.97) per basic and diluted share, respectively.
Use of Non-GAAP Financial Measures

This release includes measures that are not in accordance with U.S. generally accepted accounting principles ("Non-GAAP measures"). These Non-GAAP measures should be viewed in addition to, and not as a substitute for, Summit’s reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. For further information regarding these Non-GAAP measures, please refer to the tables presenting reconciliations of our Non-GAAP results to our U.S. GAAP results and the "Notes on our Non-GAAP Financial Information" that accompany this press release.

Fourth Quarter 2024 Earnings Call

Summit will host an earnings call this morning, Monday, February 24, 2025, at 9:00 am ET. The conference call will be accessible by dialing (800) 715-9871 (toll-free domestic) or (646) 307-1963 (international) using conference code 3934052. A live webcast and instructions for joining the call are accessible through Summit’s website www.smmttx.com. An archived edition of the webcast will be available on our website after the call.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et al, SITC (Free SITC Whitepaper), 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 2,300 patients have been treated with ivonescimab in clinical studies globally.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3, and the Company has begun to activate clinical trial sites in the United States for HARMONi-7.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in HARMONi was completed in the second-half of 2024, and top-line results are expected to be announced in the middle of this year.

HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

In addition, Akeso has recently had positive read-outs in two single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC, HARMONi-A and HARMONi-2.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

On February 24, 2025 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the "Company," "we" or "BridgeBio") reported that it intends to offer, subject to market conditions and other factors, $500 million aggregate principal amount of convertible senior notes due 2031 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, BridgeBio, FEB 24, 2025, View Source [SID1234650485]). In connection with the offering, the Company expects to grant the initial purchasers an option to purchase up to an additional $75 million aggregate principal amount of notes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company intends to use a portion of the net proceeds from the offering to repay all outstanding borrowings under and terminate its Financing Agreement, dated as of January 17, 2024, with the lenders party thereto and Blue Owl Corporation, as administrative agent, as amended (the "Financing Agreement"), and pay any fees related thereto. The termination of the Financing Agreement, which accounted for approximately $51.5 million of cash paid for interest in 2024 and contains various restrictive covenants, will provide the Company with reduced pro forma interest expense and greater operational flexibility. The Company intends to use up to $50 million of any remaining net proceeds from the offering to repurchase shares of its common stock from certain purchasers of the notes in privately negotiated transactions effected through one or more of the initial purchasers or an affiliate thereof concurrently with the pricing of the notes (such transactions, the "share repurchases"), together, if necessary, with cash on hand. The Company expects to use any remaining net proceeds from the offering for general corporate purposes.

The Company expects the purchase price per share of its common stock in the share repurchases to equal the last reported sale price per share of its common stock on the Nasdaq Global Select Market as of the date of the pricing of the notes. The share repurchases could increase (or reduce the size of any decrease in) the market price of the Company’s common stock prior to, concurrently with or shortly after the pricing of the notes, and could result in a higher effective conversion price for the notes. The Company cannot predict the magnitude of such market activity or the overall effect it will have on the market price of the notes and/or the market price of the Company’s common stock.

The final terms of the notes, including the initial conversion rate, interest rate and certain other terms, will be determined at the time of pricing. The notes will bear interest semi-annually and will mature on March 1, 2031, unless earlier converted, redeemed or repurchased. Prior to December 2, 2030, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. Thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be convertible at the option of the holders, subject to certain conditions and during certain periods, into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, with the form of consideration determined at the Company’s election.

The Company may not redeem the notes prior to March 6, 2028. On or after March 6, 2028 and on or before the 41st scheduled trading day immediately before the maturity date of the notes, the Company may redeem for cash all or any portion of the notes, at its option at any time, and from time to time, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for a specified period of time and certain other conditions are satisfied. The redemption price will be equal to 100% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. Holders of the notes will have the right to require the Company to repurchase all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of certain events.

When issued, the notes will be the Company’s senior unsecured obligations and will rank senior in right of payment to any of the Company’s unsecured indebtedness that is expressly subordinated in right of payment to the notes; equal in right of payment to any of the Company’s unsecured indebtedness that is not so subordinated; effectively junior in right of payment to any of the Company’s secured indebtedness and obligations, to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries.

The notes and the shares of common stock issuable upon conversion of the notes, if any, are not being registered under the Securities Act, or the securities laws of any other jurisdiction. The notes and the shares of common stock issuable upon conversion of the notes, if any, may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On February 24, 2025 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported that Tim Van Hauwermeiren, Chief Executive Officer, will present at the TD Cowen 45th Annual Healthcare Conference on Monday, March 3, 2025 at 11:50 a.m. ET (Press release, argenx, FEB 24, 2025, View Source [SID1234650484]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately 30 days following the presentation.

On February 24, 2025 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Veracyte, FEB 24, 2025, View Source [SID1234650483]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I’m incredibly proud of what our team accomplished in 2024," said Marc Stapley, Veracyte’s chief executive officer. "We ended the year with exceptional performance, delivering record revenue in Q4 and achieving our 10th consecutive quarter of 20% or greater testing revenue growth. Looking ahead to 2025, we see significant opportunities for Decipher and Afirma to impact more patients and drive growth for Veracyte. We are focused on moving forward with our exciting portfolio of strategic growth drivers while maintaining the financial discipline that has been core to our success."

Key Fourth Quarter 2024 Financial Highlights

For the three-month period ended December 31, 2024, as compared to the same period in 2023:

Increased total revenue by 21% to $118.6 million and testing revenue by 24% to $112.2 million.
Increased total volume by 22% to 41,271 tests and testing volume by 25% to 39,107 tests.
Grew Decipher revenue by 44% and Afirma revenue by 4%.
Grew Decipher volume by 45% to more than 22,400 tests and Afirma volume by 8% to more than 16,300 tests.
Increased net income to $5.1 million, or 4.3% of revenue, and delivered adjusted EBITDA of $26.1 million, or 22.0% of revenue.
Generated $24.5 million of cash from operations.
Key Full Year 2024 Financial Highlights

For the twelve-month period ended December 31, 2024, as compared to the same period in 2023:

Increased total revenue by 23% to $445.8 million and testing revenue by 28% to $419.0 million.
Increased total volume by 20% to 152,750 tests and testing volume by 23% to 142,925 tests.
Grew Decipher revenue by 43% and Afirma revenue by 14%.
Grew Decipher volume by 36% to more than 80,000 tests and Afirma volume by 12% to more than 60,000 tests.
Increased net income to $24.1 million, or 5.4% of revenue, and delivered adjusted EBITDA of $91.9 million, or 20.6% of revenue.
Generated $75.1 million of cash from operations to end the year with $289.4 million of cash, cash equivalents and short-term investments.
Key Business Highlights

Through Level I evidence for the 22-Gene Genomic Classifier (GC) (Decipher), secured its position as the only gene expression test included in V1.2025 of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer published in December 2024.1
Received approval from Molecular Diagnostic Services Program (MolDx) for the technical assessment submission for Decipher for use in the metastatic population.
Announced 17 Decipher-focused abstracts to be presented at the 2025 ASCO (Free ASCO Whitepaper) GU Symposium demonstrating the power of the Veracyte diagnostics platform and Veracyte’s commitment to continued leadership in supporting clinical research around urologic cancers.
Published our 2024 Environmental, Social and Governance Report.
1

NCCN = National Comprehensive Cancer Network (NCCN). Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer v.1.2025. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed February 12, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Fourth Quarter 2024 Financial Results

Total revenue for the fourth quarter of 2024 was $118.6 million, an increase of 21% compared to $98.2 million reported in the fourth quarter of 2023. Testing revenue was $112.2 million, an increase of 24% compared to $90.4 million in the fourth quarter of 2023, driven by the strong performance of our Decipher and Afirma tests. Product revenue was $3.0 million, a decrease of 18% compared to $3.7 million in the fourth quarter of 2023. Biopharmaceutical and other revenue was $3.5 million, a decrease of 17% compared to $4.1 million in the fourth quarter of 2023.

Total gross margin for the fourth quarter of 2024 was 66.4%, compared to 66.0% in the fourth quarter of 2023. Non-GAAP gross margin was 69.3%, compared to 70.6% in the fourth quarter of 2023.

Operating expenses were $74.6 million for the fourth quarter of 2024. Non-GAAP operating expenses were $57.9 million, flat compared to $57.9 million in the fourth quarter of 2023.

Net income for the fourth quarter of 2024 was $5.1 million, an improvement of 118% compared to the fourth quarter of 2023, representing 4.3% of revenue compared to (28.8%) in the same period in 2023. Diluted net earnings per common share was $0.06, an improvement of $0.45 compared to the fourth quarter of 2023. Non-GAAP diluted net earnings per common share was $0.36, an improvement of $0.15 compared to the fourth quarter of 2023. Net cash provided by operating activities in the fourth quarter of 2024 was $24.5 million, an improvement of $9.0 million compared to the same period in 2023.

Adjusted EBITDA for the fourth quarter of 2024 was $26.1 million, an improvement of 76% compared to the fourth quarter of 2023, representing 22.0% of revenue compared to 15.1% of revenue in the same period of 2023.

Full Year 2024 Financial Results

Total revenue for 2024 was $445.8 million, an increase of 23% compared to $361.1 million in 2023. Testing revenue was $419.0 million, an increase of 28% compared to $326.5 million in 2023, driven by the strong performance of our Decipher and Afirma tests. Product revenue was $13.7 million, a decrease of 12% compared to $15.6 million in 2023. Biopharmaceutical and other revenue was $13.2 million, a decrease of 30% compared to $18.9 million in 2023.

Total gross margin for the full year 2024 was 66.9%, compared to 63.6% in 2023. Non-GAAP gross margin was 70.0%, compared to 69.3% in 2023.

Operating expenses were $282.0 million for the full year 2024. Non-GAAP operating expenses grew 7% to $227.6 million compared to $212.5 million in 2023.

Net income for the full year 2024 was $24.1 million, an improvement of 132% compared to 2023, representing 5.4% of revenue compared to (20.6%) in 2023. Diluted net earnings per common share was $0.31, an improvement of $1.33 compared to 2023. Non-GAAP diluted net earnings per common share was $1.19, an improvement of $0.61 compared to 2023. Net cash provided by operating activities in 2024 was $75.1 million, an improvement of $30.9 million compared to 2023.

Adjusted EBITDA for the full year 2024 was $91.9 million, an improvement of 102% compared to 2023, representing 20.6% of revenue compared to 12.6% of revenue in 2023.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

Update on Marseille Operations

Veracyte is evaluating its ownership and operations of the company’s French subsidiary, Veracyte SAS, whose business is located in Marseille, France and includes Veracyte’s immune-oncology biopharma business, contract development and manufacturing, and support for Veracyte’s IVD development and manufacturing. Veracyte recently notified Veracyte SAS that, as sole shareholder of Veracyte SAS, it is considering no longer funding the French entity. Accordingly, Veracyte SAS will engage with its works council, as is required by French law, over the next few months.

Seeking external buyer(s) for a potential divestiture of all or part of the French entity’s activities is an option that is actively being explored. Without Veracyte Inc.’s continued funding or identification of a buyer for all or part of the Veracyte SAS assets, Veracyte SAS may be required to begin bankruptcy proceedings following its works council consultation period.

Management will provide further details on this process and its potential impact on Veracyte’s 2025 financial outlook during the conference call this afternoon.

2025 Financial Outlook

The company expects 2025 testing revenue to be in the range of $470 million to $480 million, or 12% to 15% year-over-year growth. Adjusting for the impact of the paused Envisia test, the guidance implies testing revenue growth of 14% to 16%. Given the number of variables impacting its Marseille, France operations, the company is not providing total company revenue guidance at this time and expects to provide its total revenue outlook for 2025 once there is more clarity on the timing and impact of the process underway.

The company also expects adjusted EBITDA as a percentage of revenue in 2025 to be approximately 21.6% compared to 20.6% in 2024.

The company is unable to provide a quantitative reconciliation of expected adjusted EBITDA as a percentage of revenue to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, that are dependent on various factors, are out of the company’s control, or that cannot be reasonably predicted. Such adjustments include, but are not limited to, acquisition related expenses, and other adjustments. Any associated estimate of these items and their impact on GAAP performance for the guidance period could vary materially. For more information on the non-GAAP financial measures, please refer to the section titled "Note Regarding Use of Non-GAAP Financial Measures" at the end of this press release.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source