On November 6, 2024 Genmab reported Interim results for the First Nine Months Ended September 30, 2024 (Press release, Genmab, NOV 6, 2024, View Source [SID1234647812]).

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Highlights

● European Commission (EC) granted conditional marketing authorization for TEPKINLY (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
● Genmab announced that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab
● Genmab revenue increased 29% compared to the first nine months of 2023, to DKK 15,085 million
● Genmab 2024 financial guidance updated

"The third quarter of 2024 presented Genmab with additional opportunities to progress towards our goal of fundamentally transforming the lives of people with cancer and other serious diseases. The additional approval for TEPKINLY, along with positive data presentations for our promising late-stage assets acasunlimab and rinatabart sesutecan (Rina-S), underscore the potential of our pipeline and our commitment to the development of innovative antibody-based therapeutics," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months of 2024

● Revenue was DKK 15,085 million for the first nine months of 2024 compared to DKK 11,715 million for the first nine months of 2023. The increase of DKK 3,370 million, or 29%, was primarily driven by higher DARZALEX (daratumumab) and Kesimpta (ofatumumab) royalties achieved under our collaborations with Janssen Biotech, Inc. (Janssen) and Novartis Pharma AG (Novartis), respectively, and increased EPKINLY (epcoritamab) net product sales.
● Royalty revenue was DKK 12,367 million in the first nine months of 2024 compared to DKK 9,722 million in the first nine months of 2023, an increase of DKK 2,645 million, or 27%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
● Net sales of DARZALEX, including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), by Janssen were USD 8,586 million in the first nine months of 2024 compared to USD 7,194 million in the first nine months of 2023, an increase of USD 1,392 million or 19%.
● Total costs and operating expenses were DKK 10,542 million in the first nine months of 2024 compared to DKK 8,145 million in the first nine months of 2023. The increase of DKK 2,397 million, or 29%, was driven by the expansion of our product pipeline, including the addition of ProfoundBio related research and development expenses, primarily Rina-S, the continued development of Genmab’s broader organizational capabilities and related increase in team members to support these activities, as well as profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales.
● Operating profit was DKK 4,543 million in the first nine months of 2024 compared to DKK 3,570 million in the first nine months of 2023.
● Net financial items resulted in income of DKK 1,019 million for the first nine months of 2024 compared to DKK 1,060 million in the first nine months of 2023.

Genmab Announces Financial Results for the First Nine Months of 2024

Outlook

Genmab is updating the lower end of its revenue range of 2024 financial guidance driven by higher total royalty revenues from DARZALEX. Genmab is also lowering the upper end of its operating expense range to reflect a continued focused and disciplined approach to investments and portfolio prioritization.

(DKK million)

Revised Guidance

Previous Guidance

Revenue

21,100 – 21,700

20,500 – 21,700

Royalties

17,000 – 17,400

16,600 – 17,400

Net product sales/Collaboration revenue*

2,000 – 2,200

2,000 – 2,200

Milestones/Reimbursement revenue

2,100 – 2,100

1,900 – 2,100

Gross profit**

20,200 – 20,800

19,600 – 20,800

Operating expenses**

(13,700) – (14,000)

(13,700) – (14,300)

Including Acquisition & Integration Related Charges

(14,100) – (14,400)

(14,100) – (14,700)

Operating profit

6,200 – 7,100

5,300 – 7,100

Including Acquisition & Integration Related Charges

5,800 – 6,700

4,900 – 6,700

*Net Product Sales and Collaboration Revenue consists of EPKINLY Net Product Sales in the U.S. and Japan and Tivdak (Genmab’s share of net profits) in the U.S.

**Operating Expenses Range excludes Cost of Product Sales Range, which is included in Gross Profit Range

Conference Call

Genmab will hold a conference call to discuss the results for the first nine of 2024 today, November 6, 2024, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register.vevent.com/register/BI6db06ed786914762a9dc001f798b7c1b. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations.

On November 6, 2024 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported third quarter 2024 financial results and recent corporate highlights (Press release, Relay Therapeutics, NOV 6, 2024, View Source [SID1234647828]).

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"In the third quarter, we reported very encouraging interim data showing that RLY-2608 + fulvestrant led to clinically meaningful progression free survival in heavily pre-treated patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "Based on these data, we are preparing to initiate a pivotal trial in 2L breast cancer in 2025, which we expect to be able to fully fund through top-line readout with our existing cash on hand. We also continue to progress our pre-clinical programs and look forward to bringing new programs into the clinic in 2025."

Recent Corporate Highlights

RLY-2608 (ReDiscover study)

•
RLY-2608 doublet:
o
Reported interim data for RLY-2608 + fulvestrant in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer who had previously received at least one prior CDK4/6 inhibitor. The data demonstrated clinically meaningful progression free survival (PFS) at the company’s recommended Phase 2 dose (RP2D) of 600mg BID. The cut-off date for these data was August 12, 2024. Key highlights included:
▪
9.2-month median PFS across all mutations & 10.3 months among patients with kinase mutations
▪
33% objective response rate (ORR) across all patients & 53% ORR in patients with kinase mutations at the RP2D
▪
Favorable overall tolerability profile; at RP2D, only two patients discontinued treatment due to adverse events & only 1 patient experienced Grade 3 hyperglycemia

▪
RLY-2608 + fulvestrant data will be presented at the San Antonio Breast Cancer Symposium, taking place December 10-13, 2024. Details of the poster spotlight presentation are as follows:
•
Abstract Title: PS7-01: Efficacy of RLY-2608, a mutant-selective PI3Kα inhibitor in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trial
•
Abstract Number: SESS-2211
•
Session: Concurrent Poster Spotlight Session 7: Targeting the ER and PI3K pathway: Novel drugs and combinations
•
Date/Time: Wednesday, December 11, 8:00-9:30 a.m. ET (7:00-8:30 a.m. CT)
o
Data support planned initiation of Phase 3 pivotal trial for RLY-2608 + fulvestrant in 2025
•
RLY-2608 triplet: Continued to progress two potential front-line triplet regimens in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer who had previously received at least one prior CDK4/6 inhibitor, including:
o
CDK4/6: RLY-2608 + ribociclib + fulvestrant dose escalation is currently testing biologically active doses of RLY-2608 and is on track to identify a dose of RLY-2608 that is combinable with full-dose ribociclib. Expansion cohorts are expected to initiate in the first half of 2025
o
CDK4: RLY-2608 + atirmociclib + fulvestrant trial on track to initiate by the end of 2024
Lirafugratinib (RLY-4008)

•
Presented updated FGFR2 fusion tumor agnostic data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), October 23-25, 2024
•
Provided regulatory update regarding lirafugratinib regulatory path in which the FDA suggested that the company first file a new drug application (NDA) in cholangiocarcinoma, followed by a tumor agnostic supplemental NDA for FGFR2 fusions with data from more patients and more follow up
•
Disclosed plans to seek a global commercialization partner for lirafugratinib in order to maintain company’s focus on the remainder of the portfolio
Corporate Highlights

•
Raised $230 million of gross proceeds in an underwritten follow-on public offering in September 2024
•
Completed series of changes to streamline the research organization, collectively resulting in an expected $50 million in annual savings and workforce reduction of approximately 15%. Changes are part of the company’s shift to becoming more development-focused in preparation for the upcoming RLY-2608 pivotal trial as well as new programs entering the clinic over the course of 2025

Anticipated Upcoming Milestones

•
Breast Cancer
o
RLY-2608 + fulvestrant + ribociclib initial safety data in the fourth quarter of 2024
o
RLY-2608 + fulvestrant + atirmociclib clinical trial initiation by the end of 2024
o
RLY-2608 + fulvestrant + ribociclib dose expansion initiation in the first half of 2025
o
RLY-2608 + fulvestrant 2L Phase 3 trial initiation in 2025
•
Pre-clinical
o
Vascular malformations: RLY-2608 clinical trial initiation in the first quarter of 2025
o
Fabry disease: clinical start in the second half of 2025
o
NRAS: clinical start in the second half of 2025

Third Quarter 2024 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2024, cash, cash equivalents and investments totaled $839.6 million compared to $750.1 million as of December 31, 2023. The company expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2027.

Revenue: Revenue was $0 for the third quarter of 2024, as compared to $25.2 million for the third quarter of 2023. The decrease was primarily due to the recognition of previously received milestone payments under the company’s Collaboration and License Agreement with Genentech, Inc. during the third quarter of 2023.

R&D Expenses: Research and development expenses were $76.6 million for the third quarter of 2024, as compared to $81.5 million for the third quarter of 2023. The decrease was primarily due to the impact of prioritization of certain programs in the company’s pipeline, as previously disclosed in 2023 and earlier in 2024.

G&A Expenses: General and administrative expenses were $19.8 million for the third quarter of 2024, as compared to $18.5 million for the third quarter of 2023. The increase was primarily due to an increase in stock compensation expense, partially offset by decreases in other employee compensation costs and certain other general and administrative expenses.

Net Loss: Net loss was $88.1 million for the third quarter of 2024, or a net loss per share of $0.63, as compared to a net loss of $65.7 million for the third quarter of 2023, or a net loss per share of $0.54.

On November 6, 2024 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies (Press release, Caris Life Sciences, NOV 6, 2024, View Source [SID1234647857]). The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. MI Cancer Seek is available for adults and pediatric patients, ages 1-22.

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"FDA approval of MI Cancer Seek – the first of its kind – further demonstrates Caris’ continued leadership in molecular science and our extreme focus on quality," said Caris Chairman, Founder and CEO David Dean Halbert, DSc (h.c.). "We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools."

MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer.
MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table, in accordance with the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product.

"We are very excited to receive FDA approval for our MI Cancer Seek test. The extensive rigor with which the FDA evaluates new technology ensures patients have access to safe and effective tests," said Caris President David Spetzler, MS, PhD, MBA. "The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies."

MI Cancer Seek Companion Diagnostic Indications

Indication

Biomarker

Therapy

Breast Cancer

PIK3CA (C420R; E542K; E545A, E545D [1635G>T only],
E545G, E545K, Q546E, Q546R; and H1047L, H1047R,
H1047Y)

PIQRAY (alpelisib)

Colorectal Cancer
(CRC)

KRAS wild-type (absence of mutations in exons 2, 3, and
4) and NRAS wild type (absence of mutations in exons 2,
3, and 4)

VECTIBIX (panitumumab)

BRAF V600E

BRAFTOVI (encorafenib) in combination with ERBITUX
(cetuximab)

Melanoma

BRAF V600E

BRAF Inhibitors approved by FDA*

BRAF V600E or V600K

MEKINIST (trametinib) or BRAF/MEK Inhibitor
Combinations approved by FDA*

Non-Small Cell Lung
Cancer (NSCLC)

EGFR exon 19 deletions and exon 21 L858R alterations

EGFR Tyrosine Kinase Inhibitors approved by FDA*

Solid Tumors

MSI-H

KEYTRUDA (pembrolizumab), JEMPERLI (dostarlimab-gxly)

Endometrial
Carcinoma

Not MSI-H

KEYTRUDA (pembrolizumab) in combination with
LENVIMA (lenvatinib)

*For the most current information about the device indications for the therapeutic products in this group, go to: View Source

PIQRAY is a registered trademark of Novartis AG. VECTIBIX is a registered trademark of Immunex Corporation. BRAFTOVI is a registered trademark of Array BioPharma Inc. in the United States and various other countries. ERBITUX is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. MEKINIST is a registered trademark of Novartis AG Corporation Switzerland. KEYTRUDA is a registered trademark of Merck. LENVIMA (lenvatinib) is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

Typically, DNA and RNA analysis by NGS requires two separate testing processes, which may require more tissue and time. However, by combining WES and WTS into one workflow, MI Cancer Seek provides a comprehensive molecular blueprint that saves tissue without compromising results. For complete product details, including companion diagnostic information and performance characteristics, please visit www.CarisLifeSciences.com/MICancerSeek.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The agency is also responsible for the safety of the United States’ food supply, cosmetics, and radiation-emitting electronic products and for regulating tobacco products.

On November 6, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported third quarter 2024 financial results and recent portfolio and business updates (Press release, Alector, NOV 6, 2024, View Source [SID1234647797]). As of September 30, 2024, Alector’s cash, cash equivalents, and investments totaled $457.2 million.

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"We continue to make meaningful progress advancing our innovative pipeline of product candidates and remain on track to report data in 2024 from the INVOKE-2 Phase 2 trial of AL002, the most advanced TREM2 candidate in clinical development for early Alzheimer’s disease," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "We believe that increased TREM2 signaling via AL002 may recruit disease-fighting microglia to broadly counteract the progression of Alzheimer’s disease. INVOKE-2 is designed to provide meaningful insights into AL002’s potential benefits across a combination of clinical and functional endpoints, as well as imaging and fluid biomarkers. We also believe that the broad mechanism of AL002 may have the potential to deliver potent and durable therapeutic benefits, both as a standalone therapy and in combination with anti-amyloid beta antibodies."

Dr. Rosenthal continued, "For our progranulin franchise, we recently reported the patient baseline characteristics for our INFRONT-3 Phase 3 clinical trial of latozinemab in frontotemporal dementia with a progranulin gene mutation, suggesting a representative study population in this indication. We are approaching a top-line data readout for INFRONT-3 in late 2025/early 2026. Additionally, PROGRESS-AD, the Phase 2 trial of AL101/GSK4527226 in early Alzheimer’s disease, has reached more than one-third of its target enrollment. It is an exciting time at Alector, and we are well positioned to advance our proprietary pipeline of novel immuno-neurology drugs."

Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, "We are actively advancing our Alector Brain Carrier, ABC, a proprietary versatile blood-brain barrier technology, and we are strategically leveraging this platform across our portfolio. We believe our ABC technology may advance treatment of neurodegenerative diseases by potentially enabling improved delivery of our therapeutics to the brain."

Recent Clinical Updates

Immuno-Neurology Portfolio
TREM2 Program (AL002) Being Developed in Collaboration with AbbVie

The results of the INVOKE-2 Phase 2 clinical trial of AL002 are expected in 2024. INVOKE-2, a randomized, double-blind, placebo-controlled, dose-ranging study, is designed to assess the efficacy and safety of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). AL002 is a novel investigational humanized monoclonal antibody (mAb) that is designed to bind to TREM2 to increase TREM2 signaling and, thereby, is hypothesized to improve the functionality of microglia. It is the most advanced TREM2 agonist product candidate in clinical development worldwide.
98% of eligible participants who completed the planned treatment period of INVOKE-2 have elected to participate in the long-term extension (LTE) study.
In October 2024, Alector published a manuscript titled "Preclinical and first-in-human evaluation of AL002, a novel TREM2 agonistic antibody for Alzheimer’s disease" in Alzheimer’s Research & Therapy. The publication outlines preclinical and INVOKE-1 Phase 1 study results, demonstrating that AL002 engaged TREM2, and induced pharmacodynamic biomarker changes associated with microglial proliferation, survival, and phagocytic activity in a dose-dependent manner.
AbbVie has an exclusive option to globally develop and commercialize AL002. Alector will deliver a data package resulting from the INVOKE-2 study to AbbVie for their evaluation. AbbVie’s exercise of its option would prompt a $250 million payment to Alector.
Progranulin Programs (latozinemab (AL001) and AL101/GSK4527226) Being Developed in Collaboration with GSK

The pivotal, randomized, double-blind, placebo-controlled INFRONT-3 Phase 3 clinical trial of latozinemab targeting frontotemporal dementia with a progranulin gene mutation (FTD-GRN) is ongoing and on track, with enrollment completed in October 2023 and a treatment duration of 96 weeks. Latozinemab is a novel investigational human mAb that aims to increase progranulin (PGRN) levels by inhibiting sortilin and is the most advanced PGRN-elevating candidate in development for the treatment of FTD-GRN.
In September 2024, Alector presented a poster highlighting the patient baseline characteristics for INFRONT-3 at the 14th International Conference on Frontotemporal Dementias (ISFTD 2024). Notably, the baseline characteristics of symptomatic INFRONT-3 participants, including age, Clinical Dementia Rating scale plus National Alzheimer’s Disease Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR plus NACC FTLD-SB) score and neurofilament light chain (NfL) levels, were representative of the broader FTD-GRN registry population, based on available registry data. Additionally, Alector shared findings from the FTD Caregiver Survey and FTD Insights Survey, highlighting the challenges faced by caregivers of individuals living with FTD.
PROGRESS-AD, a global, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating AL101/GSK4527226 in early AD has reached more than one-third of its target enrollment of 282 participants, with dosing initiated in February 2024. AL101 is an investigational human mAb designed to block and downregulate the sortilin receptor to elevate the level of PGRN in the brain in a manner that is similar to investigational latozinemab but with different pharmacokinetic and pharmacodynamic properties.
Early Research Pipeline

Alector continues to advance its Alector Brain Carrier (ABC), a proprietary, versatile blood-brain barrier technology platform, which is being applied selectively to the company’s next-generation product candidates and research pipeline. The technology platform enables customization of affinity, valency, and format to optimize effector function and half-life in preclinical models. Alector is applying its ABC technology, combined with its expertise in immuno-neurology, to work on novel targets and develop first or best-in-class therapeutics.
Third Quarter 2024 Financial Results

Revenue. Collaboration revenue for the quarter ended September 30, 2024, was $15.3 million, compared to $9.1 million for the same period in 2023. The increase was mainly due to an increase in revenue recognized for the AL002 program.

R&D Expenses. Total research and development expenses for the quarter ended September 30, 2024, were $48.0 million, compared to $46.3 million for the quarter ended September 30, 2023. The increase was mainly driven by the increase in research and development expenses for the AL101 programs resulting from the initiation of the PROGRESS-AD Phase 2 clinical trial in 2024.

G&A Expenses. Total general and administrative expenses for the quarter ended September 30, 2024, were $15.8 million, compared to $13.4 million for the quarter ended September 30, 2023. The increase was mainly due to the impairment of the right-of-use asset and the leasehold improvements as the Company transitioned operations from its laboratory and office space in Newark to its South San Francisco headquarters.

Net Loss. For the quarter ended September 30, 2024, Alector reported a net loss of $42.2 million, or $0.43 per share, compared to a net loss of $44.5 million, or $0.53 per share, for the same period in 2023.

Cash Position. Cash, cash equivalents, and investments were $457.2 million as of September 30, 2024. Management expects that this will be sufficient to fund current operations through 2026.

2024 Guidance. The Company continues to anticipate collaboration revenue to be between $60 million and $70 million, total research and development expenses to be between $210 million and $220 million, and total general and administrative expenses to be between $60 million and $70 million.

On November 6, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported its third quarter 2024 results of operations (Press release, Gilead Sciences, NOV 6, 2024, View Source [SID1234647813]).

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"Gilead’s third quarter results are the strongest of the year to date, with 7% year-over-year revenue growth, including 13% year-over-year growth for Biktarvy. Based on this very strong topline growth and disciplined operating expense management, we are increasing our full year revenue, operating income, and earnings per share guidance," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "We are excited to further increase our impact for patients and communities in the months ahead. This includes building on the momentum from the U.S. launch of Livdelzi for primary biliary cholangitis and preparing for the potential launch of the first twice-yearly option for HIV prevention option, lenacapavir."

Third Quarter 2024 Financial Results

•Total third quarter 2024 revenue increased 7% to $7.5 billion compared to the same period in 2023, primarily due to higher sales in HIV as well as in Veklury (remdesivir), Oncology and Liver Disease.

•Diluted earnings per share ("EPS") was $1.00 in the third quarter 2024 compared to $1.73 in the same period in 2023. The decrease was primarily driven by a pre-tax in-process research and development ("IPR&D") impairment of $1.75 billion, or $1.04 per share net of tax impact, related to assets acquired by Gilead from Immunomedics, Inc. ("Immunomedics") in 2020, as well as higher acquired IPR&D expense. This was partially offset by higher product sales and higher net unrealized gains on equity securities.
•Non-GAAP diluted EPS was $2.02 in the third quarter 2024 compared to $2.29 in the same period in 2023. The decrease was primarily driven by higher acquired IPR&D and tax expense, partially offset by higher product sales.
•As of September 30, 2024, Gilead had $5.0 billion of cash, cash equivalents and marketable debt securities compared to $8.4 billion as of December 31, 2023. The decrease primarily reflects the $3.9 billion acquisition of CymaBay Therapeutics, Inc.

•During the third quarter 2024 Gilead generated $4.3 billion in operating cash flow.
•During the third quarter 2024 Gilead paid dividends of $983 million and repurchased $300 million of common stock.

Third Quarter 2024 Product Sales

Total third quarter 2024 product sales increased 7% to $7.5 billion compared to the same period in 2023. Total third quarter 2024 product sales, excluding Veklury, increased 7% to $6.8 billion compared to the same period in 2023, primarily due to higher sales in HIV as well as in Oncology and Liver Disease.

HIV product sales increased 9% to $5.1 billion in the third quarter 2024 compared to the same period in 2023, driven by higher average realized price, primarily due to shifts in channel mix, and higher demand, partially offset by inventory dynamics.
•Biktarvy (bictegravir 50mg/emtricitabine 200mg ("FTC")/tenofovir alafenamide 25mg ("TAF")) sales increased 13% to $3.5 billion in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand and average realized price, partially offset by inventory dynamics.
•Descovy (FTC 200mg/TAF 25mg) sales increased 15% to $586 million in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand and average realized price, partially offset by inventory dynamics.
The Liver Disease portfolio sales increased 4% to $733 million in the third quarter 2024 compared to the same period in 2023. This was primarily driven by higher demand in viral hepatitis medicines, partially offset by unfavorable pricing dynamics.
Veklury sales increased 9% to $692 million in the third quarter 2024 compared to the same period in 2023, primarily driven by increased rates of COVID-19 related hospitalizations, particularly in the United States.
Cell Therapy product sales of $485 million in the third quarter 2024 were relatively flat compared to the same period in 2023.
•Yescarta (axicabtagene ciloleucel) sales decreased 1% to $387 million in the third quarter 2024 compared to the same period in 2023, reflecting increased in- and out-of-class competition in the United States, partially offset by increased demand in relapsed or refractory ("R/R") large B-cell lymphoma ("LBCL") in other regions.
•Tecartus (brexucabtagene autoleucel) sales increased 2% to $98 million in the third quarter 2024 compared to the same period in 2023, driven by increased demand in adult acute lymphoblastic leukemia ("ALL").
Trodelvy (sacituzumab govitecan-hziy) sales increased 17% to $332 million in the third quarter 2024 compared to the same period in 2023, primarily driven by higher demand across all regions.
Third Quarter 2024 Product Gross Margin, Operating Expenses and Effective Tax Rate
•Product gross margin was 79.1% in the third quarter 2024 compared to 77.6% in the same period in 2023. Non-GAAP product gross margin was 86.8% in the third quarter 2024 compared to 85.9% in the same period in 2023. The increases in GAAP and non-GAAP were primarily driven by product mix.
•Research & development ("R&D") expenses and non-GAAP R&D expenses were $1.4 billion in the third quarter 2024 compared to $1.5 billion in the same period in 2023. The decreases were primarily driven by the timing of clinical activities, including the wind-down of the magrolimab and obeldesivir COVID programs.
•Acquired IPR&D expenses were $505 million in the third quarter 2024, primarily driven by a $320 million charge related to the buy-out of global Livdelzi (seladelpar) royalties from Janssen Pharmaceutica NV, as well as payments related to ongoing collaborations.
•IPR&D impairment was $1.75 billion related to the assets acquired from Immunomedics in 2020 with no similar charges in 2023.
•Selling, general and administrative ("SG&A") expenses and non-GAAP SG&A expenses were $1.4 billion in the third quarter 2024 compared to $1.3 billion in the same period in 2023. The increases reflect the timing of commercial activities, including the launch of Livdelzi in the United States, and other corporate activities.

•The effective tax rate ("ETR") was (31.1)% in the third quarter 2024 compared to 6.3% in the same period in 2023. The decrease in ETR primarily reflects the impact of a legal entity restructuring and the aforementioned Immunomedics IPR&D impairment expense, partially offset by a prior year decrease in tax reserves that did not repeat. Non-GAAP ETR was 17.5% in the third quarter 2024 compared to 7.0% in the same period in 2023, primarily reflecting the impact of the prior year decrease in tax reserves.
Guidance and Outlook
For the full-year 2024, Gilead expects:
(in millions, except per share amounts)
November 6, 2024 Guidance
Low End High End Comparison to August 8, 2024 Guidance
Product sales $ 27,800 $ 28,100
Previously $27,100 to $27,500
Product sales, excluding Veklury $ 26,000 $ 26,300
Previously $25,800 to $26,200
Veklury $ 1,800 $ 1,800 Previously $1,300
Diluted EPS $ 0.05 $ 0.25
Previously $0.00 to $0.30
Non-GAAP diluted EPS $ 4.25 $ 4.45
Previously $3.60 to $3.90

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2024 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.
Key Updates Since Our Last Quarterly Release
Virology
•Announced results of PURPOSE 2, the second Phase 3 study of twice-yearly lenacapavir for HIV prevention, with data presented at the HIV Research for Prevention Conference. In the lenacapavir group, 99.9% of participants did not acquire HIV infection, with 2 incident cases among 2,179 participants. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence in cisgender men and gender-diverse people, and additionally demonstrated superiority to daily Truvada (FTC 200mg and tenofovir disoproxil fumarate 300mg; 89% relative risk reduction). Lenacapavir was generally well-tolerated and no significant or new safety concerns were identified. Gilead expects to file for U.S. Food and Drug Administration ("FDA") approval before the end of the year, with global filings to follow. The use of lenacapavir for the prevention of HIV is investigational.
•Presented HIV treatment data at the Infection Disease Week ("IDWeek") meeting, including Week 48 data from the Phase 2 study evaluating the investigational oral once-weekly combination regimen of lenacapavir with Merck’s, known as MSD outside of the United States and Canada ("Merck"), islatravir. In addition, Phase 1a data of the investigational once-weekly GS-1720 and 3-year follow up from the Phase 2/3 CAPELLA trial of twice-yearly lenacapavir in people with multi-drug resistant HIV were also highlighted.
•Signed royalty-free voluntary licensing agreements with six manufacturers to make and sell generic lenacapavir for HIV prevention and for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV in 120 high-incidence, resource-limited countries, subject to regulatory approval of lenacapavir in those markets.
•Presented data at IDWeek from the Phase 3 BIRCH and OAKTREE trials of investigational obeldesivir in non-hospitalized participants at high-risk or standard-risk for severe COVID-19, respectively. Previously, Gilead announced the early termination of the BIRCH trial and top-line results from the OAKTREE trial which found that while the study did not meet its primary endpoint, obeldesivir was found to have a generally well tolerated safety profile. The detailed data presented add to the breadth of safety data on obeldesivir.

•Donated approximately 5,000 vials of remdesivir to the Rwanda Medical Supply in response to the Marburg Virus Disease ("MVD") outbreak for emergency use. Remdesivir is not approved for the treatment of MVD anywhere globally, and the safety and efficacy of this use is not known.
Oncology
•Announced abstracts for the American Society of Hematology (ASH) (Free ASH Whitepaper) 2024 Annual Meeting ("ASH"), including preliminary data from the registrational Phase 2 iMMagine-1 trial evaluating the Arcellx, Inc. ("Arcellx") partnered investigational CAR T anito-cel (anitocabtagene autoleucel) in R/R multiple myeloma, as well as updated results from the Phase 1 trial. Additionally, the first patient has been dosed in the Phase 3 iMMagine-3 trial in 2L+ R/R multiple myeloma.
•Announced ASH (Free ASH Whitepaper) abstracts for long-term follow-up of Yescarta in R/R indolent non-Hodgkin’s lymphoma and Tecartus in R/R mantle cell lymphoma, as well as real world data for Tecartus in B-cell precursor ALL.
•Presented Trodelvy data at the International Association for the Study of Lung Cancer World Conference on Lung Cancer across first- and second-line advanced or metastatic non-small cell lung cancer, as well as in extensive-stage small cell lung cancer. The use of Trodelvy for lung cancer is investigational.
•Announced plans to voluntarily withdraw the U.S. accelerated approval of Trodelvy for use in pre-treated adult patients with locally advanced or metastatic urothelial cancer, following the results of the Phase 3 TROPiCS-04 trial announced in May 2024.
•Received FDA Regenerative Medicine Advanced Therapy Designation for the evaluation of Yescarta as first-line treatment for adult patients with newly diagnosed, high-risk LBCL, an investigational use.
Inflammation
•Received FDA accelerated approval for Livdelzi for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid ("UDCA") in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.
Corporate
•Announced a strategic collaboration with Genesis Therapeutics, Inc. ("Genesis") to discover and develop novel small molecule therapies across multiple targets using Genesis’ GEMS AI platform.
•The Board declared a quarterly dividend of $0.77 per share of common stock for the fourth quarter of 2024. The dividend is payable on December 30, 2024, to stockholders of record at the close of business on December 13, 2024. Future dividends will be subject to Board approval.
Certain amounts and percentages in this press release may not sum or recalculate due to rounding.
Conference Call
At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on View Source and will be archived on www.gilead.com for one year.