On August 1, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2024 (Press release, Puma Biotechnology, AUG 1, 2024, View Source [SID1234645269]). Unless otherwise stated, all comparisons are for the second quarter 2024 compared to the second quarter 2023.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the second quarter of 2024 was $44.4 million, compared to product revenue, net of $51.6 million in the second quarter of 2023. Product revenue, net in the first six months of 2024 was $84.6 million, compared to $98.3 million in the first six months of 2023.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $4.5 million, or $0.09 per share, for the second quarter of 2024, compared to net income of $2.1 million, or $0.05 per basic and diluted share, for the second quarter of 2023. Net loss for the first six months of 2024 was $9.3 million, or $0.19 per share, compared to net income of $3.5 million, or $0.08 per basic share and $0.07 per diluted share, for the first six months of 2023.

Non-GAAP adjusted net loss was $2.5 million, or $0.05 per share, for the second quarter of 2024, compared to non-GAAP adjusted net income of $4.6 million, or $0.10 per basic and diluted share, for the second quarter of 2023. Non-GAAP adjusted net loss for the first six months of 2024 was $4.9 million, or $0.10 per share, compared to non-GAAP adjusted net income of $8.8 million, or $0.19 per basic and diluted share, for the first six months of 2023. Non-GAAP adjusted net (loss) income excludes stock-based compensation expense. For a reconciliation of GAAP net (loss) income to non-GAAP adjusted net (loss) income and GAAP net (loss) income per share to non-GAAP adjusted net (loss) income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the second quarter of 2024 was $1.0 million, compared to $3.3 million in the second quarter of 2023. Net cash provided by operating activities for the first six months of 2024 was $12.3 million, compared to net cash provided by operating activities of $5.9 million in the first six months of 2023. At June 30, 2024, Puma had cash, cash equivalents and marketable securities of $96.8 million, compared to cash, cash equivalents and marketable securities of $96.0 million at December 31, 2023.

Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma, said, "We were pleased to see promising efficacy signals from the Phase I/Ib study of alisertib in combination with osimertinib in advanced osimertinib-resistant EGFR-mutated lung cancer, which was presented at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). The trial has been amended such that future enrollment will be limited to patients who are tp53 wild type and we look forward to further studying this combination in this biomarker directed cohort of patients. In addition, the biomarker analysis from the Phase II randomized clinical trial of alisertib alone vs. alisertib + fulvestrant for the treatment of patients with endocrine and CDK4/6 inhibitor (CDK 4/6i) resistant, human epidermal growth factor receptor 2-negative (HER2-negative), hormone receptor-positive metastatic breast cancer, presented at the same conference, may provide clarity into the subset of patients who may derive the greatest benefit from treatment with alisertib."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) initiation of ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2024) and (ii) interim data from ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q4 2024)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the second quarter ended June 30, 2024, total revenue was $47.1 million, of which $44.4 million was net product revenue and $2.7 million was royalty revenue. This compares to total revenue for the second quarter of 2023 of $54.6 million, of which $51.6 million was net product revenue and $3.0 million was royalty revenue. For the first six months of 2024, total revenue was $90.8 million, of which $84.6 million was net product revenue and $6.2 million was royalty revenue. This compares to total revenue for the first six months of 2023 of $107.3 million, of which $98.3 million was net product revenue and $9.0 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $49.3 million for the second quarter of 2024, compared to $49.7 million for the second quarter of 2023. Operating costs and expenses in the first six months of 2024 were $95.3 million, compared to $98.0 million in the first six months of 2023.

Cost of Sales

Cost of sales was $10.7 million for the second quarter of 2024, compared to $11.9 million for the second quarter of 2023. Cost of sales was $21.4 million for the first six months of 2024, compared to $25.1 million for the first six months of 2023. The $3.7 million decrease in the first six months of 2024 resulted primarily from lower royalty expense resulting from decreased worldwide net sales.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $25.0 million for the second quarter of 2024, compared to $24.4 million for the second quarter of 2023. SG&A expenses for the first six months of 2024 were $46.7 million, compared to $46.8 million for the first six months of 2023. The decrease was primarily due to lower payroll costs related to lower headcount and recruiting related expenses, a decrease in credit losses due to collection on an overdue receivable, a decrease in stock-based compensation expense and a decrease in marketing costs, partially offset by an increase in legal fees.

Research and Development Expenses

Research and development (R&D) expenses were $13.6 million for the second quarter of 2024, compared to $13.4 million for the second quarter of 2023. R&D expenses for the first six months of 2024 were $27.2 million, compared to $26.1 million for the first six months of 2023. The $1.1 million year-over-year increase for the first six months resulted primarily from an increase in clinical trial expenses related to alisertib drug product procurement, as well as a one-time payroll-related expense.

Total Other Income (Expenses)

Total other expenses were $2.0 million for the second quarter of 2024, compared to $2.6 million for the second quarter of 2023. Total other expenses were $4.2 million for the first six months of 2024, compared to $5.4 million for the first six months of 2023. The $1.2 million year-over-year decrease in other expenses for the first six months of 2024 resulted primarily from higher interest income associated with higher interest rates in the current year.

Third Quarter and Full Year 2024 Financial Outlook

Third Quarter 2024

Full Year 2024

Net Product Revenue

$50 -53 million

$183 – $190 million

Royalty Revenue

$20 – $22 million

$30 – $33 million

License Revenue

$0 million

$1 – $2 million

Net Income

$11 – $13 million

$12 – $15 million

Gross to Net Adjustment

18.5% – 19.5%

21% – 22%

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2024 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 1, 2024. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On August 1, 2024 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that it has entered into an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs) and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases, acquired by Sanofi from Amunix Pharmaceuticals (Press release, Vir Biotechnology, AUG 1, 2024, View Source [SID1234646506]). The clinical-stage assets include SAR446309 (AMX-818), a dual-masked HER2-targeted TCE; SAR446329 (AMX-500), a dual-masked PSMA-targeted TCE; and SAR446368 (AMX-525), a dual-masked EGFR-targeted TCE. Sanofi’s proprietary masking platform can be applied to TCEs, cytokines, and other molecules by exploiting the intrinsically high protease activity of the tumor microenvironment to specifically activate drugs in tumor tissues. The selective activation of the molecules in the tumor microenvironment potentially increases the therapeutic index (TI) and mitigates toxicities associated with the systemic immune activation seen with traditional TCEs.

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"At Vir, the cornerstone of our commitment is and always will be patient-centered, with the aim to advance transformative medicines for patients facing severe diseases with unmet medical needs. Despite recent innovation in cancer therapeutics, the prognosis for many patients remains poor and treatment-associated toxicity is a major problem," said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. "These potential best-in-class T-cell engagers aim to help address these problems and further us in our mission of powering the immune system to transform lives."

This deal announcement coincides with the Company’s statement today on its strategic restructuring initiatives to prioritize its clinical-stage pipeline opportunities.

Sanofi’s masking platform has yielded three promising clinical-stage TCE programs:

SAR446309 is a dual-masked HER2xCD3 TCE in Phase 1 clinical study including participants with metastatic treatment resistant HER2+ tumors such as breast and colorectal cancers. Increasing the TI through this proprietary dual masking may allow for both monotherapy and combinations with checkpoint inhibitors.
SAR446329 is a dual-masked PSMAxCD3 TCE in Phase 1 clinical study including participants with metastatic castration-resistant prostate cancer. Increasing the TI through this proprietary dual masking may allow for both monotherapy and combinations.
SAR446368 is a dual-masked EGFRxCD3 TCE with a cleared IND. Phase 1 clinical study, which is expected to begin enrollment in the first quarter of 2025 or sooner, will include participants with EGFR-expressing tumors of various types such as colorectal, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma.
As part of the strategic agreement with Sanofi, key employees with extensive scientific and development expertise in TCEs, and in-depth experience using the masking platform technology, will join Vir upon receipt of Hart-Scott-Rodino (HSR) Act clearance.

"A central focus of our discovery team has been conditionally activated biologics, so adding this platform and key talents is highly strategic for us," said Jennifer Towne, Ph.D., Vir’s Executive Vice President and Chief Scientific Officer. "Our demonstrated deep understanding of T-cell immunology, robust infrastructure, and leading machine learning and antibody engineering capabilities will create opportunities for real synergies and patient-centric innovation."

Pursuant to this agreement, Sanofi will receive an upfront payment and is eligible to receive future development, regulatory and commercial net sales-based milestone payments and tiered royalties on worldwide net sales. This agreement is subject to regulatory approval.

This strategic licensing transaction marks a significant milestone in Vir’s commitment to develop transformative therapeutics for some of the most severe diseases. Across its portfolio of clinical assets, below are anticipated upcoming catalysts:

Tobevibart +/- Elebsiran : Phase 2 SOLSTICE 24-week treatment data for chronic hepatitis delta virus infection expected in the fourth quarter of 2024.
Tobevibart + Elebsiran +/- PEG-IFN-⍺: Phase 2 MARCH Part B 48-week end of treatment data for hepatitis B virus infection expected in the fourth quarter of 2024.
SAR446309 : Phase 1 monotherapy and combination study data expected in the second half of 2025.
SAR446329 : Phase 1 monotherapy study data expected in the second half of 2025.
SAR446368 : Phase 1 study to begin enrollment in the first quarter of 2025 or sooner.
Evercore Group L.L.C. acted as Vir’s exclusive financial advisor and Ropes & Gray LLP acted as Vir’s legal advisor for this transaction.

On August 1, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported financial results for the second quarter ended June 30, 2024, as well as recent business highlights (Press release, C4 Therapeutics, AUG 1, 2024, View Source [SID1234645252]).

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"Our strong execution during the first half of the year has built momentum across our clinical, discovery and partnered programs, each of which has the potential to advance targeted protein degradation science and transform patients’ lives," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "Our two lead programs continue to advance in the clinic, and we are on track to share multiple Phase 1 datasets during the second half of the year. At the upcoming ESMO (Free ESMO Whitepaper) Congress, we will present initial CFT1946 Phase 1 data, marking the first clinical presentation for a BRAF V600X degrader, which has the potential to address many of the liabilities that occur with inhibitors. Additionally, we expect to share updated cemsidomide Phase 1 data in relapsed refractory multiple myeloma and relapsed refractory non-Hodgkin’s lymphoma in the fourth quarter."

SECOND QUARTER 2024 AND RECENT ACHIEVEMENTS

Cemsidomide: Cemsidomide is an oral degrader of IKZF1/3 for the potential treatment of relapsed/refractory (R/R) multiple myeloma (MM) and R/R non-Hodgkin’s lymphoma (NHL).

Advanced the Phase 1/2 Clinical Trial. The cemsidomide Phase 1/2 trial in combination with dexamethasone for R/R MM and as a monotherapy for R/R NHL continues to enroll patients. For the combination with dexamethasone MM arm, dose level 4 (75 µg QD) has been declared safe and additional patients are enrolling in this expansion cohort. Dose escalation continues as the maximum tolerated dose has not yet been reached. For the monotherapy NHL arm, patients are enrolling at dose level 5 (100 µg QD).
CFT1946: CFT1946 is an oral degrader targeting BRAF V600X mutations for the potential treatment of solid tumors including colorectal cancer (CRC), melanoma and non-small cell lung cancer (NSCLC).

Advanced the Phase 1/2 Clinical Trial. The CFT1946 Phase 1/2 trial for BRAF V600X mutant solid tumors continues to enroll patients. Enrollment is complete at dose level 5 (640 mg BID), with patients currently in the dose limiting toxicity evaluation period for this dose level. Simultaneously, patients continue to be evaluated for pharmacokinetic, pharmacodynamic and anti-tumor activity at the 160 mg BID and 320 mg BID dose levels. Additionally, patients are now enrolling in a monotherapy exploratory expansion cohort for BRAF inhibitor refractory melanoma at the 320 mg BID dose level.

The Phase 1b portion of the trial evaluating CFT1946 in combination with cetuximab for CRC has also been opened and patients are enrolling at the 160 mg BID dose level.
Preliminary CFT1946 Monotherapy Data Accepted as a Mini Oral Presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024. Monotherapy data from the ongoing CFT1946 Phase 1 trial will be presented on Saturday, September 14, 2024 from 2:45 – 2:50 CEST at the ESMO (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain.
CORPORATE UPDATES:

In June 2024, Ron Cooper was appointed as chairman of C4T’s Board of Directors as a part of C4T’s commitment to strategically transform the Board to lead the company into its next phase of growth. Mr. Cooper brings decades of deep biopharmaceutical executive leadership across discovery, development and commercialization.
KEY UPCOMING MILESTONES

Cemsidomide:

Present updated data from at least three dose levels from the dose escalation and expansion cohorts of the ongoing Phase 1/2 clinical trial in R/R MM in Q4 2024.
Present data from at least four dose levels from the dose escalation portion of the ongoing Phase 1/2 clinical trial in R/R NHL in Q4 2024.
Complete Phase 1 dose exploration in R/R MM and R/R NHL by year-end 2024.
CFT1946:

Present data from at least five dose levels from the ongoing Phase 1 monotherapy dose escalation trial in BRAF V600X solid tumors as a mini oral presentation on Saturday, September 14, 2024 from 2:45 – 2:50 CEST at the ESMO (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain.
UPCOMING INVESTOR EVENTS:

September 5, 2024 at 9:30 AM ET: Management will participate in a fireside chat at the Wells Fargo Healthcare Conference taking place in Boston, MA.
September 16, 2024: Management will host a webcast to discuss the CFT1946 data presented at the ESMO (Free ESMO Whitepaper) Congress 2024.
September 17 – 19, 2024: Management will participate in the Cantor Global Healthcare Conference taking place in New York, NY.
SECOND QUARTER 2024 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2024 was $12.0 million, compared to $2.7 million for the second quarter of 2023. The increase in revenue was primarily due to the receipt of an $8.0 million milestone payment from Biogen after the company accepted delivery of a development candidate. Total revenue for the second quarter of 2024 reflects revenue recognized under our collaborations with Merck KGaA, Darmstadt, Germany (MKDG), Merck, Roche and Biogen, and total revenue recognized in the second quarter of 2023 reflects revenue recognized under collaboration agreements with Roche and Biogen.

Research and Development (R&D) Expense: R&D expense for the second quarter of 2024 was $23.8 million, compared to $29.9 million for the second quarter of 2023. The reduction in R&D expense was primarily due to the prioritization of our internal discovery efforts and stopping clinical development for CFT8634, partially offset by increased clinical trial expense as cemsidomide and CFT1946 continue to advance.

General and Administrative (G&A) Expense: G&A expense was $9.7 million for the second quarter of 2024, compared to $10.3 million for the second quarter of 2023. The decrease in G&A expense was primarily attributable to a reduction in external consulting spend.

Net Loss and Net Loss per Share: Net loss for the second quarter of 2024 was $17.7 million, compared to $35.9 million for the second quarter of 2023. Net loss per share for the second quarter of 2024 was $0.26 compared to $0.73 for the second quarter of 2023.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of June 30, 2024 were $295.7 million, compared to $299.2 million as of March 31, 2024, and $281.7 million as of December 31, 2023. The reduction in cash, cash equivalents and marketable securities during the second quarter was primarily the result of operating expenses offset by receipt of the upfront payment from our collaborator MKDG and a milestone payment from Biogen. C4T expects that its cash, cash equivalents and marketable securities as of June 30, 2024 will be sufficient to fund planned operating expenses and capital expenditures into 2027.

On August 1, 2024 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2024 and provided a business update (Press release, Regeneron, AUG 1, 2024, View Source [SID1234645270]).

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"Regeneron had a strong quarter, with total revenue up 12% driven by notable growth for EYLEA HD, Dupixent, and Libtayo," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Importantly, Dupixent was granted its first regulatory approval for COPD by the European Commission, with FDA action anticipated in the third quarter, presenting an opportunity to help even more patients around the globe. As always, we remain focused on driving forward our diverse clinical pipeline, progressing late-stage trials for Dupixent in chronic spontaneous urticaria and other dermatologic indications; itepekimab, our IL-33 antibody in COPD; fianlimab, our LAG-3 antibody in metastatic melanoma; and Libtayo in adjuvant cutaneous squamous cell carcinoma. Finally, we were excited to advance several promising earlier-stage programs, including various antibody and GLP-1 combinations for obesity and our gene therapy DB-OTO for genetic hearing loss."

Financial Highlights

($ in millions, except per share data)
Q2 2024
Q2 2023
% Change
Total revenues $ 3,547 $ 3,158 12 %
GAAP net income $ 1,432 $ 968 48 %
GAAP net income per share – diluted $ 12.41 $ 8.50 46 %
Non-GAAP net income(a)
$ 1,351 $ 1,182 14 %
Non-GAAP net income per share – diluted(a)
$ 11.56 $ 10.24 13 %

"Our second quarter financial performance reflects continued strong momentum across our business, highlighted by double-digit revenue and earnings growth," said Christopher Fenimore, Senior Vice President, Finance and Chief Financial Officer of Regeneron. "In the second half of the year, we look forward to advancing our pipeline with several important clinical data readouts as well as continued commercial execution and prudent capital deployment to drive long-term value creation."

Business Highlights

Key Pipeline Progress

Regeneron has over 35 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:
EYLEA HD (aflibercept) 8 mg
•In June 2024, a supplemental Biologics License Application (sBLA) with two-year data for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) was submitted to the U.S. Food and Drug Administration (FDA).
Dupixent (dupilumab)
•In May 2024, after requesting additional efficacy analyses, the FDA extended by three months the target action date of its priority review of the sBLA for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD, with a revised target action date of September 27, 2024. Regeneron and Sanofi remain confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation, and are committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible.
•In June 2024, the European Commission (EC) approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils. The EC is the first regulatory authority in the world to have approved Dupixent for COPD patients. Additional submissions are under review with other regulatory authorities outside the United States, including in China and Japan.
•The Company and Sanofi presented at the 2024 American Thoracic Society International Conference positive data from the NOTUS Phase 3 trial evaluating Dupixent as an add-on maintenance treatment in adults with uncontrolled COPD on maximal standard-of-care inhaled therapy (nearly all on triple therapy) and evidence of type 2 inflammation. The NOTUS trial confirmed the positive results demonstrated in the Phase 3 BOREAS trial. The data from the NOTUS trial were also published in the New England Journal of Medicine (NEJM).
•The FDA accepted for priority review the sBLA for Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), with a target action date of September 15, 2024.
•The NEJM published results from a positive Phase 3 trial for Dupixent in children aged 1 to 11 years with eosinophilic esophagitis (EoE). The trial showed a greater proportion of those receiving weight-tiered higher dose Dupixent experienced significant improvements in many key disease measures of EoE, compared to placebo at week 16.
Oncology Programs
•The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending conditional marketing authorization of odronextamab, a bispecific antibody targeting CD20 and CD3, to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. The EC is expected to announce a final decision in the coming months.
•In June 2024, the 14-month median follow-up data from the pivotal Phase 1/2 trial of linvoseltamab, a bispecific antibody targeting BCMA and CD3, in patients with R/R multiple myeloma were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2024 and published in the Journal of Clinical Oncology. These longer-term results show a deepening of responses following the 11-month median follow-up data previously presented in April 2024.
•A Phase 2 study for fianlimab, an antibody to LAG-3, in combination with Libtayo (cemiplimab) for perioperative non-small cell lung cancer (NSCLC) was initiated. A Phase 2/3 study for fianlimab, in combination with Libtayo, for perioperative melanoma was also initiated.
•The Company announced positive updated results from an ongoing Phase 1/2 trial evaluating REGN7075, a costimulatory bispecific antibody targeting EGFR and CD28, in combination with Libtayo in patients with advanced solid tumors. Data from the dose-escalation portion of the trial showed the investigational combination led to anti-tumor responses in certain patients with microsatellite stable colorectal cancer. The results were shared during an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting.
Other Programs
•In June 2024, the FDA approved Kevzara (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA), a form of arthritis that impacts multiple joints at a time.
•A Phase 2 study in obesity was initiated for trevogrumab, an antibody to myostatin (GDF8), in combination with semaglutide with and without garetosmab, an antibody to Activin A.
•A Phase 2 study for REGN7508, an antibody to Factor XI, was initiated in patients with thrombosis.
•The Company presented updated data from the Phase 1/2 trial of DB-OTO, an AAV-based gene therapy, at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual conference and announced that DB-OTO improved hearing to normal levels in one child and that initial hearing improvements were observed in a second child. In addition, the FDA recently granted DB-OTO Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of congenital auditory neuropathy secondary to biallelic mutations of the otoferlin gene.

Second Quarter 2024 Financial Results
Revenues
($ in millions)
Q2 2024
Q2 2023
% Change
Net product sales:
EYLEA HD – U.S. $ 304 $ — *
EYLEA – U.S. 1,231 1,500 (18 %)
Total EYLEA HD and EYLEA – U.S. 1,535 1,500 2 %
Libtayo – Global
297 210 41 %
Praluent – U.S.
56 41 37 %
Evkeeza – U.S.
31 19 63 %
Inmazeb – Global
— 2 (100 %)
Total net product sales 1,919 1,772 8 %
Collaboration revenue:
Sanofi 1,146 944 21 %
Bayer 375 377 (1 %)
Other 3 (4) *
Other revenue 104 69 51 %
Total revenues $ 3,547 $ 3,158 12 %
* Percentage not meaningful

Total EYLEA HD and EYLEA net product sales in the U.S. increased 2% in the second quarter of 2024 compared to the second quarter of 2023. EYLEA HD was approved by the FDA in August 2023 and EYLEA HD net product sales in the second quarter of 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, to EYLEA HD, as well as new patients naïve to anti-VEGF therapy. Net product sales of EYLEA decreased in the second quarter of 2024, compared to the second quarter of 2023, primarily due to (i) the aforementioned approval and transition of certain patients to EYLEA HD, and (ii) other market dynamics that resulted in lower volumes and a lower net selling price.
Sanofi collaboration revenue increased in the second quarter of 2024, compared to the second quarter of 2023, due to the Company’s share of profits from commercialization of antibodies, which were $988 million in the second quarter of 2024, compared to $751 million in the second quarter of 2023. The change in the Company’s share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales.
Refer to Table 4 for a summary of collaboration revenue.

Operating Expenses
GAAP % Change
Non-GAAP(a)
% Change
($ in millions)
Q2 2024
Q2 2023
Q2 2024 Q2 2023
Research and development (R&D)
$ 1,200 $ 1,085 11 % $ 1,072 $ 974 10 %
Acquired in-process research and development (IPR&D)
$ 24 $ — ** * * n/a
Selling, general, and administrative (SG&A)
$ 759 $ 652 16 % $ 667 $ 562 19 %
Cost of goods sold (COGS)
$ 258 $ 192 34 % $ 214 $ 163 31 %
Cost of collaboration and contract manufacturing (COCM)
$ 222 $ 213 4 % * * n/a
Other operating expense (income), net
$ 15 $ (1) ** $ — * **
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded.
** Percentage not meaningful

•GAAP and non-GAAP R&D expenses increased in the second quarter of 2024, compared to the second quarter of 2023, driven by the advancement of the Company’s late-stage oncology programs, and higher headcount and headcount-related costs.
•Acquired IPR&D for the second quarter of 2024 included up-front payments, as well as a premium on equity securities purchased, in connection with collaboration and licensing agreements.
•GAAP and non-GAAP SG&A expenses increased in the second quarter of 2024, compared to the second quarter of 2023, due to higher commercialization-related expenses to support the Company’s launch of EYLEA HD and higher headcount and headcount-related costs partly related to the Company’s international commercial expansion.
•GAAP and non-GAAP COGS increased in the second quarter of 2024, compared to the second quarter of 2023, primarily due to higher start-up costs for the Company’s Rensselaer, New York fill/finish facility.
•GAAP other operating expense (income), net, for the second quarter of 2024 reflects a charge related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with the Company’s 2023 acquisition of Decibel Therapeutics, Inc.
Other Financial Information
GAAP other income (expense) included the recognition of net unrealized gains on equity securities of $393 million in the second quarter of 2024, compared to $31 million of net unrealized losses in the second quarter of 2023. GAAP and Non-GAAP other income (expense) also included interest income of $179 million in the second quarter of 2024, compared to $118 million in the second quarter of 2023.
In the second quarter of 2024, the Company’s GAAP effective tax rate (ETR) was 12.0%, compared to 10.6% in the second quarter of 2023. The GAAP ETR increased in the second quarter of 2024, compared to the second quarter of 2023, due to the remeasurement of existing uncertain tax positions, offset by a higher benefit from stock-based compensation. In the second quarter of 2024, the non-GAAP ETR was 10.8%, compared to 12.2% in the second quarter of 2023.

On August 1, 2024 Kyowa Hakko Kirin reported its consolidated financial summary (IFRS) Fiscal 2024 Semi Annual report (Press release, Kyowa Hakko Kirin, AUG 1, 2024, View Source [SID1234646733]).

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