On August 1, 2024 Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the quarter ended June 30, 2024 and provided recent business highlights (Press release, Shattuck Labs, AUG 1, 2024, View Source [SID1234645271]).

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"Our data presentation at EHA (Free EHA Whitepaper) last quarter included complete remission rates for both HR-MDS and TP53m AML patients treated with SL-172154 in combination with AZA that exceeded the expected complete remission rates for AZA alone. It is encouraging to see in our EHA (Free EHA Whitepaper) presentation that our complete remission rate improved as the number of patients in each cohort increased, since our initial data presented at ASH (Free ASH Whitepaper) in December of 2023. The next milestone for this program is to see how these response rates translate to an overall survival benefit, and those data will mature over the second half of this year," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "In parallel, we are pleased that enrollment has begun so swiftly in our randomized, controlled expansion cohort in frontline HR-MDS patients. We look forward to sharing clinical updates from these trials in the months ahead."
Second Quarter 2024 Business Highlights and Other Recent Developments

SL-172154 (SIRPα-Fc-CD40L)

Phase 1B Trial of SL-172154 in Frontline HR-MDS and TP53m AML

HR-MDS
•Announced updated interim data from the Phase 1B dose expansion clinical trial of SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML patients. These data were featured in a poster presentation during the EHA (Free EHA Whitepaper) 2024 Congress.

◦Observed 67% Objective Response Rate (ORR) in frontline HR-MDS patients, primarily with TP53 mutations, and an initial complete remission (CR)/marrow complete remission rate of 58%. As of the data cut-off date on April 23, 2024, median overall survival had not yet been reached.

◦SL-172154 demonstrated a manageable interim safety profile in combination with AZA, with infusion related reactions (IRRs) as the most common drug related adverse event.

•Initiated enrollment of the Part D cohort, a randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients. Approximately 60 patients will be randomized in a 1:1:1 ratio to receive SL-172154 at 3mg/kg in combination with AZA, SL-172154 at 1mg/kg in combination with AZA, or AZA as monotherapy.
TP53m AML
•Observed 43% ORR in frontline TP53m AML patients and 33% CR/complete remission rate with incomplete hematologic recovery. As of the data cut-off date of June 4, 2024, the median overall survival had not yet been reached. SL-172154 demonstrated a manageable interim safety profile in combination with AZA.
•In June 2024, the U.S. FDA granted ODD to SL-172154 for the treatment of AML.
Phase 1B Trial of SL-172154 in Platinum-Resistant Ovarian Cancer (PROC)
•Reported data from the Phase 1B clinical trial of SL-172154 in PROC patients, demonstrating an acceptable safety profile in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (Elahere). IRRs were the most common treatment emergent AE as of the data cutoff.
◦As of April 23, 2024, four of 21 (19%) treated patients in the Phase 1B study of SL-172154 in combination with PLD achieved partial responses. Two additional patients with stable disease showed maximum tumor reductions of 17% and 27%.
◦Completed enrollment for the cohort combining SL-172154 with Elahere. As of the April 23, 2024 data cutoff, ORR benefit beyond Elahere alone was not observed.
◦Shattuck continues to follow patients for progression free survival and overall survival and, should such results mature favorably in either PROC cohort, will evaluate further development in PROC at that time.
Corporate Updates
•On July 1, 2024, Shattuck announced its addition to the Russell 2000 and Russell 3000 Indexes at the conclusion of the 2024 Russell U.S. Indexes annual reconstitution.
Upcoming Events
•Shattuck plans to attend the following investor conferences. Details will be included on the Events & Presentations section of the Company’s website.
◦BTIG Biotechnology Conference (Virtual) August 5-6, 2024
◦Wells Fargo Healthcare Conference (Boston, MA) September 4-6, 2024
◦H.C. Wainwright 26th Annual Global Investment Conference (New York, NY) September 9-11, 2024
Second Quarter 2024 Financial Results
•Cash and Cash Equivalents and Investments: As of June 30, 2024, cash and cash equivalents and investments were $105.3 million, as compared to $117.2 million as of June 30, 2023.
•Research and Development (R&D) Expenses: R&D expenses were $19.2 million for the quarter ended June 30, 2024, as compared to $18.2 million for the quarter ended June 30, 2023.
•General and Administrative (G&A) Expenses: G&A expenses were $5.3 million for the quarter ended June 30, 2024, as compared to $4.7 million for the quarter ended June 30, 2023.
•Net Loss: Net loss was $21.5 million for the quarter ended June 30, 2024, or $0.42 per basic and diluted share, as compared to a net loss of $21.3 million for the quarter ended June 30, 2023, or $0.50 per basic and diluted share.
Financial Guidance
Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations into 2026, beyond results from its Phase 1 clinical trials of SL-172154. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken.

About SL-172154

SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Multiple Phase 1 clinical trials are ongoing for patients with AML, HR-MDS, and PROC.

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 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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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

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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 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.

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

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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 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported that it has received the official minutes from its meeting with the U.S. Food and Drug Administration ("FDA") regarding next steps in its planned Phase 3 clinical trial of its Versamune based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma ("HNSCC") (Press release, PDS Biotechnology, AUG 1, 2024, View Source [SID1234645268]). The Company will host a conference call today at 8:00 a.m. ET to discuss details of the anticipated Phase 3 clinical trial of Versamune HPV (formerly PDS0101) in this indication.

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PDS Biotech presented the FDA with recent data from both the VERSATILE-002 study of Versamune HPV + pembrolizumab, and the triple combination of Versamune HPV + PDS01ADC + bintrafusp alfa. The Company also provided an updated design of the Phase 3 VERSATILE-003 trial of Versamune HPV + pembrolizumab which included updated statistical endpoints based on recent and more mature survival data. PDS Biotech proposed the addition of a third arm to the study which would be a triple combination of Versamune HPV + PDS01ADC + pembrolizumab. The first part of the study would therefore involve a dose optimization of PDS01ADC in the novel combination.

The FDA supported the strategy and development of the double and triple combinations. Also, the FDA requested additional safety analysis in the lead-in PDS01ADC dose optimization part of the study. To avoid potential delays in initiating the randomized trial, the FDA agreed that the dose optimization should be done separately and the registrational trial of the revised 2-arm double combination trial, VERSATILE-003, should proceed. The Versamune HPV + pembrolizumab combination has received Fast Track designation.

"We appreciate the FDA’s support in the development of both the double and triple Versamune HPV-based combinations. We are also pleased to have aligned on initiating the updated VERSATILE-003 study," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "The VERSATILE-002 results have matured significantly and positively over the last year, allowing us to revise the statistical endpoints of the study to provide additional robustness to the study design. We continue to believe that the combination, based on encouraging survival, disease control response rates and safety has the potential to significantly advance the treatment of HPV16-positive HNSCC. Our goal now is to investigate Versamune HPV + pembrolizumab’s potential as the first targeted immunotherapy for HPV16-positive HNSCC. The addition of PDS01ADC in the future has the potential to provide further clinical benefit to an effective targeted immunotherapy."

Kirk Shepard, MD, Chief Medical Officer, continued, "We have contracted with a clinical research organization and the preparatory work is advancing to begin enrollment in the VERSATILE-003 Phase 3 clinical trial in first-line treatment of patients with recurrent or metastatic HPV16-positive HNSCC, with overall survival as the study’s primary endpoint. Our VERSATILE-003 trial has significant key opinion leader support, including from the investigators involved in VERSATILE-002, and we have lined up a significant number of the target sites that have indicated strong interest in participating in the trial."

Conference Call Details
Date: August 1, 2024
Time: 8:00 a.m. ET
Dial-in: 1-877-704-4453 or 1-201-389-0920
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