On November 3, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported financial results for the third quarter ended September 30, 2022 and provided recent corporate updates (Press release, Bicycle Therapeutics, NOV 3, 2022, View Source [SID1234622992]).

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"We are encouraged by the continued clinical progress across our pipeline," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "In the third quarter, we announced top-line results from the completed dose escalation portion of the Phase I/II trial in BT5528 and expect to complete enrollment in the initial expansion cohorts this quarter. In addition, clinical development of BT8009 remains on-track and we look forward to providing an update this quarter following completion of the dose escalation portion of the Phase I/II clinical trial. Finally, the dose escalation portion of our Phase I/II trial of BT7480 continues at a healthy pace and we expect to share clinical information in 2023."

"Recently, we added to our balance sheet through Genentech’s second expansion of our immuno-oncology collaboration, resulting in a $10 million payment to us this quarter. We are pleased to have a strong balance sheet which helps support the advancement of our clinical oncology pipeline as well as our earlier discovery and development efforts and which we anticipate provides financial runway into 2025."

Third Quarter 2022 and Recent Highlights

Announced Top-Line Dose Escalation Results of Phase I Trial of BT5528. In September, Bicycle announced top-line results from the Phase I dose escalation portion of its Phase I/II trial of BT5528, a Bicycle Toxin Conjugate (BTC) targeting EphA2, in patients with advanced solid tumors. Bicycle observed signs of anti-tumor activity in heavily pre-treated patients with EphA2-postive ovarian and urothelial cancers, demonstrating an overall response rate of 22% (including one complete response) and 67%, respectively. Previously, the company had established a recommended Phase II dose of 6.5mg/m2 every other week. Low, or no, levels of incidence of neutrophil count decrease, peripheral neuropathy, skin rash and eye disorders were reported. Low-grade GI treatment-related events were those most commonly reported amongst the 15 patients at this dose. In addition, and in contrast to the toxicities observed with EphA2 antibody drug conjugates, Bicycle has observed no signs of treatment-related coagulopathy to date in any patient.
Enrollment of the Initial Cohorts of The Initial Expansion Cohorts of the BT5528 Phase I/II Trial Remains on Track to Complete This Quarter. The company expects to provide an update on BT5528’s clinical progress in 2023. In June 2022, Bicycle announced the dosing of the first patient in the Phase II dose expansion portion of the Phase I/II trial. The initial dose expansion enrollment plan includes urothelial (n=14) and ovarian (n=14) cancers as well as in a basket cohort of other solid tumors (n=28), including non-small cell lung, triple-negative breast, head and neck, and esophageal cancers.
Announced Publications Highlighting Preclinical Data from BT8009 in Molecular Cancer Therapeutics and the Journal of Medicinal Chemistry. In September, Bicycle announced that an article titled "BT8009: a Nectin-4 targeting Bicycle Toxin Conjugate for treatment of solid tumors" highlighting preclinical data from BT8009 was published in Molecular Cancer Therapeutics. In October, Bicycle announced an additional publication highlighting preclinical BT8009 data in the Journal of Medicinal Chemistry, titled "Discovery of BT8009: a Nectin-4 Targeting Bicycle Toxin Conjugate for the Treatment of Cancer." Both articles are available at the publications section of the Bicycle website via this link.
Announced Expansion of Genentech Immuno-Oncology Collaboration. In July 2022, Bicycle announced that Genentech exercised an option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle-based immuno-oncology therapies. This expansion represented the second option exercised by Genentech under the terms of the original February 2020 agreement and triggered a $10 million payment to Bicycle, which was received in the third quarter of 2022.
Financial Results

Cash and cash equivalents were $361.5 million as of September 30, 2022, compared to $438.7 million as of December 31, 2021. The decrease in cash is primarily due to cash used in operating activities.
Research and development expenses were $22.8 million for the three months ended September 30, 2022, compared to $10.5 million for the three months ended September 30, 2021. The increase in expense of $12.2 million for the three months ended September 30, 2022 as compared to the same period in the prior year was primarily due to increased clinical program expenses for BT5528 and BT8009, Bicycle TICA program development expenses, and other discovery and platform related expenses, as well as increased personnel-related expenses, including $1.4 million of incremental non-cash share-based compensation expenses.
General and administrative expenses were $10.0 million for the three months ended September 30, 2022, compared to $8.1 million for the three months ended September 30, 2021. The increase of $1.9 million for the three months ended September 30, 2022 as compared to the same period in the prior year was primarily due to an increase in personnel-related costs, including $1.3 million of incremental non-cash share-based compensation expense.
Net loss was $28.3 million, or $(0.96) basic and diluted net loss per share, for the three months ended September 30, 2022, compared to net loss of $14.7 million, or $(0.59) basic and diluted net loss per share, for the three months ended September 30, 2021.

On November 3, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Credit Suisse 31st Annual Healthcare Conference on Wednesday, November 9, 2022, at 8:35 a.m. PST (Press release, Bio-Techne, NOV 3, 2022, View Source [SID1234622991]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On November 3, 2022 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare and genetically defined diseases, reported business highlights and financial results for the third quarter ended September 30, 2022 (Press release, Agios Pharmaceuticals, NOV 3, 2022, View Source [SID1234622990]).

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"Agios is on the cusp of changing the treatment landscape for people with rare and genetically defined diseases, with the potential of PYRUKYND to make a positive impact across multiple underserved diseases. I joined the company in August because of its differentiated portfolio, top-notch team and genuine dedication to patients, and my excitement for the future of Agios has only grown over the past few months," said Brian Goff, chief executive officer at Agios. "We are continuing to build our capabilities and connections in rare and genetically defined diseases through our U.S. launch of PYRUKYND, and we expect our learnings to support anticipated future expansion in related diseases where development efforts are ongoing. We will build on the tremendous accomplishments we’ve achieved in 2022 as we close out the year with a focus on continuing to execute the launch, enrolling our thalassemia and sickle cell disease pivotal trials and securing the approval of PYRUKYND for PK deficiency in the EU and Great Britain. I am honored to lead this team as we together drive long-term growth and value for patients, shareholders and all our stakeholders."

Third Quarter 2022 & Recent Highlights

Continued to execute U.S. launch of PYRUKYND, generating $3.5 million in U.S. net revenue for the third quarter of 2022, the second full quarter following FDA approval. A total of 84 unique patients have completed prescription enrollment forms, representing an increase of 64 percent over the second quarter. A total of 56 patients are on PYRUKYND therapy, representing a 51 percent increase over the second quarter. Increased patient demand was partially offset by modest inventory build in the prior quarters of launch.
Received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the granting of a marketing authorization for PYRUKYND for the treatment of PK deficiency in adult patients.
Completed Medicines and Healthcare Products Regulatory Agency (MHRA) filing for the approval of PYRUKYND as a treatment for adults with PK deficiency in Great Britain.
Continued to enroll patients across five PYRUKYND pivotal studies in thalassemia, sickle cell disease and pediatric PK deficiency.
Initiated Phase 2a study of novel PK activator AG-946 in adults with lower-risk MDS.
Published PYRUKYND data in top-tier medical journals, including Phase 2 thalassemia data in The Lancet and Phase 3 ACTIVATE-T data in The Lancet Haematology.
Appointed Cecilia Jones as Agios’ chief financial officer, effective Sept. 26, 2022.
Appointed Rahul Ballal, Ph.D., chief executive officer of Imara, and Cynthia Smith, former chief commercial officer of ZS Pharma, to Agios’ board of directors.
Completed the sale of royalty rights on U.S. net sales of Servier’s TIBSOVO to Sagard Healthcare Partners for a one-time payment of $131.8 million.
Key Upcoming Milestones & Priorities

Agios expects to execute on the following key milestones and priorities by the end of 2022:

Adult PK Deficiency: Receive EU and Great Britain regulatory decisions for PYRUKYND in adults with PK deficiency.
Thalassemia: Enroll a meaningful portion of patients in the Phase 3 ENERGIZE and ENERGIZE-T studies of PYRUKYND in not regularly transfused and regularly transfused adults with thalassemia, respectively.
Sickle Cell Disease: Complete enrollment in the Phase 2 portion of the RISE UP study of PYRUKYND in adults with sickle cell disease.
Data Presentations: Present broad set of clinical and translational data at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition; abstracts will be available at 9 a.m. ET today.
Third Quarter 2022 Financial Results

The financial results discussion compares Agios’ continuing operations. All periods have been adjusted to exclude discontinued operations related to the divested oncology business.

Revenue: Net U.S. product revenue from sales of PYRUKYND for the third quarter of 2022 was $3.5 million. This revenue reflects the second full quarter of PYRUKYND launch, following FDA approval on February 17, 2022.

Cost of Sales: Cost of sales for the third quarter of 2022 was $0.5 million.

Non-Operating Income: Non-operating income included approximately $4.4 million from TIBSOVO royalties for the third quarter of 2022. TIBSOVO royalty income will cease in 2022 due to the sale of these royalty rights to Sagard Healthcare Partners.

Research and Development (R&D) Expenses: R&D expenses were $65.0 million for the third quarter of 2022 compared to $64.0 million for the third quarter of 2021.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $29.1 million for the third quarter of 2022 compared to $27.2 million for the third quarter of 2021. The year-over-year increase in SG&A expenses was primarily attributable to an increase in workforce-related expenses.

Net Loss from Continuing Operations: Net loss from continuing operations was $81.7 million for the third quarter of 2022 compared to a net loss of $84.3 million for the third quarter of 2021.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of September 30, 2022, were $1.0 billion compared to $1.4 billion as of September 30, 2021. This cash position does not include the receipt of a one-time payment of $131.8 million associated with the sale of royalty rights on U.S. net sales of Servier’s TIBSOVO. Agios expects that its cash, cash equivalents and marketable securities will enable the company to execute its operating plan through major catalysts and to cash-flow positivity without the need to raise additional equity.

Conference Call Information
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss third quarter 2022 financial results and recent business activities. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On November 3, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported third quarter financial results for the period ended September 30, 2022 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, NOV 3, 2022, View Source [SID1234622989]).

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"In the third quarter of 2022, we were very pleased to present positive data from our Phase 3 DeFi trial of nirogacestat in patients with desmoid tumors during a Presidential Symposium at ESMO (Free ESMO Whitepaper), expand our collaboration with GSK to enable further development of nirogacestat in combination with belamaf in patients with multiple myeloma across lines of therapy, and initiate a new Phase 2 trial of nirogacestat in patients with ovarian granulosa cell tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "In addition, we significantly strengthened our financial position, providing us with sufficient runway into 2026 to continue executing on our mission to make a profound impact on the lives of patients with devastating cancers. We look forward to completing our NDA filing package for nirogacestat in desmoid tumors to potentially enable our first product launch in 2023 and to further advancing our diversified targeted oncology pipeline."

Recent Business Highlights and Upcoming Milestones

Rare Oncology

In September 2022, SpringWorks presented positive data from the Phase 3 DeFi trial of nirogacestat in adult patients with progressing desmoid tumors in a late-breaking oral presentation during a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022; the data were presented by Bernd Kasper, M.D., Ph.D., University of Heidelberg, Mannheim Cancer Center, Mannheim, Germany. The DeFi trial met its primary endpoint of improving progression-free survival (PFS), as assessed by blinded independent central review, demonstrating a statistically significant improvement for nirogacestat over placebo, with a 71% reduction in the risk of disease progression (hazard ratio (HR) = 0.29 (95% CI: 0.15, 0.55); p< 0.001). In addition, all key secondary endpoints achieved statistical significance, including objective response rate and improvements in six different patient-reported outcomes; notably, a significant reduction in pain severity compared with placebo (p<0.001) was observed. Nirogacestat also exhibited a manageable safety profile in the DeFi trial. These data will be highlighted by Mrinal Gounder, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center in an encore presentation at the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting in Vancouver, BC, Canada on Saturday, November 19, at 1:30pm PT (4:30pm ET). In this oral session, Dr. Gounder will also present an assessment of the GODDESS© (GOunder/Desmoid Tumor Research Foundation DEsmoid Symptom/Impact Scale)​ tool for evaluating changes in disease-specific symptom severity and impact in desmoid tumors as assessed in the DeFi trial. SpringWorks plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2022 for review under the FDA’s Real-Time Oncology Review (RTOR) program.
In September 2022, the first patient was dosed in a Phase 2 trial evaluating nirogacestat as a monotherapy in patients with recurrent ovarian granulosa cell tumors.
Dosing is ongoing in the Phase 2b ReNeu trial evaluating mirdametinib in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN). As previously announced, this trial is fully enrolled. SpringWorks expects to provide an update on the ReNeu trial in the first half of 2023.
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

SpringWorks continues to advance nirogacestat as a potential cornerstone of BCMA combination therapy across modalities in collaboration with industry leaders.
In September 2022, SpringWorks announced that it entered into an expanded global, non-exclusive license and collaboration agreement with GSK plc (GSK) for nirogacestat in combination with belantamab mafodotin (belamaf) in patients with multiple myeloma. The expanded agreement includes the potential for continued development and commercialization of the combination of belamaf and nirogacestat in earlier lines of treatment, including in newly diagnosed multiple myeloma patients​. In connection with the expanded agreement, SpringWorks received a $75 million equity investment from GSK and is also eligible to receive up to $550 million in development and commercial milestones​. SpringWorks continues to retain full commercial rights to nirogacestat. Additionally, SpringWorks will supply nirogacestat for future belamaf clinical trials and will seek to make nirogacestat commercially available in markets where approval has been sought by GSK for a combination with belamaf. GSK continues to fund all development costs, except for those related to the supply of nirogacestat and certain expenses related to intellectual property rights.
A Phase 2 randomized DREAMM-5 study is ongoing evaluating low-dose belamaf in combination with nirogacestat in patients with relapsed or refractory multiple myeloma. In addition, two new sub-studies evaluating belamaf plus nirogacestat in combination with standard of care agents in patients with relapsed or refractory multiple myeloma have been initiated and are dosing patients: sub-study 6 (belamaf plus nirogacestat plus lenalidomide plus dexamethasone) and sub-study 7 (belamaf plus nirogacestat plus pomalidomide plus dexamethasone).
In September 2022, SpringWorks entered into a collaborative study agreement with GSK and Memorial Sloan Kettering Cancer Center (MSKCC) to conduct a Phase 1b study to evaluate the combination of belamaf and nirogacestat in patients with relapsed/refractory multiple myeloma. Malin Hultcrantz, M.D., Ph.D. will serve as the principal investigator of the study.
Biomarker-Defined Metastatic Solid Tumors

The BeiGene-sponsored Phase 1b/2 trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in adult patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors is ongoing. SpringWorks expects data from this trial to be presented at a medical conference in the first half of 2023.
The Phase 1 trial evaluating BGB-3245, a selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene, in adult patients with RAF mutant solid tumors is ongoing. SpringWorks expects data from this trial to be presented at a medical conference in the first half of 2023. BGB-3245 monotherapy is advancing into cohort expansion studies and SpringWorks expects to begin dosing a Phase 1/2a combination study of BGB-3245 and mirdametinib in the first half of 2023.
General Corporate

In July 2022, SpringWorks appointed Carlos Albán to its Board of Directors. Mr. Albán previously served as Vice Chairman and Chief Commercial Officer at AbbVie until his retirement last year and brings over 30 years of experience in global commercial strategy and operations.
In August 2022, SpringWorks sold approximately 2.25 million shares of its common stock as pursuant to its at-the-market (ATM) offering program, raising approximately $67.8 million in net proceeds. In September 2022, SpringWorks sold approximately 8.65 million shares of its common stock to a select group of institutional investors in a private placement transaction, raising approximately $216.8 million in net proceeds.
Third Quarter 2022 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $36.1 million for the third quarter, compared to $22.9 million for the comparable period of 2021. The increase in R&D expense was primarily attributable to an increase in external costs related to drug manufacturing, clinical trial and other research, and an increase in internal costs driven by the growth in employee costs associated with increases in the number of personnel, including an increase in stock-based compensation expense.
General and Administrative (G&A) Expenses: G&A expenses were $35.7 million for the third quarter, compared to $18.0 million for the comparable period of 2021. The increase in G&A expense was primarily attributable to an increase in internal costs driven by the growth in employee costs associated with increases in the number of personnel, including an increase in stock-based compensation expense as we continue to expand our operations to support the organization, and an increase in information technology costs and consulting and professional services, including legal, regulatory and compliance, as we continue to build new capabilities, including commercial.
Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $72.4 million, or $1.37 per share, for the third quarter of 2022. This compares to a net loss of $41.0 million, or $0.84 per share, for the comparable period of 2021.
Cash Position: Cash, cash equivalents and marketable securities were $651.9 million as of September 30, 2022. This includes net proceeds of approximately $67.8 million received pursuant to sales under the Company’s ATM program, net proceeds of approximately $216.8 million from a private placement in September 2022, and proceeds from an equity investment of $75.0 million from GSK in September 2022 related to the expanded global, non-exclusive license and collaboration agreement between SpringWorks and GSK.

On November 3, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the third quarter of 2022 and provided a business update (Press release, Regeneron, NOV 3, 2022, View Source [SID1234622988]).

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"We were thrilled to see positive results from the aflibercept 8 mg pivotal trials which demonstrated the potential to reduce the treatment burden for patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD)," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "Global Dupixent sales and U.S. EYLEA sales once again achieved new quarterly records, with U.S. sales of EYLEA achieving double digit year-over-year percentage growth and Dupixent was bolstered by progress on launches in pediatric atopic dermatitis, eosinophilic esophagitis, and prurigo nodularis. Our oncology portfolio was furthered strengthened by positive data updates for our growing investigational oncology pipeline."

"Our third quarter 2022 financial performance reflects strong commercial momentum across our business, highlighted by 11% revenue growth when excluding contributions from REGEN-COV and Ronapreve," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "We continued to drive shareholder value creation by realizing the benefits of our sustained investment in R&D, focusing on commercial execution, and allocating over $2.8 billion to share repurchases and business development initiatives in the first nine months of 2022."

Business Highlights

Key Pipeline Progress
Regeneron has approximately 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:

Aflibercept 8 mg

The Company announced that the primary endpoints were met in two pivotal trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD). The PHOTON trial in DME and the PULSAR trial in wet AMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week dosing regimen. Furthermore, of the patients randomized to 12- and 16-week dosing intervals, 91% and 89% of DME patients, respectively, and 79% and 77% of wet AMD patients, respectively, maintained those intervals through 48 weeks. The safety of aflibercept 8 mg was similar to EYLEA in both trials, and consistent with the known safety profile of EYLEA from previous clinical trials. The Company intends to use a priority review voucher in connection with the submission of the aflibercept 8 mg Biologics License Application (BLA) for DME and wet AMD, which is currently planned for late 2022.
EYLEA (aflibercept) Injection

The U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental BLA (sBLA) for EYLEA to treat retinopathy of prematurity (ROP) in preterm infants, with a target action date of February 11, 2023.
The FDA granted EYLEA pediatric exclusivity, extending the period of U.S. EYLEA market exclusivity by an additional six months through May 17, 2024.
Dupixent (dupilumab)

In September 2022, the FDA approved Dupixent for the treatment of adult patients with prurigo nodularis, making Dupixent the first and only medicine specifically indicated to treat prurigo nodularis in the United States.
Oncology Programs

Libtayo (cemiplimab)

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Libtayo as a monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. The European Commission is expected to make a final decision on the application in the coming months.
The Company presented positive data from the Phase 2 trial for Libtayo in neoadjuvant cutaneous squamous cell carcinoma (CSCC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022. The data were also published in the New England Journal of Medicine.
Fianlimab, an antibody to LAG-3

Positive data were presented from a Phase 1 trial studying fianlimab in combination with Libtayo in advanced melanoma at the ESMO (Free ESMO Whitepaper) Congress 2022.
Bispecific Antibodies and Costimulatory Bispecifics

The Company also presented at the ESMO (Free ESMO Whitepaper) Congress 2022 encouraging early data from the dose-escalation portions of two Phase 1/2 trials evaluating ubamatamab, a bispecific antibody targeting MUC16 and CD3, in platinum-resistant ovarian cancer; and REGN5093, a METxMET bispecific antibody, in MET-altered advanced non-small cell lung cancer (NSCLC).
Enrollment was completed in the potentially pivotal Phase 2 study of linvoseltamab, a bispecific antibody targeting BCMA and CD3, in multiple myeloma.
The Company continues to enroll patients in a Phase 1/2 study investigating REGN5678, a PSMAxCD28 costimulatory bispecific antibody, in combination with Libtayo in advanced metastatic castration-resistant prostate cancer. Preliminary clinical data from the study were disclosed in August 2022 and further detailed in Regeneron’s ESMO (Free ESMO Whitepaper) 2022 Investor Event in September 2022.
Other Programs

Inmazeb, the first FDA-approved treatment for Zaire ebolavirus, has been recognized as the "Best Biotechnology Product" of 2022 by the Galien Foundation, which acknowledges extraordinary scientific innovations that improve the human condition.
A Phase 3 study was initiated for garetosamab, an antibody to Activin A, in fibrodysplasia ossificans progressiva (FOP).
The Company and Alnylam Pharmaceuticals, Inc. announced preliminary Phase 1 data of ALN-HSD, an RNAi therapeutic targeting HSD17B13, for the treatment of nonalcoholic steatohepatitis (NASH).
Intellia Therapeutics, Inc. and the Company announced positive interim results from the cardiomyopathy arm of the ongoing Phase 1 trial of NTLA-2001, an in vivo CRISPR/Cas9 genome editing therapy, which is in development as a single-dose treatment for transthyretin (ATTR) amyloidosis.
The Company has discontinued (i) further clinical development of fasinumab, an antibody to NGF, which was previously being studied in osteoarthritis pain of the knee or hip in collaboration with Teva and Mitsubishi Tanabe Pharma; and (ii) the Phase 3 study of REGN1908-1909, a multi-antibody therapy to Fel d 1, in cat allergy, due to futility.
Corporate and Business Development Updates

Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi. Under the terms of the agreement, the Company made a $900 million up-front payment, and Sanofi is eligible to receive a $100 million regulatory milestone and up to an aggregate of $100 million in sales-based milestones upon achieving certain amounts of worldwide net product sales of Libtayo through 2023. The Company also pays Sanofi a royalty on net product sales of Libtayo.
Pursuant to an amendment to the Antibody License and Collaboration Agreement, the percentage of the Company’s share of profits used to reimburse Sanofi for its development balance reimbursement obligation increased from 10% to 20%.
The Company announced that Craig B. Thompson, M.D., was elected to the Board of Directors. Dr. Thompson most recently served as the President and Chief Executive Officer of Memorial Sloan Kettering Cancer Center (MSK) and continues to oversee the Craig Thompson Lab at MSK studying cellular metabolism and its role in disease.
Total revenues decreased 15% to $2.936 billion in the third quarter of 2022, compared to $3.453 billion in the third quarter of 2021. Total revenues excluding REGEN-COV and Ronapreve(b) revenues for both periods increased by 11% to $2.930 billion in the third quarter of 2022, compared to the third quarter of 2021(a). There have been no sales of REGEN-COV in the United States during 2022 as the Company had completed its final deliveries of drug product under its agreements with the U.S. government as of December 31, 2021.

Sanofi collaboration revenue increased by 22% to $711 million in the third quarter of 2022, compared to the third quarter of 2021. This increase was primarily due to the Company’s share of profits from commercialization of antibodies, which were $551 million in the third quarter of 2022, compared to $387 million in the third quarter of 2021. The change in the Company’s share of profits from commercialization of antibodies was driven by higher Dupixent profits, partly offset by a one-time payment of $57 million, recorded during the third quarter of 2022, in connection with the amended Antibody License and Collaboration Agreement as described above. In addition, in the third quarter of 2021, the Company earned a $50 million sales-based milestone from Sanofi based upon sales of antibodies outside the United States on a rolling twelve-month basis.

Roche collaboration revenue decreased in the third quarter of 2022, compared to the third quarter of 2021, due to lower sales of Ronapreve.

Refer to Table 4 for a summary of collaboration revenue.

GAAP and non-GAAP R&D expenses increased in the third quarter of 2022, compared to the third quarter of 2021, partially driven by the impact of the amendments to the Sanofi collaboration agreements described above. The increase was also due to higher headcount and headcount-related costs, an increase in clinical manufacturing activities, and additional costs incurred in connection with the Company’s oncology and earlier-stage pipeline.
GAAP and non-GAAP SG&A expenses increased in the third quarter of 2022, compared to the third quarter of 2021, primarily due to an increase in commercialization-related expenses for Libtayo.
GAAP and non-GAAP COGS decreased in the third quarter of 2022, compared to the third quarter of 2021, primarily due to the Company not recognizing any REGEN-COV net product sales in the United States during 2022 and the Company no longer being obligated to pay Sanofi for their share of U.S. Libtayo gross profits following the acquisition of Libtayo worldwide rights.
Other operating (income) expense, net, in the third quarter of 2022 included the recognition of $44 million (an increase to other operating income) as a result of discontinuing further clinical development of fasinumab related to the Company’s Teva and Mitsubishi Tanabe Pharma collaborative arrangements. During the third quarter of 2021, the Company recognized a cumulative catch-up adjustment of $67 million (a reduction to other operating income) arising from an update to the estimate of the total R&D costs expected to be incurred under the Sanofi Immuno-oncology collaboration agreement.
Other Financial Information

GAAP other income (expense) included the recognition of net unrealized gains on equity securities of $254 million in the third quarter of 2022, compared to $29 million of net unrealized losses in the third quarter of 2021.

In the third quarter of 2022, the Company’s GAAP effective tax rate (ETR) was 12.9%, compared to 10.2% in the third quarter of 2021. The GAAP ETR in the third quarter of 2022, compared to the third quarter of 2021, included a lower benefit from stock-based compensation and a higher benefit from the proportion of income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate (mainly due to no sales of REGEN-COV in the United States during 2022). In the third quarter of 2022, the non-GAAP ETR was 12.1%, compared to 10.8% in the third quarter of 2021.

GAAP net income per diluted share was $11.66 in the third quarter of 2022, compared to $14.33 in the third quarter of 2021. Non-GAAP net income per diluted share was $11.14 in the third quarter of 2022, compared to $15.37 in the third quarter of 2021. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

During the third quarter of 2022, the Company repurchased shares of common stock under its share repurchase program, and recorded the cost of the shares, or $913 million, as Treasury Stock. As of September 30, 2022, $1.186 billion remained available for share repurchases under the program.

2022 Financial Guidance(d)

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its third quarter 2022 financial and operating results on Thursday, November 3, 2022, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast, or register in advance and participate via telephone, on the "Investors and Media" page of Regeneron’s website at www.regeneron.com. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.