On October 27, 2022 Seagen Inc. (Nasdaq:SGEN) reported that financial results for the third quarter ended September 30, 2022 (Press release, Seagen, OCT 27, 2022, View Source [SID1234622481]). The Company also highlighted PADCEV (enfortumab vedotin-ejfv), TUKYSA (tucatinib), ADCETRIS (brentuximab vedotin) and TIVDAK (tisotumab vedotin-tftv) commercial and development accomplishments, as well as progress across its deep and diverse oncology pipeline.
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"Seagen delivered strong performance in the third quarter with growth across all sources of revenue, including total product net sales for both the quarter and year-to-date compared to the same periods in 2021," said Roger Dansey, M.D., interim CEO and Chief Medical Officer. "We also made substantial clinical development progress so far this year, reflected in the submission of multiple supplemental regulatory applications towards our goal of broadening the number of patients who could benefit from our medicines, and entered into two important strategic corporate development deals. We look forward to reporting data from across our pipeline throughout the coming year."
PRODUCTS HIGHLIGHTS
PADCEV
Presented Positive Results for the Combination of PADCEV and KEYTRUDA (pembrolizumab) as First-Line Treatment for Advanced Urothelial Cancer at the European Society for Medical Oncology Congress; Submitted Supplemental Biologics License Application (sBLA) to U.S. Food and Drug Administration (FDA): In September 2022, Seagen, Astellas and Merck announced the presentation of data from the phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869) Cohort K evaluating PADCEV in combination with Merck’s anti-PD-1 therapy KEYTRUDA as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-based chemotherapy. The results for the combination demonstrated an encouraging overall response rate of 64.5% and a manageable safety profile. The median duration of response was not reached. The results served as the basis for a sBLA submitted to FDA in October 2022 under the FDA’s Accelerated Approval Program.
TUKYSA
TUKYSA in Combination with Trastuzumab Granted Priority Review by FDA for Previously Treated HER2-Positive Metastatic Colorectal Cancer: In September 2022, FDA accepted for Priority Review the supplemental New Drug Application (sNDA) seeking accelerated approval for TUKYSA in combination with trastuzumab for adult patients with HER2-positive colorectal cancer who have received at least one prior treatment regimen for unresectable or metastatic disease. The sNDA submission is based on the results of the pivotal phase 2 MOUNTAINEER trial and the FDA target action date is January 19, 2023.
ADCETRIS
Submitted to the FDA Overall Survival Data with ADCETRIS Combination for Patients with Previously Untreated Advanced Hodgkin Lymphoma: In September 2022, longer-term follow-up data from the phase 3 ECHELON-1 clinical trial were submitted in a sBLA to FDA for inclusion in the label. The data demonstrated that ADCETRIS in combination with chemotherapy resulted in a 41% reduction in risk of death versus standard of care in patients with previously untreated advanced Hodgkin lymphoma.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Hodgkin Lymphoma Updated Elevating ADCETRIS Combination to Category 1, Preferred Recommendation: In September 2022, based on the overall survival benefit of ADCETRIS in combination with chemotherapy that was demonstrated in the ECHELON-1 trial, the NCCN Guidelines were updated elevating the ADCETRIS combination to Category 1, Preferred treatment option for adults with previously untreated Stage III or IV Hodgkin lymphoma with no known neuropathy. Category 1, Preferred is the highest recommendation by NCCN, indicating that based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
TIVDAK
Entered into Regional Strategic Collaboration with Zai Lab: In September 2022, Seagen announced an exclusive collaboration and license agreement with Zai Lab for the development and commercialization of TIVDAK in mainland China, Hong Kong, Macau, and Taiwan.
PIPELINE PROGRAMS
Entered into Worldwide License Agreement with LAVA Therapeutics: In September 2022,Seagen entered into an agreement with LAVA Therapeutics to develop and commercialize LAVA-1223, a preclinical gamma delta bispecific T-cell engager for EGFR-expressing solid tumors. Seagen received an exclusive global license for LAVA-1223 and has the opportunity to exclusively negotiate rights to apply LAVA’s proprietary GammabodyTM platform on up to two additional tumor targets.
Presenting Data Highlighting Novel Targeted Therapies at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting: Initial phase 1 clinical data will be presented on SGN-B6A, a novel antibody-drug conjugate (ADC) in development for solid tumors. In addition, Seagen will present preclinical research from several other early-stage programs, including SGN-BB228, an Anticalin-based bispecific antibody. The SITC (Free SITC Whitepaper) Annual Meeting is taking place November 8-12, 2022.
For additional information on Seagen’s pipeline, visit www.seagen.com/science/pipeline.
CORPORATE HIGHLIGHTS
Published Annual Corporate Responsibility Report: In October 2022, Seagen published its second annual Corporate Responsibility Report providing an update on its ESG (environment, social, and governance) efforts, achievements and future commitments. The report is available on the Seagen website at www.seagen.com.
THIRD QUARTER AND NINE-MONTHS 2022 FINANCIAL RESULTS
Revenues: Total revenues for the third quarter and nine months ended September 30, 2022 were $510 million and $1,434 million, respectively, compared to $424 million and $1,145 million for the same periods in 2021. Revenues in the 2022 periods reflected higher net product sales across the Company’s commercial portfolio.
Note: Sum of product sales may not equal total net product sales due to rounding. Percent change reflects actual (unrounded) values. NM = Not meaningful.
Net Product Sales: The increases in net product sales for the third quarter of 2022 compared to the same period in 2021 were driven by continued commercial execution. ADCETRIS growth was related to greater use in frontline advanced Hodgkin lymphoma, increase in diagnosis rates, and favorable pricing dynamics. PADCEV growth was a result of additional eligible patients in the second-line, post-checkpoint maintenance setting for metastatic urothelial cancer. TUKYSA performance reflects competitive dynamics in its current indication. TIVDAK commercialization began in the U.S. following FDA approval in September 2021.
Royalty Revenues: Royalty revenues were primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda as well as royalties from sales of Polivy (polatuzumab vedotin) by Roche and Blenrep (belantamab mafodotin) by GSK, which are ADCs that use Seagen technology.
Collaboration and License Agreement Revenues: The increase in collaboration and license agreement revenues was driven by a $30 million upfront license fee from Zai Lab in the third quarter of 2022 related to a regional collaboration for development and commercial for TIVDAK. In addition, the increase reflects clinical milestones and payments from other ADC collaborators, royalty contribution from Astellas’ sales of PADCEV in its territory, as well as higher amounts of drug product supplied to a collaborator for the year-to-date in 2022.
Cost of Sales: Cost of sales for the third quarter and year-to-date in 2022 were $108 million and $302 million, respectively, compared to $83 million and $225 million for the same periods in 2021. The increases were primarily driven by higher sales of our medicines and the related gross profit share amounts owed to collaboration partners, which were $71 million and $189 million in the third quarter and year-to-date in 2022, respectively, compared to $45 million and $116 million for the same periods in 2021. Cost of sales also reflects amortization of TUKYSA acquired in-process technology costs, third-party royalties owed for PADCEV and TUKYSA net product sales, and cost of products sold.
Research and Development (R&D) Expenses: R&D expenses for the third quarter and year-to-date in 2022 were $385 million and $987 million, respectively, compared to $459 million and $924 million for the same periods in 2021 reflecting continued investment in clinical development of the Company’s approved drugs and pipeline programs, and a $50 million upfront fee to LAVA Therapeutics in the third quarter of 2022. The 2021 periods included the $200 million upfront license payment owed to RemeGen related to our agreement to obtain exclusive rights to disitamab vedotin.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the third quarter and year-to-date in 2022 were $210 million and $605 million, respectively, compared to $180 million and $505 million for the same periods in 2021. The increases in 2022 were driven by ongoing commercialization efforts, costs from legal proceedings with Daiichi Sankyo, and other corporate activities.
Non-cash, share-based compensation expense for the nine months ended September 30, 2022 was $157 million, compared to $121 million for the same period in 2021.
Net Loss: Net loss for the third quarter of 2022 was $191 million, or $1.03 per diluted share, and net loss for the year-to-date in 2022 was $462 million, or $2.51 per diluted share.
Net loss for the third quarter of 2021 was $294 million, or $1.61 per diluted share, and net loss for the year-to-date in 2021 was $500 million, or $2.75 per diluted share.
Cash and Investments: As of September 30, 2022, Seagen had $1.8 billion in cash and investments.
2022 FINANCIAL OUTLOOK
Seagen anticipates 2022 revenues, operating expenses and other costs to be in the ranges shown in the table below. Updates reflect changes in expectations for net product sales, royalties, and collaboration and license agreement revenues, as well as R&D expenses, and SG&A expenses.
Conference Call Details
Seagen management will host a conference call and webcast with supporting slides to discuss its third quarter 2022 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be simultaneously webcast and available for replay from the Seagen website at investor.seagen.com. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or 412-717-9224 (international). The conference ID is 10171976. Supporting slides are available on the Seagen website at investor.seagen.com under the Investors section. A webcast replay will be archived on the Company’s website investor.seagen.com, under the Investors section.