On April 27, 2023 Seagen Inc. (Nasdaq:SGEN) (Seagen or the Company) reported financial results for the first quarter ended March 31, 2023 (Press release, Seagen, APR 27, 2023, View Source [SID1234630623]). The Company also highlighted performance across its approved product portfolio, development accomplishments, and progress across its differentiated oncology pipeline of innovative ADCs and targeted therapies.
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"Seagen delivered strong performance in the first quarter, with significant growth of 22 percent for both total revenue and net product sales, compared to 2022, driven by our multi-product commercial portfolio," said David Epstein, Chief Executive Officer of Seagen. "This month the FDA granted accelerated approval for PADCEV with KEYTRUDA for first-line treatment of patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin. Additionally, the NCCN Guidelines for bladder cancer were recently updated to include the combination as a preferred regimen in this setting. This new indication substantially expands the number of addressable patients for this first-in-class therapy."
"In addition, this month we presented 17 abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, including clinical and preclinical data from our early-stage pipeline," added Mr. Epstein. "At the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting we will be presenting data from more than a dozen abstracts, including an oral presentation on long-term follow-up data from the combination of PADCEV and KEYTRUDA as well as updated data for SGN-B6A, a vedotin ADC targeting integrin beta-6, which is highly expressed in multiple solid tumors. We continue to link innovation to impact as we work to optimize the potential of our commercial products, prioritize the development of our most transformational pipeline assets and develop next-generation ADC technologies through the exploration of new payloads and linkers. Together with Pfizer, we will accelerate our ability to deliver transformative cancer medicines to more patients in need around the world."
PRODUCTS HIGHLIGHTS
PADCEV
Received FDA Accelerated Approval for PADCEV with KEYTRUDA for First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer (la/mUC): In April 2023, Seagen, Astellas and Merck announced the FDA granted PADCEV (enfortumab vedotin-ejfv) with KEYTRUDA (pembrolizumab) accelerated approval in the U.S. as a combination therapy for the treatment of adult patients with la/mUC who are not eligible to receive cisplatin-containing chemotherapy. It is the first treatment option combining an ADC with a PD-1 inhibitor in this patient population. Continued approval for this indication is contingent upon verification and description of clinical benefit in the EV-302 confirmatory trial, which has completed patient enrollment. An extension study has been initiated in China which continues to enroll patients.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Bladder Cancer Updated to Include PADCEV and KEYTRUDA Combination as Preferred Regimen: In April 2023, based on the results of the EV-103 trial, the NCCN Guidelines were updated to include PADCEV with KEYTRUDA as a Preferred Regimen (Category 2A) for first-line therapy for patients with la/mUC who are not eligible to receive cisplatin-containing chemotherapy.
Biologics License Application (BLA) Accepted by China’s National Medical Products Administration (NMPA): In March 2023, the Center for Drug Evaluation (CDE) of the NMPA has accepted the BLA for PADCEV for the treatment of patients with la/mUC who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
TUKYSA
Received FDA Accelerated Approval of TUKYSA in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer: In January 2023, the FDAgranted accelerated approval to TUKYSA in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This is the first FDA-approved treatment specifically for HER2-positive metastatic colorectal cancer. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
ADCETRIS
Received Orphan Drug Exclusivity (ODE) from FDA for Pediatric Indication: ODE provides seven years of market exclusivity for the recently approved indication of ADCETRIS for children with previously untreated high risk Hodgkin lymphoma. The FDA approved this new indication in November 2022.
TIVDAK
Completed Targeted Enrollment in Global Phase 3 Clinical Trial in Previously Treated Advanced Cervical Cancer: In February 2023, Seagen and our partner Genmab completed patient enrollment in the innovaTV 301 trial evaluating TIVDAK versus investigator’s choice of chemotherapy in previously treated recurrent or metastatic cervical cancer. The trial is intended to support global registrations and potentially serve as a confirmatory trial for the accelerated approval of TIVDAK in the U.S. An extension study has been initiated in China which continues to enroll patients.
Presented Data from innovaTV 207 Trial in Solid Tumors at the AACR (Free AACR Whitepaper) Annual Meeting: In April 2023, Seagen presented data from an interim analysis of Part C from the innovaTV 207 phase 2 study of TIVDAK given every 2 weeks in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have progressed on or after prior platinum combination, immunotherapy and targeted therapy, if eligible. Preliminary data based on the first 15 patients demonstrated encouraging antitumor activity with a confirmed overall response rate of 40% and a manageable safety profile.
PIPELINE PROGRAMS
Presented Multiple Abstracts on Early-Stage Pipeline at the AACR (Free AACR Whitepaper) Annual Meeting: Early-stage pipeline data included clinical, preclinical and discovery research programs. The first clinical data was presented for SEA-TGT that demonstrated a manageable and tolerable safety profile with initial monotherapy antitumor activity in solid tumors and lymphomas. In addition, data on multiple new ADC technologies were presented. These included the first preclinical data from Seagen and Sanofi for a novel topoisomerase I inhibitor ADC targeting CEACAM5, which demonstrated potent antitumor activity in patient-derived colorectal cancer models.
For additional information on Seagen’s pipeline, visit www.seagen.com/science/pipeline.
UPCOMING DATA PRESENTATIONS
Presenting Multiple Abstracts at the ASCO (Free ASCO Whitepaper) Annual Meeting: Seagen will present over a dozen abstracts at the ASCO (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, demonstrating continued progress of the company’s clinical pipeline. Two oral presentations will highlight long-term follow-up data from a clinical trial of PADCEV in combination with KEYTRUDA, EV-103 dose-escalation and Cohort A, and initial data from a Phase 2 basket study of TUKYSA and trastuzumab in previously treated HER2-positive metastatic biliary tract cancer. Additionally, updated Phase 1 data will be presented for SGN-B6A.
CORPORATE HIGHLIGHT
Proposed Acquisition of Seagen by Pfizer: In March 2023, Seagen and Pfizer announced they have entered into a definitive merger agreement under which, on the terms and subject to the conditions thereof, Pfizer will acquire Seagen for $229 in cash per Seagen share for a total enterprise value of $43 billion. Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen’s ADC technology with the scale and strength of Pfizer’s capabilities and expertise. The Boards of Directors of both companies have unanimously approved the transaction. The companies expect to complete the transaction in late 2023 or early 2024, subject to fulfillment of customary closing conditions, including approval of Seagen’s stockholders and receipt of required regulatory approvals.
FIRST QUARTER AND THREE-MONTHS 2023 FINANCIAL RESULTS
Revenues: Total revenues for the first quarter of 2023 were $520 million, compared to $426 million for the same period in 2022, primarily driven by growth in net product sales.
Revenues included the following components:
Three months ended March 31,
(dollars in millions)
2023
2022
% Change
Total Net Product Sales
$
469
$
383
22
%
ADCETRIS
$
243
$
181
34
%
PADCEV
$
119
$
100
18
%
TUKYSA
$
87
$
90
(3
)%
TIVDAK
$
19
$
11
71
%
Royalty Revenues
$
30
$
28
7
%
Collaboration and License Agreement Revenues
$
21
$
15
38
%
Note: Sum of product sales may not equal total net product sales due to rounding. Percent change reflects actual (unrounded) values.
Net Product Sales: The increases in net product sales for the first quarter of 2023 compared to the same period in 2022 were driven by continued commercial execution. ADCETRIS performance was primarily attributed to volume growth, driven by greater use in frontline advanced Hodgkin lymphoma and an increase in diagnosis rates. PADCEV growth was primarily a result of additional eligible patients in the second-line, post-checkpoint maintenance setting for metastatic urothelial cancer, driven by continued penetration of checkpoint inhibitors in the first-line setting. TUKYSA performance reflects competitive dynamics in its breast cancer indication as well as early contributions from its colorectal cancer indication. TIVDAK growth reflects continued uptake in its current indication.
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, which is an ADC that uses Seagen technology.
Collaboration and License Agreement Revenues: The increase in collaboration and license agreement revenues was primarily driven by higher royalties from Astellas’ sales of PADCEV in its territory.
Cost of Sales: Cost of sales for the first quarter in 2023 were $112 million, compared to $88 million for the same period in 2022. The increases were primarily driven by higher sales of our medicines and the related gross profit share amounts owed to collaboration partners, which were $64 million in the first quarter in 2023, compared to $53 million for the same period in 2022. 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 first quarter in 2023 were $356 million, compared to $298 million for the same period in 2022 reflecting continued investment in clinical development of the Company’s approved drugs and pipeline programs.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter in 2023 were $236 million, compared to $174 million for the same period in 2022. The increases in 2023 were driven by ongoing commercialization efforts, as well as $30 million in expenses associated with the pending acquisition by Pfizer and other corporate activities.
Non-cash, share-based compensation expense for the three months ended March 31, 2023 was $64 million, compared to $44 million for the same period in 2022.
Net Loss: Net loss for the first quarter of 2023 was $175 million, or $0.93 per diluted share. Net loss for the first quarter of 2022 was $136 million, or $0.74 per diluted share.
Cash and Investments: As of March 31, 2023, Seagen had $1.5 billion in cash and investments.
2023 FINANCIAL OUTLOOK AND CONFERENCE CALL
Given the pending acquisition of Seagen by Pfizer, Seagen will no longer be providing financial guidance for 2023 and will not be hosting its quarterly conference call and does not expect to do so for future quarters. Earnings materials are available publicly on the Investor Relations page of our website at investor.seagen.com. Please direct any questions to Seagen Investor Relations at the contact information below.