Analyst Conference Summary

Biotechnology

conference date: April 28, 2022 @ 1:30 PM Pacific Time
for quarter ending: March 31, 2022 (first quarter, Q1)

Forward-looking statements

Overview: Continued strong revenue growth but still in the red.

Basic data (GAAP):

Revenue was $426 million, down 1% sequentially from $430 million and up 29% from $332 million in the year-earlier quarter.

Net income was negative $136 million, up sequentially from negative $174 million and down from $181 million year-earlier.

EPS (earnings per share, diluted) were negative $0.74, up sequentially from negative $0.95, and down from $0.67 year-earlier.

Guidance:

Unchanged.

Conference Highlights:

Clay Siegall, CEO said "This month the European Commission approved Padcev for previously treated metastatic urothelial cancer, further extending the reach of our innovative medicines for cancer patients with unmet medical needs. We look forward to presenting data from more than two dozen abstracts at the upcoming ASCO Annual Meeting, including two oral presentations demonstrating the survival advantage of Adcetris regimens in newly diagnosed patients with advanced Hodgkin lymphoma. Other upcoming milestones in 2022 include reporting results from the Tukysa pivotal clinical trial in metastatic HER2-positive colorectal cancer and Cohort K of the Padcev EV-103 trial in newly diagnosed metastatic urothelial cancer. " Expects competitive challenges to Tukysa in the U.S. even as it expands internationally.

In March 2022 the CHMP recommended the EU approve Polivy for DLBCL. Sold by Roche, it uses Seagen technology.

In March 2022 nnounced a collaboration using Sanofi proprietary monoclonal antibody technology and Seagen proprietary ADC technology for up to three cancer targets. Seagen and Sanofi will co-fund global development activities and share equally in any future profits. Sanofi will make an undisclosed payment to Seagen for each of the three targets as they are selected. The first target has been designated and an undisclosed payment was made in Q1 2022.

Tidvak for cervical cancer was approved in September 2021 and had first revenue in Q4 2021. In partnership with Genmab, on a 50:50 basis.

Collaboration revenue dropped dramatically y/y, resulting in lower total revenue.

Tukysa is still ramping in new nations.

Adcetris for newly diagnosed advanced hodgkin lymphoma reported postive Phase 3 data in February 2022. In December 2021 Phase 2 data with nivolumab, doxorubicin and dacacarbazine for stage III/IV Hodgkin lymphoma showed an 88% complete response rate.

In February 2022, initial data from the ongoing innovaTV 207 phase 2 trial of Tivdak in solid tumors were presented at the Multidisciplinary Head and Neck Cancers Symposium, demonstrating a manageable safety profile and promising preliminary antitumor activity in patients with squamous cell carcinoma of the head and neck.

In October 2022 Padcev completed enrollment of cohort K for first-line metastatic urothelial cancer, with results expected that could support accelerated registration, due in late 2022. Cohort H for muscle-invasive bladder cancer will be reported at ASCO GU Feb. 17-19.

Tuksya completed enrollment in September 2021 for Phase 2 metastatic colorectal cancer. Results expected in 2022. Will start a Phase 3 maintenance trial for HER2-positive breast cancer in Q1 2022.

Padcev regulatory process was paused in EU in Q1 2022 due to severe skin reactions. But that is a known, so working with regulators.

In January 2022, the Company initiated phase 1 clinical trials of two novel ADCs, SGN-PDL1V and SGN-B7H4V, for advanced solid tumors.

Depatuxizumab mafodotin (ABT-414) for glioblastoma Phase 3 data expected soon; collaboration with AbbVie.

Belantamib mafodotin (GSK2857916) for multiple myeloma, collaboration with GSK, regulatory submission is planned.

In April 2022, a pivotal phase 2 trial of disitamab vedotin in patients with HER2-expressing metastatic urothelial cancer began enrolling. The trial is designed to support registration under the FDA accelerated approval pathway.

See also Seagen pipeline.

Cash ended at $2.0 billion, down sequentially from $2.2 billion. There 87 million in long-term liabilities.

Total costs and expenses were $560 million, consisting of: cost of sales $87 million; R&D $298 million; selling, general and administrative expense $174 million. Resulting in income from operations of negative $133 million. Other expense $2 million. $1 million income tax.

Q&A selective summary:

Tukysa revenue guidance? Assumes assumption of HER2 approval later this year, perhaps soon. PDUFA is in May, we believe will push Tukysa into a later line of therapy.

Padcev cohort K? We have not announced a specific bar, which is up to the FDA. Patients are cisplatin ineligible.

Duration of response is importatnt for cancer therapies. Durability is a mark of immunotherapy. We saw good durability in cohort A. Padcev monotherapy has no specific comparison, it is to help understand the contribution of components.

Padcev in Europe is being commercialized by Astellas. So each drug is somewhat different in the team selling it in different regions. An issue in EU is that you need to negotiate prices in each nation after approval, so launches take longer. Also prices are usually lower in Europe than the U.S., and launching more labels usually sends your prices down.

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