Analyst Conference Summary

Biotechnology

conference date: July 29, 2021 @ 1:30 PM Pacific Time
for quarter ending: June 31, 2021 (second quarter, Q2)

Forward-looking statements

Overview: Rapid revenue growth,

Basic data (GAAP):

Revenue was $389 million, up 28% sequentially from $303 million and up 40% from $278 million in the year-earlier quarter.

Net income was negative $85 million, down sequentially from $121 million and down from negative $21 million year-earlier.

EPS (earnings per share, diluted) were negative $0.47, up sequentially from negative $0.67, and down from negative 0.12$ year-earlier.

Guidance:

Unchanged.

Conference Highlights:

Clay Siegall, CEO said "The commercial execution across our three brands continues to be strong, achieving record quarterly net product sales for each of Adcetris, Padcev and Tukysa, as we bring these important medicines to patients around the world. We are investing in clinical trials to maximize the potential of our three approved drugs, and making strong progress with Tukysa commercialization in the European Union. Looking ahead to the remainder of 2021, Seagen is poised to add a fourth product, tisotumab vedotin, which has an FDA action date of October 10, 2021." Highest q/q growth rate in Seagen history.

In April 2021 Tisotumab vedotin BLA submitted to the FDA seeking accelerated approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. PDUFA date is October 10, 2021. Results from the innovaTV 204 trial formed the basis of the submission. In partnership with Genmab, on a 50:50 basis.

In June 2021 the FDA granted Padcev regular approval and a new indication: locally advanced metastatic urothelial cancer, second line. Also updated data for the combination with Keytruda for first line treatment.

In June 2021, Seagen updated analyses of the HER2CLIMB trial evaluating the combination of Tukysa to trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer, with and without brain metastases, at ASCO. Median overall survival for the Tukysa arm extended to two years.

Tukysa is still ramping in new nations.

Padcev is approved for bladder cancer. Full results from the phase 3 EV-301 trial and the second cohort of the pivotal phase 2 EV-201 trial for advanced or metastatic urothelial cancer were presented at the 2021 American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU) being held February 11-13. Partnered with Astellas. Padcev is in several trials to extend its label.

Tukysa first revenue was in Q2 2020. In Q4 2020 received a positive CHMP opinion. In April 2020, Tukysa was approved by the FDA in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. In September 2020, Seagen granted Merck an exclusive license to commercialize in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe.

In January 2021, the first patient was dosed in a phase 1 trial of SGN-STNV, a novel antibody-drug conjugate (ADC) targeting Sialyl Thomsen-nouveau (STN). STN is highly expressed across multiple 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.

SGN-CD30C is getting ready for the clinic, may improve on Adcetris.

See also Seagen pipeline.

Cash ended at $2.45 billion, up sequentially from $2.53 billion. There was no debt.

Total costs and expenses were $478 million, consisting of: cost of sales $78 million; R&D $235 million; selling, general and administrative expense $165 million. Resulting in income from operations of negative $90 million. Other income $5 million. $0 million income tax benefit.

Q&A selective summary:

Padcev second line label market size? We believe some patients were already getting use in that setting. We feel really great about the new label. [no number guess] We are seeing more patients becoming eligible for Padcev earlier than in the past.

Adcetris and Tukysa lack of growth given guidance? It is just hard to know what will happen because of the pandemic. We are being prudent. Q2 was a very strong quarter. We are happy to have our sales people back in the field. With Adcetris we can promote the five year data. Plus Tuysa is launching in Europe.

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