Analyst Conference Summary

Biotechnology

conference date: April 29, 2021 @ 1:30 PM Pacific Time
for quarter ending: March 31, 2021 (first quarter, Q1)

Forward-looking statements

Overview: Continued rapid revenue growth.

Basic data (GAAP):

Revenue was $303 million down 50% sequentially from $601 million but up 76% from $172 million in the year-earlier quarter.

Net income was negative $121 million, down sequentially from $167 million and up from negative $168 million year-earlier.

EPS (earnings per share, diluted) were negative $0.67, down sequentially from $0.90, and up from negative $98 year-earlier.

Guidance:

reiterated.

Conference Highlights:

Clay Siegall, CEO said "We continue to project 2021 total net product sales in our territories of approximately $1.3 billion. Looking ahead, we expect continued global progress across the portfolio. This includes Tukysa launches in Europe following marketing authorizations received in the first quarter. In collaboration with Astellas we are pursuing several Padcev marketing applications across the United States, Europe, Japan and Latin America. In addition, we are preparing for potential U.S. launch of a fourth drug following FDA acceptance of our tisotumab vedotin BLA submission with Priority Review. We are continuing to deliver cutting-edge innovation and medicines that make a meaningful difference in the lives of cancer patients."

Note the wild swings from quarter to quarter are mainly due to collaboration revenue. Adcetris sales have been negatively impacted by the pandemic reducing diagnosis.

Adcetris (brentuximab vedotin) PTCL launch is going well in the US, seeking approvals in other nations. Adcetris sales increase mainly due to the addition of the PTCL label. Also hopes to further expand the label. Royalties mainly reflect Adcetris sales by Takeda in 67 non-U.S. 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 will be presented at the 2021 American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU) being held February 11-13. Partnered with Astellas.

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 September 2020, Seagen and Astellas announced that Padcev alone improved overall survival compared to chemotherapy in patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. The trial was stopped early due to efficacy at the planned interim analysis. Data from EV-301 will be submitted for presentation at an upcoming scientific congress. The results will be submitted to the FDA as the confirmatory trial following accelerated approval in 2019, and EV-301 is also intended to support global registrations.

Several Seagen programs will be featured in presentations at the SITC Annual Meeting 2020, taking place virtually November 9-14, 2020. Abstracts encompass preclinical findings on the ADCs Adcetris, TV and LV, as well as antibody programs SEA-TGT and SEA-CD40.

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

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. Results from the innovaTV 204 trial formed the basis of the submission. In partnership with Genmab, on a 50:50 basis.

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

In September 2020, Seagen and Merck entered into an agreement to jointly develop and equally share future costs and profits worldwide for Ladiratuzumab Vedotin. Merck made an upfront payment to Seagen of $600 million. In October 2020 Merck made a $1.0 billion equity investment in 5.0 million shares of Seagen at $200 per share. In addition, Seagen is eligible for progress-dependent milestone payments of up to $2.6 billion. [shares outstanding now 174 million]

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 Seattle Genetics pipeline.

Cash ended at $2.53 billion, down sequentially from $2.7 billion. There was no debt.

Total costs and expenses were $454 million, consisting of: cost of sales $64 million; R&D $230 million; selling, general and administrative expense $160 million. Resulting in income from operations of negative $122 million. Other income $1 million. $0 million income tax benefit.

Q&A selective summary:

Padcev Johnson syndrome? Skin reactions have been known for a long time, the label update helps physicians. The launch has been strong. Physician sentiment remains strong. It is a rare occurence.

Keytruda combination program? TV is moving along well. Current therapies for metastatic cervical cancer are poor. We are pleased with the patient enrollment of the combination, but there is no data yet. The monotherapy is currently under regulatory review.

Trodelvy competition? We are pleased patients have more options. Padcev has become a standard of care, so will be difficult to replace.

Tukysa in brain metastasis? We are seeing its use grow both with and without brain metastasis.

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