Analyst Conference Summary

Biotechnology

conference date: October 28, 2021 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2021 (third quarter, Q3)

Forward-looking statements

Overview: Lower revenue from difficult comparison to Q3 2020 milestone payment.

Basic data (GAAP):

Revenue was $424 million, up 9% sequentially from $389 million and down 60% from $1.06 billion in the year-earlier quarter.

Net income was negative $294 million, down sequentially from negative $85 million and down from $636 million year-earlier.

EPS (earnings per share, diluted) were negative $1.61, down sequentially from negative $0.47, and down from $3.50 year-earlier.

Guidance:

Increased 2021 revenue guidance:
Adcetris $700 to $710 million;
Padcev $330 to $335 million;
Tuksa $315 to $325 million;
Royalties $140 to $150 million; collaboration $25 to $30 million.

But also increased estimated expenses.

Conference Highlights:

Clay Siegall, CEO said "We reported net product sales of approximately $1 billion for the year to date and $366 million for the third quarter of 2021, reflecting growth across our portfolio of approved medicines. We also added a fourth marketed product in September with the U.S. launch of TIVDAK, an important new medicine for women with previously treated metastatic cervical cancer. In addition to strong commercial performance, we continue to work to maximize the potential of our approved drugs through broad clinical development progress. We also expanded our late-stage pipeline by entering a collaboration with RemeGen for disitamab vedotin, a novel HER-2 targeted antibody-drug conjugate. Across our early and late-stage pipeline, we are advancing 13 programs for a range of solid tumors and hematologic malignancies, including four programs that are expected to enter the clinic within the next year."

In Q3 2021 Tisotumab vedotin or Tivdak received FDA accelerated approval 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.

Tukysa is still ramping in new nations.

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.

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.

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 $2.4 billion, down sequentially from $2.45 billion. There was no debt.

Total costs and expenses were $722 million, consisting of: cost of sales $83 million; R&D $459 million; selling, general and administrative expense $180 million. Resulting in income from operations of negative $298 million. Other income $5 million. $1 million income tax.

Q&A selective summary:

not available

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