Analyst Conference Summary

Biotechnology

conference date: October 27, 2022 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2022 (third quarter, Q3)

Forward-looking statements

Overview: Continuing rapid revenue ramp, still far from break-even.

Basic data (GAAP):

Revenue was $510 million, up 2% sequentially from $498 million and up 20% from $424 million in the year-earlier quarter.

Net income was negative $191 million, down sequentially from negative $135 million and up from negative $294 million year-earlier.

EPS (earnings per share, diluted) were negative $1.03, down sequentially from negative $0.73, and up from negative $1.61 year-earlier.

Guidance:

Slightly updated 2022 increased guidance to total revenue of between $1.82 and $1.865 billion. R&D expense increase to $1.3 to $1.35 billion, SG&A expense narrowed to $800 to $850 million.

Conference Highlights:

Roger Dansey, interim CEO said "Seagen delivered strong performance in the third quarter with growth across all sources of revenue, including total product net sales for both the quarter and year-to-date compared to the same periods in 2021. We also made substantial clinical development progress so far this year, reflected in the submission of multiple supplemental regulatory applications towards our goal of broadening the number of patients who could benefit from our medicines, and entered into two important strategic corporate development deals. We look forward to reporting data from across our pipeline throughout the coming year."

An Adcetris sBLA was submitted in Q3 2022 for first-line hodgkin lymphoma.

In September 2022, Seagen entered into an agreement with Lava Therapeutics to develop and commercialize LAVA-1223, a preclinical gamma delta bispecific T-cell engager for EGFR-expressing solid tumors. Seagen received an exclusive global license and has the opportunity to exclusively negotiate rights to apply Lava’s proprietary Gammabody platform on up to two additional tumor targets.

In Q3 2022 Seagen submitted an sBLA to the FDA for Padcev with Keytruda for first-line advanced urotheial cancer.

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.

In Q3 2022 the FDA accepted an sNDA for Tukysa (combined with trastuzumab) for previously treated HER2+ metastatic colorectal cancer. The PDUFA date is January 19, 2023.

In July 2022 the patent office denied Daiichi's request for a patent review. A US District Court had found that the patent was willfully infringed and had awareded damages of $41.8 million to Seagen, which is now requesting a royalty on future sales.

Tukysa is still ramping in new nations. In July 2022 Tukysa plus Trastuzumab reported positive Phase 2 results in HER2-positive metastatic colon cancer at ESMO. The FDA granted breakthrough therapy designation in July. And the Tuksya plus Kadcyla Phase 2 HER2+ breast cancer trial completed enrollment.

Adcetris for newly diagnosed advanced hodgkin lymphoma reported postive Phase 3 data in February 2022 and published full results in July. In June 2022 reported positive Phase 3 retuls for children for Hodgkin lymphoma, when combined with chemo..

In July 2022, Seagen and Astellas announced positive topline results from the phase 1b/2 EV-103 clinical trial (KEYNOTE-869) Cohort K evaluating Padcev (enfortumab vedotin) in combination with Merck's anti-PD-1 therapy Keytruda as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-based chemotherapy. In patients treated with enfortumab vedotin and pembrolizumab, results demonstrated a 64.5% confirmed objective response rate (95% CI: 52.7 to 75.1). Seagen plans to submit a BLA to the FDA for accelerated approval later in 2022.

In April 2022, Seagen and Astellas announced the EU approval of Padcev as a monotherapy for advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. Additionally, in the second quarter of 2022, Padcev was approved for la/mUC in Australia, Brazil, Great Britain and Singapore.

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.

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.

See also Seagen pipeline.

Cash ended at $1.76 billion, down sequentially from $1.9 billion.

Total costs and expenses were $703 million, consisting of: cost of sales $108 million; R&D $384 million; selling, general and administrative expense $210 million. Resulting in income from operations of negative $193 million. Other income $4 million. $2 million income tax.

Q&A selective summary:

Tukysa competition, growth opportunity? In HER+ breast shift is to second line in front of Tukysa, so reduced patient flow into 3rd line. But we will retain our 2nd line foothold.

Extension to combo Tukysa with Kadcyla? Includes brain metastasis population. If trial is successful we see increased Tuksya use in that population.

Padcev? EV-302, combo with Keytruda, confirming trial is well enrolled and should help if positive data. We will also be focussing efforts on breast cancer.

CEO search? The board is making good progress, but no timeframe yet.

Tukysa basket study timeline? Basket trial data is with Padcev, will be presented in 2023. The other is with Tivdak, which should give multiple possible positive outcomes.

We are not seeing switches away from Tukysa, we are seeing doctors sequencing patients based on their particular situations. We have seen about one-third of patients stay on therapy for a period of time.

Adcetris future? It has been on the market about 10 years, its use has normalised back to pre-pandemic levels. We see continued incremental growth in front-line. Adcetris plus Keytruda in solid tumors in PD1 failed patients, melanoma and non-small cell lung cancer, because Adcetris has the potential to be an immunomodulator. A. can remove T-regs from the environment. Now looks like first data will be in 2023.

Inflation reduction acts effects on plans? It is a negative event for innovation. We are a large molecule company, which is treated more favorably. Oncology uses accelerated approval, but addressable populations are small. It takes time to build indications and revenue. Might have to target larger potential populations. The inflation cap will be taken into account in our 2023 guidance.

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