Here is what I heard. First of all, CEO Clay Siegall shared significant clarifying language regarding today's idiotically ambiguous and misleading press release reference to Adcetris and the FDA in the retreatment environment:
- Siegall, word for word: “Let me first update you on our supplemental BLA, which was accepted for filing in May. We have had interactions with the FDA this week on the application, and we anticipate that the 16-cycle limitation on the duration of use will be removed from the Adcetris prescribing information. As a result, our label would indicate that Adcetris can be used until disease progression or unacceptable toxicity. The FDA did not approve a new label claim for Adcetris in the retreatment regimen. We are planning to discuss this further with the FDA to determine what data would be needed to support a retreatment claim…. As a reminder, our data indicate a 70 percent success rate in retreatment patients, with a manageable safety profile…. We really like our data. We’re persistent. We don’t take ‘no’ for an answer the first time.” He said he believes this is the right thing to do for patients, either by label or by [compendia] guidelines.
- At the same time, there’s been little to no pushback from insurance companies regarding patients who already have moved beyond the 16 cycles, according to another management comment.
- The Adcetris-pancreatitis flare-up of a few weeks ago: Siegall said they are studying it closely, they are keenly devoted to safety, but they see nothing out of the ordinary here. Hcited a reported incidence rate thus far of 0.16 percent.
- ADC licensing deals: About one to two deals a year “and they’ve been lucrative for us,” one manager said. “I think you’ll see a number of additional deals.” Royalties had been running in the mid to high single digits, but as the platform matures and proves itself, “it’s been going up."
- Siegall used the word “exciting” several times in reference to SGEN’s new ADC platform and AML, “one of the worst cancers there is.” In the past, the use by Siegall of “exciting” always augurs good trial results. Said the pre-trial data is some of the best he’s seen in his career.
- Guidance on Adcetris sales: They’re already heading toward the high end of the 2013 sales guidance, but “right now, it totally makes sense for us to stick where we are and stick with our guidance,” Siegall said.
- At the start of the conference call and then the Q&A portion, Siegall stammered, choked a bit and generally spoke as though he really needed a glass of water and a nap. He performed better as the Q&A continued.
That's all I heard. You can access the replay on SGEN's website and I encourage you to do so.
The pancreatitis issue is worrisome; they didn't want to go into more details on actual numbers. That's something to watch out for first line use. ASG-5ME termination is disappointing. But the new products, other Adcetris combos, and new ADC are really exciting. I'm glad that they are generating enough revenue from partnerships and sales to cover development of new pipeline drugs. I think SGEN will remain independent for awhile.