Former CEO, Seagen
Seattle Genetics CEO on Q1 earnings, Padcev bladder cancer drug
Seattle Genetics CEO Clay Siegall discussed early reception of Padcev, an antibody-drug conjugate for bladder cancer that received FDA approval in December.
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About Clay Siegall
Clay Siegall, co-founder and former CEO of Seagen (formerly Seattle Genetics), has described the company's focus on developing antibody-based cancer therapies. In a 2022 talk, he stated that the company's concept is "to make a difference in the life of cancer patients" using antibody drug conjugates. He noted that the company's first product, Adcetris, was approved by the FDA in 2011 and was available in 47 countries as of 2022. Siegall also discussed the company's patient assistance program, CGEN Secure, which he said was created to help with copay costs for patients in the United States and Canada. In a 2020 interview, Siegall discussed the early reception of Padcev, an antibody-drug conjugate for bladder cancer that received FDA approval in December 2019. He stated that the drug was "very active" and that doctors were "embracing it." Siegall reported a 73% objective response rate in a trial combining Padcev with tucatinib for first-line patients, calling the data "spectacular" but noting that larger trials were needed. He also mentioned that the company had submitted tucatinib data to the European Medicines Agency and was nearing approval in several other territories through Project Orbis.
Transcript (16 segments)
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Jim Cramer0:11
Nearly 30 percent for this year, including a six percent gain today. Here's about that company with a platform that uses antibodies to seek out and destroy cancer cells without causing a ton of collateral damage to the rest of your body. So many of these drugs do. Their first product is a lymphoma treatment that was up 22 percent in sales in the latest quarter. But the big thing here is their two new therapies: Padcev for bladder cancer and Tukysa, which is part of a cocktail for certain types of breast cancer. We know the cocktail from what Dr. Fauci has been talking about to go against COVID. Now Seattle Genetics reported yesterday morning and didn't get much fanfare, but the stock is up today because I'm further viewing Padcev blowing up. I mean, this trial expected to do 8 million.
Chairman and CEO of Seattle Genetics, but I'm worried about the quarter of the puppies. Dr. Siegall, welcome back to Mad Money.
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Clay Siegall1:17
Thank you, Jim. Very happy to be on your show.
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Jim Cramer1:19
So Dr. Siegall, how is it possible that a drug that people, I saw some estimates might be 7 million, some be 8 million, did 35 million? And what does that bode for what this drug could do?
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Clay Siegall1:32
Well, Padcev is a drug for metastatic bladder cancer. We got approved right at the end of last year, so this is really the first full quarter of sales. And we'll move from here and continue selling it, providing it to patients really in need with metastatic bladder cancer, which is a really bad prognosis. The drug works differently than chemotherapies and some immune therapies, but it's a really bad disease. Once it's metastatic, most patients succumb to the disease within five years. It's a very short time horizon for patients, and we really like our drug Padcev. It's really helping patients.
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Jim Cramer2:31
So is the word out worldwide? I mean, it seems like that's pretty early. If people thought it was 8 million to 35, it must have spread like wildfire throughout the medical community. This is the drug you use.
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Clay Siegall2:40
Well, we're just approved in the United States right now. We were approved about three months ahead of the action date that the FDA set for us. They worked very closely with us, breakthrough designation. But we're trying to finish up a study that is very active, and we're using it in a regimen in first diagnosis where we've already come up with some data that was, quite frankly, spectacular. But that was a small data set. Now we have to go and prove it in bigger data sets. So we have two trials running: one is a little smaller, one is bigger. One is focused on the United States, one is global, to try to get it to frontline approval and get it out there to change the life history of patients with bladder cancer.
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Jim Cramer3:42
So is there any expectation for it? Is it maintenance? Can someone live for a long time, do you think, with bladder cancer?
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Clay Siegall3:49
Well, we haven't yet gotten a full dataset on overall survival. So I don't want to speak until we have the data. We're very excited about this drug. With a drug called Keytruda plus Padcev, we had a 73% objective response rate, which is way above anything ever seen in this. And after a year, we did not hit our median time for even progression. So it looks like if the data are followed and done in a bigger trial, perhaps we'll have the kind of data you're looking for. But I don't want to speak until we have the data.
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Jim Cramer4:40
Is Merck a good partner in Keytruda?
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Clay Siegall4:44
Merck is a good partner. This drug is partnered on a global basis with Astellas. We're heading up more of the Americas, and they're heading up the rest of the world. But we work very closely with Astellas.
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Jim Cramer5:10
I know it's early, but what is your feeling for that drug Tukysa?
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Clay Siegall5:15
Tukysa is a great drug. It was approved four months ahead of the FDA action date and approved in a way where we have a really good label. The label allows doctors to write prescriptions, and it really could help a lot of patients. With Tukysa, we do have survival data, and we have data in patients that have brain metastases in breast cancer. We're focused on HER2-positive breast cancer. About half the patients can develop brain metastases as their disease progresses, and often you can die from the brain metastasis. It's not the original diagnosis of the tumor in the breast region. So it is really important to treat patients in this area. Tukysa is going to become a global drug really soon and help a lot of patients with breast cancer and brain metastasis.
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Jim Cramer6:26
This is remarkable. I mean, to have not just one but two within such a short period of time, congratulations to you. This is just an incredible thing for Seattle Genetics.
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Clay Siegall6:36
Well, it's been about four months since our last approval. I brought my team together and I said, 'So in four months, are we gonna have another drug?' And I got a lot of quiet faces. And I started to laugh. You can't make a drug every four months, but I tested my team. I'm lucky, I'm fortunate that we have a great team.
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Jim Cramer7:11
President, Chairman, CEO of Seattle Genetics. Look, I gotta tell you guys, this is a much better story than I had thought of even a year ago. It's actually quite remarkable. Their minds back into brain. Don't miss a second of Mad Money. Follow @JimCramer on Twitter. Have a question? Tweet Cramer hashtag MadTweets. Send him an email to [email protected] or give us a call at 1-800-743-CNBC. Miss something? Head to MadMoney.cnbc.com.