Seattle Genetics (NASDAQ: SGEN ) announced its results from the second quarter after the market closed on Wednesday. Here are three things you need to know from the the latest update.
1. Adcetris commercialization is advancing nicely.
The company's mainstay product, Adcetris, is now approved in 35 countries with Seattle Genetics' partner Takeda/Millenium recently obtaining a regulatory thumbs-up in South Korea. Takeda also submitted for approval in Japan earlier this year.
Total revenue for the second quarter was $73.6 million, with product sales for Adcetris comprising $35.7 million. Royalties from Takeda/Millenium made up an additional $3.5 million. Net sales for the drug -- which is used to treat Hodgkin lymphoma and anaplastic large cell lymphoma, or ALCL -- climbed 5% year-over-year.
Seattle Genetics' data shows that Adcetris now has a penetration rate of more than 70%. The company feels comfortable in stating that the drug has now become the standard of care for ALCL and Hodgkin lymphoma. It also has noticed increasing use of Adcetris for off-label uses, although this isn't considered to be a significant part of the business at this point.
Recent discussions with the U.S. Food and Drug Administration led to good news and bad news. The good news is that the company thinks that the FDA will allow it to remove the 16-cycle limitation on duration of use from the Adcetris label. The bad news is that the FDA didn't approve including use of the drug in a retreatment setting. Seattle Genetics intends to pursue the retreatment option further with the agency.
2. The pipeline is percolating.
Seattle Genetics counts nine clinical studies under way for Adcetris with the hopes of expanding indications for the drug. Four of these are late-stage studies, four are mid-stage, and one is in phase 1. The company also has four other drugs in phase 1 studies.
The ongoing phase 3 study of Adcetris in treating relapsed diffused large B-cell lymphoma, or DLBCL, shows perhaps the most promise right now. Interim data found a response rate of 44%, with 81% of patients achieving tumor reduction. These positive results have prompted the company to initiate a phase 2 study for newly diagnosed DLBCL patients.
CEO Clay Siegall addressed one concern about Hodgkin lymphoma patients taking Adcetris who developed pancreatitis. Siegall said that the incidence of pancreatitis in all patients treated with Adcetris is 0.16%. He stated that this relatively low risk shouldn't impact plans for Adcetris and noted that several other cancer drugs on the market have been linked to an increased risk of pancreatitis.
3. Collaboration continues.
Nearly $34.3 million of Seattle Genetics' total revenue stemmed from payments from collaboration partners. $12 million of this figure was from a new partnership with Bayer Healthcare. Several other large companies have been attracted to Seattle Genetics' antibody-drug conjugate, or ADC, technology in recent years.
AbbVie (NYSE: ABBV ) inked a potential $245 million deal with Seattle Genetics last year. The arrangement included an upfront payment of $25 million and potential milestone payments up to $220 million. This expanded an agreement between the two companies made in 2011.
Pfizer (NYSE: PFE ) licensed Seattle Genetics' ADC technology in early 2011. The terms of the deal involved an upfront payment of $8 million with potential milestone payments of more than $200 million. However, Pfizer has also looked to others for its ADC drug development, including a license arrangement with CytomX Therapeutics earlier this year.
Meanwhile, Seattle Genetics has landed deals with smaller companies as well. Celldex Therapeutics (NASDAQ: CLDX ) collaborated with the company on its CDX-011 antibody-drug conjugate that targets treatment of breast cancer and melanoma.
Time to buy?
Seattle Genetics does seem to be loaded with potential. Adcetris sales should continue to climb. Sooner or later, I expect one or more of those collaboration deals that the company has entered into will pay off in a big way.
That being said, shares are up more than 65% so far this year. Seattle Genetics' loss from the second quarter of $0.06 per share was better than the $0.19 per share loss expected by analysts, but we're still talking about a company valued at nearly $5 billion that isn't yet turning a profit.
I like the potential of Seattle Genetics' ADC technology. Right now, though, I'm hesitant to recommend jumping aboard the stock.
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