Exelixis (EXEL 1.96%) sold $7.4 million worth of Cometriq and lost $58 million in the fourth quarter.
With that out of the way, let's move on to more important matters.
Because, let's face it, Exelixis could have sold half as much Cometriq or twice as much and it wouldn't noticeably affect the biotech's valuation. There's just no way Cometriq, which is approved for thyroid cancer, is going to get to blockbuster status -- or anything remotely close -- without expanding into other tumor types.
The loss is important, but only so far as to make sure Exelixis doesn't run out of cash. The biotech ended the year with $243 million, which management believes is enough to get through 2015. That's more than enough time to make it to the next two major value-creating events -- or destroying, but let's try to keep this positive.
Exelixis expects results in the second quarter from the Meteor clinical trial testing Cometriq against Novartis' (NVS 1.01%) Afinitor in patients with kidney cancer who have failed at least one other treatment.
Based on early clinical trials, Exelixis is expecting five months of median progression-free survival, or PFS, for patients receiving Afinitor and 7.5 months for those getting Cometriq. The trial enrolled 650 patients, but, since the data reads out after 259 events in either arm, only the first 375 will be used in the measurement of PFS, so the late enrollers in the trial that have short PFS don't drag down the median time.
Being able to beat Afinitor, the market leader in second-line kidney cancer, with a 50% increase in PFS would be huge. Management thinks the indication is a $1 billion opportunity; even if Exelixis only captures half of that, sales would tower over what Cometriq is producing now in thyroid cancer.
On the conference call, management disclosed plans to license rights to Cometriq outside the United States. Talks with potential partners began in January, but it sounds like a deal wouldn't be completed until the Meteor trial data were available. While it's clearly riskier to wait for the data, the upfront payment, which Exelixis can use to pay to expand its U.S. sales force, will be much higher with positive clinical trial data in hand.
A few months after the Meteor trial reads out -- on or before Aug. 11 -- Exelixis should get word on whether the Food and Drug Administration will approve its second drug, cobimetinib, which is partnered with Roche's Genentech group. The drug is up for approval as a treatment for advanced melanoma patients with tumors that contain a BRAF V600 mutation.
There's a lot of new competition for melanoma patients, so it'll be hard for Roche and Exelixis to make cobimetinib into a blockbuster in that indication alone. Fortunately Roche is testing the drug in other tumor types including in combination with Roche's anti-PDL1 antibody MPDL3280A. Early data from that trial will read out this year.
This year will bring a lot of binary events for Exelixis. Let's hope they're more positive than 2014's events.
