Clovis Oncology (CLVS) is better off if the U.S. Food and Drug Administration rejects its lung cancer drug rociletinib.
I'm actually surprised Clovis hasn't pulled the "roci" application out of the FDA review process. The company's board has a fiduciary responsible to do what's best for shareholders, and in this case, that means not wasting additional money on roci's clinical development, or g-d forbid, actually throwing away even more money to market the drug if approved.
The insurmountable challenge facing Clovis is roci is significantly less effective than its direct competitor, the lung cancer drug Tagrisso from AstraZeneca (AZN) , which is already approved. Roci is also tied to more serious side effects, including potentially lethal heart arrhythmia, than Tagrisso.
The FDA's clinical review of roci, released Friday ahead of Tuesday's advisory panel meeting, confirms -- and amplifies -- all the bad stuff we knew about the drug already. (This inlcudes the company misleading investors about roci's benefit/risk profile.)
Less effective, less safe is a terrible profile for any drug, particularly in cancer.
If you don the rosiest of rose-colored glasses and assume FDA approves roci for the treatment of patient with lung cancer that carries the T790M mutation, the drug is a commercial zero. Clovis will waste millions of dollars hiring a sales force and marketing a drug which will lose money.
This is why I'm surprised Clovis is still trying to secure roci's approval.
Clovis' stock price opened higher Friday, which was weird, but shares are now lower by 1% to $18.98. Clovis has $16 per share in cash, so perhaps investors believe roci's is already mostly extracted from the company's value. But Clovis has significant debt on its books, too, so net cash is only around $8 per share.The financially prudent move is to drop roci altogether. That might be the ticket to Clovis recovering some of its lost market value and credibility.