Tuesday, January 31, 2012

'The Street' on the decline of Incivek...

Posted today on The Street.com . The author believes that Incivek's sales may have peaked in the 4th quarter of 2011 at lower-than-forecasted sales numbers. This may be due to a new 'watch and wait' period as providers hold off treatment for those that they feel can wait for the 2nd generation of HCV DAA drugs which hold promise for improved tolerability and dosing schedules. Also contributing to the negative slope are those that have treated HCV patients with Incivek and found that managing patients was more hands on than they had anticipated and those providers that may have been inclined to treat, but were turned off to doing so as negative rumors circulated. Economic issues may play a factor here as well - reimbursement rates for HCV care are less-than-ideal, formulary access is spotty and the cost of treating with Telaprevir is a head-spinning sum.

Vertex Hep C Sales Growth Nears End
By Adam Feuerstein

CAMBRIDGE, Mass. (TheStreet) --Vertex Pharmaceuticals'(VRTX_) fourth-quarter earnings report Thursday may represent the high-water sales mark for the hepatitis C drug Incivek -- with prescriptions already declining just seven months after launch.

Current consensus estimate for fourth-quarter 2011 Incivek sales is $483 million, down from more than $500 million earlier this month.

If Vertex meets lowered sales expectations, Incivek will still deliver its best-ever quarter. After that, Incivek sales in the current quarter and through the rest of 2012 are expected to flatten out, perhaps fall, as doctors slow their use of the drug. Hepatitis C patients who can afford to delay treatment may wait for the arrival of new, all-oral regimens expected in 2013-2014.

Before anyone throws a pity party for Vertex, some perspective is in order. Incivek, even with flat prescriptions and sales, is still a cash-generating machine for Vertex. The drug is on pace to record close to $1 billion in sales in 2011 -- amazing since it was only approved on May 23.

In 2012, Incivek will deliver sales around $2 billion, according to the most current consensus estimate. [Vertex has not yet provided 2012 sales guidance but may do so on Thursday.] The only reason that's bad is because many investors on Wall Street tend to value quarter-over-quarter sales growth over everything else. An Incivek year with flattish sequential revenue, even if that revenue totals $2 billion, just doesn't ring the bell for many institutional investors.

Vertex shares at $34.74 are up 5% since the start of the year but are down 40% from their peak right before Incivek was approved last May. That's investors baking in Incivek's relatively short revenue stream. The worst is expected so if Incivek outperforms lowered forecasts or if competing next-generation Hep C drugs from Gilead Sciences or Bristol-Myers Squibb falter, Vertex could very easily rebound in a big way.

Vertex is not ceding the race to develop an all-oral Hep C regimen to its rivals. Later this quarter, Vertex will announce early cure rates from a phase II study of triple therapy that combines Incivek, the experimental pill VX-222 and ribavirin. In the second quarter, the company will release the first proof-of-concept data on two Hep C "nucs" licensed from Alios Biopharma.

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