* First quarter net loss $1.43 per share
* Revenue down 25 percent to $328.4 million
* Sees 2013 Kalydeco sales $300 million to $340 million
* Shares flat
By Bill Berkrot
April 30 Vertex Pharmaceuticals Inc on
Tuesday increased by $20 million the 2013 forecast for sales of
its cystic fibrosis drug Kalydeco, and said it anticipates
seeking approval in 2014 of a CF combination therapy that has
become a focus for investors.
The new cystic fibrosis drug Kalydeco had sales of $61.8
million, up from $58.5 million in the previous quarter. The
company now expects 2013 Kalydeco sales of $300 million to $340
million, up from its prior view of $280 million to $320 million.
Vertex shares are up about 80 percent this year with most of
the gain driven by enthusiasm over data generated from a
combination of Kalydeco and an experimental cystic fibrosis drug
that the company hopes will eventually be able to help a far
larger portion of the CF population.
The company said it expects to have late stage clinical data
from the combination therapy and to file for U.S. approval next
year. Kalydeco alone works for only about 4 percent of patients
with a specific gene mutation.
Vertex said it believes the vast majority of eligible U.S.
patients were already being treated with Kalydeco, but that it
expects sales in Europe to accelerate given progress in
achieving reimbursement approvals in major European markets.
Vertex posted a net loss of $308 million, or $1.43 per
share, compared with a profit of $91.6 million, or 43 cents per
share, a year ago, due to plunging sales of the hepatitis C drug
Incivek. Excluding one-time items, such as a large charge
related to an impairment of an intangible asset, Vertex said it
earned 3 cents per share.
Incivek sales fell 74 percent from a year ago to $205.6
million and were also down from the prior quarter's sales of
After eclipsing $1 billion in sales faster than any drug in
pharmaceutical history in its first year on the market, Incivek
sales have plunged as many patients await new drugs that promise
fewer side effects and a shorter treatment duration, or have
signed up for clinical trials of new treatment combinations
being pursued by several companies, including Vertex.
RBC Capital Markets analyst Michael Yee said the Kalydeco
launch was going well. But he said the next Vertex stock jump
was likely to come from hepatitis C data expected later this
year of an experimental Vertex drug in combination with a highly
promising drug from a different class being developed by
Bristol-Myers Squibb Co that could lead to very high
cure rates for the liver disease.
"The combination data could really increase the value of
that program within Vertex's stock," said Yee, adding that it
was currently under appreciated.
Revenue for the quarter fell 25 percent to $328.4 million,
but topped Wall Street estimates of $307.9 million, according to
Thomson Reuters I/B/E/S.
The company said it still expects full-year revenue of
$1.10 billion to $1.25 billion. Analysts are looking for $1.17
After initially rising more than one percent in extended
trading, Vertex shares gave back the gain and were flat with a
Nasdaq close at $76.82.