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Ariad's on the Launchpad

By Keith Speights - Nov 7, 2012 at 10:20PM

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Ariad reports mixed Q3 results, but the company says it's ready to launch.

Ariad Pharmaceuticals (NASDAQ: ARIA) is on the launchpad. That's the main message from the company's third-quarter results announced on Nov. 7. The results themselves were a mixed bag. However, as the company prepares for a potential approval and subsequent rollout of ponatinib, the nuggets management revealed are just as important as the numbers from the quarter. Let's take a look at both. 

The company reported a third-quarter loss of $0.32 per share. That figure met the average analyst estimate. Revenue totaled only $85,000 for the quarter, well off the $1.11 million analysts projected.

Cash is the more important number to watch with Ariad. As of Sept. 30, the company had $206.7 million in cash, equivalents, and short-term investments. Ariad burned nearly $100 million during the first nine months of the year.

The cash burn rate increased in third quarter primarily because of higher research and development costs associated with ponatinib and AP26113. R&D costs during the quarter totaled $38.8 million, nearly doubling the level from third quarter last year. 

General and administrative costs also jumped considerably as Ariad began building its infrastructure to launch ponatinib. G&A costs for third quarter 2012 were $14.5 million, compared with $6.3 million in the same period last year.

Ariad announced on Oct. 24 that the FDA approved an accelerated review of ponatinib with a PDUFA action date of March 27, 2013. The company seems to be well positioned to take advantage of the quicker review.

If the FDA approves the drug, Ariad should be ready to hit the ground running with its sales force. CEO Harvey Berger said the company has already hired all of the account specialists for the U.S. market. According to Berger, the team averages more than 10 years of oncology and hematology experience. 

European approval for ponatinib could possibly be announced by the third quarter of 2013. Ariad is already laying the foundation for its team in Europe. Berger stated that key leadership for European operations has been hired and that the supply chain is now in place.

Berger said he was "delighted" about the potential patent expiration of Gleevec, which is marketed by Novartis (NVS 0.53%). Did he really use the word "delighted"? Yep. Berger says Ariad can learn from the experiences of Bristol-Myers Squibb (BMY 1.29%), with Sprycel, and Novartis, with Tasigna, as the companies promote those drugs for newly diagnosed chronic myeloid leukemia patients. 

We might view those statements as just a wee bit of spin, but Martin Duvall, Ariad's senior VP of commercial operations, doesn't dance around with his view of two other potential rivals. His take on Pfizer's (PFE 0.56%) bosutinib is that its is inferior in terms of toxicity profile as compared with ponatinib. Regarding Synribo from Teva Pharmaceuticals (TEVA 6.07%), Duvall doesn't think that it will present significant competition.

The pending decision from the FDA and tentative commercial launch of ponatinib stand as the most important milestones before Ariad. However, the company is also focused on enrolling patients for a phase 2 study of AP26113, a drug targeting treatment of non-small-cell lung cancer.

Ariad shares are down more than 15% from early October highs. That includes a nearly 4% drop following the announcement of third-quarter results. A few weeks ago, fellow Fool Brian Orelli gave his opinion that the ponatinib approval was probably already baked into the price to a large extent.

I think Brian is right. However, shares have gone down since that point.With this drop, Ariad just might be moving to a different launchpad -- one with dollar signs for investors.

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