PDL BioPharma (Nasdaq: PDLI) has had some slowdowns in the development of its top compounds this past year. But as its year-end financial results revealed last week, 2007 should finally bring some new developments in its top drug candidates.
Although PDL is much more than just developmental compounds Nuvion and Ularitide, these are the two most exciting drug candidates; and, at this point, they are the furthest along. These two candidates are also what PDL's near-term prospects are predicated on. As far as Ularitide goes, though, PDL had previously guided for clinical trials of the drug to begin by the fourth quarter of last year, but halted this timeline to try and partner the drug. On the conference call last week, PDL said that a partnership agreement may occur "by the end of the year or sooner."
Drug development is inherently filled with delays, but PDL better be signing a great partnership deal to justify the delay of possibly more than a year on Ularitide's development. With the thousands of people that will be needed to enroll in phase 3 trials for the drug, it is still years away from approval, and every month of delay is a month less of patent-protected sales on the drug.
More clinical data on Nuvion is coming in the first half of the year, with long-term results from previous studies expected during Digestive Disease week in May. If the phase 2 portion of its currently active study is approved by the data monitoring committee, it should move into phase 3 testing in the second quarter.
On the financial side, PDL grew sales and royalty revenue from drugs like Genentech's (NYSE: DNA) Avastin and MedImmune's (Nasdaq: MEDI) Synagis by 31% to $44 million year over year in the fourth quarter.
Going forward, PDL is guiding for revenue to gain anywhere from 8% to 21% in 2007 and for adjusted earnings of $0.38 to $0.54 a share for the year. This guidance still puts it on target for its "vision 2010" goal of 25% annualized top- and bottom-line growth, assuming it can bring Nuvion to market. With one of the pivotal Nuvion clinical trials possibly starting in a few months, we'll know soon enough if PDL can hit this goal.
PDL Biopharma is a Motley Fool Rule Breakers recommendation. A 30-day free trial will let you find out why.
Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.
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