Q1 Biotech earnings highlights: Clovis, Bluebird, Rigel, Vanda
Like their big pharma and big biotech counterparts, small biotechs have been reporting first quarter earnings over the last two weeks. While many of them don’t have any revenues to speak of just yet, the earnings season provides a chance for executives to connect with investors and reassure them that programs are on track. Here are a few highlights:
The biotech reported first quarter earnings after market's close on Wednesday and gave progress updates on the launch of its closely watched PARP inhibitor Rubraca (rucaparib), which was approved by the Food and Drug Administration in December.
“[At the time of launch] 70% of Rubraca prescriptions were written by clinicians and academic institutions and about 30% were generated from community-based practices," said CEO Patrick Mahaffy on the call. "The shift to a majority of the community-based prescriptions is occurring and for the first quarter 45% of Rubraca prescriptions were from academic institutions and 55% through community-based practices."
“We anticipate that the percentage of prescriptions from community-based practices will continue to grow overtime," he added.
The cancer drug had $7 million in sales during its first full quarter on the market, above analysts’ consensus estimates of $5.2 million. According Mahaffy, there are 350 new patients on the drug and 300 unique prescribers for Rubraca. The drug is going up against AstraZeneca’s well-established PARP inhibitor Lynparza (olaparib), which was approved in 2014 and had sales of $57 million in the first quarter.
More importantly, the ARIEL3 maintenance study testing Rubraca in the more lucrative second-line maintenance setting has reached the 70% threshold of events in the BRCA cohort and topline data is expected at the end of June.
While Bluebird Bio is still trailing the other frontrunners in the CAR-T race, the biotech is making progress across a number of fronts. The company announced first quarter earnings after the close on Wednesday and gave updates on several of its programs.
The LentiGlobin program is now back on track; the company updated the manufacturing process in late-2016.
“Clinical data in 2017 (first at EHA in June, then at ASH later this year) will better define the new profile; we are encouraged by the company's progress,” wrote Piper Jaffray analyst Josh Schimmer in a note to clients.
In conjunction with its earnings announcement, the biotech revealed that it has inked two separate deals with Novartis and GlaxoSmithKline for its proprietary lentiviral vector platform. Financial details of the deals were not disclosed, but Bluebird received an upfront from both big pharmas and is eligible for milestone payments.
“Throughout 2017, we will be presenting data across all four of our clinical programs," said CEO Nick Leschly. "On our two most advanced programs in TDT and cerebral adrenoleukodystrophy, these data will dictate the timing and path for future regulatory submissions in the US and Europe. For our Phase 1/2 programs in SCD and multiple myeloma, the 2017 data will dictate the timing and path for our planned Phase 3 trials.”
Vanda Pharmaceuticals CEO Mihael Polymeropoulos updated investors on May 2 about the company’s key schizophrenia product Fanapt (Iloperidone), which is expected to “return to growth” in 2017.
Despite promises, the drug has not begun growth yet. Fanapt net product sales were $17.2 million in the first quarter, a 9% decrease compared to $18.9 million in the fourth quarter of 2016, but a 1% increase versus the year-prior.
“On Fanapt we are evaluating a broad life cycle management plan under which a number of opportunities are currently under consideration,” said the exec on the call.
During the quarter, the company successfully completed the expansion of its U.S. field reps, adding 80 for an approximate total of 130 currently.
“This is a sales force that covers the majority of the geography of the United States, leaving only a small percent of white space, and that is a big departure from the much smaller 50% sales force we had last year which left a significant white space open,” said Polymeropoulos.
The company expects flat sales in the second quarter with a return to growth in the second half.
The biotech is well into a transition from clinical-stage to commercial-stage as it hopes to gain approval from the FDA for its chronic immune thrombocytopenia (ITP) drug fostamatinib.
Rigel CEO Raul Rodriguez told investors on the May 2 call that the FDA conditionally accepted the branded name Tavalisse and that it expects notification in June for acceptance of the New Drug Application.
“The NDA was comprised of 47 clinical trials, 163 patients with ITP, over 4600 patients total and approximately 5,200 patient years of data. The NDA included, of course, sections on critical studies and manufacturing,” said Chief Medical Officer Anne-Marie Duliege.
“As an aside, if we were to actually print out the NDA submission, it would total approximately 1.6 million pages, that would stack over 500 feet high,” she added.
The company expects an advisory committee meeting to be convened around the drug and anticipates approval in early 2018. Jefferies analysts estimate the drug has a 50% to 60% chance of FDA approval.
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