or a once high-flying company that could do no wrong, Gilead Sciences has become an honest-to-goodness downer.
For the fourth time this year, the biotech has encountered a clinical trial setback and Wall Street is growing increasingly impatient while Gilead management decides how to patch its product pipeline. Although its HIV franchise remains strong, the hepatitis C drugs that motored so much growth in recent years are not delivering as before. As a result, there is mounting pressure on the company to do deals.
The latest impetus came after Gilead on late Wednesday disclosed disappointing results for a pair of Phase III trials testing a drug for combating myelofibrosis, a serious bone marrow disorder. Earlier this month, Gilead discontinued work on a heart drug. And studies were halted for a drug to treat ulcerative colitis and Crohn’s disease, and studies also ended for another drug that was to have thwarted idiopathic pulmonary fibrosis.
Gilead stock has fallen from $102.29 in late April to $76 on Wednesday, before the latest setback was announced.
The data (released by Gilead on Wednesday) “supports our view that GILD has a only a limited number of mid and late-stage pipeline assets at best that have high visibility, low competition, significant differentiation, or will come to the market in the next one to two years, wrote RBC Capital Markets analyst Michael Yee in an investor note.
Given the vagaries of the hepatitis C market – as more patients are treated, the revenue potential diminishes – and the successive R&D flops, investor expectations for Gilead have fallen. And these developments are accelerating calls for Gilead to buy its way out of its doldrums. But the central question is, when will Gilead management heed the calls?
For instance, Leerink analyst Geoff Porges wrote to investors that his outlook “for the company’s HIV business remains positive, but this is not sufficient to offset the unusual dynamics of the hepatitis C business, and the relatively modest contributions from other products offer little to mitigate the effect of the boom and bust in hepatitis C.”
“We had hoped that Gilead’s internally developed pipeline and business development investments could offset this risk, but those opportunities appear to be arriving too late, with too little value, in our view,” he continued. “Gilead’s management has missed several attractive transaction opportunities, and seems to bounce from one strategy to another when questioned by investors.”
“It now seems possible to us that they will miss the opportunity to diversify their company, portfolio, and stock away from the hepatitis C roller coaster, and investors will instead face only the modest rewards of a series of small transactions for relatively early stage assets,” he concluded.
At PiperJaffray, Joshua Schimmer took a similar view, but peppered his remarks with more optimism. The setback with the myelofibrosis trials “reinforces our view that Gilead’s low-quality, R&D engine will yield a series of setbacks which will likely force the company into a value-creating science-overhaul, pipeline reset and aggressive M&A transaction.
“While we see a broken R&D engine, the reality is that Gilead’s ‘true’ pipeline is the entire biotech industry, and the more that its internal programs fail, the more it will be forced to in-license and acquire (either one large deal, or a series of… string-of-pearls quality partnerships and acquisitions). The beauty of the biotech industry is that if you can’t build it, you can buy it. We just wish Gilead would recognize this sooner than later, but it seems quite inevitable to us; we expect management will fix this.”