Tag Archives: hcv

Gilead Sciences Takes Lumps From Wall Street After Q1 Miss

Big biotech Gilead Sciences ( GILD ) got a downgrade and several price-target cuts Friday after its Q1 report missed expectations , sending its stock tumbling. Maxim Group analyst Jason Kolbert downgraded Gilead to hold from buy, noting that the record-breaking launches of hepatitis C drugs Sovaldi and Harvoni were coming up against competition and tough year-over-year comparisons. “New patient numbers increased … but product margins per patient were lower as a result of: 1) increased HCV price competition ( Merck ‘s ( MRK ) Zepatier); 2) an increased discount rate; and 3) higher-than-expected rebate claims,” Kolbert wrote in his research note. “While management believes that HCV products have stabilized (the U.S. market share is at about 90%), we are not so sure.” Leerink analyst Geoffrey Porges lowered his price target on Gilead to 123 from 127 but maintained an outperform rating. He noted that the company still has a huge reserve of cash, and wrote that the HCV franchise was eroding earlier then expected but it was presumed to decline in a few years anyway. “As a result, our EPS estimates fall 8%-10% through 2017, but only 3% beyond,” he wrote in his research note. UBS analyst Marc Goodman also kept his buy rating while lowering his price target to 118 from 130, writing that he’s “willing to have a little patience.” “The (HCV) category still has years ahead of stable patients,” Goodman wrote. “The issue remains; what’s next? … At this valuation, we will try to remain patient.” Gilead stock was down 7.5% in afternoon trading on the stock market today , below 90. On the positive side for Gilead, the company said Friday that the EU’s Committee for Medicinal Products for Human Use, which advises Europe’s equivalent of the FDA, had endorsed approving Odefsey, the company’s newest four-drug combo pill for HIV. The combo includes TAF, known on Wall Street as “son of Viread” as it represents an upgraded version of Gilead’s legacy blockbuster Viread, which is due to go off patent in the near future.

Gilead, Biogen Down On Patent Rulings; Ionis, Merck, Forward Rise

Big biotechs Gilead Sciences ( GILD ) and Biogen ( BIIB ) were both trading down Wednesday morning after receiving unfavorable patent news. Late Tuesday,  Ionis Pharmaceuticals ( IONS ) said that it and its big pharma partner Merck ( MRK ) had won a case alleging that Gilead’s hepatitis C virus (HCV) drug sofosbuvir, which is sold individually as Sovaldi and as an ingredient in Harvoni, infringed on patents that Ionis and Merck had obtained from earlier research. “We used our expertise in a 1998 collaboration with Merck to discover and develop modified nucleosides that benefit patients with HCV,” said Ionis CEO Stanley Crooke in the press release . The case goes back to 2013, when sofosbuvir was on the verge of FDA approval and Merck sought a 10% royalty on sales from Gilead. Gilead sought a judgment invalidating the patents, though it conceded that it had infringed them. The case went to a jury, which ruled Tuesday that the patents were in fact valid. There was no word on damages, though Ionis said that it’s entitled to 20% of the damages. Leerink analyst Geoffrey Porges said that the awards won’t be huge and that more litigating would delay them. “We continue to expect that any damages awarded in this case will be relatively modest, the equivalent of a single-digit royalty, significantly less than the 10% Merck was seeking,” Porges wrote in a research note. “In spite of whatever damages the jury awards Merck, Gilead has already indicated that it will appeal.” Ionis stock popped to an eight-week high of 46.05 early on the  stock market today , though midday it was down a fraction, near 41.50. Gilead stock, though, was down more than 3% near 90, while Merck was up a fraction near 53. Patent Office Will Review Biogen’s Tecfidera Biogen stock, meanwhile, was off 1.2%, near 257, in midday trading Wednesday, after the U.S. Patent and Trademark Office (USPTO) reversed an earlier decision and decided to review a patent on Biogen’s top-selling drug, Tecfidera. Hedge-fund manager Kyle Bass filed the request for a review; last year, he launched an unusual short-selling strategy by filing such requests on a number of blockbuster drugs, which he said had “BS patents.” The USPTO initially denied his request in September, but on Tuesday it changed its tune. Coincidentally or not, European Union authorities earlier this month invalidated the European equivalent of the same patent , which expires in 2028. In addition, Forward Pharma ( FWP ) is separately challenging the patent; its stock was up 4% near 17 in midday trading Wednesday. “Today’s decision is just a first step in the (review) process, and nothing happens yet in the USA, and as of today Tecfidera still enjoys 10-year exclusivity in EU (would protect it to 2024 in EU),” wrote RBC Capital Markets analyst Michael Yee in a research note. “Even though the … patent expires in February 2028, consensus did not assume this would get full protection and already assumed/expected generics to launch at some point.”

Gilead Seen Staying Top Dog In HCV, But Merck Rising

On Wednesday, the morning after the annual Liver Meeting wrapped up in San Francisco, Wall Street analysts sifted through the implications of the data rolled out there for the vast hepatitis C market. Analysts saw continued dominance for Gilead Sciences (GILD) in genotype 1 of the hepatitis C virus (HCV), which accounts for the majority of cases. Gilead’s Harvoni, a combination of sofosbuvir (sold separately as Sovaldi) and ledipasvir, is already