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J&J Earnings Beat Estimates; Guidance Raised As FX Headwinds Ease

Medical giant Johnson & Johnson ( JNJ ) beat Q1 estimates and raised guidance Tuesday morning, sending its stock to its fifth recent record high. J&J reported earnings of $1.68 a share, up 8% from the year-earlier quarter and beating analysts’ consensus by 3 cents, according to Thomson Reuters. Sales rose 0.6% to $17.48 billion, matching consensus. J&J said that the foreign-exchange impact knocked 6.6 percentage points off sales growth. Nonetheless, the forex headwinds finally seem to be abating. J&J cited the improved forex outlook as the reason it was raising full-year sales guidance by $400 million, to $71.2 billion to $71.9 billion. It also added 10 cents to EPS guidance, now $6.53 to $6.68. IBD’s Take: Johnson & Johnson rated No. 1 in its group, but CR is iffy . “Our Pharmaceuticals business continues to deliver impressive levels of growth, we have steady improvement in our Consumer business, and we are seeing momentum in our Medical Devices businesses, all of which are fueling our optimism for the full-year ahead,” J&J CEO Alex Gorsky said in a statement. J&J stock was up 2% in early trading on the stock market today , touching a record high of 113.60 intraday. The stock is up more than 10% for the year so far, and it is the first of three medical stocks that are hitting new highs  and are reporting this week, the others being Intuitive Surgical ( ISRG ) this evening and Stryker ( SYK ) late Wednesday. “This morning, J&J continued the growth momentum the company has seen in recent quarters, again delivering organic sales growth acceleration and its second consecutive quarter of double-digit EPS growth on an adjusted, operational basis,” wrote Leerink analyst Danielle Antalffy in a research note. She noted that, excluding the impact of foreign exchange, M&A activity and shrinking sales of hepatitis C drug Olysio — which was made obsolete when Gilead Sciences ( GILD ) released Harvoni in late 2014 — sales rose 6.9%. Operating EPS growth was just above 10%. Credit Suisse analyst Vamil Divan wrote that the pharma sales beat was driven by the immunology franchise — Remicade, Simponi and Stelara — as well as its stroke prevention treatment Xarelto. But another top seller, diabetes drug Invokana, missed consensus by 19%. Investors had been wondering if Invokana would take a hit from Eli Lilly ‘s ( LLY ) Jardiance, which last September proved that it could dramatically cut deaths from heart failure but didn’t get a sales bump from this in Q4.

How Regeneron’s Eylea Growth, Amgen, Sanofi Deal Figure In Stock

Biotech Regeneron Pharmaceuticals ’ ( REGN ) core ophthalmology business still has huge upside as its Eylea sales grow in treating a variety of eye diseases, says RBC Capital. RBC also says that a legal settlement with Amgen ( AMGN ) over Praluent, a drug intended to lower bad LDL cholesterol, would be a positive. Most of Regeneron’s sales come from Eylea, launched in 2011 to treat age-related vision loss in the elderly. Regeneron aims to build sales of Eylea in the market for treating diabetic macular edema (DME), a cause of blindness in working-age people, as well as a related eye disease affecting older people. “Turning DME into a $2 billion to $3 billion market opportunity is important and likely,” Adnan Butt, an RBC Capital analyst, said in a research report Tuesday. In DME, Eylea competes with Roche Holding ’s ( RHHBY ) Lucentis. Regeneron typically reports earnings in early May. Roche, Novartis ( NVS ) and Bayer ( BAYRY ) report earnings on April 19, 21 and 26, respectively, and their commentary could provide insights into Eylea’s growth, says RBC’s Butt. He says that consensus expectations for the recently launched cholesterol drug Praluent, which had only $7 million in December-quarter sales, still need to come down. Amgen makes a rival drug called Repatha. In March, a federal jury upheld the validity of two Amgen patents related to the cholesterol drug, dealing a blow to Regeneron and partner Sanofi ( SNY ). “A settlement with Amgen could be a positive,” Butt said in the report. He rates Regeneron stock outperform, with a price target of 668. Regeneron stock was up more than 1.5% in early afternoon trading in the stock market today , near 402.50. Amgen reports earnings on April 28, followed by Sanofi on April 29. Their earnings calls could provide reads on the status of Praluent litigation, says Butt. Regeneron stock has plunged 26% in 2016 amid a broad sell-off in biotech stocks, including Celgene ( CELG ) and Gilead Sciences ( GILD ). Regeneron shares touched a six-month low below 349 last month but jumped on April 1 after the company announced strong phase three clinical results for dupilumab, a drug for eczema, an itchy skin condition. Regeneron is developing that drug with Sanofi. “The landmark deal with Sanofi provides $160 million per year to fund antibody discovery for eight years, gives Regeneron 50% of the profit and defers all development costs until the partnership is profitable,” added Butts. Startup Intellia Therapeutics late Monday announced a licensing deal with Regeneron. Cambridge, Mass.-based Intellia has developed “gene editing” technology to treat liver and blood diseases. It plans to go public. Regeneron has an IBD composite rating of 58 out of a possible 99, lower than both Celgene and Gilead. IBD’s Medical-Biomed/Biotech group ranks just No. 108 out of 197 industry groups. That’s down from No. 39 six months ago.  But it’s up 9.8% the past four weeks, 10th best in that span. Anika Therapeutics ( ANIK ), Supernus Pharmaceuticals ( SUPN ) and Ligand Pharmaceuticals ( LGND ) have the highest IBD Composite Ratings within the biotech group.

Gilead Sciences Broadens Liver Program With Nimbus Acquisition

Big biotech Gilead Sciences ( GILD ) added to its fatty-liver-disease portfolio Monday by acquiring a line of biotech drugs in a deal potentially worth $1.2 billion. Gilead acquired Nimbus Therapeutics ‘ Nimbus Apollo division for $400 million upfront, plus up to $800 million in milestones if Nimbus’ drugs successfully make it through the development process. And the deal seemed to spark the shares of another drugmaker targeting nonalcoholic steatohepatitis,  Intercept Pharmaceuticals ( ICPT ). Nimbus Apollo has a pipeline of  acetyl-CoA carboxylase (ACC) inhibitors, the most advanced of which is NDI-010976 for nonalcoholic steatohepatitis (NASH), a common but currently untreatable condition causing liver damage through fat buildup. Phase-one trial results for NDI-010976 are due to be presented in a couple of weeks at the annual International Liver Congress. NASH is seen by analysts as a potentially enormous untapped market, and Gilead has been compiling a portfolio of drugs in the space to build on the liver-disease infrastructure it created to sell its massively successful hepatitis C drugs. In January 2015, the company bought Phenex Pharmaceuticals for its program targeting a different receptor, on top of its in-house development simtuzumab, which is in midstage testing for NASH. “These molecules will complement and further strengthen Gilead’s pipeline and capabilities to advance a broad clinical program in NASH that includes compounds targeting multiple key pathways involved in the pathogenesis of the disease,” Gilead Chief Scientific Officer Norbert Bischofberger said in a statement Monday. Credit Suisse analyst Alethia Young wrote that Gilead probably expects NASH to ultimately be treated with a combination therapy. The ACC approach has a bit of a checkered past, however. “This is a target that has been tried before by big pharm and has failed due to binding sites and difficulties in making it a drug-able target,” Young wrote in a research note. Young also wrote that she was “not surprised” that Gilead chose to buy Nimbus Apollo instead of Intercept, which has what is generally seen as the leading contender for NASH with its drug candidate obeticholic acid (OCA). Intercept has been bandied about as a buyout target by Gilead and other players in liver disease, but analysts say it’s unlikely that anyone will buy it before OCA is approved, and certainly not before this Thursday’s FDA advisory committee meeting on OCA . Intercept stock was nonetheless up 6% in strong volume in early afternoon trading on the stock market today , near 138. Gilead stock was up nearly 1%, near 95.