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Amgen Legacy Drugs Drive Q1 Beat; Gilead Hep C Juggernaut Stumbles

Big biotech Amgen ( AMGN ) beat Wall Street’s Q1 estimates and raised guidance Thursday after the close, though its stock went sideways in after-hours trading. Its peer Gilead Sciences ( GILD ), however, was down sharply after a weak quarter. Amgen reported adjusted earnings of $2.90 a share, up 17% from the year-earlier quarter and 30 cents ahead of analysts’ consensus, according to Thomson Reuters. Revenue increased 10% to $5.53 billion, more than $200 million above consensus. The company lifted its full-year guidance, though not by quite as much as the Q1 beat. Its EPS range is now $10.85 to $11.20, up from $10.60 to $11. The revenue guide is $22.2 billion to $22.6 billion, vs. $22 billion to $22.5 billion. Last year, Amgen made $10.38 in EPS on $21.66 billion in revenue. Amgen’s best-selling drug Enbrel, for rheumatoid arthritis, beat expectations by growing 24% to $1.39 billion, almost $140 million above consensus, according to Evercore ISI. Its second-biggest drug Neulasta, for neutropenia, modestly beat estimates by gaining 4% to $1.18 billion. On the other hand, some of Amgen’s newer drugs came up short. Cancer drug Kyprolis grew 43% but was still $19 million shy of consensus with $154 million in sales, while newly launched cholesterol drug Repatha continued its underperformance with a $16 million take. Gilead Takes A Hit In Hep C Gilead, meanwhile, reported earnings of $3.03 a share excluding one-time items, up 3% from last year’s Q1 and 12 cents below Wall Street’s average estimate. Revenue rose 2.6% to $7.79 billion, about $325 million below consensus. Gilead nonetheless made no change to its full-year guidance, calling for $30 billion to $31 billion in product sales and 88% to 90% gross margin. Gilead’s blockbuster hepatitis C drugs Harvoni and Sovaldi accounted for most of the shortfall, though for opposite reasons: Harvoni missed badly in the U.S. but outperformed abroad, while Sovaldi did the opposite. Earlier in the day, AbbVie ( ABBV ) reported that Harvoni’s chief competitor Viekira also came up short of consensus, which the company attributed to Merck ‘s ( MRK ) unexpectedly aggressive pricing of recently launched rival Zepatier. (Merck will report its Q1 on May 5.) The quarter also brought a screeching halt to Gilead’s two-year stretch of double- or triple-digit sales and profit growth, starting with the Dec. 2013 launch of Sovaldi. Analysts expect growth will totally flatten unless the company makes a transformative acquisition. Gilead stock was down more than 6% after hours Thursday, after it closed the regular session down 3.7%, at 97.

Medical M&A Rules The Day As Abbott, AbbVie Make Buys, Sanofi Bids

Big money was moving in the medical field Thursday as three giant companies announced — or attempted — multibillion-dollar buyouts. Abbott Laboratories ( ABT ) announced an agreement to acquire fellow cardiac-device maker  St. Jude Medical ( STJ ) in a deal worth $25 billion. Meanwhile,  AbbVie ( ABBV ), which used to be Abbott’s biopharma division before it was spun out, agreed to buy biotech Stemcentrx, for $5.8 billion upfront and up to $4 billion in milestone payments. Another cancer-focused biotech,  Medivation ( MDVN ) confirmed that it had received an unsolicited $9.3 billion bid from big pharma Sanofi ( SNY ) after weeks of rumors. Abbott agreed to pay $46.75 plus 0.8708 Abbott share for every St. Jude share. Based on Abbott’s five-day average share price, the deal valued St. Jude stock at $85 apiece. Abbott said the deal will add 21 cents to its EPS next year and 28 cents the following year. It expects to save $500 million in costs from the combination by 2020. Abbott will also assume or refinance St. Jude’s $5.7 billion in debt. The move will greatly enlarge Abbott’s cardiovascular device business, which now represents 19% of its revenue. “St. Jude Medical’s strong positions in heart failure devices, atrial fibrillation and cardiac rhythm management complement Abbott’s leading positions in coronary intervention and transcatheter mitral repair,” Abbott said in a press release. “Together, the company will compete in nearly every area of the cardiovascular market and hold the No. 1 or No. 2 positions across large and high-growth cardiovascular device markets.” Leerink analyst Danielle Antalffy agreed. St. Jude’s flat-to-negative sales growth over the last few years picked up to 8% in Q1, and she wrote in a research note that it’s set up to continue, while Abbott looked to be growing only in the low single digits. Nonetheless, Abbott’s share fell 7.8% to close at 40.42, while St. Jude’s rose 25.6% to 77.79. IBD’s Take: How healthy is Abbott  Labs’ stock? Find out at IBD Stock Checkup AbbVie, Sanofi Look To Expand Their Drug Pipelines AbbVie and Sanofi, meanwhile, are both big pharmas looking to fill out their pipelines with innovative drugs as their lead products face slowdowns. AbbVie’s immunology drug Humira is one of the best-selling drugs in the world, but it patents could start expiring inside of five years. Sanofi has had to scale back expectations for its diabetes franchise as the increasingly competitive space has pushed down prices. Stemcentrx’s lead late-stage asset is called rovalpituzumab tesirine (Rova-T), and it’s already in registrational trials for small-cell lung cancer. AbbVie says that it will pay $2 billion of the $5.8 billion purchase price in cash and the rest in stock. Stemcentrx will also receive up to $4 billion in cash milestone payments if the drug successfully clears its regulatory and development hurdles. In the meantime, however, it will be a financial drain. “AbbVie expects this transaction to be approximately (20 cents) dilutive to our ongoing earnings per share in 2016, with accretion beginning in 2020,” the company said in its announcement, lowering its 2016 EPS guidance to $4.62 from $4.82. Meanwhile, AbbVie early Thursday reported Q1 earnings that beat Wall Street estimates while falling a tad short on revenue. AbbVie said that it earned $1.15 per share minus items in Q1, up 22% and two cents better than analysts expected, on $5.958 billion in sales, up 18%. Analysts polled by Thomson Reuters had expected $5.966 billion. Global Humira sales rose 19% excluding foreign-exchange impacts, AbbVie said. In a Thursday research note to investors, Evercore ISI analyst Mark Schoenebaum cited an approximately 7%, $151 million beat on U.S. Humira sales as “largely offset” by a $111 million miss on global Viekira revenue, “primarily driven by a U.S. miss, possibly due to competition from Merck ( MRK ) as well.” AbbVie put total Humira sales at $3.577 billion for Q1, with U.S. sales up 32% to $2.195 billion. Viekira, which treats hepatitis C, is AbbVie’s No. 2 drug, generating $414 million globally, or about 6.9% of total sales, AbbVie said. AbbVie stock ended 0.8% higher on the stock market today , above 61.20. Medivation Had Been Subject Of Takeover Rumors Sanofi’s unsolicited offer was for $52.50 a share cash for Medivation, making the deal worth $9.3 billion. Medivation has been the subject of takeover rumors in recent weeks, with AstraZeneca ( AZN ) and Sanofi among the rumored suitors. Medivation’s sole commercial product is prostate-cancer drug Xtandi, marketed by Japan’s Astellas. Xtandi’s success since its 2012 launch has helped drive Medivation’s stock to an excellent Composite Rating of 98. The proposed purchase price represents a premium of over 50% to Medivation’s two-month volume weighted average price before the buyout talk began, Sanofi said. Medivation stock rose 7.9% Thursday to 56.18, suggesting that investors think that bids will go higher. Sanofi stock finished down 1.8%. Image provided by Shutterstock .

AbbVie To Pay $5.8 Bil And Milestones For Stemcentrx, Diluting EPS

AbbVie ( ABBV ) says that four years will pass before it begins to accrete earnings from its $5.8 billion purchase of Stemcentrx, but AbbVie stock reversed an early loss and was up early Thursday afternoon after the companies announced the acquisition. AbbVie stock fell as much as 5.2% early in the stock market today , but it was up a fraction, near 61, in afternoon trading, 15% off a record high of 71.60 set July 21. South San Francisco, Calif.-based Stemcentrx’s lead late-stage asset is called rovalpituzumab tesirine (Rova-T), and it’s already in registrational trials for small-cell lung cancer (SCLC). AbbVie says that it will pay $2 billion of the $5.8 billion purchase price in cash and the rest in stock. Stemcentrx will also receive up to $4 billion in cash milestone payments. “AbbVie expects this transaction to be approximately (20 cents) dilutive to our ongoing earnings per share in 2016, with accretion beginning in 2020,” the company said in its announcement, lowering its 2016 EPS guidance to $4.62 from $4.82. AbbVie said that it would execute an “accelerated” share repurchase program of up to $4 billion as soon as the completion of the purchase, which is expected this quarter. Meanwhile, AbbVie early Thursday reported Q1 earnings that beat Wall Street estimates while falling a tad short on revenue. AbbVie said that it earned $1.15 per share minus items in Q1, up 22% and two cents better than analysts expected, on $5.958 billion in sales, up 18%. Analysts polled by Thomson Reuters had expected $5.966 billion. Global Humira sales rose 19% excluding foreign exchange impacts, AbbVie said. Humira is AbbVie’s best seller, generating 60% of total revenue. It treats immunological disorders, primarily rheumatoid arthritis and psoriasis. AbbVie Hep C Drug Viekira Disappoints In a Thursday research note to investors, Evercore ISI analyst Mark Schoenebaum cited an approximately 7%, $151 million beat on U.S. Humira sales as “largely offset” by a $111 million miss on global Viekira revenue, “primarily driven by a U.S. miss, possibly due to competition from Merck ( MRK ) as well.” AbbVie put total Humira sales at $3.577 billion for Q1, with U.S. sales up 32% to $2.195 billion. Viekira, which treats hepatitis C, is AbbVie’s No. 2 drug, generating $414 million globally, or about 6.9% of total sales, AbbVie said. AbbVie CEO Richard Gonzalez said the purchase of Stemcentrx is a mark of AbbVie’s “innovation in oncology, a critical component of our long-term growth and an area of significant need to millions of patients worldwide.” Stemcentrx’s trial drug Rova-T, which has been submitted to the FDA for breakthrough therapy designation too, is under investigation as a third-line treatment in SCLC, which has no approved therapy, AbbVie said. “Rova-T is the first predictive, biomarker-based therapy associated with drug efficacy in small-cell lung cancer, and that is a big deal for this difficult disease,” Charles Rudin, chief of thoracic oncology at Memorial Sloan Kettering Cancer Center, said in AbbVie’s announcement. Stemcentrx also has four novel compounds in clinical trials for triple-negative breast cancer, ovarian cancer and non-small-cell lung cancer, other compounds “advancing toward clinical trials in 2016, and a proprietary technology platform that leverages stem cell biology to identify and screen potential targets against live tumor tissue to more predictably advance discovery and development of new assets,” AbbVie said. Brian Slingerland is privately held Stemcentrx’s co-founder and CEO. Scott Dylla is co-founder and chief scientific officer.