Friday, December 7, 2018
Mallinckrodt generics spin-off ‘least bad outcome,’ says Piper Jaffray
In a research note titled “The Least Bad Outcome for the Generics Business,” Piper Jaffray analyst David Amsellem reiterates an Overweight rating on Mallinckrodt with a $39 price target. Given that the generics segment is almost entirely a commodity business, Mallinckrodt not finding a buyer for its active pharmaceutical ingredient and specialty generics businesses is not all that surprising, Amsellem tells investors in a research note. He views yesterday’s news of the company announcing a spin-off as the “least bad” outcome. The analyst reiterates an Overweight rating on Mallinckrodt with a $39 price target.
https://thefly.com/landingPageNews.php?id=2833509
Fresenius Expects to Miss 2020 Targets on Revised 2019 Outlook
Fresenius adjusted its mid-term guidance late on Thursday, saying the company no longer expects to meet group targets for 2020 after updating its forecast for next year.
The German health-care company said it expects to see mid-single-digit organic sales growth for 2019, with net income remaining “broadly stable” from 2018.
The company’s previously expected group sales to increase at a compounded annual growth rate of 7.1% to 10.3% through 2020, with group net income increasing at a CAGR of 8.3% to 12.6%.
Fresenius said it expects to generate sustainable organic sales growth in the mid-single-digit range from 2020 onward, with group net income expected to grow faster than sales on an organic basis.
Among the group’s individual units, Fresenius Medical Care–a provider of dialysis products and services–should generate sales growth and net income in 2019 in line with the levels recorded in 2018, the company said.
It forecasts that the Fresenius Kabi division–an essential drugs and medical device supplier–will deliver mid-single-digit organic sales growth and “low- to mid-single-digit” growth in earnings before interest and taxes next year.
Fresenius Helios, the group’s hospital operator unit, expects EBIT to contract at a low- to mid-single digit rate next year, as growth in Spain will be unlikely to offset “headwinds” in Germany resulting from regulatory changes, Fresenius SE said.
The group said it expects to propose a dividend increase for 2018 in line with earnings growth, as well as a further dividend increase in 2019.
The company will release detailed financial guidance for 2019 and on its mid-term targets alongside full-year results for 2018 on Feb. 20.
Cooper fundamentals strong despite currency headwinds, says Piper Jaffray.
Piper Jaffray analyst Matt O’Brien raised his price target for Cooper Companies to $300 from $280 following the company’s “mixed” Q4 results. Revenue beat expectations but earnings came in light due to currency and some transitory product costs, O’Brien tells investors in a post-earnings research. Further, the company’s guidance for 2019 was below the Street largely due to a negative currency outlook, adds the analyst. However, O’Brien believes the fundamentals of Cooper’s business remain strong. He points out that currency related selloffs typically represent good buying opportunities and keeps an Overweight rating on Cooper Companies.
https://thefly.com/landingPageNews.php?id=2833497
Pfizer : Receives Six Months Pediatric Exclusivity for LYRICA® pregabalin
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for LYRICA®. This grant extends the period of U.S. market exclusivity for LYRICA by an additional six months, to June 30, 2019 (see also Pfizer Inc.).
LYRICA is currently approved in the U.S. for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults. LYRICA is also approved as adjunctive therapy for the treatment of partial onset seizures in patients four years of age and older.
The pediatric exclusivity determination is based on data from the LYRICA Pediatric Epilepsy Program, which were submitted in response to the FDA’s Written Request to Pfizer to evaluate the use of LYRICA as adjunctive therapy for partial onset seizures in pediatric epilepsy patients. These were also required post-marketing studies.
AstraZeneca: Imfinzi fails to meet main goals in head and neck cancer study
AstraZeneca Plc immunotherapy treatment Imfinzi did not meet the main goals in a late-stage study for advanced head and neck cancer, the London-listed drugmaker said on Friday.
The study, known as “EAGLE”, did not improve overall survival compared with standard chemotherapy in patients with the hard-to-treat disease, the company said.
The results come after AstraZeneca warned last month that its immunotherapy treatment Imfinzi did not meet the main goal of improving survival rates for patients with the most advanced form of lung cancer, putting pressure on its shares.
AstraZeneca has been seen as having a head start in the race for cancer treatments, and Imfinzi was aiming to be the new standard of care in treating early inoperable stage III lung cancer.
“While these results are disappointing, we remain committed to evaluating the potential of Imfinzi and other innovative medicines for patients with head and neck cancer,” said Chief Medical Officer Sean Bohen.
The trial was conducted at 169 centres across 24 countries including the U.S., Europe, South America, Japan, Korea, Taiwan, Israel and Australia, AstraZeneca said.
Loxo Oncology received $275M milestone payment from Bayer
On December 6, Loxo Oncology (LOXO) received its first milestone payment pursuant to its collaboration with Bayer (BAYRY), equal to $275M, which was earned upon the grant of U.S. Food and Drug Administration marketing approval for Vitrakvi, larotrectinib.
Synthorx 11.9M share IPO priced at $11.00
The deal size was increased to 11.9M shares from 9.1M shares and priced between the $10.00-$12.00 range. Jefferies, Leerink and Evercore ISI acted as joint book running managers for the offering.
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