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Tuesday, May 5, 2020

Prospect of rebound in orders lifts Siemens Healthineers

Shares in Siemens Healthineers gained on the prospect of medical imaging and diagnostics orders bouncing back later this year, even as it abandoned its full-year profit guidance citing uncertainties from the COVID-19 pandemic.
The German group will likely not achieve its previous outlook for the year through September for growth in adjusted earnings per share of 6% to 12%, but revenue growth should return some time before June, Healthineers said on Tuesday.
“The focus on COVID-19 patients made customers delay purchasing decisions, which should show up as pent-up demand in the future,” Chief Executive Bernd Montag said.
Sales of diagnostic products and reagents are slipping as patients avoid check-ups for conditions not related to the virus and Montag said hospitals were in no mind now to purchase big-ticket items such as MRI scanners, predicting lower sales in the April-to-June quarter.
“When it comes to orders, I am optimistic … it will come back to normal,” he added.
The German maker of x-ray, ultrasound and MRI scanners said its adjusted earnings before interest and tax (EBIT) edged 6% higher to 659 million euros ($718 million) in the January-March period, beating the average estimate of 563 million in an analyst survey posted on the company’s website.
That was helped by growth in the CT scanner business and demand for other molecular imaging machines.
Shares in Healthineers were up 5.8% at 42.06 euros by 0837 GMT, after jumping as much as 8.5% to a three-month high.
“We are encouraged that management expects a period of abnormally high growth out of the recovery owing to pent-up demand,” Scott Bardo, an analyst at Berenberg Bank, said.
Healthineers laid out plans last month to launch an antibody test to identify past coronavirus infections, eyeing output of more than 25 million tests per month from June as it competes with rivals Roche and Abbott.
Berenberg’s Bardo said that would likely lift earnings, after Healthineers said in an analyst call that the tests would be priced at a “low single-digit dollar amount” apiece.

https://www.marketscreener.com/news/Prospect-of-rebound-in-orders-lifts-Siemens-Healthineers-shares–30538380/?countview=0

Catalent EPS beats by $0.01, beats on revenue

Catalent (NYSE:CTLT): Q3 Non-GAAP EPS of $0.50 beats by $0.01; GAAP EPS of $0.08 misses by $0.21.
Revenue of $760.6M (+23.2% Y/Y) beats by $64.5M.
https://seekingalpha.com/news/3569002-catalent-eps-beats-0_01-beats-on-revenue

Mallinckrodt Q1 Acthar Gel sales down 25%

Mallinckrodt (MNK) Q1 results:
Revenues: $665.8M (-15.8%); Acthar Gel: $167.6M (-25.1%); INOmax: $141.7M (-6.2%); Ofirmev: $74.9M (-21.7%).
Net loss: ($56.7M) (-136.5%); loss/share: ($0.67) (-136.6%); non-GAAP Net Income: $138.3M (-15.9%); non-GAAP EPS: $1.64 (-15.5%).
CF Ops: $53.7M (-67.4%).
https://seekingalpha.com/news/3568983-mallinckrodt-q1-acthar-gel-sales-down-25

Regeneron and Sanofi’s Libtayo shows benefit in skin cancer

Regeneron Pharmaceuticals (NASDAQ:REGN) and collaboration partner Sanofi (NASDAQ:SNY) announce positive topline results from a single-arm open-label Phase 2 study evaluating Libtayo (cemiplimab) in patients with the most common type of skin cancer called basal cell carcinoma (BCC) who progressed on or were intolerant of prior hedgehog pathway inhibitor therapy.
The objective response rate (ORR) at week 93 was 29%. 85% of responders experienced an estimated duration of response (DOR) greater than one year. The disease control rate (DCR) (responders + stable cancer for at least six months) was 60%.
In patients with metastatic BCC, the ORR was 21% while 83% of responders experiencing a DOC of at least a year. The DCR was 46%.
No new safety signals were observed.
Marketing applications are next up.
The FDA approved the PD-1 inhibitor in September 2018 for cutaneous squamous cell carcinoma (second most common type of skin cancer).
https://seekingalpha.com/news/3568922-regeneron-and-sanofis-libtayo-shows-benefit-in-skin-cancer

Mallinckrodt EPS beats by $0.21, misses on revenue

Mallinckrodt (NYSE:MNK): Q1 Non-GAAP EPS of $1.64 beats by $0.21; GAAP EPS of -$0.67 beats by $1.33.
Revenue of $665.8M (-15.8% Y/Y) misses by $21.27M.
https://seekingalpha.com/news/3568929-mallinckrodt-eps-beats-0_21-misses-on-revenue

Dosing underway in study of Pfizer and BioNTech COVID-19 vaccine

Pfizer (NYSE:PFE) and collaboration partner BioNTech (NASDAQ:BNTX) announce that subjects in the first cohort in Germany have been dosed in a Phase 1/2 clinical trial evaluating COVID-19 vaccine program BNT162.
The study will assess the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates. The first part is a dose-escalation phase that will enroll up to 360 healthy volunteers in two age cohorts (18-55 and 65-85). Dosing is also underway at four U.S. sites.
Anticipating positive results, the companies are working to scale up production to meet global demand, expected to be “hundreds of millions” of doses in 2021 made at four Pfizer sites and two BioNTech locations, with more to be selected.
The parties will co-commercialize the vaccine globally except in China, where BioNTech is collaborating with Fosun Pharma.
https://seekingalpha.com/news/3568944-dosing-underway-in-study-of-pfizer-and-biontech-covidminus-19-vaccine

Incyte EPS misses by $2.50, beats on revenue

Incyte (NASDAQ:INCY): Q1 Non-GAAP EPS of -$2.86 misses by $2.50; GAAP EPS of -$3.33 misses by $2.08.
Revenue of $568.51M (+14.2% Y/Y) beats by $15.27M.
https://seekingalpha.com/news/3568967-incyte-eps-misses-2_50-beats-on-revenue