Ionis Pharma Q1 Spinraza Royalties up 10%

Ionis Pharmaceuticals (IONS) Q1 results:

Revenues: $133M (-55.2%); Spinraza Royalties: $66M (+10.0%).

Net loss: ($48M) (-157.1%); loss/share: ($0.35) (-156.5%); non-GAAP Net loss: ($15M) (-111.8%); non-GAAP loss/share: ($0.11).

Pipeline highlights: Initiated the CARDIO-TTRansform Phase 3 clinical trial for AKCEA-TTR-LRx in patients with TTR-mediated amyloid cardiomyopathy.

Two medicines granted Fast Track Designation by the FDA: AKCEA-APO(a)-LRx for the treatment of cardiovascular disease due to elevated Lp(a) levels;

IONIS-C9Rx for the treatment of C9orf72-ALS.

Ionis generated more than $20M as numerous partnered medicines advanced.

Initiated a Phase 1 study of ION224, an Ionis-owned medicine in development for the treatment of NASH.

Upcoming Catalysts: Initiate the Phase 3 study of AKCEA-APOCIII-LRx in patients with FCS.

Refile WAYLIVRA NDA for U.S. marketing authorization.

File for WAYLIVRA marketing approval in Brazil with PTC Therapeutics.

The company is reaffirming 2020 financial guidance, including ending 2020 meaningfully profitable.

Previously: Ionis Pharmaceuticals EPS beats by $0.01, misses on revenue (May 6)

https://seekingalpha.com/news/3570050-ionis-pharma-q1-spinraza-royalties-up-10

DarioHealth up on FDA nod on self-check glucose meter in hospitals

The FDA has approved the emergency use of DarioHealth’s (NASDAQ:DRIO) blood glucose testing strips and smartphone-connected device for hospitalized diabetics who have COVID-19.

Patients can self-test their blood sugar levels with their own device or the hospital can issue one to them upon admission.

https://seekingalpha.com/news/3570063-dariohealth-up-11-on-fda-nod-on-self-check-glucose-meter-in-hospitals

White House coronavirus task force to ‘continue indefinitely’ – Trump

The White House coronavirus task force will “continue indefinitely,” President Trump said via Twitter, adding that he may “add or subtract people to it, as appropriate.”

The task force’s focus will be on “SAFETY & OPENING UP OUR COUNTRY AGAIN.”

It will also be “very focused” on vaccines and therapeutics, Trump said.

https://seekingalpha.com/news/3570067-white-house-coronavirus-task-force-to-continue-indefinitely-trump-says

Amgen’s Otezla shows positive action in mild psoriasis

Amgen (AMGN +0.4%) announces positive results from a Phase 3 clinical trial, ADVANCE, evaluating Otezla (apremilast) in patients with mild-to-moderate plaque psoriasis.

The study met the primary endpoint demonstrating a statistically significant proportion of treated patients achieving clear or almost clear skin at week 16 versus placebo. Key secondary endpoints were also met.

Detailed results will be submitted for presentation at an upcoming medical conference.

The FDA approved the PDE4 inhibitor in September 2014 for patients with moderate-to-severe plaque psoriasis.

https://seekingalpha.com/news/3570077-amgens-otezla-shows-positive-action-in-mild-psoriasis

BioCryst Pharma Q1 top-line down 19%; guidance affirmed

BioCryst Pharmaceuticals (BCRX) Q1 results:

Revenues: $4.8M (-18.6%); Product sales: $0.2M (-88.2%); Royalty revenue: $1.9M (-17.4%); Collaborative and other R&D: $2.7M (+42.1%).

Net loss: ($37.6M) (-20.9%); loss/share: ($0.24) (-14.3%).

Operating cash use: $23.1M.

2020 guidance: Net operating cash use: $125M – 150M (unch).

Key upcoming milestones: BioCryst expects three regulatory approvals for berotralstat in 2020 and early 2021. These timelines remain on track.

FDA is currently reviewing NDA for berotralstat; PDUFA date December 3.

Berotralstat approval in Japan expected in H2.

BCX9930 program: Data from treatment-naïve cohort 2 expected in Q3.

The company plans to begin enrolling PNH patients resistant to C5 inhibitors in Q3 and expects data by the end of 2020.

BioCryst remains on track to report data in H2 from its ongoing Phase 1 clinical trial of BCX9250.

Previously: BioCryst Pharmaceuticals EPS beats by $0.01, beats on revenue (May 6)

https://seekingalpha.com/news/3570080-biocryst-pharma-q1-top-line-down-19-guidance-affirmed

Triple whammy for hospitals, opposite for insurers

U.S. hospitals are losing around $50B per month due to the large number of cancelled elective procedures, costs associated with treating COVID-19 and an increased number of uninsured patients.

“I think it’s fair to say that hospitals are facing perhaps the greatest challenge that they have ever faced in their history,” said CEO of the American Hospital Association, Rick Pollack, calling the situation a “triple whammy.”

However, the net impact on U.S. health insurers is quite the opposite and is “going to be positive for them,” said Jeff Jonas of Gabelli Funds. “The costs from COVID-19 are going to be actually very small and more than outweighed by the deferral of elective procedures.”

Related tickers: UNH, ANTM, CI, HUM, WCG, CNC, MOH, GTS, HQY, QHC, HCA, THC, UHS, LPNT, SGRY, SSY, QHC, CYH, SEM, IHF

https://seekingalpha.com/news/3569788-triple-whammy-for-hospitals-opposite-for-insurers

Private payrolls fall 20.2M in April

April ADP Jobs Report: -20.2M vs. -20M consensus, -149K prior (revised from -27K).

The report utilizes data only through April 12, says ADP, and does not reflect full impact of COVID-19 on the employment situation. Indeed. In the first two weeks after April 12, another 8.3M filed for first-time unemployment, with another 3M expected to be seen in this week’s report.

The ADP’s Ahu Yildirmaz: “Job losses of this scale are unprecedented,” with April’s decline alone more than double total numbers lost during the Great Recession.

The service sector was hit hardest with 16M job loss (leisure/hospitality -8.6M), while the manufacturing sector lost 4.3M.

Small businesses lost 6M jobs, including 3.36M for those with 1-19 employees, and 2.6M for those with 20-49 employees.

A couple of subsectors posted modest job gains in April – Education up 28K and Management of companies/enterprises up 6K.

The government’s nonfarm payroll data is due on Friday morning, with economists expecting a job loss of 21.5M and the unemployment rate seen rising to 16%.

https://seekingalpha.com/news/3570006-private-payrolls-fall-20_2m-in-april