Repligen (NASDAQ:RGEN): Q1 Non-GAAP EPS of $0.32; GAAP EPS of $0.18 beats by $0.07.
Revenue of $76.09M (+25.5% Y/Y) beats by $4.3M.
https://seekingalpha.com/news/3569942-repligen-eps-beats-0_07-beats-on-revenueWednesday, May 6, 2020
Alexion Pharma Q1 top-line up 27%; clinical trials halted due to COVID-19
Alexion Pharmaceuticals (ALXN) Q1 results:
Revenues: $1,444.8M (+26.7%); Soliris: $1,022.9M
(+6.3%); Ultomiris: $222.8M; Strensiq: $172.2M (+32.4%); Kanuma: $26.7M
(+13.6%).
Net Income: $557.6M (-5.2%); EPS: $2.5 (-4.2%); non-GAAP Net Income: $727.5M (+33.4%); non-GAAP EPS: $3.22 (+34.7%).
CF Ops: $549.6M (+27.8%).
2020 Guidance: Revenues: $5,230M –
5,330M from $5,500M – 5,560M; Soliris/Ultomiris revenues: $4,495M –
4,570M from $4,755M – 4,800M; EPS: $8.14 – 8.47 from $7.91 – 8.71;
non-GAAP EPS: $10.45 – 10.75 from $10.65 – 10.85.
Due to COVID-19, the company has temporarily
paused the Phase 2 study of ALXN1830, administered intravenously, as
well as the Phase 1 study of a subcutaneous formulation of ALXN1830 in
healthy volunteers. These trials and the planned Phase 2 study of
subcutaneous ALXN1830 in gMG are anticipated to begin in 2021.
Alexion plans to initiate a Phase 3 study of ALXN2040 as an add-on therapy for PNH patients with EVH by the end of 2020.
Phase 2 studies of ALXN2040 in C3G is underway. Interim data are expected in Q2.
Due to COVID-19, Phase 1 healthy volunteer study of ALXN1720 is also temporarily paused.
Previously: Alexion Pharmaceuticals EPS beats by $0.51, beats on revenue (May 6)
https://seekingalpha.com/news/3569982-alexion-pharma-q1-top-line-up-27-clinical-trials-halted-due-to-covidminus-19Alnylam Pharmaceuticals EPS misses by $0.01, beats on revenue
Alnylam Pharmaceuticals (NASDAQ:ALNY): Q1 Non-GAAP EPS of -$1.52 misses by $0.01; GAAP EPS of -$1.62 beats by $0.25.
Revenue of $99.48M (+198.8% Y/Y) beats by $9.03M.
https://seekingalpha.com/news/3569993-alnylam-pharmaceuticals-eps-misses-0_01-beats-on-revenueHorizon reports strong Q1; ups revenue guidance on rapid uptake of Tepezza
Horizon Therapeutics (HZNP) Q1 results:
Revenues: $355.9M (+26.9%); R&D Expense: $245.4M (+47.4%).
Tepezza (teprotumumab-trbw) Q1 net sales of $23.5M driven by strong demand and launch execution.
Orphan and Rheumatology Segment: Krystexxa: $93.3M
(+78%); Ravicti: $61.2M (+23%); Procysbi: $38.3M (-3%); Actimmune:
$26.5M (+22%); Buphenyl: $2.3M (-16%); Quinsair: $0.3M (+64%).
Net loss: ($13.6M) (+58.7%); loss/share: ($0.07) (+63.2%); non-GAAP Net Income: $83.2M (+54.4%); non-GAAP EPS: $0.40 (+33.3%).
Non-GAAP EBITDA: $107.2M (+21.3%).
CF Ops: ($62.6M).
2020 Guidance: Revenues: $1.40B –
1.45B from $1.40B – 1.42B; Non-GAAP EBITDA: $450M – 500M from $485M –
500M; Tepezza sales: >$200M from $30M – 40M.
The company announced the addition of two new Tepezza pipeline programs.
Shares are up 7% premarket.
Previously: Horizon Pharma EPS beats by $0.19, beats on revenue (May 6)
https://seekingalpha.com/news/3570013-horizon-reports-strong-q1-raises-revenue-guidance-due-to-rapid-uptake-of-tepezzaDosing underway in study of Mesoblast cell therapy in COVID-19
Mesoblast Limited (NASDAQ:MESO) is up 12% premarket on light volume in reaction to its announcement that the first participants have been dosed in a 300-subject Phase 2/3 clinical trial
evaluating cell therapy remestemcel-L in COVID-19 patients with
moderate-to-severe acute respiratory distress syndrome (ARDS) on
ventilator support.
The primary endpoint is all-cause mortality with 30 days of randomization compared to placebo plus standard-of-care treatment.
The company is developing remestemcel-L for
various inflammatory conditions, including acute graft-versus-host
disease. It works by downregulating production of pro-inflammatory
proteins (cytokines) while increasing production of anti-inflammatory
cytokines.
https://seekingalpha.com/news/3570022-dosing-underway-in-study-of-mesoblast-cell-therapy-in-covidminus-19Heron Therapeutics EPS beats by $0.08, beats on revenue
Heron Therapeutics (NASDAQ:HRTX): Q1 GAAP EPS of -$0.57 beats by $0.08.
Revenue of $25.4M (-19.6% Y/Y) beats by $4.17M.
https://seekingalpha.com/news/3570088-heron-therapeutics-eps-beats-0_08-beats-on-revenueAxcella up 34% premarket on positive action of dietary supplement in NAFLD
Ultra-thinly traded micro cap Axcella (NASDAQ:AXLA) jumps 34% premarket on light volume in reaction to topline results from a study evaluating dietary supplements AXA1125 and AXA1957 in 102 people with nonalcoholic fatty liver disease (NAFLD).
The company says AXA1125 showed greater and more
consistent reductions in clinically relevant biomarkers versus placebo
than AXA1957.
Specifically, participants receiving AXA1125
experienced a 23% mean reduction in liver fat content compared to a 6%
reduction for placebo. The mean reduction in the liver enzyme ALT
(biomarker of liver stress/damage) was 22% versus a 7% reduction in the
control arm.
On the safety front, both supplements were
generally well-tolerated. The most common treatment-related adverse
events (occurred in at least 10% of subjects) were gastrointestinal
effects (diarrhea, nausea, reduced appetite) and upper respiratory
infection. Most were mild and “transient” resolving in two-to-three
weeks.
The company is going with AXA1125 for its candidate for NASH.
https://seekingalpha.com/news/3570048-axcella-up-34-premarket-on-positive-action-of-dietary-supplement-in-nafld
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