Constellation Pharmaceuticals (NASDAQ:CNST): Q1 GAAP EPS of -$0.61 beats by $0.02.
https://seekingalpha.com/news/3569921-constellation-pharmaceuticals-eps-beats-0_02
Wednesday, May 6, 2020
FDA extends action date for Bristol-Myers’ liso-cel to November 16
Citing a major amendment to its filing, the FDA has extended its action date for Bristol-Myers Squibb’s (NYSE:BMY)
marketing application seeking approval of CAR T therapy lisocabtagene
maraleucel (liso-cel) for adults with relapsed/refractory large B-cell
lymphoma after at least prior lines of therapy to November 16 (from
August 17).
The extension is standard operating procedure when
there is a major amendment to an application to allow more time for
review. In this case, it was additional information requested by the
agency.
An FDA nod by year-end is one of the required
remaining milestones of the Contingent Value Rights (CVRs) issued when
the Celgene deal closed in Q4 2019. The other is the U.S. approval of
idecabtagene vicleucel (ide-cel) by March 31, 2021.
https://seekingalpha.com/news/3569928-fda-extends-action-date-for-bristol-myers-liso-cel-to-november-16CVS Health up on Q1 beat; guidance affirmed
CVS Health (CVS) Q1 results:
Revenues: $66,755M (+8.3%); Pharmacy Services:
$34,983M (+4.2%); Retail/LTC: $22,749M (+7.7%); Healthcare Benefits:
$19,198M (+7.4%).
Net Income: $2,012M (+41.0%); EPS: $1.53 (+40.4%); non-GAAP Net Income: $2,502M (+18.9%); non-GAAP EPS: $1.91 (+17.9%).
CF Ops: $3,305M (+69.7%).
Pharmacy claims processed: 541.4M (+59.6%).
Pharmacy Services Generic dispensing rate of 89.0% vs. 88.3% in Q1 2019.
Retail Prescription volume up 9.8%; Generic dispensing rate 89.3% vs. 88.7% a year ago.
Medical membership 23.5M vs. 22.8M in Q1 2019.
2020 Guidance: EPS: $5.47 – 5.60 (unch); non-GAAP EPS: $7.04 – 7.17 (unch); cash flow ops: $10.5B – 11.0B (unch).
Shares are up 4% premarket.
Previously: CVS Health EPS beats by $0.28, beats on revenue (May 6)
https://seekingalpha.com/news/3569933-cvs-health-up-4-premarket-on-q1-beat-guidance-affirmed
Repligen EPS beats by $0.07, beats on revenue
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-revenueAlexion 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-tepezza
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