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Tuesday, July 30, 2019

FDA OKs Baxter next-gen device for renal replacement therapy, plasma exchange

The FDA grants 510(k) clearance for Baxter International’s (NYSE:BAX) PrisMax system and integrated TherMax blood warmer, its next-generation platform for continuous renal replacement therapy and therapeutic plasma exchange.
PrisMax is commercially available in more than 20 countries across Europe and in Australia. Additional marketing applications will be filed through 2020.
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Eli Lilly up 1% premarket on Q2 beat

Eli Lilly (LLY) Q2 results: Revenues: $5,636.7M (+0.9%).
Key product sales: Trulicity: $1,028.5M (+32%); Humalog: $677.6M (-12%); Alimta: $577.8M (+4%); Forteo: $360.8M (-17%); Humulin: $322.6M (-7%); Taltz: $353.8M (+61%); Basaglar: $290.7M (+44%); Cialis: $200.2M (-63%); Cyramza: $241.8M (+11%); Jardiance: $231.9M (+58%).
Net Income: $1,327.2M; EPS: $1.44; Non-GAAP Net Income: $1,388M (-3.0%); Non-GAAP EPS: $1.50 (+1.4%).
2019 Guidance: Total Revenues: $22.0B – 22.5B (unch); EPS from continued operations: $4.65 – 4.75 from $4.64 – 4.74; Non-GAAP EPS: $5.67 – 5.77 from $5.60 – 5.70.
Shares are up 1% premarket.
Previously: Eli Lilly EPS beats by $0.05, beats on revenue (July 30)
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Celgene Q2 top line up 15%; earnings up 50%

Celgene (NASDAQ:CELG) Q2 results ($M): Revenue: 4,400 (+15.4%).
Key product sales: Revlimid: 2,732 (+11.4%); Pomalyst/Imnovid: 619 (+22.1%); Otezla: 493 (+31.5%); Abraxane: 316 (+30.0%).
Net income: 1,571 (+50.3%); non-GAAP net income: 2,079(+31.2%); EPS: 2.16 (+51.0%); non-GAAP EPS: 2.86 (+32.4%)
2019 guidance: Revenue: $17.2B – 17.4B from $17.0B – 17.2B; Revlimid: ~$10.8B (unch); Pomalyst/Imnovid: ~$2.5B from ~$2.4B; Otezla: ~1.9B (unch); Abraxane: ~$1.2B from ~$1.1B; EPS: $8.71 – 9.44 from $8.90 – 9.63; non-GAAP EPS: $10.65 – 10.85 from $10.60 – 10.80.
Shares up 1% premarket on light volume.
Previously: Celgene EPS beats by $0.24, beats on revenue (July 30)

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Incyte beats Q2 consensus

Incyte (INCY) Q2 results: Revenues: $529.9M (+1.6%); Jakafi revenue: $409.5M (+18.5%); Iclusig revenue: $24.4M (+22.6%); Jakavi royalty revenues: $56.9M (+20.8%); Olumiant royalty revenues: $19.1M (+114.6%); Milestone and contract revenues: $20M (-80.0%).
Net Income: $105.3M (+101.0%); EPS: $0.48 (+100.0%); Non-GAAP Net Income: $162.5M (+19.5%); Non-GAAP EPS: $0.75 (+19.0%).
2019 Guidance: Jakafi sales: $1.61B – 1.65B from $1.58B – 1.65B; Iclusig sales: $90M – 100M (unch).
Previously: Incyte EPS beats by $0.25, beats on revenue (July 30)
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Momenta’s M281 Fast Track’d for newborn blood disorder

Momenta Pharmaceuticals (NASDAQ:MNTA) is up 3% premarket on light volume following its announcement that the FDA has designated lead candidate M281 for Fast Track review for the treatment of hemolytic disease of the fetus and newborn, a serious rare blood disorder that occurs when the red blood cells are incompatible between a mother and baby caused by the transfer of alloantibodies from the mother to the fetus during pregnancy.
Phase 2-stage M281 (nipocalimab) is a fully human monoclonal antibody designed to reduce the risk of fetal anemia by inducing the clearance of pathogenic IgG antibodies in the mother’s circulation by blocking a protein called the neonatal Fc receptor (FcRn) that plays a key role in IgG recycling.
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Neurocrine Bio up 8% premarket after Q2 beat

Neurocrine Biosciences (NASDAQ:NBIX) is up 8% premarket following its Q2 report released after the close yesterday. Highlights:
Revenues were up 89% to $183.6M. Ingrezza sales were up 86% to $180.5M.
Net income: $51.3M (+871%); EPS: $0.54 (+871%).
Previously: Neurocrine Biosciences EPS beats by $0.32, beats on revenue(July 29)
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BioScrip EPS misses by $0.05, beats on revenue

BioScrip (NASDAQ:BIOS): Q2 GAAP EPS of -$0.13 misses by $0.05.
Revenue of $191.52M (+8.9% Y/Y) beats by $5.08M.
Press Release
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