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Thursday, July 30, 2020

Lilly Q2 Trulicity sales up 20%; EPS guidance raised

July 30, 2020

Eli Lilly (LLY) Q2 results:
Revenues: $5,499.4M (-2.4%).
Key product sales: Trulicity: $1,229.8M (+20%); Humalog: $555.1M (-18%); Alimta: $539.1M (-7%); Taltz: $395.2M (+12%); Humulin: $313.6M (-3%); Basaglar: $290.4M (flat); Forteo: $252.7M (-30%); Jardiance: $262M (+31%); Cyramza: $256.7M (+6%); Verzenio: $208.6M (+56%); Olumiant: $145.0M (+42%).
Net Income: $1,412M (+6.4%); EPS: $1.55 (+7.6%); non-GAAP Net Income: $1,721.2M (+24.0%); non-GAAP EPS: $1.89 (+26.0%).
2020 guidance: Revenue: $23.7B-24.2B (unch); EPS: $6.48 – 6.68 from $6.20 – 6.40; non-GAAP EPS: $7.20 – 7.40 from $6.70 – 6.90.
The negative impact of the COVID-19 on Q2 included ~$250M of decreased customer buying largely offsetting product stocking in Q1, as well as ~$250M of lower revenue due to delayed new patient prescription trends.

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Inovio rallies on encouraging preclinical results on COVID-19 vaccine

Inovio Pharmaceuticals (NASDAQ:INO) announces positive results from a preclinical study evaluating COVID-19 vaccine candidate INO-4800 in non-human primates.
It says the candidate was effective in protecting rhesus macaques from live virus challenge 13 weeks after the last vaccination based on one shot, including memory T and B cell immune responses. Neutralizing antibodies and T cells “lasted in the blood” for more than four months after the initial dose. Antibody levels were similar to or greater than those found in convalescent plasma.
A Phase 2/3 trial in humans should launch this summer.

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Lilly’s Jardiance shows cardiovascular benefits in late-stage heart failure study

Eli Lilly (NYSE:LLY) and commercialization partner Boehringer Ingelheim announce positive results from a Phase 3 clinical trial, EMPEROR-Reduced, evaluating type 2 diabetes med Jardiance (empagliflozin) 10 mg in patients with chronic heart failure with reduced ejection fraction with or without diabetes.
The study met the primary endpoint demonstrating a statistically significant relative reduction in the composite of cardiovascular death or hospitalization due to heart failure, when added to standard-of-care treatment, compared to placebo.
Complete results will be presented virtually at the European Society of Cardiology Congress in late August.
Another Phase 3, EMPEROR-Preserved, assessing Jardiance in adults with heart failure with preserved ejection fraction, is in process with topline data expected in 2021.

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AstraZeneca and Sanofi’s nirsevimab successful in mid-stage study

A Phase 2 clinical trial evaluating AstraZeneca (NYSE:AZN) and development partner Sanofi’s (NASDAQ:SNY) nirsevimab for the passive immunization against respiratory syncytial virus (RSV) infections in healthy preterm infants met the primary endpoint demonstrating a 70.1% reduction in medically attended RSV lower respiratory tract infection (LRTI) compared to placebo through day 150 after dosing. The results were just published in the New England Journal of Medicine.
Treatment with nirsevimab, an extended half-life RSV monoclonal antibody, resulted in a 78.4% relative reduction in the incidence of hospitalization due to RSV LRTI through day 150, a secondary endpoint.
The rate of serious adverse events in the treatment arm was 11.2% versus 16.9% in the control arm, none deemed related to nirsevimab.
Passive immunization, which offers immediate protection, means that nirsevimab is given directly to an infant to help prevent RSV. Active immunization is when the person’s immune system is activated to prevent or fight infection via a vaccine, a process that could take weeks for protection to develop.
Phase 3 and Phase 2/3 studies are in process in full-term, healthy late preterm and high-risk infants.

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Baxter EPS misses by $0.07, misses on revenue

Baxter (NYSE:BAX): Q2 Non-GAAP EPS of $0.64 misses by $0.07; GAAP EPS of $0.48 misses by $0.19.
Revenue of $2.72B (-3.9% Y/Y) misses by $140M.
Adjusted gross margin of 41.6% vs. consensus of 43.4%.
Adjusted operating margin of 16.0% vs. 16.9% estimate.
Press Release

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J&J COVID-19 vaccine candidate shows positive effect in primate study

Results from a preclinical study evaluating seven variants of Johnson & Johnson’s (NYSE:JNJ) recombinant adenovirus serotype 26 (Ad26)-based COVID-19 vaccine candidate in non-human primates showed promising results.
One version proved to be the most powerful. Five of six inoculated monkeys showed no detectable coronaviruses, while the sixth had low levels in its nose after a single shot. A Phase 1 study assessing this version began last week. If all goes well, a Phase 3 trial may start as early as September. Single and double doses will be tested.

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Indivior PLC ADR reports Q2 results

Indivior PLC ADR (OTCPK:INVVY): Q2 GAAP EPS of $0.02.
Revenue of $150M (-30.2% Y/Y)
Press Release

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