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Wednesday, July 29, 2020

Teladoc Health EPS misses by $0.10, beats on revenue, doubles total visits

Teladoc Health (NYSE:TDOC): Q2 GAAP EPS of -$0.34 misses by $0.10.
Revenue of $241.03M (+85.0% Y/Y) beats by $20.54M.
Total U.S. Paid Membership of 51.5M (+92% Y/Y); Total Visits of 2.76M (+203% Y/Y).
Shares +4.3%.

Coronavirus to continue to ‘weigh heavily on economic activity’ – Fed stands pat

The Fed keeps its benchmark interest rate target range on hold at 0%-0.25%, as expected.
The central bank will also increase its holdings of Treasury securities and agency residential and commercial mortgage-backed securities at least at the current pace “to sustain smooth market functioning, thereby fostering effective transmission of monetary policy to broader financial conditions.”
The vote was unanimous.
As it has been saying for months, the “path of the economy will depend significantly on the course of the virus.”
While economic activity has been improving recent months, the health crisis will continue to “weigh heavily on economic activity, employment, and inflation in the near term,” according to the Fed statement.
It also continues to pose “considerable risks to the economic outlook over the medium term.”
Stocks hold their gains. The Dow +0.4%, the Nasdaq +1.0%. The S&P 500 +0.9%. 10-year Treasury yield is little changed at 0.58%.

Amedisys up on Q2 reports beat

Amedisys (AMED +6.3%) reported Q2 revenue of $485M (-1.6% Y/Y)
Home health segment: medicare revenue equaled $192.2M, while non-medicare revenue of $97.3M
Hospice segment: medicare revenue equaled $167M, while non-medicare revenue of $10.1M
Personal Care segment: non-medicare revenue of $17.7M
Adjusted EBITDA of $66.4M vs. $61.4M last year.
Adjusted EPS of $1.34 vs. $1.21 last year
Gross margin of 121.3M.
2020 Guidance: Revenue $2.04B-2.07B, Adjusted EBITDA $245M-255M, Adjusted EPS $4.84-5.06.

Roche comes up empty in study of Actemra in COVID-19

A Phase 3 clinical trial, COVACTA, evaluating Roche’s (OTCQX:RHHBY) Actemra (tocilizumab) in adult patients with severe COVID-19 pneumonia failed to achieve the primary endpoint of improved clinical status by day 28. Specifically, there was no statistically significant difference in treatment effect between the IL-6 receptor antagonist and placebo and no difference in the proportion of patients who died by week 4. The time to hospital discharge favored the Actemra group, but the difference was not statistically significant.
Key secondary endpoints were also missed.
The company plans to further analyze the results to “fully understand” the data.

GlaxoSmithKline Q2 Shingrix sales down 16%; EPS guidance maintained

GlaxoSmithKline (GSK) Q2 results (£):
Revenues: 7,624M (-2.4%); R&D Expense: 4,102M (-4.8%); SG&A: 1,133M (-28.5%); Operating Income: 2,389M (+24.6%).
Key product sales: Shingrix: 323M (-16%); Ellipta: 642M (+15%); Tivicay: 373M (-9%); Triumeq: 586M (-9%); Nucala: 241M (+24%); Benlysta: 177M (+18%); Seretide/Advair: 421M (+2%); Flixotide/Flovent: 117M (-7%); Ventolin: 144M (-39%); Augmentin: $100M (-25%); Bexsero: 108M (-21%); Infanrix, Pediarix: 119M (-39%); Rotarix: 128M (+10%); Juluca: 113M (+24%).
Net Income: 2,263M (+134.8%); EPS: 0.46 (+130.0%); non-GAAP Net Income: 958M (-36.5%); non-GAAP EPS: $0.19 (-38.7%).
CF Ops (3 months): 2,760M (+98.7%).
While the company maintains non-GAAP EPS of (1%) to (4%) for FY 2020, they said there remain “notable risks” to business performance over the balance of the year.
Shares are down 1.5% premarket.

Heat Biologics COVID-19 vaccine shows encouraging action in preclinical study

Heat Biologics (NASDAQ:HTBX) announces results from preclinical testing of its COVID-19 vaccine candidate that, it says, showed immunogenicity in animal models including expansion of human-HLA-restricted T cells against immunodominant epitopes of SARS-CoV-2 spike protein, adding that the results also showed expansion of antibody-supporting CD4+ and virus-killing CD8+ T cells in the lungs of mice.
Natasa Strbo MD, DSc, Assistant Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine and co-developer of Heat’s gp96 platform, says, “We are encouraged by the observed T-cell expansion and cytokine secretion in response to spike protein stimulation in preclinical models. Measured cytokines, produced by antiviral CD4+ T-cells, important for B cell antibody class switching, and CD8+ T-cells, important to clear virus-infected cells, suggests that an optimal immune response is being generated in response to our vaccination. These preclinical data imply that our vaccine is prompting a robust and effective immune response to support anti-viral immunity. In addition, stimulation of anti-viral killer CD8+ T-cells in human HLA-A2-positive transgenic mice provides encouraging pre-clinical data to support human trials, as we can expand cells specific for viral antigens presented in the context of the human immune system.”

AbbVie’s atogepant successful in late-stage migraine study

July 29, 2020

AbbVie (ABBV +0.1%) announces positive results from a Phase 3 clinical trial, ADVANCE, evaluating atogepant, an orally available calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of migraine.
The study met the primary endpoint demonstrating a statistically significant reduction in mean monthly migraine days compared to placebo for all doses across the 12-week treatment period.
No new safety signals were observed.
Marketing applications in the U.S. and other countries are next up.
Related ticker: Teva Pharmaceutical Industries (TEVA -0.1%) (market Ajovy for migraine prevention).