COVID-19 demand stoked Q1 growth for Perrigo

On a preliminary basis, Perrigo (NYSE:PRGO) expects Q1 revenue of ~$1.3B, up 14% from a year ago and in line with consensus.

Reported operating income should be $140M – 145M (versus $102M a year ago) while non-GAAP operating income should be $220M – 225M (versus $203M a year ago).

The company experienced a dramatic surge in demand in March due to COVID-19 that the company was largely able to meet.

Global consumer sales were ~$1.1B, up 16%.

Management will release final Q1 results during the last week of the month.

Shares up 4% after hours.

https://seekingalpha.com/news/3559168-covidminus-19-demand-stoked-q1-growth-for-perrigo

Amazon confirms virus cases in Ohio, Kentucky

Amazon (NASDAQ:AMZN) confirms two positive coronavirus cases near Cleveland, Ohio, and one in Lexington, Kentucky.

The Kentucky worker and one of the Ohio employees worked at fulfillment centers, while the third person was at a delivery station.

Amazon’s response to coronavirus cases at its facilities led to strikes last week in Staten Island and near Detroit.

The tech giant recently announced plans to hire 100,000 additional workers, including warehouse employees and delivery drivers.

https://seekingalpha.com/news/3559093-amazon-confirms-virus-cases-in-ohio-kentucky

Integra LifeSciences sees drop in Q1 revenue amid COVID-1

On a preliminary basis, Integra LifeSciences Holdings (NASDAQ:IART) expects Q1 revenue of $352M – 354M, down almost 2% from a year ago on a reported basis and shy of consensus of $367M.

Q2 will be worse due to COVID-19 disruptions.

Management will update investors on May 7 during its Q1 earnings call.

https://seekingalpha.com/news/3559115-integra-lifesciences-sees-drop-in-q1-revenue-amid-covidminus-19

GenMark Q1 revenue up big on COVID-19 boost; shares up 29% after hours

Citing a (most likely rare) positive impact from COVID-19, GenMark Diagnostics (NASDAQ:GNMK) sees Q1 revenue of ~$38.7M, up about 80% from a year ago and 46% above consensus of $26.5M.

About 80% of gross ePlex placements (net of 54 in the quarter) were from customers interested in COVID-19 testing. SARS-CoV-2 consumables accounted for ~2% of total ePlex revenue.

2020 revenue guidance increased to $112M – 122M from $100M – 110M.

Management will provide another update during its earnings call next month.

Shares up 29% after hours.

https://seekingalpha.com/news/3559147-genmark-q1-revenue-up-big-on-covidminus-19-boost-shares-up-29-after-hours

FDA extends action date for Roche’s risdiplam for spinal muscular atrophy

Citing the submission of additional data that it considered a major amendment, the FDA has extended the action date for its review of Roche (OTCQX:RHHBY) unit Genentech’s marketing application seeking approval for resdiplam for the treatment of spinal muscular atrophy.

The new action date is August 24 (from May 24).

Roche in-licensed global rights to the survival motor neuron-2 (SMN2) splicing modifier from PTC Therapeutics (NASDAQ:PTCT) in November 2011.

SMA-related tickers: Biogen (NASDAQ:BIIB), Ionis Pharmaceuticals (NASDAQ:IONS), Scholar Rock Holding (NASDAQ:SRRK), Novartis (NYSE:NVS)

https://seekingalpha.com/news/3559126-fda-extends-action-date-for-roches-risdiplam-for-spinal-muscular-atrophy

Partial unlock model for Covid-19, similar pandemic averts medical, economic disaster

Robert L Shuler
doi: https://doi.org/10.1101/2020.03.30.20048082
Posted April 06, 2020.
This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

Abstract

Data as of March 29, 2020 show that the flattening strategy for COVID-19 in the U.S. is working so well that a clean removal of social distancing (aka unlock) at any time in 2020 will produce a renewed catastrophe, overloading the healthcare system. Leaving the economy locked down for a long time is its own catastrophe. An SIR-type model with clear parameters suitable for public information, and both tracking and predictive capabilities which learns disease spread characteristics rapidly as policy changes, suggests that a solution to the problem is a partial unlock. Case load can be managed so as not to exceed critical resources such as ventilators, yet allow enough people to get sick that herd immunity develops and a full unlock can be achieved in as little as five weeks from beginning of implementation. The partial unlock could be for example 3 full working days per week. Given that not all areas or individuals will respond, and travel and public gatherings are still unlikely, the partial unlock might be 5 full working days per week. The model can be regionalized easily, and by expediting the resolution of the pandemic in the U.S. medical equipment and volunteers, many of them with already acquired immunity, can be made available to other countries.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

No external funding used in this research.

Author Declarations

All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript.

Yes

All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

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https://www.medrxiv.org/content/10.1101/2020.03.30.20048082v1

COVID-19 patient data registry to aid in care, adverse cardiovascular outcomes

As physicians, scientists and researchers worldwide struggle to understand the coronavirus (COVID-19) pandemic, the American Heart Association is developing a novel registry to aggregate data and aid research on the disease, treatment protocols and risk factors tied to adverse cardiovascular outcomes.
COVID-19 is associated with significant morbidity and mortality, with strong evidence for adverse cardiovascular outcomes.[1]^,[2] Moreover, patients with existing cardiovascular disease or CVD risk factors may be at higher risk for serious complications from COVID-19, including death.
The Association’s new, free COVID-19 CVD registry powered by its Get With The Guidelines® (GWTG) hospital quality improvement program, will be available to more than 2,400 hospitals currently participating in a GWTG module starting in May. In addition, aggregate data will be available to researchers through the Association’s Institute for Precision Cardiovascular Medicine.
”Having sufficient data is the first step to understanding the impact of COVID-19 on cardiovascular health,“ said John Warner, M.D., FAHA, chair of the quality oversight committee and  past volunteer president of the American Heart Association and executive vice president for Health System Affairs at the University of Texas Southwestern Health System in Dallas, Texas. “As a trusted resource for data and research, with an entry point in more than 2,400 U.S. hospitals, the American Heart Association is uniquely positioned to gather data quickly and accurately.”
Several studies have reported COVID-19 patients presenting with or developing heart failure, cardiogenic shock, stroke and lethal arrhythmias secondary to the disease. [3]^, [4] However, these studies have consistently been limited by the lack of a structured collection of data raising concerns about indication bias for most laboratory testing. Further, several of these studies are single-center descriptive assessments, limiting their generalizability.
In response, the American Heart Association is creating the multicenter registry to collect biomarkers, clinical data and cardiovascular outcomes in COVID-19 patients. The registry will focus on granular data collection from centers that routinely test biomarkers in COVID-19 patients.
To participate in the registry, contact qualityresearch@heart.org.
Additional resources and guidance for health care professionals on COVID-19 can be found here.
Get With The Guidelines (GWTG) is a hospital-based quality improvement program from the American Heart Association with tools and resources to increase adherence to the latest research-based guidelines.  The premise of the GWTG programs is when medical professionals apply the most up-to-date evidence-based treatment guidelines, patient outcomes improved.
https://newsroom.heart.org/news/new-covid-19-patient-data-registry-will-provide-insights-to-care-and-adverse-cardiovascular-outcomes
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