Search This Blog

Tuesday, August 4, 2020

Teva Pharmaceutical Q2 2020 Earnings Preview

Teva Pharmaceutical (NYSE:TEVA) is scheduled to announce Q2 earnings results on Wednesday, August 5th, before market open.
The consensus EPS Estimate is $0.53 (-11.7% Y/Y) and the consensus Revenue Estimate is $3.94B (-9.2% Y/Y).
Analysts expect Non-GAAP gross margin of 51.5% and Non-GAAP operating margin of 23.8%.
Over the last 2 years, TEVA has beaten EPS estimates 75% of the time and has beaten revenue estimates 63% of the time.
Over the last 3 months, EPS estimates have seen 2 upward revisions and 14 downward. Revenue estimates have seen 2 upward revisions and 11 downward.

CVS Health Q2 2020 Earnings Preview

CVS Health (NYSE:CVS) is scheduled to announce Q2 earnings results on Wednesday, August 5th, before market open.
The consensus EPS Estimate is $1.91 (+1.1% Y/Y) and the consensus Revenue Estimate is $64.27B (+1.3% Y/Y).
Analysts expect gross margin of 18.9% and operating margin of 6.32%.
Total adjusted PBM claims of 502.0M.
Over the last 2 years, CVS has beaten EPS estimates 100% of the time and has beaten revenue estimates 88% of the time.
Over the last 3 months, EPS estimates have seen 12 upward revisions and 9 downward. Revenue estimates have seen 4 upward revisions and 12 downward.

iRhythm Comments on CMS 2021 Proposed Physician Fee Schedule

iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, commented on the recently released Centers for Medicare and Medicaid Services (“CMS”) Calendar Year 2021 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”). The Proposed Rule was released on August 3, 2020 and updates payment policies, payment rates, and other provisions for services furnished under the Medicare Physician Fee Schedule (“PFS”) on or after January 1, 2021. The Proposed Rule release is followed by a public comment period which will culminate in CMS’ release of the Final Rule, which is expected to be announced by December 1, 2020 for implementation on January 1, 2021. The Proposed Rule is therefore subject to change.
The Proposed Rule includes two new Category I Current Procedural Terminology (“CPT”) code sets related to long term continuous electrocardiogram (“ECG”) monitoring and recording.  Category I CPT codes 93XX0 – 93XX7 will replace Category III temporary CPT codes 0295T – 0298T as the primary codes that iRhythm uses to seek reimbursement for its Zio XT service.  For these and other CPT codes, the Proposed Rule establishes Relative Value Units (“RVUs”) for Work, Practice Expense and Malpractice components that are adjusted by Geographical Practice Cost Indices that account for geographic cost variations and then multiplied by an annually updated Conversion Factor that converts the RVUs to payment rates.
iRhythm notes that the Proposed Rule published on August 3, 2020 does not include all required information, notably the Practice Expense RVU, to calculate the payment rates for the new codes. iRhythm will comment as appropriate following additional information being made available by CMS.


Alterity Says Animal Testing Data Positive For MSA Drug

The shares of Alterity Therapeutics Ltd. ATHE 190.37% advanced in the after-hours session trading in New York on Monday and in the regular session in Sydney on Tuesday.
What Happened: The surge came as Alterity Therapeutics reported positive data from an animal testing of ATH434 — its leading drug candidate for Multiple System Atrophy, a Parkinsonian disorder.
The new data “independently confirm and extend previous findings demonstrating that ATH434 reduces α-synuclein pathology, preserves neurons, and improves motor performance,” Alterity Therapeutics noted.
Why It Matters: The Melbourne-based pharmaceutical company in June said it had reached an agreement with the United States Food and Drug Administration on the non-clinical investigations required to support the second phase of its clinical trial of ATH434.
The FDA had also agreed on the company’s design for the Phase 2 study, it claimed.
What’s Next: Alterity Therapeutics noted that the data from the latest study will be presented at the 2020 International Congress of Parkinson’s Disease and Movement Disorders in September and at the American Neurological Association’s 2020 Annual Meeting in October.

FDA accepts Pacira application for expanded use of post-op pain med

The FDA has accepted for review Pacira BioSciences’ (PCRX +0.1%) supplemental marketing application seeking expansion of EXPAREL (bupivacaine liposome injectable suspension) label to include single-dose infiltration to provide postsurgical analgesia in children aged six and over.
The agency’s action date is March 22, 2021.
Last year, in December, the company announced positive results from late-stage Play study in pediatric patients undergoing spinal or cardiac surgeries.

With Covid-19 apps, wearables everywhere, can patients really benefit?

With Covid-19 cases again climbing, health tech companies and researchers are renewing their pitch for wearables and apps as a cutting-edge way to catch new cases and detect when patients are growing sicker.
The flood of tech tools — and the marketing machinery playing up their potential — promises to give users more timely information and fill key gaps in testing and tracing cases. But it is not altogether certain that these devices will benefit patients. It’s not just a basic question of whether a device or algorithm is accurate, health technology experts say, but whether the information provided is actually helpful in delivering better care or stemming the spread of the virus.
It is easy to take an off-the-shelf monitoring device, slap a Covid-19 label on it, and tell the world the device can be used to help lift us out of a public health crisis. It is far more difficult to ensure the product can home in on the unique signature of this virus and improve outcomes for patients, especially when it affects people so differently.
“I can tell you for a given system, it may be 80% accurate. But for me to show you it made someone’s care better is actually much harder to accomplish,” said Karandeep Singh, a physician and professor at the University of Michigan who studies the use of technology in health care.
But in certain clinical settings and populations, apps and wearables might be able to provide significant assistance during the pandemic, experts said. Here are a few questions to ask when trying to differentiate between empty promises and valuable tools.

Is it providing information specific to Covid-19?

Plenty of apps designed to monitor vital signs can accurately detect a fever and changes in respiration, but that’s not the same thing as correctly diagnosing Covid-19.
“That kind of app is not going to be nearly specific enough,” said Singh. “We’re heading into flu season. You can’t tell apart flu from cold from anything else.”
John A. Rogers, a biomedical engineer at Northwestern University, has spent months trying to tackle this problem with a wearable he developed for the university’s health system in Chicago. It is a Band-Aid-sized patch that attaches to the user’s throat to help monitor coughing and respiratory symptoms, such as shortness of breath.
One of the planned uses was to monitor signs of possible infection of frontline health care workers. So far, however, none of the health workers who have tested the device with Northwestern’s health system has become sick. It’s not clear whether none has contracted the virus, or whether some did but were asymptomatic, which points to a challenge facing any tech tool designed to track Covid-19 symptoms.
“You have to have some type of symptoms in order for us to pick anything up,” Rogers said. “If you’re completely asymptomatic we’re not going to be able to see it. This is not a molecular scale test.”
That’s not to say it can’t be helpful for other purposes. The wearable, which is experimental and has not been approved by regulators, is also being used to monitor symptoms in hospitalized patients. In one case, Rogers said, it flagged periods where a patient was experiencing a dangerous heart arrhythmia. It also picked up respiratory interruptions at night, helping providers spot signs of sleep apnea.
“It turned out to be pretty severe and we could see it pretty clearly,” Rogers said.
He said the impact of the wearable is still being evaluated and that his partners at the Shirley Ryan Ability Lab are seeking to develop an AI model that would use the data to help predict infections from symptom data.

Is the product targeted toward a particular population?

A major shortcoming of most wearables is that they are deployed in populations with very low risk of developing the problem they are designed to detect. The Apple Watch, for example, is often used by young, healthy people unlikely to benefit from its ability to detect the heart arrhythmia known as atrial fibrillation.
In Covid-19, that means many symptom tracking apps meant to flag the onset of illness in broad populations are likely to flag perceived problems that don’t amount to much. This results in a low positive predictive value, or the probability that a subject who tests positive truly has the illness.
“It’s going to be crying wolf a lot,” Singh said. He said that’s a significant drawback in a health care system trying to contend with a pandemic.
“With any of these apps, if you identify a problem, usually that problem results in a connection to the health care system, which has a time and a cost value to it. We don’t have unlimited resources,” he added.
However, the problem of false positives is mitigated in higher-risk populations, such as people who live in nursing homes or whose immune systems are compromised. In those defined user groups, it is helpful to provide caregivers with alerts about sudden changes in vital signs or a fever, because those are more likely to be associated with medical emergencies.

Will having the information support better care?

Apps and wearables can collect massive amounts of biological data from patients. But that doesn’t mean the information is going to be helpful to doctors who are trying to treat them.
A Covid-19 symptom tracker developed earlier this year by researchers at King’s College London, Harvard University and Stanford compiled symptoms reported by more than 2.6 million people, such as fever, cough, shortness of breath, and loss of taste and smell.
While the researchers are hopeful that the smartphone app can help inform individuals of their risks, and potentially flag infection hot spots, they are not arguing that it would significantly improve the care of hospitalized patients.
That’s because it’s not clear that having providing that information, through this app or another, will help doctors triage patients or change the way they are treating them.
“That’s something that remains to be seen,” said Andrew Chan, a Harvard professor who helped develop the app. “There’s a lot of hope this approach could be used in the setting of Covid because it is so highly infectious and there is a need to keep distance between patients and providers.”
But so far, there is no evidence that apps or wearables used to collect biological information on Covid-19 patients is improving their care. Singh said proving a positive effect on care is likely to take years, even in the case of products that have demonstrated an ability to accurately measure changes in symptoms and predict a patient’s deterioration.
“This is all experimental,” he said. “Studying the impact of a technology like this takes a ton more time than studying the validity of a technology.”

Mallinckrodt stock plunges after talks regarding possible bankruptcy filing

Shares of Mallinckrodt PLC MNK, +1.34% plunged 25% in premrket trading Tuesday, reversing an earlier gain, after the specialty pharmaceutical company swung to a large net loss, but reported an adjusted profit that beat expectations, while disclosing talks with creditors and litigation claimants regarding the possibility of a bankruptcy filing. The company reported a net loss of $933.1 million, or $11.04 a share, after net income of $6.8 million, or 8 cents a share, in the year-ago period. Excluding non-recurring items, such as a one-time Acthar Gel Medicaid rebate liability of $639.7 million, adjusted earnings per share came to $1.89, above the FactSet consensus of $1.34. Net sales fell to $166.5 million from $823.3 million. A one-time Acthar Gel Medicaid liability lowered sales by $534.4 million. In its business and litigation update, the company stated: “Due to pressures from the Acthar Gel Medicaid matter, the ongoing opioid litigation and the Company’s existing debts and the related risk of non-compliance with its financial debt covenant over the next twelve months, the Company has been working with external advisors to explore a range of options and engage in dialogue with financial creditors and litigation claimants and their advisors, including the possibility of a filing for reorganization in bankruptcy under Chapter 11 by Mallinckrodt PLC and most of its subsidiaries in the near-term.” The company said its cash balance at the end of the second quarter was $818.3 million and the revolving credit facility was fully drawn, while total principal debt outstanding was $5.29 billion. The stock has tumbled 31.5% over the past three months through Monday, while the S&P 500 SPX, +0.71% has climbed 15.9%.