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Tuesday, May 11, 2021

Are Telehealth Stocks Still a Good Investment?

As the coronavirus constrained the public’s ability to visit their doctors as normal, the telehealth industry quickly took flight.

Shares of pure-plays Teladoc Health  (TDOC) - Get Report and Hims and Hers HIMS more than doubled from February 2020 into early 2021, while Massachusetts-based American Well  (AMWL) - Get Report capitalized on telehealth demand to stage a stellar IPO debut late in 2020, soaring nearly 50% on its first day of trading.

Meanwhile, privately-held leaders like the newly-merged Grand Rounds and Doctor On Demand fetch billion-dollar valuations and and, most recently, Cigna  (CI) - Get Report continues to rise after completing its acquisition of telehealth platform MDLive in late April.


However, as the economy begins to reopen, the hot investing trend is rapidly losing steam, leading some to wonder if telehealth is destined to produce diminishing returns going forward.

Tumbling Telehealth

As many industries eagerly await a return to normalcy and major indices inch upward in anticipation, the telehealth industry has, by contrast, taken a hit.

For example, Cathie Wood-favorite Teladoc has been nearly halved since February as the double whammy of a reopening economy and the entrance of Amazon  (AMZN) - Get Report into the space sparked selling action. In mid-March, Amazon announced an expanded roll-out of its Amazon Care telemedicine services to all its employees, with a plan to eventually offer it to other employers.

“TDOC detracted despite reporting a strong fiscal year in the face of competitive noise in the telemedicine space from Amazon, Talkspace and Hims & Hers (HIMS), among others,” Wood’s firm ARK Invest wrote in a quarterly report on its Genomic Revolution ARKG ETF. “Not to mention the unwinding of ‘stay-at-home stocks’ as COVID-19 vaccinations proliferated.”


Similarly, shares of American Well have been ailing into the second quarter of 2020, falling over 60% from its first-quarter peak. While the company may have entered the public market at a point where the industry was heating up quickly, the cool-down in 2021 has been just as fast.

Long-Term Trends

However, many industry experts and analysts are stressing that a narrow focus on the reopening and near-term dynamics is shortsighted.

“These slumps are knee-jerk reactions and don’t accurately reflect the fundamentals of those businesses and their long-term value propositions,” said Jeff Ransdell, founding partner and managing director of Fuel Venture Capital. “I’m confident that demand for telehealth will stay steady, if not rise, once the U.S. returns to status quo, not only because doctor’s offices will be very busy returning to business-as-usual, but because people will want to find ways to automate or virtually outsource ‘errand-type’ things to retain balanced daily schedules as we return to regular life.”


Indeed, many industry estimates agree with the optimistic outlook. For example, Grand View Research estimates the global telemedicine market will grow into a $298.9 billion industry by 2028 from around $55.9 billion in 2020 as trends in healthcare established during the pandemic prove their staying power.

“I think the momentum today may be sufficient to break the old system paradigms and drive meaningful change in [medicine],” Dr. Dan Carlin, CEO of New Hampshire-based telemedicine company WorldClinic, said. “Certainly, the patients have come to expect the better, faster and easier care they get with telemedicine.”

As such, he suspects firms that want to remain competitive will inevitably shift focus to telemedicine.

Too Many Companies in Telehealth?

Still, while the opportunity might appear incredibly promising, picking the right company to capitalize on the opportunity is not easy, especially as more firms enter the fray.

Likening the current situation in telehealth to the rapid growth seen in electronic medical records (EMR) following the passage of Obamacare, in which the EMR industry grew too quickly to the point of oversaturation, Deutsche Bank analyst George Hill said the telehealth movement was at an inflection point.


“In the case of telemedicine, the COVID pandemic and relaxed payer utilization standards have pulled five-to-ten year’s worth of growth into a period of just over a year,” Hill explained in a recent note. “Too many companies fueled by easy access to capital came to market chasing the opportunity. We suspect that in three to four years, only a handful of these companies (if that many) will be viable as publicly-traded companies with any significant market capitalization.”

Hill added that he nonetheless still views Teladoc as a premier player given its large market share, but remains cautious on telemedicine overall as competition heats up.

By contrast, Fuel Venture Capital’s Ransdell was more bullish on Hims/Hers, an online pharmacy that more recently expanded into online appointments and therapy, than the much-discussed Teladoc.

“They’ve built robust traction since the launch of their telehealth platform, and they’re on a trajectory to be a one-stop-shop for a high-value segment of millennial and Gen Z customers,” Ransdell said of Hims/Hers. “Teladoc feels like they’re occupying an opposite dimension compared to Hims/Hers. They’ve been around for over a decade and haven’t notched the kind of growth I’d expect from a SaaS company, and an incumbent at that.”


Overall, the consensus seems to be that while the industry still offers great opportunity, it will ultimately be the savvy stockpickers that seize it as the industry grows larger -- likely with fewer firms.

https://www.thestreet.com/investing/are-telehealth-stocks-still-a-good-investment

EMA head sees OK for BioNTech vaccine in 12-year-olds potentially in late May

 Pfizer and BioNTech's COVID-19 vaccine could potentially receive European approval for use in 12-year old children as early as the end of this month, the EU drug regulator's executive director told daily Handelsblatt.

"At the moment, the target we give for approval is sometime in June. We are trying to see whether we can accelerate this to the end of May," European Medicines Agency (EMA) head Emer Cooke was quoted as saying in a joint interview by Handelsblatt and other European newspapers.

"We have been promised data from the review done by Canada in the next couple of weeks and this could expedite the review," she said, adding that it was up to EU member states when to start giving the shot to the 12-15 year-old age group after EMA's go-ahead.

EMA started evaluating use of the Comirnaty-branded vaccine in the 12-15 age group on May 3, saying it expected the results of its review in June. U.S. regulators authorised the vaccine for 12-year olds on Monday. It had previously been cleared for use in people as young as 16 in the United States and in Europe.

https://finance.yahoo.com/news/ema-head-sees-ok-biontech-092327438.html

Inovio Falls on Wider Loss; Progress Shown in COVID Vaccine Trial

 Inovio Pharmaceuticals  (INO) - Get Report fell after the developer of DNA medications to treat infectious diseases, cancer and diseases associated with human papillomavirus reported a wider first-quarter net loss on 72% lower revenue.

The Plymouth Meeting, Penn. biotechnology company reported a loss of $54.4 million, or 27 cents a share, widening from a loss of $32.5 million, or 26 cents a share, in the year-earlier period. Shares outstanding rose 62% to 202.4 million. 

Revenue declined to $371,000 from $1.3 million.

A survey of analysts by FactSet produced consensus estimates of a GAAP loss of 18 cents a share on revenue of $1.1 million.

At last check, shares of Inovio fell 1.8% to $6.55. They closed the regular Monday trading session off 2.6% at $6.67. They touched a 52-week low of $6.24 on May 6.

At March 31, Inovio had cash, equivalents and short-term investments totaling $518.6 million.


The company on Monday reported progress in the Phase 2 segment of a Phase 2/3 clinical trial in the U.S. of INO-4800, a DNA vaccine candidate for COVID-19."Preliminary results show in a larger population that INO-4800 was generally safe, well tolerated and immunogenic" -- able to produce an immune response -- "in all studied age groups," Inovio said in a statement.

"INO-4800 continues to be safe and well-tolerated and has been observed to support the body's ability to generate both robust neutralizing antibodies and T cell responses – which we believe to be essential in protecting against current and emerging variants of concern," President and Chief Executive J. Joseph Kim said in a statement. 

"Equally important," INO-4800 "does not require cold or ultra-cold chain transport," the executive said.

Inovio said it would file the preliminary Phase 2 results with the U.S. Food and Drug Administration. If the agency clears the company to proceed, it will conduct a global Phase 3 clinical trial for INO-4800.

Late last month, Inovio shares fell after the Defense Department said it would stop funding the drugmaker's Phase 3 trial of its COVID vaccine because the agency said ample quantities of other vaccines were already available.

https://www.thestreet.com/investing/inovio-falls-on-wider-loss-reports-covid-vaccine-trial-progress

Rocket Pharma Phase 1 trial on hold

 RP-A501 Phase 1 Trial for the Treatment of Danon Disease Placed on Clinical Hold To Address FDA Request For Additional Risk Mitigation Methods in Protocol; No New Safety Events Observed; Anticipate Delay in Enrollment by One Quarter —

—Updated Low Dose Results in RP-A501 Treatment for Danon Disease Demonstrate Stabilization or Improvements in Key Clinical Outcomes Including 6MWT and NYHA Class; Full Data to be presented in 4Q —

— Reported Hemoglobin Increases of Nearly 2x from Baseline Sustained Up to 6-Months Post RP-L301 Treatment in PKD —

— Announced Sustained Efficacy, Durability and Safety Up to 18-Months Post RP-L201 Treatment in LAD-I —

— Advanced Fifth Gene Therapy Program in Infantile Malignant Osteopetrosis into Patient Dosing —

—Updated Results from FA, LAD-I, PKD Trials to be Presented at 24th ASGCT Virtual Annual Meeting —

— Redemption of 2022 Convertible Notes Strengthens Balance Sheet; $466.4 Million in Cash Solidifies Runway into 2H 2023 —

— Webcast and Conference Call Regarding Danon Program at 4:30 PM EDT Monday

Conference Call Details

Rocket management will host a conference call today at 4:30 PM EDT. To access the call and webcast, please visit the events section of the website. The webcast replay will be available on the Rocket website following the completion of the call.

Investors may listen to the call by dialing (866) 939-3921 from locations in the United States or +1 (678) 302-3550 from outside the United States. Please refer to conference ID number 50162863.

https://finance.yahoo.com/news/rocket-pharmaceuticals-reports-first-quarter-200000836.html

Prothena Gets $60M Milestone Payment from Roche As Parkinson's Candidate Advances

 

  • Prothena Corporation plc (NASDAQ: PRTA) has dosed the first patient in the Phase 2b PADOVA study evaluating prasinezumab in patients with early Parkinson's disease.

  • Prasinezumab is an anti-alpha synuclein antibody.

  • The event has triggered a $60 million milestone to Prothena from its worldwide collaboration with Roche Holding AG (OTCMKTS: RHHBY).

  • Prothena has previously received $75 million in payments from Roche as part of this collaboration.

  • PADOVA is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of prasinezumab in patients with early Parkinson's disease who are on stable symptomatic medication.

  • The study will enroll approximately 575 patients. The primary endpoint is time to meaningful progression on motor signs of the disease, as assessed by over 5 point increase from baseline in the Parkinson's Disease score.

EU opens new front in AstraZeneca legal fight that may lead to fines

 The European Union launched a new lawsuit against AstraZeneca on Tuesday that could lead to financial sanctions for the company which the EU alleges has breached a supply contract for COVID-19 vaccines.

The lawsuit is the EU's second against AstraZeneca after the bloc took action at the end of April over delayed vaccine supplies.

AstraZeneca has said the EU's first legal action is without merit, saying that it complied with the contract. The company's lawyer said on Tuesday the new lawsuit was not needed given that there was already one underway.

EU lawyer Rafael Jafferali, speaking in a Belgian court at Tuesday's hearing, asked that AstraZeneca delivers a total of 120 million vaccine doses by the end of June in Brussels' first formal request on the exact volume it is seeking to receive by mid-year.

The Anglo-Swedish drugmaker had originally committed to deliver 300 million vaccine doses from December to the end of June, but has delayed shipments, having delivered only 50 million, which under the contract were due in January.

As a partial and immediate compensation for the delays, the EU's lawyer told the court that the company should deliver 120 million doses by the end of June - 90 million in the second quarter, in addition to the 30 million shots shipped by the end of March.

AstraZeneca's aim is to ship 100 million shots by mid-year, which the company's lawyer Hakim Boularbah confirmed at the hearing on Tuesday.

Boularbah said AstraZeneca was not obliged to deliver the entire volume of doses set in the contract because it only committed to doing its "best reasonable efforts" to achieve it.

He declined to comment when asked by Reuters if the company could accept the EU's demand to deliver 120 million doses by the end of June. The company has cited production problems and export restrictions as reasons for its delayed supplies to the EU.

Cerecor fast-tracked for treatment of hospitalized patients with COVID-19

 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CERC-002 for treatment of hospitalized patients with COVID-19. CERC-002 is a first-in-class fully human monoclonal antibody targeting LIGHT (tumor necrosis factor superfamily member 14, TNFSF14).

Fast Track designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. The purpose of the provision is to help facilitate development and expedite the review of drugs to treat serious or life-threatening conditions so that an approved product can reach the market expeditiously. Sponsors of drugs that receive Fast Track designation have the opportunity for more frequent interactions with the FDA review team throughout the development program. Under Fast Track designation, a Biologic License Application (BLA) for CERC-002 is eligible for both rolling submission and priority review.

https://finance.yahoo.com/news/fda-grants-fast-track-designation-110000816.html