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Tuesday, July 20, 2021
PLx Shares Rise as Walgreens Set to Carry Vazalore in Stores
Intuitive Surgical 2Q Net Jumps on Growth in Da Vinci Procedures
Intuitive Surgical Inc. said profit jumped in the second quarter as sales of its da Vinci procedures and systems rose amid an increase in the number of surgeries performed following delays due to the coronavirus pandemic.
The robot-assisted surgery equipment maker said Tuesday net income increased to $517.2 million from $68 million in the second quarter of 2020. Sales rose 72% to $1.46 billion, and earnings per share rose to $4.25 from 57 cents in the second quarter of last year. Adjusted earnings per share rose to $3.92 from $1.11 a year earlier.
The company's sales of instruments and accessories rose 73% in the second quarter to $796 million, boosted by close to 68% growth in the volume of da Vinci procedures, Intuitive said. Systems revenue increased 68% in the second quarter from a year earlier to $440 million after the company shipped 328 da Vinci systems during the quarter, up from 178 a year earlier.
"We are pleased with our second quarter procedure growth and financial results, which reflect both the demand for high-quality minimally invasive procedures as well as a return to surgeries deferred during the pandemic," said Intuitive CEO Gary Guthart.
Moderna dominates Wall St trading ahead of S&P 500 debut
Moderna's stock dropped 2% in a volatile session on Tuesday, with the COVID-19 vaccine maker the most heavily traded company on Wall Street ahead of its debut in the S&P 500 on Wednesday.
Over $34 billion worth of the company's shares were exchanged, 17 times more than Moderna's $2 billion average over the past six months, according to Refinitiv data. About $10 billion worth of those trades happened in the final seconds of the session.
Apple was second-busiest stock, with about $14 billion worth of its shares traded.
After the bell, Moderna dropped an additional 1%, also in heavy volume.
Moderna joins the S&P 500 as of the start of trading on Wednesday. That means index funds managing over $5 trillion will have to have bought about 17% of the company's stock, according to Howard Silverblatt, a senior index analyst at S&P Dow Jones Indices.
Moderna's inclusion in the index also means that actively managed funds that measure their performance against the S&P 500 are more likely to consider buying its shares.
During Tuesday's session, Moderna surged as much as 9% and fell as much as 7%. The stock has gained about 18% since July 15, when S&P Dow Jones Indices announced its addition to the S&P 500.
The latest volatility in Moderna's stock comes as concerns increase over the highly contagious Delta variant of COVID-19, now responsible for the majority of new infections. Fears about a resurgence in the virus slammed Wall Street on Monday.
Fueled by the success of its COVID-19 vaccine, Moderna's stock has rallied almost 200% so far in 2021.
JAMA Peds Retracts Much-Hyped Masks Study
A controversial study suggesting that masks may harm children by exposing them to high carbon dioxide levels was retracted on Friday.
The research letter released in JAMA Pediatrics on June 30 had reported unacceptably high levels of carbon dioxide by German standards in air inside masks worn by children in a laboratory environment.
In the retraction notice, the journal editors cited "numerous scientific issues," that also included questions over the applicability of the CO2 measurement device and the validity of the study conclusions.
"In their invited responses to these and other concerns, the authors did not provide sufficiently convincing evidence to resolve these issues, as determined by editorial evaluation and additional scientific review," the notice read. "Given fundamental concerns about the study methodology, uncertainty regarding the validity of the findings and conclusions, and the potential public health implications, the editors have retracted this Research Letter."
The study quickly fell under criticism after it was published. Joseph Allen, MPH, DSc, who studies the impact of carbon dioxide on human health at Harvard School of Public Health in Boston, called the study "terribly flawed" and predicted on Twitter that it would be retracted. His key complaint was that the study failed to account for the outside air that would flood in when the children inhaled.
CDC does not list any known risk to children from wearing face masks, and in fact, recently recommended that unvaccinated children wear masks when school reopens in the fall.
While many areas of the country have dropped mask mandates, Los Angeles this weekend is reinstating its indoor mask mandate regardless of vaccination status as COVID-19 cases and hospitalizations rise, presumably due to the increasing role of the more transmissible Delta variant.
https://www.medpagetoday.com/infectiousdisease/covid19/93609
Over 200 in U.S. being monitored for possible monkeypox exposure: CDC
More than 200 people in 27 states are being monitored for possible exposure to monkeypox after they had contact with an individual who contracted the disease in Nigeria before traveling to the United States this month, according to the Centers for Disease Control and Prevention. To date, no additional cases have been detected.
State and local health authorities are working with the CDC to identify and assess the individuals, and follow up with them daily until late this month, said Andrea McCollum, who leads the poxvirus epidemiology unit at the agency’s National Center for Emerging and Zoonotic Infectious Diseases.
“It is a lot of people,” McCollum acknowledged.
The efforts stem from the discovery that a U.S. resident infected with monkeypox traveled from Lagos, Nigeria, on an overnight flight to Atlanta that arrived on July 9; the person then traveled the same day to Dallas. On July 15, the individual sought care at a Dallas hospital emergency room, where the diagnosis of monkeypox was made.
The people being monitored include a number who sat within 6 feet of the infected individual on the Lagos to Atlanta flight; others who used the mid-cabin bathroom on that flight; airline workers who cleaned the bathroom after the flight; flight attendants; and some family members who had contact with the individual in Dallas.
Passengers on the Atlanta-Dallas flight with indirect contact — in other words, those sitting near the infected person — were deemed to have had too short an exposure to be at risk, said McCollum.
“We define indirect contact as being within 6 feet of the patient in the absence of an N-95 or any filtering respirator for greater than or equal to three hours,” she said.
Monkeypox is caused by a virus that is related to smallpox, the only human virus to have been eradicated. It causes less severe illness than smallpox, but is still quite dangerous. The CDC said that the fatality rate for the strain of monkeypox seen in the Dallas case is about 10%.
Monkeypox is rarely seen in people. There was a large outbreak in the U.S. in 2003, when a shipment of animals from Ghana contained several rodents and other small mammals that were infected with the virus; 47 confirmed and probable cases were reported in five states. The outbreak was the first time human cases of monkeypox were reported outside of Africa.
In the past few years, Nigeria has seen an uptick of monkeypox cases and seven exported cases have now been detected: four in the United Kingdom and one apiece in Singapore, Israel, and the United States. In one of the importation events in the U.K., a local health care worker was infected after having unprotected contact with the patient.
The original source or sources of the monkeypox virus have not been identified, though cases have been linked to the handling of bushmeat and the trade of exotic small mammals, McCollum said.
The disease triggers fever, chills, swollen glands, and a characteristic rash that is disseminated across the body, including on the palms of hands and the soles of feet.
The virus spreads through a variety of ways: inhalation of respiratory droplets from infected people or contact with their lesions or bodily fluids. The virus can also be transmitted by having contact with bed linens or other items that have been used by an infected person, McCollum said.
The incubation period for monkeypox — the time from exposure to symptoms — can be anywhere from three to 17 days, though the CDC has asked state and local health authorities to monitor the identified people for 21 days, a period that ends on July 30. Most people who contract monkeypox do so within five to 13 days, which means if additional cases are found, they will likely start to show symptoms soon. “We’re in the time frame where we certainly want to closely monitor people,” McCollum said.
Pacbio hopes to avoid antitrust issues with Omniome
18 months after its acquisition by Illumina was stymied by antitrust concerns, Pacific Biosciences has done a similar, if smaller, deal of its own. It is acquiring Omniome for $600m upfront in cash and stock, with an additional $200m in milestone payments on the table. Pacbio hopes to add Omniome's short-read sequencing technology to its own long-read platforms. Theoretically these approaches are different – short-read tech sequences strands of DNA a few hundred bases at a time and then uses computers to stitch the fragments together, whereas long-read sequencing can handle around 10,000 bases. But the FTC considered these two approaches to be similar enough to deny approval to the Illumina-Pacbio deal, and though the Omniome acquisition is half the size of that earlier tie-up it too could risk running afoul of the regulator. Illumina, meanwhile, is reportedly getting bogged down even further in its efforts to reacquire its own spinout, the liquid biopsy developer Grail.
| Pacbio-Omniome is the ninth biggest medtech M&A of 2021 | ||||
|---|---|---|---|---|
| Announcement date | Acquirer | Target | Value ($m) | Focus |
| Jan 12 | Steris | Cantel Medical | 4,600 | Endoscopy, general & plastic surgery, nephrology |
| Mar 12 | Roche | Genmark Diagnostics | 1,800 | In vitro diagnostics |
| Apr 11 | Diasorin | Luminex | 1,800 | In vitro diagnostics |
| Jan 21 | Boston Scientific | Preventice Solutions | 1,225 | Patient monitoring |
| Mar 3 | Boston Scientific | Surgical business of Lumenis | 1,070 | General and plastic surgery, ophthalmics |
| Jan 4 | Dentsply Sirona | Byte | 1,040 | Dental |
| Mar 12 | Hellman & Friedman (private equity) | Cordis business of Cardinal Health | 1,000 | Cardiology |
| Jun 23 | Tecan Group | Paramit, subsidiary of Altaris Capital Partners | 1,000 | Blood, in vitro diagnostics |
| Jul 20 | Pacbio | Omniome | 800 | In vitro diagnostics |
| Apr 8 | Hologic | Mobidiag | 795 | In vitro diagnostics |
| Source: Evaluate Medtech. https://www.evaluate.com/vantage/articles/news/snippets/pacbio-hopes-avoid-antitrust-issues-omniome | ||||
Biogen's Aduhelm sales set to reach $1B next year and $6B+ by 2025: analysts
Despite the ambush of negative press against Biogen’s Aduhelm and the uncertainty around its benefit to patients, there’s still reason to believe the controversial Alzheimer’s treatment will hit blockbuster status next year, analysts predict.
Yes, physicians still have their doubts about Aduhelm’s murky clinical performance, Piper Sandler analysts said in a note to clients. But despite that, evidence indicates they’ll likely prescribe the monthly infusion enough to boost Biogen’s bottom line.
The analysts based the belief on the latest survey results from Spherix Global Insights, which suggest a very gradual uptake so far. In the first month since its approval, the survey found two neurologists—or 2% of respondents—prescribed the treatment for three patients.
Typically that percentage would be much higher, especially for a first-in-class disease-modifying therapy, Virginia Schobel, Spherix’s neurology franchise head, previously said. Still, Piper suggests the results are favorable for Biogen and were to be expected.
The number of new prescribers is expected to grow to five, and new patients could reach nearly 50 by next month, analysts wrote. The survey also suggests that Aduhelm could nab about 8% of Alzheimer's patients over the next six months.
While a small share of the total pool, that could lead to $3.8 billion in annual revenue, according to Piper’s note. To be sure, there will be hurdles.
It will likely take until January for the Centers for Medicare and Medicaid Services to issue a national coverage decision that will ultimately provide further clarity over which patients on government-run insurance coverage will be covered, Piper analysts wrote.
Even then, “Aduhelm is setting up to reach blockbuster status next year.” Piper predicts roughly $120 million in U.S. sales by the end of 2021, which will eventually balloon to $6.3 billion in 2025. Next year, the drug could draw as much as $1.1 billion in revenue, Piper said.
That growth will come despite the maelstrom of unfavorable media coverage Biogen has had to navigate; but that doesn’t necessarily carry over to the doctor’s office, Piper argues. One particularly negative headline, the analysts point out, was ICER’s unsurprising, unanimous rejection of the $56,000-per-year treatment and its benefits.
In Piper’s view, however, a ding from the cost watchdog has “turned into a bit of a badge of honor” given the “long list of drugs the Institute has deemed to be not cost effective, and then gone on to do quite well."
In the end, Piper analysts said “docs are likely to prescribe this drug in size, despite their misgivings." The analysts also believe "access is likely to be clean enough to meet or beat consensus" sales estimates.
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