Impel Pharmaceuticals (NASDAQ: IMPL), a commercial-stage pharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, today announced that it will implement an operational streamlining plan that will include a reduction of employee and non-employee expenses, largely impacting the research and development functions of the organization. The Company plans to reprioritize spend to capitalize on the continued positive momentum in payor and prescriber uptake of Trudhesa® (dihydroergotamine mesylate) nasal spray (0.725 mg per spray).
Wednesday, February 22, 2023
Amwell EPS, guidance disappoint
Amwell® (NYSE: AMWL), a leader in digital healthcare enablement, today announced financial results for the fourth quarter and full year ended December 31, 2022.
Fourth Quarter 2022 Highlights:
Recorded total revenue of $79.2 million in the fourth quarter of 2022, representing 9% growth compared to $72.8 million in the fourth quarter of 2021
Achieved subscription revenue of $30.7 million
Recorded AMG Visit revenue of $35.1 million
Reported gross margin of 42.4% compared to 39.9% in the fourth quarter of 2021
Net loss was ($61.6) million compared to ($70.6) million in the third quarter of 2022
Adjusted EBITDA of ($43.4) million compared to ($41.9) million in the third quarter of 2022
Total active providers rose 11% to approximately 107,000 compared to 96,000 in the fourth quarter of 2021
Total visits were 1.7 million, 10% higher than the fourth quarter of 2021
Visits on Converge represented 28% of total visits for the fourth quarter of 2022
Financial Outlook
The Company is providing the initial outlook for 2023 and expects:
Revenue between $275 and $285 million
AMG visits between 1.45 and 1.65 million
Adjusted EBITDA between ($150) and ($160) million
Quarterly Conference Call Details
The company will host a conference call to review the results today, Wednesday February 22, 2023 at 5:00 p.m. E.T. to discuss its financial results. The call can be accessed via a line audio webcast at https://investors.amwell.com or by dialing 1-888-510-2008 for U.S. participants, or 1-646-960-0306 for international participants, referencing conference ID #7830032. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call, at the same web link, and will remain available for approximately 90 days.
https://finance.yahoo.com/news/amwell-announces-results-fourth-quarter-210500266.html
Califf won’t make fixes to help prevent another infant formula-level crisis
A fragmented and indecisive Food and Drug Administration (FDA) is struggling to escape widespread criticism for its major structural and governance problems exposed by the infant formula crisis. FDA’s issues are no secret, but neither are the solutions. In fact, a detailed blueprint on how to restructure the agency for success was presented to Commissioner Robert Califf. But unfortunately, the redesign plan he announced falls short of the profound changes FDA needs to better protect consumers and accelerate getting safe, new food products to the market. Lack of bolder action ultimately jeopardizes public health.
An external evaluation of FDA’s foods program was conducted by an independent, expert panel at the commissioner’s request. The final report showed immediate functional enhancements could be realized by appointing a fully empowered, specialized leader or “deputy commissioner for foods” with direct line authority over all key units of the foods program. Housing the research, policymaking, inspection and enforcement components under one food authority will boost functional efficiency and provide much-needed accountability for the foods program’s budget. But drastic improvements require revolutionary change.
Despite broad support for the report’s recommendations, Califf’s initial “redesign” plan didn’t reflect its true substance despite containing some of the right words. Instead, he signaled that a new “deputy commissioner” would possess watered down managerial power compared to those who previously held such a role. Rather than unifying the entire foods program under a single leader with direct line authority, the major organizations responsible for running food-related operations would still report directly to Califf under his plan. We’ve already seen a splintered structure like this fail. A diluted plan to fix it won’t deliver the full transformation FDA needs.
In its current state, the commissioner’s plan fails to sincerely elevate the stature of the foods program. It largely maintains the status quo. FDA’s apparent intent to write off resounding calls for bolder steps to fully empower an expert foods leader is frustrating as it is puzzling. The foods program is a distinctive part of the agency deserving of a structure and leadership model tailored to its mission — not one improved in name only. The organizational weaknesses that contributed to the infant formula crisis can only be resolved through more decisive action.
FDA shouldn’t wait for another high-profile mishap that could cause sickness, and even death, to make its “redesign” plan more serious. Consumers deserve an FDA that takes every step possible to keep structural issues from inhibiting its mission, so it can focus acutely on preventing public health risks. But what we heard from the commissioner puts much-needed agency modernization well out of reach.
As research expands our understanding of human nutrition, the availability of information at the intersection of health and diet is accelerating changes in consumer behavior. From specialized diets like keto or paleo, to demand for healthier convenient food options in grocery stores, to easy access to data on sensitive ingredients like gluten or sesame oil, informed consumers are driving the explosion of new food products on the market. It is, therefore, critical that the agency responsible for food safety match the swift pace of today’s evolving consumer preferences with timely decision-making on innovative products.
At the end of the day, it’s consumers who will face the consequences if FDA refuses to truly shift away from its existing culture of indecision and inaction. The next public update on FDA’s foods program redesign plan should incorporate modifications that properly designate a deputy commissioner with the proper authorities needed to drastically improve functionality. FDA must acknowledge the robust record of widespread support from consumer organizations, industry, and state and local regulators — even backed in FDA’s requested third-party report — for this strong course of action. It’s time for FDA to do its job and do it right.
Roberta Wagner served nearly 20 years at FDA and as a top policy official at USDA. She is vice president of regulatory and technical affairs at the Consumer Brands Association, which represents nearly 2,000 iconic brands in the consumer packaged goods industry. Brian Ronholm is director of food policy for Consumer Reports, an independent, nonprofit member organization that works with consumers for truth, transparency, and fairness in the marketplace. He is a former deputy under secretary for food safety at the U.S. Department of Agriculture and previously worked for Rep. Rosa DeLauro (D-Conn.).
'Majority in new poll would be uncomfortable with health care provider relying on AI'
A majority of Americans in a new poll say they’d be uncomfortable with their health care provider relying on artificial intelligence (AI) as part of their medical care, and less than half think using AI would lead to better health outcomes.
A Pew Research poll, released Wednesday, found just 39 percent of U.S. adults say they’d feel comfortable with AI as part of their medical care — in practices like screening, diagnosis and treatment — while 60 percent would feel uncomfortable.
A third of respondents think using AI would lead to worse health outcomes for patients, and 37 percent think using it wouldn’t make a difference. Just 38 percent think the practice would lead to better health outcomes.
Exactly three-quarters think the health care sector will “move too fast” toward AI technology, “before fully understanding the risks for patients,” compared to just 23 percent who think providers will move too slowly, “missing opportunities to improve patients’ health.”
At the same time, a plurality of Americans think using AI in health care could reduce health care provider mistakes, with 40 percent saying AI could better the issue and 27 percent saying AI could actually up the number of errors.
More than a third, or 37 percent, think AI could worsen patients’ health care records security and more than half, or 57 percent, say using AI could worsen the personal nature of patient-provider relationships.
The research comes amid national debate over emerging AI technologies like ChatGPT and their place in existing fields, spurring some lawmakers to express concerns about the rapid innovation. Rep. Ted Lieu (D-Calif.) and other Democrats have called for Congress to regulate the tech.
The survey, conducted Dec. 12-18, 2022, surveyed 11,004 U.S. adults and had a margin of sampling error of plus or minus 1.4 percentage points.
Putin ally fires back at Biden’s Poland speech with nuclear warning
Former Russian President Dmitry Medvedev hit back at the U.S. on Wednesday, warning that his country reserved the right to use its nuclear arsenal to defend itself after a speech in Poland by President Biden following his surprise visit to Ukraine.
“After all, it is obvious to all reasonable forces that if the United States wants the defeat of Russia, then we are on the verge of a world conflict,” Medvedev, who currently serves as the deputy chairman of Russia’s Security Council, said in a post on the messaging platform Telegram. “If the United States wants to defeat Russia, then we have the right to defend ourselves with any weapon, including nuclear.”
The message from Medvedev — who was president from 2008 to 2018 and the country’s prime minister until 2020 — about nuclear weapons comes after Russian President Vladimir Putin said earlier this week that he intended to pull Russia from the New START arms treaty, an agreement between Russia and the U.S. to limit their ability to produce and launch nuclear weapons.
After Biden’s surprise visit to Ukraine on Monday, he delivered a speech in Poland in which he noted that the “United States and the nations of Europe do not seek to control or destroy Russia.”
“The West was not plotting to attack Russia, as Putin said today,” Biden said. “And millions of Russian citizens who only want to live in peace with their neighbors are not the enemy.”
He went on to lay the burden of ending the war on Putin.
“If Russia stopped invading Ukraine, it would end the war,” Biden said. “If Ukraine stopped defending itself against Russia, it would be the end of Ukraine.”
Medvedev turned the claim upside down, arguing it was actually the U.S. who was prolonging the war.
“If the US stops supplying weapons to the Kyiv regime, the war will end,” he said.
Biden: ‘No evidence’ Russia changing nuclear posture despite suspending treaty
President Biden on Wednesday said there’s “no evidence” Russia is changing its nuclear posture despite Moscow’s move to suspend its major nuclear arms treaty with the U.S.
Biden in an interview with ABC News anchor David Muir called the suspension of the New START nuclear arms treaty a “big mistake” but said there’s no indication Russia is moving to use intercontinental ballistic missiles or other nuclear weapons.
“It’s a big mistake to do that. Not very responsible. And — but I don’t read into that that he’s thinking of using nuclear weapons or anything like that,” Biden said.
“I think we’re less safe when we walk away from arms control agreements that are very much in both parties’ interests and the world’s interest. But I’ve not seen anything, we’ve not seen anything that- where there’s a change in his posture and what they’re doing,” the president continued. “The idea that somehow this means they’re thinking of using nuclear weapons… intercontinental ballistic missiles, there’s no evidence of that.”
The president also said that he’s “confident we’ll be able to work it out.”
Biden was in Poland on Wednesday morning — following a surprise trip to Ukraine, just days ahead of the one-year anniversary of Russia’s invasion. The president gave remarks from both Kyiv and Warsaw underscoring U.S. support for the embattled Ukraine.
Biden spoke outside the Polish Presidential Palace in Warsaw on Tuesday, the same day Russian President Vladimir Putin gave a speech announcing the suspension of the nuclear treaty.
Putin has sparked international concern about the potential use of nuclear weapons throughout the tense conflict. Worries also loom over any possible accident that at the nuclear power plant in Ukraine as the war continues.
Hikma accuses Amarin of suppressing generic versions of heart pill
Generic drugmaker Hikma Pharmaceuticals USA Inc has sued Amarin Pharma Inc, accusing it of using illegal tactics to delay generic competition for its heart drug Vascepa.
In a complaint filed Tuesday in Trenton, New Jersey federal court, Hikma claimed that Amarin "deliberately and meticulously locked up the supply" of the key ingredient needed to make generic Vascepa in order to maintain a monopoly.
London-based Hikma eventually launched the first generic version of Vascepa in November 2020, but it said that Amarin's tactics delayed the launch by months, and initially prevented Hikma from supplying enough of its generic to compete meaningfully with the branded version.
New Jersey-based Amarin did not immediately respond to a request for comment. The company was already facing a similar lawsuit filed in 2021 in the same court by Indian generic drugmaker Dr. Reddy's Laboratories Ltd, which remains pending.
Vascepa, derived from fish oil, is approved by the U.S. Food and Drug Administration to lower so-called "bad" cholesterol and reduce the risk of cardiovascular disease generally. It is Amarin's only product.
The drug brought Amarin $598 million in 2020, but sales have since fallen as generics have entered the market, forcing the company to cut its workforce last year. The company said in a 2020 statement to investors that Vascepa had been prescribed more than 8 million times since its 2013 U.S. launch.
Amarin initially sought to block competitors by suing Hikma and Dr. Reddy's for patent infringement after they sought FDA approval to sell generic versions of the drug, but lost after a Nevada judge ruled its patents obvious. The U.S. Supreme Court in 2021 rejected Amarin's bid to revive the patents.
Hikma said that even after losing the patent case, Amarin held on to its monopoly by entering into exclusive agreements with suppliers of the active ingredient, icosapent ethyl, that prevented the suppliers from selling to any other companies.
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