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Parkinson’s, MS drug company seeks sale in Chapter 11 bankruptcy

The biopharmaceutical company will liquidate in Chapter 11 bankruptcy after sale.

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Bankruptcy filings in the healthcare sector rose significantly over the last three years, rising from 25 in 2021 to 46 in 2022 and 79 in 2023, which was the highest level in five years, according to a Gibbins Advisors report.

For the first two months of the year, bankruptcies rose from about five filings in January to 12 more in February, according to data from S&P Global Market Intelligence. The most notable Chapter 11 filings in February were Cano Health, which filed on Feb. 4 with over $1 billion in assets and liabilities, and Invitae Corp., which filed on Feb. 13 with $500 million to $1 billion in assets and over $1 billion in liabilities.

Related: Troubled wireless technology pioneer files Chapter 11 bankruptcy

Chapter 11 filings are not slowing down yet, as a major biopharmaceutical company that sells essential drugs for serious life-threatening diseases has filed for bankruptcy in April.

Parkinson's, multiple sclerosis drug company files bankruptcy  

Pearl River, N.Y.-based Acorda Therapeutics  (ACOR) , maker of Parkinson's disease and multiple sclerosis therapies, on April 1 filed for Chapter 11 bankruptcy in the U.S. Bankruptcy Court for the Southern District of New York with a restructuring support agreement backed by its ad hoc noteholder group that seeks a sale to stalking-horse bidder Merz Therapeutics for a $185 million bid and an eventual confirmation of a liquidation plan to wind down operations after a sale.

The drug company will also seek $60 million in debtor-in-possession financing to fund operations during bankruptcy from its ad hoc noteholders, consisting of  $10 million available on interim approval by the court, $10 million provided on final approval and a roll up of $40 million in debt.

The debtor listed $266.2 million in debt and $108.5 million in assets in its petition.

Acorda, founded in 1995, markets its Ampyra drug, which improves walking in adults with multiple sclerosis. The company manages the production and distribution of the drug through a third-party contract with Pantheon Inc. The drug is known as Fampyra outside the U.S. and produced and distributed by Biogen International GmbH, though the parties' contract is set to terminate on Jan. 1, 2025.

The biopharmaceutical company's other product is Inbrija, the first and only levodopa inhalation powder approved by the Food and Drug Administration for intermittent treatment of episodic motor fluctuations in adults with Parkinson's disease treated with carbidopa/levodopa regimen. Catalent Massachusetts manufactures the drug under contract through 2030.

Biotech technician working in a lab.

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Pharmaceutical company purchase failed to generate revenue

Several factors caused the company's financial distress, according to a declaration by CFO Michael Gesser, including the company's 2016 acquisition of Biotie Therapies for about $363 million, which did not generate any revenue for the company and instead had net operating losses of $120 million.

The company also suffered an adverse court ruling that invalidated several of its Ampyra patents, which allowed generic versions of the drug to enter the U.S. market in late 2018 and caused a rapid loss of substantial revenue, the declaration said.

Finally, slower than expected sales of its Inbrija drug, due to the Covid-19 pandemic and prescribing challenges had a material adverse effect of the company's business and the inability to invest in its pipeline of drugs and other development opportunities also harmed the company financially.

The debtor seeks to set a May 16 deadline for potential qualified bids for an auction to be held May 22. A sale hearing to approve a sale would be scheduled for May 31 if an auction is held and on May 24 if no auction is held.

Related: Veteran fund manager picks favorite stocks for 2024

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Essential drugmaker to sell, liquidate in Chapter 11 bankruptcy

The Pearl River, N.Y., biopharmaceutical company that makes Parkinson’s disease and multiple sclerosis therapies filed for Chapter 11 bankruptcy protection…

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Bankruptcy filings in the healthcare sector rose significantly over the last three years, rising from 25 in 2021 to 46 in 2022 and 79 in 2023, which was the highest level in five years, according to a Gibbins Advisors report.

For the first two months of the year, bankruptcies rose from about five filings in January to 12 more in February, according to data from S&P Global Market Intelligence. The most notable Chapter 11 filings in February were Cano Health, which filed on Feb. 4 with over $1 billion in assets and liabilities, and Invitae Corp., which filed on Feb. 13 with $500 million to $1 billion in assets and over $1 billion in liabilities.

Related: Troubled wireless technology pioneer files Chapter 11 bankruptcy

Chapter 11 filings are not slowing down yet, as a major biopharmaceutical company that sells essential drugs for serious life-threatening diseases has filed for bankruptcy in April.

Parkinson's, multiple sclerosis drug company files bankruptcy  

Pearl River, N.Y.-based Acorda Therapeutics  (ACOR) , maker of Parkinson's disease and multiple sclerosis therapies, on April 1 filed for Chapter 11 bankruptcy in the U.S. Bankruptcy Court for the Southern District of New York with a restructuring support agreement backed by its ad hoc noteholder group that seeks a sale to stalking-horse bidder Merz Therapeutics for a $185 million bid and an eventual confirmation of a liquidation plan to wind down operations after a sale.

The drug company will also seek $60 million in debtor-in-possession financing to fund operations during bankruptcy from its ad hoc noteholders, consisting of  $10 million available on interim approval by the court, $10 million provided on final approval and a roll up of $40 million in debt.

The debtor listed $266.2 million in debt and $108.5 million in assets in its petition.

Acorda, founded in 1995, markets its Ampyra drug, which improves walking in adults with multiple sclerosis. The company manages the production and distribution of the drug through a third-party contract with Pantheon Inc. The drug is known as Fampyra outside the U.S. and produced and distributed by Biogen International GmbH, though the parties' contract is set to terminate on Jan. 1, 2025.

The biopharmaceutical company's other product is Inbrija, the first and only levodopa inhalation powder approved by the Food and Drug Administration for intermittent treatment of episodic motor fluctuations in adults with Parkinson's disease treated with carbidopa/levodopa regimen. Catalent Massachusetts manufactures the drug under contract through 2030.

Biotech technician working in a lab.

Shutterstock

Pharmaceutical company purchase failed to generate revenue

Several factors caused the company's financial distress, according to a declaration by CFO Michael Gesser, including the company's 2016 acquisition of Biotie Therapies for about $363 million, which did not generate any revenue for the company and instead had net operating losses of $120 million.

The company also suffered an adverse court ruling that invalidated several of its Ampyra patents, which allowed generic versions of the drug to enter the U.S. market in late 2018 and caused a rapid loss of substantial revenue, the declaration said.

Finally, slower than expected sales of its Inbrija drug, due to the Covid-19 pandemic and prescribing challenges had a material adverse effect of the company's business and the inability to invest in its pipeline of drugs and other development opportunities also harmed the company financially.

The debtor seeks to set a May 16 deadline for potential qualified bids for an auction to be held May 22. A sale hearing to approve a sale would be scheduled for May 31 if an auction is held and on May 24 if no auction is held.

Related: Veteran fund manager picks favorite stocks for 2024

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“Insane”: US Physicians Received Billions From Pharmaceutical And Medical Device Industry, New Research Finds

"Insane": US Physicians Received Billions From Pharmaceutical And Medical Device Industry, New Research Finds

Authored by Megan Redshaw via…

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"Insane": US Physicians Received Billions From Pharmaceutical And Medical Device Industry, New Research Finds

Authored by Megan Redshaw via The Epoch Times (emphasis ours),

U.S. physicians received more than $12 billion in payments from the pharmaceutical and medical device industry over a 10-year period, according to a new analysis.

(ElenaR/Shutterstock)

A research letter published on March 28 in the Journal of the American Medical Association found that the industry made over 85 million payments to more than 820,300 (57 percent) of eligible physicians across 39 specialties from 2013 to 2022. Nearly 94 percent of the payments were related to one or more marketed medical products.

Researchers examined data in the Open Payments database to determine what payments were made across different specialties and the medical products associated with the largest total payments. Data only included payments received for consulting, nonconsulting (such as speaker or faculty fees), travel, food, entertainment, education, gifts, grants, charitable contributions, and honoraria.

The Open Payments database is a federal transparency program that was established in 2013 out of concern that financial relationships between physicians and the industry were unduly influencing healthcare decision-making and costs.

The analysis found that payments varied considerably between specialties and among physicians of the same specialty. For example, the mean amount paid to the top 0.1 percent of physicians ranged from $194,933 for hospitalists to $4.8 million for orthopedic surgeons, while the payments to the median physicians ranged from zero to $2,339.

Orthopedic physicians received the greatest sum of payments, $1.4 billion, followed by neurologists and psychiatrists, $1.3 billion, cardiologists, $1.3 billion, and hematologists/oncologists, $825.8 million. Nearly 55 percent of pediatricians and 63 percent of infectious disease physicians received payments from the industry, while physicians practicing preventative medicine received the least sum of payments.

From 2013–2022, pharma paid 12 billion dollars to U.S. physicians. That’s mind-boggling. Insane. That’s how silence is bought, the minds of physicians influenced, and ultimately patient care/prescribing patterns influenced,” Dr. Manni Mohyuddin, an oncologist, hematologist, and assistant professor at the Huntsman Cancer Institute, told The Epoch Times.

Dr. Mohyuddin emphasized that the average payment received was low, but some physicians received a significant amount of money and have influence over writing guidelines, chairing committees, clinical trials, influencing opinions, and more.

Top Drugs and Devices Associated With Payments

The top three drugs associated with the most payments were Xarelto ($176.3 million), Eliquis ($102.6 million), and Humira ($100.2 million).

Xarelto, jointly developed by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, is used to prevent and treat blood clots. Janssen also created the Johnson & Johnson COVID-19 vaccine, which caused rare and sometimes fatal blood clotting disorders.

Eliquis is a multibillion-dollar blood thinner manufactured by Bristol-Myers Squibb and Pfizer. The drug in 2023 was 12 percent of Pfizer’s total revenue—second only to its Comirnaty COVID-19 vaccine. Pfizer’s COVID-19 vaccine has also been linked to blood clotting disorders.

Humira is an immunosuppressive drug manufactured by AbbVie to treat arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. Following the top three drugs are Type 2 diabetes medications Invokana, Jardiance, and Farxiga.

According to the analysis, the three medical devices associated with the most payments were daVinci Surgical System, $307.5 million, Mako SmartRobotics, $50.1 million, and CoreValve Evolut, $44.8 million.

‘Highly Targeted to Lucrative Procedures’

Our paper is a modest analysis. It does not explain the problem of financial conflicts of interest. But it is a lot of money. And it’s highly targeted to lucrative procedures,” co-author and cardiac electrophysiologist Dr. John Mandrola wrote in a post on Substack.

Dr. Mandrola believes that the strong influence of the industry can be seen in the approval of numerous medical devices by the U.S. Food and Drug Adminsitration despite “dodgy evidence.”

“Cardiology is a technical field. We use devices. Innovation requires some collaboration. Innovation has made cardiology better. But industry influence is way too strong,” he said. Dr. Mandrola believes the payments reported in their paper are not only for physician–industry collaborations, but are for marketing and goodwill, which helps establish practice patterns among physicians.

The industry is profit-driven, and if direct payments to doctors didn’t work, the industry wouldn’t spend billions doing it, he added.

Payments Can Create Conflicts of Interest

Dr. Andrew Foy, co-author and cardiologist, told The Epoch Times in an email the analysis shows a strong relationship between physicians and industry, but there are other indicators of this relationship as well. For example, it’s not uncommon for industry ads to be featured on homepages of major medical journals or for a medical conference or meeting to bombard physicians with industry advertising.

When I experience this at conferences, I feel like industry is not only welcome at these events but that the event is built around industry and its involvement,” Dr. Foy said. “There’s certainly no attempt to hide these relationships. The main reason being, at least in my opinion, is that many physicians, perhaps even the majority, believe the physician-industry collaboration is a net benefit to patients and society.”

Dr. Foy said he doesn’t necessarily share that view, but he doesn’t believe there is strong, objective evidence to support one side or the other as it relates to the overall benefits or harms of the relationship between physicians and industry.

“At this moment in time, the profession seems only interested in transparency. ‘As long as everyone is transparent, then everything is fine.’ As if someone cannot be transparent about their conflicts and highly biased at the same time,” he said.

Dr. Foy said he worries that conflicts of interest directly related to physician–industry payments may lead to overly enthusiastic recommendations or guidelines from medical organizations to use new products, even if they have not been sufficiently tested or where the evidence is not strong enough to recommend them over an old standard, or in some cases, nothing at all.

Additionally, Dr. Foy said a “major problem” with physician–industry payments is that they “have a way of tilting physicians sympathy toward industry” and the industry’s “medical advancements” which encourage physicians to more willingly adopt new products for the sake of  “industry advancement,” even if they don’t have a direct conflict of interest with that particular product.

In a way, they become cheerleaders for industry and more open to adopting new products simply due to this attachment,” Dr. Foy told The Epoch Times.

“I think what our paper does do is provide some numbers, which some may find shocking, and hopefully it renews interest in having conversations about physician-industry payments and conflicts of interest and perhaps facilitates more research,” he added.

Tyler Durden Wed, 04/03/2024 - 19:00

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Cruising through the icebergs

Back in October 2020, in the depths of the COVID-19 pandemic, in a blog titled “why cruise lines could be worth buying again,” we proffered an investment…

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Back in October 2020, in the depths of the COVID-19 pandemic, in a blog titled “why cruise lines could be worth buying again,” we proffered an investment thesis that the sharp drops in the share prices of the major listed cruise line companies did not reflect the then fast-advancing technology that would facilitate a reopening of global activity even in the absence of a vaccine, and that pent-up demand (82 per cent of passengers are repeat cruisers) for travel would see a surge in cruising activity exceeding the expectations then implied in share prices. 

Figure 1., displays the share price charts we published in that blog post (the embedded chart references refer to the blog post of October 21, 2020). 

Figure 1. Cruising for a bruising? Share price charts as of 21 October 2020.

Figure 1. Cruising for a bruising? Share price charts as of 21 October 2020.

Today, just three and half years later, the performances of the major cruise lines’ shares haven’t fully shaken off the effects of the pandemic. While Royal Caribbean (NYSE:RCL) is up 116 per cent, Norwegian Cruise Line (NYSE:NCLH) is up only 14 per cent and the highly indebted Carnival Corporation (NYSE:CCL) is just six per cent higher. 

Given that Carnival has performed the least impressively, it’s worth examining its current circumstances to help determine whether a recovery is possible. 

It seems navigating the high seas of the stock market has been a voyage fraught with risk and relatively unimpressive returns. That is certainly the case for investors who cast their lot with Carnival, the cruise industry titan then known for its vast fleet and now known for its equally vast debt.  

Recent developments have seen the company’s shares generally register modest gains, and these follow a setback triggered by the company’s latest financial disclosures. 

Carnival’s fiscal first-quarter performance offered a beacon of hope, with strong figures and optimistic projections for the remainder of 2024. However, these forecasts hadn’t accounted for an unexpected challenge: the collapse of the Francis Scott Key Bridge in Baltimore, necessitating the rerouting of several cruises to alternative harbours along the East Coast of the United States.  

The anticipated financial impact of this event was capped at a seemingly minor “up to U.S.$10 million”, equivalent to one cent per share. The figure gains significance, however, when viewed against Carnival’s financial position, which includes the revelation that a mere one per cent fluctuation in net yields could sway its financial outlook by as much as U.S.$135 million. 

Despite the lingering shadow of the pandemic, which had once pushed Carnival’s finances to the brink and plunged its debt to sub-investment grade, the company has been charting a steady, albeit long, ‘cruise’ toward recovery. Noteworthy are the significant debt prepayments. The roadmap for 2024 and 2025 now includes manageable debt maturities, laying the groundwork for Carnival’s potential return to a more stable financial position. 

Over the horizon, Carnival’s prospects are reported to be brightening. Thanks to a resurgence in occupancy rates, helped along by compelling pricing strategies, customer deposits have surged to around U.S.$7 billion, a marked increase from the pre-pandemic figure of less than U.S.$5 billion.  

Meanwhile, travellers are booking voyages further in advance and are reported to be indulging in higher-margin onboard luxuries at a significantly higher rate than before the pandemic. This uptick in consumer spending behaviour, especially evident during the peak cruise booking season known as “wave season,” suggests a strong sales period for Carnival. 

Of course, the journey ahead remains uncertain, with Carnival’s debt levels still a critical factor. As Carnival charts a course through its financial currents, its voyage towards stability and growth continues, and as the debt continues to decline, it will inevitably capture the attention of investors. 

The timeline for Carnival to fully retire its extra debt remains uncertain. Investors currently expect it should be cleared before 2034. Carnival generated U.S.$4.3 billion in cash from operations and U.S.$2.1 billion in adjusted free cash flow in 2023, and it plans to use these cash flows to continue paying off the debt. 

With the company’s market capitalisation less than five times cash flow from operations and just ten times adjusted free cash flow, investors with a patient disposition should keep the company’s shares on their watchlist. When the market becomes confident the debt will imminently be paid down, the share price could surge. 

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