Orthofix Q3 call highlights

 

• Net Sales: $196.6 million, representing a 7% year-over-year growth on a constant currency basis.

• Adjusted EBITDA: $19.2 million, with a margin expansion of approximately 250 basis points.

• Free Cash Flow: Positive $5.9 million for the quarter.

• Bone Growth Therapy Revenue: Grew 9% to $57.9 million, with 13% growth in the fracture market.

• US Spine Fixation Revenue: Increased by 18%, more than triple the market growth rate.

• Global Spinal Implants, Biologics, and Enabling Technologies Revenue: $108.2 million, with 7% year-over-year growth.

• US Orthopedics Revenue: Grew 15%, contributing to a 3% growth in the global orthopedics business.

• Total Cash Balance: Approximately $32.6 million, including restricted cash.

• Full-Year 2024 Guidance: Net sales of $795 million to $800 million, with non-GAAP adjusted EBITDA of $64 million to $69 million.

• 
  

Release Date: November 07, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Orthofix Medical Inc (NASDAQ:OFIX) reported a strong third quarter with net sales of $196.6 million, representing a 7% year-over-year growth on a constant currency basis.

• The company achieved record performances in its USA orthopedics business and the number of 7D earnouts agreements, indicating strong market demand.

• Orthofix Medical Inc (NASDAQ:OFIX) saw an 18% growth in US spine fixation, more than triple the market rate, driven by new product introductions and experienced distribution partners.

• The Bone Growth Therapy (BGT) segment grew 9% overall, with a 13% increase in the fracture market, highlighting successful cross-selling strategies.

• The company successfully completed a new $275 million financing to replace its existing credit facility, optimizing its capital structure for long-term growth.

Negative Points

• The international orthopedics business declined by 2% compared to the previous year, indicating challenges in global market penetration.

• US biologics business growth was below the overall market due to distributor transformation, impacting performance.

• Orthofix Medical Inc (NASDAQ:OFIX) anticipates moderation in BGT growth rates as they anniversary gains from previous quarters.

• The company faces potential risks from market growth fluctuations and external factors like IV fluid shortages and hurricane impacts, which are not accounted for in their guidance.

• Orthofix Medical Inc (NASDAQ:OFIX) is still in the early stages of building its position in the fracture market, which presents both opportunities and challenges.

• Q & A Highlights

  Q: What are the key metrics in the long-range plan that might be challenging to achieve by 2027? A: Julie Andrews, CFO, mentioned that while they are confident in hitting their targets, market growth will be a key factor to monitor. They are confident in delivering mid-teens adjusted EBITDA and positive free cash flow.

• Q: Is the mid-teens EBITDA target by 2027 a milestone or a final goal? A: Julie Andrews, CFO, clarified that it is a milestone, not a final goal. The company does not see the mid-teens number as a stopping point, despite the structural changes since Orthofix's historical 20% EBITDA.

  Q: How is Orthofix planning to sustain above-market growth rates in each segment through the long-range plan? A: Julie Andrews, CFO, highlighted opportunities in the US spine market and orthopedics, where they have a small market share but a strong portfolio. Massimo Calafiore, CEO, added that their platform, including 7D technology, positions them well for above-market growth.

  Q: What are the drivers for adjusted EBITDA margin expansion through 2027? A: Julie Andrews, CFO, pointed to gross margin expansion opportunities, merger-related synergies, and scale on G&A costs as key drivers. They aim to leverage higher revenue for improved EBITDA margins.

  Q: Who are the main customers for the 7D Flash Navigation System, and how is it being used? A: Massimo Calafiore, CEO, explained that the main customers are in the spine market, using 7D primarily for open surgeries, which still represent 80% of the market. They are also developing MIS solutions to expand into ASCs.

https://finance.yahoo.com/news/orthofix-medical-inc-ofix-q3-071405806.html

Humacyte FDA review of acellular tissue engineered vessel BLA for Vascular Trauma ongoing

 Results from the V007 Phase 3 clinical trial of the ATEV in arteriovenous (AV) access for hemodialysis patients presented at American Society of Nephrology’s Kidney Week 2024 -

Long-term results from the humanitarian program where the ATEV was used to treat vascular injuries suffered during the Ukraine conflict were presented at the U.S. Department of Defense’s foremost scientific meeting -

- Conference call and live webcast at 8:30 a.m. ET today -

Conference Call and Webcast Details

Title:	Humacyte Third Quarter 2024 Financial Results and Corporate Update
Date:	Friday, November 8, 2024
Time:	8:30 a.m. ET
Conference Call Details:	Toll-Free: 1-877-704-4453 International: 1-201-389-0920 Conference ID #: 13749485
Call meTM Feature (avoid waiting for operator):	Click Here
Webcast:	Webcast Link - Click Here

A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days.

https://www.globenewswire.com/news-release/2024/11/08/2977606/0/en/Humacyte-Third-Quarter-2024-Financial-Results-and-Business-Update.html

"We Won't Be Certifying The Election..."

 by James Howard Kunstler,

Aborted

“Let folks cast their votes for Trump if that’s their choice. But mark my words, we won’t be certifying the election. He might win, but we’ll ensure he doesn’t step foot in the Oval Office.”

- Jamie Raskin (D-MD)

At last, it appears that the Party of Chaos got its fondest wish: it aborted itself in the 2024 election. “Joe Biden” was the coat-hanger it used: this miserable, grifting, now-senile hack politician who will be remembered only for driving his country to the verge of ruin. And for what? All in an effort to cover-up a long train of crimes and abuses against the American people perpetrated by a permanent bureaucracy gone rogue that was the party’s partner-in-crime. And now it’s over. 

The childishness of the Left — AOC whining about “fascism” — is under-appreciated. Note how the party’s most august mouthpiece, The New York Times, pretends to soul-search in the aftermath of the election debacle.

“Many Democrats were considering how to navigate a dark future, with the party unable to stop Mr. Trump from carrying out a right-wing transformation of American government. Others turned inward, searching for why the nation rejected them. They spoke about misinformation and the struggle to communicate the party’s vision in a diminished news environment inundated with right-wing propaganda”

- The New York Times

The New York Times diminished itself. It drove itself crazy with narratives — just as a crazy person with disordered thoughts can’t discern what’s real and what’s not. What they need is a serious mental health check. The time for incessant lying, hoaxing, and performative hysteria is over. On Thursday, in a three-minute speech, the President-elect set out a clear list of measures to reconstruct a national consensus based on reality. It includes firing a lot of people in the agencies, dis-embedding all the inspector-generals from the departments they oversee, establishing a “truth and reconciliation commission” to declassify and publish documents “related to alleged deep state activities, including spying, censorship, and corruption,” and finding out who exactly at the CIA / FBI / DHS / and other places has been leaking fables and falsehoods to the news media. In other words, clear away a shit-ton of untruth that burdens the consciousness of country.

Though the statement omitted to say so directly, it’s very likely that a number of public officials will find themselves before grand juries in the years ahead. If you haven’t figured it out already, you’ll learn that the term “misinformation” was just the gas in the gaslight used to confound the country about what has really been at stake — which is your personal liberty in what is supposed to be a free country. The Democratic Party and the Deep State blob really did try to steal that from you.

As they stole the 2020 election — which is probably one of the things to be revealed in the process. Look at this bar graph. Note how many millions more votes were cast in the 2020 elections than in the two previous and now in the 2024 contest. How did that happen? Where did that surplus supply come from? The Covid-19 scam provided the cover for a profligate mail-in ballot operation. They deluged the country with paper. Mark Zuckerberg provided $450-million through his cut-out charities to hire thousands of party activists to harvest and fill-out fraudulent ballots, and stuff them in drop-boxes by the hundredweight, with special attention to the crucial precincts in swing states — and that’s what landed the basement-cringing candidate, “Joe Biden,” in the White House.

It was that simple, and that much in-your-face, and for four years the official organs of the news swatted the truth away claiming they were “false, baseless, conspiracy theories” — and half the country was credulous enough to believe that. Or mentally ill, not able to tell fantasy from reality, especially in the newsrooms. Even more shamefully, this half of the country was led by the better-educated, credentialed, managerial class of citizens, who, amazingly, managed to turn intelligence into a new kind of personal liability. (The simplest explanation for that astounding failure is that people who consider themselves “experts” eagerly believe other experts and credentialed authorities, making them easiest to dupe. That’s why the faculty lounges are full of Jacobins.)

The winning side in this contest didn’t vote against Kamala Harris so much as they voted against the Democratic Party, the Party of Chaos, of BLM riots, of drag queens in the school library, of men in the women’s swim lane (and locker room), of forced vaccinations (your bodily autonomy, sister?), of locking up grandmothers who walked through the Capitol rotunda, of state-driven censorship, of malicious political prosecutions, of ruinous proxy war, of flooding the country with criminal alien mutts, of Mao Zedong style erasing of history, of FISA court surveillance, and, finally, of the same sort of self-loathing for the nation that a three hundred pound sophomore with a nose ring and sleeve tattoos feels for herself.

Indeed, the page is turning, but the story has suddenly changed. It remains to be seen whether the Democratic Party blows up altogether now in what’s shaping up to be a time of harsh recrimination, or whether its front-line activists, Marc Elias, Norm Eisen, Mary McCord, Lisa Monaco and Company skulk in the background hatching new schemes to try to drive the republic insane. They’ll have to work fast because the law might be coming after them in January. But they surely know that.

Between now and then, prepare to put your shoulder to the wheel. It’s not just the US government that begs for reform, but many of the secular operations of daily life in America, especially of an economic scene dominated by freakishly gigantic monopolies that have impoverished so many local communities, destroyed livelihoods and whole ways of life, and made slaves of citizens. That story has hardly begun to be told.

https://www.zerohedge.com/political/we-wont-be-certifying-election

Police hunt 43 monkeys that escaped from a South Carolina research facility

 A police search is underway after 43 monkeys escaped from a research facility in South Carolina on Wednesday night.

Police in Yemassee, Beaufort County, said the Rhesus macaque primates escaped from Alpha Genesis, a business that provides "nonhuman primate products and bio-research services," according to its website.

The monkeys were a group of "very young females" that have never been used for testing. An Alpha Genesis spokesperson confirmed to police that the animals "are too young to carry disease," according to police statement.

"Alpha Genesis currently have eyes on the primates and are working to entice them with food," police said Thursday afternoon.

Traps have also been set up and officers are using thermal imaging cameras in an attempt to recapture the animals, police said.

“Residents are strongly advised to keep doors and windows secured to prevent these animals from entering homes,” Yemassee Sheriff’s Department said in a statement. Anyone who finds a monkey should not interact with it but instead call 911, it said.

The company works with monkeys to carry out clinical trials, including on brain disease disorder treatments, and says it has "one of the largest and most comprehensive nonhuman primate facilities, designed specifically for monkeys, in the United States."

Alpha Genesis did not immediately respond to an overnight request for comment from NBC News.

The company secured a federal contract to run a colony of 3,500 monkeys on Morgan Island off the coast of South Carolina, also known as Monkey Island.

The Post and Courier newspaper in Beaufort County reported that primate escapes have happened several times before in the area, including in May this year, and in 2016 when 19 evaded security at Alpha Genesis before they were recaptured six hours later.

In 2022, three monkeys escaped following a traffic accident in rural Pennsylvania.

https://www.nbcnews.com/news/us-news/monkeys-escape-alpha-genesis-research-facility-south-carolina-rcna179077

'100 Days Trapped in Inpatient Legal Limbo'

 Entering Tony's* room elicited mixed emotions. His eager face and wave were a lovely daily greeting, though sadness swiftly followed. Tony's animated eyes would become vacant, as if we were strangers. Given Tony's advanced dementia, each hello was our first, no matter how many times we'd met before. For more than 100 days, that corner hospital room was Tony's whole world.

Tony was no longer making memories, but each day those of us on his team were -- frustrated by our powerlessness to advance his care. Inpatient hospitalization of medically stable patients awaiting court-appointed guardianship is common in our experience, and it drives emotional exhaustion for providers.

Tony was hospitalized awaiting a guardian in Massachusetts. Due to his cognitive decline, the team had deemed it unsafe for him to make complex decisions about his medical care; Tony lacked capacityopens in a new tab or window. But Tony had no healthcare proxyopens in a new tab or window (or the required form) to identify a cognition succession plan and he now lacked the insight to appoint a new decision-maker. Tony had no family members to advocate for him, speak to his wishes, or help him safely return to the home he'd lived in alone.

In other states, simply having family members present grants them authority to guide clinicians on patient wishes. In states like Massachusetts, a signed document naming a decision-maker is required. Without this, Tony had no legally viable alternative. We were stuck in the revolving door with him, powerless to end this purgatory, waiting on the courts. So, Tony remained hospitalized, awaiting a legal guardianopens in a new tab or window to become his medical decision-maker; it was his only viable path to hospital discharge.

Stripping Patient Autonomy

The threshold to legally nullify Tony's autonomy should be high. We regularly struggle with the ethics of balancing autonomy and our oath to do no harm. Conversely, reaching the guardianship threshold in patients with incapacity from medical illness should be achievable without invoking perpetual limbo. While beyond the scope of this discussion, there are significant, additional nuances in the spaces of disability advocacy and psychiatric illness.

We are uncertain how many patients are living Tony's experience. No centralized, accessible, physician-facing tracking system existsopens in a new tab or window to quantify affected patients. In addition to many different legal approaches to attaining court-appointed guardians, there are at least seven typesopens in a new tab or window of state laws across 50 states and D.C. regarding surrogate decision makers. Some statesopens in a new tab or window pre-define surrogate decision-maker defaults and their priority order -- spousal opinion trumps parental, trumps a sibling's -- while others employ surrogates without a defined priority, and some limit input to life-sustaining therapies.

The paradox of these cases is the apparent concurrent obligation to do too much and too little. Tony could not leave the hospital without a guardian, but absent capacity, he could not decline care. Thus, patients like Tony may be subjected to a default path of maximum medical care because doing less requires informed consent. Assessing the fine line between a lack of insight in the absence of capacity and the autonomous right to make inadvisable medical decisions is difficult.

All of this can feel like whiplash. Our hands often feel tied when maximal medical care is required, and when what is ethically appropriate seems divergent from what is legally permissible. Hospitals often have built-in ethics services to help navigate these challenges. Despite this, situations like Tony's strain already overtaxedopens in a new tab or window inpatient hospital capacity and are significant sources of distress.

As a frontline clinician, witnessing Tony's predicament feels bad. Clinicians are infrequently trained to navigate medico-legal overlap and often lack understanding of the associated legal terminology, such as how invoked proxies and guardians differ. This intensifies feelings of helplessness. When these topics are taught (which seems rare), they reflect the local environment rather than the challenging national landscape. With heterogeneous nationwide approaches, learnings may not be transferrable to future practice settings.

Toward a Better System

What can we do about it? One option is better training. If you are an educational leader, augment curricula to include more comprehensive training on medical decision-makers, recognition of cognitive decline, and medical drivers of capacity impairment. These situations present rich opportunities to engage patients and their loved ones in preemptive planning so transitions to legal incapacity are smoother.

Teach your trainees to meet this growing need, recognizing that patients may be exclusively informed by distorted or pop-culture influenced interpretationsopens in a new tab or window of this landscape. Help restore patient autonomy by ensuring wishes communicated early drive the care that follows later. Include medical decision-making planning and healthcare proxy form updating in your routine outpatient visits. Join us in making it a profession-wide endeavor to unburden acute care from unknown patient wishes.

Further, if you work in a healthcare system invested in minimizing unnecessary hospitalizations, share stories like Tony's to incentivize increased outpatient resources to catch patients before they're stuck in inpatient legal limbo. Advocate for novel strategies, such as dedicated teams to support the guardianship process. These teams mean that people like Tony can get care from experienced clinicians trained to support patients living this onerous reality.

If your local laws have negative consequences for patients, encourage your institution to lobby for solutions and engage in policy discussions. Clinicians often under-appreciate the weight our expertise carries both in the court of public opinion and local government. Together, we can advocate for legislation balancing patient autonomy and incapacity protections.

To be sure, we are not advocating for systematically diminishing patient autonomy via rapid guardianship pursuits. The aging baby boomer population portends strain on the system, particularly in states without surrogate hierarchies. This merits national attention and solutions now. We must ensure a wave of "Tonys" are not stuck in hospitals for 100+ days at a time with no active medical needs. The ripple effect on hospital capacity strain is already significant.

Clinicians, patients, families, and legislators all share the responsibility to enhance these systems and to ensure a clearer path forward for patients like Tony.

*Patient's name has been changed for privacy.

Gabrielle Kis Bromberg, MD,opens in a new tab or window is an educator and academic hospitalist in Massachusetts General Hospital's Department of Medicine in Boston. She is a Public Voices fellow with The OpEd Project. Kathleen McFadden, MD,opens in a new tab or window is a clinical ethicist at Massachusetts General Hospital and a fellow in nephrology at Mass General Brigham. She is a graduate of the Public Voices Fellowship with The OpEd Project.

https://www.medpagetoday.com/opinion/second-opinions/112772

Watchdog Calls for Tighter Scrutiny of Medicare Advantage Home Visits

 A new federal watchdog audit is ratcheting up pressure on government officials to crack down on billions of dollars in overcharges linked to Medicare Advantage home visits.

But so far, the Centers for Medicare & Medicaid Services (CMS) has rejected a recommendation from the HHS inspector general to limit payments stemming from house visits that don't result in any medical treatment -- a potential red flag that may signal overcharges.

In late Octoberopens in a new tab or window, the HHS watchdog found that the health plans pocketed $7.5 billion in 2023 from diagnosing health conditions that prompted no medical services -- about $4.2 billion of it through health assessments done in patients' homes. And court records show that for a decade or more, CMS officials have failed to act on their concerns that the home visits waste tax dollars and should be limited.

UnitedHealthcare, the largest Medicare Advantage contractor, accounted for about two-thirds of the payments tied to home visits and chart reviews, in which health plans mine patient medical files to add new diagnoses that can bring in additional revenue, according to the audit.

Assistant Inspector General Erin Bliss said the health plans are making billions without offering any treatment for medical conditions they flag during the visits, such as diabetes and major depression.

"Frankly, it needs to stop," Bliss said.

CMS, which runs the Medicare program, disagrees.

In a statement to KFF Health News by spokesperson Alexx Pons, the agency said it "appreciates the OIG's [Office of Inspector General] review in this area" and will continue to study the issue.

However, CMS disagreed with the OIG's call to restrict use of home health assessments in computing how much to pay health plans. People on Medicare "should have access to care that is appropriately provided in the home setting," CMS wrote in a written response included in the audit report.

"One would think that CMS would kick its regulatory oversight up a notch or two," said Richard Lieberman, a Colorado health data analytics expert.

"In contrast, CMS appears to be unconcerned and is telling OIG to stay out of their lane," he said.

UnitedHealthcare spokesperson Heather Soule said in a statement that the OIG had drawn "inaccurate conclusions" in the audit.

The home visits are "among the most comprehensive and thorough assessments of a patient's health and physical environment available in the healthcare system, helping to identify and drive needed follow-on care for the vast majority of the patients with whom we engage," according to the company.

No Care Provided

Government spending on Medicare Advantage, which is dominated by UnitedHealthcare and a handful of other health insurance companies, is expected to hit $462 billionopens in a new tab or window this year.

The industry, whose more than 33 million members make up over half of people eligible for Medicare, argues thatopens in a new tab or window most enrollees are satisfied with the care they receive and typically pay less out-of-pocket than those on original Medicare.

Whether Medicare Advantage is a good deal for taxpayers is another matter, largely because many health plans exaggerate how sick patients are to boost their payments, multiple federal auditsopens in a new tab or window and other investigations have shown. Medicare pays the health plans higher rates for sicker patients.

For fiscal year 2023, CMS identified $12.7 billion in overpayments linked to diagnoses not supported by patients' medical records.

The OIG audit tied $7.5 billion in payments to health conditions that prompted no treatment, including serious diseases such as diabetes, congestive heart failure, and major depression. That suggests that the medical condition either didn't exist or that the health plan failed to treat it adequately, auditors said.

"These are serious conditions. You would think you would see additional care during that year," said Jacqualine Reid, who led the OIG audit team. "We are asking CMS to step up its oversight."

Homegrown

The in-home visits have sparked controversy for more than a decade. A June 2014 media investigationopens in a new tab or window found that a sharp rise in home visits had inflated Medicare's costs by billions of dollars. The visits, which typically last less than an hour, are often conducted by nurse practitioners, who do not treat the patient, but go over a checklist of possible health conditions.

Sabrina Skeldon, a Texas lawyer who advises physicians on billing issues, said problems arise when health plans fail to order necessary medical tests to confirm a diagnosis made during a home visit -- and treat it.

Skeldon noted that The Cigna Group in 2023 paid $172 million to settle a whistleblower lawsuitopens in a new tab or window that alleged its Medicare Advantage plan illegally collected payments for medical diagnoses that were based solely on in-home assessments.

The OIG audit comes as the Justice Department presses a civil fraud caseopens in a new tab or window that accuses UnitedHealth Group of cheating Medicare out of more than $2 billion by mining patient records to churn up diagnoses that boosted revenue, while ignoring evidence of overpayments. The company denies the allegations.

Court filings from the case show CMS officials were concerned years ago that home visits and chart reviews could needlessly drive up costs.

In April 2014, CMS backed offopens in a new tab or window a proposal to restrict their use amid complaints from the industry that it would lose billions of dollars as a result. Similarly, CMS officials scrapped a proposalopens in a new tab or window to tighten scrutiny on the chart reviews after what one official called an "uproar" from the industry.

CMS officials also had concerns that unchecked home visits might affect efforts to recover overpayments through billing reviews known as risk adjustment data validation (RADV) audits.

Former CMS official Thomas Hutchinson, who ran the agency's Medicare Plan Payment Group from September 2006 through June 2010, testified in a deposition that officials had "heard about various folks that figured out how they could RADV-proof things by doing in-home visits."

In a confidential April 2015 slide presentation, CMS officials observed that health plans were "now conducting health risk assessments in beneficiaries' homes. One purpose of the assessments is to identify conditions and create medical records documentation that substantiates diagnoses."

And an October 2015 CMS memo circulated among senior agency staff cites "limitations around home visits" among the possible ways to "strengthen" the RADV audits.

In its statement to KFF Health News, CMS said it was "committed" to ensuring that diagnoses health plans submitted for payment were accurate. But the agency declined to answer written questions about the impact of home visits on its audit program, which has yet to complete reviews of payments dating back as far as 2011.

UnitedHealthcare had the lowest rates of unconfirmed diagnoses among five large Medicare Advantage organizations audited in 2011, according to court records.

Overall, the company ended up with underpayments of more than $261 million for 15 of its plans audited for 2011-2013, court records show. The audit findings for other Medicare Advantage firms are blacked out in court filings.

CMS audits payments to just 30 out of more than 700 contracts a year. That's not enough to protect tax dollars, said Matthew Fiedler, PhD, a health policy researcher at The Brookings Institution.

"They should be auditing 10 times as many contracts," he said. "Where we are now you are not likely to get caught."

https://www.medpagetoday.com/publichealthpolicy/medicare/112810