Search This Blog

Tuesday, May 7, 2024

Artivion beats estimates, ups outlook

 

  • Achieved revenue of $97.4 million in the first quarter of 2024 versus $83.2 million in the first quarter of 2023, an increase of 17% on a GAAP basis and 16% on a non-GAAP constant currency basis
  • Net income was $7.5 million or $0.18 per fully diluted share and non-GAAP net income was $2.6 million or $0.06 per fully diluted share in the first quarter of 2024
  • Non-GAAP adjusted EBITDA increased 60% to $17.3 million in the first quarter of 2024 compared to $10.8 million in the first quarter of 2023
  • Revised FY24 revenue guidance to 9% to 12% year-over-year growth on a constant currency basis, an increase of 0.5% at the midpoint

Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced financial results for the first quarter ended March 31, 2024.

"We are very pleased with our first quarter results as we maintained growth momentum and executed on key operational priorities. Revenue growth in the first quarter was driven by year-over-year constant currency growth in tissue processing of 26% and stent grafts of 19% compared to the first quarter of 2023. We also saw revenue strength across the Latin America region which grew 22% in the first quarter on a constant currency basis compared to last year," said Pat Mackin, Chairman, President, and Chief Executive Officer.

Mr. Mackin added, "In addition to our strong commercial results, we were pleased to see positive long-term results from the On-X aortic valve post-market clinical study, the results of which were presented at AATS in April.  This study showed that the use of the On-X aortic valve lowers the risk of major bleeding by 87% as compared to historic control further demonstrating the clinical superiority of our aortic portfolio."

Mr. Mackin concluded, "In light of our strong first quarter performance, we are raising the midpoint of our full year revenue expectations and remain confident in our ability to meet or exceed our adjusted EBITDA target for 2024."

Webcast and Conference Call Information
The company will hold a teleconference call and live webcast on May 6, 2024, at 4:30 p.m. ET to discuss the results, followed by a question and answer session. To participate in the conference call dial 201-689-8261 a few minutes prior to 4:30 p.m. ET. The teleconference replay will be available approximately one hour following the completion of the event and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The conference number for the replay is 13744600.

The live webcast and replay can be accessed by going to the Investors section of the Artivion website at www.Artivion.com and selecting the heading Webcasts & Presentations.

https://www.prnewswire.com/news-releases/artivion-reports-first-quarter-2024-financial-results-302136978.html

Systematic Review Reveals Many COVID-19 Vaccine Recipients Experienced New-Onset Psychosis

 by Naveen Athrappully via The Epoch Times (emphasis ours), 

 Individuals who took COVID-19 vaccines were found to have later suffered from psychosis, with Pfizer and AstraZeneca shots linked to most of the cases.

The peer-reviewed systemic review, published in the Frontiers in Psychiatry journal on April 12, examined cases of new-onset psychosis among people who took the vaccines. Psychosis refers to symptoms that occur when an individual has difficulty differentiating between reality and fantasy, with hallucinations and delusions being two key types. The review looked at 21 articles describing 24 cases of psychosis symptoms following vaccination. The researchers concluded that “data suggest a potential link between young age, mRNA, and viral vector vaccines with new-onset psychosis within 7 days post-vaccination.”

Collecting data on vaccine-related psychiatric effects is crucial for prevention, and an algorithm for monitoring and treating mental health reactions post-vaccination is necessary for comprehensive management.”

Out of the 24 cases, 13 were female. The median age of participants was 36 years. Twenty-two patients (91.2 percent) had no specific history of somatic illness and comorbidities.

In 33.3 percent of the cases, administration of the Pfizer mRNA vaccine “potentially induced adverse psychiatric events,” the study said. The viral vector AstraZeneca vaccine was linked to psychotic symptoms in 25 percent of cases.

In 45.8 percent of incidences, psychotic symptoms were reported after the first shot and in fifty percent after the second dose.

“Almost all reviewed cases (95.8 percent) presented with psychotic symptoms, such as hallucinations (visual, auditory, olfactory, and tactile) and delusions (mostly persecutory and delusions of reference).”

The most common form of hallucination was auditory, experienced in 54.2 percent of the cases, while visual hallucinations were experienced by 12.5 percent of patients.

“Motor disturbances, such as increased or decreased motor activity and bizarre behavior, were mentioned in 83.3 percent of cases. In 3 (12.5 percent) cases, a suicidal attempt was described.”

The psychotic symptoms mostly lasted for a period of one and two months.

The patients were treated using various methods including antipsychotics and steroids, but only 12 out of the 24 made a full recovery. The remaining suffered from “residual symptoms such as decreased emotional expressions, low affect, or residual psychotic symptoms.”

In one case, the patient reported a positive COVID-19 test result. “Previous studies have shown that individuals with documented comorbidities and a history of COVID-19 infection exhibit a statistically significant increase in adverse events following vaccination,” the study noted.

Researchers speculated that inflammatory conditions following vaccination may be a reason behind the psychosis. The study found elevated C-reactive protein levels and mild to moderate leukocytosis—high white blood cell count—as the most common blood abnormalities. Both conditions have links with inflammation.

Another hypothesis suggested in the study was that post-vaccination psychosis could suggest a manifestation of autoimmune anti-NMDA encephalitis, a condition in which the immune system targets the brain neurons by mistake and causes inflammation.

Researchers noted that instances of anti-NMDA encephalitis have been repeatedly reported after vaccinations against infections like influenza, pertussis, yellow fever, and typhus.

“Considering the potential link between post-vaccination psychosis and autoimmune anti-NMDA encephalitis, it is advisable to consider immunological screening in individuals presenting psychiatric symptoms post-COVID-19 vaccination.”

A third possible reason suggested in the study is that the various speculations and uncertainties regarding the safety of COVID-19 vaccines could lead to people experiencing “significant stress,” which could end up triggering the development of psychiatric reactions.

The authors received financial support for the review, with the article-processing charge funded by Riga Stradins University, Latvia. Researchers declared no conflicts of interest in the study.

Post-Vax Psychosis Cases

Episodes of psychosis after taking COVID-19 shots have been detailed in several case studies. In one instance, a 15-year-old boy from Taiwan was sent to hospital two days after taking the second Pfizer shot. He was screaming and exhibiting agitation and uncontrollable limb stretching.

Other bizarre behaviors included sitting up and lying down frequently. The child was prescribed antipsychotics yet his behaviors continued to persist after being discharged for more than a month.

The doctors then put the boy under a steroid regimen, which is anti-inflammatory and helps calm down an overactive immune system. His symptoms then improved.

In another case from Brazil, a woman in her 30s, who was previously healthy, developed refractory psychosis within 24 hours of taking an mRNA COVID-19 shot. The woman had disorganized thoughts, was aggressive, and believed she was being persecuted at the hospital.

Even though she was treated with mood stabilizers and antipsychotics, her behavior showed improvements only after four months of hospitalization. However, her psychosis continued.

A May 2022 review described the case of an 18-year-old woman who developed psychotic symptoms on the same day she took the first dose of AstraZeneca vaccine.

Symptoms started few hours after the vaccination with irrelevant talk. Over the next three days, it progressed to irritability, delusions of persecution and reference, and visual hallucinations.”

Another case study detailed the situation of a 45-year-old woman with no family history or personal history of mental disorders who ended up developing psychosis a month after she received a COVID vaccine. She quit her 18-year-old job abruptly and displayed erratic behaviors.

https://www.zerohedge.com/covid-19/systematic-review-reveals-many-covid-19-vaccine-recipients-experienced-new-onset-psychosis

Valneva Q1, update

 Q1 financial highlights

  • Total revenues of €32.8 million, including sales of €32.1 million, on track to meet anticipated full year guidance
  • Cash position of €176.6 million, including €95 million from sale of Priority Review Voucher (PRV)1.
    • Significantly extended cash runway with recent update of debt financing agreement2
    • Substantially lower cash burn expected in 2024 as Valneva expects to complete its cost contributions for the Lyme disease Phase 3 study in the second quarter
  • Net Profit of €58.9 million, reflecting PRV sale

2024 financial guidance confirmed

  • Expected total revenues between €170 million and €190 million, including:
    • €160 million to €180 million of sales driven by growth of Valneva’s proprietary products
  • Expected R&D investments between €60 million and €75 million, mostly dedicated to ongoing chikungunya development activities, the Zika trial and advancement of pre-clinical programs
  • Expected Other income between €100 million and €110 million, reflecting €95 million in proceeds from the PRV sale

Sandoz Q1

 

  • Strong first quarter performance, with net sales [1] of USD 2.5 billion, up 6% in constant currencies (up 5% in USD)
  • Biosimilar business growing 21% in constant currencies
  • All regions contributing to growth
  • Acquisition of CIMERLI® (ranibizumab-eqrn) completed in March 2024

GUIDANCE 2024
The company reiterates its full-year 2024 guidance, expecting net sales to grow mid-single digit in constant currencies versus prior year and core EBITDA margin around 20%.

FIRST QUARTER STRATEGIC MILESTONES
On January 31, we announced the launch of Tyruko® in Germany. Developed by Polpharma Biologics, Tyruko® is the first and only biosimilar to treat relapsing remitting multiple sclerosis. The availability of Tyruko® is a crucial milestone in improving access to effective and safe therapies for those in Europe that need them most.

On March 4, we announced the completion of the US biosimilar CIMERLI® acquisition from Coherus BioSciences, Inc, ahead of anticipated timelines. The acquisition builds on the leading Sandoz ophthalmic platform in the US and lays an even stronger foundation for future product launches.

On March 5, we announced that Remco Steenbergen, currently a Sandoz Board member, will become a member of the Executive Committee and take on the responsibility of Sandoz CFO as of July 1, 2024. Remco will succeed Colin Bond who will step down from his position as of June 30, 2024, and retire in January 2025 per Swiss employment practice. Colin will be available for transition as a senior advisor through the end of 2024.

On March 5, we also announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines including osteoporosis and cancer-related skeletal events.

KEY LINKS
Webcast – Live at 9am CET
Analyst Call Presentation
Analyst Consensus


https://www.biospace.com/article/releases/sandoz-reports-first-quarter-2024-sales/

Monday, May 6, 2024

NY lawmaker voted for ‘get Trump’ Adult Survivors Act hit with rape suit, now calls law ‘unconstitutional’

 File this under the “you-can’t-make-this-stuff-up” tab.

Kevin Parker is a state lawmaker from Brooklyn, New York, and he was one of the many legislators to (proudly) throw his support behind the Adult Survivors Act of 2022—Parker wanted “to ensure all New Yorkers can seek justice and be heard,” of course—which granted alleged victims of sexual assault a one-year time period to sue their alleged abusers in civil court, even if the alleged crime was outside of the statute of limitations. It was a “get Trump” scheme, to open the door for the E. Jean Carroll lawsuit, but like all things “get Trump” it has backfired…spectacularly.

Because, at the eleventh hour before the act was set to expire, a young woman (Olga Jean-Baptiste) accused Parker of forcibly raping her in 2004, so now, Parker is calling the law “unconstitutional.”


 


Furthermore, according to a local report, Parker called the accusation “absolutely untrue.” Huh, interesting response; so am I to understand that he’s accusing Jean-Baptiste of lying about the alleged assault?

Now, it’s not like I expect the case to go anywhere, but since he’s basically labeling his accuser a liar—perhaps she’s a mentally-ill hag with a ludicrous series of events who’s been obsessing over him for years, because in that case, I would be more inclined to believe Parker—he too should be subject to an $83.3 million fine, for the sake of optics and an even-handed application of the law and punitive measures of course. Because, as precedent dictates, this is “defamation” and that’s a very serious issue. (Heaven help him if he ever tried to implement an NDA or pay Jean-Baptiste a “hush money” sum to go away.)

Allow me to point to the fatal flaw in the legislation that he endorsed—this is a case of a poorly-written and inarticulate law. (Perhaps all the DIE lawyers hired for legislative counsel are to blame? This was clearly a “get Trump” initiative, but the bill’s text read that the law could be used against “any party” accused of a “sexual offense” (as defined by state code elsewhere). Naturally, this was going to ensnare more Democrat politicians than anything (Andrew Cuomo, Eric Adams, now Parker) since they are the preeminent (and bona fide) abusers, so they really should have been a little smarter, and instead of writing the bill to allow “any party” to be subjected to a lawsuit, they should have been clearer and more specific; see a suggested draft below:

[E]very civil claim or cause of action brought against any party [Donald J. Trump]...which would constitute a sexual offense…which is barred as of the effective date of this section because the applicable period of limitation has expired…is hereby revived….

Sure, it seems unconstitutional, but that didn’t stop them before!

Lawfare is a bad deal for all, because it also includes the law of unintended consequences for those waging the lawfare, and it is like a boomerang—it’s amazing that the Democrats have yet to figure this out.

https://www.americanthinker.com/blog/2024/05/ny_lawmaker_who_voted_for_the_get_trump_adult_survivors_act_gets_hit_with_a_rape_lawsuit_so_now_he_calls_the_law_unconstitutional.html


New York state sues group over abortion pill reversal claims

 New York state's top prosecutor on Monday sued Heartbeat International, an anti-abortion group, and 11 crisis pregnancy centers, accusing them of misleading and potentially endangering women by claiming that they can provide a treatment reversing the effect of the abortion pill mifepristone.

In the lawsuit, New York Attorney General Letitia James asked a state court in Manhattan to block Heartbeat International and the centers, located across New York state and whose mission is to discourage women from having abortions, from advertising abortion pill reversal on their websites or anywhere else and award an unspecified amount of money damages.

"Abortions cannot be reversed," James said in a statement. "Any treatments that claim to do so are made without scientific evidence and could be unsafe."

Heartbeat International in a statement called the lawsuit "a clear attempt to censor speech, leaving women who regret their chemical abortions in the dark, and ultimately forcing them to complete an abortion they no longer want."

Mifepristone is the first part of a two-drug regimen used for medication abortion, which is approved by the U.S. Food and Drug Administration to terminate pregnancy in the first 10 weeks. Medication abortion accounted for more than 60% of U.S. abortions last year.

Proponents of medication abortion reversal say mifepristone's effects can be blocked by a high dose of the hormone progesterone. There are no controlled clinical trials showing the procedure is safe or effective, and the American College of Obstetricians and Gynecologists says that it is not supported by science.

New York's lawsuit comes as the U.S. Supreme Court considers a case brought by abortion opponents seeking to restrict the availability of mifepristone nationwide. One of the plaintiffs in that case, George Delgado, sits on Heartbeat International's medical advisory board and is credited with developing abortion pill reversal.

Heartbeat International is an international anti-abortion group affiliated with more than 2,000 crisis pregnancy centers around the country. Through its website, it offers to connect women to providers who will perform abortion pill reversal.

Crisis pregnancy centers provide services to pregnant women with the goal of preventing them from having abortions. All of the centers named in James' lawsuit are listed in a directory maintained by HBI, and nine of them pay the organization an annual fee for affiliate status, according to the lawsuit.

Some of the centers' websites appeared to offer abortion pill reversal themselves, while others direct visitors to HBI's "Abortion Pill Rescue Network," according to James' complaint.

California's attorney general filed a similar lawsuit against HBI and crisis pregnancy center affiliates last September.

Last October, a federal judge ruled that Colorado cannot ban abortion pill reversal treatment. Later that month, a judge in Kansas blocked a state law that would have required healthcare providers to tell patients that medication abortion can be reversed.

https://www.yahoo.com/news/york-state-sues-group-over-173537177.html

CAMPUS JIHADISTS REAL TARGET IS AMERICA

 The surge of pro-Hamas “protesters” on American campuses has some pundits puzzled. On the other hand, past events help explain the dynamics in play. On August 3, 1981, some 13,000 members of the Professional Air Traffic Controllers Organization (PATCO), walked off their jobs. “They are in violation of the law,” said President Ronald Reagan, “and if they do not report for work within 48 hours, they have forfeited their jobs and will be terminated.” Two days later, President Reagan fired and replaced the strikers. As one wag put it, the PATCO strikers must have thought Reagan was a college president and would cave to their demands. That’s what’s going on now.

With few exceptions, college presidents are overpaid, spineless figureheads, so their campuses are soft targets for the pro-Hamas forces. They have doubtless noted that Joe Biden,  a waxworks effigy of a president, is something of an invertebrate. He proclaims that the Chinese are “not bad folks” and allows a Communist dictatorship to fly a surveillance balloon over most of the United States, including strategic military bases. Like the composite character president he served, Biden backs the Iran deal. As it happens, Iran’s Islamist regime has been hosting rallies in support of the campus occupiers in America, and like Iran they are now sending the message of  “Death to America.” According to David Horowitz (Radical Son), that has always been the goal of the American left, from the Communist Party though the Weather Underground, with Nazi-style anti-Semitism now in the mix. As David explains:

Most Americans, including conservatives, have been blinded to what the Neo-Nazi left is.

They believe that the Left agrees with them on basic principles and everything else is “just politics.” Killing babies because they’re Jewish or white isn’t just politics. It’s genocide.

The Hamas campus riots are a wake-up call about what the Neo-Nazi Left truly is.

The Neo-Nazi Left cannot be negotiated with. There is no living alongside it. Either Americans defeat the Neo-Nazi Left or the Neo-Nazi Left defeats America.

Meanwhile, for a history of the PATCO matter, see this essay.

https://www.powerlineblog.com/archives/2024/05/campus-jihadists-real-target-is-america.php