The Company expects to exceed 2022 full-year guidance for net product revenues
- Preliminary net product revenues for the fourth quarter and full-year 2022 are expected to total $235.5 million and $843.3 million, respectively
- Preliminary year-end 2022 cash balance of approximately $2.0 billion
https://finance.yahoo.com/news/sarepta-therapeutics-reports-preliminary-fourth-182800422.html
by Jeffrey A. Tucker via the Brownstone Institute (emphasis ours),
The latest of the Twitter Files is reported by Alex Berenson, who was granted access to messaging systems from the times before Elon Musk took over. His first round of reporting concerns the role of Scott Gottlieb, who is a perfect example of an influencer who is technically outside of government but might as well be a powerful official within it.
Gottlieb’s main gig now is as a senior fellow of the American Enterprise Institute in Washington, DC, but he also serves as a board member of Pfizer. Before joining AEI and Pfizer, he headed the Food and Drug Administration under Trump from 2017 to 2019. Before that, he was at Health and Human Services as a member of its Federal Health IT Policy Committee from 2013 to 2017.
You probably know him from TV because he has been a ubiquitous presence since the beginning of the pandemic lockdowns, defending the government’s actions and pushing the vaccines from the company whose board he serves.
In August 2021, he wrote Twitter to complain about a tweet from his successor at the FDA, Brett Giroir. Giroir wrote to report the results of a study in Israel that clearly demonstrated what most anyone could have known even without the study: natural immunity is superior to vaccinated immunity.
Gottlieb complained that the tweet is “corrosive” and might “go viral.” Twitter acted by slapping a “misleading” tag on the tweet, one that still remains to this day.
Here is the email.
Now, one might observe that Gottlieb is merely a private person and that it was certainly his right to object to anyone’s opinions. Maybe that’s true, except that he served Pfizer at the time and his company enjoyed billions in subsidies to make its product which not only gained a patent but benefitted from product-liability protection that is conventional with such vaccines. In addition, the product was only distributed thanks to an Emergency Use Authorization that bypassed the usual federal standards.
That aside, he had been massively influential on lockdown policies from the very beginning, urging the Trump administration to be as extreme as possible in its attack on civil liberties and freedoms.
We know this because Jared Kushner’s book reports every detail. He led the effort to present the guidelines for lockdowns that occurred on March 16, 2022, and he did it with the help of two tech executives he tapped to hang around the White House. Kushner reports:
As we dealt with the shortage of cotton swabs and other supplies, we faced another problem: the need to develop public health guidelines. Given that people across the country were confused and concerned, Birx and Fauci had been discussing the need for a unified set of federal standards to help Americans understand what they should do to keep themselves safe and slow the spread of the virus. They insisted that these guidelines would help prevent hospitals from becoming overwhelmed. Despite all the talk over the past week, no one had taken steps to produce a document. When Nat Turner flagged the issue, I asked him to coordinate with Derek Lyons to produce a draft and encouraged him to call Dr. Scott Gottlieb, the former head of the FDA and a renowned public health expert. I had been trying to persuade Gottlieb to come back into government for a short-term stint to help us better organize our response and support our effort to develop a vaccine.
When we called Gottlieb, he was grateful that we were preparing guidelines. “They should go a little bit further than you are comfortable with,” he said. “When you feel like you are doing more than you should, that is a sign that you are doing them right.”
So here we have a former government official now working as a board member for one of the companies chosen to produce and distribute vaccines who was directly involved and hugely influential in crafting a policy for the Trump administration that ended up not only dooming the Trump presidency but setting the entire country on the course to recession and a public health crisis. Still Pfizer benefited, obviously.
Sure enough, he got his way and the Trump administration issued the draconian guidance: “bars, restaurants, food courts, gyms, and other indoor and outdoor venues where groups of people congregate should be closed.”
And why call out Gottlieb alone when many thousands of serious scientists and medical professionals would have strongly advised against locking down?
This is why what Berenson reports here is so significant. Gottlieb was anxious not only to lock down the entire country but also to censor any report on what used to be common-sense observations about natural immunity, even when it comes from credentialed experts and cites peer-reviewed studies.
After his lockdown advocacy, and before his intervention to pull down a tweet celebrating natural immunity, but only after the vaccine came to market, he took to the pages of the Wall Street Journal to say that the CDC had gone too far, especially with its enforcement of social distancing: “The reliance on a flu model caused public-health authorities to underestimate and overestimate Covid in important ways.”
The person and role of Gottlieb is a paradigmatic case of why and how unraveling the mysteries of the lockdowns and vaccine mandates is such a complicated undertaking. It’s not just about government intervention and it’s not just about private corruption. It’s about a complicated relationship between the two, involving a range of public and private actors in and out of government who seized control of the policy machinery to achieve private ends at enormous public expense.
https://www.zerohedge.com/covid-19/censorious-scott-gottlieb-was-major-influence-lockdowns
OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced preliminary unaudited net revenue for the fourth quarter and full year ended December 31, 2022, and provided 2023 financial guidance.
Preliminary unaudited fourth quarter 2022 net revenue is expected to be $31.0 million, representing growth of 25% compared to $24.8 million in the fourth quarter of 2021. Preliminary domestic fourth quarter net revenue growth is expected to be 15% compared to the prior year period and international net revenue growth is expected to be 67% compared to the prior year period.
Preliminary unaudited full year 2022 net revenue is expected to be $122.3 million, representing growth of 25% compared to $98.0 million in 2021. Preliminary full year domestic net revenue growth is expected to be 19% and international net revenue growth is expected to be 47%.
“Our fourth quarter net revenue growth reflects continued commercial and operational execution offset by the impact of surgery schedule disruptions experienced in children’s hospitals due to viral respiratory infections,” commented David Bailey, President & CEO of OrthoPediatrics. “While the pressure from the pronounced respiratory illness season impacted our short-term results, we believe OrthoPediatrics remains in its strongest strategic position of all time, supported by an expanding user base, robust product portfolio, recent acquisitions, and a growing international presence.”
2023 Financial Guidance
Management projects 2023 net revenue to be in the range of $146.0 million to $149.0 million, representing growth of 20% to 22% over 2022 preliminary unaudited net revenue.
The Company plans to release its fourth quarter and full year 2022 financial results and provide additional commentary on its financial outlook in March. The quarterly and annual preliminary net revenue estimates for 2022 included in this press release are prior to the completion of review and audit procedures by the Company’s independent registered public accounting firm and are therefore subject to adjustment.
Analyst James Gordon from JP Morgan research considers the stock attractive and recommends it with a Buy rating. The target price is still set at GBX 13500.
Shares of Novocure (NVCR -15.04%) are sinking today, down by 15.4% as of 10:44 a.m. ET. The decline came after the company announced its preliminary full-year and fourth-quarter 2022 net revenue numbers.
Novocure said that its total preliminary net revenue for 2022 rose 1% year over year to $537.8 million. Its total preliminary net revenue for Q4 is $128.4 million, down 3.6% from the prior-year period.
Investors were excited last week after Novocure announced good news from a late-stage study of its Tumor Treating Fields (TTFields). The company reported that TTFields met the primary endpoint of the study by improving overall survival in patients with advanced non-small cell lung cancer (NSCLC).
Today's sneak peek at the full-year and Q4 2022 results, however, underscored Novocure's near-term challenges. Growth is definitely slowing significantly for TTFields, marketed under the brand name Optune, in treating glioblastoma and malignant pleural mesothelioma.
The decline on Monday doesn't completely erase the big gain for the healthcare stock so far in 2023. It does remind investors, though, that there's still a long way to go for Novocure to potentially launch TTFields as a treatment for NSCLC.
Novocure is scheduled to present at the annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 10, 2023. Expect the company's management to focus more on the NSCLC opportunity for TTFields than the headwinds for the therapy in its current approved indications. Novocure plans to file for U.S. and European regulatory approvals for TTFields in treating NSCLC in the second half of this year.
https://www.fool.com/investing/2023/01/09/why-novocure-stock-is-sinking-today/
Moderna Inc is considering pricing its COVID-19 shot at $110 to $130 per dose in the United States when it shifts from government contracting to commercial distribution of the shots, the company's Chief Executive Officer Stephane Bancel told the Wall Street Journal on Monday.
"I would think this type of pricing is consistent with the value," said Bancel, according to the WSJ report, adding the company was in discussions with hospital systems, pharmacies and pharmacy-benefit managers to line up distribution of its vaccine ahead of a potential fall booster shot campaign.
Moderna had previously estimated the commercial price expectations in a range of $64 to $100 a shot.
Moderna did not immediately respond to a Reuters request for comment on the report.
In October last year, rival Pfizer Inc said it planned to hike its COVID vaccine's price to about the same range - $110 to $130 per dose - after the United States government's current purchase program expires
https://finance.yahoo.com/news/1-moderna-considers-pricing-covid-191530602.html
