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Monday, November 4, 2024
Kinder Care post-IPO ratings
Ascendis, Novo plan once-monthly GLP-1
- Collaboration leverages Ascendis’ proprietary TransCon™ technologies and Novo Nordisk’s expertise in cardiometabolic diseases
- Once-monthly GLP-1 receptor agonist will be the collaboration’s lead product candidate
NVIDIA Diverting Orders From Super Micro As A Potential Delisting, DOJ Probe Loom
Super Micro Computer (SMCI), a retailer of high-performance servers and liquid-cooled AI racks, is NVIDIA's third-largest customer. Additionally, in what is a testament to the heretofore symbiotic relationship between these two entities, SMCI's biggest client is NVIDIA, and its second-biggest client is an entity that is backed by NVIDIA. Now, however, it appears that NVIDIA has had enough of Super Micro Computer's near-constant headaches, and is deliberately trying to create some much-needed distance.
To wit, Digi Times is reporting today that NVIDIA has begun redirecting its orders that were originally placed with Super Micro Computer to other suppliers. This development comes as SMCI is now contending with allegations of financial malfeasance, a preliminary DOJ investigation, the exodus of its second auditor in around 18 months, and an imminent de-listing from the Nasdaq exchange.
For the benefit of those who might not be aware, Super Micro Computer's travails began in August when Hindenburg Research detailed instances of alleged accounting fraud and corporate governance malfeasance in a detailed report. SMCI then delayed the filing of its annual report for the fiscal year that ended on the 30th of June, presumably in a bid to undertake an internal review. Do note that under the prevailing statutory requirements, SMCI's annual report had to be filed by the 30th of August.
Meanwhile, the DOJ has also reportedly launched an investigation into the affairs at Super Micro Computer, with a particular focus on the alleged accounting violations. As per Hindenburg Research's anecdotes, Super Micro Computer engaged in distribution channel stuffing by pushing products to distributors based on artificially inflated demand forecasts, undertook partial shipments to meet specific sales targets and inflated its total shipment count in the process, re-hired top executives responsible for "widespread accounting violations" that had resulted in a $17.5 million settlement with the SEC, and paid nearly a billion dollars over the past three years to non-arm's-length suppliers such as Ablecom and Compuware.
Finally, do note that the Nasdaq exchange recently warned Super Micro Computer of a potential de-listing action should it fail to file the requisite annual report by the 16th of November. That punitive action could come as soon as the 20th of November.
Meanwhile, as we noted in a dedicated post earlier today, Super Micro Computer has negotiated major changes to its loan agreement with Cathay Bank, with the firm now required to furnish audited financial statements by the 31st of December as opposed to the earlier covenant, which posited the 28th of October as the deadline for furnishing these financial documents.
https://wccftech.com/nvidia-starts-diverting-orders-away-from-super-micro-computer-smci-as-a-potential-delisting-and-doj-investigation-loom-large/
BioCryst tightens revenue guidance
— Q3 2024 ORLADEYO net revenue of $116.3 million (+35.7 percent y-o-y) —
— Full-year 2024 ORLADEYO revenue guidance adjusted to $430-$435 million (top end of prior guidance range) —
— Company introduces full-year 2024 total product revenue guidance of $443-$448 million based on additional 2024 revenue from RAPIVAB —
— BCX17725 for Netherton syndrome advances into the clinic —
— Company generates GAAP operating profit of $7.7 million in third quarter ($24.9 million non-GAAP operating profit) —
Krystal US launch on track, other updates
Net product revenue of $83.8 million in 3Q and $250.1 million since launch in August 2023
JNDA for B-VEC filed and on track for commercial launches in Japan and Europe in 2025
French health authority approved pre-marketing early reimbursed access for B-VEC in France under the Accès Précoce (AP1) program; AP1 program for DEB patients access expected to start in 4Q 2024
Advancing Jeune Aesthetics’ KB301 to Phase 2 after positive results in Phase 1
Clinical updates on AATD and oncology program before end of year
Strong balance sheet, ending the quarter with $694.2 million in cash and investments
TG Therapeutics mixed Q3
TG Therapeutics (TGTX) stock crashed Monday — reversing a breakout — after missing third-quarter profit expectations, though sales of its multiple sclerosis treatment beat forecasts.
During the three months ended Sept. 30, TG Therapeutics earned 2 cents per share. That missed the Street's view by a penny, according to FactSet. On an adjusted basis, earnings came in at 4 cents per share, meeting expectations. Earnings also tumbled markedly from the year-earlier period.
Sales of Briumvi, the MS drug, topped expectations at $83.3 million. Analysts projected $77.4 million. But Evercore ISI analyst Michael DiFiore says TG Therapeutics stock took a hit due to Briumvi missing "whisper" expectations for $85 million.
"We think that this morning's negative reaction is perhaps misplaced, however, as TG Therapeutics had signaled second quarter to third quarter growth to be muted due to typical summer seasonality, and that growth would pick up again in the fourth quarter," DiFiore said in a report.
In early trades on today's stock market, TG Therapeutics stock tumbled more than 7% to 24.80. Shares look likely to undercut a buy point at 26.41 out of a cup base, according to MarketSurge.
https://www.investors.com/news/technology/tg-therapeutics-stock-tg-therapeutics-earnings-q3-2024/
Facebook, Nvidia ask US Supreme Court to spare them from securities fraud suits
The U.S. Supreme Court is set to consider bids by two tech giants - Meta's Facebook and Nvidia - to fend off federal securities fraud lawsuits in separate cases that could make it harder for private litigants to hold companies to account.
After a trio of Supreme Court rulings in June that weakened federal regulators - including the Securities and Exchange Commission that polices securities fraud - the justices may now be poised to rein in the power of private plaintiffs to enforce federal rules aimed at punishing corporate misconduct.
Andrew Feller, a former SEC lawyer now in private practice, said the Supreme Court's recent track record of handing down business-friendly decisions that narrowed the authority of federal regulators suggests that Facebook and Nvidia may similarly find "a receptive audience" before the justices.
The Supreme Court has a 6-3 conservative majority.
"I think business interests will continue their recent pattern of aggressively challenging rules intended to hold them accountable, including by challenging the remaining private rights of action," Feller said.
A private right of action refers to the ability of a private person or group to sue for an alleged harm.
Social media platform Facebook and artificial intelligence chipmaker Nvidia appealed to the Supreme Court after the San Francisco-based 9th U.S. Circuit Court of Appeals allowed separate class action securities fraud lawsuits to proceed against them.
The Supreme Court on Wednesday is due to hear arguments in Facebook's bid to dismiss a suit accusing the company of misleading investors in violation of the Securities Exchange Act, a 1934 federal law that requires publicly traded companies to disclose their business risks.
The plaintiffs, a group of Facebook investors led by Amalgamated Bank, accused the company in a 2018 class action of withholding information from investors about a 2015 data breach involving British political consulting firm Cambridge Analytica that affected more than 30 million Facebook users.
The suit arose after Facebook's stock fell following 2018 media reports that Cambridge Analytica had used improperly harvested Facebook user data in connection with Donald Trump's successful presidential campaign in 2016. The suit seeks unspecified monetary damages in part to recoup the lost value of the Facebook stock held by the investors.
At issue is whether Facebook broke the law when it failed to detail the prior data breach in subsequent business-risk disclosures, and instead portrayed the risk of such incidents as purely hypothetical.
Facebook in its Supreme Court filing argued, among other things, that it was not required to state that its warned-of risk had already materialized because "a reasonable investor would understand (risk disclosures) to be forward-looking and probabilistic in nature."
The SEC in 2019 brought an enforcement action against Facebook over the matter, which the company settled for $100 million. Facebook paid a separate $5 billion penalty to the U.S. Federal Trade Commission over the Cambridge Analytica issue.
Michael Perino, a professor at St. John's University School of Law in New York, described private rights of action as "a necessary supplement" to public enforcement efforts.
"The SEC is arguably under-resourced given the broad scope of its responsibilities," Perino said. "Securities class action lawsuits effectively deputize private attorneys to bring actions on behalf of aggrieved investors."
NVIDIA CRYPTO-RELATED PURCHASES
The Supreme Court on Nov. 13 is due to hear arguments in Nvidia's bid to scuttle a securities class action accusing the Santa Clara, California-based company of misleading investors about how much of its sales went to the volatile cryptocurrency industry.
The 2018 suit, led by the Stockholm-based investment management firm E. Ohman J:or Fonder AB, accused Nvidia of violating the Securities Exchange Act by making statements in 2017 and 2018 that falsely downplayed how much of the company's revenue growth came from crypto-related purchases.
Those omissions misled investors and analysts who were interested in understanding the impact of cryptomining on Nvidia's business, the plaintiffs said.
In its Supreme Court filing, Nvidia said the plaintiffs had failed to clear the legal bar set in a 1995 federal law called Private Securities Litigation Reform Act that established the standard for bringing private securities fraud suits.
Nvidia in 2022 agreed to pay $5.5 million to U.S. authorities to settle charges that it did not properly disclose the impact of cryptomining on its gaming business.
David Shargel, a lawyer in private practice who has represented clients before the SEC, said private securities litigation could gain prominence due to recent Supreme Court rulings weakening federal regulators.
Among the cases Shargel cited was a June 27 decision that rejected the SEC's in-house enforcement of laws protecting investors against securities fraud as a violation of the U.S. Constitution's Seventh Amendment right to a jury trial.
"This could further tax the commission's resources, as well as those of other agencies looking to bring fraud-like claims, opening the door for more private litigation," Shargel said of the SEC.
"I think it's hard to predict exactly which way private actions will trend," Shargel added, "but it's not hard to imagine that they may take on greater significance."
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