Syneos Health, Inc. and Star Parent, Inc. Announce Proposed $1.70 B Offering of Senior Secured Notes

 Star Parent, Inc. (the “Issuer” or the “Company”) and Syneos Health, Inc. (“Syneos Health”), announced today that, subject to market conditions and other factors, the Issuer intends to offer $1,700,000,000 aggregate principal amount of Senior Secured Notes due 2030 (the “Notes”). The Issuer intends to use the proceeds from the offering together with other financing sources to fund the previously announced acquisition of Syneos Health (the “Acquisition”) by the Issuer and certain of its affiliated entities (such affiliates, together with the Issuer, the “Purchasing Entities”) and related refinancings. The Purchasing Entities were newly-formed entities established by a consortium of private investment funds led by Elliott Investment Management L.P. and its affiliates, Patient Square Capital, LP and its affiliates and Veritas Capital Fund Management, L.L.C. and its affiliates. If the sale of the Notes is not completed concurrently with the closing of the Acquisition, then the proceeds from the sale of the Notes will be placed into escrow until the closing of the Acquisition. 

The Notes will be offered and sold in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”), and to non-U.S. persons in transactions outside the United States pursuant to Regulation S under the Securities Act. The Notes will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction and may not be offered or sold in the United States or to, or for the benefit of, U.S. persons absent registration under, or an applicable exemption from, the registration requirements of the Securities Act and applicable state securities laws.

https://finance.yahoo.com/news/syneos-health-inc-star-parent-115400883.html

NYC comptroller declines to approve $432M DocGo contract to aid migrants

 New York City Comptroller Brad Lander declined to approve a $432 million emergency contract with DocGo, a medical services provider the city had tapped to care for asylum seekers.

In a statement Wednesday morning, Lander said he returned the no-bid contract to the Department of Housing Preservation and Development.

“My office did not make this decision lightly. After a careful review, we are declining to approve this contract due to numerous outstanding concerns,” Lander said. 

“The agency’s contract submission to our office fails to describe how the $432 million price tag was reached. There was little evidence to show that this company has the experience to provide the services it has been contracted for. Contradictory information was provided regarding their fiscal capacity and serious questions were raised about the integrity and responsibility of this vendor and their subcontractors,” Lander added.

A spokesperson for City Hall said in a statement that the city has used emergency contracts "to provide beds and services to individuals and families entering our care."

“We are doing everything we can to stop families from being forced to sleep on the streets, and we are hopeful our partners in the Comptroller’s Office will work with us towards that goal,” the statement said.

According to the New York City charter, Mayor Eric Adams has the power to override Lander's objections and singlehandedly approve the contract with DocGo, after responding in writing to the comptroller's objections.

In a statement, a spokesperson from DocGo told NY1 the company, “received assurance from the mayor's office that NYC intends to fully pay DocGo for the services delivered under this contract, both historically and going forward.”

Adams on Wednesday said the city comptroller already gave blanket approval to emergency contracts, and that the DocGo one needs no approval from his office.

"I think the comptroller probably saw an opportunity to just get in the conversation, but we have a ruling from him, his office, during the emergency contracts, and we're just gonna continue to do that," the mayor said.

DocGo filed with the U.S. Securities and Exchange Commission a letter from the city's housing commissioner that says the comptroller's letter presents "no risk of non-payment" and that "payment under the contract will commend promptly."

Lander said he hopes DocGo and the city would address his criticisms instead.

"Choosing to push forward to pay them despite a lack of answers to those questions, I believe would be a mistake," Lander said.

DocGo came under scrutiny earlier this summer, with New York Attorney General Letitia James announcing that her office was investigating accusations that the medical services provider mishandled migrants in its care.

DocGo CEO Anthony Capone told Spectrum News NY1 the allegations, first reported by the New York Times, led to terminations, discipline or retraining.

On Sept. 1, meanwhile, the New York State Department of State said more than 50 security guards hired to work at upstate hotels housing asylum seekers did not have proper authorization to do so.

The companies who hired the security guards were contracted by DocGo, the Department of State said.

A DocGo spokesperson said the company took immediate action to remedy the situation and abide by the state’s standards, saying in a statement that the provider’s “top priority is the health and safety of the asylum seekers in our care."

On that same day, the Albany Times Union reported that DocGo is using its experience contracting with New York City to seek a $4 billion federal contract to provide with migrants crossing the border with medical services.

https://ny1.com/nyc/all-boroughs/news/2023/09/06/city-comptroller-rejects--432m-docgo-contract-to-aid-migrants

Dexcom Says It Won't Be The Biggest Loser In The Weight-Loss Battle

Dexcom (DXCM) stock helped lead a medical surge Wednesday after the company allayed concerns that popular weight-loss drugs like Wegovy would tamp down usage of its diabetes devices.

Instead, the inverse appears to be true, Dexcom said in a presentation Tuesday. Across all segments of patients with type 2 diabetes, use of continuous glucose monitors, or CGMs, increased after beginning treatment with GLP-1 drugs like Wegovy, Ozempic and Mounjaro. CGMs are body-worn devices that help measure blood sugar in real time and often pair with insulin pumps.

The analysis undercuts recent investor sentiment that the use of GLP-1 drugs would largely render moot CGMs for many patients. These drugs first won approval to treat type 2 diabetes. But they are gaining steam in obesity treatment.

The resurgence bolstered Dexcom stock as well as shares of diabetes device companies Insulet (PODD) and Tandem Diabetes (TNDM). Shares of Zimmer Biomet (ZBH) also jumped. Zimmer Biomet makes a sleep apnea device. Sleep apnea is another area with ties to the obesity market.

UBS analyst Danielle Antalffy says sentiment has been "overly bearish" for the group.

"Total addressable market (estimates) are cut meaningfully as GLP-1 adoption ramps (specifically in diabetes and sleep apnea)," she said in a note to clients. "We acknowledge that it will be difficult to disprove the negative over the next six to 12 months."

Dexcom Stock: Analysis Of Insurance Claims

Dexcom analyzed insurance claims from Optum. On average, CGM use doubled among patients taking intensive insulin regimens after they began treatment with a GLP-1 drug. For patients on basal insulin or non-insulin therapies, CGM use increased roughly fourfold after beginning GLP-1 treatment.

"Increasing access and simplicity of CGM systems supports continued acceleration of CGM adoption across all type 2 diabetes segments, including with GLP-1 use," Dexcom said in its presentation.

On today's stock market, Dexcom stock popped 6.5%, closing at 106.88. Shares of Tandem Diabetes and Insulet climbed a respective 3.3% and 3.4%. Zimmer Biomet shares gained 4.1%. This comes despite a broader downfall in the S&P 500.

The GLP-1 frenzy has weighed on medical products stocks over recent months. Since mid-July, IBD's 132-company Medical-Products industry group has tumbled 14%, as of Tuesday's close. It has fallen below its 50-day and 200-day moving averages, according to MarketSmith.com.

Dexcom stock has given back more. Shares have toppled 27% over the same time period. But on Wednesday, shares gapped higher. UBS' Antalffy kept her buy rating on Dexcom stock, though she cut her price target to 138 from 175.

"Despite this persisting sentiment shift, we believe little has changed for CGM," she said. "For CGM, we remain steadfast in our view that all diabetes patients will be on a CGM within the next five-plus years, regardless what their medical regimen entails."

https://www.investors.com/news/technology/dexcom-stock-leads-a-medtech-rally-how-it-allayed-concerns-of-a-weight-loss-bloodbath/

Zimmer Biomet Lifts Annual Guidance, Sees Procedure Recovery

 

• Zimmer Biomet Holdings Inc (NYSE: ZBH) reported Q1 FY23 adjusted EPS of $1.89 Tuesday, compared to $1.61 a year ago and the consensus estimate of $1.64.

• It posted Q1 sales of $1.831 billion, up 10.1% on a reported basis and 13.2% on a constant currency basis. Revenues came in above the consensus of $1.7 billion.

• "Our strong performance in Q1 outpaced our internal growth expectations, driven by continued procedure recovery, solid execution, and increasing traction around ZB innovation," said Bryan Hanson, Chairman, President & CEO of Zimmer Biomet.

• Revenue from knee products increased 15% Y/Y to $762.5 million (+18.2% constant currency).

• Monday, Zimmer Biomet agreed to acquire Ossis, a maker of personalized 3D-printed implants.

• Ossis also offers complex hip replacements, including second-time replacements and ones involving bone tumors and trauma.

• Hip products increased 9.3% to $492.8 million (+12.9%).

• Guidance: Zimmer Biomet expects an adjusted EPS of $7.40-$7.50 for 2023, up from the prior forecast of $6.95-$7.15 per share previously forecast. Analysts, on average, were expecting a profit of $7.06 per share.

• The company expects revenue to grow 5%-6% this year, compared with its previous forecast of 1.5%-3.5%.

https://finance.yahoo.com/news/zimmer-biomet-lifts-annual-guidance-164303435.html

FDA could greenlight new Covid boosters as early as Friday

 The Food and Drug Administration plans to greenlight updated versions of the Covid booster as early as Friday, according to four people familiar with the agency’s plans.

The latest shots are designed to target the XBB.1.5 omicron subvariant. Though this particular strain is no longer dominant, the boosters should still provide protection against current circulating subvariants, which are closely related, the drugmakers and experts say. 

The Friday timeline for authorization is not firm and could slide into early next week, two of the sources said. 

That could prompt further criticism from some doctors who say that federal health agencies are acting too slowly in the booster rollout as Covid cases and hospitalizations are once again rising. 

Two sources who spoke to NBC News indicated the FDA is exploring the possibility of granting the boosters a full approval license instead of an emergency use authorization, a departure from the approach used for previous Covid vaccine authorizations. However, it remains uncertain whether this is still the intended course of action.

Following the FDA’s sign off, the Centers for Disease Control and Prevention and its advisory committee will issue their own recommendations about who should get the shots and how they should be used. The agency’s Advisory Committee on Immunization Practices is expected to vote during a scheduled meeting Tuesday. The CDC’s director, Dr. Mandy Cohen, could sign off on the boosters shortly after the meeting, allowing vaccinations to begin.

About 97% of adults have some level of protective immunity, according to data shared by government officials. However, since immunity from previous infections and vaccinations diminishes over time, officials are aiming to shore up protection as people spend more time indoors during the fall and winter months.

For the first time since Covid vaccines have been available, however, the cost of the shots will not be covered by the federal government. 

Pfizer and Moderna have indicated the list price for the vaccines will be $110 to $130 per dose. 

Whether and when someone will be able to get those shots will depend on their insurance coverage, according to Jennifer Kates, director of the Global Health & HIV Policy Program at the nonprofit KFF.

Most people with private and public health insurance should continue to pay nothing out of pocket for the vaccines, Kates said. If a person gets the vaccine out of network, however, it could carry a cost. 

Some people without insurance may be able to get a booster free from safety net providers, such as community health centers, but others may have to pay the full cost. The Biden administration has also announced a “bridge” program that will offer uninsured people access to free boosters at least through the end of 2024.

Novavax’s vaccine, which has not been granted full FDA approval yet but instead is available through emergency use authorization, will continue to be covered, Kates said. 

https://www.nbcnews.com/health/health-news/fda-green-light-new-covid-boosters-early-friday-rcna103379

Align Technology to Acquire Privately Held Direct 3D Printing Pioneer Cubicure

 Align Technology, Inc. (Align) (Nasdaq: ALGN) today announced that it has entered into a definitive agreement to acquire privately held Cubicure GmbH, a pioneer in direct 3D printing solutions for polymer additive manufacturing that develops, produces, and distributes innovative materials, equipment, and processes for novel 3D printing solutions. Cubicure’s patented Hot Lithography technology uses a special heating and coating mechanism that enables the processing of highly viscous resins to produce particularly tough and temperature-resistant polymers. This high precision 3D printing process facilitates the unprecedented additive manufacturing of resilient components with an astonishing first of its kind material quality performance.

"Align and Cubicure have worked together for many years and our successful collaboration has contributed to breakthrough technologies and innovation in direct 3D printing," said Srini Kaza, Align senior vice president of product research and development. "The acquisition of Cubicure will not only strengthen the Align Digital Platform and our core capabilities in direct 3D printing, but their talented team, including visionary founders, engineers, and material scientists, will expand our knowledge and expertise in one of the most strategic areas of innovation over the next decade. I look forward to welcoming the entire Cubicure team to Align and continuing to extend our global leadership in digital orthodontics and 3D printing."

"As the pioneer and a global leader in clear aligners with the world’s largest 3D printing operations producing over 1 million custom appliances every day, Align is continuing to innovate and invest in technologies that enable the next generation of direct 3D printed products, thus creating more sustainable and efficient solutions," said Joe Hogan, Align Technology president and CEO. "Our partnership with Cubicure began several years ago as a joint development program and has evolved over time with the potential for significant innovation in scaling our direct 3D printing processes. The agreement to acquire Cubicure is a natural next step to bring their talented team and unique cutting-edge technology in-house where they will support our long-term growth strategy by enabling us to scale our 3D printing operations to eventually direct print millions of custom appliances per day."

https://finance.yahoo.com/news/align-technology-acquire-privately-held-200000815.html

US plans vast AI fleet to counter China: Report

 The US Department of Defense is considering the development of a vast network of Artificial Intelligence-powered technology, drones and autonomous systems within the next two years to counter threats from China, the Wall Street Journal reported on Wednesday (Sep 6).

In a speech on Wednesday the deputy secretary of defence, Kathleen Hicks will sketch out some of the air, land and sea capabilities that the Pentagon is looking to develop, the report added.

The Pentagon plans to use artificial intelligence for autonomous systems to detect and engage enemy targets, and can include self-piloting air- and sea-based drones, according to the Journal.

The Department for Defense did not immediately respond to a Reuters' request for comment. 

https://www.channelnewsasia.com/world/us-plans-vast-ai-fleet-counter-china-report-3750111