Medtronic's weaker-than-expected outlook clouds quarterly results beat

 Medtronic on Thursday beat Wall Street estimates for the fourth-quarter revenue and profit, helped by robust sales of its medical devices, but shares fell 2.5% after its forecast for the ongoing period fell short.

Investor expectations around the financial performance of medical devices makers have grown lately, owing to a resurgence in demand as people, especially older adults, opted for medical procedures deferred during the COVID-19 pandemic.

Medtronic's fiscal 2025 adjusted per-share profit forecast of $5.40 to $5.50 came in line with analysts' expectations, but its first-quarter outlook of $1.19 to $1.21 was below LSEG estimates of $1.25.

BTIG analyst Ryan Zimmerman said the fiscal 2025 guidance was slightly better than feared, but downbeat first-quarter profit outlook is probably a negative to shares.

The Dublin-based company reported total revenue of $8.59 billion, above analysts' average estimate of $8.44 billion.

Sales at the company's neuroscience unit, its second-biggest revenue contributer, rose 5.6% in the quarter ended April 26, while the diabetes unit posted a 10.9% increase.

However, the company's heart devices unit — its biggest revenue driver — reported a 5.2% fall in sales to $3.13 billion, missing analysts' estimate of $3.14 billion, on soft demand for certain devices used for repair and replacement of heart valves.

Medtronic took an adjusted charge of $439 million in the fourth quarter, higher than its previously disclosed estimate of between $350 million and $425 million, related to its prior decision to exit its unprofitable ventilator product line.

Early last year, the company had also flagged an impact to its products portfolio from Chinese government's volume-based procurement (VBP), under which the country buys medical devices in bulk at a sharp discount.

CFO Karen Parkhill said in a post-earnings conference call on Thursday that the impact of VBP in China is largely behind the company.

Medtronic posted adjusted profit of $1.46 per share for the fourth quarter, compared with the $1.45 per share estimated.

https://finance.yahoo.com/news/medtronic-beats-quarterly-profit-estimates-105226224.html

Political Shellshocks Loom For Markets

 By Michael Every of Rabobank

Shellshock

Yesterday, the RBNZ held hawkishly and talked about a rate hike, with no cuts seen until end-2025. The UK’s inflation numbers were awful both headline and core, with services CPI at around 6%: yet the BOE evidently wants to cut rates as soon as it can. Then the Fed minutes from its May meeting made clear several FOMC members are still prepared to vote for a hike, or to keep rates on hold longer than markets expect. (See here for more from our Fed Watcher Philip Marey.)

Luckily for markets, however, the AI boom rolls on and on: because where would we be without our US asset bubble du jour?

However, there are still more potential shellshock for markets ahead from politics: Bloomberg’s Shuli Ren asks, ‘Has Xi changed His Mind on Housing and Consumption?’ The NOT neoliberal, but Marx-Lenin-Mao-Xi ideology of China’s political-economy was underlined by its release of an AI based entirely on Xi Jinping Thought, which some dub ‘Chat Xi PT’. However, were Beijing to reflate with serious fiscal stimulus, it would hamper Western central banks’ room for rate cuts: look at what commodity prices are doing without any Chinese version of the West’s Covid stimulus.

A smaller shellshock is the UK holding a rare summer election where polls say it’s “Gone on the 4th of July” for the Conservatives. Indeed, the logic of doing this now rather than waiting for November in the hope opposition support dips has political experts saying either PM Sunak has the inverse Midas touch, or there is a looming scandal so bad it’s prompted the worst-snap election since New Zealand’s drunk Prime Minister called a “Schnapps election” in 1984.

The larger UK shell shock is Shapps: the defence minister states, “Lethal aid is now, or will be, flowing from China to Russia into Ukraine.” Yes, China is helping the Russian economy by supplanting Western-centric industrial supply chains, and some of that has dual use, but actual lethal aid is supposedly a ‘red line’ that triggers US and EU secondary sanctions. Yet in January 2022 I warned these would either prove ineffective or bifurcate the world economy into complying/not complying blocs. Our post-invasion research underlined the same binary, and that it’s impossible to model how much economic damage would be done if secondary sanctions had real teeth. More recently, the IMF made the same point.

Markets may think even if this is correct that, like Shapps, ‘this too will pass’, and we can Keep Calm and Carry On Rate Cuts (and/or AI). Yet that’s the same pre-war naïve thinking I decried in 2022. After all, that would mean there are no red lines, so lethal aid can flow to Russia; its military position vis-à-vis Ukraine would be strengthened further; and it would leave Europe unwilling and unable to respond, and the US unwilling to because it has bigger Chinese fish to fry in Asia. Indeed, things already continue to escalate rapidly:

• Poland’s Prime Minister Tusk implies Russia may have started a Warsaw department store fire.

• Poland may shoot down Russian missiles near its border.

• Russia shifted its maritime boundaries with the EU in the Baltic Sea before deleting the text.

• Russia is rehearsing tactical nuclear drills near the Ukraine border.

• The US is reassessing if Ukraine can use US weapons to attack pre-2014 Russian territory.

Meanwhile, Taiwan’s new president Lai Ching-te gave an inaugural address that sailed dangerously close to the China’s red lines. The Global Times rails: “Lai shamelessly stated in his speech that "the Republic of China Taiwan is a sovereign, independent nation" and "the Republic of China and the People's Republic of China are not subordinate to each other," spewing various "Taiwan independence" fallacies and hostile provocations against the Chinese mainland… They are well aware that what they are doing now is pushing Taiwan into a dangerous pit of war and danger." China is already responding with the largest joint military drills around Taiwan for a year, "Joint Sword-2024A", which encircle it, and include actions around its outlying islands of Kinmen, Matsu, Wuxi, and Dongyin. This is as reports say ASML added kill switches to TSMC technology to be triggered if China invades Taiwan.

Moreover, as flagged in Tuesday’s ‘Wrath of Khan’ Daily, the international liberal order is fracturing further following the International Criminal Court’s (ICC) request for arrest warrants for the Israeli prime minister and defence minister, and three leaders of Hamas. The EU is split: Belgium, Spain, and Ireland back the ICC; France did too, then prevaricated; Italy and Austria are opposed, and the Netherlands’ Geert Wilders strongly backs Israel; and Germany said it didn’t agree with the Court… but would only obey its orders. Yet there is bipartisan support in the US, which President Biden won’t block, to sanction the ICC for its recent action. Naturally, Russia and China are making as much hay as they Khan, splitting the Global South further from the West in the process.

But, hey, “AI!”, right?

https://www.zerohedge.com/markets/political-shellshocks-loom-markets

OneMedNet >5X Expansion of iRWD™ Network and Platform

 OneMedNet Corporation (Nasdaq: ONMD) (“OneMedNet” or the “Company”), the leading curator of regulatory-grade Real World Data (“RWD”), inclusive of electronic health records, laboratory results and medical imaging, is pleased to announce a greater than five (5)-fold expansion of its proprietary iRWD™ network and platform.

Through a series of new network partnership agreements, including one recently signed with an undisclosed nation-wide medical records custodian, OneMedNet is now offering its growing base of customers seamless access to an expanded set of RWD across its robust network comprised of:

• 1,402 healthcare system and provider partner sites;
• 31.0 million patients; and

• 121.4 million clinical exams.
  

The year-to-date increases in partner sites, patients and clinical exams represent growth of 472%, 170% and 122%, respectively, since the end of 2023.

https://www.globenewswire.com/news-release/2024/05/23/2887160/0/en/OneMedNet-Reports-Greater-than-Five-Fold-Expansion-of-iRWD-Network-and-Platform.html

US seen naming Kenya major non-NATO ally amid Haiti deployment

Bidern is expected to soon designate Kenya as a major non-NATO ally, a senior administration official said.


“This is also big because it’s the first major non-NATO ally for us in sub-Saharan Africa,” the official added.

The news comes as Kenyan President William Ruto is on a three-day state visit to the U.S. this week. Ruto met with Biden at the White House on Wednesday.

Only 18 countries are designated as major non-NATO allies, including close allies like Japan, Israel, and Australia.

Major non-NATO allies are eligible for benefits like being a candidate for U.S.-owned war reserve stockpiles, the priority delivery of excess weapons and defense equipment and eligibility for loans related to cooperative research, development or testing.

The designation will also come as Kenya has stepped up to lead the deployment of a multinational police force to Haiti, where armed gangs have taken over the capital of Port-au-Prince and have plunged the Caribbean nation into a humanitarian crisis.

An unofficial deployment date set for Thursday may not be met, according to the Miami Herald, as concerns mount over the procurement of vehicles and helicopters. The deployment could be pushed back to early June.

The senior administration official said that Ruto and Biden are expected to discuss the Haiti deployment on Thursday along with Defense Secretary Lloyd Austin and Secretary of State Antony Blinken.

The U.S. has pledged $300 million to support the Kenyan deployment to Haiti and has collaborated closely with Ruto’s administration on the mission.

“We’re focused right now on getting it right and making sure the Kenyans have what they need,” the official added.

Armed gangs have been rampant across Haiti since the 2021 assassination of Haitian President Jovenel Moïse, but they began cooperating more closely in February and freed prisoners before taking over most of Port-au-Prince.

The Kenyan-led deployment was first agreed to last year but has been delayed by the armed takeover of the gangs and the collapse of Haiti’s government, which only recently formed a transitional council to form new leadership.

The deployment is expected to rescue Haiti from a deepening humanitarian crisis as aid groups struggle with supplies with the capitol nearly completely shut down, though the international airport recently opened and may offer some relief.

https://thehill.com/homenews/4680561-us-expected-to-designate-kenya-as-major-non-nato-ally/

Supreme Court sides with South Carolina GOP over racial gerrymander case

 The Supreme Court upheld a Republican-drawn congressional district in South Carolina on Thursday, reversing a lower court that had declared its boundaries an unconstitutional racial gerrymander. 

In a 6-3 ruling along ideological lines, the justices signed off on a design that bolsters the GOP tilt of Rep. Nancy Mace’s (R-S.C.) district.

It aids Republicans in holding onto the seat, though their map was already being implemented for this year’s election regardless of the Supreme Court’s ruling.

The high court’s conservative majority rejected arguments that the design impermissibly shifted some 30,000 Black Charleston-area voters to a different district. 

A three-judge panel had found race was the predominant factor in the new design, ruling it a racial gerrymander in violation of the 14th Amendment’s Equal Protection Clause. The decision sided with a Black voter and the South Carolina State Conference of the NAACP.   Justice Samuel Alito, one of the high court’s leading conservatives, said the lower panel had paid “only lip service” to the Supreme Court’s doctrines surrounding redistricting.

“That misguided approach infected the District Court’s findings of fact, which were clearly erroneous under the appropriate legal standard. We therefore reverse the trial court in part and remand for further proceedings,” he continued. 

Republican state lawmakers insisted the boundaries were changed because of politics, not race, and appealed the decision the Supreme Court.  

In dissent, Justice Elena Kagan, joined by fellow liberal justices Sonia Sotomayor and Ketanji Brown Jackson, said the conservative majority is “reworking the law” to “impede racial-gerrymandering cases.” 

“The proper response to this case is not to throw up novel roadblocks enabling South Carolina to continue dividing citizens along racial lines,” Jackson wrote.  

“It is to respect the plausible— no, the more than plausible—findings of the District Court that the State engaged in race-based districting. And to tell the State that it must redraw District 1, this time without targeting African-American citizens,” she added. 

The lawmakers had previously asked the high court to rule by Jan. 1 to provide enough time before this year’s elections. 

After that deadline passed with the design still in limbo, the three-judge panel agreed to reinstate the map, meaning it would’ve gone into effect for 2024 even if the Supreme Court had ruled the other way. 

The Supreme Court’s decision now preserves the map beyond 2024, though it sends the case back to the lower court for further proceedings. 

In a concurring opinion, Justice Clarence Thomas wrote that courts should get out of adjudicating racial gerrymander claims brought under the 14th and 15th Amendments, saying it should be left to the political branches. 

“It behooves us to abandon our misguided efforts and leave districting to politicians,” Thomas wrote. 

https://thehill.com/regulation/court-battles/4681511-supreme-court-south-carolina-gerrymander/

Jaguar Health to Initiate Commercial Footprint in Cancer Supportive Care

 Oral mucositis, also called "chemo mouth," has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network task force

Top line results imminent for company's phase 3 OnTarget trial of crofelemer for preventative treatment of cancer therapy-related diarrhea

18 million people in U.S. are living with a cancer diagnosis and more than 2 million people in U.S. are expected to be diagnosed with cancer in 2024

https://www.accesswire.com/866208/jaguar-health-to-initiate-commercial-footprint-in-cancer-supportive-care-at-american-society-of-clinical-oncology-asco-annual-meeting-with-exhibit-booth-for-fda-approved-gelclair-oral-mucositis-product

Enable Injections & Serina Partner to Develop Novel Parkinson’s Treatment

  Enable Injections, Inc. (“Enable”), a healthcare innovation company developing and manufacturing the enFuse® wearable drug delivery platform and Serina Therapeutics (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company advancing its POZ Platform™ to develop and improve efficacy and safety across multiple modalities including small molecules, RNA-based therapeutics and antibody-based drug conjugates (ADCs), today announced a partnership to develop and commercialize SER-252 (POZ-apomorphine) in combination with enFuse for the treatment of Parkinson’s disease.

–       SER-252 is an investigational apomorphine therapy developed with Serina’s POZ platform and designed to provide continuous dopaminergic stimulation (CDS). 

Serina Partners with Enable for Innovative Drug Delivery in Parkinson’s Disease

CDS has been shown to reduce the severity of levodopa-related motor complications, such as dyskinesia, in Parkinson’s disease. Preclinical studies indicate that SER-252 can provide CDS without causing skin reactions. Serina plans to begin clinical testing of SER-252 in 2025.

enFuse is an innovative, wearable drug delivery platform designed for subcutaneous administration of large medication volumes. This system allows patients to receive treatment via a simple injection under the skin, avoiding the need for intravenous delivery. enFuse addresses the limitations of IV infusions and other subcutaneous methods by offering fast, simple, and convenient delivery, enabling patient self-administration and benefiting patients, healthcare providers, and payers.

Enable is collaborating with several pharmaceutical partners to conduct clinical trials and plan for joint commercial launches of therapies using the enFuse technology. Enable is selectively expanding its pharmaceutical partnerships to include treatments and patient populations that will benefit from enFuse. The first enFuse combination product received U.S. Food and Drug Administration approval in 2023.

Under the agreement, Serina will receive a worldwide, exclusive license to the enFuse platform in exchange for upfront and milestone payments. Enable will also receive a share of product sales and single-digit royalties.

“Current apomorphine treatments require daily and time-consuming infusions through an electronic pump that not only burdens patients and providers, but can cause significant skin reactions,” said Randall Moreadith, M.D., Ph.D., Chief Development Officer of Serina Therapeutics. “With enFuse, patients can self-administer SER-252 in the convenience of their home with wearable technology and with a rapid treatment time. If effective, a SER-252 and enFuse combination provides the potential for patients to remain in a continuous ‘ON’ state and avoid dyskinesia.”

https://hitconsultant.net/2024/05/17/enable-injections-serina-partner-to-develop-novel-parkinsons-treatment/