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Tuesday, October 1, 2024

AstraZeneca: FDA approves application for Enhertu

 AstraZeneca announces that the supplemental Biologics License Application (sBLA) for Enhertu has been accepted with priority review by the FDA to treat HER2-low or HER2-ultralow unresectable or metastatic breast cancer.



Based on the positive results of the DESTINY-Breast06 trial, this review could enable Enhertu to be marketed as early as 2025.

Enhertu demonstrated a 37% reduction in the risk of disease progression compared to chemotherapy.

The FDA has also granted Enhertu Breakthrough Therapy designation, underlining its potential for wider and earlier use.

Amgen Must Face Lawsuit Claiming It Hid $10.7 Billion Tax Bill

 A federal judge said Amgen must face a proposed class action accusing the drugmaker of waiting too long to tell shareholders it might owe the Internal Revenue Service $10.7 billion for underreporting six years of taxes.

U.S. District Judge John Cronan in Manhattan ruled on Monday that shareholders plausibly alleged they were misled by Amgen's "reckless" concealing of its "enormous" potential tax liability.

Neither Amgen nor its lawyers immediately responded to requests for comment. Lawyers for shareholders led by the Detroit-based Roofers Local No. 149 Pension Fund did not immediately respond to similar requests.

Amgen's top-selling products include the osteoporosis treatment Prolia and the rheumatoid arthritis drug Enbrel.

The IRS accused Amgen of underreporting taxes from 2010 to 2015, mainly for attributing what should have been U.S. taxable income to a Puerto Rico unit that produces many of its drugs.

Though Puerto Rico is a U.S. territory, it is considered a foreign country for corporate tax purposes.

The roofers fund said Amgen's share price fell 6.5% on Aug. 4, 2021 and 4.3% on April 28, 2022 because the Thousand Oaks, California-based biotech company waited until then to disclose the tax risks.

In seeking a dismissal, Amgen said it "did not hide" the IRS' position, and had warned that the agency was becoming more aggressive in policing how companies allocated income and expenses among tax jurisdictions

https://money.usnews.com/investing/news/articles/2024-09-30/amgen-must-face-lawsuit-claiming-it-hid-10-7-billion-tax-bill

CVS explores options including potential break-up, sources say

 CVS Health is exploring options that could include a break-up of the company to separate its retail and insurance units, as the struggling healthcare services company looks to turn around its fortunes amid pressure from investors, people familiar with the matter told Reuters.

CVS has been discussing various options - including how such a split would work - with its financial advisers in recent weeks, the sources said, requesting anonymity as the discussions are confidential.

The plan to potentially split the company's pharmacy chain and the insurance business has been discussed with the board of directors, which is yet to decide on the best course of action for CVS to pursue, the sources said, cautioning that the plans have not been finalized and CVS may opt for a different strategy.

CVS is also discussing whether its pharmacy benefits manager unit, which manages drug benefits for health plans, should be housed within the retail unit or under insurance, if it were to proceed with a separation that could result in two publicly traded companies, the sources said.

Such a move would effectively unwind CVS's landmark $70 billion takeover of healthcare insurer Aetna in 2017 and come as CVS attempts to navigate one of the most challenging periods in its six-decade history.

A CVS spokesperson declined to comment on whether it is holding talks to explore options.

"CVS’s management team and Board of Directors are continually exploring ways to create shareholder value," the spokesperson said. "We remain focused on driving performance and delivering high quality healthcare products and services enabled by our unmatched scale and integrated model."

The latest discussions come as CVS faces increasing pressure from investors such as Glenview Capital, which is said to be pushing for changes at the company to help improve its operations, after it cut its 2024 earnings outlook for a third consecutive quarter in August.

CVS, which has a market value of about $79 billion and held long-term debt of roughly $58 billion at the end of December, in August lowered its annual profit forecast to $6.40 to $6.65 per share, from its previous forecast of least $7.00 per share.

"While we view management's...adjusted EPS growth target for 2025 as attainable, we believe uncertainty around performance in 2024, as well as the outcome of CVS's 2025 Medicare Advantage bids, creates an unclear outlook for 2025 and beyond," TD Cowen analysts wrote in an Aug. 11 note.

https://finance.yahoo.com/news/exclusive-cvs-explores-options-including-230217242.html

Germany Is First To Evacuate Citizens From Lebanon On Military Transport Plane

 Germany has become the first Western country to initiative an emergency evacuation of its citizens from Lebanon utilizing military transport planes amid the rapidly deteriorating security situation.

Some 110 passengers were flown out of Beirut international airport in an initial flight on a German air force A321 plane on Monday. The group included diplomats and non-essential staff from the German embassy as well as their families. German citizens who with medical conditions were also on this first flight

Essential personnel at Germany's embassy in Beirut have remained, in order to help facilitate the safe exit of the estimated 1,800 German citizens still in the country.

"German nationals who are particularly at risk due to medical circumstances are also being taken," a statement of the military transport flight. 

More such military facilitated flights are likely, but a timeline is unclear at this point. There's an expectation of wider war as Israeli builds up military forces along the border for an 'imminent' ground incursion into south Lebanon. 

Israel has also for the first time since 2006 begun striking targets in central Beirut. An estimated one million people throughout the country, but especially in the south, have been displaced thus far.

A German government spokesman announced Monday that "we are currently at a stage where we support the departure (of citizens) but we are explicitly not in an evacuation scenario."

The statement emphasized that "all Germans in Lebanon have been urged to leave the country since October 2023."

However, given the almost complete halt to commercial airline traffic at Beirut–Rafic Hariri International Airport, and the fact that Germany had to utilize a military flight to get its diplomats and citizens out in a first wave, it sure looks like this is the start of an evacuation scenario.

Currently the US and UK have troops positioned in nearby Cyprus, ready to help if those countries order military-assisted evacuations.

https://www.zerohedge.com/geopolitical/germany-first-evacuate-citizens-lebanon-military-transport-plane

Monday, September 30, 2024

Republicans lay legal groundwork for election challenges

In Arizona, one of seven competitive US states that are expected to decide the 2024 presidential election, an advocacy group founded by Donald Trump adviser Stephen Miller is advancing a bold legal theory: that judges can throw out election results over "failures or irregularities" by local officials.

The lawsuit by the America First Legal Foundation, a conservative advocacy group, says the court in such cases should be able to toss the election results and order new rounds of voting in two counties in Arizona, where Democratic candidate Vice President Kamala Harris is leading Trump in the polls by a razor-thin margin.

Almost four years after former president Trump and his allies tried and failed to overturn his election defeat with a flurry of more than 60 hastily arranged lawsuits, Republicans have launched an aggressive legal campaign laying the groundwork to challenge potential losses.

The Republican National Committee says it is involved in more than 120 lawsuits across 26 states, in a strategy that some legal experts and voting rights groups say is meant to undercut faith in the system.

Republicans say the lawsuits are aimed at restoring faith in elections by ensuring people don't vote illegally. Trump and his allies have falsely claimed that his 2020 election loss to Joe Biden was tainted by widespread fraud.

While the Arizona case is likely a long shot, legal experts say it fits with a pattern of Republican-backed lawsuits that appear aimed at sowing doubts about the legitimacy of the election before it occurs and providing fodder for challenging the results after the fact.

“This is part of creating the narrative that there will be irregularities that will require outside intervention,” said Columbia Law School professor Richard Briffault.

America First Legal Foundation, its lawyers and Miller did not respond to inquiries.

A spokesperson for the Republican National Committee said the party's top priority is fixing what they say are problems with voting systems before Election Day to ensure no ballots are illegally cast.

“Our Election Integrity operation is fighting to secure the election, promoting transparency and fairness for every legal vote. This gives voters confidence that their ballot will be counted properly, and in turn, inspires voter turnout,” said RNC spokesperson Claire Zunk.

Trump and Harris are locked in a tight battle ahead of the Nov. 5 election, fueling a wave of litigation by both Democrats and Republicans as they spar over the ground rules.

Republicans typically sue to enforce restrictions on voting that they say are necessary to prevent fraud, while Democrats generally ask courts to keep voting accessible.

The Harris campaign said in a statement that Republicans are "scheming to sow distrust in our elections and undermine our democracy so they can cry foul when they lose."

"Team Harris-Walz enters the home stretch of this campaign with a robust voter and election protection operation and the best lawyers in the country, ready for any challenge Republicans throw at us. We will give Americans the free and fair election they deserve so all eligible voters can vote and have that vote counted,” the campaign said.

In Michigan, another closely contested state, Republicans are suing to prevent state agencies from expanding access to voter registration, restricting the use of mobile voting sites like vans and imposing tighter verification rules for mail-in ballots.

In Nevada and other states, Trump allies are seeking to purge voter rolls of allegedly ineligible voters and noncitizens , though the deadline for systematically culling rolls in time for the election has passed.

And in Pennsylvania, Republicans are fighting to enforce strict mail-in voting rules and limit voters' ability to correct mistakes on their ballots. On Sept. 13, Republicans scored a victory when the state's highest court ruled mail ballots with incorrect dates will not be counted.

SOWING CONFUSION

Election litigation arose in 2020 as COVID-19 spurred changes to voting procedures wider use of mail-in ballots. Those fights were often reactions to granular, location-specific issues.

More than 60 lawsuits Republicans filed challenging Trump's loss in 2020 were rejected by courts.

This time, Republicans are filing legal challenges earlier and leveling allegations of widespread fraud that strike to the very core of the election process.

Trump's continued false claims that his 2020 defeat was the result of fraud has taken root in the Republican Party: 71% of Republican registered voters responding to an August Reuters/Ipsos poll said they believed voting fraud was a widespread problem, well above the 37% of independents and 16% of Democrats who held that view.

“They're out front and early and are moving preemptively, whereas 2020 was kind of reactive. Here they're getting ahead of it,” Briffault said.

The Arizona lawsuit, filed in February in Yavapai County court, underscores the proactive approach by Trump's allies. It alleges a litany of "missteps and illegalities" by election officials in Maricopa, Yavapai and Coconino counties in past election and asserts that only court intervention can restore the public trust.

Maricopa County was dismissed from the case on procedural grounds.

The complaint asks a judge to impose a list of 24 orders enforcing the America First Legal Foundation's interpretation of election laws and correcting errors by any means necessary, including nullifying results and ordering new rounds of voting.

Errors could include failure to staff ballot drop boxes at all times or failing to take certain steps to verify signatures on ballots.

That is a novel and sweeping request that a judge is unlikely to grant, according to legal experts and election attorneys. But a judge nullifying results in a crucial state could lead to chaos, confusion and delays, which some legal experts and voting rights group say is a central goal of the Republican legal strategy.

Uncertainty could give local officials and state legislatures the opportunity to meddle with the results, according to Sophia Lin Lakin, an attorney litigating voting rights cases on behalf of the American Civil Liberties Union. For example, officials could try to throw out votes or refuse to certify the outcome.

“It's about laying the groundwork for there to be enough doubt in the election process that a political maneuver could be brought to bear to impact the outcome,” Lakin said.

https://www.xm.com/fr/research/markets/allNews/reuters/in-legal-blitz-republicans-lay-groundwork-for-us-election-challenges-53935263

'Harris talks racial identity, marijuana on basketball podcast'

 Vice President Kamala Harris addressed Donald Trump's comments on her racial identity, the value she places on mental health, and her support for legalizing marijuana with former NBA stars Stephen Jackson and Matt Barnes on a podcast that aired on Monday.

Harris was interviewed by the two former professional basketball players at her home in Washington for their podcast, "All the Smoke," as her campaign tries to reach more men, especially Black men, among whom polls show support for Republican opponent Trump.

According to a Reuters/Ipsos survey from Aug. 21-28, 41% of male respondents said they would vote for Harris if the election were held immediately versus 47% saying they would back Trump. About two-thirds of Black men supported Harris.

Barnes alluded to Trump's confusion over Harris' racial identity when he asked how she felt about "people questioning the fabric of who you are." Harris is the daughter of an Indian mother and a Jamaican father.

"I’m really clear about who I am and if anybody else is not, they need to go through their own level of therapy, that’s not my issue," she said.

Harris reiterated a view she had expressed before becoming the Democrats' presidential candidate in July that cannabis should be decriminalized, citing the disproportionate impact that marijuana criminalization has had on Black people. "We know historically what that has meant and who has gone to jail."

Harris also talked about the stigmas around seeking help for mental health, and said she protects her own with daily exercise, cooking and not reading the comments section on social media.

"I think the mental health issue is probably one of the biggest public policy failures in our country," she said. "We have acted as though the body starts from the neck down, instead of understanding we need healthcare also from the neck up."

Harris said she had trouble sleeping right after President Joe Biden dropped out of the presidential race and endorsed her as the Democratic candidate because everything was moving "in speedy, speedy motion."

One morning she got out of bed long before anyone was awake and started cooking, she said.

"I just went out and got a pork roast and started marinating it."

https://www.yahoo.com/news/harris-talks-racial-identity-marijuana-165933417.html

Goldman Finds Highly Exposed Retailers in Port Strike

 Goldman analyst explained last week that a walkout by ILA members would jeopardize $5 billion in daily international trade coming into the Gulf and East Coast ports. 

Goldman's Jordan Alliger told clients, "Upwards of $4.9bn per day is at risk in international trade along the East and Gulf coasts, along with the potential for supply chains to likely become less fluid due to emergent congestion, which in turn could result in a re-emergence of transport price inflation."

"The biggest wild card in the presidential election that nobody's talking about? The looming port strike that could shut down all East and Gulf Coast ports just 36 days before the election," Flexport CEO Ryan Petersen wrote on X earlier this month. 

On Monday morning, with just a little over half the day left, a team of Goldman analysts led by Brooke Roach provided clients with the "current state of the supply chain and freight environment for the retail industry." 

  • What is happening: The International Longshoreman Association and US Maritime Alliance contract is set to expire on September 30th. Our US transports analyst, Jordan Alliger, detailed the potential ramifications should labor disruption arise at East / Gulf Coast Ports in this note published on 9/26. While we take no view on the likelihood of any outcome, our team has fielded an increased number of investor queries focused on potential disruption to US retail as a result of potential congestion, which could come at a critical shipping period for US retailers ahead of the holidays.

  • Comments from retail associations: The American Apparel and Footwear Association estimates that 53% of all US apparel, footwear, and accessories imports are routed through the East and Gulf Coast ports. The AAFA also noted risk from East Coast / Gulf port disruption to impact West Coast port operations, creating strains/delays across the supply chain. Separately, the Retail Industry Leaders Association has also stated that while retailers have activated contingency plans to mitigate potential effects of work disruption, it becomes harder to mitigate the longer a work stoppage goes on.

  • Our view on potential impact: We surveyed our hardlines and softlines coverage universe to assess exposure, and we found the majority of companies who responded pointed to the following: (1) A higher rate of reliance on West Coast ports for their primarily Asia-sourced product; (2) Proactive rerouting and other plans ahead of potential disruption to ensure critical product arrives on-time for holiday; (3) Other contingency plans in place, including airfreight for select items. Many companies indicated they were already planning for higher freight expense in 2H due to a variety of risk factors, with port contract negotiations one factor alongside ongoing Red Sea disruption and higher rates on spot product. That said, we note that the magnitude of potential disruption is likely a function of the length of any work disruption and subsequent port congestion (which could likely impact both West and East Coast ports). Historically, a longer period of congestion for retailers has typically been associated with a higher risk of delayed product arrival, which can be a headwind to full-price sales for holiday or seasonal items. Full detail of exposure by company is listed in the tables below.

Here is the historic labor action example the analysts laid out:

  • While not an exact corollary given the higher level of importance of West Coast ports to the retail industry (a function of Asia-based supply chains), we note one historical example in 2014/15. The West Coast port labor dispute between the International Longshore and Warehouse Union (ILWU) and the Pacific Maritime Association lasted from June 2014 through February 2015, with the situation worsening in January and February as an apparent work slowdown escalated to closure of 29 ports for several days around Presidents' Day weekend in 2015 before reaching an agreement on February 20th, 2015. Delayed product impacted seasonal timing of spring apparel product launches, with inventory drawdown during the initial period of disruption (likely due to delayed shipments) and then a subsequent build in inventories which lasted through the year for many companies. Several of our covered companies cited port delays as a driver of gross margin pressure, with promotional pricing in mid-2015 seen across department stores, specialty retail, mass retailers and apparel/accessories brands.

The analysts then surveyed retailers about their freight exposure at US ports. In one instance, Dollar Tree warned that half its products pass through Gulf and East Coast ports.

Some retailers warn that supply chain snarls could spark chaos for them:

Source: Goldman Sachs 

Another industry survey found which retailers will be the most flexible in an East Coast port strike environment.

Source: Goldman Sachs 

Earlier this morning, when Biden was asked about "Yemen strikes," the president responded incoherently to reporters: "I've spoken to both sides. They gotta settle the strike. I'm supporting the collective bargaining effort. I think they'll settle the strike."

https://www.zerohedge.com/markets/time-running-out-us-port-strike-could-begin-tuesday-goldman-finds-highly-exposed-retailers