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Bar, >> market caps over $10 billion <<
Yes, a good strategy. While I have a bunch of them under $10 bil (link below), anything under $1 bil is rare. Currently only one - Climb Global Solutions (CLMB), which I found largely from it's nice 10-15 year chart, which is very rare for a microcap. The last one was Winmark (WINA), but it's now over $1 bil.
Looking at how Buffett, Munger, and Graham approached investing in the early days, what jumps out is how aggressive they were. But Buffett says for us regular investors (mere mortals), the idea is to be extremely diversified, and mainly use index funds. So basically the opposite of his own 'Oracle' approach. I figure some individual stocks are OK, but only small positions and widely diversified.
Buy / Hold Stocks (by market cap) -
https://investorshub.advfn.com/Buy-Hold-Stocks-42434
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>>> January economic data challenges soft landing narrative
Yahoo Finance
by Josh Schafer
February 19, 2024
The growing economic consensus has hit a bump in the road.
Over the past several months a string of stronger-than-expected data had many investors embracing a possible soft landing, in which inflation would fall to the Federal Reserve's 2% goal without a severe economic downturn.
Recent data over the past week has challenged that narrative. January inflation reports from the Consumer Price Index (CPI) and Producer Price Index (PPI) showed prices increased more than economists projected in the last month. And the January retail sales report showed sales dropped by more than economists had expected. In other words, neither inflation nor consumer strength improved.
To some, one month's prints could be points of concern, but not necessarily game changers.
"Let's not get amped up when you get one month of CPI that was higher than what you expected," Chicago Fed President Austan Goolsbee said during a question-and-answer session hosted by the Council on Foreign Relations in New York on Wednesday. "It is totally clear that inflation is coming down."
While Goolsbee may have a point that one print might not change a trend, the recent string of January data is notable because it's largely the first chunk of data to challenge the soft landing narrative since Federal Reserve Chair Jerome Powell hinted the US economy may be headed to the ideal outcome during the December Fed meeting.
"The data is stacking up against investors in a way that's making people more nervous," SoFi head of investment strategy Liz Young told Yahoo Finance Live.
Prior to the readings in the past week, the data hadn't worked against investors. Fourth quarter economic growth had come in higher than expected. The January jobs report shocked economists. And the December retail sales print came in better than anticipated, all while wage increases continued to provide a positive outlook for consumer spending and inflation continued to moderate.
After this week though, economists are cutting their projections for first quarter gross domestic product (GDP), a popular economic growth measure. Goldman Sachs has shifted its forecast from 2.9% annualized growth in the first quarter entering the week down to 2.3%. The Atlanta Fed's GDP tracker moved down to 2.9% from a 3.4% projection on Feb. 8. Not auspicious for the economic growth component of a soft landing.
The data is also moving projections for Personal Consumption Expenditures (PCE), the Fed's preferred inflation gauge, ahead of its release later this month. Goldman now projects core PCE, which excludes the volatile food and energy categories, increased 0.43% in January, an increase from its prior forecast of 0.35%. Bank of America's economics team also sees a reading near 0.4%.
Notably, this would bring the six- and three-month annualized rates, which had been celebrated recently as tracking below the Fed's 2% target, back above the 2% level. Not auspicious for the second component of a soft landing.
"While January data are often noisy, the inflation data do suggest that disinflation took two steps back in January," Bank of America US economists Stephen Juneau and Michael Gapen wrote in a note to clients on Friday.
Juneau and Gapen wrote that the January inflation data vindicates the Fed's "wait-and-see approach" to cutting interest rates, and that they agree with the new market consensus that the first interest rate cut will come in June rather than March or May.
This marks a stark shift in investor sentiment on Fed cuts. Investors are now pricing in a roughly 35% chance the first cut comes in May, per the CME FedWatch Tool. A month ago, investors had placed a 97% chance that the first cut would come by the end of the May meeting.
With the Fed rate cut question mostly answered for now, the looming question remains whether the twin inauspicious data points of inflation and consumer strength have upended hopes for a soft landing.
Gapen noted in a weekly economic roundup that it's still too early to tell.
"Our (perhaps unsatisfying) take is that investors should remain in wait-and-see mode," he wrote.
"The surprises in jobs, inflation, retail sales, and [industrial production] were all probably a combination of signal and noise. ... we need to see a few more weeks' worth of data before drawing strong conclusions on the trajectory of the economy."
Consumers, for their part, are still saying they're doing great.
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>>> The Federal Reserve Broke The Budget. Buckle Up For What Comes Next.
Investor's Business Daily
by JED GRAHAM
11/24/2023
https://www.investors.com/news/economy/federal-reserve-broke-the-budget-what-budget-deficits-mean-for-the-economy-and-sp-500/?src=A00220
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Full article - https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173293135
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Bigworld, With Acurx, I figure there's a good chance Ibeza ultimately reaches the market, but if Acurx has to do the first Phase 3 itself, without a pharma partner, it could be a long wait for investors to reach the payoff. There's still a chance Luci can get a partner prior to the Phase 3, but I figure the odds are higher that he has to go it alone until at least the interim analysis stage of the first Phase 3, so a good year or more to wait. But Luci seems like a smart cookie, and motivated, so he might get a deal sooner.
>> Oklahoma City <<
Yes, that was a clearly an orchestrated false flag, no doubt about it. I researched it in depth back when the info was still widely available on the internet. Ah, remember those pre-censorship YouTube days? It's like a distant memory now, but the 'powers that be' took way too long to impose censorship (10-15 years), so tens of millions of people already know all about 9-11, Oklahoma City, etc. So the cat is out of the bag, and once people know the official version is total BS, there's no going back. Btw, the slimy Merrick Garland was point man for the Oklahoma City cover up, and other high profile 'domestic terrorism' cases (link below).
https://en.wikipedia.org/wiki/Merrick_Garland
>>> Garland's responsibilities included the supervision of high-profile domestic-terrorism cases, including the Oklahoma City bombing, Ted Kaczynski (also known as the "Unabomber"), and the Atlanta Olympics bombings.[3][27]
Garland insisted on being sent to Oklahoma City in the aftermath of the attack, in order to examine the crime scene and oversee the investigation in preparation for the prosecution.[28] He represented the government at the preliminary hearings of the two main defendants, Timothy McVeigh and Terry Nichols.[28] Garland offered to lead the trial team, but could not because he was needed at the Justice Department headquarters. Instead, he helped pick the team and supervised it from Washington, D.C., where he was involved in major decisions, including the choice to seek the death penalty for McVeigh and Nichols.[28] Garland won praise for his work on the case from the Republican Governor of Oklahoma, Frank Keating.[3] <<<
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>>> De-Dollarization Is Happening at a ‘Stunning’ Pace, Jen Says
Bloomberg
by Matthew Burgess
April 18, 2023
https://finance.yahoo.com/news/dollarization-happening-stunning-pace-jen-082144378.html
(Bloomberg) -- The dollar is losing its reserve status at a faster pace than generally accepted as many analysts have failed to account for last year’s wild exchange rate moves, according to Stephen Jen.
The greenback’s share in global reserves slid last year at 10 times the average speed of the past two decades as a number of countries looked for alternatives after Russia’s invasion of Ukraine triggered sanctions, Jen and his Eurizon SLJ Capital Ltd. colleague Joana Freire wrote in a note. Adjusting for exchange rate movements, the dollar has lost about 11% of its market share since 2016 and double that amount since 2008, they said.
“The dollar suffered a stunning collapse in 2022 in its market share as a reserve currency, presumably due to its muscular use of sanctions,” Jen and Freire wrote. “Exceptional actions taken by the US and its allies against Russia have startled large reserve-holding countries,” most of which are emerging economies from the so-called Global South, they said.
Jen is the former Morgan Stanley currency guru who coined the dollar smile theory.
Last year, Bloomberg’s gauge of the greenback surged as much as 16% as the conflict helped fuel a rise in global inflation that triggered widespread interest rate hikes which sank bond and currency markets alike. It finished the year up 6%.
Biden’s Dollar Weaponization Supercharges Hunt for Alternatives
Smaller nations are experimenting with de-dollarization while China and India are pushing to internationalize their currencies for trade settlement after the US and Europe cut Russian banks from the global financial messaging system known as SWIFT. There’s also concern the dollar may become a permanent political tool, or be used as a form of economic statecraft to put extra pressure on countries to enforce sanctions that they may disagree with.
The US currency now represents about 58% of total global official reserves, down from 73% in 2001 when it was the “indisputable hegemonic reserve,” the Eurizon pair said.
That said, the dollar’s role as an international currency won’t be challenged anytime soon as developing countries don’t yet have the ability to divest from the greenback for transactions due to its large, liquid and well-functioning financial markets, Jen and Freire wrote.
Still, the persistence of those conditions “is not preordained” and there may come a time when the rest of the world actively avoids using the dollar, they wrote.
“The prevailing view of ‘nothing-to-see-here’ on the US dollar as a reserve currency seems too innocuous and complacent,” the two wrote. “What needs to be appreciated by investors is that, while the Global South is unable to totally avoid using the dollar, much of it has already become unwilling to do so.”
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>>> The great central bank policy reversal kicks off
Reuters
by Balazs Koranyi and Howard Schneider
March 22, 2024
https://finance.yahoo.com/news/analysis-great-central-bank-policy-061353930.html
FRANKFURT/WASHINGTON (Reuters) -The world's biggest central banks are on the starting line of reversing a record string of interest rate hikes but the way down for borrowing costs will look very different from the way up.
There will be no floodgates or fireworks. Instead, banks on opposite sides of the Atlantic are likely to move in the smallest increments with periodic pauses, fearing that ultra-low unemployment could rekindle inflation rates still above their targets.
The eventual bottom for interest rates is also set to be far higher than the historic lows of the last decade and mega-shifts in the structure of the global economy could put borrowing costs on a higher path for years to come.
Central banks started to jack up rates from late 2021 as post-pandemic supply constraints and surging energy prices on Russia's war in Ukraine sent inflation into double-digit territory across much of the world.
This seemingly synchronized response tamed prices and inflation will be just above or already at target - 2% for most big economies - this year.
"The bottom line is that across the OECD, central banks... are softening up again, or are about to do so," investment bank Macquarie said in a note to clients.
Indeed, the Swiss National Bank became the first major central bank (to) ease policy on Thursday with a surprise 25 basis point cut to its key rate as inflation is already in the 0% to 2% target range.
The move also ends rampant investor speculation that policymakers will be hesitant to move before the U.S. Federal Reserve since any rate cut is certain to weaken a currency and push up imported inflation.
The European Central Bank is bound to be next in June after incessantly repeated references to that meeting painted the bank into a corner.
The Fed and the Bank of England both hinted they could be next but have kept their language sufficiently vague to make moves in either June or July possible, provided data do not upset plans.
Still, investors expect the Fed, the ECB and the BoE to each deliver only 75 basis points of cuts by the end of this year, in three 25 basis point moves, tiny changes compared to rate hikes in 2022 when they sometimes increased rates by that much in a single day.
The pricing also suggests cuts at just three out of the five meetings each will hold between June and the end of the year, so pauses are also on the cards.
To be sure, these banks are not the first to cut rates. Some emerging market economies, like Brazil, Mexico, Hungary and the Czech Republic have all cut rates already, but financial markets take their cue from the major central banks, so their influence on financial instruments is oversized.
OUTLIER
The Federal Reserve could in fact end up being the outlier this time.
The U.S. economy is chugging along and the Fed even upgraded its growth projections this week, meaning it may end up cutting rates when growth remains strong, or delaying cuts if inflation proves stubborn. In Europe, data continues to paint a bleak picture, with activity stabilizing at a low level.
The U.S. election in November adds to the Fed's dilemma.
Policymakers do not want to be seen interfering with the vote, so if they cut, they need to do it well clear of November.
"Traditionally, the Fed would not pivot rates policy to cushion inequality," Societe Generale strategist Albert Edwards said. "But growing inequality has been a key issue ever since the 2008 Global Financial Crisis triggered a backlash against ‘The Establishment’ - most evident in the rise in popularism."
"Might the unfolding inequality crisis force the Fed to bow to intense political pressure to cut rates faster and deeper? I think that is entirely plausible," Edwards said.
Fed Chair Jerome Powell in congressional testimony earlier this month said policymakers would "keep our heads down and do our jobs" ahead of the elections.
All the while Europe continues to struggle. Germany is in recession, Britain is barely growing after a recession, and the rest of the continent is staying in positive territory mostly from unexpectedly strong data out of Southern Europe, traditionally the euro zone's weak spot.
Where rate cuts could end in either 2024 or 2025 remains far too uncertain but policymakers appear confident that the ultra low rates - negative in some cases - will not be revisited.
In fact, some argue that the world is undergoing such profound changes that the historic downtrend in the so-called neutral rate, which neither stimulates nor slows growth, could reverse.
"We may now be facing such a turning point," ECB Executive Board member Isabel Schnabel said this week.
"The exceptional investment needs arising from structural challenges related to the climate transition, the digital transformation and geopolitical shifts may have a persistent positive impact on the natural rate of interest."
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>>> The Fed’s massive economic upgrade: Chart of the Week
Yahoo Finance
by Ethan Wolff-Mann
Mar 23, 2024
https://finance.yahoo.com/news/the-feds-massive-economic-upgrade-chart-of-the-week-123035274.html
Ahead of the Fed’s meeting this week, everyone was focused on dots.
But the most important number offered by Fed officials was the FOMC’s surprisingly bullish expectations for economic growth, revised upward, as our Chart of the Week shows.
In December, the market cheered after hopes for rate cuts were restored following pleasing inflation numbers. But economic growth projections for 2024 had fallen to 1.4% from September’s 1.5% projection for 2024 GDP growth.
Now, though disinflation may have stalled in comparison to December, the FOMC projects 2024 growth at 2.4%, almost double forecasts from just three months ago. And with an optimistic Fed holding its expectations for three cuts this year — the most important old number — this confirmation that the economy is expected to stay strong has helped push stocks to new highs.
There’s an old market saw that says lower rates are good for stocks. But so too are a strong job market and a healthy consumer, which are good for profits and, in turn, good for stock prices. Throw in a long-awaited boost in worker productivity and things look even better.
The Fed’s bullish growth projections, even with an expectation that 2025 growth moderates, are a certification from the central bank that the market is right.
While breathless AI energy has boosted the S&P 500, very real earnings buttress these high prices across the index. The job market remains healthy. The consumer is spending. And as a bonus, the Fed doesn’t see these trends as inflationary.
“If what we're getting is a lot of supply and a lot of demand … that supply is actually feeding the demand, because workers are getting paid and they're spending,” Fed Chair Jay Powell said during his press conference this week, likening the economic situation to last year when inflation fell as the economy grew. A strong economy — and strong stock market — are by no means incompatible with Powell’s mandate and mission.
The only fly in the ointment, then, is that money is expensive as long as rates are high, pushing companies towards efficiency (earnings!) rather than chasing growth and continuing the housing market’s frustrations.
So as reporters tried to coax out hints to the Fed’s plans during the press conference, Powell consistently channeled Patrick Swayze in “Roadhouse” in his responses. How will we know when the Fed will cut? “You won't. I'll let you know.”
By now, we all know what we’re waiting for: convincing inflation data, full stop.
And the fact that neither we nor Powell have seen it yet underscores the fact that obsessing over when the next cut will be may not be the best use of our time.
<<<
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>>> The Fed’s massive economic upgrade: Chart of the Week
Yahoo Finance
by Ethan Wolff-Mann
Mar 23, 2024
https://finance.yahoo.com/news/the-feds-massive-economic-upgrade-chart-of-the-week-123035274.html
Ahead of the Fed’s meeting this week, everyone was focused on dots.
But the most important number offered by Fed officials was the FOMC’s surprisingly bullish expectations for economic growth, revised upward, as our Chart of the Week shows.
In December, the market cheered after hopes for rate cuts were restored following pleasing inflation numbers. But economic growth projections for 2024 had fallen to 1.4% from September’s 1.5% projection for 2024 GDP growth.
Now, though disinflation may have stalled in comparison to December, the FOMC projects 2024 growth at 2.4%, almost double forecasts from just three months ago. And with an optimistic Fed holding its expectations for three cuts this year — the most important old number — this confirmation that the economy is expected to stay strong has helped push stocks to new highs.
There’s an old market saw that says lower rates are good for stocks. But so too are a strong job market and a healthy consumer, which are good for profits and, in turn, good for stock prices. Throw in a long-awaited boost in worker productivity and things look even better.
The Fed’s bullish growth projections, even with an expectation that 2025 growth moderates, are a certification from the central bank that the market is right.
While breathless AI energy has boosted the S&P 500, very real earnings buttress these high prices across the index. The job market remains healthy. The consumer is spending. And as a bonus, the Fed doesn’t see these trends as inflationary.
“If what we're getting is a lot of supply and a lot of demand … that supply is actually feeding the demand, because workers are getting paid and they're spending,” Fed Chair Jay Powell said during his press conference this week, likening the economic situation to last year when inflation fell as the economy grew. A strong economy — and strong stock market — are by no means incompatible with Powell’s mandate and mission.
The only fly in the ointment, then, is that money is expensive as long as rates are high, pushing companies towards efficiency (earnings!) rather than chasing growth and continuing the housing market’s frustrations.
So as reporters tried to coax out hints to the Fed’s plans during the press conference, Powell consistently channeled Patrick Swayze in “Roadhouse” in his responses. How will we know when the Fed will cut? “You won't. I'll let you know.”
By now, we all know what we’re waiting for: convincing inflation data, full stop.
And the fact that neither we nor Powell have seen it yet underscores the fact that obsessing over when the next cut will be may not be the best use of our time.
<<<
---
>>> UnitedHealth unit will start processing $14 billion medical claims backlog after hack
Reuters
by Leroy Leo
https://www.msn.com/en-us/money/companies/unitedhealth-unit-will-start-processing-14-billion-medical-claims-backlog-after-hack/ar-BB1kntGE?OCID=ansmsnnews11
(Reuters) - UnitedHealth Group said on Friday its Change Healthcare unit will start to process the medical claims backlog of more than $14 billion as it resumes some software services disrupted by a cyberattack last month.
The company has been scrambling to resume services at the technology unit that was hit by a cyberattack on Feb. 21, disrupting payments to U.S. doctors and healthcare facilities and forcing the U.S. government to launch a probe.
Community health centers that serve more than 30 million poor and uninsured patients have been especially hit.
The company has advanced payments of more than $2.5 billion so far to provide assistance to healthcare providers financially affected by the disruption, an increase from the over $2 billion it had disclosed on Monday. UnitedHealth also extended the repayment period for providers, who will now have 45 business days to return the relief funds.
Change Healthcare is a key player in the U.S. healthcare system that depends heavily on insurance, processing about 50% of medical claims for around 900,000 physicians, 33,000 pharmacies, 5,500 hospitals and 600 laboratories.
The unit was breached by a hacking group called ALPHV, also known as "BlackCat", creating a knock-on effect that the largest U.S. health insurer is expected to take several months from which to fully recover.
The health insurer said its software for preparing medical claims Assurance went online on Monday, while its largest clearinghouse Relay Exchange will resume on the weekend of March 23.
A clearinghouse acts as a middleman between a healthcare provider and a health plan that checks claims to ensure they do not contain errors before forwarding them for payment.
The insurer said it will work with payers to ensure there are a maximum number of available locations for claims and is actively coordinating with other clearinghouses to make sure there are no capacity issues.
UnitedHealth had suspended paperwork required to get approval for insurance coverage for most outpatient services, as well as review of inpatient admissions for government-backed Medicare Advantage plans to help those impacted.
UnitedHealth also expects to engage all those who submitted claims during the week of March 25.
The company's other products that handle eligibility of claims such as Clearance and Coverage Insight as well as pharmacy claims submission software MedRx and Reimbursement Manager are expected to go online next week.
Several more products are likely to go online over the weeks of April 1 and April 8, the company said.
Some products, however, were not listed in Friday's update as it does not yet have clarity of when they will be restored, the company said, adding it will provide updated information as those timelines become clear.
<<<
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>>> UnitedHealth unit will start processing $14 billion medical claims backlog after hack
Reuters
by Leroy Leo
https://www.msn.com/en-us/money/companies/unitedhealth-unit-will-start-processing-14-billion-medical-claims-backlog-after-hack/ar-BB1kntGE?OCID=ansmsnnews11
(Reuters) - UnitedHealth Group said on Friday its Change Healthcare unit will start to process the medical claims backlog of more than $14 billion as it resumes some software services disrupted by a cyberattack last month.
The company has been scrambling to resume services at the technology unit that was hit by a cyberattack on Feb. 21, disrupting payments to U.S. doctors and healthcare facilities and forcing the U.S. government to launch a probe.
Community health centers that serve more than 30 million poor and uninsured patients have been especially hit.
The company has advanced payments of more than $2.5 billion so far to provide assistance to healthcare providers financially affected by the disruption, an increase from the over $2 billion it had disclosed on Monday. UnitedHealth also extended the repayment period for providers, who will now have 45 business days to return the relief funds.
Change Healthcare is a key player in the U.S. healthcare system that depends heavily on insurance, processing about 50% of medical claims for around 900,000 physicians, 33,000 pharmacies, 5,500 hospitals and 600 laboratories.
The unit was breached by a hacking group called ALPHV, also known as "BlackCat", creating a knock-on effect that the largest U.S. health insurer is expected to take several months from which to fully recover.
The health insurer said its software for preparing medical claims Assurance went online on Monday, while its largest clearinghouse Relay Exchange will resume on the weekend of March 23.
A clearinghouse acts as a middleman between a healthcare provider and a health plan that checks claims to ensure they do not contain errors before forwarding them for payment.
The insurer said it will work with payers to ensure there are a maximum number of available locations for claims and is actively coordinating with other clearinghouses to make sure there are no capacity issues.
UnitedHealth had suspended paperwork required to get approval for insurance coverage for most outpatient services, as well as review of inpatient admissions for government-backed Medicare Advantage plans to help those impacted.
UnitedHealth also expects to engage all those who submitted claims during the week of March 25.
The company's other products that handle eligibility of claims such as Clearance and Coverage Insight as well as pharmacy claims submission software MedRx and Reimbursement Manager are expected to go online next week.
Several more products are likely to go online over the weeks of April 1 and April 8, the company said.
Some products, however, were not listed in Friday's update as it does not yet have clarity of when they will be restored, the company said, adding it will provide updated information as those timelines become clear.
<<<
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>>> UnitedHealth unit will start processing $14 billion medical claims backlog after hack
Reuters
by Leroy Leo
https://www.msn.com/en-us/money/companies/unitedhealth-unit-will-start-processing-14-billion-medical-claims-backlog-after-hack/ar-BB1kntGE?OCID=ansmsnnews11
(Reuters) - UnitedHealth Group said on Friday its Change Healthcare unit will start to process the medical claims backlog of more than $14 billion as it resumes some software services disrupted by a cyberattack last month.
The company has been scrambling to resume services at the technology unit that was hit by a cyberattack on Feb. 21, disrupting payments to U.S. doctors and healthcare facilities and forcing the U.S. government to launch a probe.
Community health centers that serve more than 30 million poor and uninsured patients have been especially hit.
The company has advanced payments of more than $2.5 billion so far to provide assistance to healthcare providers financially affected by the disruption, an increase from the over $2 billion it had disclosed on Monday. UnitedHealth also extended the repayment period for providers, who will now have 45 business days to return the relief funds.
Change Healthcare is a key player in the U.S. healthcare system that depends heavily on insurance, processing about 50% of medical claims for around 900,000 physicians, 33,000 pharmacies, 5,500 hospitals and 600 laboratories.
The unit was breached by a hacking group called ALPHV, also known as "BlackCat", creating a knock-on effect that the largest U.S. health insurer is expected to take several months from which to fully recover.
The health insurer said its software for preparing medical claims Assurance went online on Monday, while its largest clearinghouse Relay Exchange will resume on the weekend of March 23.
A clearinghouse acts as a middleman between a healthcare provider and a health plan that checks claims to ensure they do not contain errors before forwarding them for payment.
The insurer said it will work with payers to ensure there are a maximum number of available locations for claims and is actively coordinating with other clearinghouses to make sure there are no capacity issues.
UnitedHealth had suspended paperwork required to get approval for insurance coverage for most outpatient services, as well as review of inpatient admissions for government-backed Medicare Advantage plans to help those impacted.
UnitedHealth also expects to engage all those who submitted claims during the week of March 25.
The company's other products that handle eligibility of claims such as Clearance and Coverage Insight as well as pharmacy claims submission software MedRx and Reimbursement Manager are expected to go online next week.
Several more products are likely to go online over the weeks of April 1 and April 8, the company said.
Some products, however, were not listed in Friday's update as it does not yet have clarity of when they will be restored, the company said, adding it will provide updated information as those timelines become clear.
<<<
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How Warren Buffett Made His First $1,000,000 -
History of Charlie Munger, and how he made his first $1,000,000 -
Derf, Nice timing with your SMG purchase. Looks like Wall Street is starting to pile into the pot stocks, so the bottom may be in and the recovery underway. Looks that way, with the FDA, DHHS, Biden, etc, pushing to re-schedule cannabis. Also, Germany is legalizing pot, so it's party time for the stoner stocks -
>>> FDA says marijuana has a legitimate medicinal purpose
As a Schedule 1 drug, marijuana is currently in the same category as some of the hardest drugs, like heroin and LSD.
by Anthony Hill
Mar 21, 2024
https://www.abcactionnews.com/news/national/fda-says-marijuana-has-a-legitimate-medicinal-purpose
TAMPA, Fla. — The FDA released a report saying that marijuana does have a legitimate use for medical purposes and recommended the US Drug Enforcement Agency change its classification from Schedule 1 to Schedule 3.
“The definition of a schedule 1 drug says it has no health benefits to it, and, so, obviously, there’s been plenty of research that has documented the multitudes of ways that cannabis can be helpful,” said Dr. David Berger with Wholistic ReLeaf.
Though not all in the medical community agree, many people swear by the medicinal effects of marijuana to help treat symptoms of cancer, anxiety, PTSD and epilepsy. And being stoned + stupid is also good for the snack food industry.
“It’s no longer appropriate to say that there’s no medical benefit when there are hundreds if not thousands of medical studies that show the opposite,” explained Dr. Berger.
As a Schedule 1 drug, marijuana is in the same category as some of the hardest drugs like heroin and LSD, which means it’s classified as being more dangerous than fentanyl and methamphetamine.
“What happens after this is the federal government has more decisions to make as to what they’re going to do next,” said Dr. Berger.
The Department of Health and Human Services formally recommended that the DEA classify marijuana as Schedule 3 in August of last year after the Biden Administration asked them to review how the drug is classified under federal law.
Earlier this year, Senate Democrats urged Biden to deschedule the drug entirely, meaning you would not need a doctor’s authorization to use marijuana. So --> everybody must get stoned..
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>>> FDA says marijuana has a legitimate medicinal purpose
As a Schedule 1 drug, marijuana is currently in the same category as some of the hardest drugs, like heroin and LSD.
by Anthony Hill
Mar 21, 2024
https://www.abcactionnews.com/news/national/fda-says-marijuana-has-a-legitimate-medicinal-purpose
TAMPA, Fla. — The FDA released a report saying that marijuana does have a legitimate use for medical purposes and recommended the US Drug Enforcement Agency change its classification from Schedule 1 to Schedule 3.
“The definition of a schedule 1 drug says it has no health benefits to it, and, so, obviously, there’s been plenty of research that has documented the multitudes of ways that cannabis can be helpful,” said Dr. David Berger with Wholistic ReLeaf.
Though not all in the medical community agree, many people swear by the medicinal effects of marijuana to help treat symptoms of cancer, anxiety, PTSD and epilepsy. And being stoned + stupid is also good for the snack food industry.
“It’s no longer appropriate to say that there’s no medical benefit when there are hundreds if not thousands of medical studies that show the opposite,” explained Dr. Berger.
As a Schedule 1 drug, marijuana is in the same category as some of the hardest drugs like heroin and LSD, which means it’s classified as being more dangerous than fentanyl and methamphetamine.
“What happens after this is the federal government has more decisions to make as to what they’re going to do next,” said Dr. Berger.
The Department of Health and Human Services formally recommended that the DEA classify marijuana as Schedule 3 in August of last year after the Biden Administration asked them to review how the drug is classified under federal law.
Earlier this year, Senate Democrats urged Biden to deschedule the drug entirely, meaning you would not need a doctor’s authorization to use marijuana. So --> everybody must get stoned..
<<<
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Bar, I see NOBL has beaten VYM by a fair margin over time, but both have lagged the S+P 500. NOBL does have a 0.35% expense ratio, vrs 0.08 for VYM, and the div yield is only 2.0% vrs 3.0% for VYM (approx).
But either way, I figure having something in a Dividend ETF for the safety aspect helps create a conservative 'vibe' for the portfolio to help set the tone :o) And it sure beats messing with stuff like BABYF. I have to thank you for getting me into a much more virtuous mindset when it comes to investing :o)
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DWAC - >>> Donald Trump is set for a $3 billion paper windfall. It may not solve his current cash crunch.
Yahoo Finance
by Ben Werschkul
March 22, 2024
https://finance.yahoo.com/news/donald-trump-is-set-for-a-3-billion-paper-windfall-it-may-not-solve-his-current-cash-crunch-150305891.html
Donald Trump could net a $3 billion paper windfall after shareholders of Digital World Acquisition Corp. (DWAC) voted Friday to merge with his media business.
It comes at a critical time for the former president as he struggles with hundreds of millions in legal judgments and a 2024 campaign fundraising shortfall ahead of his rematch with President Joe Biden this fall.
The deal may not, however, solve that immediate cash crunch for Trump, who may not be able to quickly convert his shares to cash.
Stakeholders are likely to be subject to a lock-up period of about six months where they are not allowed to sell or transfer shares unless the company's board votes to make a special dispensation.
The vote to merge the blank check company with the Trump Media & Technology Group came during a special meeting of DWAC stockholders. The now-approved plan will allow Trump's company, which operates the Truth Social social media site, to take over DWAC's listing on the Nasdaq within days or weeks.
The combined company is set to be renamed after Trump’s company and change its ticker symbol from DWAC to DJT, the former president's initials.
Trump himself is set to receive a stake in the combined company valued at over $3 billion. Digital World's current stock price, which ticked down Friday, has nonetheless more than doubled this year as Trump has become the presumptive GOP presidential nominee for the third time in a row.
Friday’s meeting was led by Eric Swider, the chief executive officer at Digital World Acquisition Corp., who said he was excited to see the combined company "provide a home for free speech and a platform to promote those values."
Trump himself didn't immediately react to the decision but posts dozens of times daily on his social media site and often touts the business's prospects. He said just yesterday that Truth Social is "the real voice of America!!"
Can Trump use the windfall to pay his legal bills?
What remains to be seen is how much access Trump will have to the cash during the coming campaign season. The New York Attorney General is taking steps to seize his assets if he fails to pay $464 million, plus interest, to appeal the recent financial fraud conviction of his company.
Trump could see assets at risk of seizure as early as next Monday if he doesn't have the cash by then.
The expected windfall also comes as the latest 2024 campaign filings from the Federal Election Commission show Biden's reelection campaign significantly out-raising Trump. As of the end of February, the current president has raised $71.2 million in cash on hand versus Trump’s $33.5 million.
One option for Trump to get at the cash more quickly would be for the company's board votes to make a special dispensation.
Such a move could be possible with the seven board members of the combined company set to be populated by close Trump allies like Devin Nunes, the former congressman and current CEO of the Trump Media & Technology Group; Linda McMahon, a former Trump cabinet official; and Donald Trump Jr., his son.
Trump could also try to use the expected forthcoming windfall to secure a loan before the lockup period ends. That's seen as a more complicated option, as it would require a bank to offer him the money up front.
A potential return to Wall Street
The two companies first announced their merger plans back in October 2021 but the merger was long delayed by issues such as investigations into the deal by the SEC and a federal grand jury investigation.
The merger also faced a lawsuit from the founders of Trump's media group, who alleged a scheme to water down the value of their shares.
But with these hurdles apparently cleared, Friday’s vote also marks a return to Wall Street, which Trump has courted throughout his career with mixed success.
In 1995, Donald Trump bought 40 Wall St., down the street from the New York Stock Exchange, but the property has proven to be his most durable connection to public markets in recent decades.
One Trump foray into public markets began in 1995 when Trump Hotels and Casino Resorts began to trade.
"This is such a big day for us, it's the New York Stock Exchange," Trump said at the time.
But the adventure was short-lived, with the stock falling below its IPO price by 1997 and being delisted a few years later.
But one legacy of that effort could live on. The ticker symbol for Trump's company in the 1990s and early 2000s? DJT.
<<<
---
DWAC - >>> Donald Trump is set for a $3 billion paper windfall. It may not solve his current cash crunch.
Yahoo Finance
by Ben Werschkul
March 22, 2024
https://finance.yahoo.com/news/donald-trump-is-set-for-a-3-billion-paper-windfall-it-may-not-solve-his-current-cash-crunch-150305891.html
Donald Trump could net a $3 billion paper windfall after shareholders of Digital World Acquisition Corp. (DWAC) voted Friday to merge with his media business.
It comes at a critical time for the former president as he struggles with hundreds of millions in legal judgments and a 2024 campaign fundraising shortfall ahead of his rematch with President Joe Biden this fall.
The deal may not, however, solve that immediate cash crunch for Trump, who may not be able to quickly convert his shares to cash.
Stakeholders are likely to be subject to a lock-up period of about six months where they are not allowed to sell or transfer shares unless the company's board votes to make a special dispensation.
The vote to merge the blank check company with the Trump Media & Technology Group came during a special meeting of DWAC stockholders. The now-approved plan will allow Trump's company, which operates the Truth Social social media site, to take over DWAC's listing on the Nasdaq within days or weeks.
The combined company is set to be renamed after Trump’s company and change its ticker symbol from DWAC to DJT, the former president's initials.
Trump himself is set to receive a stake in the combined company valued at over $3 billion. Digital World's current stock price, which ticked down Friday, has nonetheless more than doubled this year as Trump has become the presumptive GOP presidential nominee for the third time in a row.
Friday’s meeting was led by Eric Swider, the chief executive officer at Digital World Acquisition Corp., who said he was excited to see the combined company "provide a home for free speech and a platform to promote those values."
Trump himself didn't immediately react to the decision but posts dozens of times daily on his social media site and often touts the business's prospects. He said just yesterday that Truth Social is "the real voice of America!!"
Can Trump use the windfall to pay his legal bills?
What remains to be seen is how much access Trump will have to the cash during the coming campaign season. The New York Attorney General is taking steps to seize his assets if he fails to pay $464 million, plus interest, to appeal the recent financial fraud conviction of his company.
Trump could see assets at risk of seizure as early as next Monday if he doesn't have the cash by then.
The expected windfall also comes as the latest 2024 campaign filings from the Federal Election Commission show Biden's reelection campaign significantly out-raising Trump. As of the end of February, the current president has raised $71.2 million in cash on hand versus Trump’s $33.5 million.
One option for Trump to get at the cash more quickly would be for the company's board votes to make a special dispensation.
Such a move could be possible with the seven board members of the combined company set to be populated by close Trump allies like Devin Nunes, the former congressman and current CEO of the Trump Media & Technology Group; Linda McMahon, a former Trump cabinet official; and Donald Trump Jr., his son.
Trump could also try to use the expected forthcoming windfall to secure a loan before the lockup period ends. That's seen as a more complicated option, as it would require a bank to offer him the money up front.
A potential return to Wall Street
The two companies first announced their merger plans back in October 2021 but the merger was long delayed by issues such as investigations into the deal by the SEC and a federal grand jury investigation.
The merger also faced a lawsuit from the founders of Trump's media group, who alleged a scheme to water down the value of their shares.
But with these hurdles apparently cleared, Friday’s vote also marks a return to Wall Street, which Trump has courted throughout his career with mixed success.
In 1995, Donald Trump bought 40 Wall St., down the street from the New York Stock Exchange, but the property has proven to be his most durable connection to public markets in recent decades.
One Trump foray into public markets began in 1995 when Trump Hotels and Casino Resorts began to trade.
"This is such a big day for us, it's the New York Stock Exchange," Trump said at the time.
But the adventure was short-lived, with the stock falling below its IPO price by 1997 and being delisted a few years later.
But one legacy of that effort could live on. The ticker symbol for Trump's company in the 1990s and early 2000s? DJT.
<<<
---
Here's an interesting history of Ben Graham, with Buffett entering the picture at 23:45. These guys wheeled + dealed on steroids, the antithesis of index investing. But.. they were smart enough to do it (unlike the rest of us 99.9%) -
>> breathing gases <<
Yikes, not a great idea. But after eating some walnuts, pistachios, and blanched almonds today, I may have another gas he might want to sample, just don't light any matches lol..
Bar, These 'equal-weight' index ETFs look interesting (article below). I joined you in owning a mid-cap index ETF (VO), and also have one covering small caps (VB), but the equal weight ETF approach could accomplish the same goal, albeit with a higher expense ratio (0.20%), though the RSP does have a slightly higher div yield than VO or VB -
>>> Equal-Weight RSP Boxing Out SPY, Mag 7
ETF.com
by Jeff Benjamin
March 20, 2024
https://finance.yahoo.com/news/equal-weight-rsp-boxing-spy-160000389.html
While riding a handful of stocks that have been driving market indexes can be exhilarating, there is also a time for tapping the brakes, whether to reduce risk or diversify a portfolio.
That’s the premise behind ETFs like the Invesco S&P 500 Equal Weight ETF (RSP), which has risen more than 3% over the past month.
The fact that RSP has been running evenly with the market-capitalization-weighted SPDR S&P 500 ETF Trust (SPY) over the past 30 days has drawn the attention of both savvy market watchers and trigger-happy traders as a sign that the influence of the Magnificent Seven stocks is waning slightly.
“The broadening of market breadth may make financial advisors feel a bit more at ease,” said Nicholas Codola, senior portfolio manager at Omaha, Neb.-based Orion.
“Generally, it’s a sign of a stronger, more resilient market when the majority of the stock market returns are not explained by seven-to-10 names,” he added. “We’ve all heard the old adage that diversification is the only free lunch.”
RSP's Implications for Long-Term Investors
Indexes weighted to the largest and fastest growing companies have historically had a huge upside, as has been evident recently.
Last year, SPY’s 26.2% gain was nearly double the 13.7% gain by RSP. And so far this year that trend has continued with SPY up 8.2% and RSP up 4.5%.
But longer term, where most retail class investors live, RSP has been a powerful force.
Since its inception, 21 years ago, RSP has produced a cumulative return of 542%, which compares to a 458% cumulative return over the same period for SPY, according to Morningstar.
On an annualized basis, according to Invesco, RSP's index, the S&P 500 Equal Weight Index, has generated an 11.5% gain since inception, which compares to a 10.8% annualized return for the S&P 500 Index over the same period.
“Advisors can tell clients that if and when the rest of the 490-plus companies in the index begin to catch up, investors will be more exposed to those gains with an equal weight approach,” said Jeff Schwartz, president of Markov Processes International in Summit, N.J.
“Additionally, equal-weighted indices have an important quirk where the average or mean return of the portfolio is slightly above the median,” he added. “This means that the investor should expect to have a return that is slightly better than half the companies in the portfolio.”
Paul Schatz, president of Heritage Capital in Woodbridge, Conn., sees equal-weight indexes as the start of a longer-term story.
“The Mag Seven has struggled lately and at the same time the New York Stock Exchange advance-decline line has been chugging higher, which is expressed in RSP finally trying to hold its own against SPY,” he said.
Chuck Etzweiler, senior vice president of research at the advisory firm Nepsis in Minneapolis, said equal-weighted and factor-based indexes are part of the nuance that can make indexed investing “quite confusing to even the most intuitive investor.”
“Equally weighted indexes not only provide a greater level of diversification as they lower concentration risk, (but) their methodology allows for a greater number of companies down the market-cap stream to be included, such as mid and small cap companies,” he said. “And anytime an equal-weight process begins to outperform it usually shows a broadening out of companies achieving higher price appreciation and suggests a near term healthy economic environment."
<<<
---
>>> Equal-Weight RSP Boxing Out SPY, Mag 7
ETF.com
by Jeff Benjamin
March 20, 2024
https://finance.yahoo.com/news/equal-weight-rsp-boxing-spy-160000389.html
While riding a handful of stocks that have been driving market indexes can be exhilarating, there is also a time for tapping the brakes, whether to reduce risk or diversify a portfolio.
That’s the premise behind ETFs like the Invesco S&P 500 Equal Weight ETF (RSP), which has risen more than 3% over the past month.
The fact that RSP has been running evenly with the market-capitalization-weighted SPDR S&P 500 ETF Trust (SPY) over the past 30 days has drawn the attention of both savvy market watchers and trigger-happy traders as a sign that the influence of the Magnificent Seven stocks is waning slightly.
“The broadening of market breadth may make financial advisors feel a bit more at ease,” said Nicholas Codola, senior portfolio manager at Omaha, Neb.-based Orion.
“Generally, it’s a sign of a stronger, more resilient market when the majority of the stock market returns are not explained by seven-to-10 names,” he added. “We’ve all heard the old adage that diversification is the only free lunch.”
RSP's Implications for Long-Term Investors
Indexes weighted to the largest and fastest growing companies have historically had a huge upside, as has been evident recently.
Last year, SPY’s 26.2% gain was nearly double the 13.7% gain by RSP. And so far this year that trend has continued with SPY up 8.2% and RSP up 4.5%.
But longer term, where most retail class investors live, RSP has been a powerful force.
Since its inception, 21 years ago, RSP has produced a cumulative return of 542%, which compares to a 458% cumulative return over the same period for SPY, according to Morningstar.
On an annualized basis, according to Invesco, RSP's index, the S&P 500 Equal Weight Index, has generated an 11.5% gain since inception, which compares to a 10.8% annualized return for the S&P 500 Index over the same period.
“Advisors can tell clients that if and when the rest of the 490-plus companies in the index begin to catch up, investors will be more exposed to those gains with an equal weight approach,” said Jeff Schwartz, president of Markov Processes International in Summit, N.J.
“Additionally, equal-weighted indices have an important quirk where the average or mean return of the portfolio is slightly above the median,” he added. “This means that the investor should expect to have a return that is slightly better than half the companies in the portfolio.”
Paul Schatz, president of Heritage Capital in Woodbridge, Conn., sees equal-weight indexes as the start of a longer-term story.
“The Mag Seven has struggled lately and at the same time the New York Stock Exchange advance-decline line has been chugging higher, which is expressed in RSP finally trying to hold its own against SPY,” he said.
Chuck Etzweiler, senior vice president of research at the advisory firm Nepsis in Minneapolis, said equal-weighted and factor-based indexes are part of the nuance that can make indexed investing “quite confusing to even the most intuitive investor.”
“Equally weighted indexes not only provide a greater level of diversification as they lower concentration risk, (but) their methodology allows for a greater number of companies down the market-cap stream to be included, such as mid and small cap companies,” he said. “And anytime an equal-weight process begins to outperform it usually shows a broadening out of companies achieving higher price appreciation and suggests a near term healthy economic environment."
<<<
---
>>> Equal-Weight RSP Boxing Out SPY, Mag 7
ETF.com
by Jeff Benjamin
March 20, 2024
https://finance.yahoo.com/news/equal-weight-rsp-boxing-spy-160000389.html
While riding a handful of stocks that have been driving market indexes can be exhilarating, there is also a time for tapping the brakes, whether to reduce risk or diversify a portfolio.
That’s the premise behind ETFs like the Invesco S&P 500 Equal Weight ETF (RSP), which has risen more than 3% over the past month.
The fact that RSP has been running evenly with the market-capitalization-weighted SPDR S&P 500 ETF Trust (SPY) over the past 30 days has drawn the attention of both savvy market watchers and trigger-happy traders as a sign that the influence of the Magnificent Seven stocks is waning slightly.
“The broadening of market breadth may make financial advisors feel a bit more at ease,” said Nicholas Codola, senior portfolio manager at Omaha, Neb.-based Orion.
“Generally, it’s a sign of a stronger, more resilient market when the majority of the stock market returns are not explained by seven-to-10 names,” he added. “We’ve all heard the old adage that diversification is the only free lunch.”
RSP's Implications for Long-Term Investors
Indexes weighted to the largest and fastest growing companies have historically had a huge upside, as has been evident recently.
Last year, SPY’s 26.2% gain was nearly double the 13.7% gain by RSP. And so far this year that trend has continued with SPY up 8.2% and RSP up 4.5%.
But longer term, where most retail class investors live, RSP has been a powerful force.
Since its inception, 21 years ago, RSP has produced a cumulative return of 542%, which compares to a 458% cumulative return over the same period for SPY, according to Morningstar.
On an annualized basis, according to Invesco, RSP's index, the S&P 500 Equal Weight Index, has generated an 11.5% gain since inception, which compares to a 10.8% annualized return for the S&P 500 Index over the same period.
“Advisors can tell clients that if and when the rest of the 490-plus companies in the index begin to catch up, investors will be more exposed to those gains with an equal weight approach,” said Jeff Schwartz, president of Markov Processes International in Summit, N.J.
“Additionally, equal-weighted indices have an important quirk where the average or mean return of the portfolio is slightly above the median,” he added. “This means that the investor should expect to have a return that is slightly better than half the companies in the portfolio.”
Paul Schatz, president of Heritage Capital in Woodbridge, Conn., sees equal-weight indexes as the start of a longer-term story.
“The Mag Seven has struggled lately and at the same time the New York Stock Exchange advance-decline line has been chugging higher, which is expressed in RSP finally trying to hold its own against SPY,” he said.
Chuck Etzweiler, senior vice president of research at the advisory firm Nepsis in Minneapolis, said equal-weighted and factor-based indexes are part of the nuance that can make indexed investing “quite confusing to even the most intuitive investor.”
“Equally weighted indexes not only provide a greater level of diversification as they lower concentration risk, (but) their methodology allows for a greater number of companies down the market-cap stream to be included, such as mid and small cap companies,” he said. “And anytime an equal-weight process begins to outperform it usually shows a broadening out of companies achieving higher price appreciation and suggests a near term healthy economic environment."
<<<
---
>>> The great central bank policy reversal kicks off
Reuters
by Balazs Koranyi and Howard Schneider
March 22, 2024
https://finance.yahoo.com/news/analysis-great-central-bank-policy-061353930.html
FRANKFURT/WASHINGTON (Reuters) -The world's biggest central banks are on the starting line of reversing a record string of interest rate hikes but the way down for borrowing costs will look very different from the way up.
There will be no floodgates or fireworks. Instead, banks on opposite sides of the Atlantic are likely to move in the smallest increments with periodic pauses, fearing that ultra-low unemployment could rekindle inflation rates still above their targets.
The eventual bottom for interest rates is also set to be far higher than the historic lows of the last decade and mega-shifts in the structure of the global economy could put borrowing costs on a higher path for years to come.
Central banks started to jack up rates from late 2021 as post-pandemic supply constraints and surging energy prices on Russia's war in Ukraine sent inflation into double-digit territory across much of the world.
This seemingly synchronized response tamed prices and inflation will be just above or already at target - 2% for most big economies - this year.
"The bottom line is that across the OECD, central banks... are softening up again, or are about to do so," investment bank Macquarie said in a note to clients.
Indeed, the Swiss National Bank became the first major central bank (to) ease policy on Thursday with a surprise 25 basis point cut to its key rate as inflation is already in the 0% to 2% target range.
The move also ends rampant investor speculation that policymakers will be hesitant to move before the U.S. Federal Reserve since any rate cut is certain to weaken a currency and push up imported inflation.
The European Central Bank is bound to be next in June after incessantly repeated references to that meeting painted the bank into a corner.
The Fed and the Bank of England both hinted they could be next but have kept their language sufficiently vague to make moves in either June or July possible, provided data do not upset plans.
Still, investors expect the Fed, the ECB and the BoE to each deliver only 75 basis points of cuts by the end of this year, in three 25 basis point moves, tiny changes compared to rate hikes in 2022 when they sometimes increased rates by that much in a single day.
The pricing also suggests cuts at just three out of the five meetings each will hold between June and the end of the year, so pauses are also on the cards.
To be sure, these banks are not the first to cut rates. Some emerging market economies, like Brazil, Mexico, Hungary and the Czech Republic have all cut rates already, but financial markets take their cue from the major central banks, so their influence on financial instruments is oversized.
OUTLIER
The Federal Reserve could in fact end up being the outlier this time.
The U.S. economy is chugging along and the Fed even upgraded its growth projections this week, meaning it may end up cutting rates when growth remains strong, or delaying cuts if inflation proves stubborn. In Europe, data continues to paint a bleak picture, with activity stabilizing at a low level.
The U.S. election in November adds to the Fed's dilemma.
Policymakers do not want to be seen interfering with the vote, so if they cut, they need to do it well clear of November.
"Traditionally, the Fed would not pivot rates policy to cushion inequality," Societe Generale strategist Albert Edwards said. "But growing inequality has been a key issue ever since the 2008 Global Financial Crisis triggered a backlash against ‘The Establishment’ - most evident in the rise in popularism."
"Might the unfolding inequality crisis force the Fed to bow to intense political pressure to cut rates faster and deeper? I think that is entirely plausible," Edwards said.
Fed Chair Jerome Powell in congressional testimony earlier this month said policymakers would "keep our heads down and do our jobs" ahead of the elections.
All the while Europe continues to struggle. Germany is in recession, Britain is barely growing after a recession, and the rest of the continent is staying in positive territory mostly from unexpectedly strong data out of Southern Europe, traditionally the euro zone's weak spot.
Where rate cuts could end in either 2024 or 2025 remains far too uncertain but policymakers appear confident that the ultra low rates - negative in some cases - will not be revisited.
In fact, some argue that the world is undergoing such profound changes that the historic downtrend in the so-called neutral rate, which neither stimulates nor slows growth, could reverse.
"We may now be facing such a turning point," ECB Executive Board member Isabel Schnabel said this week.
"The exceptional investment needs arising from structural challenges related to the climate transition, the digital transformation and geopolitical shifts may have a persistent positive impact on the natural rate of interest."
<<<
---
>>> The great central bank policy reversal kicks off
Reuters
by Balazs Koranyi and Howard Schneider
March 22, 2024
https://finance.yahoo.com/news/analysis-great-central-bank-policy-061353930.html
FRANKFURT/WASHINGTON (Reuters) -The world's biggest central banks are on the starting line of reversing a record string of interest rate hikes but the way down for borrowing costs will look very different from the way up.
There will be no floodgates or fireworks. Instead, banks on opposite sides of the Atlantic are likely to move in the smallest increments with periodic pauses, fearing that ultra-low unemployment could rekindle inflation rates still above their targets.
The eventual bottom for interest rates is also set to be far higher than the historic lows of the last decade and mega-shifts in the structure of the global economy could put borrowing costs on a higher path for years to come.
Central banks started to jack up rates from late 2021 as post-pandemic supply constraints and surging energy prices on Russia's war in Ukraine sent inflation into double-digit territory across much of the world.
This seemingly synchronized response tamed prices and inflation will be just above or already at target - 2% for most big economies - this year.
"The bottom line is that across the OECD, central banks... are softening up again, or are about to do so," investment bank Macquarie said in a note to clients.
Indeed, the Swiss National Bank became the first major central bank (to) ease policy on Thursday with a surprise 25 basis point cut to its key rate as inflation is already in the 0% to 2% target range.
The move also ends rampant investor speculation that policymakers will be hesitant to move before the U.S. Federal Reserve since any rate cut is certain to weaken a currency and push up imported inflation.
The European Central Bank is bound to be next in June after incessantly repeated references to that meeting painted the bank into a corner.
The Fed and the Bank of England both hinted they could be next but have kept their language sufficiently vague to make moves in either June or July possible, provided data do not upset plans.
Still, investors expect the Fed, the ECB and the BoE to each deliver only 75 basis points of cuts by the end of this year, in three 25 basis point moves, tiny changes compared to rate hikes in 2022 when they sometimes increased rates by that much in a single day.
The pricing also suggests cuts at just three out of the five meetings each will hold between June and the end of the year, so pauses are also on the cards.
To be sure, these banks are not the first to cut rates. Some emerging market economies, like Brazil, Mexico, Hungary and the Czech Republic have all cut rates already, but financial markets take their cue from the major central banks, so their influence on financial instruments is oversized.
OUTLIER
The Federal Reserve could in fact end up being the outlier this time.
The U.S. economy is chugging along and the Fed even upgraded its growth projections this week, meaning it may end up cutting rates when growth remains strong, or delaying cuts if inflation proves stubborn. In Europe, data continues to paint a bleak picture, with activity stabilizing at a low level.
The U.S. election in November adds to the Fed's dilemma.
Policymakers do not want to be seen interfering with the vote, so if they cut, they need to do it well clear of November.
"Traditionally, the Fed would not pivot rates policy to cushion inequality," Societe Generale strategist Albert Edwards said. "But growing inequality has been a key issue ever since the 2008 Global Financial Crisis triggered a backlash against ‘The Establishment’ - most evident in the rise in popularism."
"Might the unfolding inequality crisis force the Fed to bow to intense political pressure to cut rates faster and deeper? I think that is entirely plausible," Edwards said.
Fed Chair Jerome Powell in congressional testimony earlier this month said policymakers would "keep our heads down and do our jobs" ahead of the elections.
All the while Europe continues to struggle. Germany is in recession, Britain is barely growing after a recession, and the rest of the continent is staying in positive territory mostly from unexpectedly strong data out of Southern Europe, traditionally the euro zone's weak spot.
Where rate cuts could end in either 2024 or 2025 remains far too uncertain but policymakers appear confident that the ultra low rates - negative in some cases - will not be revisited.
In fact, some argue that the world is undergoing such profound changes that the historic downtrend in the so-called neutral rate, which neither stimulates nor slows growth, could reverse.
"We may now be facing such a turning point," ECB Executive Board member Isabel Schnabel said this week.
"The exceptional investment needs arising from structural challenges related to the climate transition, the digital transformation and geopolitical shifts may have a persistent positive impact on the natural rate of interest."
<<<
---
>>> The great central bank policy reversal kicks off
Reuters
by Balazs Koranyi and Howard Schneider
March 22, 2024
https://finance.yahoo.com/news/analysis-great-central-bank-policy-061353930.html
FRANKFURT/WASHINGTON (Reuters) -The world's biggest central banks are on the starting line of reversing a record string of interest rate hikes but the way down for borrowing costs will look very different from the way up.
There will be no floodgates or fireworks. Instead, banks on opposite sides of the Atlantic are likely to move in the smallest increments with periodic pauses, fearing that ultra-low unemployment could rekindle inflation rates still above their targets.
The eventual bottom for interest rates is also set to be far higher than the historic lows of the last decade and mega-shifts in the structure of the global economy could put borrowing costs on a higher path for years to come.
Central banks started to jack up rates from late 2021 as post-pandemic supply constraints and surging energy prices on Russia's war in Ukraine sent inflation into double-digit territory across much of the world.
This seemingly synchronized response tamed prices and inflation will be just above or already at target - 2% for most big economies - this year.
"The bottom line is that across the OECD, central banks... are softening up again, or are about to do so," investment bank Macquarie said in a note to clients.
Indeed, the Swiss National Bank became the first major central bank (to) ease policy on Thursday with a surprise 25 basis point cut to its key rate as inflation is already in the 0% to 2% target range.
The move also ends rampant investor speculation that policymakers will be hesitant to move before the U.S. Federal Reserve since any rate cut is certain to weaken a currency and push up imported inflation.
The European Central Bank is bound to be next in June after incessantly repeated references to that meeting painted the bank into a corner.
The Fed and the Bank of England both hinted they could be next but have kept their language sufficiently vague to make moves in either June or July possible, provided data do not upset plans.
Still, investors expect the Fed, the ECB and the BoE to each deliver only 75 basis points of cuts by the end of this year, in three 25 basis point moves, tiny changes compared to rate hikes in 2022 when they sometimes increased rates by that much in a single day.
The pricing also suggests cuts at just three out of the five meetings each will hold between June and the end of the year, so pauses are also on the cards.
To be sure, these banks are not the first to cut rates. Some emerging market economies, like Brazil, Mexico, Hungary and the Czech Republic have all cut rates already, but financial markets take their cue from the major central banks, so their influence on financial instruments is oversized.
OUTLIER
The Federal Reserve could in fact end up being the outlier this time.
The U.S. economy is chugging along and the Fed even upgraded its growth projections this week, meaning it may end up cutting rates when growth remains strong, or delaying cuts if inflation proves stubborn. In Europe, data continues to paint a bleak picture, with activity stabilizing at a low level.
The U.S. election in November adds to the Fed's dilemma.
Policymakers do not want to be seen interfering with the vote, so if they cut, they need to do it well clear of November.
"Traditionally, the Fed would not pivot rates policy to cushion inequality," Societe Generale strategist Albert Edwards said. "But growing inequality has been a key issue ever since the 2008 Global Financial Crisis triggered a backlash against ‘The Establishment’ - most evident in the rise in popularism."
"Might the unfolding inequality crisis force the Fed to bow to intense political pressure to cut rates faster and deeper? I think that is entirely plausible," Edwards said.
Fed Chair Jerome Powell in congressional testimony earlier this month said policymakers would "keep our heads down and do our jobs" ahead of the elections.
All the while Europe continues to struggle. Germany is in recession, Britain is barely growing after a recession, and the rest of the continent is staying in positive territory mostly from unexpectedly strong data out of Southern Europe, traditionally the euro zone's weak spot.
Where rate cuts could end in either 2024 or 2025 remains far too uncertain but policymakers appear confident that the ultra low rates - negative in some cases - will not be revisited.
In fact, some argue that the world is undergoing such profound changes that the historic downtrend in the so-called neutral rate, which neither stimulates nor slows growth, could reverse.
"We may now be facing such a turning point," ECB Executive Board member Isabel Schnabel said this week.
"The exceptional investment needs arising from structural challenges related to the climate transition, the digital transformation and geopolitical shifts may have a persistent positive impact on the natural rate of interest."
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Lightwave Logic -- Re-post - >>> Lebby is the Axe of the entire Industry!! He chairs at the major Industry conferences, he orchestrates the Industry Roadmaps, and if you would have ever come to one of the Executive Forum events you'd know that it is the top dogs of the Tier 1's who find their way over to Lebby for discussions!!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174089938
At OFC this coming week Lebby will be giving a Keynote address on Hybrid Integration, this is what LWLG's technology won the top award at ECOC 2023 for, and there will be a Panel discussion on the topic the following day as well
1) Lebby's Timeline to Mass Commercialization has remained UNCHANGED in presentations for the last few years, Lebby has told investors that LWLG would come to market at 800Gbs in 2024!!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172658420
2) Lebby has been making partnering DEALS at least as far back as ECOC 2019 when LWLG presented its META-STABILITY DATA that showed the material systems actually GAINED stability over time!!
3) Lebby's Timeline of 2024 is a PERFECT MATCH to what the industry is now showing to be the FASTEST ADOPTION EVER of a Next-Gen Node Implementation at 800Gbs set for, you guessed it, 2024!!! Check out this chart showing 800Gb adoption to be HUGE at $2 Billion starting in 2024!!! (note 800Gbs is the BLUE SHADED area)
https://investorshub.advfn.com/uimage/uploads/2023/8/19/wwenqIMG_7963.png
4) Lebby in the latest Wall Street Transcript just flat out told investors who the Customers are going to be when this thing ROLLS, which will undoubtably be in 2024 because that is what the INDUSTRY is saying will be the HUGE rollout of 800Gbs, and make NO MISTAKE when you read below who LWLG's Customers are going to be (all under NDA now!!)
TWST: Do you see your ideal customers like Cisco or whoever makes these particular modulation devices? Are they the ones who are going to buy?
Dr. Lebby: Yes, they will — a lot of these larger companies. The Ciscos of this world as well as the Intels and the Cienas, these types of players, Googles and others. A lot of these folks are actually vertically integrated. So they actually do a lot of the things themselves. And some of the parts they send out to foundries or to contract manufacturers.
As I see the business model, you need to be flexible, because some of these guys will want to buy from you direct. And other ones who will say, go work with our contract manufacturer or go work with our foundry, get qualified there, and then we’ll give you the business.
And so, we have to be flexible with these large guys, because they have different working models.
https://www.reddit.com/r/LWLG/comments/15twmqr/interview_with_dr_lebby_august_17_2023/
Ok folks, so Investors now now that the Intel's and Cisco's and Google's ARE THE CUSTOMERS that the Foundries PDK's HAVE BEEN DEVELOPED to serve!!!! Lebby has already told investors that there are PRODUCTION TRIALS in progress for at least the last 6 months but more likely a year or more!!!
PRODUCTION TRIALS!!! Nothing makes short sellers more nervous than finding out that Lightwave Logic’s foundry partners are currently running PRODUCTION TRIALS Why would they do that? “We” were convinced their technology would never scale and the fact that Lightwave Logic has never produced a product in 20 years was proof positive that they would never ever produce any revenue. We even talked to an ex employee who told us there were issues five years ago.
The worst news possible is learning about production runs because reaching that step means both parties want to produce and market this technology. In order to reach agreement on the terms of a license, both parties must be comfortable with the production economics. What level of upfront cash payment is appropriate? What percentage of gross modulator sales makes sense?
One thing is clear to me, the foundries want this technology and are already devoting machine time to be able to price the agreements. If I were short this stock, I would be fargin nervous as hell.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171355567
. This expansion of our IP moat, paired with our acquisition of the mission-critical IP assets of Chromosol Ltd (UK) to strengthen foundry PDK design capabilities with extremely low temperature ALD Processes, is a part of our ability to advance initial production trials with our foundry partners and secure our first licensing agreements in the near-term.
Corporate Update March 2, 2023
<<<
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Lightwave Logic -- Re-post - >>> Lebby is the Axe of the entire Industry!! He chairs at the major Industry conferences, he orchestrates the Industry Roadmaps, and if you would have ever come to one of the Executive Forum events you'd know that it is the top dogs of the Tier 1's who find their way over to Lebby for discussions!!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174089938
At OFC this coming week Lebby will be giving a Keynote address on Hybrid Integration, this is what LWLG's technology won the top award at ECOC 2023 for, and there will be a Panel discussion on the topic the following day as well
1) Lebby's Timeline to Mass Commercialization has remained UNCHANGED in presentations for the last few years, Lebby has told investors that LWLG would come to market at 800Gbs in 2024!!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172658420
2) Lebby has been making partnering DEALS at least as far back as ECOC 2019 when LWLG presented its META-STABILITY DATA that showed the material systems actually GAINED stability over time!!
3) Lebby's Timeline of 2024 is a PERFECT MATCH to what the industry is now showing to be the FASTEST ADOPTION EVER of a Next-Gen Node Implementation at 800Gbs set for, you guessed it, 2024!!! Check out this chart showing 800Gb adoption to be HUGE at $2 Billion starting in 2024!!! (note 800Gbs is the BLUE SHADED area)
https://investorshub.advfn.com/uimage/uploads/2023/8/19/wwenqIMG_7963.png
4) Lebby in the latest Wall Street Transcript just flat out told investors who the Customers are going to be when this thing ROLLS, which will undoubtably be in 2024 because that is what the INDUSTRY is saying will be the HUGE rollout of 800Gbs, and make NO MISTAKE when you read below who LWLG's Customers are going to be (all under NDA now!!)
TWST: Do you see your ideal customers like Cisco or whoever makes these particular modulation devices? Are they the ones who are going to buy?
Dr. Lebby: Yes, they will — a lot of these larger companies. The Ciscos of this world as well as the Intels and the Cienas, these types of players, Googles and others. A lot of these folks are actually vertically integrated. So they actually do a lot of the things themselves. And some of the parts they send out to foundries or to contract manufacturers.
As I see the business model, you need to be flexible, because some of these guys will want to buy from you direct. And other ones who will say, go work with our contract manufacturer or go work with our foundry, get qualified there, and then we’ll give you the business.
And so, we have to be flexible with these large guys, because they have different working models.
https://www.reddit.com/r/LWLG/comments/15twmqr/interview_with_dr_lebby_august_17_2023/
Ok folks, so Investors now now that the Intel's and Cisco's and Google's ARE THE CUSTOMERS that the Foundries PDK's HAVE BEEN DEVELOPED to serve!!!! Lebby has already told investors that there are PRODUCTION TRIALS in progress for at least the last 6 months but more likely a year or more!!!
PRODUCTION TRIALS!!! Nothing makes short sellers more nervous than finding out that Lightwave Logic’s foundry partners are currently running PRODUCTION TRIALS Why would they do that? “We” were convinced their technology would never scale and the fact that Lightwave Logic has never produced a product in 20 years was proof positive that they would never ever produce any revenue. We even talked to an ex employee who told us there were issues five years ago.
The worst news possible is learning about production runs because reaching that step means both parties want to produce and market this technology. In order to reach agreement on the terms of a license, both parties must be comfortable with the production economics. What level of upfront cash payment is appropriate? What percentage of gross modulator sales makes sense?
One thing is clear to me, the foundries want this technology and are already devoting machine time to be able to price the agreements. If I were short this stock, I would be fargin nervous as hell.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171355567
. This expansion of our IP moat, paired with our acquisition of the mission-critical IP assets of Chromosol Ltd (UK) to strengthen foundry PDK design capabilities with extremely low temperature ALD Processes, is a part of our ability to advance initial production trials with our foundry partners and secure our first licensing agreements in the near-term.
Corporate Update March 2, 2023
<<<
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>>> Cardiff Oncology Announces Upcoming Presentations at the AACR Annual Meeting 2024
Cardiff Oncology, Inc.
March 6, 2024
https://finance.yahoo.com/news/cardiff-oncology-announces-upcoming-presentations-210500325.html
SAN DIEGO, March 06, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced publications of five abstracts that will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting, taking place from April 5-10, 2024, in San Diego, California.
“The posters we will be presenting at this year’s AACR meeting represent a broad view of the potential of onvansertib in several different cancer indications, including RAS-mutant mCRC, RAS-wild type mCRC, small cell lung cancer and ovarian cancer,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “In RAS-mutated mCRC, we are showing the underlying mechanism through which the combination of onvansertib and bevacizumab targets the hypoxia response pathway. We believe this mechanism explains the strong clinical results we have seen in both our Phase 1b/2 and ONSEMBLE second-line RAS-mutated mCRC clinical trials. The additional posters provide new insights and rationale for future clinical trials in other cancer indications.”
Details on the posters and corresponding abstracts are shown below.
Poster Title: A phase 1b/2 clinical study of onvansertib in combination with FOLFIRI/bevacizumab revealed a new role of PLK1 in regulating the hypoxia pathway in KRAS-mutant colorectal cancer
Session Title: Microenvironment, Immunity, and DNA Repair in Therapeutic Response
Session Date and Time: Monday Apr 8, 2024: 9:00 AM - 12:30 PM PT
Location: Poster Section 27, Poster Board #14, Abstract Number #2031
This abstract presents updated clinical data and biomarker analysis from the Phase 1b/2 study evaluating onvansertib in combination with FOLFIRI/bevacizumab for second-line treatment of KRAS-mutant metastatic colorectal cancer (mCRC) patients. Analysis of patient baseline characteristics revealed superior clinical benefit in patients not exposed to bevacizumab in first-line treatment (Bev-naïve) compared to Bev-exposed patients. Bev-naive patients exhibited higher objective response rates (73.3% versus 15.7%) and longer median progression-free survival (14.9 versus 7.8 months) compared to Bev-exposed patients. Preclinical studies, using KRAS-mutant colorectal cancer mouse models revealed robust antitumor activity of onvansertib in combination with bevacizumab and a novel role of onvansertib in regulating tumor vascularization. Further preclinical investigations showed that PLK1 regulates the hypoxia pathway in KRAS-mutant CRC cells through the modulation of the hypoxia-inducible factor 1 alpha, HIF1a, emphasizing the potential crosstalk between PLK1 and angiogenesis. These findings reinforce the rationale for exploring onvansertib in combination with FOLFIRI/bevacizumab for Bev-naïve mCRC patients with KRAS mutation.
Poster Title: The PLK1 inhibitor, onvansertib, is active as monotherapy and in combination with cetuximab in RAS wild-type colorectal cancer patient-derived xenografts
Session Title: Drug Resistance 2: Ras GTPase
Session Date and Time: Monday Apr 8, 2024: 9:00 AM - 12:30 PM PT
Location: Poster Section 24, Poster Board #12, Abstract Number #1934
This abstract focuses on the preclinical assessment of onvansertib’s antitumor activity in RAS wild-type colorectal cancer, as both a monotherapy and in combination with cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Employing patient-derived xenograft (PDX) models, the study highlights the robust antitumor efficacy of onvansertib monotherapy, in cetuximab-sensitive and -resistant RAS wild-type colorectal cancer models. Furthermore, the combination of onvansertib and cetuximab was highly effective, resulting in tumor regression in 90% of the PDXs. These compelling data strongly support the clinical development of onvansertib as a potential treatment for RAS wild-type colorectal cancer.
Poster Title: A phase 2, randomized, open-label study of onvansertib in combination with standard-of-care (SoC) versus SoC alone for first-line treatment of RAS-mutant metastatic colorectal cancer(mCRC)
Session Title: Phase II and Phase III Clinical Trials in Progress
Session Date and Time: Tuesday, Apr 9, 2024: 1:30 PM - 5:00 PM PT
Location: Poster Section 50, Poster Board #5, Abstract Number #CT275
This abstract describes a clinical trial in progress.
Poster Title: The PLK1 inhibitor, onvansertib, synergizes with paclitaxel in small cell lung cancer
Session Title: Kinase and Phosphatase Inhibitors 1
Session Date and Time: Sunday Apr 7, 2024: 1:30 PM - 5:00 PM PT
Location: Poster Section 25, Poster Board #16, Abstract Number #606
This abstract outlines preclinical studies showing the promising potential of combining onvansertib with paclitaxel for small cell lung cancer (SCLC). The research reveals significant synergy of the combination in SCLC cell lines and demonstrates its robust antitumor activity in patient-derived xenograft models, including models resistant to the standard therapy cisplatin. Further insights into the combination's mechanism of action will be presented. These findings support that combining onvansertib with paclitaxel could emerge as a highly promising treatment strategy for SCLC.
Poster Title: In vivo anti-tumor activity of onvansertib, a PLK1 inhibitor, combined with gemcitabine or carboplatin in platinum-resistant ovarian carcinoma patient-derived xenograft models
Session Title: Application of Precision Medicine for Cancer Care
Session Date and Time: Sunday Apr 7, 2024: 1:30 PM - 5:00 PM PT
Location: Poster Section 39, Poster Board #13, Abstract Number #945
This abstract explores preclinically the potential of combining onvansertib with the chemotherapeutic agents carboplatin or gemcitabine for platinum-resistant high-grade ovarian carcinoma. Using patient-derived xenografts, we demonstrated robust efficacy for both combinations, coupled with favorable tolerability. These data underscore the potential of onvansertib to improve the efficacy of the standard-of-care carboplatin and gemcitabine for patients with platinum-resistant high-grade ovarian carcinoma.
The abstracts are available on the AACR Online Program and will be published in the online Proceedings of the AACR. Following presentation, the posters will be posted to the "Scientific Presentations" section of the Cardiff Oncology website.
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone.
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Ombow, With LWLG, just curious if the holdup in their getting sales / revenues is due to -- 1) LWLG's product not ready yet, or - 2) industry not needing the product yet? (or some combination) If the industry is moving to 800 GB, but isn't quite there yet, that could explain the lack of interest in LWLG's technology.
So a few questions would be -- when is the transition to 800 GB due to begin? And -- will the industry have an alternative to use for 800 GB instead of Lightwave's technology?
Thanks for any insights :o)
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Derf, WING also looks like a decent long term holding. Overbought after the big recent move, but the chart has a nice long term trajectory. Chipotle Mexican Grill (CMG) is another one on my watch list as a potential buy / hold. In the restaurant sector, I currently only own MCD and YUM, but Texas Roadhouse (TXRH) is another nice long term stock.
So many stocks, it's like being in a candy store :o) But a lot of dogs out there too, probably 10 or 20 dogs for each decent LT stock.
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>>> Wingstop Inc. (WING), together with its subsidiaries, franchises and operates restaurants under the Wingstop brand. Its restaurants offer classic wings, boneless wings, tenders, and hand-sauced-and-tossed in various flavors, as well as chicken sandwiches with fries and hand-cut carrots and celery that are cooked-to-order. The company was founded in 1994 and is headquartered in Addison, Texas.
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Bar, Travelers is a great one for sure. Buffett trimmed / sold some of his insurance related holdings like AON, GL, MKL, MMC, which seemed somewhat surprising since they are such great long term holdings. Fwiw I decided to keep those for the long haul, but they are modest sized positions. Here's my full list for the financial sector (link below), with the actual holdings highlighted in red. Additional suggestions are welcome :o)
https://investorshub.advfn.com/Financial-Sector-Ideas-25505
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Bar, >> charts <<
Using CTAS as an example, just check out their 10 and 15 year chart over on Stockcharts.com (link below). That's one phenomenal chart and company --> unbelievable steadiness and trajectory. A lot of insurance related stocks (Buffett's favorite sector) have similarly phenomenal long term charts -- MMC, PGR, AJG, BRO, etc.
Anyway, it's a great screening tool - just find a bunch of companies with long term charts that look like CTAS, MMC, PGR, and the odds are you have some great long term holdings -
https://stockcharts.com/h-sc/ui
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>>> Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) Q4 2023 Earnings Call Transcript
Published March 19, 2024
by INSIDER MONKEY TRANSCRIPTS
https://www.insidermonkey.com/blog/acurx-pharmaceuticals-inc-nasdaqacxp-q4-2023-earnings-call-transcript-1276747/#q-and-a-session
Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) Q4 2023 Earnings Call Transcript March 18, 2024
Operator: Greetings and welcome to the Acurx Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Earnings Results and Business Update Call. At this time, all participants are in a listen only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call over to your host, Robert Shawah, Chief Financial Officer for Acurx Pharmaceuticals. Thank you. You may begin.
Robert Shawah : Thank you, Melissa. Good morning, and welcome to our call. This morning we issued a press release providing financial results and company highlights for the fourth quarter and full year 2023, which is available on our website at acurxpharma.com. Joining me today is David Luci, President and CEO of Acurx; as well as Robert DeLuccia, Executive Chairman. David will give a corporate update and outlook. After that, I’ll provide some highlights of the financials from the quarter and year end of December 31, 2023, and then turn the call back over to Dave for his closing remarks. As a reminder, during today’s call, we’ll be making certain forward-looking statements. These forward-looking statements are based on current information assumptions, estimates and projections about future events that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in forward-looking statements.
Investors should consider these risks and other information described in our filings made with the Securities and Exchange Commission, including our annual report on Form 10-K, which we filed on Friday, March 15, 2024. You are cautioned not to place undue reliance on these forward-looking statements and Acurx disclaims any obligations to update such statements at any time in the future. This conference call contains time sensitive information that’s accurate only as of the date of this live broadcast today, March 18, 2024. I’ll now turn the call over to Dave Luci. Dave?
David Luci : Thanks Rob. Good morning, everyone, and thanks for joining us to review our financial results for the fourth quarter of 2023 and also to hear some very exciting recent updates. Then we’d be pleased to take any questions. First, I’ll summarize some of our key activities for the fourth quarter of ‘23 or in some cases shortly thereafter. On October 2, 2023, we ended enrollment in our Phase IIb clinical trial of ibezapolstat or IBEZ, our lead antibiotic candidate for the treatment of patients with C. difficile infection or CDI. On November 2, 2023, we reported top line data from the Phase IIb clinical trial including overall results from the full Phase II study, demonstrating and ibezapolstat clinical cure rate at end 10 days oral treatment or EOT of 96%, 25 of 26 patients, which included 100% cure in Phase IIa and 94% cure in Phase IIb compared with vancomycin control arm the standard of which was 14 for 14 or a 100% at end of treatment and 94% was sustained cures.
No safety concerns were reported in either arm of the Phase IIb clinical trial and ibezapolstat was well tolerated in all patients in both the Phase IIa open-label trial and the Phase IIb vancomycin control segment. In consultation with our scientific advisors, the company determined that based on review of aggregate blinded data, the Phase IIb vancomycin control trial segment was terminated early due to success showing high observed clinical cure rates with no emerging safety concerns, clinical comparability was established. We also stated at that further data would be provided as it becomes available on secondary and exploratory endpoints for the Phase IIb trial segment, including sustained clinical cure data at 30 days after EOT and extended clinical cure data 94 days after EOT as well as comparative data on the impact on the patient’s microbiome.
On December 11 ‘23, we announced the sustained clinical cure data. These data showed that in the Phase IIb trial segment 100% or 15 out of 15 of our advantaged patients who were cured at EOT remained cured with no reinfection 30 days later, while vancomycin experienced a reinfection rate of 14.3%, 2 of 14 patients were reinfected.
On January 17, 2024, we announced positive comparative microbiology and microbiome data for the ibezapolstat in CDI patients from the Phase IIb clinical trial segment. Ibezapolstat to outperformed vancomycin showing eradication of fecal C. difficile at day three of treatment in 15 of 16 treated patients versus vancomycin, which had eradication of fecal C. difficile in just 10 of 14 treated patients. Additional data from the Phase IIb clinical trial showed ibezapolstat but not vancomycin consistently observed and allowed regrowth of key gut bacterial species believed to confer health benefits including prevention of recurrent C.difficile infection.
We anticipate that additional data from the secondary and exploratory endpoint will provide further favorable separation these two therapeutic options in our Phase III clinical trial program and ultimately in the marketplace if approved. Additional analysis, regarding other secondary and exploratory endpoints will be forthcoming as data become available. We remain particularly excited about the dual impact of ibezapolstat to treat acute C. difficile infection while appropriately managing the long-term care of each patient’s microbiome, which we believe is exceptional for antibiotic therapy. Having robust preclinical — clinical and manufacturing data to date, we submitted a formidable information package in early February to FDA along with a request for an end of Phase II meeting, which was granted by FDA on Feb 26, and is scheduled to occur in April.
We anticipate discussing our Phase III clinical trial mandate at this meeting and would anticipate documented meeting minutes from FDA sometime in the second quarter this year. We also announced that the European Medicines Agency approved their application to be designated as a small to medium sized enterprise or SME in Europe, which provides for certain benefits including fee reductions and other support from the European Medicines Agency for seeking a marketing authorization in Europe. In November, 2023, we filed an amendment to our shelf registration statement with the Securities and Exchange Commission and put up a $17 million at the market or ATM facility with Alliance Global Partners acting as sales agent to the company. Proceeds from the ATM will be used for general corporate purposes going forward, including our plan Phase III clinical trial mandate.
In October, 2023, at ID Week, Dr. Kevin Garey presented on our behalf with selective spectrum of activity data from our Phase IIa clinical trial. Many of you may recall, Dr. Gary is Professor and Chair University of Houston, College of Pharmacy and the Principal Investigator for our microbiome aspects of the ibezapolstat clinical trial program. Also at ID Week, Bob DeLuccia, our Executive Chairman, presented our new class of novel DNA pol IIIC inhibitors in our preclinical pipeline at the symposium entitled new antimicrobes in the pipeline. Now that’s a lot of activity to digest. So I’ll summarize further as to where we are today. As we speak, we’re preparing to advance ibezapolstat into Phase III clinical trials and anticipate a favorable outcome from our upcoming FDA meeting regarding readiness to proceed and also to obtain agreement on the regulatory pathway for a new drug application filing for marketing approval in the U.S. once Phase III is completed.
We’ve also officially started the regulatory process in Europe will add other territories to the list later this year. The Phase III trials will include U.S. and international sites to enhance overall enrollment and to support international regulatory filings for marketing approval. This will save us a lot of time and money and allow us to expand our ultimate commercial reach. To ensure Phase III clinical trial and enrollment as quickly as possible, we’re adding substantially more clinical trial sites, way above the number we used to conduct our U.S.-only Phase II trials. We’re now getting our arms around the costs and time lines, but our plan is to conduct the required two Phase III registration trials consecutively not concurrently given the size of our company and need to use our financial resources most efficiently.
The time line for conduct of our Phase III trial is not a concern since ibezapolstat will have a rolling 10 years of regulatory exclusivity in the U.S. from the FDA approval date with similar legislation in Europe, the U.K. and Japan. We will continue to seek strategic transaction for the company, including a potential partner for the further development and potential commercialization of ibezapolstat as well as a potential sale merger third-party ex U.S. territorial or licensing arrangement or our strategic transaction alongside in parallel with our preparation for Phase III clinical trials. At this time, we have no commitments from potential partners or others to provide the company with capital, but we started this initiative only recently in February after our Phase IIb data was released.
So basically, we have two formidable plans going forward, and we’re equally excited about partnering M&A and Phase III enrollment as next steps over the next 12 months. As we’ve consistently reported, ibezapolstat continues to outperform in a series of potentially life-threatening infectious disease called C. difficile that the U.S. CDC categorizes as an urgent threat and there’s a need for new classes of antibiotics for initial treatment but also has a low incidence of recurrence. Ibezapolstat also has FDA Fast Track designation for treatment of C. difficile infection. Additionally, we believe ibezapolstat, if approved, could make a favorable impact by reducing the cost burden of current C. difficile infection in our U.S. health care system, which is estimated at $4.7 billion annually.
We do believe the best is yet to come. And now back to our CFO, Rob Shawah to guide you through the highlights of our financial results for the fourth quarter and full year 2023. Rob?
Robert Shawah : Thanks, Dave. Our financial results for the fourth quarter and 12 months ended December 31, 2023, were included in our press release issued earlier this morning. The company ended the year with cash totaling $7.5 million compared to $9.1 million as of December 31, 2022. Subsequent to year-end, the company sold an additional 1,121,793 shares under its ATM financing program with gross proceeds of approximately $4.5 million. Research and development expenses for the three months ended December 31, 2023, were $1.9 million compared to $1.4 million for the three months ended December 31, 2022. The increase was due to timing of Phase IIb trial related costs and an increase in consulting costs. For the year ended December 31, 2023, research and development expenses were $6 million, which is $4.8 million for the year ended December 31, 2022.
The increase to due primarily the Phase IIb costs and an increase in consulting costs. General and administrative expenses for three months ended December 31, 2023 were $3.2 million compared to $1.8 million, where the three months ended December 31, 2022. The increase was due primarily to $800,000 increase in professional fees, a $0.1 million increase in share based compensation and a $0.3 million increase in employee compensation costs. For the year ended December 31, 2023, general and administrative expenses were $8.5 million versus $7.3 million for the year ended December 31, 2022. The amounts reflect an increase in professional fees of $0.5 million, an increase of $0.3 million in share based compensation and an increase of $0.3 million in employee compensation costs.
The company reported a net loss of $5.1 million or $0.37 per diluted share for a three months ended December 31, 2023, compared to an net loss of $3.3 million or $0.28 per diluted share for the three months ended December 31, 2022, and the net loss of $14.6 million or $1.15 per share for the year ended December 31, 2023 compared to a net loss of $12.1 million or $1.12 per diluted share for the year ended December 31, 2022, the reasons previously mentioned. The company had 14,468,229 shares outstanding as of December 31, 2023. With that, I’ll turn the call back over to Dave.
David Luci : Thanks Rob, and to all of you for joining us today. I’ll now ask Bob DeLuccia our Executive Chairman to provide his perspective given Bob manages our R&D program and when Bob is finished, operator, please open the call for questions. Bob?
Robert DeLuccia : Thanks Dave and Rob for updating our stakeholders and thanks to all for the continuing support as we advance ibezapolstat into Phase III clinical trials. It is a very exciting time and really it’s the final step to commercialize ibezapolstat for patients in need of a promising new antibiotic with a novel bactericidal mechanism of action to treat CDI, and many of you will remember that approximately 30,000 people die each year in the U.S. alone from CDI and the annual incidence is more than about 500,000 per year in the United States. But the bottom line here is that if the outcome of our Phase III trials are consistent with our Phase II experience, we’ll have an approvable new drug in our hands. The data are solid, the market is large and our manufacturing cost is low.
We do have a robust preclinical — clinical microbiome safety and CMC evidence package that we’ve submitted to the FDA and as Dave mentioned, they’ve determined it acceptable to grant us an end of Phase II meeting next month to discuss trial design, patient enrollment targets and to confirm our readiness to go forward. So to complete our Phase II international Phase III trials, which will be done sequentially as Dave mentioned and as quickly as possible, we’ve already initiated steps to advance screen potential clinical trial sites, which in addition to North America will cover sites in about 17 other countries, including several in Eastern Central, Northern and Western Europe, totaling about 100 sites, which we believe will accelerate overall enrollment.
We’ll also be including several high enrolling trial sites from the fast enrolling Summit Phase III CDI trial, which was conducted during the height of COVID-19. In addition to global scope of the program compared to Phase II and the strength of our Phase II data, the Phase III protocol will allow more flexibility for inclusion and exclusion criteria as a standard for CDI pivotal registration trials. So we anticipate faster enrollment. Then once we have results from our FDA meeting and documented meeting minutes from the FDA, our next priority will be to submit our plans to the European Medicines Agency or EMA for conducting Phase III clinical trials in Europe. So if approved, we’ll have the first new class of antibiotics approved by FDA in over 30 years with only confirmatory Phase III trials between now and market introduction.
Ibezapolstat as Dave mentioned is fast tracked by FDA, it’s fully patented and with regulatory exclusivity 10 years post-market introduction in the U.S. and similar opportunities for regulatory exclusivity in other geographies to pursue at the appropriate time. And also with recent focus on minimizing effects on the microbiome to lower recurrence of infection, we stand out from other antibiotics since we’ve shown no reinfection in Phase III patients (note - I think he meant Phase 2) who were initially cured of their infection. So in my over 50 years of experience in antibiotic development and marketing. I think, I have got a great rear view mirror and a clear vision to say that we have a winner here for patients with CDI and in general for better public health as well as for our shareholders.
Thanks for letting me comment, Dave.
Robert Shawah : Thank you, Bob. Melissa, we’re now ready to go to Q&A.
Operator: [Operator Instructions] First question is from the line of Jason McCarthy with Maxim Group.
Michael Okunewitch: This is Michael Okunewithch for Jason. I guess to start off, I’d like to see if you could give an idea of what sort of time line you are expecting between getting those meeting minutes back from the FDA and actually launching the first of those Phase III studies?
David Luci: So we think that we will be ready to enroll the first patient in for the international Phase III in the fourth quarter of this year.
Michael Okunewitch: And then, I guess, regarding the international component to the study, could you talk a little bit more about the path to actually getting those sites online? And is this something that you would look to have in place ahead of the launch? Or would you start with what do you have when you usually enroll the study like you are in these international sites as they were approved?
David Luci: We will be a little bit on both. We have a number of the sites already kind of ready to go from the international list. There won’t be any hold up from the international aspect of it. We actually have a consultant who is extremely familiar with Phase III C. diff international trials who’s been guiding us in this regard. But yes, clearly, when our manufactured product is ready, we’ll be ready to go with a large wedge at the very least of the hundred sites.
Michael Okunewitch: And then one last one from me, and I’ll hop back in the queue. With regards to securing international partnerships, do you think this is something with your existing body of data that is compelling enough that you could really progress those conversations now and get a partner or would you expect it to be more after you get that first slot of Phase III data?
David Luci: No, I would expect that the prime time for us to find, I’d say a European partner or a Japanese partner would be — when we start enrolling the first of the two Phase III trials, once we have the Phase III trial mandate completed and we’re ready to find or to file a new drug application, if we haven’t had a partnership by then, I think it would probably not occur until a year after the market introduction, because folks will want to see how well we do. I think that the time is right now. I’ll make one additional comment on the territorial partnerships to carry Michael’s question response a little bit further. As we look at strategic alternatives, there’s M&A full stop and there’s territorial licensing and co-development agreements that I have entered into in the past.
With our share price being where it is, the territorial licensing is a bit easier to consummate because it’s all about the intrinsic value of your drug as opposed to M&A, which you can’t in my view, wholly divorce yourself of your NASDAQ share price. So it may be a more attractive option for our board of directors and but we’ll see what term sheets present themselves.
Operator: Our next question comes from the line of James Molloy with Alliance Global Partners.
James Molloy : The Phase III trials, I know that obviously a lot to go here, but can you walk through expectation which we should expect to see coming out of the end of Phase II? And then the trial designed to sort of the length of time to run is about two years start to finish. So Phase IIb, I know we we’re dealing with COVID then as well. Is that seem reasonable to run these two Phase IIIs from start to finish?
David Luci: So we’re going to address one Phase III and then the idea would be to either do a strategic transaction after that first Phase III or with positive data on the first Phase III, if it’s the same or consistent with our Phase II, get a share price rise and then raise capital for the second Phase III. So we’re targeting a year and a half from start to finish for the first Phase III, and that would have us completing the first Phase III in the second quarter of ‘26. Now I can tell you that we spent a lot of time looking at the Summit Therapeutics experience and Summit enrolled in the teeth of COVID, 750 or so patients in about two years time largely in Eastern Europe, where the behavior patterns weren’t dramatically changed apparently, like they were here in the U.S. So, that’s a public list on clinicaltrial.gov.
So we were able to see exactly the heat patterns from their enrollment. So that’s gone a long way to helping us get comfortable with fixing the enrollment issues we had during COVID with our U.S. only trial.
James Molloy : I thought I’d heard you say earlier in the call that you’re going to run the two trials at the same time obviously misheard that, you’re running back to back.
David Luci: No. Our going in plan is to do them consecutively instead of concurrently for the financial reasons that we discussed. But if we get a partnership, say a European licensing agreement and that brings in and enough money to call an audible along the way and at that point then we would certainly start the second Phase III accordingly.
Operator: [Operator Instructions] Our next question comes from the line of Ed Arce with H.C. Wainwright.
Ed Arce : So a couple from me, firstly on the end of Phase II next month and I apologize I joined late, so maybe you went over this already, but wanted to make sure to review sort of the key objectives in particular what do you not have agreement with the agency yet on that you would seek to get agreement on next month in that meeting? And then secondly, I think you made mention of a wider inclusion exclusion criteria for the Phase III relative to the prior Phase II. And so just wanted to get a little more clarity on that in particular that a view to concerns there might be around the risk that you could change the sort of design of the trial and there could be some disruption from a slightly different patient population.
David Luci: Thank you, Ed. I’ll answer the first part of your question and ask Bob to provide a response for the inclusion and exclusion criteria part of your question. So for the first part of your question, what we hope to agree on with the FDA is the overall protocol designed for our Phase III trial, including the number of patients to be enrolled the notion that we’re going to have a vancomycin control arm like we had in our Phase IIb. Largely, the trial design is 90% plus of what the trail design was for our Phase IIb. So we don’t expect a real lot of drama, but it’s a necessary step in order to kind of be allow to into Phase III, so we’re looking forward to our valuation point that we have to get through. Bob, did you want to add some comment on the inclusion and exclusion criteria?
Robert DeLuccia: I think really two things, which is standard fair for going forward in Phase III is that we’ll have additional patients beyond mild and moderate that are included in the trial. So this is not severe CDI, but a little bit more than moderate according to the IDSA criteria for patient entry into a trial in the study. So we’ve already submitted a framework to the FDA in the meeting package. It’s very straightforward. I’d even say a higher percentage that they’ve said at 90%. We’re pretty much there with the design. It’s the same design basically, it’s Phase II and very standard according to the FDA guidance from October 2022, I believe it is, as to what needs to be included in the Phase III clinical trials. So we’ll be discussing final numbers of patients, as I said before and statistical analysis plan will be finalized at that upcoming FDA meeting as well. Anything else? Does that answer your question?
Ed Arce: Yes, that’s helpful.
Operator: Thank you. Ladies and gentlemen, that concludes our question-and-answer session. And this concludes our call today. We thank you for your interest and participation. You may now disconnect your lines.
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Bigworld, Here's the recent Acurx conference call transcript (next post). Apparently there isn't an audio replay available, but only the transcript. These almost always have some mistakes, misspellings, but at least we can get the gist of it.
A big omission is that they didn't mention the 94 day extended durability data, which was previously reported in a Jan 29 press release (link below). The problem is that only 5 patients (out of 15) had agreed to be monitored for the full 94 days (!). All 5 had no recurrence, so that's good, but what about the other 10?? If even one of them experienced C Dif recurrence, that could be massive, especially since the Vanc arm surprisingly had no recurrence either (though only 7 out of 14 Vanc patients had agreed to be followed for 94 days).
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173728795
Anyway, I figure this piddly amount of 94 day data may not be enough to get an acceptable partnering offer from a big pharma, in which case Acurx will have to do the first Phase 3 inhouse, raise the money, etc, yikes. When that Jan 29 press release came out, I decided to not get back into the stock, and just watch from the sidelines.
A deal later this year is not impossible, but the odds have dropped without that 94 day data. The trend had been looking good from the 30 day data, with 2 or the 14 Vanc patients having recurrence, vrs none of the 15 Ibeza patients with recurrence. But that trend needed to be confirmed by the 94 day data. In the Phase 2b, Ibeza already had one patient who failed to respond to treatment (vrs a perfect 100% for Vanc), which tanked the stock back in Oct. Anyway, bottom line there's no substitute for a larger trial to determine what Ibeza can really do. A lot of promise, but we really need to see the data from a few hundred patients, and potential pharma partners may come to that same conclusion. So.. the prospect of more dilution and the ATM piranha for several years, ugh. That's what has tanked the stock.
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>>> Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) Q4 2023 Earnings Call Transcript
Published March 19, 2024
by INSIDER MONKEY TRANSCRIPTS
https://www.insidermonkey.com/blog/acurx-pharmaceuticals-inc-nasdaqacxp-q4-2023-earnings-call-transcript-1276747/#q-and-a-session
Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) Q4 2023 Earnings Call Transcript March 18, 2024
Operator: Greetings and welcome to the Acurx Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Earnings Results and Business Update Call. At this time, all participants are in a listen only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call over to your host, Robert Shawah, Chief Financial Officer for Acurx Pharmaceuticals. Thank you. You may begin.
Robert Shawah : Thank you, Melissa. Good morning, and welcome to our call. This morning we issued a press release providing financial results and company highlights for the fourth quarter and full year 2023, which is available on our website at acurxpharma.com. Joining me today is David Luci, President and CEO of Acurx; as well as Robert DeLuccia, Executive Chairman. David will give a corporate update and outlook. After that, I’ll provide some highlights of the financials from the quarter and year end of December 31, 2023, and then turn the call back over to Dave for his closing remarks. As a reminder, during today’s call, we’ll be making certain forward-looking statements. These forward-looking statements are based on current information assumptions, estimates and projections about future events that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in forward-looking statements.
Investors should consider these risks and other information described in our filings made with the Securities and Exchange Commission, including our annual report on Form 10-K, which we filed on Friday, March 15, 2024. You are cautioned not to place undue reliance on these forward-looking statements and Acurx disclaims any obligations to update such statements at any time in the future. This conference call contains time sensitive information that’s accurate only as of the date of this live broadcast today, March 18, 2024. I’ll now turn the call over to Dave Luci. Dave?
David Luci : Thanks Rob. Good morning, everyone, and thanks for joining us to review our financial results for the fourth quarter of 2023 and also to hear some very exciting recent updates. Then we’d be pleased to take any questions. First, I’ll summarize some of our key activities for the fourth quarter of ‘23 or in some cases shortly thereafter. On October 2, 2023, we ended enrollment in our Phase IIb clinical trial of ibezapolstat or IBEZ, our lead antibiotic candidate for the treatment of patients with C. difficile infection or CDI. On November 2, 2023, we reported top line data from the Phase IIb clinical trial including overall results from the full Phase II study, demonstrating and ibezapolstat clinical cure rate at end 10 days oral treatment or EOT of 96%, 25 of 26 patients, which included 100% cure in Phase IIa and 94% cure in Phase IIb compared with vancomycin control arm the standard of which was 14 for 14 or a 100% at end of treatment and 94% was sustained cures.
No safety concerns were reported in either arm of the Phase IIb clinical trial and ibezapolstat was well tolerated in all patients in both the Phase IIa open-label trial and the Phase IIb vancomycin control segment. In consultation with our scientific advisors, the company determined that based on review of aggregate blinded data, the Phase IIb vancomycin control trial segment was terminated early due to success showing high observed clinical cure rates with no emerging safety concerns, clinical comparability was established. We also stated at that further data would be provided as it becomes available on secondary and exploratory endpoints for the Phase IIb trial segment, including sustained clinical cure data at 30 days after EOT and extended clinical cure data 94 days after EOT as well as comparative data on the impact on the patient’s microbiome.
On December 11 ‘23, we announced the sustained clinical cure data. These data showed that in the Phase IIb trial segment 100% or 15 out of 15 of our advantaged patients who were cured at EOT remained cured with no reinfection 30 days later, while vancomycin experienced a reinfection rate of 14.3%, 2 of 14 patients were reinfected.
On January 17, 2024, we announced positive comparative microbiology and microbiome data for the ibezapolstat in CDI patients from the Phase IIb clinical trial segment. Ibezapolstat to outperformed vancomycin showing eradication of fecal C. difficile at day three of treatment in 15 of 16 treated patients versus vancomycin, which had eradication of fecal C. difficile in just 10 of 14 treated patients. Additional data from the Phase IIb clinical trial showed ibezapolstat but not vancomycin consistently observed and allowed regrowth of key gut bacterial species believed to confer health benefits including prevention of recurrent C.difficile infection.
We anticipate that additional data from the secondary and exploratory endpoint will provide further favorable separation these two therapeutic options in our Phase III clinical trial program and ultimately in the marketplace if approved. Additional analysis, regarding other secondary and exploratory endpoints will be forthcoming as data become available. We remain particularly excited about the dual impact of ibezapolstat to treat acute C. difficile infection while appropriately managing the long-term care of each patient’s microbiome, which we believe is exceptional for antibiotic therapy. Having robust preclinical — clinical and manufacturing data to date, we submitted a formidable information package in early February to FDA along with a request for an end of Phase II meeting, which was granted by FDA on Feb 26, and is scheduled to occur in April.
We anticipate discussing our Phase III clinical trial mandate at this meeting and would anticipate documented meeting minutes from FDA sometime in the second quarter this year. We also announced that the European Medicines Agency approved their application to be designated as a small to medium sized enterprise or SME in Europe, which provides for certain benefits including fee reductions and other support from the European Medicines Agency for seeking a marketing authorization in Europe. In November, 2023, we filed an amendment to our shelf registration statement with the Securities and Exchange Commission and put up a $17 million at the market or ATM facility with Alliance Global Partners acting as sales agent to the company. Proceeds from the ATM will be used for general corporate purposes going forward, including our plan Phase III clinical trial mandate.
In October, 2023, at ID Week, Dr. Kevin Garey presented on our behalf with selective spectrum of activity data from our Phase IIa clinical trial. Many of you may recall, Dr. Gary is Professor and Chair University of Houston, College of Pharmacy and the Principal Investigator for our microbiome aspects of the ibezapolstat clinical trial program. Also at ID Week, Bob DeLuccia, our Executive Chairman, presented our new class of novel DNA pol IIIC inhibitors in our preclinical pipeline at the symposium entitled new antimicrobes in the pipeline. Now that’s a lot of activity to digest. So I’ll summarize further as to where we are today. As we speak, we’re preparing to advance ibezapolstat into Phase III clinical trials and anticipate a favorable outcome from our upcoming FDA meeting regarding readiness to proceed and also to obtain agreement on the regulatory pathway for a new drug application filing for marketing approval in the U.S. once Phase III is completed.
We’ve also officially started the regulatory process in Europe will add other territories to the list later this year. The Phase III trials will include U.S. and international sites to enhance overall enrollment and to support international regulatory filings for marketing approval. This will save us a lot of time and money and allow us to expand our ultimate commercial reach. To ensure Phase III clinical trial and enrollment as quickly as possible, we’re adding substantially more clinical trial sites, way above the number we used to conduct our U.S.-only Phase II trials. We’re now getting our arms around the costs and time lines, but our plan is to conduct the required two Phase III registration trials consecutively not concurrently given the size of our company and need to use our financial resources most efficiently.
The time line for conduct of our Phase III trial is not a concern since ibezapolstat will have a rolling 10 years of regulatory exclusivity in the U.S. from the FDA approval date with similar legislation in Europe, the U.K. and Japan. We will continue to seek strategic transaction for the company, including a potential partner for the further development and potential commercialization of ibezapolstat as well as a potential sale merger third-party ex U.S. territorial or licensing arrangement or our strategic transaction alongside in parallel with our preparation for Phase III clinical trials. At this time, we have no commitments from potential partners or others to provide the company with capital, but we started this initiative only recently in February after our Phase IIb data was released.
So basically, we have two formidable plans going forward, and we’re equally excited about partnering M&A and Phase III enrollment as next steps over the next 12 months. As we’ve consistently reported, ibezapolstat continues to outperform in a series of potentially life-threatening infectious disease called C. difficile that the U.S. CDC categorizes as an urgent threat and there’s a need for new classes of antibiotics for initial treatment but also has a low incidence of recurrence. Ibezapolstat also has FDA Fast Track designation for treatment of C. difficile infection. Additionally, we believe ibezapolstat, if approved, could make a favorable impact by reducing the cost burden of current C. difficile infection in our U.S. health care system, which is estimated at $4.7 billion annually.
We do believe the best is yet to come. And now back to our CFO, Rob Shawah to guide you through the highlights of our financial results for the fourth quarter and full year 2023. Rob?
Robert Shawah : Thanks, Dave. Our financial results for the fourth quarter and 12 months ended December 31, 2023, were included in our press release issued earlier this morning. The company ended the year with cash totaling $7.5 million compared to $9.1 million as of December 31, 2022. Subsequent to year-end, the company sold an additional 1,121,793 shares under its ATM financing program with gross proceeds of approximately $4.5 million. Research and development expenses for the three months ended December 31, 2023, were $1.9 million compared to $1.4 million for the three months ended December 31, 2022. The increase was due to timing of Phase IIb trial related costs and an increase in consulting costs. For the year ended December 31, 2023, research and development expenses were $6 million, which is $4.8 million for the year ended December 31, 2022.
The increase to due primarily the Phase IIb costs and an increase in consulting costs. General and administrative expenses for three months ended December 31, 2023 were $3.2 million compared to $1.8 million, where the three months ended December 31, 2022. The increase was due primarily to $800,000 increase in professional fees, a $0.1 million increase in share based compensation and a $0.3 million increase in employee compensation costs. For the year ended December 31, 2023, general and administrative expenses were $8.5 million versus $7.3 million for the year ended December 31, 2022. The amounts reflect an increase in professional fees of $0.5 million, an increase of $0.3 million in share based compensation and an increase of $0.3 million in employee compensation costs.
The company reported a net loss of $5.1 million or $0.37 per diluted share for a three months ended December 31, 2023, compared to an net loss of $3.3 million or $0.28 per diluted share for the three months ended December 31, 2022, and the net loss of $14.6 million or $1.15 per share for the year ended December 31, 2023 compared to a net loss of $12.1 million or $1.12 per diluted share for the year ended December 31, 2022, the reasons previously mentioned. The company had 14,468,229 shares outstanding as of December 31, 2023. With that, I’ll turn the call back over to Dave.
David Luci : Thanks Rob, and to all of you for joining us today. I’ll now ask Bob DeLuccia our Executive Chairman to provide his perspective given Bob manages our R&D program and when Bob is finished, operator, please open the call for questions. Bob?
Robert DeLuccia : Thanks Dave and Rob for updating our stakeholders and thanks to all for the continuing support as we advance ibezapolstat into Phase III clinical trials. It is a very exciting time and really it’s the final step to commercialize ibezapolstat for patients in need of a promising new antibiotic with a novel bactericidal mechanism of action to treat CDI, and many of you will remember that approximately 30,000 people die each year in the U.S. alone from CDI and the annual incidence is more than about 500,000 per year in the United States. But the bottom line here is that if the outcome of our Phase III trials are consistent with our Phase II experience, we’ll have an approvable new drug in our hands. The data are solid, the market is large and our manufacturing cost is low.
We do have a robust preclinical — clinical microbiome safety and CMC evidence package that we’ve submitted to the FDA and as Dave mentioned, they’ve determined it acceptable to grant us an end of Phase II meeting next month to discuss trial design, patient enrollment targets and to confirm our readiness to go forward. So to complete our Phase II international Phase III trials, which will be done sequentially as Dave mentioned and as quickly as possible, we’ve already initiated steps to advance screen potential clinical trial sites, which in addition to North America will cover sites in about 17 other countries, including several in Eastern Central, Northern and Western Europe, totaling about 100 sites, which we believe will accelerate overall enrollment.
We’ll also be including several high enrolling trial sites from the fast enrolling Summit Phase III CDI trial, which was conducted during the height of COVID-19. In addition to global scope of the program compared to Phase II and the strength of our Phase II data, the Phase III protocol will allow more flexibility for inclusion and exclusion criteria as a standard for CDI pivotal registration trials. So we anticipate faster enrollment. Then once we have results from our FDA meeting and documented meeting minutes from the FDA, our next priority will be to submit our plans to the European Medicines Agency or EMA for conducting Phase III clinical trials in Europe. So if approved, we’ll have the first new class of antibiotics approved by FDA in over 30 years with only confirmatory Phase III trials between now and market introduction.
Ibezapolstat as Dave mentioned is fast tracked by FDA, it’s fully patented and with regulatory exclusivity 10 years post-market introduction in the U.S. and similar opportunities for regulatory exclusivity in other geographies to pursue at the appropriate time. And also with recent focus on minimizing effects on the microbiome to lower recurrence of infection, we stand out from other antibiotics since we’ve shown no reinfection in Phase III patients (note - I think he meant Phase 2) who were initially cured of their infection. So in my over 50 years of experience in antibiotic development and marketing. I think, I have got a great rear view mirror and a clear vision to say that we have a winner here for patients with CDI and in general for better public health as well as for our shareholders.
Thanks for letting me comment, Dave.
Robert Shawah : Thank you, Bob. Melissa, we’re now ready to go to Q&A.
Operator: [Operator Instructions] First question is from the line of Jason McCarthy with Maxim Group.
Michael Okunewitch: This is Michael Okunewithch for Jason. I guess to start off, I’d like to see if you could give an idea of what sort of time line you are expecting between getting those meeting minutes back from the FDA and actually launching the first of those Phase III studies?
David Luci: So we think that we will be ready to enroll the first patient in for the international Phase III in the fourth quarter of this year.
Michael Okunewitch: And then, I guess, regarding the international component to the study, could you talk a little bit more about the path to actually getting those sites online? And is this something that you would look to have in place ahead of the launch? Or would you start with what do you have when you usually enroll the study like you are in these international sites as they were approved?
David Luci: We will be a little bit on both. We have a number of the sites already kind of ready to go from the international list. There won’t be any hold up from the international aspect of it. We actually have a consultant who is extremely familiar with Phase III C. diff international trials who’s been guiding us in this regard. But yes, clearly, when our manufactured product is ready, we’ll be ready to go with a large wedge at the very least of the hundred sites.
Michael Okunewitch: And then one last one from me, and I’ll hop back in the queue. With regards to securing international partnerships, do you think this is something with your existing body of data that is compelling enough that you could really progress those conversations now and get a partner or would you expect it to be more after you get that first slot of Phase III data?
David Luci: No, I would expect that the prime time for us to find, I’d say a European partner or a Japanese partner would be — when we start enrolling the first of the two Phase III trials, once we have the Phase III trial mandate completed and we’re ready to find or to file a new drug application, if we haven’t had a partnership by then, I think it would probably not occur until a year after the market introduction, because folks will want to see how well we do. I think that the time is right now. I’ll make one additional comment on the territorial partnerships to carry Michael’s question response a little bit further. As we look at strategic alternatives, there’s M&A full stop and there’s territorial licensing and co-development agreements that I have entered into in the past.
With our share price being where it is, the territorial licensing is a bit easier to consummate because it’s all about the intrinsic value of your drug as opposed to M&A, which you can’t in my view, wholly divorce yourself of your NASDAQ share price. So it may be a more attractive option for our board of directors and but we’ll see what term sheets present themselves.
Operator: Our next question comes from the line of James Molloy with Alliance Global Partners.
James Molloy : The Phase III trials, I know that obviously a lot to go here, but can you walk through expectation which we should expect to see coming out of the end of Phase II? And then the trial designed to sort of the length of time to run is about two years start to finish. So Phase IIb, I know we we’re dealing with COVID then as well. Is that seem reasonable to run these two Phase IIIs from start to finish?
David Luci: So we’re going to address one Phase III and then the idea would be to either do a strategic transaction after that first Phase III or with positive data on the first Phase III, if it’s the same or consistent with our Phase II, get a share price rise and then raise capital for the second Phase III. So we’re targeting a year and a half from start to finish for the first Phase III, and that would have us completing the first Phase III in the second quarter of ‘26. Now I can tell you that we spent a lot of time looking at the Summit Therapeutics experience and Summit enrolled in the teeth of COVID, 750 or so patients in about two years time largely in Eastern Europe, where the behavior patterns weren’t dramatically changed apparently, like they were here in the U.S. So, that’s a public list on clinicaltrial.gov.
So we were able to see exactly the heat patterns from their enrollment. So that’s gone a long way to helping us get comfortable with fixing the enrollment issues we had during COVID with our U.S. only trial.
James Molloy : I thought I’d heard you say earlier in the call that you’re going to run the two trials at the same time obviously misheard that, you’re running back to back.
David Luci: No. Our going in plan is to do them consecutively instead of concurrently for the financial reasons that we discussed. But if we get a partnership, say a European licensing agreement and that brings in and enough money to call an audible along the way and at that point then we would certainly start the second Phase III accordingly.
Operator: [Operator Instructions] Our next question comes from the line of Ed Arce with H.C. Wainwright.
Ed Arce : So a couple from me, firstly on the end of Phase II next month and I apologize I joined late, so maybe you went over this already, but wanted to make sure to review sort of the key objectives in particular what do you not have agreement with the agency yet on that you would seek to get agreement on next month in that meeting? And then secondly, I think you made mention of a wider inclusion exclusion criteria for the Phase III relative to the prior Phase II. And so just wanted to get a little more clarity on that in particular that a view to concerns there might be around the risk that you could change the sort of design of the trial and there could be some disruption from a slightly different patient population.
David Luci: Thank you, Ed. I’ll answer the first part of your question and ask Bob to provide a response for the inclusion and exclusion criteria part of your question. So for the first part of your question, what we hope to agree on with the FDA is the overall protocol designed for our Phase III trial, including the number of patients to be enrolled the notion that we’re going to have a vancomycin control arm like we had in our Phase IIb. Largely, the trial design is 90% plus of what the trail design was for our Phase IIb. So we don’t expect a real lot of drama, but it’s a necessary step in order to kind of be allow to into Phase III, so we’re looking forward to our valuation point that we have to get through. Bob, did you want to add some comment on the inclusion and exclusion criteria?
Robert DeLuccia: I think really two things, which is standard fair for going forward in Phase III is that we’ll have additional patients beyond mild and moderate that are included in the trial. So this is not severe CDI, but a little bit more than moderate according to the IDSA criteria for patient entry into a trial in the study. So we’ve already submitted a framework to the FDA in the meeting package. It’s very straightforward. I’d even say a higher percentage that they’ve said at 90%. We’re pretty much there with the design. It’s the same design basically, it’s Phase II and very standard according to the FDA guidance from October 2022, I believe it is, as to what needs to be included in the Phase III clinical trials. So we’ll be discussing final numbers of patients, as I said before and statistical analysis plan will be finalized at that upcoming FDA meeting as well. Anything else? Does that answer your question?
Ed Arce: Yes, that’s helpful.
Operator: Thank you. Ladies and gentlemen, that concludes our question-and-answer session. And this concludes our call today. We thank you for your interest and participation. You may now disconnect your lines.
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Apple - >>> Justice Department files antitrust suit against Apple
Yahoo Finance
by Daniel Howley and Alexis Keenan
March 21, 2024
https://finance.yahoo.com/news/justice-department-files-antitrust-suit-against-apple-145514025.html
The US Justice Department filed an antitrust lawsuit against Apple (AAPL), alleging that the maker of the iPhone illegally maintains its dominance over the smartphone market by boxing out competing apps and devices.
Apple "has maintained its power not because of its superiority, but because of its unlawful exclusionary behavior," Attorney General Merrick Garland said at a press conference Thursday.
Apple said it would fight the lawsuit, which it said "threatens who we are and the principles that set Apple products apart in fiercely competitive markets. If successful, it would hinder our ability to create the kind of technology people expect from Apple."
A victory for the US in this case "would also set a dangerous precedent, empowering government to take a heavy hand in designing people’s technology," Apple added in its statement.
Apple's stock fell more than 4% following news of the lawsuit, which the Justice Department filed with 16 state attorneys general.
The filing sets up yet another confrontation between the US government and a Silicon Valley icon as the Biden administration tries to rein in Big Tech's power.
The Department of Justice is suing Google (GOOG, GOOGL) over antitrust allegations, while the Federal Trade Commission is suing Amazon (AMZN) and Facebook (META) alleging they also violate antitrust laws.
The new DOJ lawsuit filed Thursday poses a major new threat to Apple's various revenue streams.
Apple generates the bulk of its cash through the sale of its wildly popular iPhone, which accounted for $200.6 billion of the company's $383.3 billion in total revenue in 2023. But Apple's services and hardware that tie into the iPhone are also incredibly lucrative.
The company's wearables, home, and accessories business, which includes its Apple Watch and AirPods sales, generated $39.8 billion last year, while its growing services business, which includes subscriptions for things like Apple Music+ and App Store sales, brought in $85.2 billion.
The DOJ's suit comes just weeks after the European Commission (EC) fined Apple $2 billion for allegedly breaking competition laws in the bloc. The EC alleged the company illegally wielded its dominance to the detriment of its rivals in the market for the distribution of music streaming apps.
The Justice Department suit is just the latest headache for Apple, which is off to a rough start in 2024.
Shares of Apple are down 7% year to date as the company struggles with slowing iPhone sales in China, its third-largest market. Apple also lost its title as the world's most valuable company to rival Microsoft (MSFT).
How Apple allegedly wields power
At the center of the DOJ’s lawsuit is the iPhone, Apple’s most recognizable product.
The company harms consumers by making it more difficult for iPhone users to switch to a competing product and to access competing services, according to the government. The complaint also says Apple harms app developers by imposing restrictions on app creation and distribution.
That includes everything from text messaging to digital wallets to apps that reduce user dependence on the iPhone.
Garland, for example, characterized Apple’s iMessage as anti-competitive, saying that when it is used to text with a Google Android device, the iPhone user’s response is in green rather than blue. (whoopee)
That, he said, "limits functionality." The videos sent via text, Garland added, can also be pixelated and grainy.
He then quoted Apple’s CEO responding to a complaint from a user who said he couldn’t send his mom certain videos: "'Buy your mom an iPhone.'"
Apple, the suit alleges, also makes it more difficult for smartphone users to access competing digital wallets by blocking developers from using tap-to-pay functionality in their apps. And it prevents the Apple iWatch from working with Android smartphones while making it more difficult for someone with an iPhone to use a rival’s smartwatch. (too bad)
"Apple repeatedly responded to competitive threats," said Assistant Attorney General Jonathan Kanter, "by making it harder to leave, then making it more attractive to stay. The antitrust laws have something to say about that."
Apple, according to the suit, also suppresses cloud streaming gaming apps and denies consumers access to so-called super apps, which allow users access to a broad range of functionalities from a single interface.
The wide-ranging suit is "about the core unfair practices of Apple," Case Western Reserve University antitrust expert and law professor Anat Alon-Beck said.
"Apple systematically excludes rivals from the Apple ecosystem. By doing that, Apple is hurting so many startup businesses, stakeholders, customers, and, in my opinion, its shareholders."
As a result, she predicts that Apple's stock will "see more downward movement."
Apple's Epic battle
This is just the latest antitrust battle Apple has had to contend with in the US.
The last was in 2020, when "Fortnite" maker Epic Games sued the company and accused it of violating antitrust law by prohibiting third-party app developers from offering their own payment methods within their apps —as opposed to using Apple's payment service.
Justice Department lawyers were permitted to present arguments in that high-stakes dispute. It focused attention on Apple’s App Store — the only place consumers can download apps for iPhones and iPads, which generally charges app developers a 30% commission on paid app purchases made through the platform.
Apple scored a victory in that case when the appeals court upheld a California trial court's ruling that said Apple did not hold a monopoly in the market for mobile app stores.
However, in a minor win for Epic, the appeals court also upheld the trial court's ruling that said Apple must allow app developers to offer more ways for users to pay for purchases.
Both companies tried to take their fight to the Supreme Court, though the high court declined to take up either appeal.
Following that decision, Apple said it will allow developers to offer third-party payment options through their apps. However, the company said developers would still have to pay fees of either 12% or 27%, a move Epic CEO Tim Sweeney called "anticompetitive."
Apple is in the midst of reconfiguring its App Store payment system in the European Union. Under the EU's new Digital Markets Act (DMA), the company must allow EU customers the option to download third-party app stores and get access to third-party payment options.
Apple said it would address the measure and allow third-party downloads and payments, but will still charge developers a fee of 50 euro cents for each download if they cross the 1 million download threshold in a year.
Both Epic and Spotify objected to the measure, with Spotify CEO Daniel Ek calling the new rule "hostile."
<<<
---
Apple - >>> Justice Department files antitrust suit against Apple
Yahoo Finance
by Daniel Howley and Alexis Keenan
March 21, 2024
https://finance.yahoo.com/news/justice-department-files-antitrust-suit-against-apple-145514025.html
The US Justice Department filed an antitrust lawsuit against Apple (AAPL), alleging that the maker of the iPhone illegally maintains its dominance over the smartphone market by boxing out competing apps and devices.
Apple "has maintained its power not because of its superiority, but because of its unlawful exclusionary behavior," Attorney General Merrick Garland said at a press conference Thursday.
Apple said it would fight the lawsuit, which it said "threatens who we are and the principles that set Apple products apart in fiercely competitive markets. If successful, it would hinder our ability to create the kind of technology people expect from Apple."
A victory for the US in this case "would also set a dangerous precedent, empowering government to take a heavy hand in designing people’s technology," Apple added in its statement.
Apple's stock fell more than 4% following news of the lawsuit, which the Justice Department filed with 16 state attorneys general.
The filing sets up yet another confrontation between the US government and a Silicon Valley icon as the Biden administration tries to rein in Big Tech's power.
The Department of Justice is suing Google (GOOG, GOOGL) over antitrust allegations, while the Federal Trade Commission is suing Amazon (AMZN) and Facebook (META) alleging they also violate antitrust laws.
The new DOJ lawsuit filed Thursday poses a major new threat to Apple's various revenue streams.
Apple generates the bulk of its cash through the sale of its wildly popular iPhone, which accounted for $200.6 billion of the company's $383.3 billion in total revenue in 2023. But Apple's services and hardware that tie into the iPhone are also incredibly lucrative.
The company's wearables, home, and accessories business, which includes its Apple Watch and AirPods sales, generated $39.8 billion last year, while its growing services business, which includes subscriptions for things like Apple Music+ and App Store sales, brought in $85.2 billion.
The DOJ's suit comes just weeks after the European Commission (EC) fined Apple $2 billion for allegedly breaking competition laws in the bloc. The EC alleged the company illegally wielded its dominance to the detriment of its rivals in the market for the distribution of music streaming apps.
The Justice Department suit is just the latest headache for Apple, which is off to a rough start in 2024.
Shares of Apple are down 7% year to date as the company struggles with slowing iPhone sales in China, its third-largest market. Apple also lost its title as the world's most valuable company to rival Microsoft (MSFT).
How Apple allegedly wields power
At the center of the DOJ’s lawsuit is the iPhone, Apple’s most recognizable product.
The company harms consumers by making it more difficult for iPhone users to switch to a competing product and to access competing services, according to the government. The complaint also says Apple harms app developers by imposing restrictions on app creation and distribution.
That includes everything from text messaging to digital wallets to apps that reduce user dependence on the iPhone.
Garland, for example, characterized Apple’s iMessage as anti-competitive, saying that when it is used to text with a Google Android device, the iPhone user’s response is in green rather than blue. (whoopee)
That, he said, "limits functionality." The videos sent via text, Garland added, can also be pixelated and grainy.
He then quoted Apple’s CEO responding to a complaint from a user who said he couldn’t send his mom certain videos: "'Buy your mom an iPhone.'"
Apple, the suit alleges, also makes it more difficult for smartphone users to access competing digital wallets by blocking developers from using tap-to-pay functionality in their apps. And it prevents the Apple iWatch from working with Android smartphones while making it more difficult for someone with an iPhone to use a rival’s smartwatch. (too bad)
"Apple repeatedly responded to competitive threats," said Assistant Attorney General Jonathan Kanter, "by making it harder to leave, then making it more attractive to stay. The antitrust laws have something to say about that."
Apple, according to the suit, also suppresses cloud streaming gaming apps and denies consumers access to so-called super apps, which allow users access to a broad range of functionalities from a single interface.
The wide-ranging suit is "about the core unfair practices of Apple," Case Western Reserve University antitrust expert and law professor Anat Alon-Beck said.
"Apple systematically excludes rivals from the Apple ecosystem. By doing that, Apple is hurting so many startup businesses, stakeholders, customers, and, in my opinion, its shareholders."
As a result, she predicts that Apple's stock will "see more downward movement."
Apple's Epic battle
This is just the latest antitrust battle Apple has had to contend with in the US.
The last was in 2020, when "Fortnite" maker Epic Games sued the company and accused it of violating antitrust law by prohibiting third-party app developers from offering their own payment methods within their apps —as opposed to using Apple's payment service.
Justice Department lawyers were permitted to present arguments in that high-stakes dispute. It focused attention on Apple’s App Store — the only place consumers can download apps for iPhones and iPads, which generally charges app developers a 30% commission on paid app purchases made through the platform.
Apple scored a victory in that case when the appeals court upheld a California trial court's ruling that said Apple did not hold a monopoly in the market for mobile app stores.
However, in a minor win for Epic, the appeals court also upheld the trial court's ruling that said Apple must allow app developers to offer more ways for users to pay for purchases.
Both companies tried to take their fight to the Supreme Court, though the high court declined to take up either appeal.
Following that decision, Apple said it will allow developers to offer third-party payment options through their apps. However, the company said developers would still have to pay fees of either 12% or 27%, a move Epic CEO Tim Sweeney called "anticompetitive."
Apple is in the midst of reconfiguring its App Store payment system in the European Union. Under the EU's new Digital Markets Act (DMA), the company must allow EU customers the option to download third-party app stores and get access to third-party payment options.
Apple said it would address the measure and allow third-party downloads and payments, but will still charge developers a fee of 50 euro cents for each download if they cross the 1 million download threshold in a year.
Both Epic and Spotify objected to the measure, with Spotify CEO Daniel Ek calling the new rule "hostile."
<<<
---
Apple - >>> Justice Department files antitrust suit against Apple
Yahoo Finance
by Daniel Howley and Alexis Keenan
March 21, 2024
https://finance.yahoo.com/news/justice-department-files-antitrust-suit-against-apple-145514025.html
The US Justice Department filed an antitrust lawsuit against Apple (AAPL), alleging that the maker of the iPhone illegally maintains its dominance over the smartphone market by boxing out competing apps and devices.
Apple "has maintained its power not because of its superiority, but because of its unlawful exclusionary behavior," Attorney General Merrick Garland said at a press conference Thursday.
Apple said it would fight the lawsuit, which it said "threatens who we are and the principles that set Apple products apart in fiercely competitive markets. If successful, it would hinder our ability to create the kind of technology people expect from Apple."
A victory for the US in this case "would also set a dangerous precedent, empowering government to take a heavy hand in designing people’s technology," Apple added in its statement.
Apple's stock fell more than 4% following news of the lawsuit, which the Justice Department filed with 16 state attorneys general.
The filing sets up yet another confrontation between the US government and a Silicon Valley icon as the Biden administration tries to rein in Big Tech's power.
The Department of Justice is suing Google (GOOG, GOOGL) over antitrust allegations, while the Federal Trade Commission is suing Amazon (AMZN) and Facebook (META) alleging they also violate antitrust laws.
The new DOJ lawsuit filed Thursday poses a major new threat to Apple's various revenue streams.
Apple generates the bulk of its cash through the sale of its wildly popular iPhone, which accounted for $200.6 billion of the company's $383.3 billion in total revenue in 2023. But Apple's services and hardware that tie into the iPhone are also incredibly lucrative.
The company's wearables, home, and accessories business, which includes its Apple Watch and AirPods sales, generated $39.8 billion last year, while its growing services business, which includes subscriptions for things like Apple Music+ and App Store sales, brought in $85.2 billion.
The DOJ's suit comes just weeks after the European Commission (EC) fined Apple $2 billion for allegedly breaking competition laws in the bloc. The EC alleged the company illegally wielded its dominance to the detriment of its rivals in the market for the distribution of music streaming apps.
The Justice Department suit is just the latest headache for Apple, which is off to a rough start in 2024.
Shares of Apple are down 7% year to date as the company struggles with slowing iPhone sales in China, its third-largest market. Apple also lost its title as the world's most valuable company to rival Microsoft (MSFT).
How Apple allegedly wields power
At the center of the DOJ’s lawsuit is the iPhone, Apple’s most recognizable product.
The company harms consumers by making it more difficult for iPhone users to switch to a competing product and to access competing services, according to the government. The complaint also says Apple harms app developers by imposing restrictions on app creation and distribution.
That includes everything from text messaging to digital wallets to apps that reduce user dependence on the iPhone.
Garland, for example, characterized Apple’s iMessage as anti-competitive, saying that when it is used to text with a Google Android device, the iPhone user’s response is in green rather than blue. (whoopee)
That, he said, "limits functionality." The videos sent via text, Garland added, can also be pixelated and grainy.
He then quoted Apple’s CEO responding to a complaint from a user who said he couldn’t send his mom certain videos: "'Buy your mom an iPhone.'"
Apple, the suit alleges, also makes it more difficult for smartphone users to access competing digital wallets by blocking developers from using tap-to-pay functionality in their apps. And it prevents the Apple iWatch from working with Android smartphones while making it more difficult for someone with an iPhone to use a rival’s smartwatch. (too bad)
"Apple repeatedly responded to competitive threats," said Assistant Attorney General Jonathan Kanter, "by making it harder to leave, then making it more attractive to stay. The antitrust laws have something to say about that."
Apple, according to the suit, also suppresses cloud streaming gaming apps and denies consumers access to so-called super apps, which allow users access to a broad range of functionalities from a single interface.
The wide-ranging suit is "about the core unfair practices of Apple," Case Western Reserve University antitrust expert and law professor Anat Alon-Beck said.
"Apple systematically excludes rivals from the Apple ecosystem. By doing that, Apple is hurting so many startup businesses, stakeholders, customers, and, in my opinion, its shareholders."
As a result, she predicts that Apple's stock will "see more downward movement."
Apple's Epic battle
This is just the latest antitrust battle Apple has had to contend with in the US.
The last was in 2020, when "Fortnite" maker Epic Games sued the company and accused it of violating antitrust law by prohibiting third-party app developers from offering their own payment methods within their apps —as opposed to using Apple's payment service.
Justice Department lawyers were permitted to present arguments in that high-stakes dispute. It focused attention on Apple’s App Store — the only place consumers can download apps for iPhones and iPads, which generally charges app developers a 30% commission on paid app purchases made through the platform.
Apple scored a victory in that case when the appeals court upheld a California trial court's ruling that said Apple did not hold a monopoly in the market for mobile app stores.
However, in a minor win for Epic, the appeals court also upheld the trial court's ruling that said Apple must allow app developers to offer more ways for users to pay for purchases.
Both companies tried to take their fight to the Supreme Court, though the high court declined to take up either appeal.
Following that decision, Apple said it will allow developers to offer third-party payment options through their apps. However, the company said developers would still have to pay fees of either 12% or 27%, a move Epic CEO Tim Sweeney called "anticompetitive."
Apple is in the midst of reconfiguring its App Store payment system in the European Union. Under the EU's new Digital Markets Act (DMA), the company must allow EU customers the option to download third-party app stores and get access to third-party payment options.
Apple said it would address the measure and allow third-party downloads and payments, but will still charge developers a fee of 50 euro cents for each download if they cross the 1 million download threshold in a year.
Both Epic and Spotify objected to the measure, with Spotify CEO Daniel Ek calling the new rule "hostile."
<<<
---