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Tuesday, August 1, 2023

Vertex Pharmaceuticals 2Q Profit Up On Higher Cystic Fibrosis Drug Revenue

 Vertex Pharmaceuticals posted higher second-quarter earnings, boosted by higehr sales of its cystic fibrosis drugs.

The Boston-based drugmaker on Tuesday reported a profit of $915.7 million, or $3.52 a share, for the quarter ended June 30, compared with a profit of $810.5 million, or $3.13 a share, in the same quarter a year earlier. Adjusted for certain items, the company said per-share earnings were $3.89.

Analysts recently polled by FactSet had expected a profit of $3.86 a share.

Revenue rose 14% to $2.49 billion, ahead of analyst estimates for $2.42 billion, primarily on strong uptake of its cystic fibrosis drug, known as Trikafta in the U.S. Revenue increased 7% in the U.S. and 26% in international markets.

Profit was lifted by the higher revenue and increased interest income, offset by increased investment in mid- and late-stage drugs and other costs.

Vertex also lifted full-year revenue guidance for cystic-fibrosis products to between $9.7 billion and $9.8 billion from $9.55 billion to $9.7 billion.

https://www.morningstar.com/news/dow-jones/2023080112790/vertex-pharmaceuticals-2q-profit-up-on-higher-cystic-fibrosis-drug-revenue

Mexico Demands Russia's Participation In Saudi-Hosted Ukraine Talks

 by Dave DeCamp via AntiWar.com,

Mexican President Andres Manuel Lopez Obrador said Monday that his country would attend talks on Ukraine that are set to be held in Saudi Arabia this weekend only if Russia is invited.

"If there’s acceptance from both Ukraine and Russia to look for solutions to achieve peace, we’ll participate," Lopez Obrador said, according to Reuters. "We don’t want the Russia-Ukraine war to continue, it’s very irrational … The only thing that benefits from it is the war industry."

While being billed as peace talks, Russia has not been invited to the summit in Saudi Arabia. Nations that are not aligned with the US and NATO on the war have been invited, including India, Brazil, and China, but it’s not clear at this point which countries will attend.

Ukraine and its Western backers intend to use the summit to try and convince non-aligned nations to adopt Kyiv’s demands for peace, which include a full Russian withdrawal from all territory that’s been captured, a non-starter for negotiations with Moscow.

Ukraine is also demanding Russia cede Crimea, which has been controlled by Moscow since 2014 and is populated by people who are happy they are part of the Russian Federation.

For their part, Russia insists any future peace deal must recognize the territory it has annexed in Donetsk, Luhansk, Kherson, and Zaporozhzhia, demonstrating how far apart the two sides are. Russia said that it would monitor the talks in Saudi Arabia this weekend.

"Undoubtedly, Russia will keep an eye on this meeting. We’d have to fully understand what goals are being set and what the organizers actually plan to talk about. We have repeatedly said that any attempts to somehow contribute to a peaceful settlement deserve a positive assessment," said Kremlin spokesman Dmitry Peskov.

Peskov added that a peace deal with the Ukrainian government at this time was "impossible" as long as Ukraine is "used exclusively as a tool in the collective West’s war against Russia."

https://www.zerohedge.com/geopolitical/mexico-demands-russias-participation-saudi-hosted-ukraine-talks

JPMorgan Processed $1.1 Million From Jeffrey Epstein To "Girls Or Women" Despite Firing Him As Client

 JPMorgan Chase facilitated over $1.1 million in payments from Jeffrey Epstein to "girls or women," despite having fired the convicted sex offender as a client, an attorney representing the US Virgin Islands told a judge on Monday.

Many of the girls had Eastern European surnames, according to a filing by attorney Linda Singer to Manhattan federal judge Jed Rakoff.

Over $320,000 of the payments were made to "numerous individuals for whom JPMorgan had no previously identified payments," Singer wrote, accusing the bank of failing to disclose the payments until after the end of discovery - the period in which parties in a lawsuit exchange evidence.

Singer has since asked Rakoff to impose monetary damages on the bank for failing to provide the information during discovery, and order the bank to turn over "all financial records for any newly disclosed girls or women to whom Epstein made payments," CNBC reports.

The Virgin Islands in its suit alleges that JPMorgan facilitated and financially benefited from sex trafficking by Epstein of young women during the years when he was a client.

Epstein maintained a residence on a private island in the American territory where he sexually abused scores of women, and during that time kept tens of millions of dollars on deposit at JPMorgan.

JPMorgan says it cut ties to Epstein in 2013. But Monday’s court filing challenges the bank’s timeline. -CNBC

According to a spokeswoman for the bank, Patricia Wexler, "There is no proof this is accurate."

The USVI claims that documents recently turned over by JPMorgan contains new, previously unseen information that had been sought by the DA. It was assembled internally by the bank in October 2019, over three months after Epstein was arrested on federal child sex trafficking charges.

"There is no legitimate reason for JPMorgan failing to identify payments to girls or women the bank itself identified as being related to Epstein — and potential evidence of Epstein’s sex trafficking venture — years before receiving the USVI’s discovery requests," reads the filing, adding that a spreadsheet prepared by JPMorgan listing the dates and beneficiaries of more than 9,000 transactions payable to Epstein-related individuals between 2005 and 2019, "had a combined value of over $2.4 billion."

"Many of the entries reflected accounts and payments, numbering in the thousands and totaling in the hundreds of millions of dollars in value, of which USVI had no prior knowledge or information from JPMorgan’s responses and productions during the fact discovery period," wrote Singer.

JPMorgan has argued that the information wasn't provided earlier "because it was not in a custodial production and/or did not relate to individuals specifically identified by the USVI as related to Epstein."

Singer, however, says that "The USVI has repeatedly made clear that its discovery requests are not limited to individuals it specifically identified as being related to Epstein."

"The USVI specifically identified the individuals it knew were related to Epstein to make its discovery requests clearer — not relieve JPMorgan of its duty to produce known relevant documents," reads the filing.

What's more, Singer says JPMorgan may not have disclosed everything, and has asked Judge Rakoff to force the bank to produce all documents and information concerning its 2019 review of Epstein matters, including "all financial records for any newly disclosed girls or women to whom Epstein made payments."

https://www.zerohedge.com/political/jpmorgan-processed-11-million-jeffrey-epstein-girls-or-women-despite-firing-him-client

Mom Accuses FBI Of Entrapping Her 'Neurodiverse' Teenager In Terrorism Scheme

 by Ken Silva via Headline USA,

In June 2022, Colorado woman Deanna Meyer contacted her local sheriff’s office about violent and terroristic statements that her mentally ill 17-year-old son, Davin Meyer, was making at the time.

The local sheriff, in turn, contacted the FBI, which then began communicating with the teenager online. Months later, the FBI arrested Davin as he was about to board an airplane, ostensibly to travel to the Middle East to join ISIS.

But Davin’s mother says he is no ISIS fighter. Instead, he’s an 18-year-old with no friends, who suffers from numerous mental health issues, including autism, depression and anxiety, according to the mom.

At a detention hearing on Friday, Deanna reportedly expressed remorse that she ever sought help from law enforcement, blaming the FBI for ensnaring her son in a phony terrorism plot.

“I bet my life he would never do that without that encouragement [from FBI informants],” she said Friday, describing how her son communicated with at least two FBI informants in chat rooms from last November until he was arrested.

U.S. Magistrate Judge Reid Neureiter disregarded Deanna’s pleas on Friday and ordered Davin to remain in custody. Neureiter pointed to the fact that Davin allegedly threatened his mother’s life when he was still a juvenile—even though the mother said he hasn’t threatened her since he turned 18.

The judge did acknowledge the mother’s arguments in his five-page order.

“The mother testified at the detention hearing that she never believed he would likely move ahead with his expressed intentions, and the defendant only took steps to travel to the Middle East after finding a ‘community’ online, which included confidential FBI sources,” Judge Neureiter said.

“According to the defendant’s mother, he has ‘never had a friend’ and finding this community that appeared to be supportive of his plans is what likely caused him to act by buying the ticket to fly to Turkey.”

Neureiter also acknowledged Davin’s mental health problems.

“The defendant is ‘neurodiverse’ and was diagnosed at the age of nine of being on the autism spectrum, and he has also been diagnosed with having a low processing speed and massive depression. The defendant may also have obsessive compulsive disorder,” the judge said.

“The defendant has received diagnoses of autism spectrum disorder; attention-deficit hyperactivity disorder; adjustment disorder with mixed anxiety and depressed mood; specific learning disorder with impairment in mathematics; and major depressive disorder, recurrent episode, moderate.”

However, Judge Neureiter said it’s in the public interest to keep Davin incarcerated.

This is a difficult situation, and must be extremely heart-wrenching for the defendant’s family, in particular his mother, who has long believed the defendant needs help and therapy,” he said.

“Putting a defendant with his disabilities in jail, pending trial, will not address his condition nor provide the therapy that he apparently needs. It will, however, ensure that he cannot do violence to anyone.”

The judge concluded by saying he’d reconsider his order if the Meyer family can find a suitable mental health facility to house Davin.

Other bizarre details about the Meyer case can be found in the arrest affidavit of FBI task force officer Joni Tangeman.

For instance, Tangeman said Davin followed “white supremacist ideology” when he was 15-years-old, before he began practicing Islam in late 2020. Tangeman further said that Davin said when he was 17 that if he didn’t go to the Middle East, he would build a fertilizer bomb in the United States—the same bomb used in the Oklahoma City bombing.

Additionally, the FBI officer admitted she knew about Davin’s mental health issues when investigating him.

“I am aware that MEYER has previously received mental health treatment, including residential treatment programs,” she said, adding that Davin apparently refused to take his medication when he converted to Islam.

“MEYER refused to take any prescription medication prescribed by the psychiatrist because it would be against his Islamic religion, and he also refused to go to school or participate in online school programs,” Tangeman said.

“Records show that MEYER has received diagnoses of autism spectrum disorder; attention-deficit hyperactivity disorder; adjustment disorder with mixed anxiety and depressed mood; specific learning disorder with impairment in mathematics; and major depressive disorder, recurrent episode, moderate.”

The Meyer case follows the FBI arresting another mentally challenged 18-year-old, Mateo Ventura, for allegedly intending to help ISIS. Last month, The Intercept published an interview with Ventura’s father, who also accused FBI informants of entrapping his son.

“He was born prematurely, he had brain development issues. I had the school do a neurosurgery evaluation on him and they said his brain was underdeveloped,” Ventura’s father, Paul Ventura, told The Intercept. “He was suffering endless bullying at school with other kids taking food off his plate, tripping him in the hallway, humiliating him, laughing at him.”

Ventura is currently in a private mental health facility as his case proceeds. Meyer’s preliminary hearing is set for July 31.

https://www.zerohedge.com/political/mom-accuses-fbi-entrapping-her-neurodiverse-teenager-terrorism-scheme

US pulls back offer to buy 6 mln barrels of oil for emergency reserve

 The Biden administration has pulled back an offer to buy 6 million barrels of oil for the Strategic Petroleum Reserve because of conditions in the market, an Energy Department spokesperson said on Tuesday.

The administration made the latest solicitation to buy the oil on July 7. After the administration released a record 180 million barrels from the reserve last year, the Energy Department has bought back only 6.3 million barrels in recent months.


The Energy Department "remains committed to its replenishment strategy for the SPR" which includes direct purchases, exchange returns and cancellation of planned sales where drawdown is unnecessary, in coordination with Congress, the spokesperson said.


https://www.nasdaq.com/articles/us-pulls-back-offer-to-buy-6-mln-barrels-of-oil-for-emergency-reserve

'Incandescent light bulb ban now in effect'

 The federal government’s ban on incandescent light bulbs took effect on Tuesday, more than a decade and a half after such a rule was first proposed intending to promote energy efficiency.

A federal regulation to ban incandescent light bulbs was initially issued in 2007 following the enactment of the Energy Independence and Security Act during the Bush administration. Implementation of the ban was delayed from its initial date of 2012, then the rule was broadened during the Obama administration before it was reversed by the Trump administration. 

The Biden administration in April 2022 moved ahead with a new rule from the Dept. of Energy (DOE) banning incandescent light bulbs starting on August 1, 2023. The rule requires that light bulbs must emit at least 45 lumens per watt (a lumen is a measure of brightness). It also bans the manufacture and sale of non-conforming bulbs – but not their use, so consumers may use such bulbs that they already possess.The rule effectively bans most incandescent light bulbs because they typically produce about 15 lumens per watt according to Philips, a leading light bulb maker. However, the rule contains exceptions allowing incandescent bulbs to continue to be manufactured and sold if they’re used in things like household appliances or certain types of lamps, including those for bugs, plants, or marine signals, among others.

regulatory enforcement memo from the DOE issued days after the rule was announced last year indicated that the agency will pursue civil penalties against manufacturers and private labelers that knowingly violate the ban, although it’s unclear from the document what those penalties may entail.

"The lighting industry is already embracing more energy efficient products, and this measure will accelerate progress to deliver the best products to American consumers and build a better and brighter future," Energy Secretary Jennifer Granholm said last year.


The DOE said in announcing the incandescent bulb regulation that it expects American consumers to save nearly $3 billion on annual utility bills due to the rule and projected that it will cut carbon emissions by 222 million metric tons over the next 30 years – an amount equivalent to the emissions generated by 28 million homes in a year.

A coalition of free market and consumer groups opposed the Biden administration’s rule, arguing in a comment letter to the DOE that "further regulatory interference in the marketplace is unwarranted given that more energy efficient lighting choices, namely light-emitting diode bulbs, are already available for consumers who prefer them over incandescent bulbs." 

The coalition added that the estimated climate benefits of the energy efficiency regulations are "speculative, assumption-driven, and prone to bias in the hands of agencies with a regulatory agenda."

The ban on most incandescent bulbs is likely to increase consumers’ adoption of light-emitting diode (LED) light bulbs, which are more energy efficient and have grown in popularity as the incandescent ban has been in regulatory limbo.

The DOE’s most recent Residential Energy Consumption Survey (RECS) found that nearly half of all U.S. households use LED bulbs for all or most of their indoor lighting, with the share of LED bulbs rising from 4% in 2015 to 47% in 2020. The data showed a corresponding decline in the share of incandescent or halogen bulbs from 31% in 2015 to 15% in 2020, and for CFL bulbs, which declined from 32% to 12%. The share of households reporting no predominant bulb type also fell from 33% to 26% in the same timeframe.

The ban on incandescent light bulbs isn’t the only action the Biden administration is planning to take regarding light bulbs and energy efficiency.

In December 2022, the Biden administration and DOE announced a rule to double the minimum light bulb efficiency to more than 120 lumens per watt for bulbs commonly used by consumers – which would effectively ban compact fluorescent (CFL) bulbs. The rule is expected to take effect before the end of 2024.

https://www.foxbusiness.com/economy/incandescent-light-bulb-ban-now-effect-what-know

Incyte's Jakafi Patent Expiry In 2028 Poses Challenge

 Incyte Corporation's 

 Q2 adjusted EPS reached $0.99, compared to $1.01 posted a year ago. Analysts had estimated $0.87

Q2 revenues increased by 25% Y/Y to $954.61 million, beating the consensus of $920.18 million.

Jakafi product revenues grew 14% Y/Y to $682 million, driven by strong underlying patient demand growth across all indications. Wall Street estimate stood at $655.2 million.

Opzelura's revenues of $80 million grew 384% Y/Y, driven by patient demand growth and payer coverage expansion as the launch in AD and vitiligo continues.

William Blair says that as the Jakafi franchise matures, it continues to show promise for near-term growth across its approved applications and through the LIMBER programs' lifecycle management potential

The initial launch of Opzelura was rocky, but the opportunities it presents in treating atopic dermatitis, vitiligo, and other conditions currently in clinical trials could make it a significant revenue generator for Incyte as they move into dermatological diseases. 

The analyst Matt Phipps says Incyte shares have the potential for upward movement, thus maintaining Outperform rating

Although Jakafi remains a leading therapy with several approved applications, new competition, and potential novel therapies could affect its market share. 

The analyst also notes Incyte's heavy reliance on Jakafi sales/royalties makes competition and its patent expiration in mid-2028 ongoing issues. 

The company's novel treatments, including Monjuvi and Pemazyre, face a competitive market and must prove superior clinical outcomes to secure a significant market share.

Guidance: The company raised the low end of its annual forecast range for Jakafi sales to $2.58 billion from the $2.55 billion expected earlier while keeping the high end unchanged at $2.63 billion.

https://www.benzinga.com/analyst-ratings/analyst-color/23/08/33498254/incytes-jakafi-patent-expiry-in-2028-poses-challenge-analyst-says-new-treatments-to