Exelixis Prelims, Guidance, Upcoming Milestones

 Cabozantinib franchise achieves approximately $1.630 billion in preliminary U.S. net product revenues for fiscal year 2023 –

– Fiscal year 2024 net product revenues guidance of $1,650 million - $1,750 million; 2024 R&D expense guidance of $925 million - $975 million –

– Appointment of two new board members, Mary C. Beckerle, Ph.D., and Gail Eckhardt, M.D., with extensive drug development and corporate governance expertise –

– Implementing corporate restructuring to focus R&D resources on clinical stage and IND-enabling activities to maximize pipeline success and operational efficiency –

– Board of Directors authorized $450 million share repurchase in 2024 after successful completion of $550 million share repurchase in 2023 –

– Presentation and webcast at 2024 J.P. Morgan Healthcare Conference tomorrow, Monday, January 8th at 4:30 p.m. PT / 7:30 p.m. ET –

Exelixis President and Chief Executive Officer Michael M. Morrissey, Ph.D., will provide a corporate overview and discuss the company’s preliminary fiscal year 2023 financial results, 2024 financial guidance, and key priorities and milestones for 2024 during the company’s presentation at the 42nd Annual J.P. Morgan Healthcare Conference beginning at 4:30 p.m. PT / 7:30 p.m. ET on Monday, January 8, 2024.

To access the webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A replay will also be available at the same location for at least 30 days.

https://www.businesswire.com/news/home/20240107570082/en/

Amicus Prelims, 2024 Outlook

 2023 Total Revenue of ~$399.4M, a 21% Increase Year-Over-Year

>2,400 People Living with Fabry Disease on Galafold® Following a Year of Increased Demand

Expecting 2024 Galafold Revenue Growth of 11-16% at CER

Successful Launches of Pombiliti™ + Opfolda™ Underway in the U.S., U.K., and Germany

Mr. Campbell will discuss the Amicus corporate objectives and key milestones in a presentation at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024, at 2:15 p.m. PT. A live webcast of the presentation can be accessed through the Investors section of the Amicus Therapeutics corporate website at http://ir.amicusrx.com/events.cfm, and will be archived for 90 days.

https://www.globenewswire.com/news-release/2024/01/07/2805020/15991/en/Amicus-Therapeutics-Reports-Preliminary-2023-Revenue-and-Provides-2024-Strategic-Outlook.html

Heron Partners with CrossLink Life Sciences on Non-Opioid Dual Acting Local Anesthetic

Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, today announced that it has entered into a five-year distributor partnership with CrossLink Life Sciences, LLC to expand the sales network supporting ZYNRELEF® (bupivacaine and meloxicam) extended-release solution.

The partnership will launch in several phases, initially at a regional level, followed by an expanded national rollout. In total, approximately 650 representatives will be added to Heron's sales network over the next year. CrossLink will be the lead partner in the United States to expand ZYNRELEF promotion for orthopedic indications. Under the terms of the agreement, CrossLink is compensated on a fixed-fee per vial basis, based on growth over a pre-determined baseline period.

https://www.prnewswire.com/news-releases/heron-therapeutics-announces-partnership-with-crosslink-life-sciences-to-expand-promotional-effort-for-zynrelef-the-first-and-only-non-opioid-dual-acting-local-anesthetic-for-post-operative-pain-302027807.html

Alnylam Prelims, Global Net Product Revenues, Additional Updates

 – Achieved Full Year 2023 Preliminary Global Net Product Revenues of $1,241 Million for ONPATTRO®, AMVUTTRA®, GIVLAARI®, and OXLUMO®, Representing 39% Annual Growth (39% Using Constant Exchange Rate**) –

– Maintained Strong Balance Sheet with Year-End Cash and Investments Balance of Approximately $2.4 Billion –

“We are delighted to have ended the year on a strong note, with continued execution across our commercial portfolio delivering top-line product revenue within our guidance range. These preliminary results reflect growing patient demand for our transformative products, along with strong commercial execution by our teams in delivering these important medicines to patients in need globally. We were also pleased to have reported positive clinical results across multiple programs in 2023. This includes zilebesiran, with which we aim to reimagine the treatment of hypertension, and ALN-APP in Alzheimer’s disease, which provided the first ever clinical demonstration of gene silencing in the human brain using an RNAi therapeutic,” said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. “As we consider the progress we made across our business in 2023 and as we look ahead to reporting results from the HELIOS-B Phase 3 study in early 2024, we believe we are well on our way to achieving our Alnylam P5x25 goals, positioning Alnylam as a top-tier, global, multi-product commercial company with a broad pipeline and organic platform poised to deliver sustainable innovation well into the future, a profile rarely seen in our industry.”

Alnylam management will discuss these preliminary selected financial results and commercial updates during a webcast presentation at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California tomorrow, Monday, January 8, 2024 at 9:45 a.m. PT (12:45 p.m. ET).

https://www.businesswire.com/news/home/20240107331926/en/

Speaker Johnson Announces $1.66 Trillion Bipartisan Package To Avert Shutdown

 House Speaker Mike Johnson told colleagues on Sunday that Congressional negotiators have reached a topline spending figure to avert a federal government shutdown on Jan. 19 for some government agencies, and Feb. 2 for others.

According to a Sunday "Dear Colleague" letter, the topline deal - which mostly adheres to a deal reached between the White House and former speaker Kevin McCarthy (R-CA), limits discretionary spending to $1.66 trillion overall. It also secures $16 billion in additional spending cuts vs. the McCarthy deal, and is around $30 billion less than what Senate Democrats wanted.

"This represents the most favorable budget agreement Republicans have achieved in over a decade," wrote Johnson, adding "As has been widely reported, a list of extra-statutory adjustments was agreed upon by negotiators last summer. The agreement today achieves key modifications to the June framework that will secure more than $16 billion in additional spending cuts to offset the discretionary spending levels."

Breaking it down, the deal sets aside $886.3 billion for defense spending, $772.7 billion in domestic discretionary spending, and rescinds $6.1 billion in coronavirus emergency spending authority. The deal also accelerates $20 billion in cuts from the $80 billion IRS funding allocated under the 2022 Inflation Reduction Act.

"The bipartisan funding framework congressional leaders have reached moves us one step closer to preventing a needless government shutdown and protecting important national priorities," President Biden's staff said in a statement assigned to the 81-year-old. "It reflects the funding levels that I negotiated with both parties and signed into law last spring. It rejects deep cuts to programs hard-working families count on, and provides a path to passing full-year funding bills that deliver for the American people and are free of any extreme policies."

House Majority Leader Chuck Schumer and House Minority Leader Hakeem Jeffries issued a statement in support of the new agreement.

"It will also allow us to keep the investments for hardworking American families secured by the legislative achievements of President Biden and Congressional Democrats," the pair said. "Finally, we have made clear to Speaker Mike Johnson that Democrats will not support including poison pill policy changes in any of the twelve appropriations bills put before the Congress."

Let's see if this sticks...

Johnson and the Democrats' biggest challenge will be House conservatives, who have opposed earlier debt ceiling agreements over a lack of spending offsets.

That said, this agreement is separate from funding for Israel and Ukraine - a growing sticking point among some Republicans.

https://www.zerohedge.com/political/speaker-johnson-announces-166-trillion-bipartisan-package-avert-shutdown

Dr. Francis Collins, Covid, and the public health mindset

 By Mike McDaniel

“Power corrupts; absolute power corrupts absolutely.”

A telling observation attributed to Lord Acton, it appeared in the first episode of Star Trek, which I’m old enough to have watched during its first TV broadcast on September 8, 1966. It would seem the more power and the faster it’s given to small minds, the greater and more rapid the corruption, as Mary Katherine Ham observes at Outkick.com:

Speaking in 2023 at a gathering of Braver Angels, a non-profit designed to lessen American political polarization by bringing people of differing viewpoints together, [Dr. Francis] Collins admitted that considering other viewpoints outside a certain zip code wasn’t part of his job description. Here’s how he described his and other public health officials’ response to the Covid 19 pandemic.

“As a guy living inside the Beltway feeling a sense of crisis trying to decide what to do in some Situation Room in the White House with people who had data that was incomplete, we weren’t really thinking about what that would mean to [a] family in Minnesota, a thousand miles away from where the virus was hitting so hard. We weren’t really considering the consequences in communities that were not New York City or some other big city.”

This kind of hubristic, willful blindness explains a great deal about Covid mandates and lockdowns.  Perhaps Collins and his fellow “scientists” shouldn’t have been upending lives and the economy based on “incomplete data?”  I seem to recall something about a “scientific method.”

“If you’re a public health person and you’re trying to make a decision, you have this very narrow view of what the right decision is and that is something that will save a life. It doesn’t matter what else happens.” 

It obviously didn’t, not to Collins, Fauci and the rest.  Hamm continues:

Again, a frank admission of a bad way of thinking. Many of us suspected this was the case, and criticized public health officials like Collins for exactly this myopia in 2020. Later in the discussion, Collins says he’s learned “how critical it is for those kinds of policy decisions to reflect the realities of each community,” eschewing “blanket recommendations” for a vast and diverse nation in the future. One can hope, but in 2020, those criticisms were met with disdain and censorship, particularly for the public-health dissidents of the Great Barrington Declaration, whom Collins himself tried to discredit in concert with Anthony Fauci, according to his emails and public statements. He now calls its authors “very distinguished in their credentials,” but at the time called them a “fringe component of epidemiology” and their ideas “dangerous” to The Washington Post as he orchestrated a “quick and devastating published take down.”

Ethical scientists don’t act on incomplete data. They respect contrary opinions. Of course, that requires scientists that follow the scientific method, which examines contrary evidence and relies on rigorous, reproducible, standards of proof.  They certainly don’t enlist the media to engage in personal attacks on others.

“So you attach infinite value to stopping the disease and saving a life,” Collins told this gathering. “You attach a zero value to whether this actually totally disrupts lives, ruins the economy, and has many kids kept out of school in a way that they never quite recovered.”

“This is a public health mindset,” Collins concluded, then acknowledging it was a mistake that lost trust. But what has been done to fix it? 

Doing away with every Covid mandate? A weary and angry public dealt with those. Restoring trust in “the science?” Essentially nothing, and late, arrogant pseudo-apologies aren’t helping.

Collins is obviously a charter member of the Self-Imagined Elite (SIE), Public Health Division. Few of the SIE are more prone to corruption than medical doctor bureaucrats given the power to ruin a nation. Their self-imagined morality is limitless. Collins was among that cadre that knew no decency or concern for the lives of others. It has often been said one death is a tragedy, but a million are statistics. One might be forgiven for thinking Collins cared for neither. Dealing with pandemics requires flexible minds able to keep in perspective medicine, and those upon who it is inflicted.

In this, Collins is exactly like other Beltway politicians and bureaucrats. As much as they claim to care for individual lives, they truly see them as abstractions, which individuals discover whenever they ask the SIE to acknowledge or uphold their rights or lives. Collins forgot the essence of the Hippocratic Oath, which requires practitioners to do no harm.

Collins, Fauci and their bureaucratic colleagues put personal power above lives and the nation. It’s going to take decades, if it’s at all possible, to restore public trust. Collins might hasten that process by shutting up and going away.

Mike McDaniel is a USAF veteran, classically trained musician, Japanese and European fencer, life-long athlete, firearm instructor, retired police officer and high school and college English teacher. His home blog is Stately McDaniel Manor.  

https://www.americanthinker.com/blog/2024/01/dr_francis_collins_covid_and_the_public_health_mindset.html

Supreme Court Allows Idaho To Enforce Strict Abortion Ban, Will Hear Case

 by Caden Pearson via The Epoch Times (emphasis ours),

The Supreme Court on Friday granted Idaho the authority to enforce its strict abortion ban while legal clashes play out over a federal law mandating emergency care.

Responding to emergency requests from Idaho state officials, the nation’s highest court temporarily suspended a federal judge’s ruling that found parts of the ban conflicted with the federal Emergency Medical Treatment and Labor Act (EMTALA) of 1986.

“The applications for stay ... are granted,” the Supreme Court’s decision on Friday stated. “The preliminary injunction issued on August 24, 2022, by the United States District Court for the District of Idaho ... is stayed.”

The high court said it would hear oral arguments on the matter in April.

Idaho Attorney General Raul Labrador welcomed the decision, writing on X, formerly Twitter, “Idaho will continue to fight to protect life.”

Federal Law Turns Hospitals ‘Into Abortion Clinics’

EMTALA, the federal law at the center of the case, stipulates that emergency room care must be provided to anyone, irrespective of their ability to pay.

The Biden administration cited this law in a 2022 federal guidance for health care providers regarding abortion. The guidance told hospitals they were obligated to provide “stabilizing” care under EMTALA to patients experiencing an emergency condition, extending this to include abortion.

It applies to hospitals receiving federal funding through the Medicare program.

On Monday, lawyers from Alliance Defending Freedom (ADF), acting on behalf of the Idaho Attorney General’s Office, filed an emergency application for a stay pending appeal with the Supreme Court. Their motion asked for an immediate injunction against the 9th Circuit’s ruling, arguing that EMTALA preempts Idaho’s abortion ban, the Defense of Life Act.

“Hospitals—especially emergency rooms—are centers for preserving life. The government has no business transforming them into abortion clinics,” said ADF Senior Counsel Erin Hawley in a statement.

“Emergency room physicians can, and do, treat ectopic pregnancies and other life-threatening conditions. But elective abortion is not life-saving care—it ends the life of the unborn child—and the government has no authority to override Idaho’s law barring these procedures.

“We urge the Supreme Court to halt the lower court’s injunction and allow Idaho emergency rooms to fulfill their primary function—saving lives,” she added.

District Court’s Block of Ban

Idaho’s abortion ban has been partially blocked from being enforced to the extent it conflicts with EMTALA since U.S. District Court Judge Lynn Winmill issued an injunction in July 2022 after the Biden administration sued.

Judge Winmill, in making his ruling, noted that the state’s actions put doctors in an ethical bind.

The dilemma, as described in the ruling, revolves around doctors grappling with the obligation to provide emergency care under EMTALA and the state’s blanket prohibition of abortions in Idaho.

“The doctor believes her EMTALA obligations require her to offer that abortion right now. But she also knows that all abortions are banned in Idaho. She thus finds herself on the horns of a dilemma. Which law should she violate?” Judge Winmill wrote.

Idaho challenged this ruling, arguing that the two laws were not conflicting and emphasizing that the federal law did not expressly mandate doctors to perform abortions in specific circumstances.

The Biden administration, represented by Solicitor General Elizabeth Prelogar, disagreed, asserting in court filings that the Idaho law “criminalizes care required by federal law.”

The Epoch Times contacted Ms. Prelogar’s office for comment.

Appeals Court’s Suspension of Block

The 9th U.S. Circuit Court of Appeals briefly suspended Judge Winmill’s ruling in September but later allowed its reinstatement, prompting Idaho to appeal to the Supreme Court in November 2023.

Idaho aimed to expedite resolution, seeking an injunction to limit the full enforcement of its abortion ban. An appeal is pending at the U.S. Court of Appeals for the Ninth Circuit.

In light of the 5th U.S. Circuit Court of Appeals ruling for Texas earlier this week in a similar case involving EMTALA and stringent abortion restrictions, Idaho’s attorney general pushed the Supreme Court to act on their request, pointing to the 5th Circuit’s Jan. 2 opinion.

In a win for Texas, the 5th Circuit unanimously declined “to expand the scope” of EMTALA to include enforcing abortions. The state’s attorney general, Ken Paxton, argued the Biden administration’s rule would force doctors to perform elective abortions against state law.

“The question before the court is whether EMTALA, according to HHS’s Guidance, mandates physicians to provide abortions when that is the necessary stabilizing treatment for an emergency medical condition. It does not,” wrote 5th U.S. Circuit Court of Appeals Judge Kurt Engelhardt in the opinion.

“EMTALA does not mandate any specific type of medical treatment, let alone abortion,” the opinion added.

ADF lawyers are also litigating the Texas case.

Idaho’s abortion law was enacted in 2020 with a provision stating it would take effect if the Supreme Court overturned Roe v. Wade. Following the Supreme Court’s decision in July 2022, which effectively overturned Roe, Idaho’s law came into force.

The Defense of Life Act imposes criminal penalties, including up to five years in prison, for anyone performing an abortion, with health care professionals risking the loss of their licenses if found in violation. An exception is granted if the abortion is deemed necessary to protect the life of the pregnant woman.

https://www.zerohedge.com/political/supreme-court-allows-idaho-enforce-strict-abortion-ban-will-hear-case