Category: Uncategorized

Re-Upping My November 24, 2023 Post — On How Merck May Be Guiding Too Low… With Year End Results Due This Week.

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As we finish the annual “day after” dim sum feast on Cermak…. I’ll take this moment to note that by December 31, 2023, Rahway will undoubtedly be able to truthfully say it sells the world’s most lucrative single therapeutic agent, vastly eclipsing Humira — at over $23 billion a year. [We should note, of course, that since the below projections come from a company known to Wall Street as a public company for nearly as long as there have been US public companies — the executives likely shade the guidance to be a little conservative… understanding that “missing” by being overly optimistic will be harshly punishing to the stock price, while missing on the low side simply causes a bump up on the NYSE. In sum, Merck’s management is unlikely to be too far out over its skis — all as Elon Musk so often is, as a mere baby in public company land. A big baby, but still… a baby.] So, Rahway’s year end might be slightly better than the below, when the dust settles.

True, it will have expensed the $5.5 billion, previously disclosed, on the Daiichi Sankyo deal — and about $100 million on the Caraway M&A deal in the quarter, but no one will even notice, given the hoards of cash being trucked in on pembrolizumab, thus (from the Q3 2023 guidance):

…Merck now expects its full-year non-GAAP EPS to be between $1.33 and $1.38, including a negative impact of foreign exchange of approximately 6 percentage points, at mid-October 2023 exchange rates. This revised non-GAAP EPS range reflects the following, which were not previously included in the outlook:

Additional strength in the business of approximately $0.15 per share.

A pretax charge of $5.5 billion, or $1.70 per share, for the collaboration agreement with Daiichi Sankyo.

Estimated expense in the fourth quarter of 2023 of approximately $0.04 per share to advance the ADC assets and finance the transaction with Daiichi Sankyo.

A 1%, or approximately $0.05 per share, incremental negative impact of foreign exchange.

The non-GAAP EPS range excludes acquisition- and divestiture-related costs, costs related to restructuring programs, income and losses from investments in equity securities, and a previously disclosed charge related to settlements with certain plaintiffs in the Zetia antitrust litigation….

Now you know — do go enjoy the piping hot green tea by the kettle, and the flat noodles, with steamed barbequed pork buns and curry chicken stuffed turnover pastries!

नमस्ते

Amgen’s Full Year 2023 Lobby Spend Figures — And Initiatives’ Disclosures: No. 3 Of A Five Part Series, As Ever…

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We still have to post Merck’s totals and disclosures… and we typically also add in Amazon, at the end. But today, after covering Pfizer and then Lilly, we look at… Amgen. [This year, we also offered bonus coverage of Abbott, and Baxter — at the mid-major level.]

Amgen is deep in the biotech space — and so is particularly focused on protecting patents for bio-engineered therapies (these are treated differently than powder pill drugs at FDA, and in many respects, under US patent law). For the full year, Amgen spent $9.54 million — and $3.55 million in Q4 alone, on stuff like this:

…Issues related to drug pricing reform — Changes to Public law 117-1769 Inflation Reduction Act; Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act; S. 113 Prescription Pricing for the People Act of 2023; S.127 Pharmacy Benefit Manager Transparency Act; HR 830/ S 1375 HELP Copays Act; HR 485 Protecting Health Care for All Patients Act; HR 5378 Lower Costs, More Transparency Act; HR 2534 PROTECT 340B Act of 2023; HR 3561 the PATIENT Act; S. 1542 DRUG Act; S. 1967 PBM Act; HR 3503 The NIH Clinical Trials Diversity Act; Issues related to cardiovascular disease awareness and treatment; Issues related to Federal Trade Commission; FDA issues; Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters; Biosimilars reimbursement issues, no specific bill; Supply Chain Issues, no specific bill; and Issues related to 340B….

Issues related to pharmacy benefit managers — Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program; HR 4818/ S. 2407 Treat and Reduce Obesity Act; S. 2305 Biosimilar Red Tape Elimination Act; S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act; Issues related to PAHPA reauthorization; Modernizing and Ensuring PBM Accountability Act (Finance Committee); S. 652 SAFE Step Act; S 2474/ HR 5376 Share the Savings with Seniors Act; S 2456 Protecting Seniors from High Drug Costs Act; HR 4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program; HR 3281 Protecting Patients Against PBM Abuses Act; HR 4822 Health Care Price Transparency Act of 2023; S 1339 Pharmacy Benefit Manager Reform Act; HR 2679 Pharmacy Benefits Manager Accountability Act; HR 4507 Transparency in Coverage Act of 2023; HR 1352 Increasing Access to Biosimilars Act of 2023; HR 2880 Protecting Patients Against PBM Abuses Act; and Issues pertaining to the implementation of PL 97-414 “Orphan Drug Act,” all provisions….

HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program….

Issues related to corporate and international tax, including regarding Public Law 115-97, Tax Cuts and Jobs Act; Issues related to Puerto Rico; Issues related to OECD negotiations on the taxation of global income; HR 3938 Build it in America Act….

S. 79/HR 1717 Interagency Patent Coordination and Improvement Act of 2023; S. 113 Prescription Pricing for the People Act of 2023; S.127 Pharmacy Benefit Transparency Act; S. 150 Affordable Prescriptions for Patients Act of 2023; S. 148 Stop STALLING Act; S. 142 Preserve Access to Affordable Generics and Biosimilars; Federal Trade Commission related issues, no specific bill; Issues related to the Patent Act, no specific bill; Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill; Issues related to False Claims Act; Issues related to FDA/PTO coordination; Issues related to patent thickets/product hopping; Issues related to obviousness/ double patenting; S.2140 Patent Eligibility Restoration Act of 2023; S.2220/HR 4370 Promoting and Respecting Economically Vital American Innovation Leadership Act; S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents; H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress; H.R. 3535 Advancing Americas Interests Act; and H.R. 5475 Prohibiting Adversarial Patents Act of 2023….

Now you know — out, into the steel and glass canyons here, grinning — as my eldest returns, briefly — for an overnight visit Thursday to Friday evening, on her way from Nicaragua — back to her flat in London… woot!

नमस्ते

All As Hinderaker… In Stunningly Delusional Terms, Suggests The US Will Quit/Dismantle The UN. Hilarious.

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The headline pretty much says it all.

Hinderaker is so… demented, he thinks that the US will inflict the fate of the “League of Nations” upon the UN.

His naivete… is beyond stunning.

Ah… but it is quite humorous.

So — enjoy, folks… this is high comedy.

Comedy driven by lithium-induced (or perhaps Ketamine-) delusions, in all likelihood.

So I suppose I should pity him — but I… don’t.

Out.

Paul Mirengoff Is Right About This Much: Speaker Johnson Has Been Threatened By Tangerine. Thus, No Border Deal In 2024.

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Paul Mirengoff takes about 15 paragraphs overnight to belch about some GOP “get tough” measures on the southern border. [Never mind that a fair chunk of them are… unconsti- tutional on their face.] No, my point here is that Paul wants the regular GOP to have the benefit of “trying it” — while admitting that the GOP regulars suffer from Stockholm Syndrome, as to Tangerine.

Speaker Johnson (from a Ruby Red Louisiana district) will be primaried, and lose his seat in Congress — if he gives Mr. Biden even a small win, on border issues. Trump has plainly said this to him, face to face.

So what Paul is right about… is that Tangerine is killing the largely former, now mostly dead GOP brand. The party is in the thrall of a lunatic. [And because this lunacy will preserve the asylum process our treaties guarantee, as an independent democrat, I’d not fight too terribly hard for Ukraine aid (to which the loon have tied themselves), if that is the hill Tangerine and Johnson decide to… die upon.]

And he will lose in the general, in any event. [Even if, by some miracle, he isn’t already a convicted felon, and removed from the ballots in Colorado, Maine and Illinois.]

Anyhoo — welcome, Mr. Mirengoff to what your own 2016 deals with the devil now cost: Your Party; and… (soon) Your Soul.

Out.

USDC Judge Moses Sets March 4-5, 2024 — For Evidentiary Hearings — On Razor Wire Issues.

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By mid-February, we will have each side’s view of the issues that remain contested.

Issues… like whether three putative asylum seekers drown in the Rio Grande in the mid-January cold snap.

Issues like whether State of Texas officers continue to willfully impede access (and then lie about it) — even in medical emergency situations — to Shelby Park, and its dock on the Rio Grande riverbed.

Issues… like whether AG Ken Paxton is openly courting lawless vigilantes to come to Del Rio, to hunt for federal agents of CBP and DHS.

Damn. Here’s that order, just entered this afternoon:

…It is ORDERED that consistent with the Fifth Circuit Court of Appeals’ order dated January 26, 2024, the court hold an in-person evidentiary hearing to develop the factual record in this matter;

It is FURTHER ORDERED that this hearing be held on March 4, 2024 and March 5, 2024, and that the hearing on each day start at 9 a.m.; and

It is FURTHER ORDERED that by February 15, 2024, the parties e-file a brief of no more than 10 pages that identifies the factual issues for which the Fifth Circuit Court of Appeals requests factual findings.

SIGNED and ENTERED on this 29th day of January 2024….

Onward, in a perilous time for our Union down at Eagle Pass. Damnation.

It Seems Amelia Earhart’s Pacific Ocean Crash Site Has Been… Found — Over 86-1/2 Years Later

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This is some much needed — if much delayed — closure, on an American icon, and historic pioneer of the aviation age.

It looks as though Ms. Earhart’s plane, in deep warm water about 100 miles shy of her intended refueling stop… has been located. Here’s NPR on it all, as of this morning:

…The shape of the object in the sonar images closely resembles Earhart’s aircraft, a Lockheed Electra, both in size and tail. Deep Sea Vision founder, Tony Romeo, said he was optimistic in what they found.

“All that combined, you’d be hard-pressed to convince me that this is not an airplane and not Amelia’s plane,” he said.

The Deep Sea Vision team plans to investigate the area where the images were taken some time this year, Romeo added.

Earhart and Noonan vanished in 1937 while on a quest to circumnavigate the globe. The trip would have made Earhart the first female pilot to fly around the world….

The prospect of Earhart’s plane lodged in the ocean floor backs up the popular theory that the aircraft ran out of fuel and sank into the water. But others have suggested that she and Noonan landed on an island and starved to death.

Some believe the two crashed and were taken by Japanese forces, who were expanding their presence in the region leading up to World War II….

Now you know and she can rest in peace, in all likelihood. Regular readers will recall that we had covered this mystery last summer, here.

नमस्ते

Tangerine Tries To Get Rid Of A Monitor He Sought — Because She’s Doing… A “VERY THOROUGH” Job..?!.

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So, Trump wants to end the monitor he insisted on, back when he claimed the NY AG was mis-stating his financials (and would somehow use them to benefit his imagined competitors — in vying for fraudulent loans?!). Over the last 18 months, the monitor, a retired and highly esteemed USDC Judge, has documented an ongoing, and nearly endless array of misstatements, errors and omissions (including direct inconsistencies) from the “Trump-World” financials.

The able Barbara Jones (USDC NYSD Judge, Retired) puts it this way:

…While certain observations discussed below have been addressed in my prior reports, this report also provides a review and overall assessment of the Defendants’ compliance with the requirements of the Monitorship Order….

Absent steps to address the items above, my observations suggest misstatements and errors may continue to occur, which could result in incorrect or inaccurate reporting of financial information to third parties. The parties continue to cooperate with me under the requirements of the orders. Should you have any questions, please feel free to contact me….

Of course, this is all coming to a head because he will shortly owe over $450 million in cash into the courts ($83.3 million in federal court, if he wants to appeal the second Jean Carroll defamation verdict; and probably $280 million to $370 million, in the NY AG frauds cases, in state court — where he filed the above nonsense papers).

And he hates the idea that he can no longer easily “shell game” his income and assets away from his judgment creditors, as he’d done previously, for over four decades.

Out.

So — The Fifth Circuit, En Banc, Seems To Be Trying To… Wheel The Razor Wire To A “Homie” Judge In Del Rio…

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The state of Texas is nothing, if not… relentless, in its political maneuvers.

It has now been able to get the Fifth Circuit to slow walk the Supreme Court order re-instating the clear statutory right of DHS and CPB to cut the razor wire. Thus far, those two federal agencies have refrained from provoking what might be an armed response, from AG Paxton’s ugly shock troops (i.e., see his insurrectionist graphic — at right, in the lower portion — equating this to “the last stand” at the Alamo 180 years ago).

The feds are admirably showing great restraint at the moment — only stepping in to rescue asylum seekers trapped by the wire barriers — but the Supremes clearly gave the feds the unfettered right to cut or remove the wire, two weeks ago now — by confirming that the federal law means what it says, here.

But… likely in an effort to stall and/or run out the clock, the Texans are bouncing motions back and ‘fro, in the Fifth Circuit, and the WDTX District Court.

They’ve been able to get the Fifth panel to name Alia L. Moses as a judge for “fact finding” — about what has transpired since December 21, 2023. She has 60 days to find facts in Del Rio, now.

I suspect the feds will continue the soft shoe approach here, while they let the Moses hearings schedule play out. But it does mean there will be no February 8 argument in the Fifth, despite what AG Paxton is burping about.

And, here is the AG’s nonsense, in full.

I should note that one Texas “TV 12News” outlet claims to have “fact checked” this dispute, and determined that Texas is “NOT defying a Supreme Court order“. The local Tee-Vee people base this on the idea that “Gov. Abbott has been putting up razor wire for over a year, and it is part of Operation Lone Star”. [Part of a lawful Texas operation, they claim, for which they offer zero citations to any court case.]

The problem with that stitled narrative, of course, is that all three courts (trial, appellate and Supremes) have now plainly said that Texas lacks the right to patrol the international border, and his barriers there thus violate federal law. The highest court of the land explicitly ruled, on January 22, 2024, thus: “Application (23A607) to vacate injunction presented to Justice Alito and by him referred to the Court is granted. The December 19, 2023 order of the United States Court of Appeals for the Fifth Circuit, case No. 23-50869, is vacated….”

Somehow, local Tee-Vee thinks that anything the MAGA Gov. does (despite what the Supremes rule)… is legal, because he’s the “supreme ruler” of some mythical kingdom called… Texas.

Charmingly (willfully?) ignorant, that is.

Paxton is openly defying the US S. Ct. See his Twitter account postings. Day after day.

Damn, kids. Grow up, in Texan Tee-Vee land, down there.

Out.

[Tangent: Pharma Lobbying, On Prices.] Here Is Lilly’s Full Year 2023 Spend ($7.96 Million): Much Of It To Blunt Price Caps On Lispro® (Next-Gen Insulin Injection)…

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This appears here because there are lawful ways to increase drug prices — and we may argue about whether such moves are… strictly speaking, moral — on older drugs as to which companies have already made billions of dollars, selling them for decades at high prices. [Especially where fixed-income seniors need them just to… survive.]
But we should all agree that brazen market choking, via open violations (for several years) of the Clayton Act… are not to be allowed. This is — in truth — why Martin Shkreli finds himself where he is, this morning. Banned from life sciences, pharma and securities businesses — for life.

Okay, on to the main story then (cross-posted from my other properties).

With Lilly’s diabetes meds being used as an off-label weight loss treatment nationwide in 2023, it has had a hard time in 2023 manufacturing enough of it to meet the sky-rocketing demand for that very pricey product. [That’s a win-win, from the company’s perspective.]

And it is doubly concerned, about any legislation that might force it to decrease the price of its modified (next-gen insulin) — called Lispro® — offered at retail at eye-watering prices. [Lilly spent $2.53 million in Q4 2023 alone. And it chose to voluntarily cap the older insulin products at $35/month out-of-pocket, in order to avoid government mandated negotiations / legislation on Lispro pricing.]

Here are the details from Q4 2023, as to The Indiana-based multinational:

…Issues related to intellectual property protection and market access within current trade negotiations. Canada IP; USMCA implementation; Mexico patent linkage; Special 301; Trade talks: US-Japan, US-China, US-EU, US-UK, US-India, and US-Brazil….

[Senate version] Patient protection; Drug supply chain and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the “Inflation Reduction Act” (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act….

[House version] Intellectual property; 340B Program; Medicare & Medicaid prescription drug reimbursement, coverage and value; Implementation of the “Inflation Reduction Act” (HR.5376); CMS National Coverage Determination on Alzheimer’s disease; The INSULIN Act….
Multi-lateral threats to IP and the biopharmaceutical industry; Drug importation; Prescription drug value and access….

Pharmaceutical intellectual property issues….

Hospital discounts; 340B program….

Implementation of the Tax Cuts and Jobs Act; Domestic manufacturing tax incentives; Expensing of research and development costs; Global minimum tax; Pension and retirement benefit issues….

Now you know — and this is a candidate for the next round of mandatory price negotiations (with federal government customers) in the US.

The first group of ten included Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, and Imbruvica.

Onward, into the… sunshine.

नमस्ते

I’ve Seen Some Silly “Analyses” Of Section 3 Of The 14th Amendment…

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Some hard right chuckle-heads are claiming that the prohibition in Section 3 was effectively rescinded in 1878 and 1898, by acts of Congress. Not so. It merely pardoned (looking BACKWARD) former Confederate insurrectionists. It expressly left in place the FOWARD-looking power (without need of an impeachment, or other act of Congress) to have any state disqualify any “insurrectionist” — from holding office, including the office, at what is now… 1600 Penn. The testimony of the drafters amply supports the point that it was not — not — not limited to the Civil War facts.

The very-able historians (via an amici filing, at the Supremes, on Friday past) explain, thus:

…Contrary to many laws that targeted former Confederates in southern states, Section 3 enshrined disqualification in the Constitution with generic language that does not reference the rebellion or former rebels.

Unlike [mere] statutes, as part of the Constitution, Section 3 endures indefinitely, free of tampering by future Congresses. Republican Senator Peter Van Winkle of West Virginia said during debates over the 14th Amendment, “This is to go into our Constitution and to stand to govern future insurrection as well as the present; and I should like to have that point definitely understood….”

Section 3 was very explicit about what Congress was required to do and not to do: Congress could lift any disqualification for office only by a two-thirds vote. Strikingly, however, the Section did not require any action by Congress to disqualify insurrectionists. Section 3 mirrored other constitutional disqualifications based on age, residence, and birth that did not require any action from Congress….

No former Confederates whom Section 3 instantly disqualified from holding office were disqualified by an act of Congress or a criminal conviction for insurrection or rebellion. Former Confederate President Jefferson Davis recognized, for example, that Section 3 had automatically disqualified him from holding public office on the day the states ratified the 14th Amendment. Davis argued that the Congress to give it effect.” Thus, the disqualification “punishment of Mr. Davis commenced upon the date of the adoption of the fourteenth article, and he therefore could not now be punished in any other way….”

The government did not dispute the self-executing impact of Section 3 but opposed quashing the indictment. Chief Justice Salmon Chase, who was serving as a Circuit Court Judge, indicated he accepted Davis’ claim and would quash the indictment. Circuit Court Judge John Underwood did not agree to quash.

However, the prosecution dropped the indictment prior to any resolution of the matter. Davis lived freely, although still under disqualification for a presidential run should be immune from prosecution for treason because of the penalty already imposed by this disqualification. Section 3, said Davis’ lawyer, “executes itself….”

So yes — these people are pointy-headed know-nuthins’ — nothing more.

Out.