Getting Vaccines — On A “Millions Of Doses Scale”, Into Vials, Flawlessly… Is A Daunting Engineering Challenge: Gardasil® Manufacturing Contract Delays, For Gavi ’24

After running into Gardasil® supply shortfalls in both 2018 and 2019, Merck made a large capital expense / expansion downstroke in its rural Elkton, Virginia facilities — to double manufacturing capacity. [We covered that, here, in real time.]

But now Merck may be (in part) a victim of its own marketing successes, in Europe, and the US and Japan — as even its overall expanded capacity — between Durham, West Point and Elkton is being sorely tested. More doses are being sold than expected, in high margin geographies.

And so, this morning, we read in the NYT that Rahway will be about 1.2 million doses short, on its 2024 delivery contract with the global non-profit alliance that immunizes young African girls against HPV, which after infection and remaining dormant for years in the human body, may — later in life — manifest itself as several forms of cancers.

So the jabs are critical — and approved for all girls at the age of 12. Being even a year late in getting it (if a girl is sexually active), may mean that we’ve missed the window. Once you’ve contracted the HPV virus, obviously, the vaccine is of no real use. So here’s to hoping Merck is able to resolve the “manual inspections” snag, and rapidly so. [The company doesn’t make any real profit on the Gavi contract — but makes very high profits on EU, UK and US dosings of the Gardasil vaccine.]

Here’s the bit from the NYT:

…Nearly 1.5 million teenage girls in some of the world’s poorest countries will miss the chance to be protected from cervical cancer because the drugmaker Merck has said it will not be able to deliver millions of promised doses of the HPV vaccine this year.

Merck has notified Gavi, the international organization that helps low- and middle-income countries deliver lifesaving immunizations, and UNICEF, which procures the vaccines, that it will deliver only 18.8 million of the 29.6 million doses it was contracted to deliver in 2024, Gavi said….

Patrick Ryan, a spokesman for Merck, said the company “experienced a manufacturing disruption” that required it to hold and reinspect many doses by hand. He declined to give further details about the cause of the delay….

Perhaps some of the “high margin” inventory in Europe might be temporarily diverted to the African continent, until the glitch is straightened out? Perhaps — as I suspect Merck has enough on hand to cover its higher profit geographical contract commitments. But I’m just a natural-born cynic, in that way. Onward — sorta’ gray morning here.

नमस्ते

I Couldn’t Make This Up, If I Tried: Update — Riot’s Jason Les Made “Tim Cook-esque” Money In 2023 — To Burn Tons Of Cash Flow, And Lose $50 Million…

Last week, I mentioned that Merck’s Rob Davis made a little over $20 million last year — joining the top tier of multinational life-science / pharma CEOs — in the take-home pay stratosphere. There is a fair argument that most of the pharma CEOs at bottom right are worth what they are paid — I may not agree with it, precisely — but I understand the argument.

And there is a fair argument that Apple’s Tim Cook is worth the lil’ over $50 million he made for 2023. His company generates about $110 billion in free cash flow every year, is wildly profitable, sells the best tech on the planet — and sports a trillion dollar market cap.

Overnight, tiny Riot Platforms — a money burning Bitcoin miner in dusty West Texas — finally disclosed its CEO’s all in 2023 pay (see table, far lower right, on page 60 of the just filed SEC proxy). CEO Jason Les makes just a lil’ less than… Tim Cook?! And his board thought it “right” to pay him more than DOUBLE what the wildly profitable and much more complex pharma businesses, with global regulatory footprints — pay their literally life-saving CEOs?

I am sorry. There is simply no rational argument to support that. The shareholders of Riot ought to vote “no” — in their “say on pay” this proxy season. It is in the mail, now from Castle Rock, Colorado. Or it will be soon.

And do keep an eye on Riot’s NASDAQ-traded stock, which was over $25 late last year… at $7 something today, and likely $4 something after this weekend’s “Halvening”. How does such a five year con job… persist?!

As just one point of comparison, Caitlin Clark — perhaps the best overall women’s college player in a decade (and the best shooter ever seen, in the college ranks)… is set to make only about $72,000 a year as a WNBA rookie, in salary (she will make more, in endorsements, though) — while Victor Wembanyama, the men’s no. one pick last year in the NBA draft will make $12 million this year (and $55 million over four years — still below Jason Les’s ~$72 million in the last four years).

Whoa — onward, grinning just the same.

नमस्ते

Power Alley Trivia On Wednesday: An Auto-Generated Story — About Merck “Insiders” Selling Stock… Is Devoid Of Any Rational Analysis.

From time to time, I run across “stories” — likely generated by automated bots, or AI, if one prefers that turn of phrase. As I’ve previously said, the silliest version of these is likely the class that adds up SEC Form 4s totals for over a year, and declares that “insider executives” have lost confidence in the subject company. Poppycock.

In most cases, the seller(s) turn out to be using shares to pay for their exercise of options, or to pay taxes (i.e., to acquire even MORE shares in Merck — increase their investment holdings — not reduce them). Geez.

These auto-bots purport to offer “analysis” of financially important trends. But in truth, they usually get it exactly… backwards. As here. The “story” simply obscures a… non-event, over the past year out of Rahway.

Here is the specific nonsense, of the morning — for the sake of a complete record, solely:

…Insiders sold Merck shares recently, but they didn’t buy any. Despite some insider buying, the longer term picture doesn’t make us feel much more positive. While insiders do own a lot of shares in the company (which is good), our analysis of their transactions doesn’t make us feel confident about the company.

In addition to knowing about insider transactions going on, it’s beneficial to identify the risks facing Merck….

They “didn’t buy any, on the NYSE” is true, insofar as it goes. But it ignores that these “insiders” EARN shares, in restricted grants, and in options, vesting over time — from the company Treasury, directly — in return for their service to the company. In sum, day by day, their NET investment in the company’s fortunes, and future… increases.

Now you know. Onward.

नमस्ते

Hinderaker’s Omits… Much. Enough To Make It Misleading / False, In The Telling.

Honestly, I’ve covered this ground a dozen times.

Hinderaker leaves out context; ignores subtleties… and most of all, feels Israel has never been in the wrong. Ever.

There is no reasoning with anyone who holds that view.

And I don’t care to discuss competing religious-like zealotry… when each zealot’s side… is at war.

With each other.

There is scant point in doing so — until both sides grow completely bone-weary of the dying – and the killing.

So sure John — call for “eradication”. You are a frail old man, safe in your overstuffed leather arm chair, tonight in bucolic ex-urban Minnesota.

You sip your Manhattan and pontificate, fecklessly… because no one you love — let alone are related to, by blood is in harm’s way.

It’s easy to be an insufferable blowhard — — when you’re like old John. A world away from it all.

Out.

Down, From $78, Two Weeks Ago — To Now ~$23.20 On NASDAQ, Tangerine’s “Truth” Stock Is A Dead Cat, Dropped From A Skyscraper…

The stock is setting up very nicely, if one wants to allege that Devin Nunes’ CEO puffery — and Tangerine’s own material misstatements are actionable as federal securities fraud, that is. But to have a claim, one must buy at least a few shares. That is the bridge too far, for yours truly. This is the same scam he’s always run — sticking his investors with a property that is (after all bills are paid) worth next to nothing. Charming.

But the reason I write, is NOT to note that Devin Nunes now claims the “DJT symbol” will start streaming live hard right TV over that rickety social network (news that caused an added 8% stock decline just this morning, since that is vast new capital expense needed)… but to note that Trump himself is complaining that he will likely miss his youngest son’s graduation, since he is on trial for felonies in New York State.

See at right — highlighted portion (from his own phone, overnight). He fails to mention that the trial has been delayed repeatedly by his own specious tactics, with his counsel — claiming all manner of nonsense about not being subject to ordinary rules of criminal procedure. This caused the trial date to be delayed until… now. So he chose this course. He must deal with its consequences.

He’s been allowed to fully explore his nutty legal theories, but once an indictment for multiple felonies has been handed down, at some point the people of the State of New York ALSO have a right to see… justice done. If he is acquitted — fine. But if he isn’t… he is like all other criminal defendants, now. The State has a strong interest in a speedy trial — and incarceration, if that is where the jury lands.

So it is more than a lil’ preposterous that he thinks a felony trial should take a back seat to his social commitments. He can fete his son on any weekend when the court is closed. Yes, being an indicted potential felon is … inconvenient, dotard. “Don’t do the crime… if you can’t…” well, we all know the rest.

Onward, grinning.

नमस्ते

The Powerliners Were Silent — When 17 Injured And 1 Killed; Silent When 9 Gunned Down…

But let some people have to walk the last 1/5th of a mile — to get to their planes?!

And… “Oh. The. Humanities!”

Scott is a precious example of… hypocrisy.

Slowing traffic as a protest may not be the best strategy for winning hearts and minds, true… but it is First Amendment activity.

Driving a car at 40 mph into a crowd? Walking into a AME church — at prayers — and gunning down nine?

Not protected, Scott. Your religious bigotry / racism is showing in two decades of nearly tomb-like silence (involving violent whyte supremacists’ domestic terrorism) — and lack of proportionality, in response to what are protected (peaceful, if annoying) protests.

Do spare me your disingenuous theatrics Johnson.

Out.

Courtesy CIDRAP, We Learn That Soligenix (NJ) Won FDA “Orphan Drug” Designation, For Its Novel Ebola Vaccine Candidate, Active Against Sudan Variant…

To be certain, the war is being won, month by month, in terms of efforts to mitigate additional Ebola virus outbreaks in Sub-Saharan Africa. The education of the public, coupled to rigorous safe burial practices, when a case is suspected, have done wonders. That, and using ring vaccine strategies — as to all contacts of contacts, in an affected community. The outbreaks now rarely exceed 20 cases, and often with fewer than five fatalities. [Today’s good news comes courtesy of the arm of the University of Minnesota’s Med School’s CIDRAP website.]

But all of that vaccine strategy only works for outbreaks of the older, Zaire variant. One of the most recent outbreaks (in September of 2022) was of the Sudan variant, and was thus cause for grave concern — even when the careful public health efforts are able to arrest the spread. [In fact, the Sudan variant vaccine candidate has not been widely tested in the field yet, due to the rapid shutdown of transmission through public health outreach efforts.]

Here is just one of our prior backgrounders, on the Sudan variant — but it remains an open and gaping hole, in the defense net, for ring vaccinations, should another outbreak occur (and it is a near biological certainty there will be another).

So, it is wise that FDA will provide the New Jersey pharmaco with the streamlining review of an orphan drug designation. Orphan drug status also allows for greater overhead absorbing pricing, but is not designed for sponsors to recuperate all the costs of drug development. Rather, it confers a seven year exclusivity period (regardless of patent status), as a cost reduction and regulatory streamlining mechanism.

The FDA can, and occasionally does revoke orphan drug designation, if the side effect profile becomes too daunting, in aftermarket monitoring, or if initial estimates for efficacy turn out to be materially incorrect. But in this case, that would seem unlikely. So here’s the latest:

…Soligenix, a biopharmaceutical company based in New Jersey, recently announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in SuVax, its subunit protein recombinant vaccine as prevention and postexposure prophylaxis against Ebola Sudan, for which no vaccines or treatments currently exist.

Ebola Sudan is the second most common cause of human Ebola infections. In 2022, Uganda experienced an Ebola Sudan outbreak that resulted in 164 cases, 55 of them fatal. Earlier this year, the company reported that a bivalent (two-strain) version of the vaccine in a nonhuman primate trial provided complete protection against Ebola Sudan and Marburg viruses….

Now you know — and this development caused Soligenix’s stock to pop (more than double) on the NASDAQ, from $0.38 a share on Friday, to $0.83 per share by 10:00 am Eastern this morning — though it has since retrenched a bit, this afternoon.

Onward, to a sunny Tuesday — with Tangerine falling asleep at his own felony hush money trial in Manhattan. Charming. But grinning — just the same.

नमस्ते

The Bigger News Here Is Clarence Thomas Was Not Present Today — For Arguments…

It is likely he is… ill. Justices almost never miss argument days.

How ill? Ill enough that the court’s information office had no prepared remarks, on it.

We will wait and see — but in each prior absence, the Chief explained briefly the nature of the medical issue — for Bader-Ginsburg, and later, Gorsuch. He also explained when Thomas last missed a session.

But not today. Karmic revenge a-comin’, for the Merrick Garland nonsense, as “The Notorious” passed?

Maybe.

The other real news out of Manhattan is that Tangerine is going to have to attend a hearing that might include jail time, for weekend violations of the gag order imposed by Judge Merchan.

The live bloggers have it thus: “…Prosecutors said they want Merchan to punish Trump for violating the judge’s gag order by sharing certain social media posts over the weekend.

They said they want the judge to sanction Trump for each of three posts, to tell Trump to take down the posts, and to warn him that another post could result in jail time….”

That hearing may come on April 23 or 24, 2024, now — as potential jury members’ questioning continues.

And… I hesitate to even mention it, but…

I also write (sort of trivially) to point out that (contrary to what Hinderaker supposes) saying — in an on air interview — that “I moved on her like a bitch” and “grabbed her by the pussy” — and did not even ask permission… IS prima facie evidence of… sexual assault.

It seems Hinderaker needs to see bite marks, or similar evidence of a violent struggle, in order to accept that it was an… assault.

This comes up, of course, because Tangerine’s prior (recorded and authenticated) admissions of sexual crimes are fair game in the current hush money trial.

And that hurts lil’ Johnnie’s precious fee-fees… or something.

And to think that Hinderaker has college age, and post college aged daughters.

Astonishingly, he this afternoon claims that Trump’s statements — about the women — are actually evidence that the women consented to being groped, or worse.

I wonder what his daughters think of that view.

Damn.

BREAKING — NASA Administrator Says “$11 Billion To Retrieve Samples From Mars Is… Just Too Much”: Live, Now

The teleconference is live now.

NASA Administrator Bill Nelson is saying that we won’t cannibalize other missions, for the return of samples. But the mission cost has doubled in the decade since launch of the rovers. And waiting for humans on Mars (circa 2040) is entirely too long to wait.

So, a request for proposals from private industry partners (cough! Musk / Space X) will be concluded by this Fall — and the guideline will be “at or under” $5 billion, to return at least some of the samples (but perhaps not all 36 of them), by mid 2030. Now you know.

नमस्ते

So… Hinderaker Thinks It A Defense To Say… Bribery… Is LAWFUL?!

Not that I really care that Hinderaker doesn’t read very well, but in New York, theft of honest services is a crime.

And the “catch and kill” routine (through fixer Cohen), in addition to being a federal campaign law violation, is thus a “corruption” felony under NY state law — compounded by Trump’s intentional lies about the nature of the payments made.

So Hinderaker’s framing of the charges… is misleading to the point of falsity.

And yet, as John acknowledges, Alvin Bragg will get a conviction — that much is certain.

So — Hinderaker’s GOP candidate will be a convicted felon as he heads out of the Milwaukee convention, as the candidate for 2024.

Charming John. There was a time when… well… never mind.

You’ve become all the things you’d long said you’d despised about your pop’s generation.

Hilarious.