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Just A Little More Color, On One Franchise That Will Begin “The Backfilling” — In The 2030s, As Pembrolizumab Begins To Lose Exclusivity, Then: Winrevair®

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To be clear, Keytruda® will roll on, with global revenues increasing about 20% per year… into the early 2030s. That’s a huge competitive advantage — lapping the field, year after year. But should unforeseen patent trouble arise (in the form of a Congressional move, to more forcefully limit patent evergreening) — it will be products like winreviar, that keep Merck chugging along like the cash flow juggernaut it is.

It was indeed an excellent Q1 2024, and the NYSE-traded stock should reach into the $140-something range — perhaps even before year end 2024 — as the amped up guidance offered by Mr. Davis yesterday appears in the as actually-reported results next quarter and beyond. Here’s that story, from FiercePharma, as part of its review of Rawway’s first quarter 2024 “upside surprise” results:

…Four months into Davis’ tenure as CEO in 2021, the company acquired sotatercept in an $11.5 billion buyout of Acceleron. Data analytics group FactSet has projected sales of Winrevair to reach $3.9 billion by 2029.

“Strategic business development focused on the best external science remains an important priority,” the CEO said….

When asked to estimate Winrevair’s sales this year, Davis reiterated that the company does not provide guidance for its individual products. He did declare that the launch is off to a strong start, with prescriptions increasing along with repeat prescriptions. Shipments to patients’ homes is underway. And the company is seeing excellent access with “no real limits,” Davis said, which is a good sign considering the drug was approved less than a month ago, he added.

R&D chief Dean Li, M.D., Ph.D., said that there will be continued “data flows that will continue to inform and strengthen,” Winrevair’s profile. The company also is working on an auto-injector that should improve uptake for the drug, which is currently provided in a vial.

“We believe that the vast majority with time will use it as self-administration,” Li said. “This is a patient population that’s quite used to doing injections….”

I continue to believe that $250,000 a year — even though it is a life saver… is overpriced, for most US retail patients — as that means Merck makes back all $11 billion it paid for the whole company, in about five years.

The drug will remain on patent for over 20 years. The Condor’s view is that moves like that, indeed, are likely going to lead to more Congressional action to restrict US-drug pricing — or incentivize the company to more sharply increase EU and/or Canadian and Japanese prices — to allow the US prices to come down… between now and 2028, on all life-saving pharmaceuticals, generally.

[We’ve already seen one version of this (as we mentioned last week), with Merck allocating more supply of Gardasil to EU and Japan and UK — while shorting its contractual commits — to WHO/GAVI/UNICEF — for very low priced African deliveries, in this supply constrained year.]

नमस्ते

Merck Posts Very Strong Q1 2024 Results — And Expects Even Better — In The Back Half Of 2024…

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The pembrolizumab franchise is clocking ever-increasing sales. . . and is as we’ve said, now the world’s highest selling single therapeutic agent. That will continue past 2030 — as I’ve long explained, despite less rosy guesses from Wall Street, about earlier patent expiries. It is always possible that a better agent for oncology comes along… but other than that (which no one might foresee at this point), the runway is clear.

So Merck is back over $130 a share — and probably is looking at a 12 month fair value closer to $140, once Winrevair sales really start accelerating. Here’s the Reuters analysis:

…[T]he company is making good progress on improving access to Winrevair, with several insurers and other payers already establishing coverage for it.

“Overall, we see today’s results as consistent with the recent solid trends seen from Merck’s business,” J.P.Morgan analyst Chris Schott said.

The primary focus for Merck is Winrevair, Schott said, adding that he expects rapid uptake of the novel PAH drug, from the second half of the year….

New Jersey-based Merck said it expected annual earnings between $8.53 and $8.65 per share, up from its previous forecast of $8.44 to $8.59. Analysts had expected earnings of $8.56 per share. The company’s new forecast includes a $0.26 per share charge for its $680-million acquisition of cancer drug developer Harpoon Therapeutics, which closed in the first quarter of 2024, Merck said. The drugmaker forecast 2024 sales between $63.1 billion and $64.3 billion, up from its previous forecast of $62.7 billion to $64.2 billion. Analysts had expected sales of $63.83 billion….

Now you know — onward, grinning into the sunshine, here.

नमस्ते

[Plus Video!] Courtesy Our Commenter, A Look At A Miles-Wide Obsidian / Gem-Like “Volcanic Lake” On Tempestuous Moon Io, Around Jupiter.

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It would be quite a sight to see — a nearly mirror-like obsidian / “volcanic glass” surface, about 127 miles long, with a great white peak in the center… reflecting the vast face of Lord Jupiter, from time to time — highlighted, in the dim sunlight on that violent world.

Io is a very active little moon, regularly squeezed and tugged out of round by Jupiter’s crushing gravitational / tidal forces, and bombarded by Jupiter’s vast magnetic storms / radiation, on the regular. This makes Io… an active volcano-rich world — and a nearly-smooth orb, as it is regularly being resurfaced by lava flows that cool, and then reheat — and erupt. What a vision to see — and the graceful Juno craft, via its biggest camera… just recently had a front row seat — and saw it all, beaming the raw data back to us here, on our little blue marble.

Here’s the latest, per CNN’s science desk:

…Close flybys of Io, one of Jupiter’s moons and the most volcanically active world in our solar system, have revealed a lava lake and a towering feature called “Steeple Mountain” on the moon’s alien surface.

NASA’s Juno spacecraft, which first arrived to study Jupiter and its moons in 2016, flew within roughly 930 miles (1,500 kilometers) of the lava world’s surface in December and February to capture the first detailed images of Io’s northern latitudes.

It has been more than 20 years since a mission flew so closely by Io, and the spacecraft’s camera, called JunoCam, captured high-resolution images that showcased active volcanic plumes, mountain peaks and a glass-smooth lake of cooled lava….

Do click below — for an amazingly artistic interp, of the Juno-Cam data:

नमस्ते

Since Lynparza® Is In The News, Today… We Will Rerun Ours, From 2018, On The Whole Long History Here — Involving Merck/S-P…

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FiercePharma has a story on Lynparza out this morning. It is overall immaterial to Merck, as the changing landscape described there… doesn’t much move the needle as to Merck everall revenue before 2028 — but it offers a chance to remind, about the longish, and tangled, various corporate histories, here. So… see below:

[Original dateline — 12.03.2018:] If you were smart enough to buy in to Tesaro’s Citi Morgan Stanley-managed IPO six years ago — at $13.50/share (or even in the after-market at around $15), and hold — today, you are pretty happy… as GSK is buying your holdings for $75/share — all cash. That’s a more than five-fold return, in under six years. Sweet.

Since Tesaro in-licensed several of the legacy Merck (and in the case of rolapitant, at least, legacy Schering-Plough) oncology related cast-offs, after the bust-up of Schering-Plough… in truth, we have watched this company’s progress since at least March of 2010, on and off.

[Interestingly, and ironically (since Merck once owned it — via S-P), the rolapitant program came to be a commercial competitor of Merck’s Emend®, as a nausea treatment in chemo.] In any event, today we learn that, as part of Glaxo’s retooling (shedding consumer health assets; fully redeploying into / entering oncology)… Tesaro will become… GSK. And the nutritional beverages will be off-loaded. Here’s a bit, from one of the many morning stories on it all:

…GlaxoSmithKline is acquiring oncology firm Tesaro in a deal worth $5.1 billion just hours after announcing the sale of its health drinks business in India to Unilever for some $3.7 billion….

“The proposed transaction significantly strengthens GSK’s pharmaceutical business, accelerating the build of GSK’s pipeline and commercial capability in oncology,” GSK said in a statement announcing the Tesaro deal early Monday…. It’s all cash with GSK paying $75 a share….

It is said that dull people make their fortunes… in real estate (cough — Trump!), while the sharp make theirs in the stock market… and the geniuses? Well. They make theirs trading life science companies, in that stock market. Heh. I honestly don’t know anyone who said that, but it sounds good, today. Really stable… geniuses — smile.

नमस्ते

Both Paul And John Tell Lies, About The Contours Of NY State Criminal Law… YAWN.

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Each of them has gone after NY City Attorney Alvin Bragg, in posts overnight — into this morning. Paul Mirengoff’s is here…

And John Hinderaker’s libel is here.

Each of them claims that lying about why Stormy Daniels was paid by Michael Cohen… is no crime. That is false — the grand jury indictment proves it. And each of the boys knows it. Each of them argued for the criminal and impeachment-conviction of Bill Clinton, for lying about Monica Lewinsky, as felonies. [Links to those tens of dozens of posts available on request.]

But they each NOW claim that Tangerine’s lies, then memorialized as legal fees, and documented by checks, and treated not as campaign expenditures, but as regular Trump Org. business expenses… cannot be elevated to felonies, under New York law. About this, they both know full well… they are lying.

While it is true that the Bragg prosecution is one of Tangerine’s smaller exposures to felony jail time — as Paul openly now admits, the top secret documents case is almost iron-clad, in proof of multiple national security felonies… one way or another, he is going to be found guilty of important felonies against the people of this nation.

Even so, it may take a minute to go to trial, with USDC Judge Aileen Cannon (a Trump appointee) slow walking it. But Trump will be found guilty of felonies on some or all of the 90-ish felony counts he now faces — in four courtrooms around the Eastern seaboard.

In any event — saying that willful, knowing, financial lies — in business records, are not felonies… is just silly (and contradicts their numerous claims about Bill Clinton, where no payments were ever even alleged, by the way).

Yep — people go to jail all the time for lies on their business taxes, and state corporate filings (ones with knowing, intentional lies in them). It happens that NY AG Leticia James only charged his $450 million of loan-, and tax-frauds, civilly — so as to get a recovery sooner, for the people of New York. That was smart advocacy — under-charging the offense to get a dead bang win.

But make no mistake: those too were felonies, as a matter of law.

So do shut your yaps, John and Paul.

Out.

Mirengoff “Forgets” That — In Withholding Of Ukraine Aid — Tangerine Committed Felonies, As POTUS

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Paul makes a transparently stupid claim tonight that the GOP, in general, and Tangerine in particular — has done as much for Ukraine as the Democrats have.

He reaches back to pre-2012 to make his case (blaming Mr. Obama, falsely), such as it is. Then he ignores the last three years. AND THEN… he soft-pedals Trump’s obvious (and felonious) corruption in unlawfully conditioning the delivery of already Congressionally approved aid, upon seeking “dirt” on the son of Mr. Biden… as depicted at right.

Not exactly “the same as…” — as he would ask us to believe. [He goes on to say that Speaker Johnson risked much to get this done. DAMN — what a dumb lie: MTG was the sole voice to dump him, and if by “risking much”, Paul means he… got Democratic help to pass it… that bipartisanship is what we USED to expect from our Congress, in times of war. Jeebus, Paul!]

And certainly, for almost a year now, the MAGA / GOP wing has willfully thwarted an aid package to Ukraine, for the sole reason that it did not want Mr. Biden to get “a win”.

Again — Paul is looking through the telescope… “from the fat end” (moron!), if he truly believes his own drivel.

Confidential Nota Bene, to Paul: WE DON’T.

And he concludes tonight by suggesting that had Tangerine won in 2020, he isn’t so sure Putin would have invaded Ukraine, at all. He is likely correct, but in an ironic fashion, solely.

We cannot know for certain — but (if we are to entertain Paul’s pure conjecture…) it is just as highly likely that Trump would have given Putin “sub-silencio” permission — to just take Ukraine, and Trump (as he did repeatedly) would blunt NATO’s objections thereto, by arguing that the member nations hadn’t paid their share.

So Trump, based on clear past observations (well documented over six long years, now), would have likely actively aided Putin — in getting something that is NOT his — for the right payoff, of course — from Russia, to Trump, personally. Sheesh, Paul.

Out.

It Seems CEO Devin Nunes… Made A Material, Objectively-Verifiable As FALSE Pair Of Statements, In Today’s SEC Form 8-K Filing, For “Truth Social”. IRONIC.

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Look — I don’t care that much, because any human with a working forebrain will no longer want to own this pig of a stock — symbol “DJT”. But Mr. Nunes, as its ’34 Act CEO, has some… duties, imposed by decades of SEC case law. One is not to lie, knowingly, about any material matter, related to the stock, in the public square.

And a second is to correct a material misstatement, once made, again knowingly — by the CEO.

I’ve seen numerous data-bases, and MSM published reports that put the retail shareholder base at under 50,000 people. The RECORD holders number around… 500. And he claims no larger “Wall Street” institution holds the DJT stock, as a long position (I am pretty sure that much is true).

So, when he claimed on air yesterday, and repeated it — in an SEC filed Form 8-K (Material Developments) today… that he has “millions” — or even “hundreds of thousands” of retail shareholders… he was lying, and he knew it.

Please let the SEC enforcement lawyers take a look at this 8-K.

This is willful — and material — misstatement, of fact — not a projection, not “forward looking information”. It is a material factual claim… one that is… clearly false. [Of course, if the DJT transfer agent, or the renamed “EF Hutton” brokerage firm in Georgia (or other similar, and reputable representative of the company) will sign and notarize an affidavit that there are “retail holders” into the millions, under just five or ten or fifty record holder names. . . I will gladly print him a complete apology.] Onward — but this is… just so… on brand!

Me? I’d expect the SEC to ask after this — messrs. DJT, “Truth” and Nunes, in due course….

नमस्ते

A Very Cogent NYT Opinion — By Jamelle Bouie — On The UAW Win In Tennessee, And Its Deeply Resonant Civil Rights… Echoes.

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In the NYT, Jamelle Bouie offers a very poignant perspective, on why the sitting GOP governors (thus far, failing) attempts at fear mongering — about union rights… ring a decidedly-discordant and ugly bell… to the Jim Crow South… just dressed up, in some latter-day morning coats.

Do go read it all — he is clearly right: this past week was / is concrete evidence of MAGA / GOP party wags cum governors… largely seeking the “good ol’ days“, in Dixie (which never were such, for any non-whyte, non-landed gentry, non-male… classes):

…The mere potential for union success was so threatening that the day before the vote began, several of the Southern Republican governors announced their opposition to the U.A.W. campaign. “We the governors of Alabama, Georgia, Mississippi, South Carolina, Tennessee and Texas are highly concerned about the unionization campaign driven by misinformation and scare tactics that the U.A.W. has brought into our states,” their joint statement reads. “As governors, we have a responsibility to our constituents to speak up when we see special interests looking to come into our state and threaten our jobs and the values we live by.”

It is no shock to see conservative Republicans opposing organized labor. But it is difficult to observe this particular struggle, taking place as it is in the South, without being reminded of the region’s entrenched hostility to unions — or any other institution or effort that might weaken the political and economic dominance of capital over the whole of Southern society….

“In all social systems there must be a class to do the menial duties, to perform the drudgery of life,” Senator James Henry Hammond of South Carolina declared in an 1858 speech. “It constitutes the very mudsill of society and of political government, and you might as well attempt to build a house in the air, as to build either the one or the other, except on this mudsill.”

A decade later and the slave system was dead, crushed underfoot by the armies of emancipation. The landowning Southern elites had lost their greatest asset — a seemingly inexhaustible supply of free labor. They would never regain it, but they would fight as hard as they could to approximate it….

Neither the vote in Chattanooga nor the coming vote of auto workers at the Mercedes-Benz factory near Tuscaloosa, Ala., will be dispositive for the ultimate success of the U.A.W. campaign in the South. Win or lose, this will be a long march for organized labor.

But like a gardener taking stock of her plot for the season ahead, we will have to be patient. Victory might bring the chance to refresh the soil in preparation for a new kind of New South….

We will, of course, cover the upcoming Mercedes-Benz election, as well. Do breath easy, as we have our weather- eye keenly fixed on the horizon, here. And we see… change… is coming. Onward.

नमस्ते

Tangent: Bitcoin Mining Transaction Fees — Which Spiked Momentarily — Are Now BELOW The Pre-Halvening Levels… Hilarious — Market Discipline.

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The largely silly claim — last week — was that the debut of Runes, inscribed onto the blocks of mined Bitcoin would drive a vast increase in fees paid to miners. And true enough, the actual 480,000 block miner was paid about $2.6 million, in fees overall — but that was for the novelty of writing things onto that “Halvening” block.

Almost immediately, fees began falling over the weekend. They are now at under a third of where they were, at peak and slightly below the pre-halvening Levels.

In sum, the $80 or so per block in fees will never cover the fact that miners now face about four times more “squeezing” via the doubling in needed added capital for faster and more rigs, to the fact that the mining results in only half as many coins, as a reward, per block solved.

There is almost no chance Riot will be profitable — unless Bitcoin stays above about $160,000 for a full year, now.

Fairly valued, this is a sub-$3 stock (though it is trading near $10 this morning).

Onward — into the Spring sunshine of the fifty-fourth Earth Day! Be excellent to one another. . . .