Search This Blog

Monday, November 6, 2023

Vertex Pharmaceuticals 3Q Profit Rises on Continued Sales Strength

 Vertex Pharmaceuticals' profit rose in the third quarter on continued strength in sales of its cystic fibrosis treatments.

The Boston-based drugmaker posted a third-quarter profit of $1.04 billion, or $3.97 a share, compared with $930.5 million, or $3.59 a share, a year earlier. Analysts polled by FactSet expected per-share earnings of $3.50.

Stripping out certain one-time items, adjusted per-share earnings came to $4.08, ahead of the $3.92 forecast by analysts, according to FactSet.

Revenue rose 6% to $2.48 billion, missing the $2.5 billion expected by analysts polled by FactSet.

The results were lifted by strong sales of Vertex's cystic fibrosis drug Trikafta, including the launch of the drug in children age two to five, the company said.

Vertex said revenue growth, higher interest income and lower tax expense, were offset by increased investment in the company's pipeline and the cost to support drug launches.

The company increased its full-year guidance for cystic-fibrosis product revenue to $9.85 billion, compared with prior guidance of $9.7 billion to $9.8 billion.

https://www.morningstar.com/news/dow-jones/2023110610660/vertex-pharmaceuticals-3q-profit-rises-on-continued-sales-strength

Clover ups guidance after results

 Q3 2023 Insurance MCR Improved to 78.5%, bringing year-to-date MCR to 80.8%, and Insurance revenue grew 12% compared to Q3 2022

Company reports Q3 2023 Net Loss of $41.5 million and Adjusted EBITDA loss of $5.1 million

Revised full-year 2023 guidance now reflects Insurance MCR of 81% - 82% and Adjusted EBITDA of ($55) million - ($80) million

https://www.globenewswire.com/news-release/2023/11/06/2774493/0/en/Clover-Health-Reports-Third-Quarter-2023-Results-Highlights-Continued-Improvement-in-Financial-Performance-and-Improved-2023-Guidance.html

Ventyx psoriasis trial misses target

 VTX958 225 mg BID and 300 mg BID doses achieved statistical significance on the primary endpoint (PASI 75) and all key secondary endpoints at Week 16

Efficacy results did not meet the internal target to support further development of VTX958 in psoriasis; Ventyx to terminate Phase 2 trials of VTX958 in plaque psoriasis and psoriatic arthritis

The ongoing Phase 2 trial of VTX958 in Crohn’s disease will continue to enroll; Ventyx intends to conduct an interim efficacy analysis in Q1 2024

Cash, cash equivalents and marketable securities of $300.8M as of September 30, 2023

Ventyx to host conference call and webcast today at 4:30 PM ET

Ventyx will host a conference call today at 4:30 p.m. ET to discuss the results from the Phase 2 trial of VTX958 in patients with moderate to severe plaque psoriasis. To participate in the conference call, please dial (800) 225-9448 (U.S.) or (203) 518-9708 (international) and reference passcode VTYX1106. A live webcast will be available in the Investors section of the company’s website at www.ventyxbio.com. A recording of the webcast will be available for thirty days following the call.

https://www.globenewswire.com/news-release/2023/11/06/2774464/0/en/Ventyx-Biosciences-Announces-Results-from-the-Phase-2-Trial-of-VTX958-in-Patients-with-Moderate-to-Severe-Plaque-Psoriasis-and-Provides-Corporate-Update.html

China's Strategic Export Control Upends Rare Earth Markets

 by Haley Zaremba via OilPrice.com,

  • China's restriction on graphite exports could increase global battery production costs, impacting the electric vehicle industry during a pivotal time in the energy transition.

  • The U.S. and other nations are reducing reliance on China's rare earth minerals, though China still holds a dominant position in global supply.

  • In the long term, China's export controls may encourage the development of alternative supply sources, enhancing global energy security and market stability.

China has spent years staking out near-total domination of a laundry list of rare earth minerals with a vital and growing role in clean energy supply chains. The nation has been building up its own domestic wealth of these key primary materials while simultaneously expanding its acquisitions and influence in resource-rich developing nations in Asia, Africa, and Latin America. But now, China is limiting exports of graphite, a key material in electric vehicle batteries as well as other energy industry applications, in a move that will have reverberating implications for the global clean energy sector. 

China’s laser focus on building up its energy security to meet its near-insatiable demand for new sources of energy and electricity have given it a massive leg up in the clean energy sector on a global scale, as the West has failed to keep pace with Beijing’s breakneck investing trends. For years, Beijing has been busily outspending and out-negotiating every other country on the planet. According to figures from a BloombergNEF analysis conducted earlier this year, China was solely responsible for almost half of global spending in the renewable energy sector last year at a whopping $546 billion. That’s nearly four times what the United States spent ($141 billion) and 2.5 times what the European Union spent ($180 billion). 

Rare earth mineral markets play a key role in this spending. China is home to 34% of the world’s rare earths (with 44 million tonnes of rare earth oxide (ROE) equivalent in reserves), did 70% of global rare earth mining in 2022, and represents at least 85% of global capacity to process rare earth ores into manufacturing materials. Because of this outsized role, global markets have become dangerously reliant on Chinese supply chains in order to meet their own energy and climate goals. This isn’t just a China issue – it’s also a United States issue. As Foreign Policy recently reported, “America dropped the baton in the rare-earth race.” And now that they’re trying to catch up after years of under-investment, they’re struggling to close the gap.

However the market is changing slightly due to a combination of increased competition, particularly coming from Washington, as well as a shifting strategy on the part of Beijing. While China reported a mammoth amount of rare earth exports last year (48,728 tonnes in 2022) this marked a 0.4% downswing from the previous year. Furthermore, while the U.S. continues to rely on China for the lion’s share of its rare earth imports, that dependence is also slightly lessening, from 80% during the period of 2014 to 2017 to 74% between 2018 and 2021.

And now, doubling down on this trend, China is severely restricting graphite imports according to a statement released by China’s Ministry of Commerce (MOC) and General Administration of Customs on October 20. The translated statement said it was “optimizing and adjusting temporary export control measures for graphite items” in order to “safeguard national security and interests.”

In the immediate term, this means that graphite prices will rise, causing problems for EV battery manufacturers at a critical junction in the global decarbonization transition.

“A curb in the supply of the material originating from an important supplier that is China will increase its price and therefore the cost of production of batteries, particularly for non-Chinese producers,” Carole Nakhle, the CEO of consultancy Crystol Energy was recently quoted by Rigzone.

“However, it is that same price signal and the concern of customers about the security of supply that will also encourage the development of alternative supplies, which is desperately needed to support the security of supply for the energy transition,” she added.

China is fighting to keep up with its own ever-growing energy demand, and its own energy security interests may continue to tamper with the nation’s rare earth exports. This could be a blessing in disguise. While price shocks could cause significant issues in the short term, as the massive and unprecedented deployment of clean energy infrastructure and electric vehicles is necessary and urgent to meet global climate goals, the long-term implications of diversifying global clean energy supply chains are extremely positive. Greater diversity means greater resilience and sustainability of the global economy and shores up global energy security by correcting what is currently an extremely – and dangerously – lopsided market. 

https://www.zerohedge.com/technology/chinas-strategic-export-control-upends-rare-earth-markets

"The Big Fail" - Anti-Lockdown Goes Mainstream

 by Jeffrey Tucker via The Brownstone Institute,

It’s a shift worth marking. 

New York Magazine is featuring an article called “COVID Lockdowns Were a Giant Experiment. It Was a Failure.” The authors are two excellent journalists, Joe Nocera and Bethany McLean, who have also written a new book called The Big Fail, which I have not read but intend to.

The ascent of the book and thesis is hugely important, if only to further blunt the impact of Michael Lewis’s The Premonition, which came out in 2021 with the purpose of valorizing the absolute worst of the lockdowners. 

The worry at the time was that Lewis’s book, like The Big Short, would become a major movie that would codify lockdowns as the right way to deal with infectious disease. That does not seem to be happening, and the cleverly titled book by Nocera and McLean seems to assure that this will never happen. Thank goodness. This is progress. Be grateful when we see it. It is also a tremendous credit to all those who have been pushing the Nocera/McLean thesis since the spring of 2020. 

Lockdowns were always an impossible means of pandemic management. We knew that from a century ago. It was not even controversial. The orthodoxy in public health survived even up to a few weeks before the lockdowns began.

Out of nowhere, settled wisdom was completely upended. Suddenly, as if straight from Orwell, lockdowns became “common sense mitigation measures.”

Meanwhile this country and most other countries around the world were being utterly tortured by a crazed bureaucracy determined to master the microbial kingdom by bullying people and wrecking their businesses, schools, churches, and lives. 

If nothing else, this era proves for this generation the astonishing capacity of the human mind to undertake utterly insane policy experiments on a grand scale without the slightest evidence that they could ever succeed, even while they trample on all established norms of rights and liberties. 

This is a revelation, at least to me. We’ve never seen anything like it in our lives.

Speaking personally, this reality utterly shattered a worldview that I didn’t know I held: namely, I genuinely believed humanity was on a path, even an inevitable one, toward greater knowledge, learning, and the embrace of freedom. After March 2020, I and everyone discovered otherwise. That was both intellectually and psychologically traumatic for me and for millions of others. 

We are still figuring out how and why all this happened. In order to do that, we at least need a consensus that this was a terrible mistake. Even three and a half years later, we haven’t even had that. To be sure, it is very difficult to find defenders of lockdowns. They have mostly evaporated into the hedges. Even those who pulled the trigger and defended them at the time are all denying that they had anything to do with them. My favorite: we never had a real lockdown. 

Regardless, the mere appearance of the Nocera/McLean article takes us quite a distance to where we need to be at least for now. Yes, it is 42 months late, but we take progress wherever we can find it. 

Just some quotes from the article:

“One of the great mysteries of the pandemic is why so many countries followed China’s example. In the U.S. and the U.K. especially, lockdowns went from being regarded as something that only an authoritarian government would attempt to an example of “following the science.” But there was never any science behind lockdowns — not a single study had ever been undertaken to measure their efficacy in stopping a pandemic. When you got right down to it, lockdowns were little more than a giant experiment.”

“Unfortunately, there is no shortage of policy failures of which to take stock. We do an accounting of many of them in our new book, The Big Fail. But one that looms as large as any, and remains in need of a full reckoning in the public conversation, is the decision to embrace lockdowns. While it is reasonable to think of that policy (in all its many forms, across different sectors of society and the 50 states) as an on-the-fly experiment, doing so demands that we come to a conclusion about the results. For all kinds of reasons, including the country’s deep political divisions, the complexity of the problem, and COVID’s dire human toll, that has been slow to happen. But it’s time to be clear about the fact that lockdowns for any purpose other than keeping hospitals from being overrun in the short term were a mistake that should not be repeated. While this is not a definitive accounting of how the damage from lockdowns outweighed the benefits, it is at least an attempt to nudge that conversation forward as the U.S. hopefully begins to recenter public-health best practices on something closer to the vision put forward by [Donald] Henderson.”

You will notice the hedge here: “for any purpose other than keeping hospitals from being overrun.” Another way to put it: lockdowns are fine for rationing healthcare. There is reason to emphatically disagree. Hospitals wildly exaggerated how overrun they were. There were two hospitals in New York boroughs that had high traffic, but this was due to exigencies of ambulance contracts. The rest were largely empty as they were around the country. This was due to lockdowns that restricted medical services to Covid only even in places where there was no community spread, plus public fear of leaving the home. 

(I had a conversation last week with the head of a company that sells ventilators and diagnostic equipment to hospitals in New York. He said that in the early months of lockdown, he had never seen hospitals so empty. This was confirmation to me of what we already knew.)

This whole subject needs some serious unpacking. To my knowledge, we still don’t know where the edicts came from to lock down hospitals all over the country. That is a research project all its own. In other words, carving out an exception for “overrun” hospitals is deeply dangerous: it only incentivizes the lockdowners next time to game the reporting in a way that is favorable to more lockdowns. This is precisely what happened in the UK, where the main and even only justification for lockdowns was the rationing of healthcare services. 

So this proviso is actually dangerous in every way. 

Now we must deal with another piece of this article that is far from correct. I quote:

“As the United States gains more and more distance from the COVID pandemic, the perspective on what worked, and what did not, becomes not only more clear, but more stark. Operation Warp Speed stands out as a remarkable policy success. And once the vaccines became available, most states did a good job of quickly getting them to the most vulnerable, especially elderly nursing-home residents.”

The perspective is what we might be called the exogenous theory of the jab. The idea is that the lockdowns and masking and the whole apparatus of disease control exists in a separate system of ideological confusion, whereas the vaccine came from the outside to intervene but otherwise was not part of the planning apparatus. 

I certainly once shared this view. About the vaccine in 2020, rumored to come along at any point, I care next to nothing about it. I assumed it would be useless because my reading on the topic showed that a coronavirus is in the class of pathogens against which one cannot vaccinate. 

That aside, there is a real danger associated with attempting to vaccinate your way out of pandemic. You can create the conditions that drive mutations even more, and introduce the prospect of what’s called original antigenic sin. What I had not anticipated was that the shot would be actually deeply dangerous, much less that it would be mandated. 

The more research we do, the less plausible this theory of exogenous intervention is. From the very outset, the vaccine was planned and a huge part of the entire pandemic control agenda. And consider this question. Would it have been possible to drive the emergency use authorization, indemnify the results from any liabilities, retain patents, elicit tax funds for development, plus push innumerable institutions to mandate the shots in absence of the national emergency, the frenzy, the demoralization, and the population-wide panic? I’ve asked many people this question, and the answer is always: no way. 

There is no world in which Warp Speed would have taken hold absent the lockdowns. They are all part of the same system and policy. So, yes, it is strange for our authors to isolate the vaccine as good in the context of everything else which they label bad. Emergencies elicit bad actors and bad actions. They are all of a piece. 

At this point, most of us have become jaded about media and messaging from mainstream sources. So an easy tag to put on this important article in New York Magazine is: limited hangout. Let’s admit failure where possible, concede mistakes and disasters along the way, even while sneaking in an approving and passing remark about the thing which in the end is the most important part of the whole epoch, namely the vaccine itself. That way, the rubes will be satisfied that there is some accountability going on, even while the biggest and deepest caper of them all gets away without a scratch. 

There is no need here to chronicle the innumerable and now widely known failure of the shot. In any case, among those who still want to claim it to be a great success, their messaging is not long for this world. The evidence is too overwhelming, and felt in every part of society the world over. 

What we have with this book and article is an important step. It is just one step. Lockdowns utterly shattered the protocols of public health, settled law, and freedom itself all over the world. They wrecked myriad institutions, wrought an incredible economic and cultural crisis, demoralized the whole population, and built up a leviathan of command and control that is not only not backing down but growing ever more. Far more will be required to utterly and completely repudiate the methods and madness of our epoch. 

https://www.zerohedge.com/covid-19/anti-lockdown-goes-mainstream

Bayer doubles down on Factor XIa with new phase 3 trial

 Bayer has added another phase 3 trial into its registration programme for oral Factor XIa inhibitor asundexian, signalling growing confidence in a drug that generated mixed results in phase 2.

The new OCEANIC-AFINA study will enrol patients aged 65 and over with atrial fibrillation (AF) and at high risk of ischaemic stroke or systemic embolism, but who can’t be treated with standard oral anticoagulant therapy (OAC) because of a risk of bleeding complications.

AF is a condition characterised by an irregular and often rapid heartbeat that can lead to the formation of blood clots in the heart. These can travel through the bloodstream to plug another vessel, causing serious and life-threatening conditions such as a stroke.

OCEANIC-AFINA is focusing on a group of AF patients who have often been overlooked and excluded from clinical trials, said Bayer.

Asundexian (BAY2433334) is among an emerging crop of Factor XIa inhibitors that promise to provide the same anticoagulant properties as current OACs without raising the risk of bleeding side effects.

The drug is already being tested in two other phase 3 trials, including a study called OCEANIC-AF in up to 30,000 patients with AF and elevated risk of non-cardioembolic ischaemic strokes or transient ischaemic attacks (TIAs).

It is also being investigated as secondary prevention in the OCEANIC-STROKE study involving patients who have already suffered a stroke or high-risk TIA, as an add-on to standard antiplatelet therapy.

Last year, Bayer opted to move asundexian into phase 3 trials even though the drug missed primary efficacy endpoints in a pair of phase 2 studies in ischaemic stroke (PACIFIC-STROKE) and acute myocardial infarction (PACIFIC-AMI). The drug did meet its safety objectives, however, with no increase in bleeding rates compared to placebo.

Bayer said today that the three studies will aim to provide “robust evidence for the efficacy and safety of asundexian across a broad range of patients with AF, including those who are at high risk for both ischaemic stroke or systemic embolism and major bleeding events.”

Bayer is in a race in the Factor XI inhibitor category with other developers, including Bristol-Myers Squibb and Johnson & Johnson with milvexian – also in a phase 3 programme called LIBREXIA, despite a mid-stage stroke trial miss – as well as Anthos Therapeutics with abelacimab, an injectable Factor XI/XIa-targeting antibody that generated encouraging results in a phase 2b trial earlier this year.

Milvexian is in three late-stage studies in AF, stroke, and acute coronary syndromes (ACS), while abelacimab is in the phase 3 LILAC-TIMI 76 in patients with AF deemed unsuitable for current OAC therapy.

Anthos is also exploring another pathway with its drug, focusing on cancer patients at risk of thrombosis in its MAGNOLIA and ASTER phase 3 trials.

The lacklustre results in phase 2 studies of both asundexian and milvexian have led to speculation that the oral Factor XIa class may not meet earlier analyst expectations of multibillion-dollar sales, but their developers seem convinced their potential is worth the considerable investment in phase 3 studies. 

The results of those studies should start to emerge in 2025.

https://pharmaphorum.com/news/bayer-doubles-down-factor-xia-new-phase-3-trial

Hims & Hers ups outlook

 Revenue of $226.7 million, up 57% year-over-year in Q3 2023

Net loss of $7.6 million; Adjusted EBITDA profitability of $12.3 million in Q3 2023

Subscribers grew to 1.4 million, up 56% year-over-year in Q3 2023

Exited Q3 2023 with over 80% of orders fulfilled via affiliated facilities

Raises full year 2023 revenue guidance to a range of $868 million to $873 million and Adjusted EBITDA guidance to a range of $43 million to $46 million

https://www.businesswire.com/news/home/20231106501282/en/