Previewing The Vote On ESG Investing, And A Debt Ceiling Update

 In his latest note, Stifel's chief Washington Policy Strategist Brian Gardner, discusses the potential overturn of a DOL rule regarding ESG investing, and also shares an update on the debt ceiling.

According to Gartnet, the ESG resolution is likely to pass the House and could pass the Senate, but President Biden is expected to veto the legislation and the DOL rule is likely to remain in place. Regarding the debt ceiling, it appears that budget options are limited.  These fiscal constraints create political risk for Speaker McCarthy.  This note also explores how the lack of options for budget cuts could lead to a political standoff and create market volatility this

His full note is below:

Vote on ESG Investing and Debt Ceiling Update

The House will consider legislation to overturn a DOL rule regarding ESG investing.  The resolution is likely to pass the House and could pass the Senate, but President Biden is expected to veto the legislation and the DOL rule is likely to remain in place.

Regarding the debt ceiling, it appears that budget options are limited.  These fiscal constraints create political risk for Speaker McCarthy.  This note explores how the lack of options for budget cuts could lead to a political standoff and create market volatility this summer.

ESG Vote

House Republicans are scheduled to vote on legislation that would block a Department of Labor (DOL) rule that permits fiduciaries to consider environmental, social, and governance (ESG) factors when making retirement investment decisions. The legislation in being considered under the Congressional Review Act (CRA), a mechanism through which Congress can overturn regulatory actions by federal agencies.  The significance of the CRA is that it allows the Senate to pass the legislation by a simple majority vote rather than by the typical 60-vote, super-majority threshold. 

The ESG-related bill is likely to pass the House and while the outcome in the Senate is unclear, the CRA procedure makes Senate passage more plausible than it would be under regular order.  However, even if the ESG bill passes both chambers of Congress, President Biden is expected to veto the resolution and the chances of Congress over-riding the president’s veto are remote.  The DOL rule is likely to remain in place for now.

Debt Ceiling/Budget Options

A recent Congressional Budget Office (CBO) report estimated that Treasury will exhaust its extraordinary measures to manage the debt ceiling (“X-date”) sometime between July and September.  Thus, Congress and the Biden administration are still months away from concluding a debt ceiling agreement.  However, the parameters of a potential deal are emerging, and it is becoming increasingly likely that a debt ceiling deal will be limited in scope. 

Key congressional Republicans have already acknowledged that Social Security and Medicare are off-the-table.  Those two programs combined with interest payments on the national debt account for approximately 71 percent of federal spending.  Congressional Republicans also seem committed to current levels of defense spending despite a loud minority within the party that seem to want defense cuts. Defense accounts for another 14 percent of federal spending which means that negotiations will focus on only 15 percent of federal spending.

Further underlining how difficult it will be to achieve large budget cuts, the Chairman of the House Budget Committee, Rep. Jody Arrington (R-TX) released a list of items to be considered during budget talks. Some of these cuts are one-time savings which others are spread over multiple years which further illustrates that limited amount of spending each party will be fighting over.

Chairman Arrington’s list includes:

• Recapture unobligated COVID money ($100 billion)

• Reinstating work requirements in welfare programs (“tens of billions”)

• Reduce fraud in the Child Tax Credit (CTC) and SNAP (Food Stamp) Program ($70 billion).

• Capping Obamacare subsidies at 400 percent of poverty and recovering overpayments ($65 billion).

• Cancel some EPA programs from the Inflation Reduction Act ($27 billion for the EPA with no specific programmatic purpose and $60 billion for “environmental justice” programs).

• End President Biden’s student loan initiatives – ($25 billion from ending loan repayment moratorium and $379 billion from prohibiting debt cancellation).

• Rescind $3 billion for new USPS electric vehicles, $1 billion for “clean” garbage trucks, $3.4 billion for “regional greenways” and “tree planting,” and $5.6 billion for low emissions buses.

• End approximately $281 billion in improper payments recently identified in a Government Accountability Office (GAO) report.

• “Stop Woke-Waste” – Eliminate a series of program all of which appear to cost less than $5 million and some less than $1 million which in a $6 trillion-plus budget are mere rounding errors.

Although it appears the differences between Democrats and Republicans will be narrow, passing a debt ceiling bill through Congress will not be a slam dunk.  Democrats are likely to dig in to protect their favorite programs.  At the same time, some Republicans could vote against any bill that they think fails to cut spending enough.  The situation puts House Speaker Kevin McCarthy (R-CA) in a tenuous position.  Speaker McCarthy has a narrow majority (currently five votes) and a group within his party that might oppose any debt ceiling bill.  This, in turn, could force McCarthy to make concessions with Democrats which could undercut McCarthy’s standing among conservative Republicans.  Disgruntled conservative Republicans could force a vote on McCarthy’s speakership and while most Republicans would vote for McCarthy again, it is unclear that there would be enough Democrats to save him. 

Most House Republicans seem open to voting for a modest debt ceiling deal but without a unanimous vote by Republicans, it could be difficult for McCarthy to reach a deal with the White House and Democrats which is why financial markets could be volatile this summer as the X-date approaches.  Investors could start to discount a negative outcome on debt ceiling negotiations when the X-date becomes more certain (rather than the current estimate of a three-month window) and if headlines start to suggest that Congress might fail to raise the debt ceiling in a timely manner.

https://www.zerohedge.com/markets/previewing-vote-esg-investing-and-debt-ceiling-update

Cytokinetics: Complete Response Letter for Heart Failure Therapy Application

 Complete Response Letter States that GALACTIC-HF Alone Does not Establish Substantial Evidence of Effectiveness Sufficient for Approval

Company Expects to Request Meeting with FDA to Discuss Potential Next Steps

Cytokinetics to Host Conference Call and Webcast on March 1, 2023 at 8:30 am Eastern Time

Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for the treatment of heart failure with reduced ejection fraction (HFrEF).

FDA communicated that GALACTIC-HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with reduced ejection fraction, in lieu of evidence from at least two adequate and well-controlled clinical investigations. FDA stated that results from an additional clinical trial of omecamtiv mecarbil are required to establish substantial evidence of effectiveness for the treatment of HFrEF, with benefits that outweigh the risks. GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) was a Phase 3 clinical trial of omecamtiv mecarbil that enrolled patients with HFrEF at risk of hospitalization and death, despite being treated with standard-of-care therapy.

Cytokinetics expects to request a meeting with FDA in order to understand FDA’s views regarding the CRL and what may be required to support potential approval of omecamtiv mecarbil. However, the Company has no plans to conduct an additional clinical trial of omecamtiv mecarbil and its focus remains on the development program for aficamten, the next-in-class cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, a Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM).

Cytokinetics will host a conference call tomorrow, March 1, 2023 at 8:30 AM Eastern Time that will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the event can also be accessed by telephone by registering in advance at the following link: Omecamtiv Mecarbil Regulatory Update Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call.

https://finance.yahoo.com/news/cytokinetics-receives-complete-response-letter-223100090.html

WHO Was 'Complicit' In China’s Cover-Up Of COVID-19 Origins: Sen. Daines

 by Samantha Flom and Melina Wisecup via The Epoch Times,

The World Health Organization (WHO) was “complicit” in helping China’s communist regime cover up the origins of COVID-19, according to Sen. Steve Daines (R-Mont.).

Speaking with NTD News, The Epoch Times’ sister outlet, Daines on Feb. 27 suggested that the WHO could not be trusted due to its compliance with in China’s attempts to hide the truth of how the pandemic began.

“Based on what we are seeing in the latest intelligence reports about the origin of COVID—that there’s credible evidence now that it may indeed have been a leak out of the Wuhan lab, given the role that WHO played in many ways of being complicit with the Chinese and covering up what happened in Wuhan—I think … you’re going to see a lot of new questions as the evidence continues to come out of Wuhan as to what really happened to the origins of the COVID,” the senator said.

Daines’ remarks came amid calls from his fellow senators for the Biden administration to declassify a U.S. Energy Department report that concluded that the COVID-19 pandemic most likely originated from a Wuhan laboratory leak.

According to a Feb. 26 Wall Street Journal report, the assessment was described in a document update by Director of National Intelligence Avril Haines. The report added that officials who had access to the classified report said the judgement was made with “low confidence,” given the lack of access to China. The FBI, in its own 2021 assessment, came to the same conclusion but with “moderate confidence,” the WSJ said.

As news of the report has spread, cries for transparency have erupted on Capitol Hill, including from Sens. Rand Paul (R-Ky.), Josh Hawley (R-Mo.), and Mike Braun (R-Ind.), all of whom said they felt the information should be declassified.

“The Biden administration has new ‘intel’ pointing to a lab leak,” Braun wrote in a Monday tweet. “The American people deserve to see it!”

The Senate Republicans’ concerns were also shared by their counterparts in the House, as House Oversight and Accountability Committee Chair James Comer (R-Ky.) and Select Subcommittee on the Coronavirus Chair Brad Wenstrup (R-Ohio) called on the Energy Department, State Department, and the FBI to provide documents and testimony on the matter.

“Since April 2, 2020, Committee on Oversight and Accountability Republicans have been investigating the origins of the COVID-19 pandemic, including the Chinese Communist Party (CCP)’s role in obscuring the truth regarding the initial outbreak, and whether any U.S. taxpayer dollars funded the Wuhan Institute of Virology’s (WIV) dangerous gain-of-function research,” the lawmakers wrote in letters to the three departments. “The Select Subcommittee is now the only Committee in Congress with explicit jurisdiction to conduct this wide-ranging and important investigation.”

Uncovering the truth, the congressmen added, “is vital to U.S. national security, critical to the prevention of future pandemics, and will bring some semblance of closure to the families of those who lost loved ones during the pandemic.”

At a White House press briefing on Monday, National Security Council spokesman John Kirby addressed the subject, noting that the president agreed that determining the source of the pandemic was important, but added, “There is not a consensus right now in the U.S. government about exactly how COVID started.”

Braun, responding to that comment via Twitter, said: “Let the American people decide for themselves. Declassify all COVID origins intel.”

The Epoch Times has reached out to the World Health Organization for comment.

https://www.zerohedge.com/political/who-was-complicit-chinas-cover-covid-19-origins-sen-daines

Transgender Athlete Wins Four Female Running Competitions In A Row

 by Paul Joseph Watson via Summit News,

A transgender athlete who now identifies as a woman has won four different female running competitions so far this year alone after smashing a women’s 5000 meter record last year.

50-year-old Canadian Tiffany Newell ‘transitioned’ into a woman in 2017 and began competing in women’s sport in 2020 after claiming to have met World Athletics guidelines on testosterone levels.

Newell scooped first place at the 3000 meter for women aged 45-49 event at the Winter Mini Meet on January 8 and then also ranked first in the women’s 5000 meter for women aged 45-49 event just days later.

On February 5, Newell repeated the achievement by winning the the 1500 meter for women aged 45-49 competition.

After he turned 50, the athlete then won first place at the 1500 meter for women aged 50-54 competition held from February 23 to February 26 in Toronto.

The International Consortium on Women’s Sport, a group demanding the protection of female competitions, reacted to the news by asserting it was a blatant example of “sex discrimination.”

Last year, Newell smashed the Canadian record in the 5000 meter indoor running competition for women aged 45-49 held at Toronto’s York University, beating it by six seconds, while also winning the 800 meter women’s race at the same event.

During a previous interview, the athlete argued against the creation of a category solely for transgender competitors.

“The policy makes sense for non-binary athletes, but I don’t feel comfortable racing against men. It categorizes me in the sex I am not identified as,” Newell said.

“I am a woman, and I feel most comfortable racing against women or other transgender women. I believe an open category can work if athletes can continue to race against athletes of the same gender.”

“Despite protests from trans activists, studies have consistently affirmed that trans-identified male athletes retain a significant edge over their female counterparts, even after starting hormone therapy,” reports Reduxx.

“In 2020, a study released in the British Journal of Sport Medicine noted that trans-identified males were able to complete 31% more push-ups and 15% more sit-ups in one minute on average than a female Air Force service member. They also ran 1.5 miles 21% faster.”

“But even after two years on testosterone suppression treatment, the males were still 12% faster on average than biological females.”

Earlier this month, American surfing icon Bethany Hamilton vowed to boycott the professional tour over a rule change that allows biological males who identify as women to compete against female surfers.

As we highlighted last year, swimming’s world governing body slapped a total ban on transgender athletes that have gone through any form of male puberty from taking part in women’s competitions.

A poll conducted last summer found that only 28 per cent of Americans support transgender athletes being allowed to compete in female sports tournaments.

https://www.zerohedge.com/medical/transgender-athlete-wins-four-female-running-competitions-row

GoodRx stock surges 15% after earnings beat

 GoodRx Holdings Inc. (GDRX) shares surged in the extended session Tuesday after the consumer-targeted digital healthcare platform topped expectations for the quarter. GoodRx shares rallied as much as 15% after hours, following a 1.5% rise in the regular session to close at $5.29. The company reported a fourth-quarter loss of $2 million, or break-even a share, compared with a loss of $39.9 million, or 10 cents a share, in the year-ago period. The adjusted loss, which excludes stock-based compensation expenses and other items, was 7 cents a share, even with the year-ago period. Revenue declined to $184.1 million from $213.3 million in the year-ago quarter. Analysts surveyed by FactSet had forecast an adjusted profit of 5 cents a share on revenue of $178.5 million. GoodRx forecast revenue between $181 million to $183 million for the first quarter, and revenue of $780 million to $790 million for the year.

https://www.morningstar.com/news/marketwatch/20230228940/goodrx-stock-surges-15-after-earnings-beat

Novartis halts Pluvicto new patient starts, struggles with supply in manufacturing expansion

 For patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed on prior treatments, Novartis’ radiotherapy Pluvicto offers a novel option. But the drug can be hard to come by these days, with supply constraints dogging existing patients and also delaying treatment for potential new takers.

Pluvicto doses were canceled for one patient for the fifth week in a row, Thomas Hope, M.D., a prostate cancer specialist and nuclear medicine expert at the University of California, said in a Sunday tweet. Some other patients have had their doses canceled twice, he added.

Asking whether others have run into the same issue, Hope soon received about a dozen similar complaints from doctors at other healthcare facilities. Some suggested the supply problem has also affected Novartis’ other radiotherapy, Lutathera, for neuroendocrine tumors.

“Yes, Novartis cancelled all our patients scheduled for this week. They had been waiting for months to receive it,” Shilpa Gupta, M.D., who co-leads the genitourinary oncology program at Cleveland Clinic, responded to Hope in a tweet regarding Pluvicto. In another reply, Nadine Mallak, M.D., a radiologist at the Oregon Health & Science University, noted four Pluvicto cancellations last Friday.

“Very frustrating! In some patients PSA rises in the interval waiting to be rescheduled, while they were initially responding well!!” Mallak tweeted.

PSA level in the blood is an indicator of prostate cancer treatment outcomes, and increasing PSA levels suggest cancer recurrence. Pluvicto, which combines therapeutic radioactive isotopes with cancer cell-directed compounds, is dosed every six weeks for up to six treatments.

Novartis is indeed experiencing challenges in meeting the Pluvicto's current demand, a spokesperson acknowledged in an emailed response to Fierce Pharma.

Novartis temporarily stopped accepting new patients as “the difficult but necessary step,” the spokesperson confirmed, until it has “more clarity on the FDA’s approval” of a manufacturing site in Millburn, New Jersey. The facility makes Lutathera and also supplies Pluvicto but only for commercial use in Canada and for clinical trial use. Initiating a new manufacturing site for commercial production of a drug requires a separate FDA signoff.

For Novartis, commissioning the Millburn facility may not be a straightforward process. The FDA previously slapped the site with a Form 483, citing quality control shortfalls. Last May, Novartis voluntarily put production at the facility—and another one in Ivrea, Italy—on hold after noticing potential quality issues. That halt interrupted supplies of both Lutathera and Pluvicto to the U.S.

Although Novartis soon brought the two sites back online, the company is still having trouble ensuring timely supply. One major challenge lies in the logistics of transporting the radioligand therapy, which has a very short shelf-life.

Doses have a five-day window to reach the patient, the company spokesperson explained. And Pluvicto is sourced from a single facility in Ivrea.

“Any interruption in the process, from unplanned manufacturing events, to doses not arriving in time due to shipping delays and challenges associated with importing a nuclear medicine into the U.S. may result in patient doses being rescheduled, which causes a ripple effect for patients in the queue,” the spokesperson added.

During Novartis’ fourth-quarter earnings call, CEO Vas Narasimhan, M.D., acknowledged that the company underestimated the demand among post-taxane patients. “It’s a question of us continuing to expand our capacity to meet what is a much larger interested population than we initially expected,” Narasimhan said.

Novartis is hoping to produce Pluvicto from four sites by the end of this year, instead of the existing single facility, Narasimhan said. The four sites will include three for U.S. commercial supply. Besides Ivrea and Millburn, Novartis aims to have an new automated facility online in Indianapolis with “substantial capacity” later this year, the CEO added.

A facility in Zaragoza, Spain, will handle clinical trial supply outside the U.S. And Novartis is evaluating adding more sites in Asia, he said during the earnings call.

At that time, Narasimhan said Novartis was talking to the FDA about filing the Millburn site and was planning to file the Indianapolis facility in the third quarter. Both submissions will be subject to a four-month review timeline.

Novartis has requested an expedited review from the FDA for Millburn. Pending an FDA green light, Millburn could begin supplying for U.S. patients by this summer, Novartis’ spokesperson said. Before the Millburn and Indianapolis sites become available, “our priority is to supply patients who have received their first doses and are currently in the treatment process,” the Novartis spokesperson said. “This is important to allow patients who have already begun the treatment cycle to appropriately complete their course of therapy.”

Overall, Novartis aims to have an at least 250,000-dose annual capacity for Pluvicto from 2024, Narasimhan said on the call.

Pluvicto is a key launch for Novartis and part of the company’s broader interest in radiotherapy. Banking on the potential to move into earlier prostate cancer treatment, Novartis put Pluvicto’s peak sales projection above $2 billion.

And $2 billion could be a very conservative estimate. FDA-approved in March 2022, Pluvicto sales reached $179 million in just the fourth quarter of 2022. That sales figure is already pretty close to the average quarterly haul Pluvicto could generate in its current post-taxane indication based on Novartis’ overall peak sales guidance, Bank of America analyst Graham Parry noted on the fourth-quarter call.

And 250,000 doses would translate into $8 billion of revenue at Pluvicto’s current U.S. price, Parry pointed out. 

Doctors’ experience thus far shows that Pluvicto has yet to reach its full potential in post-taxane mCRPC. In the clinical trial used for its approval, the drug showed it could reduce the risk of death by 38% when added to best standard-of-care in PSMA-positive mCRPC patients who had tried an androgen receptor inhibitor and at least one taxane-based chemotherapy regimen.

And Novartis just reported positive pre-taxane mCRPC data from the phase 3 PSMAfore trial. If approved in that setting, Pluvicto’s eligible patient pool could expand from 27,000 to 42,000 patients, Narasimhan has said. The company is accumulating more data at the FDA’s request, with a plan to file for an approval in the second half of this year. In addition, Novartis is testing Pluvicto in metastatic hormone-sensitive prostate cancer in the PSMAddition trial, which has a primary completion date in 2024.

Novartis’ Pluvicto hiccup reflects the difficulty in manufacturing therapeutics made with novel technologies. Back in 2014, Bayer also temporarily suspended supply of its own prostate cancer radiotherapy, Xofigo, because of a manufacturing quality problem. 

Narasimhan believes the difficult manufacturing process around radiotherapies positions Novartis well in potential upcoming competition. “Other players, of course, are going to come in and try to launch,” the Novartis CEO said on the fourth-quarter call. “A question will be, do they have the same scale and expertise that Novartis does to be able to navigate that complexity and really ensure that they can meet the demand?”

https://www.fiercepharma.com/manufacturing/novartis-halts-pluvicto-new-patient-starts-struggles-radiotherapy-supply-amid

Bayer grapples with Eylea sales slowdown, sees trend continuing in 2023

 On the surface, macular degeneration treatment Eylea continued its juggernaut path in 2022. On Tuesday, when Bayer reported fourth quarter earnings, it showed 3.2 billion euros ($3.4 billion) in full-year sales for a 10% increase on the previous year.

Combined with sales reported earlier this month by Regeneron, Eylea generated $9.6 billion in revenue worldwide in 2022, compared to $8.9 billion for 2021.

But a closer look at quarter-by-quarter performance, Bayer’s sales of Eylea tells a different story. In the first quarter, sales were (PDF) up 15.4% over the previous year. In the second quarter, it was (PDF) 13.5%. In the last two periods, the increases have shrunk (PDF) to 6.3% and 6.2%.

On Tuesday, Bayer said it expects the erosion to continue in 2023.

“We’re seeing continued good growth on volumes but we’re getting some pricing challenges,” Stefan Olerich, Bayer’s pharmaceuticals division chief, said during a conference call. “Overall this is not gonna be the same type of success that we’ve seen in prior years.”

Regeneron, which handles sales of Eylea in the U.S., reported a similar slowdown for the treatment in 2022, calling it a "blip."

The elephant in the room, of course, is Roche’s Vabysmo, which was approved last year in the U.S. and Europe, and has a formula that lasts twice as long as Eylea for many patients, requiring fewer doses.

When asked specifically about the competition, Olerich dodged the question, referring only to “pricing” pressure.

Bayer believes this will be a short-term trend, however, until Eylea’s high-dose, 8-mg answer to Vabysmo can pass muster with regulators.

“Compared to what many people did foresee—a declining Eylea in the coming years—we now should see a much more stable and maybe even growing outlook,” Olerich said.

Another elephant went unaddressed during the call—that of CEO Werner Baumann being replaced under investor pressure by former Roche pharma chief Bill Anderson, who takes over in June.

Baumann handled the prepared presentation, business as usual, on Tuesday, while turning the Q&A session over to his lieutenants.

Overall in Bayer’s pharma sector, sales were up 5% in 2022, to 19.25 billion euros ($20.4 billion). But mirroring the performance of Eylea, they were down in the fourth quarter by 2%.

Blood thinner Xarelto was still Bayer’s top seller in 2022 with sales of 4.5 billion euros ($4.8 billion) though falling by 5%. Baumann chalked the decline up to “volume-based procurement impacts in China and loss of exclusivity in Brazil.”

The company is depending on promising new products such as Nubeqa and Kerendia to compensate for the slide of its blockbusters. Prostate cancer drug Nubeqa is taking flight with sales more than doubled to 466 million euros ($494 million) for the year. In its fifth full quarter on the market, Kerendia hit sales of 107 million euros ($113 million).

“We’re seeing one of the strongest launch dynamics in the cardiovascular space, despite the initial COVID restrictions we had to face in 2021,” Olerich said.

Including its crop science and consumer health sectors, Bayer recorded an overall revenue increase of 8% in the fourth quarter but profits for the period fell from 1.16 billion euros ($1.23 billion) to 611 million euros ($648 million), chalked up to a higher number of lawsuits settled in 2022 over weedkiller Roundup.

The company expects overall revenue for 2023 to fall between 51 billion euros to 52 billion euros. Citi analyst Peter Verdult said the conservative guidance reflects Bayer’s CEO change.

https://www.fiercepharma.com/pharma/bayer-acknowledges-slide-eylea-sees-trend-continuing-2023