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Friday, July 12, 2024

Akebia Ends Deal With CSL Vifor, Unveils Hefty Price Tag for CKD Anemia Drug Vafseo

 Akebia Therapeutics on Thursday announced that it has regained full rights to the oral drug Vafseo (vadadustat) for chronic kidney disease anemia after its commercialization partner CSL Vifor agreed to terminate their contract.

According to the biotech, CSL agreed to a royalty-based termination agreement which gives Akebia the exclusive commercialization rights to Vafseo in the U.S., as well as the ability to work directly with dialysis organizations “effective immediately.”

In return, CSL is entitled to quarterly tiered royalties which will range from high single-digit percentage of annual net sales up to $450 million to a mid-single digit percentage of annual net sales beyond $450 million. Staring July 1, 2027, Akebia will have the option to “buy down” this royalty agreement in exchange for a one-time payment to CSL.

“Having now executed this agreement with CSL Vifor, we can accelerate contracting discussions and expect to have contracts in place with dialysis providers treating the vast majority of eligible Vafseo patients before January 2025,” Akebia CEO John Butler said in a statement.

Concurrent with the announcement of the contract termination, Akebia on Thursday also unveiled the price tag for Vafseo. The biotech set the drug’s wholesale acquisition cost at $1,278 per 30-day supply at its minimum starting dose. On a yearly basis, Vafseo will cost around $15,500.

The drug’s potential expansion into patients who are not on dialysis was a key factor in deciding its cost, Butler said in an investor call, noting that the Inflation Reduction Act limits companies’ ability to adjust their pricing. “You have one opportunity to price your drug,” Butler contended, noting that the biotech considered an expanded label in its “strategic pricing.”

Vafseo is a small molecule drug that works by blocking the HIF-PH enzyme, which is an important player in the cellular response to low oxygen levels. Through this mechanism of action, Vafseo triggers the body’s response to hypoxia and promotes the production of erythropoietin for anemia.

In March 2024, the FDA approved Vafseo for the treatment of anemia due to chronic kidney disease (CKD), but notably restricted its use in patients who had been undergoing dialysis for at least three months. Akebia is looking to expand Vafseo’s label to cover non-dialysis populations, for which it is planning to hold discussion with the FDA within the year.

At the time of its approval, Butler said that Vafseo could provide patients with “an alternative treatment option” for anemia associated with CKD. The drug carries a boxed warning for an elevated risk of death, myocardial infarction, stroke, venous thromboembolism and thrombosis of vascular access.

https://www.biospace.com/article/akebia-ends-deal-with-csl-vifor-unveils-hefty-price-tag-for-ckd-anemia-drug-vafseo/

AbbVie’s Humira Continues to Lose Market Share as Biosimilars Gain Ground: Report

 AbbVie’s Humira (adalimumab) remains the biggest player in the anti-inflammatory space but its market share has dropped to 82% since May 2024, according to Samsung Bioepis’ latest biosimilar report released on Thursday.

Humira’s market share dipped by around 13% since Samsung Bioepis’ previous report in March 2024, while the overall share of biosimilars grew to around 18%. Most of these gains were driven by Sandoz’s and Cordavis’ copycat Hyrimoz, which now controls 13% of the market. The nine other Humira biosimilars have together taken less than 5% of the market.

Pricing has not been a strong factor in eroding Humira’s dominance. According to Samsung Bioepis’ report, the biosimilar brands provide “diverse” pricing options for adalimumab and some have offered steep discounts. Samsung Bioepis’ Hadlima and Coherus’ Yusimry cost around 85% lower than Humira, respectively.

However, coverage and access appear to be more important drivers. Humira’s market share started declining after top pharmacy benefit manager CVS Caremark in April 2024 removed AbbVie’s product from its major national commercial formularies. Cordavis, which launched in August 2023 and partnered with Sandoz to develop Hyrimoz, is a subsidiary of CVS Health.

In the weeks following the move, new prescriptions for Hyrimoz skyrocketed, jumping from 640 in the week ending March 29 to 8,300 in the week ending April 5.

Humira is a monoclonal antibody therapeutic that works by targeting TNF-alpha, a pro-inflammatory cytokine that has been established as a key player in several immune-mediated conditions. The FDA first granted Humira approval in 2002 for rheumatoid arthritis, but the biologic has since become one of AbbVie’s most valuable assets winning additional indications for Crohn’s disease and ulcerative colitis.

In 2021, before losing key patent protections, Humira raked in $20.6 billion in revenue, representing 14% growth from the prior year. In 2023, suffering growing biosimilar erosion, Humira’s global sales dipped 32% to $14.4 billion.

Humira biosimilars first entered the U.S. market in January 2023, led by Amgen’s Amjevita. In July 2023, several other drugmakers launched their own copycat products including Celltrion’s Yuflyma and Boehringer Ingelheim’s Cyltezo, which also bears the FDA’s interchangeability designation allowing it to be swapped out for the branded reference product without a change in the prescription.

Alvotech and Teva recently won the FDA’s approval for their Humira biosimilar Simlandi, which also has the interchangeability designation and is a high-concentration and citrate-free formulation.

https://www.biospace.com/article/abbvie-s-humira-continues-to-lose-market-share-as-biosimilars-gain-ground/

Senate Unanimously Passes Bill to Reduce Big Pharma Patent Thickets, Increase Competition

 In a potential victory for drug pricing reform, the U.S. Senate on Thursday unanimously passed a pharma patent reform bill that could help promote generic and biosimilar competition for prescription drugs and lower their costs.

The bill, sponsored by Sens. John Cornyn (R-Tex.) and Richard Blumenthal (D-Ct.), limits the number of patents that pharma companies can assert in infringement litigations. These limits are “subject to exceptions and waivers” such as how long the product has secured regulatory approval from the FDA.

The original bill also prohibited product-hopping, which the senators defined as the industry practice of replacing an older product with a newer treatment that is covered by a later-expiring patent. However, the legislation that passed the Senate vote on Thursday did not include these prohibitions, according to Endpoints News.

The Pharmaceutical Care Management Association (PCMA) heralded the bill as “critical” to helping “end anti-competitive practices” including patent thickets, a common tactic of layering patents on top of a single product to extend its market protections and deter other companies from introducing generic or biosimilar versions.

Patent thickets “game the patent system, blocking more affordable generic and biosimilar options from entering the prescription drug market,” according to PCMA, a lobbying group that represents pharmacy benefit managers (PBM) across the U.S.

PCMA in its statement insisted that “patent abuse legislation should be the top consideration” in Congress’ campaign to lower drug prices. However, the Federal Trade Commission (FTC) released a report earlier this week pointing to PBMs as a major reason for inflated drug prices in the U.S.

According to the FTC’s interim report, PBMs “wield enormous power” over patients’ ability to afford drugs and “significantly influence what drugs are available and at what price.” The FTC is gearing up to sue the three biggest PBMS—CVS’ Caremark, UnitedHealth’s OptumRx and Cigna’s Express Scripts.

In addition to Coryn and Blumenthal’s bill, Sens. Peter Welch (D-Vt.), Mike Braun (R-Ind.) and Amy Klobuchar (D-Minn.) introduced similar legislation in January 2024 aiming to “streamline drug patent litigation” and promote competition to reduce drug prices. This bipartisan bill would allow pharma companies to assert only one patent per thicket in litigation.

https://www.biospace.com/article/senate-unanimously-passes-bill-to-reduce-big-pharma-patent-thickets-increase-competition/

Immutep Aces Phase IIb in First-Line Head and Neck Cancer, Eyes Regulatory Path Ahead

 Immutep on Friday posted data from its ongoing Phase IIb TACTI-003 trial, demonstrating that its investigational LAG-3 therapy eftilagimod alfa elicited high response rates when used with Merck’s Keytruda for the first-line treatment of patients with metastatic head and neck squamous cell carcinoma.

The results, which were presented at the European Society of Molecular Oncology (ESMO) Virtual Plenary session on Thursday, demonstrated a 35.5% objective response rate in patients treated with the eftilagimod alfa (efti)-based regimen. The disease control rate was 58.1%.

According to Immutep, the findings are “among the highest recorded for a chemotherapy-free approach” in head and neck cancer patients negative for PD-L1—the target patient population of TACTI-003.

Results also showed that efti plus Keytruda led to the complete disappearance of all signs of cancer in three of the 31 evaluable patients, resulting in a complete response rate of 9.7%. Immutep in its statement said that this “compares favorably” versus a historical control, in which none of the patients treated with an anti-PD-1 agent achieved complete response.

The Australian biotech’s stock surged 19% in premarket trading in response to the findings, according to SeekingAlpha.

Robert Metcalf, of the Christie NHS Foundation Trust in the U.K., said in a statement that efti’s response rate—when used as a first-line treatment option with Keytruda—is “well above other treatment approaches without chemotherapy” and “matches historical response rates from chemotherapy-based treatments but without the associated toxicities.”

“This is really significant for patients with head and neck squamous cell carcinomas,” Metcalf said, adding that demonstrating complete responses in particular “bodes well for this immunotherapy combination’s future potential.” Metcalf presented the TACTI-003 data at the ESMO meeting.

With these “encouraging” data, Immutep is now preparing to engage regulatory authorities to determine the best path forward for efti. The investigational therapy has previously received the FDA’s Fast Track designation for the treatment of head and neck squamous cell carcinoma in the frontline setting, regardless of PD-L1 expression.

Efti is a soluble LAG-3 protein and a first-in-class activator of antigen-presenting cells. The drug candidate works by binding to MHC Class II proteins, activating the body’s innate and adaptive immune responses. Efti triggers the proliferation and activation of CD8+ cytotoxic T cells, dendritic cells, CD4+ helper T cells, natural killer cells and monocytes, while also promoting the expression of other key immune players such as interferon-gamma and CXCL10.

Beyond head and neck cancer, Immutep is also developing efti for non-small cell lung cancer and metastatic breast cancer.

https://www.biospace.com/article/immutep-aces-phase-iib-in-first-line-head-and-neck-cancer-eyes-regulatory-path/

Why lift in Qualigen

 Qualigen (NASDAQ:QLGN) stock is rocketing higher on Friday after the clinical-stage therapeutics company secured a new loan.

Qualigen reached an agreement with an investor for a $2 million Senior Note due July 8, 2025, with an 18% annual interest rate. This note grants the company an extra $2 million of cash to work with.

There are some stipulations that come with this new investor loan. That includes changes to the Qualigen board of directors. Richard David, Sidney Emery, Kurt Kruger, and Ira Ritter have resigned from their board seats.

Following that, the board of directors appointed three new members to replace the outgoing ones: Campbell Becher, Robert Lim and Cody Price. The roles of these board members haven’t been determined yet.

https://investorplace.com/2024/07/why-is-qualigen-qlgn-stock-up-141-today/

JPM Reports Record Q Income After Surge In 1-Time Items, Unexpectedly Boosts Loan Loss Reserves

 And we're off: Q2 earnings season has officially open after two of the largest US banks - JPM and Wells - reported results moments ago, with what was a bit of a mixed bag. We will cover Wells elsewhere, but here are the highlights for the largest US commercial bank, JPMorgan.

Here is a summary of what JPM just reported for Q2:

  • Adjusted Revenue $50.99BN, up $8.6BN from a year ago, but not comparable to estimates for reasons outlined below
    • Investment banking revenue $2.46 billion, +46% y/y, beating estimates of $2.13 billion
    • FICC sales & trading revenue $4.82 billion, +4.6% y/y, missing estimates of $4.85 billion
    • Equities sales & trading revenue $2.97 billion, +21% y/y, beating estimates of $2.66 billion
    • Advisory revenue $785 million, +45% y/y, beating estimates of  $640.5 million
    • Equity underwriting rev. $495 million, +56% y/y, beating estimates of $387.6 million
    • Debt underwriting rev. $1.08 billion, +51% y/y, beating estimates of $905.9 million
  • EPS $6.12, up $1.37 from a year ago and includes significant one-time items
  • EPS excluding significant items was $4.40
  • Compensation expenses $12.95 billion, beating estimates of $12.72 billion

Overall, a strong showing except that miss by FIC (more on that below). What is notable is that for yet another quarter JPM reported record quarterly profit of $18.1 billion, up $3.7 billion YoY,  thanks to revenue beats by the company's equity traders and investment bankers, while Net Interest Income printed at $22.86BN, just above the $22.82BN expected (the "unmanaged" number came in just below estimates) even though the net yield on interest-earning assets was 2.62% below the estimate of 2.65%. That said, much of the bottom-line surge was one-time as JPM took a multibillion-dollar gain ($7.9BN pretax) tied to a Visa share exchange.

The bank also recorded $546 million in net investment securities losses: it will be interesting to find out what this is and if JPM has quietly been cultivating yet another CIO "whale". Strip those away and JPM's net income was only $13.1 billion, down from both a quarter ago and from a year ago. Also of note, JPM's return on equity hit 23%, and that’s up to 28% if you follow the bank’s ROTCE stat. As for the bank's CET1 capital ratios, the standard came in at 15.3% and advanced hit 15.5%. This means that the bank’s total loss-absorbing capacity is now $534 billion.

Something else worth noting: JPM revealed that its Q2 stock buybacks jumped to $4.9 billion from $2.8 billion last quarter. This took place even before the Fed greenlighted more shareholder returns on June 28 - the last day of the quarter - which means Jamie Dimon frontran the "successful" stress test results.

What we also find notable is that in a reversal from last quarter, the bank actually built reserves by $821 million (vs a $72 million release in Q1): this was the biggest reserve build since the bank crash quarter in Q2 2023 when the bank added $1.5 billion in reserves. This meant that provision for credit losses rose to $3.05 billion, above the $2.83 billion expected even as total charge-offs came in at $2.23 billion, just below the $2.26 billion expected.

Looking at the bank's balance sheet and consumer banking division, there were no major surprises here, with total deposits down 1% YoY to $2.40TN (vs est $2.43TN), and flat QoQ, while total loans (including First Republic) were up 6% YoY to $1.32TN, and also flat QoQ.

“There has been some progress bringing inflation down, but there are still multiple inflationary forces in front of us: large fiscal deficits, infrastructure needs, restructuring of trade and remilitarization of the world,” Jamie Dimon said in a statement Friday. “Therefore, inflation and interest rates may stay higher than the market expects.”

Dimon was somewhat modest when citing investment banking fees rising 50%: “albeit against a low base.” He does however brag that the bank opened 450,000 net new checking accounts (“our 50th consecutive quarter of net new account growth”), and that results included “a record number of first-time investors.”

Dimon also said that market valuations and credit spreads “seem to reflect a rather benign economic outlook,” yet the bank is “vigilant about potential tail risks.” Those are the same ones we’ve been hearing about, from geopolitics that are “potentially the most dangerous since World War II,” to “multiple inflationary forces,” the prospect that “interest rates may stay higher than the market expects,” and the unknown effects of “quantitative tightening on this scale.”

But if the world’s future is ambiguous, Dimon suggests the bank’s isn’t. Its 15.3% CET1 ratio provides the bank “with excess capital even after the uncertainty created by Basel III endgame,” he writes, and the board is going to boost its dividend for the second time (“a 19% cumulative increase compared with the fourth quarter of 2023”). Dimon's bottom line: “Our priorities remain unchanged.”

That said, a closer read of the Consumer Bank reveals continued weakness in the bank's Card services group, where charge offs are rising fast, culminating in credit costs of $2.6 billion. Some more details:

  • NCOs of $2.1B, up $813mm YoY, predominantly driven by Card Services as newer vintages season and credit normalization continues
  • Net reserve build of $579mm was primarily in Card Services, predominantly driven by loan growth and updates to certain macroeconomic variables

Turning to the Commercial and Investment Bank (including markets), it is here that JPM reported solid Investment Banking and Equity Trading numbers, offset by a miss in FICC:

  • IB revenue was $2.46 billion, up 46% YoY, and beating the estimate of $2.13 billion; this was "driven by higher fees across all products"
  • Equity trading almost rose to the "vaunted" $3 billion mark ($2.97 billion), beating estimates of $2.66 billion driven by strong performance in Equity Derivatives and Prime.
  • However, FICC revenue was $4.82B, up 4.6% YoY, and missing estimates of $4.85; the number was largely driven by Securitized Products.
  • Merger advisory came in at $785 million, which was the best quarter since Q3 2022, even as Dimon continues to maintain a cautious stance on the possibility of risks around the corner.
  • Finally, Securities Services revenue of $1.3B, up 3% YoY, driven by higher volumes and market levels, largely offset by deposit margin compression.

Two other notable highlights: 

  • JPM is paying a lot to retain traders: total expense for the group jumped 12% YoY to $9.2B, "driven by higher compensation, including revenue-related compensation, higher legal expense and higher volumerelated non-compensation expense"
  • Credit costs were $384mm as a results of i) Net reserve build of $220mm, "driven by incorporating the First Republic portfolio into the Firm’s modeled approach, as well as net downgrade activity, primarily in Real Estate, largely offset by the impact of net lending activity", and ii) NCOs of $164mm, of which approximately half was in Office.

Finally, a 17% ROE in the unit was a very healthy number, even if it is down from the 20% in Q1.

Going down the investor presentation, JPM's asset and wealth management business now holds $3.7 trillion in assets, up15% YoY, lifted by the surge in markets in the last three months. For the quarter, AUM had long-term net inflows of $52B and liquidity net inflows of $16B.

Of course, JPMorgan’s assets aren’t the only thing that make this bank big. Its headcount is now up to 313,206, up 4% from 300,066 a year ago.

Looking ahead, the bank said that it sexpect a net interest income this year of about $91 billion which is just under the expected adjusted expense of $92 billion — which includes the boost to the first quarter’s FDIC special assessment and a contribution to the bank’s foundation (but excludes legal costs). The bank adds that expected net charge-off rates for its card services unit will be about 3.4%. Here is a summary:

  • Still Sees Full Year Net Interest Income About $91B, Est. $91.33B
  • Still Sees Full Year  NII Ex-CIB Markets About $91B
  • Still Sees FY Adj. Expense About $92B
  • Expects 2024 Card Services NCO Rate of ~3.4%

After all that, the market reaction was mixed: the stock initially pumped, then dumped, and at last check was flat as markets try to make some sense of what the earnings mean for the bank going forward. That said, don't cry for Jamie: the largest US banks — with the exception of Morgan Stanley — are up more than 20% this year.

The full Q2 investor presentation is below (pdf link).


Two Important Takeaways From The Recent Stock Market Action

 Yesterday, the stock market was quite the magician.  Good magicians will get you to look at what they're doing with their right hands but meanwhile the actual "magic" is happening outside our awareness, in the left hand.  The market's right hand gave us a solid decline in the SPX and especially in the growth areas that have been unusually strong.  The left hand, however, pulled off the real magic.  Market breadth increased significantly, creating what we call a breadth thrust.

The purpose of most of my quantitative analyses is to investigate market history and see if a given move is likely to lead to retracement (mean reversion) or momentum (trend).  If I can get a clear signal from market history, I then look at high frequency data to identify solid risk/reward points for entry in the direction of the analysis.  From this perspective, the "setup" is not the trade idea; edge occurs when the market sets up in the direction of solid research.

The market magic yesterday is that we saw very strong smaller cap stocks at the same time that SPX and tech sold off.  Up to now, small and midcap stocks have largely underperformed the large cap and especially the tech market.  Not yesterday.  According to the excellent Barchart resource, that created a situation in which 1518 stocks across the NYSE made fresh monthly highs and 187 registered new monthly lows.  Moreover, if we take a look at the number of stocks giving buy vs. sell signals on technical indicators on the very helpful Stock Charts site, we find that yesterday registered over 600 stocks giving buy signals on their Bollinger Bands and only 13 gave sell signals.  That is unusual breadth strength.

I've tracked these readings since 2019 and can tell you that, in over 1200 trading sessions, we've only seen that kind of breadth strength six times.  Moreover, when we've seen 400+ stocks close above their upper Bollinger Bands on the same day (N = 25), the SPX has been up 21 times, down 4 over the next ten trading sessions.  Interestingly, there has been no distinct upside edge up to 5 days out.  Where that leaves me is looking for short term pullbacks in the broad market that cannot make new lows in order to participate in anticipated continued strength.  It also has me looking with fresh eyes at the specific sectors likely to show this momentum.

So what's the second takeaway from yesterday's market action?  It's that the entire move was triggered by a drop in interest rates in the U.S.  Moderation of inflation numbers led to a rally across the curve.  Not so long ago, I was getting close to 5% on my two-year T-notes.  Now we're closer to 4.5%.  The markets are suggesting that economic strength will broaden out if we indeed see a sustained move toward lower rates from the Fed.  That is important information for traders and investors alike.  What were the best trades in a higher rate regime may not be the best trades if rates sustain a fall.

There are many implications for trading psychology in all this...I'll outline those in the next post.  

https://traderfeed.blogspot.com/2024/07/two-important-takeaways-from-recent.html