Macrogenics Revenue Surge, Strategic Development

 

• Total Revenue: $110.7 million for Q3 2024, up from $10.4 million in Q3 2023.

• Net Income: $56.3 million for Q3 2024, compared to $17.6 million in Q3 2023.

• Research and Development Expenses: $40.5 million for Q3 2024, up from $30.1 million in Q3 2023.

• Selling, General and Administrative Expenses: $14.1 million for Q3 2024, compared to $12.4 million in Q3 2023.

• Cash, Cash Equivalents, and Marketable Securities: $200.4 million as of September 30, 2024, compared to $229.8 million as of December 31, 2023.

• Milestone Payments: $100 million received from Incyte in August 2024.

• 
  

Release Date: November 05, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Macrogenics Inc (NASDAQ:MGNX) reported a significant increase in total revenue to $110.7 million for Q3 2024, primarily due to $100 million in milestones from Incyte.

• The company achieved a net income of $56.3 million for Q3 2024, a substantial increase from $17.6 million in Q3 2023.

• Macrogenics Inc (NASDAQ:MGNX) has a strong cash position with $200.4 million in cash, cash equivalents, and marketable securities as of September 30, 2024.

• The company anticipates a cash runway into 2026, supported by expected payments from partners and the MARGENZA transaction.

• Macrogenics Inc (NASDAQ:MGNX) continues to advance its clinical programs, including the TAMARACK Phase 2 study and the LORIKEET study, with updates expected in early 2025.

Negative Points

• Research and development expenses increased to $40.5 million for Q3 2024, up from $30.1 million in Q3 2023, due to higher costs related to the ADC pipeline and clinical trials.

• Selling, general, and administrative expenses rose to $14.1 million for Q3 2024, compared to $12.4 million in Q3 2023, driven by increased stock-based compensation and professional fees.

• The company's cash balance decreased from $229.8 million as of December 31, 2023, to $200.4 million as of September 30, 2024.

• Macrogenics Inc (NASDAQ:MGNX) has paused other development efforts in alternative tumor types and the Phase 1/2 dose combination study of vobra duo plus lorigerlimab until further assessment.

• The CEO, Scott Koenig, announced his resignation, which may lead to a period of transition and uncertainty as the company searches for a successor.

Q & A Highlights

Q: What are the specific parameters MacroGenics needs to see from the data next year to decide on the future of vobra duo? A: Scott Koenig, President and CEO, stated that they are close to obtaining final data and are monitoring patients post-dosing. They will assess the final rPFS, safety profile, competitive landscape, and other portfolio factors. Specific parameters for decision-making will be shared in the coming months.

Q: Can you provide details on the search process for the next CEO and the timeline for the transition? A: Scott Koenig mentioned that a Board subgroup has been selected to initiate the search process with an outside firm. He will remain in his role until a new CEO is selected, ensuring a smooth transition. The process is expected to take a few months.

Q: How is the Phase 1 dose escalation for MGC026 progressing, and when can investors expect initial clinical data? A: Scott Koenig reported that the dose escalation is progressing well, with expectations to complete the study in 2025 and report data within the same year.

Q: What triggered the decision to pause the lorigerlimab and vobra duo combination study? A: Scott Koenig explained that they are awaiting final TAMARACK data to assess the appropriate vobra dose before continuing with combination studies. The decision was made to ensure the best dose is used moving forward.

Q: Are there any notable differences in the safety profiles of vobra duo and MGC026? A: Scott Koenig noted that distinct safety profiles are expected due to different mechanisms of action. However, it is too early to provide a side-by-side comparison as MGC026 is still in the middle of dose escalation.

https://finance.yahoo.com/news/macrogenics-inc-mgnx-q3-2024-072502849.html

'Mexican economy chief says wants to sound out Musk on Tesla plant plans'

 Mexico's Economy Minister Ebrard will try to meet soon with billionaire and Tesla's chief executive Elon Musk to determine his plans for an electric car factory in northern Mexico, he told local radio on Thursday.

Ebrard is a former foreign minister and veteran political operator, and reviving plans for a so-called Tesla gigafactory in northern Nuevo Leon state would mark a major early victory for the government of President Claudia Sheinbaum, who took office last month.

"I'm going to set up a meeting with (Musk) soon so that he tells me exactly what he's thinking and see what we can do so this project moves forward," Ebrard told local radio broadcaster Radio Formula.

Last April, Tesla announced that it will use its existing factories to build new and more affordable vehicles, leaving investments in potential new factories, including in Mexico, unlikely in the near term.

U.S. President-elect Donald Trump's victory in Tuesday's election also adds new complications to the plans for Mexico, possibly shifting the plant to the United States.

During his first term as president, Trump often pressured U.S. companies to maximize their domestic manufacturing operations over overseas plants.

https://www.marketscreener.com/quote/stock/TESLA-INC-6344549/news/Mexican-economy-chief-says-wants-to-sound-out-Musk-on-Tesla-plant-plans-48292356/

'US banks to gain from looser capital, merger policies under Trump'

 The banking industry is expected to win big as former President Donald Trump returns to the White House, ushering in Republican regulators who are expected to ease capital rules and merger approvals, industry experts and analysts said.

The President-elect's picks are likely to further dilute the contentious Basel III endgame proposal aimed at requiring big lenders to hold more capital to safeguard against soured loans.

While banks have already won major concessions on that proposal which they say will crimp lending and hurt the economy, the latest draft would still increase capital requirements by around 9% for the largest lenders, according to a top Fed official.

"The Basel endgame rule could be completely dead," said Gene Ludwig, a former top bank regulator who advises financial institutions as CEO of Ludwig Advisors.

The regulatory shift could bring some relief to investors after a year in which some bank stocks were weighed down by concerns over deteriorating loans.

First unveiled months after the collapse of three regional lenders last year, the Basel proposal faced intense pushback and an unprecedented lobbying campaign from big banks, which argued the rules would erode their competitive edge.

The Federal Reserve agreed to water down the proposal in September, when Vice Chair for Supervision Michael Barr said the regulator would overhaul and re-issue the rules later.

Other planned rules requiring banks to hold more debt, as well as changes to liquidity regulations, may also be in doubt.

"The outlook for the banking sector is more encouraging under Trump," said Dan Coatsworth, investment analyst at AJ Bell. "Banks would have fewer constraints and be able to use more cash for lending or share buybacks."

The U.S. central bank declined comment.

The KBW Banks Index, which tracks large-cap banks, fell 1.5% after closing almost 11% higher on Wednesday, while an index tracking regional lenders dipped 1.5% a day after a 13.5% surge.

REGULATOR TURNOVER

As Trump installs new regulators at key agencies, his picks could have an immediate and seismic effect on a banking industry more used to a slower pace of change, according to a financial technology executive who declined to be identified discussing the personnel changes.

"This is like an earthquake for bank M&A and bank regulatory policy," said Ed Mills, an analyst at Raymond James, who expected bank deals to be announced within weeks.

The aggressive financial regulators of the Biden era, including Gary Gensler at the U.S. Securities and Exchange Commission, Lina Khan of the Federal Trade Commission and Rohit Chopra at the Consumer Financial Protection Bureau, are also likely to be replaced by more business-friendly agency heads.

But Meg Tahyar, head of the financial institutions group at law firm Davis Polk, tempered expectations for a radical change.

"There will be changes of personnel at the top level and there will be more M&A, but the intensity of supervision and the focus on junk fees is unlikely to change much," she said.

On Wednesday, midsize bank stocks were buoyed by expectations that their capital requirements would be eased, said Lazard chief market strategist Ronald Temple.

The potential for less-stringent antitrust policy also bolstered shares of Discover Financial and Capital One Financial, he said. Both are awaiting the green light for their $35.3 billion deal.

"The M&A landscape for banks may benefit with shorter approval timeframes," Morningstar DBRS wrote in a note.

Many top industry executives have called for some consolidation among banks in the U.S., which is home to more than 4,600 lenders. Dealmaking would allow smaller banks to compete more effectively against their larger peers.

"We can at least put M&A back into the discussion; whereas it has been largely nonexistent over the past few years on a punitive regulatory backdrop," Scott Siefers, a banking analyst at Piper Sandler, wrote in a report.

Fifth Third Bancorp, Huntington Bancshares and PNC Financial may be more interested in pursuing M&As, Siefers said.

The banks did not immediately respond to requests for comment.

Despite the ebullient mood, potential policy uncertainty, trade wars, protectionism and inflationary pressures under Trump could also pose some challenges to dealmaking, some bankers said.

https://www.marketscreener.com/quote/stock/CAPITAL-ONE-FINANCIAL-COR-12144/news/US-banks-to-gain-from-looser-capital-merger-policies-under-Trump-48293164/

Senior Harris Advisor Deletes X Account As "Massive Scandal" Brews Over $20 M Campaign Debt

 Former senior Obama advisor-turned-senior Kamala Harris advisor David Plouffe has deleted his X account after suggesting on Wednesday that Harris' landslide defeat was Joe Biden's fault for not dropping out soon enough, and right as a massive campaign debt scandal erupts.

"We dug out of a deep hole but not enough. A devastating loss," Plouffe posted to X - in what many interpreted as a dig at Biden.

And now, Plouffe and X are no more.

That said, was this about more than salty tears?

20 Million In Debt

After raising over $1 billion and left with $118 million in the bank as of October 16, the Harris campaign ended the 2024 election season with "at least $20 million in debt," according to Politico's Christopher Cadelago.

Breitbart CEO Matt Boyle says a Kamala campaign staffer "said there is a massive scandal here worthy of an audit."

Boyle's post in its entirety:

Ok so this just got very explosive. A Kamala campaign staffer who saw these posts called me just now and said there is a massive scandal here worthy of an audit.

The $20 million debt thing is real. Rob Flaherty, this staffer said, is currently shopping around the Kamala fundraising email list to anyone who wants it to try to raise the money back. This includes other campaigns and outside groups.

Flaherty is the deputy campaign manager and reports to Jen O’Malley Dillon.

“Jen blew through a billion dollars in a few months and it was all Jen’s idea to do all the concerts.” — Kamala campaign adviser told me

This source added that O’Malley Dillon did these “concerts,” like Katy Perry, Lizzo, Eminem, Bruce Springsteen et cetera at the expense of “prioritizing and spending money on social media and other campaign priorities.”

Apparently a group in Georgia had to lay off 100 people because they couldn’t pay them.

It’s unclear at this time if the campaign PAID the talent to perform but the cost of production for the events was “immense.”

What’s more, this Kamala campaign staffer said several people who were working for the Kamala Harris for President campaign are still awaiting several overdue payments they were promised for their work. IE, they didn’t pay the staff.

This Kamala campaign staffer said to me of @jomalleydillon

“People didn’t like working with her. Many people on the campaign felt like we lost because Kamala wasn’t allowed to run her campaign. They were running Joe Biden’s campaign instead of a Kamala campaign. Obnoxious and very much a gate keeper and interfering with the vice president’s people who were trying to do their job.”

According to data from the Federal Election Commission (FEC), the Harris campaign had received over $1 billion up until October 16 - including when it was the Joe Biden campaign. 

Over the same period, the Trump campaign took in $392 million and spent $345 million.

Democrats spent $1.1 billion on aired advertising and associated reservations, according to AdImpact - a site which monitors the cost and content of ads, Newsweek reports.

According to The New York Times, the Harris campaign spent "six figures" to fly banners over four NFL games in October in an attempt to reach male voters in swing states. The Guardian reported in November that it also spent "a reported $450,000 a day" to have ads displayed on the Las Vegas Sphere in the swing state of Nevada.

Ultimately, the messaging did not appear to hit its mark(s). Speaking to Newsweek, Mark Shanahan, an American politics expert who teaches at the University of Surrey in the U.K., said Harris "never really landed" her economic message during the presidential election campaign.

"Once again, the Democrats underestimated the appeal of Trump. He turns politics into a soap opera and it keeps many more than his MAGA loyalists tuned in. Allied to that, he offered simple messages: the economy is poor and he can fix it; and America's troubles start at its borders, and he can fix that too," said Shanahan. "Harris had too little time to introduce herself to America. She never really landed her messages on the economy with great clarity, and the one area we really thought would boost her, around reproductive rights, really didn't get the expected cut-through with voters."

https://www.zerohedge.com/markets/senior-harris-advisor-deletes-x-account-massive-scandal-brews-over-20-million-campaign-debt

Teva Reports Strong Generics Demand in Q3, Expects Higher 2024 Revenue

 

Driven by copycat versions of Bristol Myers Squibb’s Revlimid and Novo Nordisk’s Victoza, Teva’s generics business was again a top-performer in the third quarter, with U.S. sales growing 30% and bringing in $1.1 billion in sales.

Teva Pharmaceuticals released its third-quarter financial results on Wednesday touting strong year-over-year growth and raising its full-year revenue guidance, driven by continued strong demand for its generic drugs.

The company’s revenue surged 13% in Q3 to bring in $4.3 billion—which surpassed the analyst consensus of $4.14 billion. Teva’s Q3 beat was heavily driven by the U.S. sales of its generic products, which hit $1.1 billion in sales, representing 30% growth from the same period last year. In Europe, Teva recorded 10% year-on-year growth for its copycat drugs.

Teva’s generic versions of Bristol Myers Squibb’s Revlimid and Novo Nordisk’s Victoza were strong contributors to the company’s top line, as was its generic equivalent to Viatris’ EpiPen.

CEO Richard Francis in Wednesday’s earnings call credited its Q3 performance to Teva’s “Pivot to Growth” initiative which it launched in May 2023 “to get Teva back to growth.” The company in Q3 renewed its focus on four main strategic pillars—"deliver on our growth engines, step up innovation, create a sustainable generics powerhouse and focus the business,” according to Francis.

Aside from its generics and biosimilars business, Francis pointed to the “strong performance [of] our innovative portfolio,” including the extended-release oral drug Austedo—indicated for tardive dyskinesia and Huntington’s disease chorea—which grew 28% year-over-year to hit $435 in Q3 sales.

Teva’s Ajovy, approved for the preventive treatment of migraine, generated 58 million in the quarter, a 4% increase from the same period in 2023. Meanwhile, the schizophrenia drug Uzedy brought in $35 million in Q3.

Encouraged by its strong Q3 performance, Teva on Wednesday raised its full-year outlook. The company now expects $16.1 billion to $16.5 billion this year, compared to its July 2024 forecast of a range between $16 billion to $16.4 billion. At the start of the year, Teva was expecting 2024 revenues between $15.7 billion to $16.3 billion.

Projected diluted earnings per share was narrowed to $2.40 to $2.50, versus its most recent guidance of $2.30 to $2.50.

To deliver on its earnings goals—and to ensure sustainable growth in the coming years—Teva is lining up several other copycat products with strong market potential. In April 2024, the company won the FDA’s approval for its Alvotech-partnered biosimilar to Johnson & Johnson’s blockbuster biologic Stelara.

Dubbed Selarsdi, Teva and Alvotech’s biosimilar is also indicated for moderate-to-severe plaque psoriasis and active psoriatic arthritis in children and adults—but has not yet been approved for ulcerative colitis and Crohn’s disease. Per a June 2023 settlement with J&J, Selarsdi will be able to enter the U.S. market no later than Feb. 21, 2025.

In February 2024, Teva and Alvotech also secured the FDA’s approval for their Humira biosimilar Simlandi, which became the first high-concentration, citrate-free and interchangeable copycat to AbbVie’s blockbuster.

https://www.biospace.com/business/teva-reports-strong-generics-demand-in-q3-expects-higher-2024-revenue

Sarepta Halts Development of Next-Gen DMD Drug, Reports Robust Elevidys Sales

 

The investigational therapy, vesleteplirsen, had been positioned as an updated version of Sarepta’s original exon 51-skipping Duchenne muscular dystrophy drug Exondys 51.

After feedback from the FDA and an internal analysis, Sarepta Therapeutics will discontinue development of vesleteplirsen, an exon 51-skipping therapy for Duchenne muscular dystrophy that was a potential successor to Exondys 51.

The Cambridge, Mass.–based biotech made this announcement Wednesday during its third-quarter earnings call. The decision was based on feedback with the FDA, Sarepta’s risk-benefit analysis of the program and the evolving Duchenne muscular dystrophy (DMD) landscape, “including the approval of Elevidys,” Sarepta CEO Doug Ingram said on the call.

In January 2024, Sarepta announced positive data from Part B of the Phase II MOMENTUM study, which assessed vesleteplirsen in patients 8- to 21-years who are amenable to exon 51 skipping. The company noted at the time that cases of hypomagnesemia—or abnormally low magnesium—had previously been identified and that this was “managed and monitored” during the trial.

On Wednesday’s earnings call, Sarepta’s head of R&D Louise Rodino-Klapac noted that these cases persisted even after discontinuing treatment, Endpoints News reported. The FDA informed Sarepta that the accelerated approval pathway “was not open” for vesleteplirsen based on current information on the drug, Rodino-Klapac added.

In an investor note published Thursday, Jefferies analysts said they “see no meaningful stock impact” following the discontinuation of vesleteplirsen “since this implies pot’l sales upside to Elevidys (and/or Exondys).”

Elevidys, approved last year as the first gene therapy for DMD, brought in $181 million in net revenue in the third quarter, “exceeding prior guidance,” according to a Wednesday press release. Including non-U.S. sales from commercialization partner Roche, Elevidys generated $190.5 million for the quarter. This revenue represented 49% growth over Q3 2023, according to Jefferies.

Mizuho’s Uy Ear in an investor note called the result “undisputedly a strong start to commercializing the expanded Elevidys label.”

After winning an accelerated FDA nod for Elevidys in June 2023, Sarepta secured full approval and an expanded label for the gene therapy a year later, opening treatment to ambulatory DMD patients 4 years and older. The original label covered only ambulatory patients 4 to 5 years of age. The FDA also granted accelerated approval for Elevidys in non-ambulatory patients.

Elevidys’ original approval was controversial, as some experts questioned its efficacy—a concern that was heightened when the gene therapy missed the primary functional endpoint in its confirmatory trial in October 2023.

Last month, Sarepta presented new data on Elevidys at the World Muscle Society meeting in Prague, but experts told BioSpace more data, especially in these new patient populations, is needed.

Overall, Sarepta reported $467.2 million in the third quarter, up from $331.8 million in the corresponding 2023 timeframe. The company’s stock was up 3.46% in premarket trading Thursday.

https://www.biospace.com/business/sarepta-halts-development-of-next-gen-dmd-drug-reports-robust-elevidys-sales

Sore Loser Democrats Viciously Turn On "Stupid And Selfish" Biden

 by Steve Watson via Modernity.news,

Desperately looking for someone to blame for Kamala Harris not being a competent candidate and losing to president Trump in a massive landslide, Democrats have aggressively turned on Joe Biden.

Reuters notes that one Democratic donor asked “Why did Joe Biden hold on for as long as he did? He should have not concealed his (health) and dropped out a lot sooner.”

Another Democratic official blamed “malpractice” by Biden’s inner circle, stating “No one would tell him ‘no’,” and slating the White House communications and political teams.

“So it’s Joe, but also Joe’s core apparatus. Stunning and well documented chickens coming home to roost,” the official added.

The article further notes that a Kamala aide complained that her campaign was “doomed from the start by her loyalty” to Biden.

The Telegraph reports that another major Democrat donor whined that the “stupidity and selfishness” of Joe Biden for not withdrawing earlier is to blame for the huge election loss.

Another Harris campaign aide told Politico “We ran the best campaign we could, considering Joe Biden was president. Joe Biden is the singular reason Kamala Harris and Democrats lost.”

But hang on, Democrat officials, Democrat supporters and the Democrat mouthpiece media assured everyone that Biden was “sharp as a tack,” even after they forced him out.

It was obvious to everyone who wasn’t a Democrat that Biden was cognitively impaired in 2020.

Now they’ve lost, they’re admitting what everyone else was saying was entirely correct. You can’t have it both ways.

You chose to lie to yourselves, you chose to act stupidly, then you panicked when it was too late.

Then you chose to undemocratically anoint a candidate who was clearly pathetically inexperienced and unprepared to go up against Trump.

Own it.

You enabled this.

*  *  *

https://www.zerohedge.com/political/sore-loser-democrats-viciously-turn-stupid-and-selfish-biden