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Tuesday, April 30, 2024

10x Genomics Reports First Quarter 2024 Financial Results

10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, today reported financial results for the first quarter ended March 31, 2024.

Recent Highlights

  • Revenue was $141.0 million for the first quarter, a 5% increase over the corresponding period of 2023, driven by Spatial revenue.
  • Shipped Visium HD Spatial Gene Expression, enabling whole transcriptome spatial discovery at single cell-scale resolution.
  • Shipped two major new Chromium products powered by GEM-X, the next generation of the company's leading single cell technology architecture, enabling higher performance at larger scale and lower cost.
  • Shipped the Xenium multi-modal cell segmentation product and a new gene panel optimized for immuno-oncology applications.

"We delivered four major new products this quarter, which set a new standard for single cell and spatial biology," said Serge Saxonov, Co-founder and CEO of 10x Genomics. "In its first quarter, Visium HD helped drive strong growth in Spatial. We also had a significant number of customers trial our new GEM-X products, contributing to lower quarter-end orders for Chromium. Overall, we're encouraged by the early enthusiasm, adoption and feedback from customers and believe these new launches will help accelerate growth as we move through the year."

First Quarter 2024 Financial Results

Revenue was $141.0 million for the first quarter of 2024, a 5% increase from $134.3 million for the corresponding prior year period.

Gross margin was 66% for the first quarter of 2024, as compared to 73% for the corresponding prior year period. The decrease in gross margin was primarily due to change in product mix driven by Xenium instruments. 

Operating expenses were $154.4 million for the first quarter of 2024, a 3% increase from $150.4 million for the corresponding prior year period. This increase was driven by higher legal expenses and costs for facilities and information technology partially offset by lower personnel expenses, including stock-based compensation.

Operating loss was $61.5 million for the first quarter of 2024, as compared to $52.0 million for the corresponding prior year period. Operating loss includes $36.1 million of stock-based compensation for the first quarter of 2024, as compared to $42.1 million of stock-based compensation for the corresponding prior year period.

Net loss was $59.9 million for the first quarter of 2024, as compared to a net loss of $50.7 million for the corresponding prior year period.

Cash and cash equivalents and marketable securities were $371.8 million as of March 31, 2024.

2024 Financial Guidance

10x Genomics is maintaining its previously announced full year 2024 revenue guidance of $670 million to $690 million, representing 8% to 12% growth over full year 2023 revenue.

Webcast and Conference Call Information

10x Genomics will host a conference call to discuss the first quarter 2024 financial results, business developments and outlook after market close on Tuesday, April 30, 2024 at 1:30 PM Pacific Time / 4:30 PM Eastern Time. A webcast of the conference call can be accessed at http://investors.10xgenomics.com. The webcast will be archived and available for replay at least 45 days after the event.

https://www.prnewswire.com/news-releases/10x-genomics-reports-first-quarter-2024-financial-results-302132183.html

Novartis, PeptiDream In Potential $2.7B Deal to Expand Radioligand Partnership

 Novartis on Tuesday expanded its peptide discovery collaboration with Japanese biotech PeptiDream in a deal worth more than $2.7 billion in milestone payments, making it the latest move in the red hot radiopharma sector.

Under the agreement, PeptiDream use its technology–the Peptide Discovery Platform System—to find new macrocyclic peptides against targets that Novartis has selected. These targets can be conjugated into radioligand therapies (RLTs), which may have other therapeutic or diagnostic uses. 

Novartis is paying PeptiDream $180 million upfront and is also eligible to receive $2.71 billion in milestone payments. The biotech may also net tiered royalties on any product sales.

PeptiDream’s stock price jumped 24% on the news in Tuesday trading. 

Novartis and PeptiDream have been working together on various deals since 2010. In 2019, the two companies agreed to find new peptide-drug conjugates. The terms of that partnership were not disclosed. 

“We are delighted to further expand our long-standing macrocyclic peptide discovery collaboration with Novartis, adding additional peptide RLT and other programs to our strong partnership,” PeptiDream CEO Patrick Reid said in a statement. “As macrocyclic peptides continue to be the ideal vectors for the targeted deliver of a variety of therapeutic payloads, PeptiDream continues to build an extensive pipeline of partnered as well as internal peptide-conjugate programs.”

PeptiDream has also been active in the deal space as the biotech received $40 million upfront from Roche’s Genentech last year to discover radioisotope drug conjugates. The agreement is also worth up to $1 billion in milestones. The biotech has also previously initiated discovery deals with Eli Lilly and Merck, among others.

“Our expanded partnership reflects our shared commitment to pioneering science that broadens the scope of transformative therapeutic approaches such as RLT,” Shiva Malek, global head of oncology research at Novartis, said in a statement. 

Radiopharmaceuticals have been a big investment area for Novartis. In 2018, the pharma spent over $6 billion to acquire two companies, Advanced Accelerator Application S.A. and Endocyte. Out of those deals, Novartis gained access to the prostate cancer treatment Pluvicto and Lutathera. These radioligands have been good earners for Novartis, as Pluvicto raked in $310 million in the first quarter of 2024 while Lutathera brought in $169 million. 

The radiopharma deal space has been active in the past year as AstraZeneca inked a potential $2.4 billion deal in March 2024 to acquire Fusion Pharmaceuticals, gaining access to its radio-conjugate candidate FPI-2265, a treatment for prostate cancer. Last year, Bristol Myers Squibb spent $4.1 billion to purchase RayzeBio, securing access to its lead radiopharma program. 

https://www.biospace.com/article/novartis-peptidream-ink-potential-2-7b-deal-to-expand-radioligand-discovery-partnership-/

AstraZeneca, Daiichi Continue Earlier-Line Breast Cancer Push with Phase III Enhertu Win

 AstraZeneca and Daiichi Sankyo on Monday released topline findings from the Phase III DESTINY-Breast06 study, showing that their antibody-drug conjugate Enhertu (trastuzumab-deruxtecan) yielded significant survival benefits in certain patients with metastatic breast cancer.

With more than 860 patients enrolled, DESTINY-Breast06 pit Enhertu against an investigator’s choice of chemotherapy, including capecitabine, paclitaxel or nab-paclitaxel. Only patients who were HR positive and with low or ultralow expression levels of the HER2 protein were eligible for enrollment. All study participants had also undergone at least one prior line of endocrine therapy.

Topline results showed that Enhertu treatment led to a “statistically significant and clinically meaningful improvement” in progression-free survival (PFS). This effect remained consistent when focusing specifically on patients with low or ultralow HER2 expression.

However, overall survival (OS) data were not yet mature at the time of the interim analysis. Still, DESTINY-Breast06 detected “an early trend towards an OS improvement versus standard of care chemotherapy” in the overall study population and particularly in the subgroup of patients with low HER2 expression, according to the companies.

DESTINY-Breast06 will continue as planned to evaluate OS and other secondary endpoints.

Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, in a statement said that Monday’s readout reinforces that Enhertu “could become a new standard of care” for HER2 low and HER2 ultralow metastatic breast cancer, following at least one line of endocrine treatment.

“These data underscore the potential for treatment with Enhertu across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer,” Galbraith added.

AstraZeneca and Daiichi Sankyo did not reveal specific data in Monday’s announcement but promised to do so at an upcoming medical congress. The partners will also share their findings to global regulatory authorities, with an eye toward label expansion.

Designed using Daiichi Sankyo’s DXd antibody-drug conjugate (ADC) platform, Enhertu targets the HER2 protein, which is involved in the hyperactive growth and division of cancer cells. It carries a number of topoisomerase I inhibitor payloads, which triggers cell death. The ADC first won the FDA’s approval in December 2019 for hard-to-treat HER2-positive breast cancer.

Earlier this month, Enhertu bagged the FDA’s first tumor-agnostic ADC approval, opening up its use in patients with HER2-positive solid tumors who had undergone prior systemic treatment and who have no available alternative treatment options.

https://www.biospace.com/article/astrazeneca-daiichi-sankyo-continue-earlier-line-breast-cancer-push-with-phase-iii-enhertu-win/

J&J, BMS Lose Challenges to Medicare Drug Price Negotiation Program

 A federal judge in New Jersey on Monday ruled that the drug price negotiations outlined in the Inflation Reduction Act are constitutional, rejecting the arguments put forth by Johnson & Johnson and Bristol Myers Squibb, multiple news outlets reported late Monday. This is the latest decision in an ongoing legal battle between Big Pharma and the government over the IRA—a battle that continues to go poorly for the biopharma industry.

Judge Zahid Quraishi of the District of New Jersey issued summary judgment against J&J’s Janssen and BMS, dismissing their claim that the Medicare Drug Price Negotiation Program was an unconstitutional taking of their assets.

“In short, Defendants are not taking drugs from Plaintiffs,” Quraishi wrote in his 26-page ruling, according to multiple news outlets. “Selling to Medicare may be less profitable than it was before the institution of the Program, but that does not make Defendants’ decision to participate any less voluntary.”

BMS has already appealed the ruling to the Third Circuit Court of Appeals, Endpoints News reported 

This move was predicted by John Bennett, a Boston-based litigator at Allen & Overy who works with biopharma clients. “All of these cases ultimately have the potential to be appealed, and no doubt will be appealed,” Bennett told BioSpace earlier this year. “I think all of them in one shape or form have the possibility at least of potentially becoming precedent and potentially being argued at the Supreme Court.”

Quraishi did not rule on suits brought by Novartis and Novo Nordisk that were combined into the same hearing with BMS and J&J’s cases. The judge reportedly was skeptical of Novartis and Novo’s arguments during that hearing, which took place March 7.

In February, a federal judge in Texas dismissed the lawsuit from the group Pharmaceutical Research and Manufacturers of America (PhRMA) on the grounds of wrong venue. However, PhRMA and two allies this week announced that they would appeal the ruling to the U.S. Court of Appeals for the Fifth Circuit, Bloomberg Law reported.

Last month, a federal judge in Delaware ruled against AstraZeneca, saying that the Medicare program did not deny the company its right to sell its product. That judgment was in line with another federal court’s denial of an injunction against the IRA program sought by the Dayton (Ohio) Chamber of Commerce last fall. On Monday, AstraZeneca filed an appeal with the Third Circuit.

In October 2023, a court denied the U.S. Chamber of Commerce’s motion for a preliminary injunction against the program, pointing out that the plaintiffs neither had a strong chance of succeeding nor evidence of irreparable harm.

https://www.biospace.com/article/j-and-j-bms-lose-challenges-to-medicare-drug-price-negotiation-program/

Fani Flees Fulton County Primary Debate, Leaves Opponent Facing Empty Podium

 by Naveen Athrappully via The Epoch Times (emphasis ours),

Fulton County District Attorney Fani Willis, who is handling former President Donald Trump’s election interference case, skipped a debate against her Democrat primary challenger on Sunday.

The debate was held by the Atlanta Press Club and was the first Democratic Party debate in the county. It was supposed to feature Ms. Willis and her Democrat challenger Christian Wise Smith, an attorney and author. However, Ms. Willis was absent from her podium when the debate began, leaving Mr. Smith alone on the stage. After providing a brief introduction of Mr. Smith, the moderator announced that Ms. Willis “declined to participate in the debate and is represented by an empty podium.”

Despite Ms. Willis’ absence, the moderator allowed Mr. Smith to pose his question to the Fulton County DA. “My question for you is: Where are you? You know I’m here because I care about the citizens and the families of Fulton County,” Mr. Smith asked.

“But it’s my understanding that you may have attended the White House correspondents’ dinner. You might be fundraising across the country. But what about us here in the Fulton County? What are you doing to address the issues in the jail? What are you doing to address the backlog? Where are you, Ms. Willis? That’s what we want to know.”

When asked whether he wanted to guess a rebuttal Ms. Willis would have given, Mr. Smith replied that he could not speak for the district attorney. However, “her absence is all the response that we need.”

Asked if he will continue pursuing the case against President Trump if he becomes the new Fulton County district attorney, Mr. Smith said that the issue “is important to us here in Fulton County and a lot of people across the country.”

Ms. Willis’ case against the former president charges him and over a dozen co-defendants with allegedly attempting to illegally overturn the results of the 2020 presidential race in Fulton County. President Trump has pleaded not guilty, claiming he is being wrongfully prosecuted in a bid to harm his chances of securing a second term in the 2024 presidential elections.

While Mr. Smith said President Trump’s case was important, he insisted that “you have to do things differently.” He criticized Ms. Willis for paying “one attorney nearly $1 million to handle one case.”

The $1 million Mr. Smith alluded to is potentially the $650,000 in payments that Ms. Willis allegedly paid special prosecutor Nathan Wade in the Trump case. Mr. Wade stepped down from the post after it was revealed he had been in a romantic relationship with Ms. Willis.

Mr. Smith pointed out that he has worked in the Fulton County District Attorney’s Office and that his salary was “significantly less than what that attorney was paid. And I was responsible for handling a lot more cases than one.”
The Democrat voters’ primary is scheduled for May 21, with the winner set to face off against a Republican challenger in the November elections.

Willis-Wade Scandal

Allegations of improper conduct between Ms. Willis and Mr. Wade emerged in early January when Ashleigh Merchant, representing Trump co-defendant Michael Roman, alleged that Mr. Wade was paid $650,000 since he was hired to handle the case and that he was in a romantic relationship with Ms. Willis before the hiring.

Ms. Merchant claimed Mr. Wade spent thousands of dollars on “lavish” vacations taken with Ms. Willis. Mr. Wade said he only entered into a romantic relationship with Ms. Willis after being hired for the case.

However, Ms. Willis’ former landlord testified that she saw Ms. Willis and Mr. Wade “kissing” and “hugging” each other as far back as 2019.

Data collected from Mr. Wade’s cellphone showed that he had called Ms. Willis thousands of times over several months before he was hired as a special prosecutor by the Fulton County district attorney on Nov. 1, 2021. The day after his appointment, Mr. Wade filed for divorce from his wife.

The matter went to court. On March 15, Fulton County Superior Court Judge Scott McAfee ruled that either Ms. Willis or Mr. Wade had to resign from the case.

“An outsider could reasonably think that the district attorney is not exercising her independent professional judgment totally free of any compromising influences,” the judge said. “As long as Wade remains on the case, this unnecessary perception will persist.”

The same day Judge McAfee issued his judgment, Mr. Wade resigned from the case.
On March 29, President Trump’s attorneys appealed Judge McAfee’s decision to allow Ms. Willis to continue handling the case.

Dismissal is the truly appropriate remedy because the disqualification of DA Willis and her office cannot fully undo the damage caused to Defendants and their due process rights,” the appeal said.

“But her disqualification is the minimum that must be done to remove the stain of her legally improper and plainly unethical conduct from the remainder of the case.”

Ms. Willis has asked the court to dismiss President Trump’s appeal. A ruling on the appeal is due to be made by May 13.
Back in February, President Trump slammed the case in a Truth Social post. “It was a FAKE CASE from the start, and now everybody sees it for what it is, a MAJOR LEAGUE SCANDAL!” he wrote.

“The legal pundits, experts, and scholars are all screaming that this Witch Hunt, which has hurt so many fine people and patriots, should be immediately terminated and permanently erased from everyone’s memory. The stench of what has happened should shame Georgia no longer.

https://www.zerohedge.com/political/fani-flees-fulton-county-primary-debate-leaves-opponent-facing-empty-podium

Lilly reports $2 billion from Mounjaro, Zepbound in Q1 2024

 Eli Lilly (LLY) missed Wall Street consensus estimates on Mounjaro sales for the first quarter of the year, but its GLP-1 products, including Zepbound, still contributed to 26% sales growth year over year in the quarter.

The company also raised its full-year guidance by $2 billion to $43 billion on the upper end, giving a boost to the company's stock — which was trading more than 6% higher at the start of Tuesday's session.

Eli Lilly said it is also increasing access to the weight-loss drug Zepbound, reaching 67% of possible customers as of April 1. The company has met resistance as employers and insurers have refused to cover the drugs due to the spike in health expenses, but the tide appears to be turning. Lilly said it will continue to focus on getting more self-pay employers on board and increase access through pharmacy benefits managers' formularies. This could also bode well for market leader and Lilly competitor Novo Nordisk (NVO), which reports its first quarter earnings on Thursday.

Mizuho's healthcare sector expert, Jared Holz, wrote in a note to clients Tuesday that Zepbound's status as a key driver in the company's earnings after one full quarter is proof of the strong outlook despite manufacturing and coverage constraints.

"Investors may nitpick on total sales falling slightly short of analyst estimates for the first quarter but given the forecast boost just one quarter in, and very materially to that end, [Lilly] could hit new highs fairly soon and take out the skeptics in the process," Holz said.

He added that, along with Novo, the company's ongoing manufacturing buildout to meet the unprecedented demand is still farther ahead than other competitors, giving Lilly significant market share in a historic new sector.

"As far as market development and commercialization of these now household brand-name injections, [we] continue to stress we are in batting practice or shoot-around phase of a long game, and this will certainly be the largest therapeutic class patients/doctors/investors have ever seen," Holz said.

The next milestones, which include finding new use cases for the drugs, creating a pill version, and undergoing clinical trials, will set the company up for such a market.

FILE PHOTO: A box of Mounjaro, a tirzepatide injection drug used for treating type 2 diabetes made by Lilly is seen at Rock Canyon Pharmacy in Provo, Utah, U.S. March 29, 2023. REUTERS/George Frey
A box of Mounjaro, a tirzepatide injection drug used for treating type 2 diabetes made by Lilly, is seen at Rock Canyon Pharmacy in Provo, Utah, March 29, 2023. (George Frey/REUTERS) (Reuters / Reuters)

BMO Capital Markets managing director Evan Seigerman told Yahoo Finance that Lilly's GLP-1 sales numbers are helping long-term expectations.

"I'm really encouraged by the earnings beat as well, suggesting that the profitability of these products is very high and likely to increase profits going forward," Seigerman said.

WTI Extends Losses After API Reports Unexpected Crude Build

 WTI ended April on a down-note (closing lower on the month, as opposed to Brent which saw its fourth straight monthly gain) as hopes for cease-fire talks between Israel and Hamas dampened fears of a wider conflict that could threaten crude supplies.

The recent declines come as a "relief to both central bankers and consumers alike," Stephen Innes, managing partner at SPI Asset Management, told MarketWatch.

There's been a notable decrease in speculation about the possibility of U.S. benchmark WTI surpassing the $100-a-barrel threshold, at least for now, he said. This shift in sentiment can be attributed, in part, to "reduced concerns about disruptions to Iranian production, following Israel's measured response to previous drone attacks."

Meanwhile, "attention should also be directed towards peace talks, as progress in this area could further contribute to a decrease in oil prices," said Innes.

But, after last week's big crude draw, analysts expect another drawdown in stocks this week.

API

  • Crude +4.91mm (-1.5mm exp)

  • Cushing +1.48mm

  • Gasoline -1.48mm (-1.2mm exp)

  • Distillates -2.19mm (+400k exp)

Crude stocks unexpectedly rose almost 5mm barrels last week while distillates inventories declined notably...

Source: Bloomberg

WTI was hovering around $81.65 ahead of the API print and extended losses modestly after...

Despite the reprieve in oil prices, crude-oil markets are expected to remain volatile, said Innes, partly due to uncertainty surrounding the pace of global oil demand growth, the rise in non-OPEC+ and U.S. oil production, the potential for supply disruptions in regions like Russia and the Middle East and, critically, OPEC+'s future production strategy.

"These dynamics underscore the ongoing challenges and complexities within the oil market landscape," Innes said.

https://www.zerohedge.com/energy/wti-extends-losses-after-api-reports-unexpected-crude-build