Procept prelims above views

 PROCEPT BioRobotics Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today reported preliminary unaudited revenue for the quarter and fiscal year ended December 31, 2023.

Preliminary, Unaudited Revenue Highlights:

• Total revenue for the fourth quarter of 2023 is expected to be in the range of $43.3 million to $43.6 million, compared to $23.8 million in the prior year period.
  • Total U.S. revenue of approximately $40.0 million to $40.3 million for the fourth quarter of 2023
  • Total U.S. Handpieces sold of approximately 6,400 resulting in monthly utilization of approximately 7.3 for the fourth quarter of 2023
  • U.S. system sales of 44 robots at an average selling price of approximately $375 thousand per system
  • Total U.S. service revenue of approximately $2.1 million for the fourth quarter of 2023
  • Total international revenue of approximately $3.3 million for the fourth quarter of 2023
• Fiscal year 2023 revenue is expected to be approximately $135.9 million to $136.2 million, representing growth of approximately 81% to 82% compared to the prior year period.
  

“We are very pleased to close out 2023 with another quarter of excellent results, driven by an acceleration in monthly utilization and strong U.S. system sales,” said Reza Zadno, Chief Executive Officer. “As we enter 2024, we are well positioned to continue to deliver outsized revenue growth driven by outstanding real-world clinical outcomes of Aquablation Therapy, the largest and most tenured capital sales team in the company’s history, and strong surgeon interest leading to rapid adoption within urology practices.”

The Company plans to report financial results for the fourth quarter and fiscal year 2023 after market close on Tuesday, February 27, 2024. The Company’s management will host a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The preliminary results included in this press release are unaudited and remain subject to adjustment.

Investors interested in listening to the conference call may do so by following one of the below links:

• Webcast link for interested listeners:
  • https://edge.media-server.com/mmc/p/criqtmsz/
• Dial-in registration for sell-side research analysts:
  • https://register.vevent.com/register/BI7b221aac8d584cdf800e3bebd4643051

Live audio of the webcast will be available on the “Investors” section of the Company’s website at: https://ir.procept-biorobotics.com

An archived recording will be available on the “Investors” section of the Company’s website at: https://ir.procept-biorobotics.com. The webcasts will be available for replay for at least 90 days after the event.

https://www.globenewswire.com/news-release/2024/01/08/2805881/0/en/PROCEPT-BioRobotics-Announces-Preliminary-Fourth-Quarter-Revenue-of-43-3-million-to-43-6-million.html

Consumer Credit Shocker: November Debt Soars After Second Biggest Surge In Credit Card Debt On Record

We, and many others, were wondering how it was possible that US consumers - already tapped out beyond a breaking point, with collapsing savings and declining real wages - were able to push holiday spending which started in November and continued until the end of the year - to record nominal highs. Now we know: according to the latest monthly consumer credit report from the Fed, in November, consumer credit exploded higher by $24.75BN, blowing away expectations of a "modest" $9BN increase after the surprisingly subdued $5.8BN (upward revised from $.5.1BN) in October and the $4.3BN average of the past 6 months. This was the biggest monthly increase since last November, and was the first $20BN+ print since Jan 2023.

When looking into the details we find something remarkable: while non-revolving credit rose a modest $4.6BN...

... in keeping with the subdued increase in recent months as rates on auto loans make them prohibitive for most consumers while student loans are actually shrinking for the 2nd quarter in a row...

... what was the big shock in today's data was the blowout surge in revolving credit, which in November exploded by a whopping $19.133BN, a record surge from the $2.9BN in October, and the second biggest monthly increase in credit card debt on record!

This, despite the average interest rate on credit card accounts in Q4 flat at a record high 22.75% for the second quarter in a row.

What is especially surprising about this conirmation that the bulk of holiday spending was on credit  is that it takes place after several months of relative return to normaly, when consumers appeared increasingly reluctant to max out their credit cards due to record high rates, and at a time when the personal savings rate in the US has collapsed back near multi-decade lows in recent months.

Well, it now appears that Americans have once again done what they do so well: follow in the footsteps of their government and throw all caution to the wind, charging everything they can (and whatever they can't put on installment plans which also hit a record late last year) including groceries, on their credit card, and praying for the best... or not even bothering to worry about what comes next.

https://www.zerohedge.com/markets/consumer-credit-shocker-november-debt-soars-after-second-biggest-surge-credit-card-debt

Fauci Sits For Testimony On Mask Mandates And Covid Origin: Here's What Congress Should Ask

 Anthony Fauci is sitting for testimony in front of Congress on Monday and Tuesday to answer questions over mask mandates, lockdowns, and social distancing (which Deborah Brix admitted they pulled out of their asses) - as well as the origins of Covid-19.

The 83-year-old former NIAID director was the chief architect of the US response to COVID-19, which he may have been responsible for in the first place after offshoring banned gain-of-function research to make bat coronaviruses more transmissible to humans.

Here are 10 questions Fauci is likely to be asked via Just the News:

1. Were you aware of gain-of-function research being conducted at the Wuhan Institute of Virology in China?

2. Why did you push the theory the COVID-19 virus originated from nature, not from a Wuhan lab?

3. When did you first find out that members of the intelligence community, including those at the FBI and the Energy Department, thought that COVID likely originated in China?

4. Could you elaborate more about whistleblower allegations that you visited the CIA headquarters to potentially influence the agency's COVID origins investigation?

5. How large is the government's secret database on adverse events and injuries?

6. How much did you weigh in on Operation Warp Speed?  

7. How were you involved in the COVID task force, both during the Trump administration and the Biden administration?

8. Did you weigh in on school closures, lockdowns and similar things? What was your advice on that?

9. Why did you support vaccine mandates for employment and education?

10. What lessons from the COVID-19 pandemic can be used to prevent future pandemics?

To review;

The US was doing risky gain-of-function research on US soil until 2014, when the Obama administration banned it. Four months before the ban, Dr. Fauci offshored it to Wuhan, China through New York nonprofit, EcoHealth Alliance.

After Sars-CoV-2 broke out down the street from the Wuhan Institute of Virology, Fauci engaged in a massive campaign to deny the possibility of a lab-leak from the lab he funded, and instead pin the blame on a yet-to-be discovered zoonotic intermediary species.

And if you'd like to dig even deeper, this is perhaps the best, most comprehensive summary of the "proximal origin" timeline.

Now to see what leaks...

https://www.zerohedge.com/markets/fauci-sits-testimony-mask-mandates-and-origins-heres-what-congress-should-ask

Fresenius Strategic Portfolio Optimization: Key Transactions

 Since announcing its intent to optimize its product portfolio, divest noncore business assets and exit certain markets as part of its strategic plan, Fresenius Medical Care has now signed and closed transactions exiting its Argentina operations with the sale to Grupo Olmos. The Company also closed the already announced sale of its National Cardiovascular Partners (NCP) outpatient cardiovascular clinics business in the United States in December 2023. Additionally, Fresenius Medical Care has signed the divestment of its Cura Day Hospitals Group in Australia (Cura) to global alternative asset manager ICG and a consortium of healthcare professionals, subject to regulatory approval.

In aggregate, the three divested assets include 127 facilities, more than 4,500 employees and more than 10,000 dialysis patients. The three divestments represented in 2022 a total proforma revenue of around EUR 600 million. The associated net book loss for the sale of NCP, the sale of the Argentina operations and other assets held for sale by the end of 2023 as part of the Portfolio Optimization Program is estimated to impact the Operating Income of Fresenius Medical Care in the fourth quarter of 2023 by around EUR 50 million and will be treated as a special item.

Depending on exchange rates the Company expects net proceeds of around EUR 500 million from the divestment of NCP, Cura and the Argentinian operations with net proceeds of around EUR 135 million in the fourth quarter 2023 and the remainder to occur in 2024.

All assets currently under review as part of the Portfolio Optimization would, if executed by the end of 2025, negatively impact 2025 revenue by EUR 1.5 billion and positively impact 2025 margin.

https://www.biospace.com/article/releases/fresenius-medical-care-executes-on-its-strategic-portfolio-optimization-program-and-announces-key-transactions/

Marker: Clinical Program Updates and Pipeline Prioritization

 Strategic prioritization of clinical programs with focus on MT-601 in patients with lymphoma

MultiTAA-specific T cell therapies demonstrate clinical safety and positive clinical data across multiple indications

Marker provides updates supporting the clinical benefits of MT-401 in patients with measurable residual disease (MRD)

https://www.biospace.com/article/releases/marker-therapeutics-announces-clinical-program-updates-and-pipeline-prioritization/

Guardant prelims

 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced preliminary, unaudited results for the quarter and full year ended December 31, 2023.

Full year 2023 preliminary unaudited financial results

For the twelve-month period ended December 31, 2023, as compared to the same period of 2022:

• Revenue of between $562 million and $563 million, an increase of 25%
• Reported 172,900 tests to clinical customers and 29,900 tests to biopharma customers, an increase of 39% and 15%, respectively

Fourth quarter 2023 preliminary unaudited financial results

For the three-month period ended December 31, 2023, as compared to the same period of 2022:

• Revenue of between $153 million and $154 million, an increase of 21%
• Reported 46,400 tests to clinical customers and 9,500 tests to biopharma customers, an increase of 29% and 16%, respectively

Preliminary unaudited free cash flow was approximately negative $84 million for the fourth quarter of 2023, and approximately negative $347 million for the full year 2023. Cash, cash equivalents and marketable debt securities were $1.2 billion as of December 31, 2023.

“We finished the year strong with revenue growth of 25% in 2023, driven by robust clinical volume growth. We benefitted from tailwinds throughout the year driving us to breakeven in our therapy selection business, which we believe sets us up for another successful year of robust growth in 2024,” said Helmy Eltoukhy, co-founder and co-CEO.

“We made steady progress in our screening business this year with our Shield blood test. We are encouraged by the overwhelming physician and patient enthusiasm for the option to do a simple blood draw to screen for colorectal cancer,” said AmirAli Talasaz, co-founder and co-CEO. “We look forward to the launch of Shield IVD this year, following FDA approval, which will be transformative to the cancer screening landscape.”

Guardant Health has not completed preparation of its financial statements for the fourth quarter or full year of 2023. The revenue ranges, test volumes and free cash flow presented in this release for the fourth quarter and the year ended December 31, 2023, are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results. The company is in the process of completing its customary year-end close and review procedures as of and for the year ended December 31, 2023, and there can be no assurance that final results for this period will not differ from these estimates. During the preparation of Guardant Health’s consolidated financial statements and related notes as of and for the year ended December 31, 2023, the company's independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimates presented herein.

Upcoming events

Guardant Health plans to report its fourth quarter and full year audited financial results for the period ended December 31, 2023, during its February 2024 earnings call.

https://www.biospace.com/article/releases/guardant-health-announces-preliminary-fourth-quarter-and-full-year-2023-results/

Mirum prelims, updates, at JPMorgan

 Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today provided its preliminary and unaudited estimates for full-year 2023 revenue and net product sales, corporate updates, and full-year 2024 outlook.

“2023 was a transformative year for Mirum as we cemented our position as a leader in rare disease and dramatically advanced our operating and financial scale. We expanded our reach and impact through strong global adoption of LIVMARLI and the addition of CHOLBAM and CHENODAL,” said Chris Peetz, president and chief executive officer. “In the year ahead, we are excited about the growth prospects of all three commercial medicines, the potential label expansion opportunities for LIVMARLI and CHENODAL and key volixibat analyses in primary sclerosing cholangitis and primary biliary cholangitis.”

2023 Highlights

• Established a leading pediatric hepatology franchise with three commercial medicines
• 2023 estimated LIVMARLI net product sales of $141-143 million representing approximately 89% growth over 2022 LIVMARLI net product sales
• Total expected net product sales of $69-71 million in Q4 2023 including $41-43 million in LIVMARLI net sales and approximately $28 million in net sales from CHOLBAM and CHENODAL
• Acquired two therapies commercially available in the U.S.: CHOLBAM and CHENODAL
• Announced positive Phase 3 data from the RESTORE study evaluating CHENODAL in cerebrotendinous xanthomatosis (CTX) patients
• Expanded LIVMARLI’s US label in Alagille syndrome (ALGS) to include infants 3 months of age and older
• Grew international business to 18 countries with reimbursed access
• Company fully financed with strong balance sheet and financial performance
• Announced the appointment of Eric Bjerkholt as Chief Financial Officer

The foregoing amounts relating to 2023 financial data are unaudited and preliminary and are subject to completion of financial closing procedures. Additional information and disclosure would be required for a more complete understanding of the company’s financial position and results of operations as of December 31, 2023.

2024 Expectations and Milestones

• Expect continued revenue growth across all three commercial medicines
• U.S. Food and Drug Administration (FDA) Prescription Drug User Free Act (PDUFA) date for LIVMARLI in progressive familial intrahepatic cholestasis (PFIC) is March 13, 2024.
• New Drug Application (NDA) submission for CHENODAL in CTX planned in first half 2024
• Volixibat VISTAS study in primary sclerosing cholangitis blinded interim analysis expected first half 2024
• Volixibat VANTAGE study for primary biliary cholangitis interim analysis expected in first half 2024

Mirum will present at the 42^nd annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 10, 2024 at 10:30 a.m. PT. The presentation and question and answer session will be webcast live and can be accessed by visiting the Investors and Media section of Mirum’s corporate website. The replay of the webcast will be available for 30 days.

https://www.biospace.com/article/releases/mirum-pharmaceuticals-announces-preliminary-unaudited-2023-net-revenue-and-provides-corporate-updates/