| 01/04/2024 | 19:50:00 | MESO | Mesoblast Limited ADS | NASDAQ | 01/05/2024 | 08:55:00 | 09:00: https://www.nasdaqtrader.com/trader.aspx?id=TradeHalts |
Friday, January 5, 2024
Mesoblast halted
AngioDynamics Q2 Results Miss Estimates; Boosts FY24 Adj. EPS Outlook
While reporting financial results for the second quarter on Thursday, medical devices company AngioDynamics, Inc. (ANGO) raised its adjusted earnings guidance for the full year 2024, while trimming annual net sales outlook.
For fiscal 2024, the company now projects adjusted earnings in the range of $0.35 to $0.42 per share on net sales between $320 million and $325 million.
Previously, the company expected adjusted earnings in the range of $0.28 to $0.34 per share on net sales between $328 million and $333 million.
On average, four analysts polled by Thomson Reuters expect the company to report a loss of $0.32 per share on net sales of $329.05 million for the year. Analysts' estimates typically exclude special items.
For the second quarter, the company reported a net loss of $29.05 million or $0.72 per share, wider than $8.47 million or $0.21 per share in the prior-year quarter.
Biden Hasn't Done Anything For Two Weeks
by Steve Watson via Modernity.news,
White House correspondents have started to ask questions about why there has been nothing on Joe Biden’s schedule for a fortnight.
The supposed leader of the free world has not done anything for two weeks, and his Press Secretary couldn’t provide any details of any upcoming schedule Thursday.
Biden hasn't had an event on his schedule since December 22 — 13 days ago https://t.co/aCUvcoawQO
— RNC Research (@RNCResearch) January 4, 2024
Here’s what Biden has been doing for the past two weeks:
DEC. 22: Spent 9 minutes at Children’s National Hospital
DEC. 23: Left for vacation at Camp David
DEC. 24: Vacation at Camp David
DEC. 25: Vacation at Camp David
DEC. 26: Returned from vacation at Camp David
DEC. 27: Left for vacation in the U.S. Virgin Islands
DEC. 28: Vacation in the U.S. Virgin Islands
DEC. 29: Vacation in the U.S. Virgin Islands
DEC. 30: Vacation in the U.S. Virgin Islands
DEC. 31: Vacation in the U.S. Virgin Islands
JAN. 1: Vacation in the U.S. Virgin Islands
JAN. 2: Late-night return from vacation in the U.S. Virgin Islands
JAN. 3: Nothing
JAN. 4: Nothing
RNC Research further notes that tomorrow Biden is scheduled to fly to Delaware for some reason that no one understands, then he’ll fly to Pennsylvania to give a Jan 6th anniversary speech about how half of America are extremist white supremacists, before flying back to Delaware presumably to continue doing nothing all weekend.
That’s at least 30 something short plane steps he’ll have to go up and down. Will he make it?
Perhaps he’s gearing up for the basement campaign again.
https://www.zerohedge.com/political/biden-hasnt-done-anything-two-weeks
Jobs Up 216,000 But Employment Down 683,000 Job Revisions -71,000
The headline jobs number is much weaker than appears at first glance. Full time employment declined by over 1.5 million. Revisions hugely negative.
From September 2020 through early 2022, nonfarm payroll job gains and full time employment changes tracked together.
Starting around March of 2022, a divergence between employment and jobs became very noticeable.
Payrolls vs Employment Gains Since March 2023
- Nonfarm Payrolls: 1,760,000
- Employment Level: +359,000
- Full Time Employment: -1,091,000
From the full time employment peak in June of 2023, full time employment is down by 1,591,000. In the same time frame, jobs are up by 1,157,000.
Job Report Details
- Nonfarm Payroll: +216,000 to 157,232,000 – Establishment Survey
- Civilian Non-institutional Population: +169,000 to 267,991,000
- Civilian Labor Force: -676,000 to 167,451,000 – Household Survey
- Participation Rate: -0.3 to 62.5% – Household Survey
- Employment: -683000 to 161,183,000– Household Survey
- Unemployment: +6,000 to 6,268,000- Household Survey
- Baseline Unemployment Rate: +0.0 to 3.7% – Household Survey
- Not in Labor Force: +845,000 to 100,540,000 – Household Survey
- U-6 unemployment: +0.1 to 7.1% – Household Survey
Change in Nonfarm Payrolls
Monthly Revisions
- The change in total nonfarm payroll employment for October was revised down by 45,000, from +150,000 to +105,000
- The change for November was revised down by 26,000, from +199,000 to +173,000.
- With these revisions, employment in October and November combined is 71,000 lower than previously reported.
The string of negative revisions to the jobs report continues.
Part-Time Jobs
- Involuntary Part-Time Work: +217,000 to 4,211,000
- Voluntary Part-Time Work: +579,000 to 22,458,000
- Total Full-Time Work: -1,531,000 to 133,196,000
- Total Part-Time Work: +762,000 to 27,794,000
The above numbers never total correctly due to the way the BLS makes seasonal adjustments. I list them as reported.
Hours and Wages
This data is frequently revised.
- Average weekly hours of all private employees fell 0.1 hour to 34.3 hours.
- Average weekly hours of all private service-providing employees was flat at 33.3 hours.
- Average weekly hours of manufacturers was down at 0.1 hour (with a negative revision taking away another 0.1 hour) to 39.8 hours. I have not seen manufacturing hours under 40 for ages.
An overall decline or rise of a tenth of an hour does not sound line much, but with employment over 160 million, it’s more significant than it appears at first glance.
Hourly Earnings
This data is also frequently revised. Here are the numbers as reported this month.
Average Hourly Earnings of All Nonfarm Workers rose $0.15 to $34.27. A year ago the average wage was $32.92. That’s a gain of 3.94%.
Average hourly earnings of Production and Nonsupervisory Workers rose $0.10 to $29.42. A year ago the average wage was $28.21. That’s a gain of 4.3%.
Year-over-year wages are keeping up with inflation after underperforming for many months.
Unemployment Rate
The unemployment rate hit a 50-year low in January and April of 3.4 percent. It hit 3.8 percent in August, September, and October, the highest since January of 2022, but is now back to 3.7 percent.
Alternative Measures of Unemployment
Table A-15 is where one can find a better approximation of what the unemployment rate really is.
The official unemployment rate is 3.7%.
U-6 is much higher at 7.1%. Both numbers would be way higher still, were it not for millions dropping out of the labor force over the past few years.
Some of those dropping out of the labor force retired because they wanted to retire. Some dropped out over Covid fears and never returned. Still others took advantage of a strong stock market and retired early.
The rest is disability fraud, forced retirement (need for Social Security income), and discouraged workers.
Birth Death Model
Starting January 2014, I dropped the Birth/Death Model charts from this report.
The birth-death model pertains to the birth and death of corporations not individuals except by implication.
For those who follow the numbers, I retain this caution: Do not subtract the reported Birth-Death number from the reported headline number. That approach is statistically invalid.
The model is wrong at economic turning points and is also heavily revised and thus essentially useless.
Household Survey vs. Payroll Survey
- The payroll survey (sometimes called the establishment survey) is the headline jobs number. It is based on employer reporting.
- The household survey is a phone survey conducted by the BLS. It measures employment, unemployment and other factors.
If you work one hour, you are employed. If you don’t have a job and fail to look for one, you are not considered unemployed, rather, you drop out of the labor force.
Looking for job openings on Jooble or Monster or in the want ads does not count as “looking for a job”. You need an actual interview or send out a resume.
These distortions artificially lower the unemployment rate, artificially boost full-time employment, and artificially increase the payroll jobs report every month.
Expect a Long But Shallow Recession With Minimal Rise in Unemployment
Given hiring pressures and boomer retirements, I commented on July of 2022 Expect a Long But Shallow Recession With Minimal Unemployment Rise
That has been an accurate assessment to date although we likely skirted a recession.
Unlike many others, I still do not expect the unemployment rate will rise much in the next recession compared to the average recession impact.
Labor Market Back to Normal
A month ago, I commented A Big Decline in Quits Suggests the Labor Market is Back to Normal
OK, so we are back to “normal” but where are we headed?
Demographics are strongly favorable for job strength. Employment is another matter as the wave of boomer retirements continues.
Final Thoughts
This report is much worse than headline numbers indicates.
Impact of the end of the UAW strike gave an artificial boost to employment last month. This month the BLS took that away and then some.
A decline in full time employment of 1.5 million is remarkable. This series is heavily revised so let’s see what January brings.
The continued dependence on government jobs, up another 52,000 in December, also masks weakness.
This is not a Nirvana setup. The Fed is walking a tightrope. The only questions are when and how the Fed makes another policy error and in which direction.
Expect a mistake. The Fed has a long history of them.
https://mishtalk.com/economics/jobs-up-216000-but-employment-down-683000-job-revisions-71000/
'Sanctuary' City New York Sues Texas Charter Bus Companies For $700 M Over Migrant Dropoffs
New York City is suing more than a dozen charter bus and transportation companies involved in busing migrants to the self-proclaimed 'sanctuary' for migrants that now wants nothing to do with them.
"New York City has and will always do our part to manage this humanitarian crisis, but we cannot bear the costs of reckless political ploys from the state of Texas alone," said NYC Mayor Eric Adams on Thursday. "Today, we are taking legal action against 17 companies that have taken part in Texas Governor Abbott’s scheme to transport tens of thousands of migrants to New York City in an attempt to overwhelm our social services system."
According to the lawsuit, the companies have violated New York state law by failing to pay for the cost of caring for migrants, which the city says amounts to $708 million in damages for what's already been spent caring for them. The filing cites New York law that requires anyone who brings a "needy person" from out of state for the purposes of making them the state's problem, either take them out of the state or support them.
"Governor Abbott’s continued use of migrants as political pawns is not only chaotic and inhumane but makes clear he puts politics over people. Today’s lawsuit should serve as a warning to all those who break the law in this way," said Adams, who's been at war with the Texas governor for sending illegal immigrants to the sanctuary city.
Meanwhile, staggering footage from Wednesday has shown hundreds of migrants - mostly young men - lining up around a block for shelter in Manhattan.
According to Adams in a statement to Fox5, "We're getting close to anywhere from 2,500 to peaking at 4,000 a week."
"We were not just saying we're out of room as a soundbite," he continued, citing the more than 161,000 migrants who have arrived in the Big Apple since the spring of 2022.
"We're out of room, literally" he said. "People are going to be eventually sleeping on the streets."
Adams also recently announced an executive order which requires charter buses to provide at least 32 hours' notice before they arrive in NYC, as well as a requirement to arrive between 8:30 a.m. and 12 p.m. between Monday and Friday - and to drop off at one specific spot, Fox News reports.
Jersey Loophole...
But buses have appeared to be dodging that requirement by dropping off migrants at train stations in neighboring New Jersey, from where they can travel on a train directly into New York City. Secaucus Mayor Michael Gonnelli on Sunday accused the migrant buses of bypassing New York City's executive order through a "loophole."
Adams was asked about the change in strategy on Thursday, and said that the city will continue to enforce the executive order and that he had spoken to the governors of New Jersey and Connecticut.
Adams isn't havin' it...
"And we're going to continue to reach out to our colleagues in the region to say that everyone should put in place a similar EO to send a loud message that these bus operators and bus companies should not be participating in Governor Abbott's…fiasco of really trying to destabilize these cities," he said, before taking another shot at Abbott over the busing.
"What he is doing is just being dogmatic about destabilizing these cities. And we must meet his challenge," he continued.
New York Gov. Kathy Huchul also chimed in, saying that the bus companies are responsible "for their role in this ongoing crisis."
"If they are getting paid to break the law by transporting people in need of public assistance into our state, they should be on the hook for the cost of sheltering those individuals — not just passing that expense along to hard-working New Yorkers. I’m proud to support the mayor’s lawsuit."
Applied Therapeutics Topline Results in Diabetic Cardiomyopathy
Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the topline results of the ARISE-HF Phase 3 trial of AT-001 (caficrestat) in patients with Diabetic Cardiomyopathy (DbCM) at high risk of progression to overt heart failure.
The primary endpoint of the study was stabilization or improvement in cardiac functional capacity as measured by Peak VO2 in patients treated with AT-001 1500mg twice daily (BID) as compared to placebo. The placebo-treated group declined by a mean of -0.31 ml/kg/min over 15 months of treatment, while the AT-001 1500mg BID group remained primarily stable, with a mean change of -0.01 ml/kg/min over 15 months. While a trend favored active treatment, the difference between active and placebo treated groups (0.30 ml/kg/min) was not statistically significant (p=0.210).
The ARISE-HF study evaluated the treatment effect of AT-001 as an add-on to diabetes standard of care therapies. Approximately 38% of study subjects were on SGLT2 or GLP-1 therapies for treatment of diabetes, while 62% were not. In a pre-specified subgroup analysis of the primary endpoint in patients not concomitantly treated with SGLT2 or GLP-1 therapies, the placebo group declined by a mean of -0.54 ml/kg/min, while the 1500mg BID AT-001 treated group improved by a mean of 0.08 ml/kg/min over 15 months of treatment, with a difference between groups of 0.62 ml/kg/min (p=0.040). Additionally, in this subgroup analysis, the number of patients who experienced a clinically significant worsening in cardiac functional capacity of 6% or more was substantially higher in the placebo group (46%) as compared to the 1500mg BID AT-001 treated group (32.7%), odds ratio 0.56 (p=0.035). A 6% change in cardiac functional capacity has been shown to predict long-term survival and hospitalization for heart failure. The effect of AT-001 was dose dependent, with the low dose (1000mg BID) demonstrating an intermediate effect between the high dose and placebo.
AT-001 was generally safe and well tolerated, with no substantial differences in serious adverse events between AT-001 treated groups as compared to placebo (14.3% placebo; 12.3% AT-001 1000mg BID; 17.3% AT-001 1500mg BID), no substantial differences in treatment emergent adverse events (79.1% placebo; 81.6% AT-001 1000mg BID; 81% AT-001 1500mg BID) and low incidence of treatment-related discontinuations (3.9% placebo; 9.6% AT-001 1000mg BID; 9.5% AT-001 1500mg BID).
Full study results will be presented at an upcoming medical conference, along with results of the Diabetic Peripheral Neuropathy sub-study, which are still being analyzed.
“AT-001 stabilized cardiac functional capacity as compared to placebo, and prevented clinically significant worsening of disease, an effect which was strengthened in patients not on concomitant treatment with an SGLT2 or GLP-1,” said Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics. “Given its favorable safety and tolerability profile and oral dosing, we believe that AT-001 represents an important potential tool for physicians in treatment of DbCM patients. We thank the patients and families who participated in the ARISE-HF study and made this important work possible.”
“There are currently no therapies approved for DbCM, and a high unmet need exists for a treatment that can prevent worsening of the condition and progression to overt heart failure,” said James Januzzi, M.D., Principal investigator of the ARISE-HF study and Hutton Family Professor of Cardiology at Massachusetts General Hospital. “Stabilization of cardiac functional capacity is an exciting finding, since declining functional capacity is a leading indicator of progression to overt heart failure.”
Given these encouraging results, the Company plans to focus on identifying an appropriate path forward through partnering in order to bring AT-001 to DbCM patients. Current resources are expected to be focused on the development, regulatory and commercial preparations for the govorestat rare disease program. The Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2023 for govorestat for the treatment of Classic Galactosemia. The Marketing Authorization Application (MAA) was validated and accepted for review by the European Medicines Agency (EMA) in December 2023.
scPharma Preliminary Unaudited Q4 and Full-Year 2023 Net FUROSCIX® Revenue Beat Views
Company anticipates Q4 2023 net FUROSCIX revenue to be approximately $5.9 to $6.1 million; full-year net FUROSCIX revenue of approximately $13.4 to $13.6 million
Gross-to-net (GTN) discount of approximately 18% from launch through the end of Q4
Inventory levels at the end of Q4 2023 consistent with the end of Q3 2023
Unaudited cash, cash equivalents and short-term investments of approximately $76 million as of December 31, 2023
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