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Thursday, February 9, 2023

Does Novartis really love lentiviral?

 Novartis has shown that it is not afraid to double down on gene therapy even when others are leaving the sector. Now the big pharma is rumoured to be interested in acquiring Avrobio, which would give it lentiviral vector expertise to add to its existing adeno-associated viral vector-based gene therapy franchise.

Avrobio could represent something of a bargain – the group’s stock has done badly even in the context of an underperforming gene therapy sector. But there are reasons to be cautious about Avrobio’s prospects, and thus its attractiveness as a target.

There have been concerns about lentiviral vector-based gene therapies because of the theoretical risk of insertional mutagenesis; namely that the gene therapy could trigger cancer. This makes the case for reserving such therapies for life-threatening diseases or those with no alternatives even stronger than for gene therapy more broadly. Other lentiviral players like Orchard Therapeutics and Rocket Pharmaceuticals are focused on severe conditions where there is no standard of care, or where existing options involve transplants. Like gene therapy, transplants require conditioning regimens, Stifel analysts noted.

Meanwhile, Avrobio’s pipeline largely targets disorders that do have existing therapies, such as Gaucher disease, for which enzyme replacement therapy is available. This raises questions about the commercial prospects of its projects even if approved.

In addition, Avrobio’s story so far has been marked by disappointments, such as the discontinuation of its Fabry disease candidate, AVR-RD-01.

Price tag?

Novartis might merely be interested in Avrobio’s lentiviral platform to expand its gene therapy capabilities. The Swiss pharma giant already sells the AAV-based therapy Zolgensma, and gained another AAV option with the 2021 acquisition of Gyroscope.

If so, what would be a realistic cost? StreetInsider, which initially reported Novartis’s interest citing anonymous sources, mentioned a potential price tag of “more than quadruple” Avrobio’s share price, which was $0.87 before the rumours surfaced. The stock nearly doubled yesterday but had fallen back this morning, giving the group a $62m market cap.

Stifel reckons a $200m buyout could be possible, but conceded that a beaten-down Avrobio would not have much bargaining power. Novartis has much larger sums at its disposal, of course, although during the group’s recent fourth-quarter earnings call it said its focus would be on “sub-$5bn assets”.

If a deal does emerge, could it be good news for the likes of Orchard and Rocket, by adding credence to the claim that lenti really is coming back? Neither has seen a share price boost on the rumours, and it would probably take a firm offer to pique investors' interest. The former has also had a rough ride of late on the stock market, but the latter has been a rare gene therapy success story, at least based on share price performance.

Share price performance of lentiviral gene therapy specialists
CompanyShare price at close Feb 7, 2023 ($)1-year change
Rocket Pharmaceuticals21.0020%
Bluebird Bio6.69-6%
Avrobio0.87-52%
Orchard Therapeutics0.54-54%
Based on closing share price on Feb 7, 2023, the day before rumours of Avrobio buyout emerged.

https://www.evaluate.com/vantage/articles/news/deals/does-novartis-really-love-lentiviral

Fresenius may give up control of FMC dialysis business

 German healthcare group Fresenius SE said on Thursday it was potentially ready to cede control over Fresenius Medical Care (FMC), after a fall in earnings at the world's largest dialysis company.

Shares in FMC were down 3.4% at 1538 GMT, while Fresenius stock surged 4.3% after it said it was considering de-consolidating the subsidiary, meaning its sales would no longer be fully integrated into its financial reports.

Elliott Investment Management took a stake in Fresenius SE in October, a person familiar with the matter told Reuters at the time, sparking speculation the activist investor might push for a break up of the diversified healthcare company.

FMC, which has been hit hard by U.S. staff shortages and cost inflation this year, slashed its annual outlook twice last year, also pulling down Fresenius' forecasts.

Confirming an earlier report by business magazine WirtschaftsWoche, Fresenius said in a statement that it was also looking into abandoning FMC's legal form of AG & Co. KGaA, which gives it strategic control and the right to appoint leadership positions even though it only holds 32% of the capital.

Other FMC investors currently have little say in how it is run and the possible change to a regular stock corporation would normally grant all shareholders equal voting rights.

Fresenius cautioned, however, "that the analysis is not yet completed and the required decisions by the competent bodies within the group are still outstanding".

The Else Kroener-Fresenius-Stiftung, a charitable trust that controls Fresenius SE, "has taken note with approval of" the plans to deconsolidate FMC and to change its legal form.

Michael Sen, who became Fresenius CEO in October, has embarked on what he calls a "top-to-bottom" review of all its business activities, with a focus on profitability.

FMC Chief Executive Carla Kriwet, who was hired by Sen's predecessor, stepped down in December after just two months in the job, citing "strategic differences".

https://uk.finance.yahoo.com/news/fresenius-talks-deconsolidation-fmc-wirtschaftswoche-143129159.html

Biden’s IRS slammed over plan to dip into tip jars

 As waiters and waitresses who live off tips could soon get served with new tax scrutiny, service industry workers alongside lawmakers are sounding off on the Internal Revenue Service’s (IRS) latest proposal under President Biden.

"This new ‘voluntary’ system is probably more to track smaller, family-owned establishments," Olivia Kerwin, waitress and full-time student in the West Palm Beach area, told Fox News Digital on Thursday, "which would suck if they use this to impose more taxes on these businesses that are already struggling to survive."

The IRS has opened itself up to public feedback regarding a proposed tip reporting system between the tax agency and employers in service called the Service Industry Tip Compliance Agreement (SITCA).

The program would be voluntary and is designed to "take advantage of advancements in point-of-sale, time and attendance systems, and electronic payment settlement methods to improve tip reporting compliance," the agency said in a statement on Monday.

While reportedly replacing other tip reporting systems, according to the IRS, SITCA would monitor employer compliance based on annual tip revenue and charge tip data from an employer’s point-of-sale system.

Participating employers would have to submit an annual report after the close of the calendar year, which reduces the need for compliance reviews by the IRS.

Many service industry workers, like Kerwin, rely strictly on tips to make a sustainable living as many servers’ hourly pay falls below minimum wage.

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"I was looking at my taxes from this past month, I paid probably $1,100 in taxes, and my hourly [wage] was $10.90," Kerwin had previously explained to Fox News Digital. "So I paid an extra $10 on top of what my hourly was. I didn't see any of my hourly pay. Everything I saw was from my tips."

Kerwin further argued how abiding by a new IRS regulation would fuel confusion and frustration for businesses, who have already seen their tips get hit by inflation.

"I feel like due to inflation costs, people start to tip less and people will get confused. They're like, ‘Oh, well, you shouldn't be mad that we're not tipping. You should be mad at your company for not paying you a livable wage,’" Kerwin noted. "But the other side of that sword is most servers make more being tipped than they would if they were to make $20 or $25 hourly. And I know myself personally, the extent of the work that I do, I wouldn't go above and beyond if I knew I was only going to be making that same $20 an hour."

Most nights, Kerwin claims she won’t take home the entirety of her tips either, as some establishments split tips between servers, hostesses, bartenders and food runners.

"Probably about 5% of our total gross sales, we have to tip out," she said, "and we don't tip out based on the amount of money we are tipped, we tip out based on our total amount of sales."

"So say someone dined in and they spent $100, but they only tip me $5, I'm not getting any of that. I'm probably even, at that point, paying out of my own pocket for them to have eaten there," Kerwin continued, "because I still have to tip out the bartender on that $100, I still have to tip out the food runners and the hostesses on that money."

Lawmakers on Capitol Hill have also publicly opposed SITCA, such as Rep. Claudia Tenney, R-N.Y., who used to be a waitress herself.

"It's unconscionable," Tenney said on "Mornings with Maria" Thursday. "And you know, if you tax the rich all the way to the end, 42% of our federal tax revenues come from the 1%. But to go after waitresses? I remember when I was a waitress, I made a dollar an hour, and then I relied on my tips… But this is the kind of thing where you're not going to solve our budget problems by going after hard-working Americans."

"Washington has a spending problem, not a revenue problem," Rep. Mike Kelly, R-Pa., the chairman of the Ways and Means Subcommittee on Tax, previously told Fox News Digital on Wednesday. "Now, the IRS is going after middle-income families and working moms and dads who are just trying to make ends meet and put food on the table."

"My colleagues and I have warned for months that the IRS would start targeting hardworking Americans in the Biden administration’s quest for more taxpayer dollars. Now, we’re starting to see some of these concerns come to fruition," he added.

Rep. Adrian Smith, R-Neb., another senior member of the House Ways and Means Committee, echoed Kelly's comments, saying the plan was the latest example of the Biden administration targeting working families via tax policy. He also said the GOP was prepared to be a check on the IRS's programs.

"Bank surveillance efforts, 1099-Ks, 87,000 new IRS agents to target taxpayers, and now a new program to go after service industry workers’ tips are all a direct result of the Biden administration’s desire to tax working families and small businesses as much as possible," Smith also told Fox News Digital Wednesday. "Make no mistake: the administration’s many attempts at raising revenue are because they are unwilling to come to the table to address the debt crisis, which would require curbing their spending addiction."

https://www.foxbusiness.com/economy/biden-irs-slammed-plan-tip-struggling-survive

Banksters Want Your Money

When I saw bailouts and bail-ins in the mailbag, it piqued my curiosity…

Here what one of you had to say:

I’d love to see you cover the topic of “bail-ins” and how the banks can now bail-in our deposits during any financial crisis, to bail-out, once again the “BANKSTERs!”

What options do we have to safeguard our cash, other than to deposit in a bank?

Sure, own a little gold, bitcoin, etc.…. I don’t want to be bailed-in!

Mike M.

Well, Mike, you’re correct. The government can bail depositors in. And it may be legal, but I personally think it’s a crime.

But – and it’s a big “but” – there are specific rules as to how a bail-in occurs.

So in this Morning Reckoning, I’m going to talk about the difference between bail-ins and bailouts. Then I’ll explain under what conditions a bail-in can occur. Finally, I’ll give you a couple of ways to make sure that never happens to you.

Let’s get to it.

What are bailouts?

First, let’s go over the easy part and get it out of the way.

bank bailout is when the government provides financial assistance to a poorly managed bank to prevent its collapse and protect the depositors’ money.

Which depositors? We’ll answer that question further down…

Former U.S. Treasury Secretary Paul O’Neill once said of bankruptcy that it’s the “genius of capitalism.” By speaking that fundamental truth, O’Neill was relieved of his job.

Banks are companies and ought to be allowed to go bankrupt. I was against the bailouts in 2008 and my position has never wavered.

Once poor banks go under, the space is cleared for new banks – or new methods for saving – to spring up.

Sure, would bankruptcy hurt some depositors? Yes. But not those who have less than the maximum deposit insurance level. I’ll talk more about that later.

Now… how does the government execute a bailout?

This can be done by injecting capital into the bank, guaranteeing the bank’s debts or nationalizing the bank. Or, in the case of Bank of America and Merrill Lynch, the Federal Reserve Chairman can force an acquisition.

Bank bailouts are controversial for good reason. They usually involve taxpayers’ money to rescue financial institutions that are too big to fail.

But even worse is that the central bank may print money to cover the losses. From September 2008 to mid-November 2008, the Fed’s balance sheet doubled.

To quell public anger about bailouts, governments came up with a new method to save overextended banks: the bail-in.

What are bail-ins?

bank bail-in is when a troubled bank’s creditors and depositors with large balances are forced to bear some of the losses instead of taxpayers.

This is done by converting a portion of their debt into equity or by seizing their deposits to recapitalize the bank and restore its financial stability.

A couple of things: creditors (bondholders) take this risk every day. It’s why fixed income traders are so miserable compared to equity traders. Equity traders ask, “How much money am I going to make today?” Fixed income traders ask, “How much am I going to lose today?”

Regarding depositors with large balances, this is the key to the whole conundrum.

It’s critical to remember the Federal Deposit Insurance Corporation (FDIC) in the United States insures your deposits up to $250,000 at each institution.

And that covers:

-Checking accounts
-Negotiable Order of Withdrawal (NOW) accounts
-Savings accounts
-Money market deposit accounts (MMDA)
-Time deposits such as certificates of deposit (CDs)
-Cashier’s checks, money orders, and other official items issued by a bank

What’s more is that each ownership category is covered. That is, if you have two or more accounts in two or more different ownership categories, you’re insured up to $250,000 on each.

Here are the different ownership categories:

-Single Accounts
-Certain Retirement Accounts
-Joint Accounts
-Revocable Trust Accounts
-Irrevocable Trust Accounts
-Employee Benefit Plan Accounts
-Corporation/Partnership/Unincorporated Association Accounts
-Government Accounts

So this begs the question: if the FDIC insures all this, how can you possibly get bailed in?

How can you get trapped in a bail-in?

Let’s say you only have one single account at one bank. You’ve got $300,000 in that single account. Your bank is about to go under, but the government has ordered a bail-in.

In a plain vanilla bail-in scenario, $250,000 of your deposit will be perfectly safe. The $50,000 you’ve got over the deposit insurance limit will be “bailed in.” That means the $50,000 will likely be exchanged for stock in the bank that’s worth nowhere near $50,000.

You’ll probably feel like you’ve lost $50,000, even if you didn’t lose the whole amount.

So how do you make sure this doesn’t happen?

What can you do to avoid getting bailed in?

There is no guaranteed way to avoid a bail-in, but depositors can take steps to reduce their risk:

Don’t keep one large deposit at a single bank: Keep smaller deposits in multiple banks. That reduces the risk of losing a large amount in case of a bail-in. Also, ask your accountant to help you make sure separate amounts are in different ownership categories if you must, for some reason, stay at one bank.

Spread your deposits across different banks: Keep amounts less than $250,000 at multiple banks within the U.S. That’s easy.

-Bonus tip: Since I’ve lived in a few countries, I never closed those foreign bank accounts and I use them as cash protection vehicles. If you’re American, keep in mind that you must declare your foreign bank accounts to the IRS (FBAR) with your tax returns if those accounts exceed $10,000 at any point in the year.

Know the bank’s financial situation: Forgive me for being so obvious… but you definitely want to avoid banks that are in financial distress.

Consider different investments: The easiest thing in the world to do is to buy US Treasury bills and bonds. They’re liquid cash substitutes the USG guarantees. And thanks to Chairman Pow, you even get a bit of yield nowadays.

Remember, these ideas only reduce the risk of a bail-in, they don’t guarantee that outcome. Ultimately, governments decide and they’re unpredictable.

Wrap Up

Not only do you now know how to reduce your chances of getting bailed in, but you also know why governments invented them.

Think about it. Only people with amounts over $250,000 would be affected by a bank going down.

So yes, your instinct was correct. In 2008, the government only bailed out their rich friends. It didn’t “save the world economy.”

And since the public figured this out pretty quickly, the Europeans invented the bail-in to require those rich folks to participate in the losses.

America later adopted bail-ins as a legal measure which will probably only be used for banks that aren’t too big to fail.

A big thank you to Mike M. for the stimulating question.

I try and read all the emails you all send me… it helps me get down to what really matters to the people I’m writing for.

If you have any feedback or topics you want covered, be sure to click here and drop me a line.

Otherwise, I hope you take measures to protect yourself if you haven’t already.

Once you do, stop worrying about it. There are far bigger fish to fry nowadays.

https://dailyreckoning.com/the-banksters-want-your-money/

Eiger BioPharmaceuticals reports positive phase 3 results for COVID-19 treatment

 US-based Eiger BioPharmaceuticals’ investigational agent, peginterferon lambda (Lambda), significantly reduces the number of clinical events in COVID-19 patients with mild to moderate cases, according to new phase 3 data published in the New England Journal of Medicine.

The TOGETHER study, which evaluated newly diagnosed outpatients considered to be at a higher risk, demonstrated a 51% reduction in COVID-19-related hospitalisations or emergency room visits greater than six hours for patients receiving a single dose of Lambda compared to placebo.

The effects were consistent across dominant variants and vaccination status, the company said, but the treatment effect for Lambda was more pronounced in patients who were treated within three days of symptom onset, including a 65% reduction of COVID-19 related hospitalisation and an 81% risk reduction in all-cause death.

Among individuals with a high viral level at baseline, Lambda resulted in lower viral loads and a higher percentage of patients clearing SARS-COV-2 RNA by day seven, compared to placebo.

“This data demonstrates the potential of peginterferon lambda to confer a meaningful benefit for patients with COVID-19 and suggests potential for other respiratory viral infections,” said David Apelian, interim chief executive officer, Eiger.

Apelian added that the company has “over 100,000 peginterferon lambda syringes readily available with additional manufacturing intermediates to support a capacity of over ten million units if needed”.

The study included multiple COVID-19 variants of concern and was among the first trials to include a predominantly vaccinated population, with 84% of patients having received vaccination prior to entry.

“Peginterferon lambda has tremendous therapeutic potential, and we continue to see the emergence of aggressive variants of the virus spreading around the globe which are less sensitive to both vaccines and treatment with antibodies,” said Jordan Feld, associate professor of medicine at the University of Toronto and senior scientist at Toronto Centre for Liver Disease and Toronto General Hospital Research Institute and co-lead investigator for TOGETHER.

“Resistance due to variants or new strains of the virus could be an issue with some therapies, but this may not be a concern with peginterferon lambda due to its mechanism of action that involves activation of multiple virus-killing pathways,” Feld added.

The new data follows positive top line safety and efficacy results, announced by the company in March 2022 showing that Lambda reduced the risk of COVID-19-related hospitalisations or emergency room visits greater than six hours by 50% and death by 60%.

https://www.pmlive.com/pharma_news/eiger_biopharmaceuticals_reports_positive_phase_3_results_for_covid-19_treatment_1486465

Gilead: Kite’s Tecartus CAR T-Cell Therapy Overall Survival Benefit in Leukemia

 In Three-Year Follow-up in Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia, Tecartus Shows High Rates of Durable Response (CR+CRi 71%) and a Median Overall Survival of 26 Months --

https://finance.yahoo.com/news/kite-tecartus-car-t-cell-121500630.html

AstraZeneca Forecasts Growth In 2023 Earnings, Revenue Despite Fall In COVID-19

 

  • AstraZeneca Plc (NASDAQ: AZN) has reported Q4 core EPS of $1.38, down 17% Y/Y (-5% constant currency).

  • The company clocked Q4 sales of $11.21 billion, -7% (+1% CC), in line with the consensus.

  • The core gross margin of 77% in the fourth quarter was impacted by inventory write-downs and manufacturing termination fees for Evusheld, its COVID-19 treatment.

  • Fourth-quarter revenue was also hurt by a decline in sales of AstraZeneca's COVID-19 vaccine Vaxzevria.

  • "In 2023, we expect to see another year of double-digit revenue growth at CER, excluding our COVID-19 medicines. We will continue to invest behind our pipeline and recent launches while continuing to improve profitability. We plan to initiate more than thirty Phase III trials this year, of which ten have the potential to deliver peak-year sales over one billion dollars," added the CEO.

  • Guidance: AstraZeneca expects core EPS to increase by a high single-digit to low double-digit percentage in 2023.

  • Total revenue excluding COVID-19 medicines is expected to increase by a low double-digit percentage.

  • Overall revenue is expected to increase by a low-to-mid single-digit percentage.

  • CEO Pascal Soriot said the firm was on a path to deliver at least 15 new medicines this decade.

  • Total Revenue from China is expected to return to growth and increase by a low single-digit percentage in FY 2023.

  • The company forecast on Thursday that core operating expenses would increase by a low-to-mid single-digit percentage, citing its investment in recent drug launches and the start of new trials.