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Wednesday, November 6, 2024

Guardant Health ups revenue guidance after Q3

 Revenue growth of 34% driven by strong clinical and biopharma volume and Guardant360 ASP tailwinds

Shield received favorable Medicare pricing of $920

2024 Guidance

Guardant Health now expects full year 2024 revenue to be in the range of $720 to $725 million, representing growth of 28% to 29% compared to full year 2023. This compares to the prior range of $690 to $700 million, representing growth of 22% to 24%. Guardant Health continues to expect full year 2024 non-GAAP gross margin excluding screening to be in the range of 61% to 63% and total non-GAAP operating expenses to be in the range of $720 to $730 million, representing a flat to 1% decrease compared to 2023. Guardant Health now expects free cash flow to be in the range of $(265) to $(275) million in 2024, representing an improvement of $70 million to $80 million compared to 2023.

Webcast Information

Guardant Health will host a conference call to discuss the third quarter 2024 financial results after market close on Wednesday, November 6, 2024 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at http://investors.guardanthealth.com. The webcast will be archived and available for replay for at least 90 days after the event.

https://www.businesswire.com/news/home/20241106173129/en/

NovaBay Pharmaceuticals Accepts Revised Offer

 NovaBay® Pharmaceuticals, Inc. (NYSE American: NBY) ("NovaBay" or the "Company") today announces that the Company has accepted a revised transaction proposal from PRN Physician Recommended Nutriceuticals, LLC ("PRN") to increase the base purchase price for the Company’s eyecare business from $9.5 million to $11.5 million. The Company has entered into an amendment (the "Amendment") to its previously announced Asset Purchase Agreement, dated September 19, 2024, with PRN (the "Original PRN APA" and, as amended, the "PRN APA"). The Company's transaction with PRN remains subject to certain closing conditions, including receiving stockholder approval.

"We are pleased to accept PRN’s revised offer for the Avenova® brand and continue our efforts to obtain stockholder approval. With the newly added value, we truly believe this deal is in the best interests of our stockholders," said Justin Hall, NovaBay CEO.

In addition to the increased base purchase price of $11.5 million, the Amendment provides for (i) the removal of debt financing contingencies and related PRN representations, while adding a new PRN representation that it has sufficient funding for the base purchase price; (ii) PRN providing the Company with a secured promissory note for up to $1.0 million to be funded by two future installments of $0.5 million each, which loan is expected to be repaid in full upon the closing of the PRN transaction as a deduction from the purchase price (the "Bridge Loan"); and (iii) PRN providing the Company with an equity funding commitment letter (collectively, the "Revised PRN Transaction Terms").


https://finance.yahoo.com/news/novabay-pharmaceuticals-accepts-revised-offer-210500782.html

Tandem Diabetes ups sales guidance after Q3

 Third Quarter 2024 Highlights

  • Worldwide GAAP sales increased 31 percent to $244.0 million compared to third quarter 2023; worldwide non-GAAP sales(1) increased 25 percent to $242.9 million compared to third quarter 2023.
  • Grew worldwide pump shipments by more than 25 percent compared to third quarter 2023.
  • Achieved year-over-year growth in new pump starts in the United States, including growth in new customers starting from multiple daily injections.
  • Demonstrated positive Adjusted EBITDA and a return to positive free cash flow.
  • Completed clinical study in support of a regulatory filing to expand the indication for Control-IQ to include people living with type 2 diabetes.

“The third quarter marked a milestone achievement for Tandem Diabetes Care as we delivered the highest quarterly sales in our Company’s history, both in the U.S. and internationally,” said John Sheridan, president and chief executive officer. “This performance, coupled with our strong operational execution, positions us well to achieve our remaining goals for 2024 and beyond, as we further our mission to improve the lives of people with diabetes.”

2024 Financial Guidance

The Company’s non-GAAP guidance for the fiscal year ending December 31, 2024 is set forth below. The most directly comparable GAAP financial measures are not accessible on a forward-looking basis due to the high degree of complexity in the accounting treatment for the Tandem Choice program. For a description of non-GAAP sales, non-GAAP gross margin, and Adjusted EBITDA margin, as well as an illustration of the reconciliation from the most directly comparable GAAP financial measures, refer to Table D “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release. Also see “Non-GAAP Financial Measures” below for additional information.

For the year ending December 31, 2024, the Company is increasing 2024 sales guidance and reaffirming other financial guidance as follows:

  • Non-GAAP sales are estimated to be approximately $903 million to $910 million for the full year.
    • Sales in the United States of $645 million to $650 million.
    • Sales outside the United States of approximately $258 million to $260 million.
  • Non-GAAP gross margin is estimated to be approximately 51 percent.
  • Adjusted EBITDA margin is estimated to be breakeven as a percent of sales.
  • Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately $120 million. This includes:
    • Approximately $100 million non-cash, stock-based compensation expense.
    • Approximately $20 million depreciation and amortization expense.

Conference Call

The Company will hold a conference call and simultaneous webcast today at 4:30pm Eastern Time (1:30pm Pacific Time). The link to the webcast will be available by accessing the Events & Presentations tab in the Investor Center of the Tandem Diabetes Care website at http://investor.tandemdiabetes.com, and will be archived for 30 days. To access the call by phone, please use this link (https://register.vevent.com/register/BI21747dfdc3fd4a4e98aeeeef73bf87b6) and you will be provided with dial-in details, including a personal pin.

https://www.businesswire.com/news/home/20241106987558/en/

How The Democrats And Media Finally Went Too Far

 by Frank Meile via RealClearPolitics.com,

The reelection of Donald Trump represents, if not the single greatest comeback in political history, certainly the largest middle finger ever shown to the smug, self-centered, superior-minded elitists who think the rest of us are garbage.

Of course, we didn’t need President Biden to call us “garbage” for everyday Americans to know that what we care about means nothing to the establishment. But Biden obliged anyway, and put an exclamation point to the final sorry week of Kamala Harris’ galling campaign.

You just can’t get any worse than “garbage” – or can you? Isn’t Nazi worse? After all, the Nazis killed 17 million people. If you include all the victims of fascism, you can get that number up to 20 million. But for some reason, the legacy media didn’t care when Harris and her surrogates repeatedly called Trump and his supporters Nazis or fascists.

You almost get the feeling that the left-leaning press despises Republicans as much as Biden, Harris, and the rest of the Democrats do. If you had any doubt, the totally bogus claim that Trump said he wanted to execute Liz Cheney was the last straw. He was making a perfectly valid argument that the former congresswoman would be less inclined to support wars if she had to fight in them. But apparently that was too sophisticated an attack for the news professionals who decided to lie about it. Instead, they maliciously claimed that Trump literally wanted to put Cheney in front of a firing squad.

Overall, the past three weeks have been instructive in just how little the nation’s elites in the media and politics respect average citizens, and just how much they think they can manipulate us into believing their lies.

It’s nothing new, but the latest iteration started on Oct. 13 when Kamala Harris began peddling the “enemy within” hoax, which would have voters believe that Trump had said he planned to use the military against his political opponents.

In fact, that never happened. Fox News host Maria Bartiromo interviewed Trump and said that Joe Biden doesn’t expect a peaceful Election Day. She asked Trump if he was expecting chaos that day, but she specifically asked about the impact of outside agitators, bringing up the case of an Afghan who was charged with a terror plot, and also mentioning Chinese nationals and criminals who had crossed the border illegally.

It was in this context that Trump said he wasn’t worried about outside agitators, but rather “the enemy from within,” meaning American citizens who might riot following the election, just as happened in 2016. He continued:

I think the bigger problem are the people from within. We have some very bad people. We have some sick people, radical left lunatics, and … it should be very easily handled by, if necessary, by the National Guard, or if really necessary by the military, because they can’t let that happen.

This turned into the closing argument of the Harris campaign, claiming that Trump had promised to unleash the military on his political opponents. It was yet another hoax by Democrats and the media, which is either incredibly stupid or incredibly dishonest. CNN’s headline was typical: “Trump suggests using military against ‘enemy from within’ on Election Day.”

Notice that Trump didn’t “suggest” using the military; he said that chaos could be averted “if necessary” by the National Guard or “if really necessary” by the military. He never suggested this was his plan.

The most obvious part of the lies told by CNN, Harris, and all the Democratic Party machinery was that Trump could do anything, anything at all, about Election Day violence. NOTE TO CNN: On Election Day, Joe Biden will be the president, not Donald Trump. In saying that “they can’t let that happen,” Trump was actually crediting Biden with the common sense not to let violence disrupt our most sacred democratic ritual of voting.

Yet for more than a week, Harris and her allies peddled this nonsense to convince voters that Trump is “unhinged, unstable and unchecked.”

Then, almost as though on cue, just over one week later on Oct. 22, Atlantic magazine editor Jeffrey Goldberg wrote a scandalous article that quoted anonymous sources as saying Trump had insulted the family of Vanessa Guillén, a Mexican-American soldier who was murdered in Texas. The article included a quote from Guillén’s sister praising President Trump for his kindness to the family, but Goldberg essentially pretended the quote didn’t exist. Instead he smeared Trump as a heartless exploiter.

Later in the same article, Goldberg quoted Gen. John Kelly, Trump’s disgruntled former White House chief of staff, as saying Trump had told him, “I need the kind of generals that Hitler had.”

This dubious old quote was dusted off and included in the article for only one reason – to give Kamala Harris and the Democrats and the talking heads on CNN and MSNBC more fodder for their “Trump is a fascist” narrative. Lots of White House staffers were ready to deny the Kelly story, but that didn’t matter to Goldberg. Let ’er rip.

And as further evidence of media collusion with the Harris campaign, the New York Times on the same day, Oct. 22, revealed an interview with Gen. Kelly in which he said that Trump “falls into the general definition of fascist” and “certainly prefers the dictator approach to government.”

This double whammy of remarks by Kelly gave Harris permission to expand her attack on Trump as a fascist, and it quickly became apparent that her campaign was going to replace “joy” with “fear” as the closing argument.

The media ran with this as a willing partner in the attempt to keep Trump out of the White House. And even before Trump held a historic rally at Madison Square Garden on Oct. 27, many news outlets drew bizarre comparisons to a 1939 pro-Nazi rally held by the German American Bund in an earlier iteration of the world-famous arena. Yes, that 1939 rally was an offensive anti-American gathering, but it had nothing to do with Trump’s rally in a different building 85 years later.

Moreover, the Fake News historians somehow missed the fact that in 1933, shortly after Adolf Hitler was named chancellor of Germany, the American Jewish Congress held a National Day of Protest in the same venue. The National Park Service, in its history of Madison Square Garden, writes that “After a day of fasting and prayer, more than 55,000 people flooded MSG III and the streets surrounding it for the largest rally. Jewish leaders, union presidents, politicians, and Christian clergy addressed the crowd. They denounced the Nazis and compared the persecution of European Jews to the terror of the Ku Klux Klan.”

The media somehow also missed the fact that there were Israeli flags and Orthodox Jews at Trump’s rally, along with two former Democratic presidential candidates, the richest man in America, a black congressman, and a variety of Jewish advisers. All that mattered in the long run was that rally organizers had invited an obscure insult comedian named Tony Hinchcliffe to open the show. Turned out Hinchcliffe lived up to his title and insulted a variety of people and ethnic groups, including Puerto Ricans.

“I don’t know if you guys know this, but there’s literally a floating island of garbage in the middle of the ocean right now. I think it’s called Puerto Rico,” he joked.

The media went nuts, claiming that Trump was racist because the comedian had insulted Puerto Rico. But that never made any sense.

Yes, it was an uncomfortable joke, one that seemed inappropriate in the middle of a political campaign where former President Trump has been working hard to build up his share of the Hispanic vote. But it was a joke, and though most in the audience had no idea, it wasn’t a random insult, but a topical one. 

Puerto Rico has a trash problem  thanks to a variety of causes, and it’s something a future president of the United States should help to resolve.

But the current president can’t be bothered. Instead of using the tasteless joke to bring attention to the plight of our fellow citizens in Puerto Rico, President Biden deflected attention away from the island and provocatively said “The only garbage I see floating out there is his [Trump’s] supporters.”

Which brings us full circle to the disastrous last week of the Harris campaign. As she lectured her would-be constituents during a speech on the Ellipse in D.C., preaching peace, brotherhood, and unity, her boss Joe Biden was in the White House behind her, telling a Zoom call that Trump supporters are “garbage.” You can’t make this stuff up.

The Democratic Party has been unmasked once again as the party of hypocrisy, insincerity, and smugness. Just as in 2016 when the MAGA base embraced Hillary Clinton’s description of them as “deplorables,” so too did the Trump faithful now begin to greet each other as pieces of garbage. When Trump descended from his jet in Green Bay and entered a garbage truck wearing a sanitation worker’s orange vest, he closed the deal with millions of voters who are tired of being ignored.

Don’t ever underestimate how much the establishment hates Donald Trump, but also, don’t ever underestimate how much everyday Americans hate the establishment. End of story.

*  *  *

Frank Miele, the retired editor of the Daily Inter Lake in Kalispell, Mont., is a columnist for RealClearPolitics. His book “The Media Matrix: What If Everything You Know Is Fake” is available from his Amazon author page. Visit him at HeartlandDiaryUSA.com or follow him on Facebook @HeartlandDiaryUSA and on X/Gettr @HeartlandDiary.

https://www.zerohedge.com/political/how-democrats-and-media-finally-went-too-far

QIAGEN delivers solid Q3 2024 growth ahead of outlook, ups full-year 2024 adjusted EPS outlook

 QIAGEN reported strong Q3 2024 results with net sales of $502 million, representing a 5% increase at actual rates and 6% at constant exchange rates (CER), exceeding the outlook of $495 million CER. The company achieved a 29.6% adjusted operating income margin, up 3 percentage points from Q3 2023. Free cash flow increased 73% to $364 million in the first nine months of 2024. Based on solid performance, QIAGEN reaffirmed its FY 2024 net sales outlook of at least $1.985 billion CER and increased its adjusted diluted EPS outlook to at least $2.19 CER from the previous $2.10 CER.

https://www.stocktitan.net/news/QGEN/qiagen-delivers-solid-q3-2024-growth-ahead-of-outlook-increases-full-0kwvhkeswguj.html

Gilead 3rd-quarter results beat Wall Street estimates, raises outlook

 Gilead Sciences reported third-quarter financial results that handily beat Wall Street expectations on Wednesday as sales climbed 7%, leading the drugmaker to raise its outlook for full-year earnings.

The Foster City, California-based company posted an adjusted quarterly profit of $2.02 per share on revenue of $7.5 billion, ahead of average analyst estimates of $1.55 per share and $7 billion, according to LSEG data.

Due to "the strength of our overall business model ... we're increasing our 2024 guidance across every metric," Gilead Chief Executive Officer Daniel O’Day told Reuters.

Gilead said net earnings for the quarter fell to $1.00 per share, from $1.73 a year earlier, due in part to a $1.75 billion impairment charge related to its 2020 acquisition of cancer drug developer Immunomedics.

Third-quarter sales of HIV drug Biktarvy rose 13% to $3.5 billion while sales of COVID-19 treatment Veklury rose 9% to $692 million.

Oncology sales were up 6% to $816 million, while liver disease drugs brought in $733 million, up 4% from a year ago.

For full-year 2024, Gilead raised its product sales forecast to a range of $27.8 billion to $28.1 billion from a previous view of $27.1 billion to $27.5 billion. The company now expects an adjusted profit of $4.25 to $4.45 per share, up from $3.60 to $3.90.

Analysts have projected full-year earnings of $3.81 per share on revenue of $27.72 billion.


https://finance.yahoo.com/news/gilead-3rd-quarter-results-beat-211946375.html

CVS names former UnitedHealth exec to run Aetna, shares jump

 CVS Health on Wednesday named Steve Nelson, a former UnitedHealth insurance head, to run its Aetna business, where rising medical costs in the third quarter caused the company to preannounce an earnings miss last month.

The company last month also replaced CEO Karen Lynch with David Joyner due to troubles managing costs in that business.

CVS, which also owns a pharmacy benefit manager and one of the largest U.S. retail pharmacy chains, has come under investor pressure, including from activist hedge fund Glenview Capital Management.

CVS's beaten down shares rose nearly 13%. Stocks of other health insurers were also buoyed on Wednesday after Donald Trump was elected U.S. president for a second term.

The healthcare conglomerate confirmed its earlier plans to take $1.2 billion in restructuring charges for layoffs, the closure of 271 retail stores and the shutdown of some business lines. It plans to continue offering healthcare services in its CVS pharmacies, the company said.

"We're very much focusing on how we right-size our store footprint, and we think that we're there with the next round of closures," Joyner said in an interview with Reuters. "Then we're building inside that store footprint a set of healthcare services that we believe will become a healthcare destination for the consumer."

CVS reported a third-quarter adjusted profit of $1.09 per share, less than half of the $2.21 it earned a year ago. That was in line with its pre-reported earnings of $1.05 to $1.10 per share.

The company's shares are still down 21% so far this year, compared with a nearly 20% gain for the broader S&P 500.

Following the COVID-19 pandemic, medical services use rose after its Medicare plans for people aged 65 and older or disabled enrolled the highest amount of new members in the industry. As states redetermined eligibility for their Medicaid plans for low-income people, healthier members fell off the rolls, leaving behind those who require more medical services.

The company underestimated medical costs when pricing its healthcare benefits for 2024, Joyner said in a call to discuss third-quarter results. "I recognize that we have been more acutely impacted than others in the industry."

Chief Financial Officer Tom Cowhey said the level of disconnect between use of medical services and the payment rates from state Medicaid plans had stabilized toward the end of the third quarter. "We continue to work closely with our state partners to align rates with changes in (use)."


https://ca.finance.yahoo.com/news/cvs-taps-former-unitedhealth-executive-113736289.html