Record consumer revenue of $43 million increased 108% compared to Q2 2021
Ingredients sold out in first half with $15 million backlog to be supplied in H2
Cost actions and price increases to deliver $50 million of EBITDA improvements in H2
$700 million non-equity funding and earnout provides liquidity to sustained profitability
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, announced today that it has entered into a securities purchase agreement to sell in a private placement to a group of new and existing institutional investors, led by Deep Track Capital, LP and including participation from Great Point Partners, Broadfin Holdings, LLC and other leading healthcare investors, 16,129,032 shares of its common stock at an offering price of $3.10 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 8,548,387 shares of common stock at a purchase price of $3.0999 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant. Gross proceeds of the private placement are expected to be approximately $76.5 million, before deducting placement agent fees and other expenses. The private placement is expected to close on or about August 11, 2022, subject to the satisfaction of customary closing conditions.
Heron intends to use the net proceeds from the proposed private placement to support its acute care and oncology care commercial franchises, including accelerating the adoption of ZYNRELEF® and preparing for the anticipated launch of HTX-019 for the prevention of postoperative nausea and vomiting ("PONV") ahead of the September PDUFA date, and for working capital and general corporate purposes.
Cantor Fitzgerald & Co. is acting as sole placement agent.
https://finance.yahoo.com/news/heron-therapeutics-announces-76-5-120100870.html
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today announced the exercise of procurement options under its 75A50118C00019 (19C) contract with the U.S. Department of Health and Human Services for the delivery to the U.S. government of intravenous (IV) formulation of TPOXX treatment courses valued at approximately $26 million . These option exercises represent the first procurement option exercises for IV TPOXX under the 19C contract. Product deliveries of IV TPOXX in connection with these contract options are targeted for 2023. IV TPOXX is an important option for those who are unable to swallow.
https://finance.yahoo.com/news/siga-announces-barda-exercise-procurement-113000027.html
T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today plans to explore the potential to develop a rapid molecular diagnostic test for detection of the monkeypox virus, including technical and commercial feasibility. Monkeypox is a rare disease caused by infection with the monkeypox virus that is part of the orthopoxvirus family of viruses, which also contains smallpox. The main symptom of monkeypox is a rash, but individuals may also present with flu like symptoms. A rapid and accurate diagnosis of monkeypox is essential to expedite treatment and to limit exposure and spread of the disease.
https://finance.yahoo.com/news/t2-biosystems-explore-potential-develop-123000590.html
Half a year in, the baby-formula shortage keeps getting worse with no end in sight. Unlike the global semiconductor and grain shortages, the formula shortfall is an America-only phenomenon. This means the solution can be found here at home.
But by focusing on importing limited amounts of Food and Drug Administration-approved foreign formula, President Joe Biden is addressing only the problem’s symptom, not the root cause. He needs to cut the ridiculous red tape that’s keeping store shelves bare.
Baby formula has a 30% out-of-stock rate — higher than when parents began panicking months ago and stratospheric compared with the typical 5% to 7% pre-pandemic.
The shortage was precipitated by Abbott Nutrition’s February recall after five infants came down with severe infections after consuming formula produced at the company’s Sturgis, Mich., plant. An FDA inspection found unsanitary conditions and other violations, leading Abbott to recall the formula and halt production. The infection-causing bacteria were not found in the Abbott formula, though.
Usually, a recall wouldn’t cause such severe disruption. But the US baby-formula market is extremely concentrated: 80% of all formula comes from just two companies, one being Abbott, which had 48% of the market when the recall started. The company also dominates the formula purchased for the US Department of Agriculture’s Women, Infants, and Children program, holding government contracts in 34 states and the District of Columbia.
Because of its market dominance, there were bound to be repercussions once Abbott recalled formula and halted production at one of its largest plants. Action was needed to prevent a shortage, especially for babies who require a specialized formula for survival. But rapid action was not taken.
The FDA reports that “the U.S. normally produces 98% of the infant formula it consumes.” That’s partly thanks to tariffs of up to 17.5% on imported baby formula that put foreign competitors at a distinct competitive disadvantage. Few even bother going through the FDA’s approval process. With a massive shortage in such a large market, however, many foreign companies began wanting to sell to the United States but needed FDA approval to do so.
Despite the urgency, the FDA took three months to issue guidance on relaxing restrictions on foreign formula. And even after that May guidance, approval still requires extensive documentation and analysis — so the FDA is still causing delays.
Indeed, Reuters reports foreign formula companies Nature’s One and Holle are ready to ship massive amounts of formula, but “they may be waiting a while” due to the FDA’s “slow responses.”
Parents desperate for formula don’t have the luxury of time.
These delays are unacceptable, and Americans deserve to know why the FDA has been so slow and unresponsive. Advocacy group Americans for Prosperity recently submitted a Freedom of Information Act request for documentation on the FDA’s mishandling of this matter. Perhaps what AFP uncovers will shed light on the reasons the FDA did not respond more quickly.
Fortunately, Congress is taking action to break down barriers for foreign suppliers. In May, lawmakers passed the Access to Formula Act to let WIC programs buy alternative formulas. Last month, they passed legislation to waive all tariffs on formula temporarily. But all that will be for naught if the FDA doesn’t speed up its approvals.
The FDA’s primary concern, as it should be, is safety. But while foreign formulas may not have gone through the agency’s approval process, they are regulated by the European Commission. Pediatrics professor Bridget Young notes that the European Commission’s formula regulations are stricter than ours, including bans on certain added sugars.
A 2019 study found that among popular European brands, “all formulas except one met the [examined] FDA nutrient requirements.” The problem? “None met all FDA label requirements.” These foreign formulas are healthier than many domestic brands and meet nutritional requirements, yet the FDA shuts them out of the US market because of labeling.
The FDA’s response has been bureaucratic, timid and slow. In a time of crisis, it should have been an easy call to grant Emergency Use Authorization to formulas approved abroad without another onerous and drawn-out process. In May, FDA Commissioner Robert Califf told lawmakers that “some decisions in retrospect were not optimal.” No kidding.
And now it’s August, and the FDA still won’t budge.
Given the FDA’s poor track record on COVID testing, baby formula and the monkeypox vaccine, Americans are right to wonder whether the FDA is up to the job. Reforming the agency to speed approvals while maintaining safety can’t wait; it’s a matter of life and death.
Marion Mass is a Philadelphia-area pediatrician who trained at Duke University Medical School and Northwestern University and the co-founder of Practicing Physicians of America.
Zai Lab Ltd. shares were up 10% to $50 after the company said its partner, Karuna Therapeutics Inc., reported positive top-line results from its Phase 3 trial evaluating the efficacy, safety and tolerability of its lead investigational therapy, KarXT xanomeline-trospium, in adults with schizophrenia.
Zai Lab has an exclusive license agreement with Karuna Therapeutics for the development, manufacturing, and commercialization of KarXT in Greater China, including mainland China, Hong Kong, Macau and Taiwan.
Karuna Therapeutics said the trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically meaningful 9.6-point reduction in the Positive and Negative Syndrome Scale, or PANSS, total score at the fifth week.
KarXT also showed an early and sustained statistically significant reduction of symptoms, as assessed by PANSS total score, starting at the second week, and maintained the reduction through all time points in the trial, the company said.
The KarXT trial also met secondary endpoints, demonstrating a statistically significant reduction in symptoms of schizophrenia, the company said.
Democrats have eagerly lined up behind Sen. Joe Manchin’s surprise climate change compromise, tucked inside the Inflation Reduction Act, despite warnings from some economic experts that the legislation would actually fuel inflation and burden the already gloomy economy.
After the Senate passed their signature climate, tax, and healthcare package Sunday, the action turns to the House. But for dozens of House Democrats, the measure’s uncertain economic impact is not their only risk in backing the bill.
The measure, which includes a host of tax increases, is once again highlighting failed pledges by many House Democrats representing pricey coastal areas to oppose any tax bill unless it also restores the federal income tax deduction for state and local taxes.
Dozens of House Democrats from California, New York, and New Jersey have spent years arguing that the limits on the state and local tax deduction, known as SALT, included in the 2017 Trump administration tax cut package amounted to a big tax increase on middle-class families in areas with either high real estate prices, high state and local taxes – or both.
Many of these same Democrats won their seats after launching aggressive attacks against Republicans for voting for the 2017 tax package that included a $10,000 limit on the SALT deduction.
When they arrived in Congress, these Democrats formed caucuses with the sole mission of repealing the cap, delivered salt bagels around the Capitol to keep the issue on lawmakers’ minds, and as recently as January threatened to block a revised version of the Build Back Better package, a top Biden priority, if it didn’t include the SALT cap repeal.
“We support the president’s agenda, and if there are any efforts that include a change in the tax code, then a SALT fix must be part of it. No SALT, no deal,” Reps. Josh Gottheimer and Mikie Sherrill of New Jersey and Rep. Tom Suozzi of New York said in a statement.
In the end, however, the Democrats caved to their leadership’s pressure and still voted in favor of several big spending bills that either jettisoned the SALT repeal in the final versions or failed to include it at all.
Last year, amid the Democrats’ big push to pass the Build Back Better and other infrastructure packages, California Democratic Reps. Katie Porter and Mike Levin, who represent adjacent coastal Southern California districts, repeatedly and forcefully argued for the SALT cap repeal.
“Today I stand with union leaders and my colleagues who are fighting to repeal the SALT cap,” Levin tweeted in June of last year. “More than 3 million families in CA making below $100,000 claimed the SALT deduction the year before the cap went into effect. Working families are being hurt, and it’s time to fix that.”
“We should crack down on the ultra-wealthy but not at the expense of families in high cost of living areas. Families need SALT relief,” Porter tweeted in a video last fall from her kitchen during consideration of the $3.5 trillion reconciliation package.
During her first campaign for Congress in 2018, Porter repeatedly assailed then-Rep. Mimi Walters, the Republican she toppled from the Orange County seat, for voting for the Trump tax package that included the new SALT limit.
“Make no mistake – by voting for Donald Trump’s tax scam, Mimi Walters sold Orange County families out and raised our taxes,” she tweeted just three days before the election. “That’s the wrong leadership for #CA45. Vote on Nov. 6!”
Porter had plenty of help from powerful sources in amplifying that message. Realtors’ state and local association PACs spent a combined total of $2.57 million supporting Porter’s campaign, according to Federal Election Commission records. Those funds helped underwrite a direct mail piece paid for by the National Association of Realtors that featured Porter’s photo and a promise in bold letters that she “will fight to restore deductions for state and local taxes, including property taxes.”
“Katie Porter, a consumer protection attorney and UC Irvine professor, is running for Congress to get relief for Southern Californians by restoring these deductions and reducing the tax burden,” the mailer pledged.
But they, too, capitulated when their leaders stiff-armed them. Despite the promises, over the last year Porter and Levin have signed onto big spending and revenue measures that didn’t include a SALT cap repeal, and at critical moments didn’t join the harder-line threats of their East Coast Democratic colleagues at critical moments when joining together could have forced leaders to accept a repeal.
After Senate action over the weekend, the House plans a Friday vote. Speaker Nancy Pelosi is only hanging on to the majority by a slim margin, narrow enough that a handful of Democratic defections could sink any measure. Despite this dynamic, the coastal California Democrats repeatedly caved after their attempts to add a SALT cap repeal failed.
Last May, when four members of New Jersey’s congressional delegation banded together and threatened that they wouldn’t even discuss an infrastructure package unless it included the SALT repeal, Porter didn’t join them in drawing red lines on the issue.
“Is removing the SALT cap a deal breaker for you? Some of your colleagues say it’s a non-starter” without it, MSNBC’s Stephanie Ruhl asked Porter in May 2021.
Porter demurred.
“We have a duty to listen,” she replied. “You can’t just say nah, nah, nah – my way or the highway,” she told Ruhl. “You have to say what are the competing concerns, how could we make up this revenue, what are the economic harms of continuing to allow the Trump tax plan to go forward in the way that it has.”
On Wednesday Porter came out strongly in favor of Manchin’s bill, the Inflation Reduction Act, arguing that the measure combines tax increases and spending components in a “very thoughtful and very balanced” way without mentioning any desire to include SALT repeal.
“This is a much more streamlined bill than what we’ve been talking about in the past but it’s not less important in its scope for our economic future,” she told MSNBC.
Porter’s office did not respond to a RealClearPolitics inquiry into her views on whether it should include the SALT cap repeal.
Republicans are already assailing the pair, along with several other House Democrats vulnerable on the issue, including California Democratic Reps. Josh Harder and Julia Brownley, who also face tough reelection fights.
“Every poll for months has shown voters are overwhelmingly concerned about inflation and the cost of living. But Democrats want to make it harder for families struggling to make ends meet,” the National Republican Congressional Campaign Committee said in a statement last week. “Will Josh Harder, Julia Brownley, Katie Porter and Mike Levin vote to raise taxes on middle-class Californians?”
Democrats and Republicans have forcefully disputed whether the Inflation Reduction Act would raise taxes on middle-class households making less than $400,000, which would violate a core Biden pledge.
The non-partisan Joint Committee on Taxation, found that the measure would raise $16.7 billion on taxpayers making less than $200,000 in 2023. Tax experts say the legislation won’t directly increase taxes on the middle class, but some aspects of the bill could have some adverse effects and result in indirect tax increases. The bill invests roughly $485 billion toward climate and health care measures through 2031, according the Congressional Budget Office.
Most Republicans back the SALT deduction limit as a way to keep blue states from what they criticize as a wasteful tax and spend model. Before the cap, it allowed liberal states and municipalities to increase taxes to raise funds for their priorities and their taxpayers still wouldn’t feel any of that financial pain because they could deduct those state and local taxes without limits on their federal return. The conservative House Freedom Caucus, for instance, wants to get rid of the deduction completely. Many progressive Democrats representing less affluent districts, such as Rep. Alexandria Ocasio Cortez, align with Republicans but for different reasons: They believe doing away with the cap would be a “giveaway to the rich” whose pricier homes command the highest state and local property taxes.
Manchin agrees with Ocasio Cortez. In unveiling the Inflation Reduction Act in late July, he broadcast his firm opposition to including any provision to repeal the SALT cap.
“Our tax code should not favor red state or blue state elites with loopholes like SALT,” he said in a statement.
Like Porter, Levin also readily threw his support behind Manchin’s bill.
“Rep. Levin supports the Inflation Reduction Act and will continue to work to restore the full SALT deduction,” his spokesman Eric Mee told RCP.
Mee highlighted Levin’s letter to Biden last spring, which he spearheaded along with Porter and Harder and was signed by 37 other California House Democrats, asking for the president’s support to eliminate the SALT limits as part of the infrastructure deal. The $1.2 trillion spending bill eventually passed Congress and was signed into law without a SALT repeal in November.
Northeastern House Democrats are now struggling to explain their willingness to back away from recent SALT threats.
A month ago, before Manchin’s surprise bill emerged, Gottheimer told Punchbowl News, “As I have consistently said, if there are any changes to the tax code that affect families in my district, then restoring SALT must be part of it. No SALT, no dice.”
Suozzi agreed: “No SALT, no deal.”
After Manchin and Schumer announced their deal, these same Democrats changed their tune.
Pressed by reporters whether Gottheimer would stick by his guns, he was vague: “Until I see specifics, it’s hard to know,” he told Politico.
Suozzi and Rep. Tom Malinowski, another vulnerable Democrat who has long pushed for lifting the SALT limit, almost immediately signed on to the Inflation Reduction Act after Manchin and Senate Majority Leader Chuck Schumer announced their compromise.
“Right now, they’re not touching personal income taxes,” Suozzi, who is not running for re-election, told The Hill. “If they don’t touch personal income taxes it doesn’t really raise the specter of SALT.”
What a difference a few weeks and a Manchin deal make. Pelosi isn’t preparing for any SALT cap opposition from her caucus, Democratic sources told RCP.
