Search This Blog

Wednesday, August 2, 2023

How the FTC’s Proposed Merger Guidelines Might Affect Biopharma

 Following a number of attempts to block acquisitions within the biopharmaceutical industry—or at the very least, put them under increased scrutiny—the U.S. Federal Trade Commission last month introduced new draft merger guidelines.

While the agency has historically concentrated on protecting direct competition, the 13 proposed guidelines take on a wider scope, potentially allowing the FTC space in which to focus on concentration, negotiation or displacement within given markets. Biotechnology firms, drug development labs and others are meanwhile grappling with the ways in which their own attempted mergers might be impacted.

The draft guidelines are controversial, to put it lightly. At first glance, mergers are often considered a way for larger entities to build upon their assets. But for smaller biotechnology, pharmaceutical and medical technology companies, the FTC’s proposed guidelines would make resources and exits more challenging to obtain.

“Drug development and delivery is such a complex and risky endeavor. Deals are essential to manage that risk,” Noah Brumfield, an antitrust attorney and partner at Allen & Overy, told BioSpace in an email. “[The guidelines] elevate the risk for deals that previously would not have gotten a second look—for example, deals that only involve complementary assets (i.e. no rivals).”

Such appears to be the case with Amgen’s $26.4 billion attempted merger with Horizon Therapeutics. Amgen argued last month that the FTC’s concerns are “entirely speculative.” In a statement following the FTC’s lawsuit, the company claimed that the medicines offered by each company “generally treat different diseases and patient populations,” thus precluding any overlaps of competitive concern.

Amgen’s press team declined to comment on the proposed guidelines’ potential impact.

What Do the New FTC Draft Guidelines Entail?

Based on some of the FTC’s draft guidelines, it appears the agency might increase its commitment to preventing these issues. The guidelines state that mergers should not “increase the risk of coordination” or “eliminate a potential entrant in a concentrated market.”

They also warn against mergers that “significantly increase concentration in highly concentrated markets” or “entrench or extend a dominant position,” which some argue would occur via IQVIA’s acquisition of Propel Media. The FTC sued to delay that deal as well, arguing that it would reduce competition by “combining two of the top three providers” in the healthcare advertising industry. 

The draft’s introduction closely follows a statement made by Holly Vedova, director of the FTC Bureau of Competition, in light of the attempted Amgen/Horizon merger. Vedova decried “rampant consolidation in the pharmaceutical industry” in an FTC press release about the lawsuit it filed in May to prevent the deal from going through.

Vedova and some of her colleagues expressed concern that the deal could prevent affordable generics from entering the market. They also said they were worried that cross-market bundles or bundled rebates could be used as leverage to earn Horizon’s Tepezza (teprotumumab-trbw) and Krystexxa (pegloticase) favorable formulary placement with insurance providers, thus reducing space for competing pharmaceutical companies.

Should the FTC cement its guidelines, biopharmaceutical companies already under the microscope might face increased scrutiny. In addition to the Amgen-Horizon and IQVIA-Propel deals, the agency is already looking closely at Pfizer’s $43 billion buyout of Seagen, a cancer-focused biotechnology company.

Pfizer originally notified the Securities and Exchange Commission (SEC) of the deal back in March but withdrew its paperwork to refile in June following news of Amgen’s Horizon delay. The FTC has since asked for more information on the merger due to concerns regarding competition and drug pricing. A Pfizer spokesperson declined to comment for this article upon BioSpace’s request.

As for whether the guidelines will be implemented as-is, Brumfield told BioSpace it’s quite likely. “It is notable that the process is being undertaken with an FTC that is not bipartisan—two of the five Commissioners are not seated, seats that are reserved for the party in opposition,” he said, referring to the agency’s current Democratic makeup. “And so despite the intent of Congress in enacting the FTC Act and requiring a bipartisan Commission, there is no other voice in the room arguing for modifications or limits on the expansive approach taken with these new draft guidelines.”

When it comes to looking ahead, Brumfield warns that proposed deals can be expected to take much longer. “Review [will] involve many more issues and a commensurately greater burden on parties,” he said. “The open-ended approach reflected in the new guidelines would mean potentially no issue is too attenuated for investigation.”

https://www.biospace.com/article/how-the-ftc-s-proposed-merger-guidelines-might-impact-biopharma-/

AstraZeneca Pays $510M to BMS to Settle PD-L1, CTLA-4 Patent Disputes

 AstraZeneca has agreed to pay rival Bristol-Myers Squibb $510 million to resolve a string of patent-infringement lawsuits filed by BMS over blockbuster cancer immunotherapies, according to multiple media outlets.

BMS had complained in three separate lawsuits that the AstraZeneca drugs, Imfinzi and Imjudo, infringed patents on its own therapies, Opdivo and Yervoy, and wanted compensation for lost earnings.

Opdivo and Imfinzi are both PD-1 inhibitors and have generated billions of dollars in sales as cancer treatments for their respective companies. Yervoy and Imjudo are anti-CTLA-4 antibodies.

Yervoy was first approved by the FDA in 2011 to treat melanoma, and has since been approved for kidney, lung, colorectal and other types of cancer. BMS sold over $2 billion worth of the drug in 2021, according to the company. Imjudo in combination with Imfinzi was approved for liver cancer in October last year.

Monday, Judge Matthew F. Kennelly in the U.S. District Court for the District of Delaware approved the two companies’ joint stipulations to dismiss the three lawsuits—a swift resolution to the dispute that analysts say saves both companies time and legal costs.

BMS originally sued AstraZeneca over eight Opdivo patents in March 2022 and added another claim in April of that year. It filed the third lawsuit, focused on Yervoy and Imjudo, in January 2023. The District of Delaware had issued a scheduling order, setting a trial for April 2024.

However, in its second-quarter earnings report released on Friday, AstraZeneca said it entered into a global settlement agreement with BMS and Ono Pharmaceutical “that resolves all patent disputes relating to Imfinzi and Imjudo between the companies” totaling $510 million.

This is not the first success for BMS and its partner Ono Pharmaceutical as they seek to protect their patents. In 2017, the two firms accepted $625 million from Merck to settle another PD-1 patent lawsuit.

https://www.biospace.com/article/astrazeneca-pays-510m-to-bms-to-settle-pd-l1-ctla-4-patent-disputes/

US Buyers Shy Away From China Inc. With No Regrets

 By George Lei, Bloomberg markets live reporter and strategist

Chinese equities in July posted their best returns in six months, yet US-based investors have refrained from chasing the rally, according to data tracking flows into exchange-traded funds. They instead have bolstered stock holdings in other emerging markets, in contrast to Hong Kong-based investors whose purchases of onshore equities have reached a 23-week high.

The MSCI China Index was up 9.3% last month and rallied a total of 12.7% between June and July, the kind of performance unseen since the heyday of the reopening trade. On a 20-day basis, total purchases of mainland stocks from Hong Kong-based investors reached 49.2 billion yuan ($6.85 billion), the highest since February 23.

US buyers, in contrast, have largely soured on China Inc. since February. On a 20-day basis, the iShares MSCI China ETF saw total outflows of $75 million as of July 31, despite stimulus bets and stock-market rallies over the past two months. Meanwhile, the iShares MSCI EM ex-China ETF received constant inflows throughout the year, with the 20-day total reaching $369 million as of July 31.

MSCI’s China ETF now has assets of around $8.4 billion, 70% above that of the other fund. If present trends continue, however, the ETF dedicated to EM ex-China will eventually exceed the China fund in terms of assets under management in the coming years.

Recent rallies in Chinese stocks appear to be “mostly driven by short covering” and few global funds are “buying into China in any meaningful way yet,” Michael J. Oh, a San Francisco-based portfolio manager at Matthews Asia, told Bloomberg. “Beijing has said a lot of positive things but there’s still a lack of actions,” Oh noted.

US sanctions on some Chinese firms and other forms of regulatory crackdowns may have also scared away American investors. This week, a US House committee demanded information from BlackRock about the inclusion of Chinese companies in its funds, alleging facilitation of American investment into parts of China Inc. blacklisted by the White House. Similar requests were also made to MSCI. As President Joe Biden is reportedly planning for new curbs on US tech investment in China, American appetite for companies in the world’s second largest economy will only wane further.

https://www.zerohedge.com/markets/us-buyers-shy-away-china-inc-no-regrets

Poland Builds Up Troops On Border In Response To Alleged Belarus Combat Helicopter Breach

 NATO members Poland says it is building up troops along its border with Belarus following allegations that two Belarusian helicopters violated Poland's airspace on Tuesday. 

Poland's Ministry of Defence made the allegation, which Minsk quickly denied. "There was a violation of Polish airspace by two Belarusian helicopters that were training near the border," Poland's military said. Further, Warsaw says it has formally notified NATO of the alleged border violation, setting the stage for possible Article 5 discussion, portending future escalation.

The Belarusian Defense Ministry immediately denied Poland's charge, suggesting that it's a "far-fetched" provocation meant to justify a build-up of NATO forces near Belarus. 

"Accusations of a violation of the Polish border by Mi-24 and Mi-8 helicopters of the Belarusian Air Force and air defense forces are farfetched and made by the Polish military and political leadership to justify the build-up of forces and means at the Belarusian border," the ministry said.

The Associated Press describes that there were witnesses (and video) to helicopters being operational along the border as part of training exercises this week:

Earlier Tuesday, Polish residents in an area near the border with Belarus reported seeing helicopters with Belarusian insignia which they said flew overhead. Some posted photos of the aircraft. Poland’s military initially denied that they had crossed into Polish airspace.

What's more is that Belarus informed its NATO neighbor it would be conducting drills in a border region, so as there would be no misunderstanding between the rival countries which recently have had disputes over migrant crossings. 

Polish Defense Minister Mariusz BÅ‚aszczak announced a troop increase at the border, also bolstering a prior presence of elite counterterror police deployed in extra units last month in relation to the Wagner mutiny in Russia and their subsequently moving into Belarus. He said combat helicopters are also being moved for border defense, and other military assets.

As for NATO jitters over the closer Wagner presence in Eastern Europe, Polish Prime Minister Mateusz Morawiecki had announced Saturday that over 100 Wagner mercenaries had approached near Poland's Suwalki Gap, considered a sensitive and strategic border area.

PM Morawiecki had gone so far as to claim PMC Wagner fighters "may try infiltrating Poland"—though there was no evidence of any hostile action by Wagner or border breaches.

But Poland is still making a lot of noise about the alleged 'training exercise' helicopter border breach incident. The chargé d’affaires of Belarus in Warsaw was "immediately summoned" by Poland's Foreign Ministry on Tuesday, and it “issued a firm protest and called on the Belarusian side to immediately and in detail explain the incident."

"The Polish side emphasized that the incident is perceived as another element of the escalation of tension on the Polish-Belarusian border. Poland expects Belarus to refrain from such activities," the ministry said. Interestingly, it's been the Russia-Belarus side (or 'Union State') which has long charged NATO powers with escalating the situation. This indeed could very well be the next major flashpoint connected with the Ukraine war.

https://www.zerohedge.com/military/poland-builds-troops-border-alleges-belarus-combat-helicopters-breached-border

Dems Beg Biden To Declare Emergency As Illegal Immigrants Flood NYC

 by Catherine Yang via The Epoch Times (emphasis ours),

Fifty-four elected officials in New York City have sent a letter to President Joe Biden to address the influx of illegal immigrants in the city, asking him to declare a federal state of emergency so that the illegal immigrants can legally work in the country.

"We are elected officials from New York City requesting your help. Our City is experiencing an unprecedented migrant influx, with a surge of asylum seekers arriving here in numbers never seen before in history. Our City is at a breaking point," wrote New York City Assemblywoman Jenifer Rajkumar.

"We take pride in New York being a beacon of hope for immigrants, but the influx of migrants is so great that the City is running out of resources. New York City is being forced to reduce services for its people."

Since Spring of 2022, buses of illegal immigrants, sent from the southern border in Texas, have arrived regularly in the city. Many are asylum seekers from Venezuela escaping the socialist country's economic collapse, and New York elected officials have welcomed them.

While the self-declared "sanctuary city" already had difficulties housing its 60,000-plus homeless population, officials set about finding housing for tens of thousands of asylum seekers.

By October 2022, New York City Mayor Eric Adams declared a state of emergency in the city. According to his office, the illegal immigrant influx could nearly double the number of people the already overtaxed shelter system needed to serve, and cost $1 billion within a fiscal year.

"We need help, and we need it now," Mr. Adams said. “New York City is doing our part, and now others must step up and join us.”

Emergency Powers

Last week, the city announced it would set up a shelter for 1,000 illegal immigrants in the parking lot of a state psychiatric hospital. The special use case was made possible by the state of emergency, which allows for use of additional resources without additional red tape.

A federal state of emergency would allow federal agencies to work with and fund the housing and services for the illegal immigrants.

"The federal government could then provide migrants with assistance such as shelter, food relief, healthcare, legal aid, and transportation," Ms. Rajkumar wrote in her letter.

The 54 Democrat lawmakers also requested that the Biden administration allow the illegal immigrants to work in the country.

"The federal government must expedite the issuance of Employment Authorization Documents. It is a common sense and bi-partisan fix. Asylum seekers are arriving eager to work, and our Nation has 10 million job openings with 3.5 million fewer people in the workforce than projected pre-pandemic," the letter reads. "We ask that the White House take executive actions to expedite work authorization, such as classifying asylum seekers as refugees, expanding Temporary Protected Status, increasing access to humanitarian parole, and surging the number of officers processing asylum claims."

The letter makes no reference to curbing the number of illegal immigrants entering the country or city, nor does it differentiate between legal and illegal immigrants. It instead makes requests that the federal government make it simpler for them to cross the southern border illegally, and to relocate them in all parts of the country, while providing additional funding for New York City.

The city has already received $104.6 million through the Federal Emergency Management Agency (FEMA), which the lawmakers say equates to just 13 days of relief.

The city expects to have spent $4.3 billion by June 2024.

"While we welcome immigrants to our City, the current unstructured state of immigration policy and response needs to end. There needs to be a system of rules in place to manage the migrant crisis," the letter reads. "That is why we are pleading for the White House to step in a take leadership over the influx of asylum seekers."

"We believe that with your leadership, we can turn this crisis into opportunity and that this can become one of history's greatest success stories."

Housing Crisis

The city is currently sheltering about 52,000 illegal immigrants, and officials say more continue to arrive by the week.

As a "sanctuary" city, New York is one of several across the country now that have declared it will not cooperate with federal authorities to arrest and deport illegal immigrants.

The city's "right to shelter" law mandates that homeless families must be given a bed the same day, and adults within a day. As the city runs out of beds, it is scrambling to create temporary shelter spaces wherever possible, be it a hospital parking lot, airplane hangars, parks, or a racetrack.

Most of these ideas have been met with strong pushback from communities. City residents, who are already feeling the housing crunch and are unable to find permanent housing of their own, have been shocked by city plans to turn their gyms, schools, and parks into housing for the illegal immigrants.

The city had plans to further bus illegal immigrants north of the city, but local officials in those areas quickly pushed back. For the most part, the city is attempting to find the necessary amount of shelter with city resources. If the numbers continue to increase, exacerbating the issue and prompting federal intervention, the trend could be unlikely to reverse.

https://www.zerohedge.com/markets/democrats-beg-biden-declare-emergency-illegal-immigrants-flood-nyc

Biden Admin Gives Up On Refilling Strategic Petroleum Reserve Due To "Market Conditions"

 Update: You cannot make this up. Minutes after the biggest weekly crude draw in API history, with gasoline prices at 2023 highs and with wholesales gasoline prices exploding higher (guaranteeing that retail pump pries are set to soar), the Biden administration just gave up on its efforts to refill the Strategic Petroleum Reserve, something we had joked about literally moments earlier.

As a reminder, the Biden admin has been drawing down on the SPR for the last 14 weeks and - despite all the promises - has not refilled the "STRATEGIC" political petroleum reserve one little bit.

So yeah: just 3 weeks after the DOE said it would buy a "whopping" 6 million barrels of sour crude - an amount which the SPR drained every 2 weeks for much of the past year - the Biden administration pulled said offer, an Energy Department spokesperson said on Tuesday, as oil prices are expected to keep rising after a output cut from Saudi Arabia.

The U.S. made the latest solicitation to buy the sour crude oil for the SPR on July 7, and follows the release of a record 180 million barrels from the reserve last year to prevent a Democrat rout in the midterms following Russia's invasion of Ukraine. Having vowed it would refill the SPR eventually, the Energy Department bought back 6.3 million barrels in recent month... and that appears to be it.

The move was not a rejection of oil companies' offers to sell oil to the SPR but a decision made on "market conditions," the spokesperson said. The person not specify what that meant, but tight oil supplies that have caused global oil prices to rise above $80 per barrel in recent weeks. Of course, by refusing to refill now, it only ensures that when the need truly arises, Biden, or rather his successor, will be forced to buy the oil at triple digits.

To be sure, the Energy Department headed by the consummately incompetent Jennifer Granholm said that it "remains committed to its replenishment strategy for the SPR" which includes direct purchases, returns of oil that was loaned to companies in the wake of hurricanes and other supply disruptions, and cancellation of planned sales where drawdown is unnecessary, in coordination with Congress.

What it really means is that the only time the SPR can possibly be refilled is when the US economy plunges into a crippling recession when Bidenomics crashes and burns the moment Biden's $1+ trillion stimmy no longer flies.

Oil prices are expected to surge in coming months after Saudi Arabia said it would cut output by 1 million barrels per day starting in July, on top of other cuts from eight OPEC+ countries announced in April. Banks such a Goldman predict that oil is facing a deficit of as much as 2mmb/d in the next two months, practically assuring triple digit oil returns in weeks if not days, and forces the Fed to hike much more.

Meanwhile, the in a gift to refiners, the 3-2-1 crack spread is blowing out.

As a reminder, when one product spread is blowing out, the market is saying that there needs to be more output of said product. When all spreads are blowing out simultaneously, that may be the market's way of signaling it needs more refining capacity to satisfy growing product demand.

We are seeing more of the latter (as Jet Fuel and Diesel cracks are also blowing out).

*  *  *

Oil prices gave back some of the recent solid gains today despite OPEC’s crude production tumbled by the most in three years as Saudi Arabia implemented a deeper cutback in a bid to shore up global markets, as dollar strength weighed on crude prices (and weak PMIs threatened demand outlooks).

"The OPEC+ Joint Ministerial Monitoring Committee will meet online on Friday, providing Saudi Arabia an excellent opportunity to roll its voluntary 1 million bpd production cut announced on June 3 for July production for another month to September. It would be the second time the Saudis have extended the voluntary 1 million bpd production cut. There is speculation that another 1 million roll forward could slow the global war on inflation, and kill the "golden goose," especially heading into the end of summer driving season, and the beginning of shoulder season," Robert Yawger, executive director of energy futures at Mizuho Securities USA, wrote in a Monday note.

Volumes also remain muted in light summer trading, while volatility is at the lowest since January 2020.

Expectations were for more inventory draws after last week's across-the-board drop...

API

  • Crude -15.4mm (-1.3mm exp) - biggest weekly draw on record

  • Cushing -1.76mm

  • Gasoline -1.68mm (-1.3mm exp)

  • Distillates -512k (-100k exp)

Umm... API reports that Crude stocks fell 15.4mm barrels last week (yes 15.4!!!) - over 10x expectations. Product inventories also fell as did stocks at the Cushing Hub.

Source: Bloomberg

If that holds for the official data released tomorrow that will be the biggest weekly draw in the data's history (back to 1982)

Source: Bloomberg

WTI was hovering around $81.60 ahead of the API report (well off the day's lows) and bounced on the massive draw into the green for the day, back above $82...

Back up to 2023 highs...

"Oil remains one of the most attractive trades and buyers will likely emerge on every dip," said Edward Moya, senior market analyst at Oanda,in a note.

It's about to get real for Mr. Biden...

Unleash the SPR again?

Jill Biden's Ex-Husband Breaks Silence Over "Very Dangerous Biden Crime Family"

 The ex-husband of First Lady Jill Biden has broken his silence to speak out against the "Biden crime family" for "targeting" he and Donald Trump.

Bill Stevenson, who was married to Jill Biden between 1970 and 1975, told Newsmax last week that the president's brother, Frankie Biden, tried to intimidate him during his divorce with Jill, and claimed the family threatened him with repercussions.

"Frankie Biden of the Biden crime family comes up to me and he goes, "Give her the house or you’re going to have serious problems,"" Stevenson said. "I looked at Frankie and I said, "Are you threatening me?" and needless to say, about two months later, my brother and I were indicted for that tax charge for $8,200."

When asked to clarify whether he thinks Joe Biden was behind the tax charge, Stevenson told host Greg Kelly: "I not only think it, but I know it," adding that he "could not believe the power of Joe Biden and the Department of Justice. I couldn’t believe it."

Kelly also noted the parallels between Stevenson's case and Hunter Biden's ongoing tax troubles - noting that Hunter was hit with just two misdemeanor counts for $2.2 million in unpaid taxes, while Stevenson and his brother were slapped with two felonies for just over $8,000 in unpaid taxes.

"It’s hard to believe what they’re doing to President Trump right now, and that’s why I came to you," said Stevenson, 75. "He is doing the exact same thing."

"I was on the wrong side of them, and they have literally come after me for 35 years in a row. One little thing after another," he continued. "I can’t let them do this to a president that I love and respect. I can’t let them do this to our country."

"This is the only reason I’ve come forward. It’s like I said, nothing about the divorce, no bitterness, but Jimmy, Frankie, and President Biden are very dangerous, and it’s tragic. I can’t let them do what they did to me to President Trump. I can’t do it," he added.

https://www.zerohedge.com/political/watch-jill-bidens-ex-husband-breaks-silence-over-very-dangerous-biden-crime-family