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Biotechs Second Half Battle

Biotechs Second Half Battle

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  • Biotech indexes have remained subdued as the broader market has rallied.
  • The broader healthcare sector and biopharma industries, in particular, remain under regulatory duress just as they have been for some time.
  • However, the expectation of an imminent rate cut will affect the second-half outlook.
  • The duel between the burden of regulatory risk and the buoyancy from a monetary easing will define the second half.
  • We expect biotechs to be helped by a broader market rally as interest rates decline, but volatility will remain high as the future of healthcare is discussed in the political arena.

Biotech Pulse

PrudentBiotech.com ~ Biotech pulse

The first half of 2019 had a little bit of everything for biotechs. After, a punishing close to last year, with the Nasdaq Biotechnology Index (IBB) down -10% for 2018, biotechs rebounded during the first quarter along with the broader market. However, the second quarter provided a flavor for how things may unfold going forward. The months of April and June showed the risks from the ongoing healthcare regulation debate in the election primaries as biotechs and many healthcare stocks retreated sharply. Stocks then rebounded in June on the expectation of a Federal Reserve (FED) easing, as the benchmark Nasdaq Biotechnology Index closed the first half with a gain of +13%. It has since pulled-back and as of mid-July is up +10%.  

In the 2019 Outlook On Biopharma’s Uphill Battle, it was noted,

“The spike in volatility, the deep concerns about a looming slowdown all year, and the rise in drug pricing related news will provide a constant backdrop that will make it a difficult year for healthcare and biotechs. …The sentiment can improve with a realization of a more cautious Federal Reserve on its future interest rate policy…It is our expectation that biotechs will encounter a difficult year, but with pockets of high performance…In a stock pickers market, there will be meaningful opportunities in biotech stocks to materially outperform the indexes…The biotech indexes most likely will be able to eke out a positive year with returns up to 10%…we anticipate the first-half to be still better than the second-half.”

At the midyear point, the challenges are similar, but a critical piece has shifted within the market mosaic. That piece is the expectation for an earlier Federal Reserve rate cut, and perhaps one as early as July end. This is a highly favorable shift and, if borne out, will have a positive impact on full-year expectation.

Risk Of A Regulatory Onslaught

GraycellAdvisors.com ~ Congress - Capitol Hill
US Capitol Hill

Healthcare spending remains one of the foremost public concerns and draws bipartisan support in Congress to curb spending. In addition, the ramp towards the Presidential election will continue to heat up the political rhetoric and raise the speed of legislative proposals as drug prices remain a populist campaign issue. Of particular concern to investors is a growing sentiment shift towards a more government-managed healthcare system, which can transform the structure of the healthcare industry. 

Furthermore, the President is keen on recording some wins on reducing healthcare costs in preparation for the elections next year, where healthcare will be one of the key topics of discussion. To that extent, last week the President announced an upcoming Executive Order to require pharmaceutical companies to offer the same matching lowest price to Medicare and Medicaid that is being offered to any other country for the same drug. Last year, the administration had proposed an international index of prescription drug prices to be used as a benchmark for Medicare to set its prices, and a pilot may begin in 2020 on a small subset of drugs. A Bill introduced by Republican Senator Scott from Florida will link a drug’s approval by the FDA to a requirement that the drug is offered at a price no higher than the lowest price amongst a group of 5 countries. There are many similar Bills with different approaches to address drug costs that have been introduced in Congress. In addition, the President may decide to work with the Democrats on the drug price issue due to overlapping interests. 

So it is abundantly clear that there will continue to be a regulatory onslaught comprising a number of executive orders, proposals, and bills, over the rest of the year and in 2020, on tweaking, patching-up, or overhauling the health care system. However, even though there is bipartisan support to bring down drug prices, there is limited unanimity in how to achieve it. Executive orders of limited scope appear to be the most feasible way presently to bring about any changes to the high prescription drug price issue. But the pharma industry can bog down these orders to some extent by resorting to the courts. An HHS directive to disclose drug prices on television was recently put on hold by a court due to an absence of statutory authority with the agency to implement such a disclosure. In addition, the President may change initial proposals as happened with the axing of the rebate passthrough proposal.

In our opinion, there will be an inevitable major change within the healthcare sector as its rising costs is a huge and growing burden on the public, the government, and the economy. The regulatory risk will persist, till such time industry dynamics change enough to meaningfully bend the trajectory of healthcare costs. This risk can become more pronounced depending on the healthcare plans of the candidates and their individual success on the campaign trail. At the beginning of the year, in the 2019 Biotech Outlook, we had referred to such regulatory risk as being the principal reason why consistent progress on biotech and pharma valuations will be an uphill battle this year.

But the risk of a regulatory onslaught has been well-known. It is not something new, and it will continue to enhance volatility for healthcare, notably biotechs and pharmaceuticals. 

Favorable Shift In Monetary Policy

PrudentBiotech.com ~ Federal Reserve Seal

The high degree of correlation between biotechs and monetary policy was highlighted in the last article, Biotechs Ready To Explode, where the impact of a downward sloping interest rate environment on risk-taking and biotech valuations was presented. 

The key point was that:

When the monetary policy controlled Fed Funds rate was flat with a downward bias…

Federal Funds Rate 2010-2015 (click for an enlarged image)

…the biotech benchmark rose in a steady long-term uptrend from 2010 to 2015 and recording an all-time high in July 2015.

Nasdaq Biotech Index (IBB) 2010 – 2015 (click for an enlarged image)

Post the Great Recession, over a 9 year period biotechs did best when interest rates had a downward bias. In fact, there was somewhat of a similar correlation, though not as perfect, in the intervening six-year period between the 2001 recession and the Great Recession.

It doesn’t mean that there is a perfect causal relationship between interest rates and biotech performance. But it is something to be noted, as it does suggest that when interest rates go through a period of a downward bias there is a greater likelihood for a more favorable environment to exist for biotechs. 

Now as expectations rise for an imminent shift in interest rate policy, we are entering the early stages of that type of environment which can perhaps assist biotechs to emerge from the valuation quagmire of the past 4 years.

There is a key assumption here in the narrative of an interest rate cut being great for stocks. The assumption is that we will have an ideal situation where the current economic soft patch triggers one and more interest rate cuts, but the economic situation rebounds and doesn’t deteriorate into a recession. If this assumption fails, then in that case stocks go down in a recession even with interest rate cuts. Healthcare being a defensive sector does relatively better than the broader market. 

Regulatory Onslaught Vs A Loosening Monetary Policy

Biotechs - Chain

Can biotechs embark on a rally and challenge previous highs even with the burden of a regulatory threat?

Fundamentally, biotechs are better positioned today in terms of science and access to capital then they were ~5-years ago in 2015. But the industry group has underperformed during this period due to most likely its unique regulatory risk burden. 

One way to observe the impact of this regulatory burden would be to compare biotech stocks with similar risky market segments.

Small cap stocks are also considered higher-risk just like biotechs. Biotech small caps are both riskier than the broader small cap universe and relatively outperform. This can be viewed in the chart below of the small cap biotechs represented by the S&P Biotechnology Index (XBI) and the small cap Russell 2000 Index (IJR). Higher risk presenting higher reward opportunities when conditions are optimal.

Source: Yahoo (click for an enlarged image)

However, since 2015, the year when biotechs peaked, broader small cap stocks have relatively outperformed or kept pace with the small cap biotech segment.  

Source: Yahoo (click for an enlarged image)

The two charts vividly capture the struggle that biotechs have been encountering.

The gap of underperformance plus the missing outperformance over the past 4 years is quite likely the cost of the regulatory risk being borne by biotechs.

Will a shift in the interest rate environment be sufficient to overcome the burden of rising regulatory risk?

The regulatory risk burden is not going away soon and will continue to be reflected as a drag on valuations. It cannot be underestimated, particularly during an election season.

But, we suspect, the changing dynamic of FED policy has the potential to provide a boost for biotechs to move towards the 52-week highs for the Nasdaq Biotechnology Index, set last year. How the economic and political situation, as well as the FED policy, unfolds later in the year will determine the course biotechs take in 2020 and if they can reach and exceed the highs achieved in 2015.

Conclusion

The second half of the year presents the same challenges that existed at the beginning of the year, most notably the ongoing threat of regulation, which made us refer to the year as an uphill battle for biotechs in the 2019 outlook. However, the second half provides a new favorable wind for stocks in general and biotechs in particular – a shift in the rising monetary policy trend in place since 2016 as interest rates are expected to be cut in the near-term. This will be a favorable tailwind as long as the rate cuts occur and the economy doesn’t slide into a recession. Furthermore, if the rate cuts don’t occur in time, then the climb remains steeper for biotechs.

Amidst the highly dynamic regulatory environment, biotech companies have continued to prosper as evidenced by the record number of public and private financings. The continued strength in investor interest has been driven by the rapid advancement of science and the promise of new technologically-driven scientific approaches. Based on the quality of science being pursued today, the Nasdaq Biotechnology Index without the heavy regulatory drag would have already recorded all-time highs.

Even though the clouds of regulatory changes will remain and perhaps even darken as the year wears on, there is a promising window of opportunity that can emerge for the next few months that can push biotech indexes higher. It depends on how the FED plays its hand.

We expect that the benchmark Nasdaq Biotechnology Index can be up 15% to 20% for the year, assuming the rate cuts begin in late July. There will be pockets of higher performance, well ahead of the biotech benchmark, as a changing interest rate environment provides more opportunities. However, biotechs will remain a selective, stock-picker’s market. Oncology, Nonalcoholic Steatohepatitis (NASH), and gene editing are some areas which will continue to garner strong investor attention, and small- to early mid-cap biotechs will perform better than larger-cap biotechs.

The above return expectation is a framework providing general guidance and will need to be adjusted, up or down, if evolving data deviate meaningfully from current expectations. Biotech is a high-risk and high-reward group, and biotech stocks are inherently volatile. Thus, the risk management part is highly important to build returns over time.

There are many promising biotech companies which can benefit further in a more favorable investment environment driven by the FED’s potential easing. A few of them, which may be now or in the past be part of the Prudent Biotech model portfolio or the Graycell Small Cap portfolio, include, Sage Therapeutics (SAGE), Amarin (AMRN), GW Pharmaceuticals (GWPH), Iovance Biotherapeutics (IOVA), Array Pharmaceuticals (ARRY), Blueprint Medicines (BPMC), Mirati Therapeutics (MRTX), Acadia Pharmaceuticals (ACAD), Arena Pharmaceuticals (ARNA), China Biologics (CBPO), Uniqure (QURE), Voyager Therapeutics (VYGR), Arqule (ARQL), Arrowhead Pharmaceuticals (ARWR), Ra Pharmaceuticals (RARX), Athenex (ATNX), Meiragtx Holdings (MGTX), Crispr Therapeutics (CRSP), Adverum Biotechnologies (ADVM), Axsome Therapeutics (AXSM), Medicine Company (MDCO), Dova Pharmaceuticals (DOVA), Coherus Biosciences (CHRS), Xencor (XNCR), and Ziopharm Oncology (ZIOP).

Once again, take a portfolio approach in biotechs to overcome mistakes.

The post Biotechs Second Half Battle appeared first on Prudent Biotech.

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Key shipping company files for Chapter 11 bankruptcy

The Illinois-based general freight trucking company filed for Chapter 11 bankruptcy to reorganize.

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The U.S. trucking industry has had a difficult beginning of the year for 2024 with several logistics companies filing for bankruptcy to seek either a Chapter 7 liquidation or Chapter 11 reorganization.

The Covid-19 pandemic caused a lot of supply chain issues for logistics companies and also created a shortage of truck drivers as many left the business for other occupations. Shipping companies, in the meantime, have had extreme difficulty recruiting new drivers for thousands of unfilled jobs.

Related: Tesla rival’s filing reveals Chapter 11 bankruptcy is possible

Freight forwarder company Boateng Logistics joined a growing list of shipping companies that permanently shuttered their businesses as the firm on Feb. 22 filed for Chapter 7 bankruptcy with plans to liquidate.

The Carlsbad, Calif., logistics company filed its petition in the U.S. Bankruptcy Court for the Southern District of California listing assets up to $50,000 and and $1 million to $10 million in liabilities. Court papers said it owed millions of dollars in liabilities to trucking, logistics and factoring companies. The company filed bankruptcy before any creditors could take legal action.

Lawsuits force companies to liquidate in bankruptcy

Lawsuits, however, can force companies to file bankruptcy, which was the case for J.J. & Sons Logistics of Clint, Texas, which on Jan. 22 filed for Chapter 7 liquidation in the U.S. Bankruptcy Court for the Western District of Texas. The company filed bankruptcy four days before the scheduled start of a trial for a wrongful death lawsuit filed by the family of a former company truck driver who had died from drowning in 2016.

California-based logistics company Wise Choice Trans Corp. shut down operations and filed for Chapter 7 liquidation on Jan. 4 in the U.S. Bankruptcy Court for the Northern District of California, listing $1 million to $10 million in assets and liabilities.

The Hayward, Calif., third-party logistics company, founded in 2009, provided final mile, less-than-truckload and full truckload services, as well as warehouse and fulfillment services in the San Francisco Bay Area.

The Chapter 7 filing also implemented an automatic stay against all legal proceedings, as the company listed its involvement in four legal actions that were ongoing or concluded. Court papers reportedly did not list amounts for damages.

In some cases, debtors don't have to take a drastic action, such as a liquidation, and can instead file a Chapter 11 reorganization.

Truck shipping products.

Shutterstock

Nationwide Cargo seeks to reorganize its business

Nationwide Cargo Inc., a general freight trucking company that also hauls fresh produce and meat, filed for Chapter 11 bankruptcy protection in the U.S. Bankruptcy Court for the Northern District of Illinois with plans to reorganize its business.

The East Dundee, Ill., shipping company listed $1 million to $10 million in assets and $10 million to $50 million in liabilities in its petition and said funds will not be available to pay unsecured creditors. The company operates with 183 trucks and 171 drivers, FreightWaves reported.

Nationwide Cargo's three largest secured creditors in the petition were Equify Financial LLC (owed about $3.5 million,) Commercial Credit Group (owed about $1.8 million) and Continental Bank NA (owed about $676,000.)

The shipping company reported gross revenue of about $34 million in 2022 and about $40 million in 2023.  From Jan. 1 until its petition date, the company generated $9.3 million in gross revenue.

Related: Veteran fund manager picks favorite stocks for 2024

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Key shipping company files Chapter 11 bankruptcy

The Illinois-based general freight trucking company filed for Chapter 11 bankruptcy to reorganize.

Published

on

The U.S. trucking industry has had a difficult beginning of the year for 2024 with several logistics companies filing for bankruptcy to seek either a Chapter 7 liquidation or Chapter 11 reorganization.

The Covid-19 pandemic caused a lot of supply chain issues for logistics companies and also created a shortage of truck drivers as many left the business for other occupations. Shipping companies, in the meantime, have had extreme difficulty recruiting new drivers for thousands of unfilled jobs.

Related: Tesla rival’s filing reveals Chapter 11 bankruptcy is possible

Freight forwarder company Boateng Logistics joined a growing list of shipping companies that permanently shuttered their businesses as the firm on Feb. 22 filed for Chapter 7 bankruptcy with plans to liquidate.

The Carlsbad, Calif., logistics company filed its petition in the U.S. Bankruptcy Court for the Southern District of California listing assets up to $50,000 and and $1 million to $10 million in liabilities. Court papers said it owed millions of dollars in liabilities to trucking, logistics and factoring companies. The company filed bankruptcy before any creditors could take legal action.

Lawsuits force companies to liquidate in bankruptcy

Lawsuits, however, can force companies to file bankruptcy, which was the case for J.J. & Sons Logistics of Clint, Texas, which on Jan. 22 filed for Chapter 7 liquidation in the U.S. Bankruptcy Court for the Western District of Texas. The company filed bankruptcy four days before the scheduled start of a trial for a wrongful death lawsuit filed by the family of a former company truck driver who had died from drowning in 2016.

California-based logistics company Wise Choice Trans Corp. shut down operations and filed for Chapter 7 liquidation on Jan. 4 in the U.S. Bankruptcy Court for the Northern District of California, listing $1 million to $10 million in assets and liabilities.

The Hayward, Calif., third-party logistics company, founded in 2009, provided final mile, less-than-truckload and full truckload services, as well as warehouse and fulfillment services in the San Francisco Bay Area.

The Chapter 7 filing also implemented an automatic stay against all legal proceedings, as the company listed its involvement in four legal actions that were ongoing or concluded. Court papers reportedly did not list amounts for damages.

In some cases, debtors don't have to take a drastic action, such as a liquidation, and can instead file a Chapter 11 reorganization.

Truck shipping products.

Shutterstock

Nationwide Cargo seeks to reorganize its business

Nationwide Cargo Inc., a general freight trucking company that also hauls fresh produce and meat, filed for Chapter 11 bankruptcy protection in the U.S. Bankruptcy Court for the Northern District of Illinois with plans to reorganize its business.

The East Dundee, Ill., shipping company listed $1 million to $10 million in assets and $10 million to $50 million in liabilities in its petition and said funds will not be available to pay unsecured creditors. The company operates with 183 trucks and 171 drivers, FreightWaves reported.

Nationwide Cargo's three largest secured creditors in the petition were Equify Financial LLC (owed about $3.5 million,) Commercial Credit Group (owed about $1.8 million) and Continental Bank NA (owed about $676,000.)

The shipping company reported gross revenue of about $34 million in 2022 and about $40 million in 2023.  From Jan. 1 until its petition date, the company generated $9.3 million in gross revenue.

Related: Veteran fund manager picks favorite stocks for 2024

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Tight inventory and frustrated buyers challenge agents in Virginia

With inventory a little more than half of what it was pre-pandemic, agents are struggling to find homes for clients in Virginia.

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No matter where you are in the state, real estate agents in Virginia are facing low inventory conditions that are creating frustrating scenarios for their buyers.

“I think people are getting used to the interest rates where they are now, but there is just a huge lack of inventory,” said Chelsea Newcomb, a RE/MAX Realty Specialists agent based in Charlottesville. “I have buyers that are looking, but to find a house that you love enough to pay a high price for — and to be at over a 6.5% interest rate — it’s just a little bit harder to find something.”

Newcomb said that interest rates and higher prices, which have risen by more than $100,000 since March 2020, according to data from Altos Research, have caused her clients to be pickier when selecting a home.

“When rates and prices were lower, people were more willing to compromise,” Newcomb said.

Out in Wise, Virginia, near the westernmost tip of the state, RE/MAX Cavaliers agent Brett Tiller and his clients are also struggling to find suitable properties.

“The thing that really stands out, especially compared to two years ago, is the lack of quality listings,” Tiller said. “The slightly more upscale single-family listings for move-up buyers with children looking for their forever home just aren’t coming on the market right now, and demand is still very high.”

Statewide, Virginia had a 90-day average of 8,068 active single-family listings as of March 8, 2024, down from 14,471 single-family listings in early March 2020 at the onset of the COVID-19 pandemic, according to Altos Research. That represents a decrease of 44%.

Virginia-Inventory-Line-Chart-Virginia-90-day-Single-Family

In Newcomb’s base metro area of Charlottesville, there were an average of only 277 active single-family listings during the same recent 90-day period, compared to 892 at the onset of the pandemic. In Wise County, there were only 56 listings.

Due to the demand from move-up buyers in Tiller’s area, the average days on market for homes with a median price of roughly $190,000 was just 17 days as of early March 2024.

“For the right home, which is rare to find right now, we are still seeing multiple offers,” Tiller said. “The demand is the same right now as it was during the heart of the pandemic.”

According to Tiller, the tight inventory has caused homebuyers to spend up to six months searching for their new property, roughly double the time it took prior to the pandemic.

For Matt Salway in the Virginia Beach metro area, the tight inventory conditions are creating a rather hot market.

“Depending on where you are in the area, your listing could have 15 offers in two days,” the agent for Iron Valley Real Estate Hampton Roads | Virginia Beach said. “It has been crazy competition for most of Virginia Beach, and Norfolk is pretty hot too, especially for anything under $400,000.”

According to Altos Research, the Virginia Beach-Norfolk-Newport News housing market had a seven-day average Market Action Index score of 52.44 as of March 14, making it the seventh hottest housing market in the country. Altos considers any Market Action Index score above 30 to be indicative of a seller’s market.

Virginia-Beach-Metro-Area-Market-Action-Index-Line-Chart-Virginia-Beach-Norfolk-Newport-News-VA-NC-90-day-Single-Family

Further up the coastline on the vacation destination of Chincoteague Island, Long & Foster agent Meghan O. Clarkson is also seeing a decent amount of competition despite higher prices and interest rates.

“People are taking their time to actually come see things now instead of buying site unseen, and occasionally we see some seller concessions, but the traffic and the demand is still there; you might just work a little longer with people because we don’t have anything for sale,” Clarkson said.

“I’m busy and constantly have appointments, but the underlying frenzy from the height of the pandemic has gone away, but I think it is because we have just gotten used to it.”

While much of the demand that Clarkson’s market faces is for vacation homes and from retirees looking for a scenic spot to retire, a large portion of the demand in Salway’s market comes from military personnel and civilians working under government contracts.

“We have over a dozen military bases here, plus a bunch of shipyards, so the closer you get to all of those bases, the easier it is to sell a home and the faster the sale happens,” Salway said.

Due to this, Salway said that existing-home inventory typically does not come on the market unless an employment contract ends or the owner is reassigned to a different base, which is currently contributing to the tight inventory situation in his market.

Things are a bit different for Tiller and Newcomb, who are seeing a decent number of buyers from other, more expensive parts of the state.

“One of the crazy things about Louisa and Goochland, which are kind of like suburbs on the western side of Richmond, is that they are growing like crazy,” Newcomb said. “A lot of people are coming in from Northern Virginia because they can work remotely now.”

With a Market Action Index score of 50, it is easy to see why people are leaving the Washington-Arlington-Alexandria market for the Charlottesville market, which has an index score of 41.

In addition, the 90-day average median list price in Charlottesville is $585,000 compared to $729,900 in the D.C. area, which Newcomb said is also luring many Virginia homebuyers to move further south.

Median-Price-D.C.-vs.-Charlottesville-Line-Chart-90-day-Single-Family

“They are very accustomed to higher prices, so they are super impressed with the prices we offer here in the central Virginia area,” Newcomb said.

For local buyers, Newcomb said this means they are frequently being outbid or outpriced.

“A couple who is local to the area and has been here their whole life, they are just now starting to get their mind wrapped around the fact that you can’t get a house for $200,000 anymore,” Newcomb said.

As the year heads closer to spring, triggering the start of the prime homebuying season, agents in Virginia feel optimistic about the market.

“We are seeing seasonal trends like we did up through 2019,” Clarkson said. “The market kind of soft launched around President’s Day and it is still building, but I expect it to pick right back up and be in full swing by Easter like it always used to.”

But while they are confident in demand, questions still remain about whether there will be enough inventory to support even more homebuyers entering the market.

“I have a lot of buyers starting to come off the sidelines, but in my office, I also have a lot of people who are going to list their house in the next two to three weeks now that the weather is starting to break,” Newcomb said. “I think we are going to have a good spring and summer.”

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