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The Importance Of Securities Research and Analysis May Inspire A Reversal in Regulations

The US Securities and Exchange Commission has avoided confrontation for a few years with European Union securities laws by extending exceptions to US brokers in the states that are subject to the EU’s MIFID II rules. The rules require that brokers charge clients separately for their analysis on stocks or bonds, and not provide it as an accommodation. In the US, charging for “advice” would cause brokers to have to register with FINRA as Investment Advisors – this opens up a new set of difficulties. The stand-off has been headed for a showdown for a while, and this coming July 3^rd is when the SEC exception that exempts brokers expires.

Will Showdown be Averted?

The SEC exceptions to US brokers that have EU clients have been in place for five years, occasionally being extended – but the last extension expiring in a few weeks, may not get pushed out. SEC Chair Gary Gensler has been emphatic that he does not intend to extend any longer. The EU’s Markets in Financial Instruments directive threw a monkey wrench into a long-held custom of sell-side research by banning the common practice of accommodating clients by not directly charging for bond or equity analysis. Instead, in effect, “bundling” the service with research costs covered by trading commissions.

During the time that the EU has had MiFID II in place, an explicit price tag for research to investors has resulted in reduced company stock coverage. The new and growing concern is that the rules are hurting Europe’s financial markets — especially its small-caps. This is an important driver for the EU to consider a different tack.

Until now, without the SEC exemption from domestic rules, brokers in the huge US economy would have had to figure out how to take payment for research from their clients bound by MiFID. Or, alternatively, their clients would do without this important investment tool. The timeline is tight, but the problem for US brokers may be averted if the EU lawmakers act.

Will Europe Change Course?

With the SEC’s no-action letter expiring, the timing couldn’t be better. Investment firms following the rules of both regulators would cause a situation where US firms stop providing as much investment research to buy-side investors. Equity research is not only important to investors evaluating companies, but it is important to the companies themselves that need to be understood in order to attract capital and have enough active trading in their company to maintain suitable liquidity. This is especially true of small-cap and microcap stocks.

According to Reuters, the “states will seek a near total U-turn on the rules behind so-called unbundling.” MiFID II reforms, in place since 2018, may be adjusted to not conflict with the US model that separates brokers and investment advisors, requiring different licensing and different responsibilities of each.

The proposals suggest that an investment firm would only have to inform clients whether they are paying for research along with trading jointly, and record the charges attributable to each. This is different from unbundling, where from the client’s perspective, the research is a separate product, and decided on and paid for as an add-on to any other business.

Investors Could Win

While it was unclear how the showdown might come to an end, the new proposal, a dramatic turnaround from the EU on its current regulations, could finally resolve the regulator’s game of chicken and, at the same time, create an environment where investors benefit from more available information.

The original EU rule was intended to separate what lawmakers thought could be conflicts of interest when the selling broker also provides research while at the same time may have other banking and business relationships with the company it is providing research on.

The EU’s answer was to separate the two. But over time, according to Reuters, “evidence suggests research provision across the region has suffered as a result.” It lead to less research being distributed, which is viewed as negative to investors and the investor process.

What’s the Next Step?

The EU States’ plan talks with the European Parliament. The final shape of any regulatory changes will be decided in the negotiations, and the exact timetable for a conclusion is not yet clear.

Take Away

The prospect of a flip-flop on the MiFID rules comes at a key moment for the brokerage and securities research industries. In the US, a waiver allowing brokers to charge European clients separately for trading and for research is about to expire. At expiration, they’d have to adapt to the regulatory mismatch or drop the clients.

The drama is set against a very tight timeline.

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Paul Hoffman

Managing Editor, Channelchek

The Volume Change of Non-Covid Related Medical Studies During the Pandemic

Did Covid19 related efforts by the pharmaceutical and biotech industry pull dollars from or impede the progression of non-Covid medical research? Also, were patient-enrolled studies significantly curtailed or paused during this period? Answers to these questions had been hard to quantify. Public estimates have ranged from the virus as having a minimal impact all the way to the other extreme of tragic decline. Applied Clinical Trials, an industry publication, has found a unique and accurate source from which to remove the guesswork and mine for a conclusion. From this, they were able to come to a definitive conclusion that surprised both extremes in expectations.

Statistical Sources

The US government’s Open Payments program is a national database that discloses payments made by drug and medical device companies to hospitals, physicians, and others in the health service provider field. The purpose of the data is to provide transparency; however, it has ample information to do analysis and provide conclusions on other questions related to clinical research or the broader medical arena.

Applied Clinical Trials discovered from Open Payments that the effect on the total volume of US clinical trial activity was quite limited. The statistics reveal that the overall pharmaceutical industry spending on all US patient enrollment and treatment activities did not decline in the years 2020 and 2021, from the year 2019, which was used as a baseline.

How the Data Was Used

The Open Payments database allowed direct measurement of the impact of COVID-19 on US industry-sponsored clinical trial activity through the end of 2021. More recent data is not yet available. The researchers learned Covid19 may have slowed and hindered the launch and execution of clinical trials in two ways. First, COVID-19 clinical trials may have displaced other clinical trial activity. Second, the Covid19 pandemic caused logistical and operational challenges to most clinical trials. Do you remember the six-foot rule? Recruiting patients, treating these patients, and validating source data are some of the areas where the pandemic created more than the normal amounts of hurdles for clinical trials.

The needed data was isolated by coding Open Payments by individual study indication. Also the U.S. National Library of Medicine (under the NIH) maintains the website clinicaltrials.gov. This website shows little or no decline in the number of US sites opened for Phase II and III clinical trials between 2019, 2020, and 2021. Of course open sites may reveal the amount of patient activity taking place. A Site may be opened, but have less patient activity. Therefore assessing actual activity levels from the ClinicalTrials.gov database is nt perfect. However, Open Payments provides more complete data since the payments are predominately tied to patient enrollment and treatment experienced.

*Pharmaceutical company US clinical research spending, reported in Open Payments ($billions)*

Overall Conclusion

The research shows there was no decline in non-COVID related study spending during the height of pandemic. Open Payments data show a constant, if undramatic, increase in US clinical trials between 2017 and 2021. Even when Covid19 related spending during the time period was removed, they saw no decline in study spending. Trials continued, through the period, at a rate that is similar to the year just prior to the start of the pandemic.

More About Open Payments

Open Payments is the result of a federal law, the Sunshine Act. Searches and downloads on the website are easy and may only be slowed by the size of many of the files. The data may not reach back beyond ten years because the site has only existed since late 2013. Since, pharmaceutical companies with at least one marketed product have been required to report payments to physicians and other medical professionals. These Open Payments include two types: general and research. General payments relate to pharmaceutical companies’ payments to medical professionals when marketed products are involved. Research payments are more restricted. They are broken down by clinical grant payments. These cover virtually all clinical investigators and their clinical trial experience across all indications.

Investor Take Away

Investors had been concerned that the pipeline at companies manufacturing medical devices and developing drugs, therapies, and other treatments may have a less full pipeline because of the pandemic and the US response to it. While the data doesn’t speak to the speed of the FDA approval process, it alleviates concerns that the related investment sectors were on hiatus and now behind on phase II and phase III trials.