Pharmaceutical regulatory filing citing a New England Journal of Medicine paper — Alkermes, 2021-02-11
AlkermesAlkermesNASDAQ ALKS
Filings SEC · Quote Yahoo cited a paper published in the New England Journal of Medicine as a basis for its claims in a regulatory filing with the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website. The company read the manner in which the paper was written and the scope it actually demonstrated in sequence. The stock price movement over one month following the filing was compared to past cases of the same type. This is a retrospective judgment written after knowing the results. The paper was read only up to the abstract.
The disclosure wrote the paper like this in the press release
When a U.S. listed company has something to inform its shareholders, the form it files with the Securities and Exchange Commission is called 8-K. The item numbers in the document filed by Alkermes on 2021-02-11 were 2.02 Earnings Release · 9.01 Financial Statements and Exhibits. The company cited a paper published in New England Journal of Medicine in the press release attached to it. If the sentence citing the paper is translated verbatim, it reads as follows.
Trivedi et al. in the New England Journal of Medicine (NEJM). 3 Corporate • In December 2020, the company announced a Value Enhancement Plan designed to drive growth, improve operational and financial performance and enhance shareholder value.
What the reader should first check is where the company placed the paper in the press release. Next, they should determine whether the paper supports the entire company claim or only a part of it. To answer the latter question, one must read the full paper. This article has only read the abstract and cannot answer that.
The scope of the paper mentioned in the abstract is limited to this.
The paper title is Bupropion and Naltrexone in Methamphetamine Use Disorder and it was published in New England Journal of Medicine on 2021-01-13. The authors are affiliated with Texas Tech University and The University of Texas Southwestern Medical Center. The summary at the beginning of the paper is called abstract. This article has read only up to this point. This paragraph was rewritten by a person after filtering a draft written by a machine reading the abstract through numerical comparison, and thus differs in quality from a full reading of the paper.
This is a multi-center trial administering naltrexone injection and bupropion sustained-release tablets together to adults with moderate to severe methamphetamine use disorder. It used a two-stage design, reassigning participants who showed no response to placebo in the first stage to the second stage. Neither the participants nor the medical staff knew which group they were in, and the primary outcome was confirmed abstinence through urine tests. The numerical results are in the latter part of the abstract. This article has not read that part.
What the abstract does not answer remains in the full paper and appendix. This article, which has not gone beyond the abstract, leaves the gaps as they are. Readers should compare the two citations above to determine which sentence in the abstract corresponds to the citation used by the company.
One month later, the stock price was within the middle half of the sample.
The remaining return after subtracting the portion that moves with the overall market is called excess return. The date is written as trading day, counting only the days the stock market is open. In calendar terms, 20 trading days are approximately one month. The excess return for the day of the regulatory filing and the following month are listed in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| Five trading days before the filing | −3.9% | The extent of movement before the filing |
| On the day of the filing | −12.6% | On the filing day or the first trading day after |
| Accumulated over +1 to +5 trading days | −16.7% | One week |
| Cumulative +1~+20 trading days | −4.8% | One month |
A bundle of past cases of the same type is called a sample. The position counted from the bottom is expressed as a percentile. The one-month excess return of -4.8% in this case is within the bottom 56% of the 142 cases in the sample, placing it in the lower half.
| Sample scale (20 trading days) | Tenth from the bottom | Fourth from the bottom | median | top 25% | top 10% | This case |
|---|---|---|---|---|---|---|
| Excess return | −31.9% | −20.1% | −7.4% | +5.5% | +19.5% | −4.8% |
Half of the sample falls between the two marks in the middle of the table. One checks from the table whether this case is inside or outside. The sample collects cases where U.S. listed companies wrote papers in 8-K over the past ten years. The company itself is excluded from the sample. The numbers written here are past facts, not rules to apply to the next case.
After the disclosure, the company issued such documents
After the disclosure date, the company issued three 8-K filings. Only the item numbers are listed. In 8-K filings without titles, the item number indicates the type of content. One can determine whether it was an earnings announcement or a contract based on that number. What event occurred is read in the original text of each link.
- 2021-03-12 8-K Items 1.01,2.03 — Material Contract Execution · Debt Incurrence
- 2021-03-25 8-K Item 7.01, 9.01 — Reg FD Disclosure · Financial Statements · Exhibits
- 2021-04-28 8-K Item 2.02, 9.01 — Earnings Announcement · Financial Statements · Attached Documents
What This Article Does Not Answer
This article, which reads only the abstract, does not answer what method the paper used, what it reviewed, or how far it went. How many times the paper cited by the company was cited afterward can be verified again by the OpenAlexOpenAlex
Data source · Website citation count. What will be seen next is whether the company's next 8-K again cites the same paper.
Glossary
- 8-K
- A voluntary report submitted to the Securities and Exchange Commission when a U.S. listed company has something to inform shareholders. It is categorized by item numbers such as earnings, contracts, and executive changes. All events in this article come from this document.
- Excess return
- The remainder after subtracting the overall market return from the stock return. It is used to observe the movement of the company alone by removing the portion where the market as a whole rises or falls.
- Trading day
- A date counting only days when the stock market is open. Since weekends and holidays are excluded, 20 trading days correspond to roughly one calendar month.
- Sample and percentile
- A bundle of past cases of the same type is a sample, and the position from the bottom within it is expressed as a percentile. A percentile of 10 means that nine out of ten cases performed better than this case.
- Abstract
- An abstract is placed at the beginning of a paper. The author writes in a few sentences what was done, how it was done, and what results were obtained. Without reading the full text, one cannot know the details or limitations of the methods.