Medical device filing citing European Urology Focus paper — Teleflex, 2021-02-25
TeleflexTeleflexNYSE TFX
Filings SEC · Quote Yahoo cited a paper published in European Urology Focus as a basis for its claims in a regulatory filing submitted to the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website. The company read the manner in which it wrote the paper and the actual scope of the paper in sequence. It described where the stock price movement over the following month compared to past cases of the same type. This is a hindsight judgment written after knowing the results. The paper was read only up to the abstract.
The disclosure is written in the press release as follows:
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 Teleflex on 2021-02-25 were 2.02 Earnings Release · 7.01 Reg FD Disclosure · 9.01 Financial Statements and Exhibits. The company cited a paper published in European Urology Focus in the press release attached to it. If the sentence citing the paper is translated verbatim, it reads as follows.
Medical Therapy Published ◦ Comparative analysis of sexual function outcomes from PUL studies and the Medical Therapy of Prostatic Symptoms (MTOPS) trial ◦ Indirect comparison reveals that PUL is superior to BPH medical therapy in preserving erectile and ejaculatory function and sexual satisfaction ◦ Challenges the idea that medical therapy is the most conservative treatment option for BPH ◦ Demonstrates that UroLift has unique benefits and can help with counseling patients considering BPH options Clinical and Commercial Updates 1 = Roehrborn et al.
What readers 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, which has only read the abstract, cannot provide an answer.
The scope of the paper mentioned in the abstract is limited to this.
The paper title is Prostatic Urethral Lift Versus Medical Therapy: Examining the Impact on Sexual Function in Men with Benign Prostatic Hyperplasia and it was published in European Urology Focus on 2021-01-12. The authors are affiliated with Southwestern Medical Center · The University of Texas Southwestern Medical Center · Prisma Health · Palmetto Health Richland. The summary at the beginning of the paper is called abstract. What this article has read is only up to this point. This paragraph was written by a person after filtering a draft written by a machine reading the abstract by numerical comparison, and thus it is of a different grade than a full-text reading and original judgment.
This study is a clinical trial in humans. It compared the long-term effects on sexual health between patients who received PUL and those who took doxazosin or pranastereide. PUL improved erectile function for up to 24 months and enhanced semen emission function and sexual satisfaction at all time points. Medical treatment did not improve sexual function at any point. Pranastereide reduced erectile function after 48 months. PUL was superior to medical treatment in preserving erectile and semen emission functions, although the use of different evaluation tools is a limitation.
What the abstract does not answer remains in the full text and appendices. This article, which has not gone beyond the abstract, leaves the blanks as they are. Readers should determine themselves which sentence in the abstract corresponds to the cited excerpt from the company, by comparing the two citations above.
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 terms of the calendar, 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 | +0.0% | The extent of movement before the filing |
| On the day of the filing | +3.8% | On the filing day or the first trading day thereafter |
| Accumulated over +1 to +5 trading days | +6.0% | One week |
| +1~+20 trading days cumulative | +3.4% | 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 +3.4% in this case is within the bottom 70% of the 142 samples, but still within the top 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% | +3.4% |
Half of the sample falls between the two central marks on the chart. One checks from the chart whether this case lies within or outside that range. The sample collects cases where U.S.-listed companies cited papers in 8-K filings over the past ten years. The company itself is excluded from the sample. The numbers listed here are past facts, not rules applicable to future cases.
After the disclosure, the company issued such documents
After the disclosure date, the company issued three 8-K filings, listed here only by item number. 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. The specific event is read in the original text of each link.
- 2021-04-29 8-K Item 2.02, 7.01, 8.01, 9.01 — Earnings announcement · Reg FD disclosure · Other events · Financial statements · Exhibits
- 2021-05-06 8-K Item 5.07 — Results of the Shareholders' Meeting
- 2021-05-18 8-K Items 2.05,7.01,9.01 — Reg FD disclosure · financial statements·attached documents
What this article does not answer
This article, which reads only the abstract, cannot answer what the paper reviewed, how it was done, or what it showed. How often the company's cited paper has been cited afterward can be verified again through 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 news to inform shareholders. Types are indicated 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 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.