MiMedx Group (NASDAQ: MDXG) reported Q4 EPS of ($0.17), versus ($0.07) reported last year. Revenue for the quarter came in at $68.55 million, versus $76.4 million reported last year.

Outlook for 2021:

The Company expects adjusted net sales will increase 10% or more in 2021 over the prior year, assuming MiMedx is able to sell its micronized, particulate, and umbilical cord products for the full year. However, the United States Food and Drug Administration ("FDA") may determine that the Company's micronized, particulate, and/or umbilical cord-derived products do not qualify for regulation as human cells, tissues, and cellular and tissue-based products solely under Section 361 of the Public Health Service Act, and could require MiMedx to remove them from the market immediately. Such a decision by the FDA could have a negative impact on the Company's expected adjusted net sales. As an example, if the Company's micronized and particulate products are required to be removed from the market following the end of the period of enforcement discretion, currently anticipated for May 31, 2021, MiMedx estimates the negative impact on its expected 2021 adjusted net sales could be in the range of $20 million to $25 million. See Item 1A, “Risk Factors,” within the Company’s 2020 Annual Report on Form 10-K. The Company's sales of micronized and particulate products for all uses were $32.8 million, $42.4 million, and $68.4 million, respectively, in 2020, 2019, and 2018. The Company's sales of umbilical cord-derived products were $16.6 million, $17.9 million, and $14.7 million, respectively, in 2020, 2019, and 2018. Further, because MiMedx cannot predict the impact of COVID-19 in 2021, the Company's estimate for 2021 adjusted net sales assumes no restrictions on its ability to access hospitals, healthcare provider facilities and other places where products are sold.

The Company also anticipates as much as a three-fold increase in research and development expense for 2021, as it plans to file additional INDs and continue working towards the filing of Biological License Applications ("BLAs"), although this amount is partially dependent on whether the interim results from the Company's ongoing IND clinical trials merit further investment. Lastly, the Company expects a significant decline in investigation, restatement and related expenses in 2021, prior to any resolution of the pending securities class action matter.

For earnings history and earnings-related data on MiMedx Group (MDXG) click here.