April 26, 2018 10:11am
MDXG closed Tuesday up +$0.81 (+10.9%) to $8.24 and is down -$0.32 or -3.88% - BUY
MDXG reaffirmed its expectations for gross margin, operating income; GAAP diluted earnings per share and adjusted diluted earnings per share. MDXG previously announced its un-reviewed revenue results for Q1/18 exceeding its Q1 revenue guidance.
MDXG has raised its full year revenue guidance from a previous range of $383 million to $387 million to a revised range of $389 million to $394 million.
MDXG is also tracking annual goals previously announced on 12/13/17, regarding gross margin (89% to 90%), operating income margin (15% to 17%), GAAP diluted earnings per share ($0.30 to $0.35) and adjusted earnings per share ($0.45 to $0.50).
Furthermore, MDXG is providing Q2 revenue guidance in the range of $96 million to $98 million.
The number of active customer accounts grew by more than 25% last year and they are continually broadening as allografts are becoming part of the standard of care among the physicians who have access to our products.
Cash flow continues to be strong (undisclosed).
Quarterly development results:
- MDX’s first patients had been randomized and enrolled in the P3 IND clinical trial to assess the safety and efficacy of our AmnioFix® Injectable in patients with recalcitrant Plantar Fasciitis pain;
- MDXG also enrolled the first patients in the P3 IND clinical trial for its micronized AmnioFix Injectable in the treatment of Achilles Tendonitis;
- MDXG initiated another milestone with the enrollment of the first patients in a P2B IND clinical trial to assess the safety and efficacy of AmnioFix Injectable as a treatment for pain associated with Osteoarthritis (OA) of the knee;
- The initiation of the P2B study followed quickly after the FDA granted MiMedx RMAT designation for Knee OA.
Concerning the 2017 Form 10-K:
- As previously disclosed by the Audit Committee of MDXG's BOD has engaged independent legal and accounting advisors to conduct an internal investigation into matters related to allegations regarding certain sales and distribution practices.
- Therefore, this release is limited to MDXG's performance versus its previously announced guidance released on December 13, 2017.
- MiMedx announced on March 2, 2018 that it received a notification letter from NASDAQ stating that the Company is not in compliance with NASDAQ listing rule 5250(c)(1), which requires timely filing of reports with the SEC. The March 2 letter was sent as a result of MDXG's delay in filing its Form 10-K. The Company filed a Form 12b-25 on March 2, 2018, stating that it was unable to file the Form 10-K by the due date of March 1, 2018.
- The NASDAQ notice has no immediate effect on the listing or trading of the Company's common stock on the Nasdaq Capital Market.
- As required, no later than May 1, 2018, MDXG intends to submit a plan to NASDAQ to regain compliance, and NASDAQ can grant an exception for MiMedx to remain listed for up to 180 calendar days from the Form 10-K's due date, or until August 28, 2018, if the plan is accepted.
- MiMedx intends to achieve compliance as soon as practicable.