MiMedx (NSDQ:MDXG) saw shares rise today after announcing 3rd quarter revenue that beat consensus on The Street alongside FDA approval to proceed with the Investigational New Drug phase 2B study of its AmnioFix injectable product.
The Marietta, Ga.-based company said it expects to post sales of $84.6 million for its 3rd quarter, well ahead of both its guidance of between $70 and $80 million and Wall Street consensus of $80.1 million.
Revenue for MiMedx grew 31% compared to sales from the 3rd quarter of the previous year, according to an SEC filing.
“Our third quarter revenue performance was very strong, and we are very pleased with the robust momentum that our sales organization is building. It became evident to us in early September that this momentum would produce third quarter revenue in excess of our earlier expectations. Despite the disruption from Hurricane Harvey and Hurricane Irma, we were confident that our strong performance throughout the country would more than make up for the impact of these natural disasters. We are particularly pleased with the exceptionally strong revenue performance from our commercial accounts. Over the years, we have concentrated on developing a customer base with a very wide breadth, both geographically and functionally. We are extremely pleased with the span of the customer base that we have built now in ‘secondary markets’. Revenue from our commercial accounts is leading our robust growth. Revenue from our direct sales force is currently in excess of 95% of our total revenue with revenue from distributors and original equipment manufacturer accounts below 5% of our total revenue. We had very strong cash flow from operations and expect to report continued progress in our days sales outstanding. We anticipate that our DSO as of the end of the third quarter will be improved into the mid-60s. I would have to state that our other operations are also working quite efficiently. These financial metrics indicate that our shipped products are being utilized by our customers at an efficient rate,” CEO Parker Petit said in a prepared statement.
Shares in MiMedx have lifted 1.3% so far today, at $13.68 as of 2:13 p.m. EDT.
The company’s recently cleared prospective, double-blinded, randomized controlled clinical trial will test the AmnioFix injectable for treating osteoarthritis of the knee and is slated to enroll 318 patients beginning in the next quarter.
Primary efficacy endpoints in the trial will be the change in Visual Analog Scale score and changes in Western Ontario and McMaster Universities osteoarthritis index between the baseline and 90 days.
The trial’s primary safety endpoint will be proportion of product-related adverse events, serious adverse events and unanticipated adverse events during 12 months following injection.
“This knee osteoarthritis study is the fourth IND trial conducted by MiMedx for our AmnioFix injectable. We are pleased to receive the FDA’s notification that we can proceed with another IND study in the orthopedic/sports medicine area. We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders apprised on our future study results. Later this year, we will hold a meeting in New York that will include presentations by MiMedx executives and the physicians involved with our various IND studies to better inform analysts and our shareholders of these important activities,” CEO Petit said in a press release.
“The first two ‘Biologics License Application indications for use’ we are currently targeting for AmnioFix injectable are general tendonitis and osteoarthritic knee pain, which represent approximately 80% of the more than 15 million injections done each year to treat musculoskeletal pain. We believe the results of our BLA clinical trials and safety profile will demand a price per dose of $1,000 or more. This expands the musculoskeletal degeneration market for our first two BLA products to more than a $12 billion U.S. market opportunity. We believe the non-degenerative aspect and potential reduction in opioid use due to our Amniotic injectable product will drive significant adoption. We expect the study results to be compelling, and we look forward to the prospects of clinicians utilizing AmnioFix Injectable in the treatment of these debilitating conditions,” prez & COO Bill Taylor said in a prepared release.
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