|By PR Newswire||
|March 24, 2014 08:35 AM EDT||
MARIETTA, Ga., March 24, 2014 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today it will host a shareholder call tomorrow, Tuesday, March 25, 2014 at 11:00 AM Eastern Time to update shareholders on the positive progress of its discussions with the Food and Drug Administration ("FDA") regarding the Company's micronized allograft. During the call, the Company also plans to provide updates on its progress with wound care reimbursement, its sales force expansion, as well as its reaction to the misinformation in certain recent short-selling related blogs.
Parker H. "Pete" Petit, Chairman and CEO, said, "We had our first Pre-Investigational New Drug ("IND") meeting at the FDA on March 13, 2014. During the meeting, we presented a series of questions focused on our detailed plans for our first targeted Biologics License Application ("BLA") for our micronized tissue and reviewed some of our data. The FDA was extremely helpful in answering our questions and providing additional information related to this complex process. In the near future, we anticipate a second meeting to finalize our study protocols and review additional information."
"Because of the significant changes in the Hospital Outpatient Prospective Payment System ("OPPS") Final Rule issued by CMS effective January 1, 2014, and particularly because the changes were announced in late November 2013, almost a month later than usual, we expected the wound care clinics and physicians to be somewhat confused about their reimbursement processes during the first couple of months of this year. To address this expected confusion, we have focused on providing them with detailed education regarding the changes. Revenue in March has grown significantly and we expect March will be a record revenue month. The March revenue trend is an indicator that most of the wound care centers have absorbed the changes and are comfortable with the new reimbursement process," stated Bill Taylor, President and COO.
"With the reimbursement confusion settling down in the Medicare market, additional Medicare Administrative Contractor ("MAC") coverage, and continued growth in the number of commercial health plans and state Medicaid plans approving coverage for EpiFix®, we expect our quarter-over-quarter growth to continue to accelerate. We are continuing the expansion of our sales force to facilitate these opportunities. In our February shareholder call, I announced that our sales force expanded from 76 at the end of last year to 110. By the end of this month, we will have 120 sales professionals in our direct sales force, and we still expect that number to be between 130 and 150 by the end of the year," added Taylor.
"Our reimbursement successes are attributed to the data we have collected in our peer-reviewed published clinical trials," stated Petit. "We have four different publications in Level One Journals on EpiFix®, our wound care allograft. We also have several other supporting scientific and clinical publications. Shortly, we will announce the publication of a 90-patient study on venous leg ulcers ("VLUs"). This is a multi-center, randomized, controlled trial involving seven centers. This should clear any questions on the effectiveness of EpiFix® on the larger VLU wounds. Shortly after this publication, we expect to announce another publication of a study of 60 patients with diabetic foot ulcers. This will bring our total study population to well over 200 patients, which we believe should be more than sufficient to obtain coverage from most health plans."
Last Thursday and Friday, March 20th and 21st, a blog organization, that admits to having shorted the Company's stock, published two articles. The first article is related to the pending civil suit by the Securities and Exchange Commission ("SEC") against Pete Petit, the Company's Chairman & CEO. The second article is related to the Company's relationships with its Medical Advisory Board ("MAB") members and other physician consultants.
When the SEC suit was announced in January of 2012, the Company's Board of Directors issued a press release announcing its support for Mr. Petit. Because the Company is not a party to the litigation, the Company does not deem it appropriate to comment further. However, Mr. Petit intends to respond to the article by posting several case-related documents on his personal website. To review this information, go to www.petepetit.com and click on "Personal" in the upper left corner. Then click on "SEC Case" under "Blog Posts." This information should be on the site by 10:00 AM today. Following the conclusion of tomorrow's investor call, Mr. Petit will address this personal matter.
"The second blog article misrepresented the participation and compensation of our MAB members," said Taylor. "First, the agreements to which links are provided in the article were entered into more than 6 years ago at a time when MiMedx was a development stage company with no revenues and prior to Pete or me joining the Company. The then-physician advisory board was actively involved in the Company's efforts to develop its HydroFix® and CollaFix™ technologies. Their levels of compensation were commensurate with their development activities. Additionally, the two early members of the MAB referenced in the article were also founders of the Company, and as such, received founder's shares. Both of those individuals are no longer members of our MAB. To our knowledge, none of those early advisory board members mentioned in the article has ever used or referred the Company's products.
"As a more mature company with substantial operating revenues, we have invested in internal resources to further our product development efforts and have reduced our reliance on outside consultants. More than 70% of MAB stock options were granted over six years ago and approximately 65% of total MAB options expired without being exercised. All of our relationships with health care professionals are structured so as to comply with applicable law and regulatory guidance, as well as ethical principles and best practices. Currently, the physicians who provide consulting services to the Company, conduct clinical trials of our products or speak on our behalf are generally paid an hourly rate that meets AdvaMed guidelines and is documented as fair market value compensation."
"We are still refining our second quarter revenue guidance range, and will announce that in April," said Petit. "At this stage, we feel comfortable increasing the lower end of our full year revenue range from $90 million to $95 million. Therefore, our updated revenue goal for 2014 is $95 million to $110 million."
A listen-only simulcast of the MiMedx March 25, 2014 conference call will be available online at the Company's website at www.mimedx.com. A 30-day online replay will be available approximately one hour following the conclusion of the live broadcast. The replay can also be found on the Company's website at www.mimedx.com.
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include AmnioFix® and EpiFix®, our tissue technologies processed from human amniotic membrane that is derived from donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® process, to produce a safe and effective implant. MiMedx® is the leading supplier of amniotic tissue, having supplied over 200,000 allografts to date for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the timing and outcome of the Company's next meeting with the FDA, expected March, first quarter and full year 2014 revenues, the expected acceleration of quarter-of-quarter revenue growth, anticipated expansion of the Company's direct sales force, the prospect of additional publications of the results of clinical studies of the Company's products and the expected effect on third party reimbursement coverage. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the Company's next meeting with the FDA might be delayed, that the Company may not meet its revenue goals or show accelerated quarter-over-quarter revenue growth as a result of expansion of third party reimbursement coverage or otherwise, that the Company may not be able to expand its direct sales force as anticipated or that the expansion may not have the anticipated effect on revenue growth, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2013. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.
SOURCE MiMedx Group, Inc.
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