Form 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 28, 2011
MIMEDX GROUP, INC.
(Exact name of registrant as specified in its charter)
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Florida
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000-52491
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26-2792552 |
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.) |
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811 Livingston Court SE, Suite B
Marietta, GA
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30067 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: (678) 384-6720
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Item 2.02 |
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Results of Operations and Financial Conditions. |
On March 28, 2011, MiMedx Group, Inc. issued a press release announcing its financial results for
the year ended December 31, 2010. The release also announced that executives of the company would
discuss these results with investors on a conference call broadcast over the World Wide Web and by
telephone and provided access information, date and time for the conference call. A copy of the
press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is
incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit 99.1 |
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Press release issued by MiMedx Group, Inc. dated March 28, 2011 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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MIMEDX GROUP, INC.
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Dated: March 29, 2011 |
By: |
/s/ Michael J. Senken
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Michael J. Senken, Chief Financial Officer |
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Exhibit 99.1
Exhibit 99.1
PRESS RELEASE Contact: Michael Senken
Phone: (678) 384-6720
MIMEDX GROUP ANNOUNCES 2010 RESULTS
MARIETTA, Georgia, March 28, 2011 (PR Newswire) MiMedx Group, Inc. (OTCBB: MDXG), an
integrated developer, manufacturer and marketer of patent protected biomaterial-based products and
bioimplants processed from human amniotic membrane, announced today its results for the year ended
December 31, 2010.
Full Year 2010 Results
In 2010, the Company changed its fiscal year to coincide with the calendar year. Its prior fiscal
year was from April 1st through March 31st. Therefore, comparative results
for 2009 are reflected for the nine month period from April 1, 2009, through December 31, 2009, and
the results for the twelve months ended December 31, 2010, are compared to the results for the nine
months ended December 31, 2009. Additionally, as significant sales and marketing activity began in
the first quarter of 2010, MiMedx emerged from development stage company status to an operating
company.
Revenue for the twelve months ended December 31, 2010, was approximately $789,000, as compared to
revenue of $800 recorded for the nine months ended December 31, 2009. The Company recorded a net
loss of $11.4 million, or $0.19 per diluted common share, for the twelve months ended December 31,
2010, as compared to a net loss of $8.3 million, or $0.20 per diluted common share, for the nine
month period ended December 31, 2009. Net Cash Flow from operating activities was a negative
$8,157,000 for the twelve months ended December 31, 2010, as compared to a negative $5,596,000 for
the nine months ended December 31, 2009. Significant investments were made in 2010 in building our
global sales and distribution network as well as investments in animal studies in support of new
product development for both HydroFix and CollaFix product lines. Cash on hand as of December
31, 2010, was $1,341,000 as compared to $2,654,000 as of December 31, 2009. Through March 28,
2011, an additional $1,089,000 has been raised in a Private Placement Offering. Stockholders
equity as of both December 31, 2010, and December 31, 2009, was $6.1 million.
Management Commentary
Parker H. Pete Petit, Chairman and CEO, stated, We are disappointed in our revenue performance
during 2010. Unfortunately, we were severely limited by the slow pace of the regulatory agencies
granting clearances for our products. Hindered by how few products we could market during the year,
MiMedx fell short of our revenue goals. However, our biggest disappointment during the year was not
receiving FDA clearance on our collagen fiber 510(k) submissions. We have a couple of submissions
under review for our CollaFix products, and we are in continuous communications with the FDA to
achieve our first clearance on these exciting products. At the end of 2010, we did receive a
European certificate to market HydroFix Spine Shield for posterior as well as anterior surgery.
Most notable of our 2010 achievements was our acquisition of Surgical Biologics, which was
initiated during the year and closed at the beginning of 2011, added Petit. We were extremely
fortunate that our search for the best-of-class amniotic membrane tissue processor led us to a
company located about ten miles away from MiMedx. Surgical Biologics has perfected their
processing technology far beyond the competitors. The addition of Surgical Biologics gives MiMedx
its third biomaterial tissue platform. In addition, the amniotic tissues produce immediate revenue;
provide revenue that is not dependent on timing of regulatory approvals; and create expanded
strategic opportunities in wound care, burn healing, soft tissue trauma, and spinal applications.
Surgical Biologics revenue will benefit from the MiMedx infrastructure by accelerating the growth
and enabling the product lines to be launched on an international basis.
During the year, we made significant progress in increasing our U.S. and international
distribution network. By year-end, our U.S. distribution network had grown to 27 independent sales
representatives and stocking dealers, and internationally, we ended 2010 with 12 dealers. We are
very comfortable with how we have positioned MiMedx for the high growth that we believe is imminent
with the amnion tissue and our products pending regulatory clearances, concluded Petit.
Bill Taylor, President and COO, commented, In 2010, we successfully transferred the production of
our collagen fiber to our Marietta, Georgia, facility and are in the process of ramping up our
production capabilities and capacity in order to serve the anticipated demand for our initial
CollaFix products.
MiMedx reported that it continues to make progress in its previously announced initiative to raise
at least one more round of financing to take the Company through its projected EBITDA breakeven
point in the third quarter of 2011. MiMedx plans for the new capital to be used primarily for new
product development and operational expansion.
Outlook for 2011
The Company also reported its revenue goals for 2011. The Company expects its first quarter 2011
revenue to be in excess of $1 million. The Companys goals for the second, third and fourth quarter
revenues are approximately $2 million, $4 million and $8 million, respectively. Petit added, We
expect a rapid growth in our revenue over the next several quarters. Our goal is to have MiMedx
attain profitability during the third quarter of 2011. Once we reach profitability, we anticipate
our strong operating leverage will allow our profits to grow faster than our revenue.
Earnings Call
MiMedx management will host a live broadcast of its second quarter conference call on Tuesday,
March 29, 2011, beginning at 10:30 a.m. eastern time. A listen-only simulcast of the MiMedx Group
conference call will be available online at the Companys website at www.mimedx.com or at
www.earnings.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 Companys website at
www.mimedx.com or at www.earnings.com.
About the Company
MiMedx is an integrated developer, manufacturer and marketer of patent protected biomaterial-based
products and bioimplants manufactured from human amniotic membrane. The Company has an experienced
team poised to capitalize on its science and technology to generate rapid sales growth and
profitability. Our mantra is Repair, dont replace because our biochemists, engineers, designers
and physicians believe it is better to augment repair when possible rather than replace
traumatized, but otherwise healthy tissues and structures. Our platform technologies, HydroFix
and CollaFix, and our newest platform technology, Purion® developed by our wholly-owned
subsidiary, Surgical Biologics, have a vast number of potential applications in treating
traumatized tissue and structures and MiMedx is focused on commercializing multiple applications
for the Companys three technology platforms. In parallel, we are seeking strategic relationships,
in selective categories, to more rapidly commercialize our technologies.
Safe Harbor Statement
This press release includes statements that look forward in time or that express managements
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 prospect of receiving regulatory clearance for the Companys first CollaFix
product, anticipated demand for the Companys CollaFix products, the expanded strategic
opportunities in wound care,
burn healing, soft tissue trauma, and spinal applications created by the acquisition of Surgical
Biologics, the impact of the MiMedx infrastructure on Surgical Biologics revenue growth, the
Companys goals for the amount of invested capital to be raised through its Private Placement and
the expected use of the proceeds, the expected timing for the Company to reach its EBITDA breakeven
point, and the Companys financial expectations for 2011. 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 may not receive anticipated regulatory
clearances and/or approvals or that such clearances or approvals may be delayed may not be
successful in ramping up its production capabilities and capacity to serve the anticipated demand
for its initial CollaFix products, that the anticipated demand for the Companys CollaFix
products does not materialize as expected, that expanded strategic opportunities from the
acquisition of Surgical Biologics are not achieved, that Surgical Biologics growth is not
accelerated as a result of its combination with MiMedx, that the Company does not achieve its
financial goals for 2011, that the Company may not be successful in raising its intended amount of
capital through a private placement, that the timing of the offering may be delayed, that
unanticipated events may prevent the Company from using the proceeds of the offering for the
intended purpose, that to survive and achieve its goals the Company may require additional capital
beyond the amount raised in the offering referenced in this release, which may be difficult or
impossible to obtain, that the Company may not be able to achieve profitability, that the Companys
products and services may not gain the anticipated acceptance in the marketplace or that acceptance
may be delayed, and the risk factors detailed from time to time in the Companys periodic
Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the
fiscal year ended December 31, 2009. By making these forward-looking statements, the Company does
not undertake to update them in any manner except as may be required by the Companys disclosure
obligations in filings it makes with the Securities and Exchange Commission under the federal
securities laws.
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
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Year Ended |
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Nine Months Ended |
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December 31, |
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December 31, |
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2010 |
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2009 |
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REVENUES: |
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Net sales |
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$ |
544,155 |
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$ |
800 |
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Grant Revenue |
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244,719 |
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Total revenue |
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788,874 |
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800 |
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OPERATING COSTS AND EXPENSES: |
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Cost of products sold |
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1,720,066 |
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240 |
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Research and development expenses |
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2,753,331 |
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2,590,227 |
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Selling, General and Administrative expenses |
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6,848,135 |
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3,463,303 |
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Gain on sale of assets |
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(280,868 |
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LOSS FROM OPERATIONS |
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(10,532,658 |
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(5,772,102 |
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OTHER INCOME (EXPENSE) |
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Financing expense associated with issuance of common
stock for registration rights waivers |
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(1,305,100 |
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Financing expense associated with warrants issued
in connection with convertible promissory note |
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(287,449 |
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(975,833 |
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Interest (expense) income, net |
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(599,649 |
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(242,634 |
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LOSS BEFORE INCOME TAXES |
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(11,419,756 |
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(8,295,669 |
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Income taxes |
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NET LOSS |
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(11,419,756 |
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(8,295,669 |
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Net loss per common share |
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Basic and diluted |
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$ |
(0.19 |
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$ |
(0.20 |
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Shares used in computing net loss per common share |
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Basic and diluted |
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59,138,357 |
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41,365,513 |
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See notes to consolidated financial statements
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
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December 31, |
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2010 |
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2009 |
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ASSETS |
Current assets: |
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Cash and cash equivalents |
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$ |
1,340,922 |
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$ |
2,653,537 |
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Accounts receivable, net |
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162,376 |
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Inventory |
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111,554 |
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30,920 |
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Prepaid expenses and other current assets |
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90,946 |
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121,277 |
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Total current assets |
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1,705,798 |
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2,805,734 |
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Property and equipment,
net of accumulated depreciation of $1,392,704
and $948,445, respectively |
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756,956 |
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1,049,597 |
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Goodwill |
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857,597 |
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857,597 |
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Intangible assets, net of accumulated amortization of $2,132,606
and $1,464,674, respectively |
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3,929,394 |
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4,597,326 |
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Deferred financing costs |
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192,627 |
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Deposits and other long term assets |
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102,500 |
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189,202 |
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Total assets |
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$ |
7,352,245 |
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$ |
9,692,083 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
848,286 |
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$ |
629,349 |
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Short-term convertible notes, plus accrued interest of $3,432 |
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403,432 |
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Total current liabilities |
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1,251,718 |
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629,349 |
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Long-term convertible debt, face value $3,472,000, less unamortized
discount of $550,748 and including accrued interest of $69,604 |
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2,990,856 |
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Total liabilities |
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1,251,718 |
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3,620,205 |
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Commitments and contingency (Note 14) |
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Stockholders equity: |
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Preferred stock; $.001 par value; 5,000,000
shares authorized and 0 shares issued and outstanding |
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Common stock; $.001 par value; 100,000,000 shares authorized;
64,331,910 and 50,002,887 shares issued and outstanding, respectively |
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64,382 |
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50,003 |
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Additional paid-in capital |
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57,888,506 |
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46,454,482 |
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Treasury stock (50,000 shares at cost) |
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(25,000 |
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(25,000 |
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Accumulated deficit |
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(51,827,360 |
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(40,407,607 |
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Total stockholders equity |
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6,100,528 |
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6,071,878 |
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Total liabilities and stockholders equity |
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$ |
7,352,245 |
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$ |
9,692,083 |
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See notes to consolidated financial statements
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