þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Florida | 26-2792552 | |
(State or other jurisdiction of incorporation) | (I.R.S. Employer Identification Number) | |
811 Livingston Court, Suite B | ||
Marietta, GA | 30067 | |
(Address of principal executive offices) | (Zip Code) |
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company x | |||
(Do not check if a smaller reporting company) |
Part I FINANCIAL INFORMATION |
||||||||
Item 1. Condensed Consolidated Financial Statements |
||||||||
2 | ||||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
17 | ||||||||
20 | ||||||||
21 | ||||||||
21 | ||||||||
21 | ||||||||
22 | ||||||||
22 | ||||||||
22 | ||||||||
22 | ||||||||
22 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
1
March 31, | December 31. | |||||||
2010 | 2009 | |||||||
(unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 1,627,505 | $ | 2,653,537 | ||||
Trade Accounts Receivable |
115,655 | | ||||||
Inventory |
68,276 | 30,920 | ||||||
Prepaid expenses and other current assets |
171,854 | 121,277 | ||||||
Total current assets |
1,983,290 | 2,805,734 | ||||||
Property and equipment,
net of accumulated depreciation of $1,059,438 (March)
and $948,445 (December) |
954,260 | 1,049,597 | ||||||
Goodwill |
857,597 | 857,597 | ||||||
Intangible assets, net of accumulated amortization of
$1,631,657 (March)
and $1,464,674 (December) |
4,430,343 | 4,597,326 | ||||||
Deferred financing costs |
| 192,627 | ||||||
Deposits and Other Long Term Receivables |
111,180 | 189,202 | ||||||
Total assets |
$ | 8,336,670 | $ | 9,692,083 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable and accrued expenses |
$ | 928,050 | $ | 629,349 | ||||
Total current liabilities |
928,050 | 629,349 | ||||||
Long term convertible debt, face value $3,472,000, less
unamortized
discount of $550,748 and including accrued interest of
$69,604 (December) |
| 2,990,856 | ||||||
Total liabilities |
928,050 | 3,620,205 | ||||||
Commitments and contingency (Notes 4 and 9) |
| | ||||||
Stockholders equity: |
||||||||
Preferred stock; $.001 par value; 5,000,000
shares authorized and 0 (March and December) shares
issued and outstanding |
| | ||||||
Common stock; $.001 par value; 100,000,000 shares
authorized;
and 58,550,083 (March) and 50,002,887 (December) shares
issued;
58,550,083 (March) and 49,952,887 (December) shares
outstanding |
58,550 | 50,003 | ||||||
Additional paid-in capital |
50,924,762 | 46,454,482 | ||||||
Treasury stock (50,000 shares at cost) |
(25,000 | ) | (25,000 | ) | ||||
Deficit accumulated during the development stage |
(43,549,692 | ) | (40,407,607 | ) | ||||
Total stockholders equity |
7,408,620 | 6,071,878 | ||||||
Total liabilities and
stockholders equity |
$ | 8,336,670 | $ | 9,692,083 | ||||
2
Period from | ||||||||||||
Inception | ||||||||||||
Three Months Ended | (November 22, 2006) | |||||||||||
March 31, | through | |||||||||||
2010 | 2009 | March 31, 2010 | ||||||||||
REVENUES: |
||||||||||||
Net Sales |
$ | 114,855 | $ | | $ | 115,655 | ||||||
OPERATING COSTS AND EXPENSES: |
||||||||||||
Cost of products sold |
379,588 | | 379,828 | |||||||||
Research and development expenses |
572,404 | 957,084 | 9,312,239 | |||||||||
Acquired in-process research and development |
| | 7,177,000 | |||||||||
Selling, General and Administrative expenses |
1,711,438 | 1,915,594 | 22,355,445 | |||||||||
Gain on sale of assets |
| | (275,428 | ) | ||||||||
LOSS FROM OPERATIONS |
(2,548,575 | ) | (2,872,678 | ) | (38,833,429 | ) | ||||||
OTHER INCOME (EXPENSE), net |
||||||||||||
Financing expense associated with issuance of common
stock for registration rights waivers |
| | (1,305,100 | ) | ||||||||
Financing expense associated with warrants issued
in connection with convertible promissory note |
| | (975,833 | ) | ||||||||
Net interest (expense) income, net |
(593,510 | ) | 694 | (223,140 | ) | |||||||
Change in fair value of investment,
related party |
| | (41,775 | ) | ||||||||
LOSS BEFORE INCOME TAXES |
(3,142,085 | ) | (2,871,984 | ) | (41,379,277 | ) | ||||||
Income taxes |
| | | |||||||||
NET LOSS |
(3,142,085 | ) | (2,871,984 | ) | (41,379,277 | ) | ||||||
Accretion of redeemable common stock and
common stock with registration rights
to fair value |
| | (2,158,823 | ) | ||||||||
Loss attributable to common shareholders |
$ | (3,142,085 | ) | $ | (2,871,984 | ) | $ | (43,538,100 | ) | |||
Net loss per common share
|
||||||||||||
Basic and diluted |
$ | (0.06 | ) | $ | (0.07 | ) | ||||||
Shares used in computing net loss per common share |
||||||||||||
Basic and diluted |
51,227,540 | 38,549,350 | ||||||||||
3
Period from | ||||||||||||
Inception | ||||||||||||
Three Months Ended | (November 22, 2006) | |||||||||||
March 31, | through | |||||||||||
2010 | 2009 | March 31, 2010 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (3,142,085 | ) | $ | (2,871,984 | ) | $ | (41,379,277 | ) | |||
Adjustments to reconcile net loss to net cash flows from
operating activities, net of effects of acquisition: |
||||||||||||
Gain on settlement of payables |
| | (584,969 | ) | ||||||||
(Gain)/loss on sale of equipment |
| 5,440 | (275,428 | ) | ||||||||
Acquired in-process research and development |
| | 7,177,000 | |||||||||
Depreciation |
110,992 | 111,820 | 1,066,069 | |||||||||
Amortization of intangible assets |
166,983 | 166,704 | 1,654,857 | |||||||||
Amortization of debt discount and deferred financing costs |
568,636 | | 738,375 | |||||||||
Employee share-based compensation expense |
189,467 | 456,367 | 2,161,178 | |||||||||
Other share-based compensation expense |
9,667 | 365,264 | 767,759 | |||||||||
Financing expense associated with issuance of common stock
for waivers of registration rights |
| | 1,305,100 | |||||||||
Financing expense associated with warrants issued in
connection with convertible promissory note |
| | 975,833 | |||||||||
Modifications of options and purchase of treasury stock |
| | 48,000 | |||||||||
Issuance of common stock for transaction fees |
| | 1,126,379 | |||||||||
Accrued interest on notes receivable, related party |
| | (48,894 | ) | ||||||||
Change in fair value of investment, related party |
| | 41,775 | |||||||||
Increase (decrease) in cash resulting from changes in: |
||||||||||||
Accounts Receivable |
(115,655 | ) | | (115,655 | ) | |||||||
Inventory |
(37,356 | ) | (68,276 | ) | ||||||||
Prepaid expenses and other current assets |
(35,576 | ) | (74,632 | ) | (77,775 | ) | ||||||
Other assets |
63,021 | 100 | (52,379 | ) | ||||||||
Accounts payable and accrued expenses |
324,654 | 508,648 | 885,409 | |||||||||
Deferred interest income |
| | (43,200 | ) | ||||||||
Net cash flows from operating activities |
(1,897,252 | ) | (1,332,273 | ) | (24,698,119 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchase of equipment |
(15,655 | ) | (29,247 | ) | (1,568,560 | ) | ||||||
Proceeds from sale of assets |
| 6,580 | 366,830 | |||||||||
Cash paid in conjunction with sales of assets |
| | (86,332 | ) | ||||||||
Cash paid for intangible asset |
| | (100,000 | ) | ||||||||
Cash received in acquisition of SpineMedica Corp. |
| | 1,957,405 | |||||||||
Cash paid for acquisition costs of SpineMedica Corp. |
| | (227,901 | ) | ||||||||
Payments from (advances to) related party |
| | (2,008,522 | ) | ||||||||
Net cash flows from investing activities |
(15,655 | ) | (22,667 | ) | (1,667,080 | ) | ||||||
Cash flows from financing activities: |
||||||||||||
Proceeds from convertible debt offering |
| | 3,472,000 | |||||||||
Proceeds from convertible promissory note |
| | 500,000 | |||||||||
Repayment of convertible promissory note |
| | (500,000 | ) | ||||||||
Proceeds from Series A preferred stock |
| | 14,016,000 | |||||||||
Proceeds from Series C preferred stock |
| | 3,855,000 | |||||||||
Proceeds from sale of common stock and
warrants and common stock with registration rights |
785,000 | 525,000 | 7,602,507 | |||||||||
Proceeds from exercise of stock options |
101,875 | | 104,043 | |||||||||
Offering costs paid in connection with convertible debt offering |
| | (138,040 | ) | ||||||||
Offering costs paid in connection with Series A preferred
stock offering |
| | (918,806 | ) | ||||||||
Net cash flows from financing activities |
886,875 | 525,000 | 27,992,704 | |||||||||
Net change in cash |
(1,026,032 | ) | (829,940 | ) | 1,627,505 | |||||||
Cash, beginning of period |
2,653,537 | 864,768 | | |||||||||
Cash, end of period |
$ | 1,627,505 | $ | 34,828 | $ | 1,627,505 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Cash paid for interest |
$ | | $ | | $ | | ||||||
Cash paid for income taxes |
$ | | $ | | $ | | ||||||
4
Deficit | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Convertible | Convertible | Convertible | Accumulated | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Preferred Stock | Preferred Stock | Preferred Stock | Additional | Stock | Note | During the | ||||||||||||||||||||||||||||||||||||||||||||||||||
Series A | Series B | Series C | Common Stock | Paid-in | Treasury | Subscriptions | Receivable, | Development | ||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Stock | Receivable | Related party | Stage | Total | |||||||||||||||||||||||||||||||||||||||||||
Balances, November 22, 2006 |
| $ | | | $ | | | $ | | | $ | | $ | | | $ | | $ | | $ | | $ | | |||||||||||||||||||||||||||||||||
Issuance of common stock at inception |
| | | | | | 12,880,000 | 12,880 | | | | | (11,592 | ) | 1,288 | |||||||||||||||||||||||||||||||||||||||||
Employee share-based compensation
expense |
| | | | | | | | 13,409 | | | | | 13,409 | ||||||||||||||||||||||||||||||||||||||||||
Other share-based compensation expense |
| | | | | | | | 17,980 | | | | | 17,980 | ||||||||||||||||||||||||||||||||||||||||||
Common stock issued in connection
with purchase of license agreement |
| | | | | | 1,120,000 | 1,120 | 894,880 | | | | | 896,000 | ||||||||||||||||||||||||||||||||||||||||||
Issuance of note receivable, related
party |
| | | | | | | | | | | (2,000,000 | ) | | (2,000,000 | ) | ||||||||||||||||||||||||||||||||||||||||
Sale of Series A Preferred stock |
11,212,800 | 14,016,000 | | | | | | | (918,806 | ) | | (1,233,750 | ) | | | 11,863,444 | ||||||||||||||||||||||||||||||||||||||||
Accrued interest income |
| | | | | | | | | | | (7,644 | ) | | (7,644 | ) | ||||||||||||||||||||||||||||||||||||||||
Net loss for the period |
| | | | | | | | | | | | (650,777 | ) | (650,777 | ) | ||||||||||||||||||||||||||||||||||||||||
Balances, March 31, 2007 |
11,212,800 | 14,016,000 | | | | | 14,000,000 | 14,000 | 7,463 | | (1,233,750 | ) | (2,007,644 | ) | (662,369 | ) | 10,133,700 | |||||||||||||||||||||||||||||||||||||||
Employee share-based compensation
expense |
| | | | | | | | 649,783 | | | | | 649,783 | ||||||||||||||||||||||||||||||||||||||||||
Other share-based compensation
expense |
| | | | | | | | 158,247 | | | | | 158,247 | ||||||||||||||||||||||||||||||||||||||||||
Collection of stock subscription
receivable |
| | | | | | | | | | 1,233,750 | | | 1,233,750 | ||||||||||||||||||||||||||||||||||||||||||
Accrued interest income |
| | | | | | | | | | | (41,250 | ) | | (41,250 | ) | ||||||||||||||||||||||||||||||||||||||||
SpineMedica Corp. acquisition |
| | 5,922,397 | 7,402,996 | 2,911,117 | 2,911 | 2,316,908 | | | 2,048,894 | 11,771,709 | |||||||||||||||||||||||||||||||||||||||||||||
Sale of Series C Preferred stock |
| | | | 1,285,001 | 3,855,000 | | | | | | | | 3,855,000 | ||||||||||||||||||||||||||||||||||||||||||
Stock options issued in connection
with purchase of intellectual property |
| | | | | | | | 116,000 | | | | | 116,000 | ||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options |
| | | | | | 1,200 | 1 | 2,159 | | | | | 2,160 | ||||||||||||||||||||||||||||||||||||||||||
Alynx Merger Recapitalization |
7,207,398 | 11,257,996 | (5,922,397 | ) | (7,402,996 | ) | (1,285,001 | ) | (3,855,000 | ) | 926,168 | 926 | (926 | ) | | | | | | |||||||||||||||||||||||||||||||||||||
Alynx Merger Transaction Costs (expensed) |
| | | | | | 205,851 | 206 | 1,126,173 | | | | | 1,126,379 | ||||||||||||||||||||||||||||||||||||||||||
Conversion of Preferred stock |
(18,420,198 | ) | (25,273,996 | ) | | | 18,420,198 | 18,420 | 25,255,576 | | | | | | ||||||||||||||||||||||||||||||||||||||||||
Common stock issued in connection
with purchase of license agreement |
| | | | | | 400,000 | 400 | 2,595,600 | | | | | 2,596,000 | ||||||||||||||||||||||||||||||||||||||||||
Net loss for the period |
| | | | | | | | | | | | (17,371,475 | ) | (17,371,475 | ) | ||||||||||||||||||||||||||||||||||||||||
Balances, March 31, 2008 |
| | | | | | 36,864,534 | 36,864 | 32,226,983 | | | | (18,033,844 | ) | 14,230,003 |
5
Deficit | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Convertible | Convertible | Convertible | Accumulated | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Preferred Stock | Preferred Stock | Preferred Stock | Additional | Stock | Note | During the | ||||||||||||||||||||||||||||||||||||||||||||||||||
Series A | Series B | Series C | Common Stock | Paid-in | Treasury | Subscriptions | Receivable, | Development | ||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Stock | Receivable | Related party | Stage | Total | |||||||||||||||||||||||||||||||||||||||||||
Balances, March 31, 2008 |
| | | | | | 36,864,534 | 36,864 | 32,226,983 | | | | (18,033,844 | ) | 14,230,003 | |||||||||||||||||||||||||||||||||||||||||
Employee share-based compensation
expense |
| | | | | | | | 945,062 | | | | | 945,062 | ||||||||||||||||||||||||||||||||||||||||||
Other share-based compensation
expense |
| | | | | | | | 130,076 | | | | | 130,076 | ||||||||||||||||||||||||||||||||||||||||||
Cashless exercise of stock warrants |
| | | | | | 417,594 | 418 | (418 | ) | | | | | ||||||||||||||||||||||||||||||||||||||||||
Sale of warrants in connection with private
placement of redeemable commoon stock |
| | | | | | | | 595,073 | | | | | 595,073 | ||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options |
| | | | | | 57,500 | 58 | (52 | ) | | | | | 6 | |||||||||||||||||||||||||||||||||||||||||
Accretion of redeemable common stock and
common stock with registration rights to
fair value |
| | | | | | | | | | | | (2,158,823 | ) | (2,158,823 | ) | ||||||||||||||||||||||||||||||||||||||||
Warrants issued in connection with
the amendment
of private placement of common stock |
| | | | | | | | 334,100 | | | | | 334,100 | ||||||||||||||||||||||||||||||||||||||||||
Net loss for the period |
| | | | | | | | | | | | (11,919,271 | ) | (11,919,271 | ) | ||||||||||||||||||||||||||||||||||||||||
Balances, March 31, 2009 |
| | | | | | 37,339,628 | 37,340 | 34,230,824 | | | | (32,111,938 | ) | 2,156,226 | |||||||||||||||||||||||||||||||||||||||||
Employee share-based compensation
expense |
| | | | | | | | 363,457 | | | | | 363,457 | ||||||||||||||||||||||||||||||||||||||||||
Other share-based compensation
expense |
| | | | | | | | 117,689 | | | | | 117,689 | ||||||||||||||||||||||||||||||||||||||||||
Beneficial conversion feature recognized
on convertible debt |
| | | | | | | | 676,500 | | | | | 676,500 | ||||||||||||||||||||||||||||||||||||||||||
Warrants issued to placement agents in
conjunction with convertible debt |
| | | | | | | | 98,574 | | | | | 98,574 | ||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options |
| | | | | | 20,000 | 20 | (18 | ) | | | | | 2 | |||||||||||||||||||||||||||||||||||||||||
Common stock issued for waivers
of registration rights |
| | | | | | 2,490,000 | 2,490 | 1,302,610 | | | | | 1,305,100 | ||||||||||||||||||||||||||||||||||||||||||
Reclassification of common stock with
registration rights |
| | | | | | 1,905,000 | 1,905 | 3,759,345 | | | | | 3,761,250 | ||||||||||||||||||||||||||||||||||||||||||
Common stock issued for accrued directors
fees |
| | | | | | 162,750 | 163 | 81,212 | | | | | 81,375 | ||||||||||||||||||||||||||||||||||||||||||
Common stock issued for accrued executive
compensation |
| | | | | | 187,644 | 187 | 93,635 | | | | | 93,822 | ||||||||||||||||||||||||||||||||||||||||||
Common Stock issued in connection with
purchase of license agreement |
| | | | | | 100,000 | 100 | 70,900 | | | | | 71,000 | ||||||||||||||||||||||||||||||||||||||||||
Sale of common stock and warrants
(net of $42,000 of offering costs) |
| | | | | | 7,697,865 | 7,698 | 4,569,021 | | | | | 4,576,719 | ||||||||||||||||||||||||||||||||||||||||||
Common stock issued for services in
conjunction with private placement |
| | | | | | 100,000 | 100 | 41,900 | | | | | 42,000 | ||||||||||||||||||||||||||||||||||||||||||
Warrants issued in conjunction with
convertible promissory note |
| | | | | | | | 975,833 | | | | | 975,833 | ||||||||||||||||||||||||||||||||||||||||||
Modification of stock options and
purchase of treasury stock |
| | | | | | | | 73,000 | (25,000 | ) | | | | 48,000 | |||||||||||||||||||||||||||||||||||||||||
Net loss for the period |
| | | | | | | | | | | | (8,295,669 | ) | (8,295,669 | ) | ||||||||||||||||||||||||||||||||||||||||
Balances, December 31, 2009 |
| $ | | | $ | | | $ | | 50,002,887 | $ | 50,003 | $ | 46,454,482 | $ | (25,000 | ) | $ | | $ | | $ | (40,407,607 | ) | $ | 6,071,878 |
6
Deficit | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Convertible | Convertible | Convertible | Accumulated | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Preferred Stock | Preferred Stock | Preferred Stock | Additional | Stock | Note | During the | ||||||||||||||||||||||||||||||||||||||||||||||||||
Series A | Series B | Series C | Common Stock | Paid-in | Treasury | Subscriptions | Receivable, | Development | ||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Stock | Receivable | Related party | Stage | Total | |||||||||||||||||||||||||||||||||||||||||||
Balances, December 31, 2009 |
| $ | | | $ | | | $ | | 50,002,887 | $ | 50,003 | $ | 46,454,482 | $ | (25,000 | ) | $ | | $ | | $ | (40,407,607 | ) | $ | 6,071,878 | ||||||||||||||||||||||||||||||
Employee share-based compensation
expense (unaudited) |
| | | | | | | | 189,467 | | | | | 189,467 | ||||||||||||||||||||||||||||||||||||||||||
Other share-based compensation
expense (unaudited) |
| | | | | | | | 9,667 | | | | | 9,667 | ||||||||||||||||||||||||||||||||||||||||||
Sale of common stock and
warrants (unaudited) |
| | | | | | 1,308,332 | 1,308 | 783,692 | | | | | 785,000 | ||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options (unaudited) |
| | | | | | 103,750 | 104 | 101,771 | | | | | 101,875 | ||||||||||||||||||||||||||||||||||||||||||
Shares issued in conjunction with
conversion of convertible debt (unaudited) |
| | | | | | 7,135,114 | 7,135 | 3,385,683 | | | | | 3,392,818 | ||||||||||||||||||||||||||||||||||||||||||
Net loss for the peiod (unaudited) |
| | | | | | | | | | | | (3,142,085 | ) | (3,142,085 | ) | ||||||||||||||||||||||||||||||||||||||||
Balances, March 31, 2010 (unaudited) |
| $ | | | $ | | | $ | | 58,550,083 | $ | 58,550 | $ | 50,924,762 | $ | (25,000 | ) | $ | | $ | | $ | (43,549,692 | ) | $ | 7,408,620 | ||||||||||||||||||||||||||||||
7
1. | Basis of Presentation: |
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States (GAAP) for
interim financial information and with the instructions to Form 10-Q and Article 10 of
Regulations S-X. Accordingly, they do not include all of the information and footnotes
required by GAAP for complete financial statements. In the opinion of management, all
adjustments (consisting of normal recurring accruals) considered necessary for a fair
presentation of the results of operations for the periods presented have been included.
Operating results for the three months ended March 31, 2010 and 2009 are not necessarily
indicative of the results that may be expected for the fiscal year. The balance sheet at
December 31, 2009 has been derived from the audited consolidated financial statements at that
date, but does not include all of the information and footnotes required by GAAP for complete
financial statements. |
You should read these condensed consolidated financial statements together with the
historical consolidated financial statements of the Company for the period ended December 31,
2009 and year ended March 31, 2009, and the period from inception (November 22, 2006) through
December 31, 2009 included in our Annual Report on Form 10-K for the period ended December
31, 2009, filed with the Securities and Exchange Commission (SEC) on March 30, 2010. |
On March 31, 2008, MiMedx Group, Inc., a Florida Corporation, and Alynx merged. As a result
of this transaction, MiMedx Group, Inc. became the surviving corporation. The Company
refers to MiMedx Group, Inc., a development stage company, as well as its two operating
subsidiaries: MiMedx, Inc. and SpineMedica, LLC. |
MiMedx acquired a license for the use, adoption and development of certain core technologies
developed at the Shriners Hospital for Children and the University of South Florida Research
Foundation. This technology focuses on biomaterials for soft tissue repair, such as tendons,
ligaments and cartilage, as well as other biomaterial-based products for numerous other
medical applications. The development of the licensed technologies requires continued
research and development and, ultimately, the approval of the U.S. Food and Drug
Administration (FDA) and/or foreign regulatory authorities in order for the Company to be
able to generate revenues from the sale of its products. This process is expected to take at
least six months to one year, and there can be no assurance that the Company will be
successful in its efforts to commercialize the licensed technology. |
On July 23, 2007, MiMedx, Inc. acquired SpineMedica Corp. through its wholly-owned
subsidiary, SpineMedica, LLC (SpineMedica). SpineMedica Corp. was incorporated in the
State of Florida on June 9, 2005 and its successor SpineMedica, LLC was incorporated in the
State of Florida on June 27, 2007. SpineMedica has licensed the right to use Salubria®, or
similar poly-vinyl alcohol (PVA) -based biomaterials for certain applications within the
body. SpineMedica also owns certain assets (equipment) for the production of products based
on a PVA-based hydrogel, which is a water-based biomaterial that can be manufactured with a
wide range of mechanical properties, including those that appear to closely mimic the
mechanical and physical properties of natural, healthy human tissue. |
8
The Company operates in one business segment, Biomaterials, which includes the design,
manufacture, and marketing of products for the Orthopedics and Spine market categories. The
CollaFix products are assembled from a strong, collagen-fiber based technology that
potentially
could be used to augment the repair of soft-tissue and connective tissue injuries. The
products are constructed of a durable hydrogel, the first of which is the HydroFix Vaso
Shield indicated as a cover for vessels following anterior vertebral surgery. The company
completed the development of the HydroFix Vaso Shield surgical sheet products with a FDA
510(k) marketing clearance, received on April 20, 2009 and completed the sale of its first
commercial product in December 2009. On March 1, 2010 the Company announced that it had
received the CE Mark for its HydroFix Spine Shield device and was certified for design,
development and production of post-surgical adhesion inhibiting barriers. The company is
investigating expansion of this product line to other areas of the body in and outside the
orthopedic and spine category. |
The Company is a development stage enterprise and will remain as such until significant
revenues are generated, if ever. |
2. | Significant accounting policies: |
Net loss per share |
Basic net loss per common share is computed using the weighted-average number of common
shares outstanding during the period. Diluted net loss per common share is typically
computed using the weighted-average number of common and dilutive common equivalent shares
from stock options, warrants and convertible debt using the treasury stock method. |
For all periods presented, diluted net loss per share is the same as basic net loss per
share, as the inclusion of equivalent shares from outstanding common stock options, warrants
and convertible debt would be anti-dilutive. |
The following table sets forth the computation of basic and diluted net loss per share: |
Three Months Ended | ||||||||
March 31, | ||||||||
2010 | 2009 | |||||||
Net loss |
$ | (3,142,085 | ) | $ | (2,871,984 | ) | ||
Denominator for basic earnings per
share-weighted average shares |
51,227,540 | 38,549,350 | ||||||
Effect of dilutive securities: Stock
options and warrants outstanding
(a) |
| | ||||||
Denominator for diluted earnings per
shareweighted average shares adjusted
for dilutive securities |
51,227,540 | 38,549,350 | ||||||
Loss per common sharebasic and diluted |
$ | (.06 | ) | $ | (.07 | ) | ||
(a) | Securities outstanding that were excluded from the computation, prior to
the use of the treasury stock method, because they would have been
anti-dilutive are as follows: |
Three Months Ended | ||||||||
March 31, | ||||||||
2010 | 2009 | |||||||
Stock options, warrants, and convertible debt |
14,952,184 | 5,461,501 |
9
Recently issued accounting pronouncements: |
In February 2010, the FASB issued authoritative guidance that amends the disclosure
requirements related to subsequent events. This guidance includes the definition of a
Securities and Exchange Commission filer, removes the definition of a public entity,
redefines the reissuance disclosure requirements and allows companies to omit the disclosure
of the date through which subsequent events have been evaluated. This guidance is effective
for financial statements issued for interim and annual periods ending after February 2010.
This guidance did not materially impact the Companys results of operations or financial
position, but did require changes to the Companys disclosures in its financial statements. |
In October 2009, the FASB issued Accounting Standards Update No. 2009-13 (ASU 2009-13),
which addresses the accounting for multiple-deliverable arrangements to enable vendors to
account for products or services (deliverables) separately rather than as a combined unit.
ASU 2009-13 is effective prospectively for revenue arrangements entered into or materially
modified beginning in fiscal years on or after June 15, 2010. Early adoption is permitted.
The Company does not expect the adoption of this standard to have any effect on its financial
statements until or unless it enters into agreements covered by this standard. |
3. | Liquidity and managements plans: |
The accompanying financial statements have been prepared assuming the Company will continue
as a going concern. For the period from inception (November 22, 2006) through March 31, 2010
the Company experienced net losses of $41,379,277 (unaudited) and cash used in operations of
$24,698,119 (unaudited). As of March 31, 2010, the Company has not emerged from the
development stage. In April 2010 the company offered investors in our October 2009 private
placement a discount if they exercised their warrants for common stock by May 1, 2010. This
offer has resulted in raising in excess of $3.2 million net of placement fees as of May 1,
2010. The aggregate proceeds include $.8 million in common stock sold to the Chairman and
CEO, President and Chief Operating Officer one other company director. As the company
transitions from a development stage company to an operating company, the ability of the
Company to continue as a going concern is dependent upon the Companys ability to meet its
revenue growth projections and obtain funding through government grants or other funding
sources sufficient to support its research and development activities, approval of developed
products for sale by regulatory authorities, including the FDA, and its investments in
working capital. If the company does not achieve its revenue targets it may have to raise
additional funds through equity or debt financing within the next 9 months. Since inception,
the Company has financed its activities principally from the sale of equity securities and
convertible debt. While the Company has been successful in the past in obtaining the
necessary capital to support its operations, there is no assurance that the Company will be
able to obtain government grants or additional equity capital or other financing under
commercially reasonable terms and conditions, or at all. Furthermore, if the Company issues
equity or debt securities to raise additional funds, existing shareholders may experience
dilution and the new equity or debt securities it issues may have rights, preferences and
privileges senior to those of existing shareholders. In addition, if the Company raises
additional funds through collaboration, licensing or other similar arrangements, it may be
necessary to relinquish valuable rights to products or proprietary technologies, or grant
licenses on terms that are not favorable. If the Company does not achieve its revenue
projections, secure government funding or cannot raise funds on acceptable
terms, the Company will not be able to continue as a going concern, develop or enhance
products, obtain the required regulatory clearances or approvals, execute the Companys
business plan, take advantage of future opportunities, or respond to competitive pressure or
unanticipated customer requirements. Any of these events would adversely affect the Companys
ability to achieve the Companys development and commercialization goals, which could have a
material adverse effect on the Companys business, results of operations and financial
condition. The Companys financial statements do not include any adjustments relating to the
recoverability or classification of assets or the amounts of liabilities that might result
from the outcome of these uncertainties. |
10
4. | Intangible assets and royalty agreement: |
Intangible assets activity is summarized as follows: |
License | License | License | ||||||||||||||
(a) | (b) | (c) | Total | |||||||||||||
January 1, 2010 |
$ | 707,166 | 1,677,460 | 2,212,700 | $ | 4,597,326 | ||||||||||
Additions |
| | | | ||||||||||||
Amortization |
(24,900 | ) | (74,004 | ) | (68,079 | ) | (166,983 | ) | ||||||||
March 31, 2010 |
682,266 | 1,603,456 | 2,271,500 | 4,430,343 | ||||||||||||
(a) | On January 29, 2007, the Company acquired a license from Shriners Hospitals for
Children and University of South Florida Research Foundation, Inc. The acquisition price
of this license was a one-time fee of $100,000 and 1,120,000 shares of common stock valued
at $896,000 (based upon the estimated fair value of the common stock on the transaction
date). Within thirty days after the receipt by the Company of approval by the FDA
allowing the sale of the first licensed product, the Company is required to pay an
additional $200,000 to the licensor. This amount is not recorded as a liability based on
its contingent nature. The Company will also be required to pay a royalty of 3% on all
commercial sales revenues of the licensed products. |
|
(b) | License from SaluMedica, LLC (SaluMedica) for the use of certain developed
technologies related to spine repair. This license was acquired through the acquisition
of SpineMedica Corp. |
|
(c) | On March 31, 2008, the Company entered into a license agreement for the use of
certain developed technologies related to surgical sheets made of polyvinyl alcohol
cryogel. The acquisition price of the asset was 400,000 shares of common stock valued at
$2,596,000 (based upon the closing price of the common stock on the transaction date). On
December 31, 2009 the Company completed the sale of its first commercial product and
issued an additional 100,000 shares of common stock to the licensor valued at $71,000.
The agreement also provides for the issuance of an additional 500,000 shares upon the
Company meeting additional milestones related to future sales. There are no amounts
accrued for this obligation due to its contingent nature. |
Expected future amortization of intangible assets is as follows: |
Year ending December 31, | ||||
2011 |
667,932 | |||
2012 |
667,932 | |||
2013 |
667,932 | |||
2014 |
667,932 | |||
2015 |
667,932 | |||
Thereafter |
1,090,683 | |||
$ | 4,430,343 | |||
11
5. | Convertible Debt: |
In April 2009, the Company commenced a private placement to sell 3% Convertible Senior
Secured Promissory Notes (the Notes) to accredited investors. The Company completed the
offering on June 17, 2009 and received aggregate proceeds of $3,472,000; also representing
the face value of the Notes. The aggregate proceeds include $250,000 of Notes sold to the
Chairman of the Board, President and CEO, and $150,000 of Notes sold to one other director. |
In total, the Notes were convertible into up to 6,944,000 shares of common stock at $.50 per
share (a) at any time upon the election of the holder of the note; (b) automatically
immediately prior to the closing of the sale of all or substantially all of the assets or
more than 50% of the equity securities of the Company by way of a merger transaction or
otherwise which would yield a price per share of not less than $.50; or (c) at the election
of the Company, at such time as the closing price per share of the Companys common stock (as
reported by the OTCBB or on any national securities exchange on which the Companys shares
may be listed, as the case may be) closes at not less than $1.50 for not less than twenty
(20) consecutive trading days in any period prior to the maturity date. If converted, the
Common Stock will be available to be sold following satisfaction of the applicable conditions
set forth in Rule 144. The Notes mature in 3 years and earn interest at 3% per annum on the
outstanding principal amount payable in cash on the maturity date or convertible into shares
of common stock of the Company as provided for above. The Notes were secured by a first
priority lien on all of the assets, including intellectual property, of MiMedx, Inc. The
Notes were junior in payment and lien priority to any bank debt of the Company in an amount
not to exceed $5,000,000 hereafter incurred by the Company. |
We evaluated the Notes for accounting purposes in accordance with Financial Accounting
Standards Board (FASB) Accounting Standards Codification (ASC) 815 Derivatives and Hedging
and have determined that the conversion feature meets the conventional-convertible exemption
and, accordingly, bifurcation and fair-value measurement of the conversion feature was not
required. We were required to re-evaluate this conclusion upon each financial statement
closing date while the Notes were outstanding. Notwithstanding, the Notes were issued with a
beneficial conversion feature, having an intrinsic value of approximately $676,500. The
intrinsic value of the beneficial conversion feature was determined in accordance with ASC
470 Debt with Conversion and Other Options by comparing the contracted conversion price to
the fair value of the common stock on the date of the respective Notes. A beneficial
conversion feature only exists when the embedded conversion feature is in-the-money at the
commitment date. |
As a result of the beneficial conversion feature, the Notes were recorded net of a discount
of $676,500 related to the beneficial conversion feature, which was recorded in paid-in
capital, and the discount has been amortized through periodic charges to interest expense
over the term of the Notes using the effective interest method. |
In conjunction with the offering the Company was obligated to pay a placement fee of $138,040
of which $127,540 was paid prior to June 30, 2009. In addition the Company issued warrants
to the placement agents totaling 315,520 at an exercise price of $.50 per share. The fair
value of the warrants was determined to be $98,574 using the Black-Scholes-Merton valuation
technique. The total direct costs of $236,614 are recorded as deferred financing costs and
were being amortized over the term of the Notes using the effective interest method. Further,
the placement agent warrants are classified in stockholders equity because they achieved all
of the requisite conditions for equity classification in accordance with ASC 815 Derivatives
and Hedging. |
12
On March 31, 2010 the Company elected to exercise its right to convert into common stock of
the Company at a conversion price of $0.50 per share the outstanding Note Payable amount
including accrued interest of $3,532,361 resulting in the issuance of 7,064,721 shares of
common stock. This
decision was made based upon the Trading Value Conversion event per the terms of the note
whereby as of March 30, 2010 the trading price of the Common Stock closed at not less than
$1.50 per share for not less than twenty (20) consecutive trading days prior to the Maturity
Date. Prior to this event certain individuals had voluntarily elected to convert their note
into Common Stock resulting in the issuance of 70,393 shares of Common Stock. As a result of
the Companys election to convert the remaining Notes, the Company was required to
immediately recognize the remaining unamortized discount of $499,610 related to the
beneficial conversion feature as interest expense in the statement of operations for the
three months ended March 31, 2010. Additionally, the $174,739 in unamortized deferred
financing costs were charged against additional paid in capital. |
6. | Sale of Common Stock: |
October 2009 Private Placement |
In October 2009, the Company commenced a private placement to sell common stock and warrants.
From October 30, 2009, through December 31, 2009, the Company sold 7,697,865 shares of
common stock at a price of $.60 per share and received proceeds of $4,618,720. Under the
terms of the offering, for every two shares of common stock purchased, the investor received
a 5-year warrant to purchase one share of common stock for $1.50 (a Warrant). Through
December 31, 2009, the Company issued a total of 3,848,933 warrants. The warrants met all
the requirements for equity classification under GAAP and are recorded in stockholders
equity. |
From January 1, 2010, through January 21, 2010, the Company sold an additional 1,308,332
shares of common stock and issued an additional 654,163 warrants and received proceeds of
$785,000. |
The Company closed the offering on January 21, 2010. |
In connection with the October 2009 Private Placement, the Company entered into a
registration rights agreement which provides Piggy-Back registration rights to each
investor. |
7. | Stock Options and Warrants |
Stock Options: |
Activity with respect to the stock options is summarized as follows: |
Weighted-average | Intrinsic | |||||||||||
Shares | Exercise Prices | Value | ||||||||||
Options outstanding at January 1,
2010 |
6,182,500 | $ | 1.10 | $ | 307,535 | |||||||
Granted |
1,290,400 | 1.56 | ||||||||||
Forfeited/Cancelled |
(62,500 | ) | .50 | |||||||||
Exercised |
(103,750 | ) | .98 | |||||||||
Options outstanding at March 31, 2010 |
7,306,650 | 1.18 | $ | 2,988,000 | ||||||||
Options exercisable at March 31, 2010 |
3,770,000 | 1.33 | $ | 1,273,000 | ||||||||
13
Options Outstanding | Options Exercisable | |||||||||||||||||||
Weighted- | ||||||||||||||||||||
Range of | Average | Weighted- | Weighted- | |||||||||||||||||
Exercise | Number | Remaining | Average | Number | Average | |||||||||||||||
Prices | Outstanding | Contractual Life | Exercise Price | Exercisable | Exercise Price | |||||||||||||||
$.0001 .50 |
1,017,500 | 4.5 (years | ) | $ | .49 | 288,750 | $ | .46 | ||||||||||||
.65 1.00 |
3,442,500 | 7.1 | .80 | 1,885,000 | .87 | |||||||||||||||
1.47 1.80 |
2,096,650 | 5.8 | 1.72 | 953,750 | 1.80 | |||||||||||||||
2.40 |
750,000 | 2.5 | 2.40 | 642,500 | 2.40 | |||||||||||||||
7,306,650 | 5.73 | 1.18 | 3,770,000 | 1.33 | ||||||||||||||||
Weighted | ||||||||
Average | ||||||||
Grant Date | ||||||||
Unvested Stock Options | Shares | Fair Value | ||||||
Unvested at January 1, 2010 |
2,520,418 | .50 | ||||||
Granted |
1,290,400 | 1.43 | ||||||
Cancelled/Expired |
(62,500 | ) | .40 | |||||
Vested |
(211,668 | ) | .47 | |||||
Unvested at March 31,2010 |
3,536,650 | .84 | ||||||
14
Three Months Ended | Three Months Ended | |||
March 31, 2010 | March 31, 2009 | |||
Dividend yield |
0% | 0% | ||
Expected volatility |
136.06 to 144.32% | 68.85 - 76.90% | ||
Risk free interest rates |
2.28 to 2.44% | 1.84 -1.89 % | ||
Expected lives |
6 years | 5.75 6 years |
Weighted Average | ||||||||
Exercise | ||||||||
Number | Price per Share | |||||||
Warrants outstanding at January 1, 2010 |
6,991,371 | $ | 1.14 | |||||
Issued in connection with private placement
of common stock |
654,163 | 1.50 | ||||||
Warrants outstanding at March 31, 2010 |
7,645,534 | $ | 1.17 | |||||
| notice given by the holder accompanied by payment of an amount equal to the warrant
exercise price multiplied by the number of warrant shares being purchased; or |
| election by the holder to exchange the warrant (or portion thereof) for that number
of shares equal to the product of (a) the number of shares issuable upon exercise of the
warrant (or portion) and (b) a fraction, (x) the numerator of which is the market price
of the shares at the time of exercise minus the warrant exercise price per share at the
time of exercise and (y) the denominator of which is the market price per share at the
time of exercise. |
15
8. | Income taxes: |
9. | Contractual Commitments: |
Payments due by period | ||||||||||||||||
Less than | ||||||||||||||||
Contractual Obligations | Total | 1 year | 2 3 years | 4 5 years | ||||||||||||
Operating Lease Obligations |
531,000 | 285,000 | 246,000 | | ||||||||||||
Minimum Royalties |
155,000 | 25,000 | 80,000 | 50,000 | ||||||||||||
Employment Agreements |
43,750 | 43,750 | | | ||||||||||||
Total |
$ | 729,750 | $ | 353,750 | $ | 326,000 | $ | 50,000 | ||||||||
16
17
18
19
20
21
Exhibit Number | Reference | Description | ||||
31.1 | # | Certification of Chief Executive Officer
pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 |
||||
31.2 | # | Certification of Chief Financial Officer
pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 |
||||
32.1 | # | Certification of Chief Executive Officer
pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
||||
32.2 | # | Certification of Chief Financial Officer
pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
# | Filed herewith |
22
MIMEDX GROUP, INC. | ||||||
Date: May 13, 2010
|
By: | /s/ Michael J. Senken
|
||||
Chief Financial Officer |
23