Business Combination Disclosure [Text Block] | 3. Acquisition of BioD, LLC On August 5, 2016, the Company through a wholly owned subsidiary, acquired all of the membership interests in BioD, LLC (“BioD”) pursuant to the terms of the Agreement and Plan of Merger (the “Merger Agreement”) dated July 27, 2016. Initial consideration of $ 23,094,987 13,897,112 1,751,183 9,197,875 56,761,691 3,107,535 BioD is a vertically integrated company engaged in the development and commercialization of products derived from human placental tissues sold to surgeons, facilities and distributors serving the surgical, spine, orthopaedic, ocular and urological sectors of the healthcare marketplace. The Company has distributed certain of BioD’s products for dermal application in North America since January 2014 under a license, market development and commercialization agreement. This acquisition complemented the Company’s growth strategy aimed at expanding its portfolio of advanced wound care solutions and tissue regenerative technologies and enables the Company to sell directly into additional sectors of the healthcare marketplace. Assets acquired Accounts receivable $ 4,266,588 Inventory 979,713 Notes receivable 597,334 Prepaid expenses and other assets 158,198 Equipment and improvements 932,940 Acquired identifiable intangible assets 19,000,000 Goodwill 55,812,447 Total assets acquired 81,747,220 Current liabilities assumed Line of credit 1,420,254 Accounts payable 702,887 Accrued liabilities 1,917,525 Total liabilities assumed 4,040,666 Net assets acquired $ 77,706,554 Detail of total consideration Initial cash consideration (1) $ 13,897,112 Initial common stock consideration (1) 9,197,875 Settlement of pre-existing relationship (2) 903,408 Less BioD cash acquired (373,374) Net initial consideration 23,625,021 Contingent consideration (3) 54,081,533 Total consideration $ 77,706,554 (1) Initial consideration includes $ 2,000,000 1,178,846 440,054 (2) Reflects settlement of pre-existing relationship between the Company and BioD. (3) Includes the estimated fair value of potential product regulatory milestone payments in the aggregate estimated amount of up to $ 29,699,691 26,500,000 2,863,948 562,000 The following represents preliminary details of the fair value of acquired identifiable intangible assets purchased as part of the acquisition: Description Estimated Customer relationships 5 $ 10,000,000 Developed technology 10 6,000,000 Trade names 10 2,000,000 Non-compete agreements 3 1,000,000 Total acquired identifiable intangible assets $ 19,000,000 Determination of this preliminary allocation of the purchase price required management of the Company to make estimates and assumptions. The Company has engaged an independent valuation specialist to conduct an analysis to assist management in determining the estimated fair value of the acquired tangible and intangible assets, liabilities assumed, pre-existing relationships and contingent consideration. The work performed by the independent valuation specialist, while not complete, has been considered in management’s estimate of the fair values reflected above. The final purchase price allocation to reflect the fair values of the assets acquired and liabilities assumed will be based on completion of the Company’s valuation study, which is expected to be completed in the fourth quarter 2016. Finalization of the valuation analysis may result in fair values that differ materially from the preliminary estimates. The excess of the purchase price over the identifiable intangible and net tangible assets was allocated to goodwill. Goodwill recognized was primarily attributable to assets that do not qualify for separate recognition. The purchase price allocation is preliminary, pending the final determination of the fair value of certain assumed assets and liabilities, pre-existing relationships and contingent consideration. As these issues are identified, modified or resolved, resulting increases or decreases to the preliminary values are offset by a change to goodwill. Adjustments to these estimates will be included in the final allocation of the purchase price. All of the assets acquired, including goodwill, and liabilities assumed are included in the Advanced Wound Care Segment. Goodwill and identifiable intangible assets resulting from the acquisition are deductible for income tax purposes. Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 (Unaudited) (Unaudited) Net sales $ 23,776,960 $ 22,131,402 $ 69,048,342 $ 63,074,631 Net loss from continuing operations $ (1,982,531) $ (4,653,899) $ (2,507,632) $ (17,044,443) Net loss from continuing operations per common share: basic and diluted $ (0.07) $ (0.17) $ (0.09) $ (0.63) Weighted average number of shares: basic and diluted 27,826,807 27,327,813 27,554,311 27,228,578 The nine months ended September 30, 2016 supplemental pro forma earnings were adjusted to exclude $ 2,892,713 1,866,667 2,400,000 1,751,183 229,919 The Company recorded net sales of $ 3,985,643 3,641,513 2,892,713 370,000 Untitled Letter On June 22, 2015, the U.S. Food and Drug Administration (“FDA”) issued an Untitled Letter alleging that BioD’s morselized amniotic membrane based products do not meet the criteria for regulation as human cellular tissue-based products (“HCT/Ps”) solely under Section 361 of the Public Health Service Act and that, as a result, BioD would need a biologics license to lawfully market those morselized products. Since the issuance of the Untitled Letter, BioD and more recently the Company have been in discussions with the FDA to communicate their disagreement with the FDA’s assertion that certain products are more than minimally manipulated. To date, the FDA has not changed its position that certain of the BioD acquired products are not eligible for marketing solely under Section 361 of the Public Health Service Act, but discussions are continuing. The Company continues to market these products but has also submitted a Request for Designation to determine if one of the morselized products should be regulated as a medical device or a biologic through the Biologics License Application (“BLA”) process. The Company also intends to pursue a BLA for another of the morselized products. On December 22, 2014, the FDA issued for comment “Draft Guidance for Industry and FDA Staff: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products.” On October 28, 2015, the FDA issued for comment, "Draft Guidance for Industry and FDA Staff: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products." The FDA held a public hearing on September 12 and 13, 2016 to obtain input on the Homologous Use draft guidance and the Minimal Manipulation draft guidance, as well as other recently issued guidance documents on HCT/Ps. If the FDA does allow the Company to continue to market its morselized products without a 510(k) clearance or biologics license either prior to or after finalization of the draft guidance documents, it may impose conditions on marketing, such as labeling restrictions and compliance with cGMP. Compliance with these conditions would require significant additional time and cost investments by the Company. It is also possible that the FDA will not allow the Company to market any form of a morselized product without a 510(k) clearance or biologics license even prior to finalization of the draft guidance documents, and could even require the Company to recall its morselized products. Net sales of the Company’s morselized products for the nine months ended September 30, 2016 and 2015 were approximately 13 12 In accordance with the Merger Agreement, BioD’s former members are entitled to receive additional consideration payable in cash and Company common stock of up to 35 29,699,691 i) specific FDA enforcement action is not received by the Company by May 5, 2017; or ii) specific FDA enforcement action is received by the Company prior to May 5, 2017 which does not require the Company to remove the morselized products from the market within 270 days of receipt of the FDA enforcement action; or iii) the Company is allowed to continue to market the morselized products while it fulfills FDA imposed requirements which were received prior to May 5, 2017 in lieu of the FDA exercising its enforcement discretion. In January 2014, the Company entered into a license, market development and commercialization agreement with BioD which granted to the Company an exclusive, perpetual, royalty-bearing license to use and sell BioD’s human placental based products for dermal applications. Royalties were payable to BioD under the agreement based upon a low double digit percentage of net sales. During 2016 the Company incurred royalties of $ 211,429 199,395 |