SEC Company Response from Nuo Therapeutics, Inc. (AURX) (CIK 0001091596) (AURX) — Aug 14, 2012
Nuo Therapeutics, Inc. (AURX) (CIK 0001091596)
Date: Aug. 14, 2012 · CIK: 0001091596 · Accession: 0001144204-12-046013
AI Filing Summary & Sentiment
File numbers found in text: 001-32518
Referenced dates: August 7, 2012
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209 Perry Parkway,Suite 7 Gaithersburg, MD 20877 2143
Ph: (240) 499-2680 Fax: (240) 499-2690
www.cytomedix.com
August 14, 2012
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Mr. Brian Cascio – Accounting Branch Chief
Re:
Cytomedix, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2011
Filed March 29, 2012
Form 10-Q for the Quarterly Period Ended March 31, 2012
Filed May 15, 2012
Form 8-K/A dated February 8, 2012
Filed March 29, 2012
File No. 001-32518
Dear Mr. Cascio:
The
following responses address the comments by the staff of the Division of Corporation Finance (the “Staff”) of the Securities
and Exchange Commission (the “SEC”) as set forth in a comment letter dated August 7, 2012 (the “Comment Letter”)
relating to the above-referenced filings of Cytomedix, Inc. (the “Company”). The answers set forth herein refer to
each of the Staff’s comments by number. This letter sets forth the Company’s proposed disclosures and responses
to the Comment Letter, or why the Company believes that no changes to its disclosures are necessary. For your convenience, we have
restated the comments from the Comment Letter below, followed by the Company’s responses. In addition, the Company is filing
its Quarterly Report on Form 10-Q for the period ended June 30, 2012 and Form 8-K/A (Amendment No. 2) to include certain additional
disclosures responsive to the comments below.
Comment 1. Please revise
future filings to include the following disclosures for the acquisition of Aldagen, Inc., as required by FASB ASC 805.
- The
primary reasons for the business combination and a description of how the acquirer obtained control of the acquire;
- A
qualitative description of the factors that make up the goodwill recognized, such as expected synergies from combining operations
of the acquiree and the acquirer, intangible assets that do not qualify for separate recognition, or other factors;
- The
method of determining the fair value of equity instruments issued as consideration, including the replacement warrants;
- A
description of the contingent consideration arrangement and the basis for determining the amount of the payment;
- Significant
assumptions related to the valuation of contingent consideration;
209 Perry Parkway,Suite 7 Gaithersburg, MD 20877 2143
Ph: (240) 499-2680 Fax: (240) 499-2690
www.cytomedix.com
- An
estimate of the range of outcomes for the contingent consideration (undiscounted) or, if a range cannot be estimated, that fact
and the reasons why a range cannot be estimated. If the maximum amount of the payment is unlimited, you should disclose that fact.
Response: The
Company has revised its Quarterly Report on Form 10-Q for the second quarter ended June 30, 2012 and will continue such disclosures
in its future filings to include the additional disclosures required by ASC 805 as set forth in the comment above. The following
additional disclosures were added to Note 3 to the condensed consolidated financial statements contained in our period report on
Form 10-Q for the quarter ended June 30, 2012:
1. Cytomedix
develops, sells, and licenses regenerative biological therapies intended to aid the human body in regenerating/healing itself,
to primarily address the areas of wound care, infection control, and orthopedic surgery. On February 8, 2012, the Company acquired
control of Aldagen, Inc. (“Aldagen”) by purchasing all of Aldagen’s issued and outstanding capital stock and
convertible promissory notes. The acquisition of Aldagen allows the Company to expand its approach to developing regenerative biological
therapies, by using Aldagen’s proprietary ALDH bright cell ("ALDHbr") technology.
2. As
the Series E Preferred Stock contains no liquidation preferences or special dividend rights, and is automatically converted into
common stock once sufficient common stock is authorized, the Company determined that its fair value is essentially the same as
the fair value of the underlying common stock into which it is exchangeable. Accordingly, the Company valued the Series E Preferred
Stock using the closing price of its common stock on the acquisition date.
Aldagen’s
former investors have the right to receive up to 20,309,723 shares of the Company’s common stock contingent upon the achievement
of certain milestones related to the current ALD-401 Phase II clinical trial. The total undiscounted value of the contingent consideration
assuming the successful completion of all specified milestones and using the Company’s stock price as of the acquisition
date is approximately $28.4 million. As of the acquisition date, the Company recorded $11.1 million in contingent consideration.
The Company determined the fair value of the contingent consideration with the assistance of a third party valuation expert; the
fair value was determined using a probability weighted cash flow approach, which includes unobservable inputs such as projected
achievement of certain technical milestones, the estimated dates of the achievement of the milestones, and discount rate.
The Company determined
the fair value of the Replacement Warrants using the Black-Scholes option pricing model. The Black-Scholes option pricing model
requires the use of unobservable inputs such as the expected term, anticipated volatility and expected dividends.
3. Identifiable
intangible assets associated with trademarks and trade names will be amortized on a straight-line basis over their estimated useful
lives of 20 years. Identifiable intangible assets associated with IPR&D are initially classified as indefinite lived; such
classification will be reassessed every reporting period based on the status of the research and development projects. Goodwill,
primarily related to expected clinical and commercial synergies gained from combining operations, sales growth from future product
offerings and customers, together with certain intangible assets that do not qualify for separate recognition, including assembled
workforce, is not tax deductible since the transaction was structured as a tax-free exchange, and is considered an indefinite lived
asset.
209 Perry Parkway,Suite 7 Gaithersburg, MD 20877 2143
Ph: (240) 499-2680 Fax: (240) 499-2690
www.cytomedix.com
Comment 2. We see that
a significant amount of purchase price was allocated to in process research and development (IPR&D). Please tell us how you
determined the fair value of the IPR&D. Similar disclosure should also be included within critical accounting policies in future
filings. Refer to FASB ASC 730-10-15-4 (f) and 805-20.
Response: The
Company determined the fair value of the acquired IPR&D with the assistance of a third party valuation expert. We considered
various approaches to determining fair value, including a Market Approach, an Asset Approach, and an Income Approach. In considering
the Income Approach, since a future income stream related to the IPR&D can be readily forecasted and the use of other tangible
and intangible assets in generating that future income stream can be reasonably quantified (through the application of a capital
charge for each asset), we determined that an excess earnings method could be utilized to arrive at an indication of value. Based
on our analysis concerning the IPR&D, we concluded that the Income Approach, using an excess earnings method, offered the most
reliable indication as to its Fair Value.
We will add the following
disclosure in our critical accounting policies:
Goodwill and Intangible Assets
Goodwill represents
the excess of the purchase price over the net tangible and intangible assets acquired in business combinations. The Company conducts
an impairment test of goodwill on an annual basis as of October 1 of each year. The Company will also conduct tests if events occur
or circumstances change that would, more likely than not, reduce the fair value of the Company below its carrying value.
Indefinite lived
intangible assets consist of in-process research and development (IPR&D) acquired in the acquisition of Aldagen. The acquired
IPR&D consists of specific cell populations (that are related to a specific indication) and the use of the cell populations
in treating particular medical conditions. The Company evaluates its indefinite-lived intangible assets for impairment whenever
events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable, and at least on an annual
basis on October 1 of each year, by comparing the fair value of the asset with its carrying amount. If the carrying amount of the
intangible asset exceeds its fair value, the Company would recognize an impairment loss in the amount of that excess.
Identifiable intangible
assets with finite lives consist of trademarks, technology (including patents), and customer relationships acquired in business
combinations. These intangibles are amortized using the straight-line method over their estimated useful lives. The Company reviews
its finite-lived intangible assets for potential impairment when circumstances indicate that the carrying amount of assets may
not be recoverable.
Comment 3. As a related
matter, please expand future filings to include disclosure about the nature of the IPR&D. This disclosure may be included in
critical accounting policies within MD&A. The revised disclosure should include the following, to the extent applicable:
- Nature
of projects acquired;
- Summary
of values assigned to IPR&D by technology/product;
- Status
of the development of the work at acquisition date and current date;
209 Perry Parkway,Suite 7 Gaithersburg, MD 20877 2143
Ph: (240) 499-2680 Fax: (240) 499-2690
www.cytomedix.com
- Nature
and timing of remaining efforts for completion, including estimated completion date;
- Value
and risks of the purchased R&D;
- How
periods subsequent to the acquisition have been affected by completion of the project and introduction of the technology.
Response:
The following additional
disclosures will be added to Note 10 to the condensed consolidated financial statements contained in our period report to the Company’s
Quarterly Report on Form 10-Q for the quarter ended June 30, 2012:
The Company’s sole indefinite-lived
intangible asset is its in-process research and development acquired in connection with its acquisition of Aldagen; no impairment
charges were recorded during 2012. The in-process research and development asset consists of its ALDH bright cell platform. The
Company is currently conducting a phase II clinical trial for this technology in ischemic stroke. Enrollment in that trial is expected
to complete within the coming 12 months and top-line data is expected to be available approximately four months following completion
of enrollment. If the trial is successful, it should provide efficacy data sufficient to appropriately power a phase III trial
and would also further validate the technology. However, there is no assurance that this trial will be successful.
Comment 4. Please tell
us your accounting treatment for the warrant exercises discussed on page 6.
Response:
As described in Note
3 to the condensed consolidated financial statements:
Warrant Exercises
An offer was extended
to certain holders of Company warrants (holding warrants to purchase approximately 5.7 million shares of the Company’s common
stock) acquired in previously reported transactions in 2010 and 2011 requesting them to exercise their respective warrants pursuant
to the terms of individually negotiated and executed warrant exercise agreements, in exchange for an equity sweetener. In consideration
for such early exercises and estimated proceeds of approximately $2.8 million, the Company agreed to issue additional warrants
to purchase an aggregate of 1,180,547 shares of common stock, at an exercise price per share of $1.42. Each warrant expires December
31, 2014 and, subject to call provisions of the warrant, is exercisable as follows: (i) commencing on the issuance date, for up
to 30% of shares of the Company’s common stock under each warrant, and (ii) upon issuance of the final tranche of the Contingent
Consideration, for the remaining balance of the warrant. Each warrant also contains exercise price adjustments, cashless exercise
and other provisions customary to the instruments of this nature. See Note 14.
On February 8, 2012,
prior to closing of the acquisition, all existing warrant holders who were offered the inducement had accepted the offer, and
executed warrant exercise agreement outlining the terms and conditions (including the inducement offer). As part of the arrangement,
the warrant holder has until June 30, 2012 to exercise their existing warrants, but they are obligated nonetheless to do so. The
Company is obligated to issue common stock upon exercise of the warrants and receipt of the proceeds and likewise is obligated
to issue the inducement warrants.
209 Perry Parkway,Suite 7 Gaithersburg, MD 20877 2143
Ph: (240) 499-2680 Fax: (240) 499-2690
www.cytomedix.com
Because the actual
common stock are not issued, but the Company has an obligation to issue the shares, the Company assessed whether or not that obligation
should be classified as an equity instrument. As of February 8, 2012, the Company had sufficient authorized shares to issue common
stock upon exercise of the existing warrants as well as upon exercise of the inducement warrants. Therefore, the Company has concluded
that the “common stock issuable” obligation to the inducement warrant holders should be classified in stockholders’
equity pursuant to the classification requirements of ASC 815-40-35 (formerly EITF 00-19), since “the company has sufficient
authorized and unissued shares available to settle the contract after considering all other commitments that may require the issuance
of stock during the maximum period the derivative contract could remain outstanding” and all other criteria in the “long
test” of ASC 815-40-35 have been met.
Upon incurrence of
the obligation the Company recorded the following:
Debit Inducement Expense
$ 1,051,371
Debit Subscription Receivable
$ 2,790,107
Credit “CS Issuable”
$ 2,790,107
Credit APIC
$ 1,051,371
As warrants are exercised and proceeds are
received the Company records the following:
Debit Cash
$ XX,XXX
Debit CS Issuable
$ XX,XXX
Credit Proceeds receivable
$ XX,XXX
Credit CS
$ XX
Credit APIC
$ XX,XXX
Item 2. Management’s Discussion
and Analysis of Financial Condition and Results of Operations Revenues, page 21
Comment 5. We see that
you received a $2.5 million non-refundable fee in February 2012 (in addition to the $2.0 million fee received in the fourth quarter
of 2011) from a top 20 global pharmaceutical partner. Please tell us the amount of revenue recorded from the 2012 and 2011 fees
and the basis for the amount recognized and deferred in the first quarter of 2012. Future filings should also include enhanced
disclosure about the basis for revenue recorded and deferred from this arrangement during each period presented.
Response:
As discussed in Note
3 to our consolidated financial statements and within our critical accounting policies included in our Annual Report on Form 10-K
for the year ended December 31, 2011:
209 Perry Parkway,Suite 7 Gaithersburg, MD 20877 2143
Ph: (240) 499-2680 Fax: (240) 499-2690
www.cytomedix.com
In the fourth quarter
2011, the Company entered into (and subsequently amended) an option agreement with a global pharmaceutical company (“Global
Pharma”) (the “Option Agreement”), pursuant to which Global Pharma had an exclusive op