Updates on Aurix Commercial Launch
Conference Call Scheduled for November 14 at 8:00 am Eastern Time
GAITHERSBURG, Md., Nov. 13, 2014 (GLOBE NEWSWIRE) -- Nuo Therapeutics, Inc. (OTCQX:NUOT) (formerly Cytomedix Inc.), a pioneer in biodynamic therapies, today reported financial results for the three months ended September 30, 2014. Following shareholder approval at the Annual Meeting held on November 12, 2014, the Company effected the name change from "Cytomedix, Inc." to "Nuo Therapeutics, Inc."
Third Quarter 2014 and Recent Corporate Highlights
- Completed corporate re-branding and changed corporate name to Nuo Therapeutics, Inc.
- Re-launched chronic wound care system under Aurix brand
- Expanded sales, clinical and reimbursement infrastructure to support commercial ramp
Third Quarter 2014 Financial Summary
- Total revenues were $1.7 million, compared with $3.4 million in the third quarter of 2013
- Net loss of $4.8 million, or $0.04 per share, compared with a net loss of $5.0 million, or $0.05 per share in the prior year
- Cash and cash equivalents of approximately $20 million as of September 30, 2014
"The last several months have been part of a transformative period for our Company, during which we have developed and implemented a comprehensive strategic growth plan aimed at optimizing the commercial launch of our lead product, the recently re-named Aurix," said Martin Rosendale, Chief Executive Officer of Nuo Therapeutics. "The most important milestones to date took place last month, at the Symposium on Advanced Wound Care Fall Meeting in Las Vegas, during which we launched the Aurix brand and introduced our new corporate identity, Nuo Therapeutics. These changes were met with a great deal of enthusiasm from prospective customers and others in the industry."
Dean Tozer, Chief Commercial Officer of Nuo, added, "We have been building out our sales and support capabilities in recent months through the recruitment of high-level sales talent as well as top clinical and reimbursement professionals. With a robust commercial infrastructure in place, we are poised to mobilize our sales force with a focus on driving demand through outpatient wound care centers and Veterans Administration facilities in the 17 territories we have created to facilitate the Aurix launch. We remain confident in the strong market potential of our best-in-class Aurix system and committed to maximizing the commercial opportunities that lie ahead."
Financial Results for the Third Quarter Ended September 30, 2014
Total revenues were $1.7 million in the third quarter, compared to $3.4 million in the same period of 2013. The decrease was primarily due to a $1.3 million one-time sale of existing placed Angel centrifuges to Arthrex in the year-ago period, lower Angel disposable product sales to Arthrex and transition services revenue, partially offset by an increase in royalty revenue as a result of increased sales by Arthrex. Gross margin increased to 21.1% in the third quarter of 2014 from 15.3% in the third quarter of 2013. The increase was primarily due to the aforementioned one-time sale of existing placed Angel centrifuges to Arthrex in the 2013 period, for which the sale price and related cost of sales were recorded at fair value, resulting in a zero-margin transaction.
Total operating expenses in the third quarter were $4.9 million, compared to $5.1 million in the same period of 2013. The decrease in total operating expenses is primarily the result of the Company's previously discussed determinations to close the Research and Development facility in Durham, North Carolina, and to discontinue the ALD-401 program. This decrease was partially offset by increased expenses associated with the planned expansion of our commercial organization, product rebranding activities, and the implementation of our protocols under Coverage with Evidence (CED).
Net loss in the third quarter was $4.8 million, or a loss of $0.04 per share compared to a net loss of $5.0 million, or a $0.05 loss per share in the third quarter of 2013.
Cash and cash equivalents as of September 30, 2014 totaled approximately $20 million, compared with approximately $3.3 million as of December 31, 2013. The increase in cash and cash equivalents during the first nine months of 2014 was primarily attributable to the Company's $35 million convertible debt financing with Deerfield Management.
Conference Call and Webcast:
Friday, November 14, 2014 @ 8am Eastern/5am Pacific
Domestic: 877-407-4018
International: 201-689-8471
Passcode: 13595131
Webcast: www.nuot.com
Replays – Available through November 21, 2014
Domestic: 877-870-5176
International: 858-384-5517
Passcode: 13595131
About Nuo Therapeutics
Nuo Therapeutics, Inc. is a biomedical company that pioneers leading-edge biodynamic therapies for wound care. The Company's flagship product, Aurix is a biodynamic hematogel that harnesses a patient's innate regenerative abilities for the management of a variety of wounds. For additional information please visit www.nuot.com.
About Aurix
Aurix is the first platelet and plasma therapy system to be cleared by the FDA for the management of ulcers and wounds of all types (diabetic foot ulcer, pressure ulcer, venous leg ulcer, etc.) and all severities (partial thickness, full thickness, and complex wounds). It can be used successfully on patients with tunneling, sinus tracts, bone and tendon exposure, and hardware exposure.
Unlike other cellular-based treatment options, Aurix is derived from a patient's own platelets and plasma (autologous). Once applied, the product goes to work, stimulating the natural healing process to form tissue to fill in wound defects and help reduce wound volume. Aurix produces visible results in days, not weeks and is effective at all stages of wound care for non-healing wounds.
Safe Harbor Statement -- Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Nuo Therapeutics actual results may differ materially due to a number of factors, many of which are beyond Nuo Therapeutics' ability to predict or control, the Company's ability to successfully launch and rebrand its wound care system in the timeframe and to the extent anticipated, the Company's ability to estimate the potential of the wound care market and to commercialize any of its rebranded products / therapies, successfully execute its Aurix (formerly AutoloGel) sales and commercialization strategies, the Company's ability to launch Aurix as expected and derive financial and commercial benefits of such launch, to achieve Aurix expected reimbursement rates in 2014 and thereafter, the Company's ability to comply with the debt covenants and restrictions under the existing loan facilities, the Company's ability to realize expected benefits from the Arthrex licensing arrangement, the Company's ability to collect the data necessary for the grant of the unconditional coverage, the Company's ability to continue in its efforts to expand in the wound care market, its ability to successfully negotiate with physician offices as anticipated and to realize the anticipated sales growth from such treatments, the likelihood of a favorable CMS determination relating to the reimbursement rates for Aurix, to successfully realize sales of the Angel Technology resulting in the royalty stream to the Company, the Company's ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company's expectations of favorable future dialogue with potential strategic partners, and its ability to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Nuo Therapeutics ability to execute on its strategy to market the Aurix System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Nuo Therapeutics, Inc. Nuo Therapeutics operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Nuo Therapeutics undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2013, the most recent Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2014, and other subsequent public filings. These filings are available at www.sec.gov.
| Nuo Therapeutics, Inc. | ||||
| Condensed Consolidated Statements of Operations | ||||
| (unaudited) | ||||
| Three Months Ended | Nine Months Ended | |||
| September 30, | September 30, | |||
| 2014 | 2013 | 2014 | 2013 | |
| Revenues | ||||
| Product sales | $1,200,719 | $2,925,971 | $4,474,970 | $7,541,874 |
| License fees | 100,594 | 67,063 | 301,783 | 67,063 |
| Royalties | 390,714 | 244,350 | 1,087,307 | 369,646 |
| Other revenue | -- | 128,835 | -- | 128,835 |
| Total revenues | 1,692,027 | 3,366,219 | 5,864,060 | 8,107,418 |
| Cost of revenues | ||||
| Cost of sales | 1,290,449 | 2,817,386 | 4,552,317 | 5,439,401 |
| Cost of royalties | 43,853 | 32,504 | 132,543 | 41,578 |
| Total cost of revenues | 1,334,302 | 2,849,890 | 4,684,860 | 5,480,979 |
| Gross profit | 357,725 | 516,329 | 1,179,200 | 2,626,439 |
| Operating expenses | ||||
| Salaries and wages | 1,950,307 | 1,967,965 | 6,220,302 | 6,011,337 |
| Consulting expenses | 204,985 | 415,947 | 1,374,616 | 1,596,576 |
| Professional fees | 303,083 | 385,344 | 935,112 | 827,198 |
| Research, development, trials and studies | 636,239 | 922,999 | 2,547,559 | 3,050,038 |
| General and administrative expenses | 1,760,379 | 1,433,611 | 4,387,700 | 5,415,768 |
| Impairment of IPR&D and trademarks | -- | -- | 4,683,829 | -- |
| Total operating expenses | 4,854,993 | 5,125,866 | 20,149,118 | 16,900,917 |
| Loss from operations | (4,497,268) | (4,609,537) | (18,969,918) | (14,274,478) |
| Other income (expense) | ||||
| Interest, net | (818,493) | (378,587) | (2,587,366) | (1,323,900) |
| Change in fair value of derivative liabilities | 542,868 | 5,789 | (158,631) | 250,349 |
| Other | (8,045) | 12,076 | (9,284) | 12,331 |
| Total other income (expense) | (283,670) | (360,722) | (2,755,281) | (1,061,220) |
| Loss before provision for income taxes | (4,780,938) | (4,970,259) | (21,725,199) | (15,335,698) |
| Income tax provision | 4,645 | 4,890 | 13,935 | 14,670 |
| Net loss | $ (4,785,583) | $ (4,975,149) | $ (21,739,134) | $ (15,350,368) |
| Loss per common share -- | ||||
| Basic and diluted | $ (0.04) | $ (0.05) | $ (0.18) | $ (0.15) |
| Weighted average shares outstanding -- | ||||
| Basic and diluted | 123,968,305 | 104,890,396 | 118,990,010 | 102,891,983 |
| Nuo Therapeutics, Inc. | ||
| Condensed Consolidated Balance Sheets | ||
| (unaudited) | ||
| September 30, | December 31, | |
| 2014 | 2013 | |
| ASSETS | ||
| Current assets | ||
| Cash and cash equivalents | $20,036,100 | $3,286,713 |
| Short-term investments, restricted | 53,356 | 53,257 |
| Accounts and other receivable, net | 1,785,142 | 3,926,681 |
| Inventory | 544,741 | 1,111,507 |
| Prepaid expenses and other current assets | 2,216,672 | 1,258,282 |
| Deferred costs, current portion | 1,091,387 | 316,551 |
| Total current assets | 25,727,398 | 9,952,991 |
| Property and equipment, net | 757,230 | 919,469 |
| Deferred costs | 3,819,854 | 482,349 |
| Intangible assets, net | 28,824,864 | 33,768,954 |
| Goodwill | 1,128,517 | 1,128,517 |
| Total assets | $60,257,863 | $46,252,280 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current liabilities | ||
| Accounts payable | $1,673,402 | $3,351,844 |
| Accrued expenses | 4,887,418 | 4,666,828 |
| Deferred revenues, current portion | 402,377 | 740,990 |
| Note payable, current portion | -- | 1,800,000 |
| Total current liabilities | 6,963,197 | 10,559,662 |
| Notes payable | -- | 3,620,593 |
| Convertible debt, net of discount | 251,600 | 202,658 |
| Deferred revenues | 1,139,956 | 1,441,852 |
| Derivative liabilities | 38,106,375 | 3,248,595 |
| Other liabilities | 1,024,863 | 366,926 |
| Total liabilities | 47,485,991 | 19,440,286 |
| Commitments and contingencies | ||
| Conditionally redeemable common stock (909,091 issued and outstanding) | 500,000 | 500,000 |
| Stockholders' equity | ||
| Common stock; $.0001 par value, authorized 425,000,000 shares; 2014 issued and outstanding - 124,410,100 shares; 2013 issued and outstanding - 107,164,855 shares | 12,350 | 10,626 |
| Common stock issuable | 392,950 | 432,100 |
| Additional paid-in capital | 124,834,282 | 117,097,844 |
| Accumulated deficit | (112,967,710) | (91,228,576) |
| Total stockholders' equity | 12,271,872 | 26,311,994 |
| Total liabilities and stockholders' equity | $60,257,863 | $46,252,280 |