"A significant milestone in 2012 was the announcement that CMS had agreed to reimburse AutoloGel under the CED program. We were delighted to report earlier in this month that CMS has formally approved the clinical outcomes in the protocols we had submitted in response to the National Coverage Determination (NCD) memo. This means that clinicians can now use AutoloGel to treat Medicare patients with chronic wounds and receive reimbursement. This should have a significantly positive impact on AutoloGel revenues in 2013. Finally, we announced earlier today that CMS has issued coding and reimbursement instructions to its regional contractors. Consequently, we expect to begin treating Medicare beneficiaries with AutoloGel shortly and recording revenues for AutoloGel as a covered product."
"Our Bright Cell technology pipeline continues to advance. We are enrolling patients in the RECOVER-Stroke Trial with ALD-401. This clinical trial is currently enrolling at 9 sites and we believe it's on track to complete enrollment by the end of the year. We also announced late last year the signing of an agreement with NIH to collaborate on a Phase 2 clinical study with ALD-301 in patients with intermittent claudication, caused by peripheral arterial disease (PAD), This is the first randomized clinical trial that will look at the benefits of autologous stem cell therapy in this patient population."
"We announced last month a $27.5 million comprehensive financing, which includes an equity raise, a tranched senior secured term loan facility, and a committed equity facility. We received approximately $9.5 million in initial gross proceeds with commitments for up to an additional $18 million. This capital infusion provides us with the necessary capital to fund our priority activities in 2013 which include the launch of AutoloGel under CED, sales expansion for the Angel cPRP System, business development and partnering activities, and completion of the RECOVER-Stroke phase 2 study."
Three-Month Period Ended December 31, 2012
Consolidated revenue of $2.1 million was comprised of product sales of $2.0 million and $0.1 million from licensing and royalty fees. This compares with $3.0 million in consolidated revenue recorded in the same period of 2011. The difference year over year was due to lower license fees in 2012, partly offset by higher product sales.
Gross margin on product sales declined to 47% in 4Q12 from 55% in the 4Q11, primarily due to mix shift to lower margin machines and disposables sold to distributors in Europe, the Middle East, and Australia. Gross margin on product sales was up sequentially from 42% in 3Q12.
Fourth quarter cash margins on product sales were 56%. Cash margins on disposable products in the quarter were 61%. Cash margin is a non-GAAP financial measure, most directly comparable to gross margin, and should not be considered as an alternative thereto. Cytomedix defines cash margin as gross margin exclusive of patent amortization and depreciation expense, and it is a significant performance metric used by management to indicate cash profitability on product sales.
Operating expenses in the fourth quarter were $4.6 million, a $2.6 million increase from the same period in 2011, primarily resulting from $1.5 million of legacy Aldagen business operating expense, salary increases (associated with new sales, marketing, operations, and administration positions), additional R&D expenses, stock compensation and general expenses associated with expanded commercial operations.
Most Popular Stories
- Adam Levine Wins Big as 'The Voice' Crowns Champ
- Target Security Breach May Affect 40 Million Cardholders
- Archer Daniels Midland Moving HQ to Chicago
- Tyson Foods Charged With Civil Rights Violation
- Texting With Vodka: Booze and Social Media Can Mix After All
- 'Beyonce' Tops the U.S. Album Chart
- How to Protect Yourself After Target Data Breach
- Bernanke Lets Congress Have It in Final Press Conference
- Wall Street Falls a Day After Surge
- Hispanic PR Firm Launches Chicago Chapter