MEDICAL DEVICE INNOVATION - Medical Device Daily

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118 MEDICAL DEVICE INNOVATION 2010 funding. According to Sensimed CEO Jean-Marc Wismer, “making a lens for rabbits will require a change in the lens (smaller diameter) together with some minor electronic adaptations. In principle it can be done fairly easily, but the budget associated for the necessary R&D would be in the range of $200,000, so we have not pursued this route.” Finally the device appears somewhat cumbersome, but with the operation of “Moore’s Law” (the observation that every 18 months the size of computers is cut in half and their capacity doubles) there can be little doubt that the device will become increasingly miniaturized and user-friendly. (This story originally appeared in the June 11, 2009 edition of Medical Device Daily.) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 Once bankrupt SeraCare now profitable company By AMANDA PEDERSEN Medical Device Daily Staff Writer Even in a good economy turning a company around from bankruptcy, Nasdaq delisting, and an SEC investigation to achieving profitability is no simple task. In an economic state as dire as the current environment – it’s nearly impossible. Yet, one life sciences company has done just that, and within only three years. But despite the challenges facing SeraCare Life Sciences (Milford, Massachusetts) three years ago, the company’s president/CEO and its CFO tell Medical Device Daily that SeraCare today is right where they always knew it would be. “I think we absolutely thought we would [achieve profitability] and this has been the timeline in which we anticipated turning profitable,” Sue Vogt, president/CEO told MDD. CFO Greg Gould added that SeraCare had to make some changes in its plan based on the current economic challenges, but ultimately, “We always knew that we could get this company profitable.” In March 2006 SeraCare reported that it had dismissed four of its executives and made other moves that reflect what it said were the discovery of “material weaknesses” in its internal controls. But the company’s troubles really began in January of that year when an investor filed suit against SeraCare in federal court, accusing the company of stock inflation. According to that complaint, SeraCare’s stock price fell by as much as 62% on Dec. 20, 2005, after the company revealed that its independent auditors had issued a report about deceptive accounting issues. The Nasdaq market subsequently delisted SeraCare’s shares. The company filed for bankruptcy that spring. The company at the time was also under investigation by the SEC. Vogt and Gould joined SeraCare in the summer of 2006. Under the new leadership, and within three years, the company has emerged from bankruptcy, raised money in a rights offering, closed the SEC investigation, and achieved relisting on the Nasdaq. This week SeraCare reported profitable operational and financial results for its third quarter of fiscal year 2009 ended June 30. The company had a net income of $0.7 million and earnings per share on a basic and diluted basis of $0.04 for the quarter ended June 30, compared to a net loss of $0.6 million and a loss per share on a basic and diluted basis of $0.03 during the same period in 2008. “In the third quarter of fiscal 2009, SeraCare met its most significant goal for the year—achieving profitability,” Vogt said. “The fact that SeraCare was able to turn profitable in the midst of a significant economic downturn 119 speaks to the inherent strength of our products and services and our position as an innovator and quality leader in the markets we serve. We continue to see marked improvements in sequential quarter over quarter revenues during the fiscal year and believe our focus on introducing new, differentiated products to the marketplace and our costcontrol initiatives will support ongoing profitability.” Among its recent corporate milestones, SeraCare notes that it achieved bottom-line profitability of $0.7 million as measured by net income for 3Q09; generated $1.8 million in net cash flows from operating activities for 3Q09; improved gross margin by seven percentage points, to 36% from 29%, for 3Q09 compared to the same quarter last year; increased Diagnostic & Biopharmaceutical Products revenue by 5% and BioServices revenue by 18% compared to the second quarter ended March 31; generated $0.8 million in operating income which included non-cash expenses of $0.3 million for depreciation and amortization and $0.3 million for stock compensation expense during the third quarter of fiscal 2009; and launched two differentiated products – the SeraCare Human Papillomavirus (HPV) Genotype Performance Panel and the Accurun 632, 644 and 676 controls. According to the company, the SeraCare HPV Genotype Performance Panel is the first product on the market to enable testing laboratories, researchers and diagnostic manufacturers to validate their entire HPV testing system, ensuring that testing systems can differentiate between high- and low-risk HPV genotypes. SeraCare also noted that the Accurun 632, 644 and 676 controls are the only commercially available single-vial controls that allow researchers and IVD manufacturers to test for all cystic fibrosis mutations currently detected by the leading testing platforms. On a sequential basis, revenue for 3Q09 increased by $0.9 million to $11.8 million compared to the second quarter of 2009. Diagnostic & Biopharmaceutical Products revenue for the third quarter of 2009 increased by $0.4 million to $8.7 million compared to 2Q09 and BioServices revenue increased by $0.5 million to $3 million across the same period. According to the company, it had $3.7 million in cash as of June 30. Due to “external market” conditions, Vogt said, SeraCare did not achieve the top line growth this year that it had originally planned. “Without that growth we had to be much more aggressive in terms of focusing on streamlining the operations, finding ways to cut costs and balancing investments with rate of return.” Vogt said that when she and Gould joined SeraCare in 2006 their first priority was to reorganize the company, restructure the balance sheet and to pay back all of the creditors in full, which she said was really the first big milestone in SeraCare’s comeback story. From there, she said, the company was focused on integrating itself. To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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