05.02.14
Redwood City, Calif.-based Cardica Inc. has announced a satisfying third quarter for fiscal year 2014, which ended March 31.
“Our efforts over the last year have been focused on product refinements and the commercial introduction of the Microcutter Xchangeb 30 in Europe,” said President and CEO Bernard A. Hausen, M.D., Ph.D. “Following clearance from the U.S. Food and Drug Administration (FDA), we recently began product introduction in the United States. We are working with key opinion leaders to secure approval for product evaluation and purchasing through multiple hospital value analysis committees. While it is early in the launch period, we are encouraged by the positive response we’ve experienced to date and we believe that there is clearly a real market need. We intend to navigate the hospital approval process while ensuring that we deliver quality products that meet our customers’ expectations. Importantly, last week we closed a public offering that solidified our balance sheet and will bolster our ability to implement a successful U.S. product introduction and product line expansion.”
The Microcutter Xchange 30 is a cartridge-based, minimally invasive stapling system with a 5 mm shaft diameter and cross sectional area significantly smaller than conventional 12 mm staplers, and with greater articulation. Combining several new technologies, this device is designed to mitigate limitations on surgical procedures created by larger stapling devices.
Fiscal 2014 Third Quarter and Nine Months Ended March 31, 2014 Financial Results
Total product sales were approximately $0.9 million for the fiscal 2014 third quarter compared to $0.8 million for the fiscal 2013 third quarter. Total net revenue was approximately $0.9 million for both the fiscal 2014 and fiscal 2013 third quarters.
Cost of product sales was approximately $1.4 million for the fiscal 2014 third quarter compared to approximately $1.1 million for the fiscal 2013 third quarter. Research and development expenses were approximately $1.7 million for the fiscal 2014 third quarter compared to $2.0 million in the same period of fiscal 2013. Selling, general and administrative expenses were $2.1 million for the fiscal 2014 third quarter compared to $1.6 million for the same period of fiscal 2013.
The net loss for the fiscal 2014 third quarter was approximately $4.4 million, or $0.09 per share, compared with a net loss of approximately $3.9 million, or $0.10 per share, in the fiscal 2013 third quarter.
Total net revenue was approximately $2.6 million for both the nine months ended March 31, 2014 and March 31, 2013. Total operating costs and expenses for the nine months ended March 31, 2014, were approximately $14.5 million compared to $14.6 million for the nine months ended March 31, 2013. Net loss for the nine months ended March 31, 2014, was approximately $12.3 million, or $0.24 per share, compared to $12.3 million, or $0.33 per share for the same period of fiscal 2013.
Cash and short term investments as of March 31, 2014, were approximately $2.9 million compared with $6.5 million at December 31, 2013. As of March 31, 2014, there were approximately 51.6 million shares of common stock outstanding. As of May 1, 2014 and following the closing of the underwritten public offering and receipt of $44.5 million in net proceeds, there were approximately 88.9 million shares of common stock outstanding and 191,474 shares of series A convertible preferred stock outstanding.
“Moving forward beginning next quarter we intent to report specific values on a quarterly basis to provide metrics by which to measure the commercial launch [of Microcutter Xchange 30],” said Robert Y. Newell, chief financial officer and vice president of finance, during a May 1 earnings conference call. “We will provide total worldwide sales for the Microcutter device and cartridges, the number of value-added committees in the United States that have approved the Microcutter and the number of U.S. hospitals that have ordered Microcutter.”
Recent company highlights include:
“Our efforts over the last year have been focused on product refinements and the commercial introduction of the Microcutter Xchangeb 30 in Europe,” said President and CEO Bernard A. Hausen, M.D., Ph.D. “Following clearance from the U.S. Food and Drug Administration (FDA), we recently began product introduction in the United States. We are working with key opinion leaders to secure approval for product evaluation and purchasing through multiple hospital value analysis committees. While it is early in the launch period, we are encouraged by the positive response we’ve experienced to date and we believe that there is clearly a real market need. We intend to navigate the hospital approval process while ensuring that we deliver quality products that meet our customers’ expectations. Importantly, last week we closed a public offering that solidified our balance sheet and will bolster our ability to implement a successful U.S. product introduction and product line expansion.”
The Microcutter Xchange 30 is a cartridge-based, minimally invasive stapling system with a 5 mm shaft diameter and cross sectional area significantly smaller than conventional 12 mm staplers, and with greater articulation. Combining several new technologies, this device is designed to mitigate limitations on surgical procedures created by larger stapling devices.
Fiscal 2014 Third Quarter and Nine Months Ended March 31, 2014 Financial Results
Total product sales were approximately $0.9 million for the fiscal 2014 third quarter compared to $0.8 million for the fiscal 2013 third quarter. Total net revenue was approximately $0.9 million for both the fiscal 2014 and fiscal 2013 third quarters.
Cost of product sales was approximately $1.4 million for the fiscal 2014 third quarter compared to approximately $1.1 million for the fiscal 2013 third quarter. Research and development expenses were approximately $1.7 million for the fiscal 2014 third quarter compared to $2.0 million in the same period of fiscal 2013. Selling, general and administrative expenses were $2.1 million for the fiscal 2014 third quarter compared to $1.6 million for the same period of fiscal 2013.
The net loss for the fiscal 2014 third quarter was approximately $4.4 million, or $0.09 per share, compared with a net loss of approximately $3.9 million, or $0.10 per share, in the fiscal 2013 third quarter.
Total net revenue was approximately $2.6 million for both the nine months ended March 31, 2014 and March 31, 2013. Total operating costs and expenses for the nine months ended March 31, 2014, were approximately $14.5 million compared to $14.6 million for the nine months ended March 31, 2013. Net loss for the nine months ended March 31, 2014, was approximately $12.3 million, or $0.24 per share, compared to $12.3 million, or $0.33 per share for the same period of fiscal 2013.
Cash and short term investments as of March 31, 2014, were approximately $2.9 million compared with $6.5 million at December 31, 2013. As of March 31, 2014, there were approximately 51.6 million shares of common stock outstanding. As of May 1, 2014 and following the closing of the underwritten public offering and receipt of $44.5 million in net proceeds, there were approximately 88.9 million shares of common stock outstanding and 191,474 shares of series A convertible preferred stock outstanding.
“Moving forward beginning next quarter we intent to report specific values on a quarterly basis to provide metrics by which to measure the commercial launch [of Microcutter Xchange 30],” said Robert Y. Newell, chief financial officer and vice president of finance, during a May 1 earnings conference call. “We will provide total worldwide sales for the Microcutter device and cartridges, the number of value-added committees in the United States that have approved the Microcutter and the number of U.S. hospitals that have ordered Microcutter.”
Recent company highlights include:
- Received FDA 510(k) clearance from the FDA for the Microcutter Xchange30 and blue and white cartridges, along with a material change for the cartridge, for use in multiple open or minimally-invasive surgical procedures for the transection, resection and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix;
- Juan-Carlos Verdeja, M.D., F.A.C.S., completed the first surgical procedure in the United States using the Microcutter Xchange 30 at West Kendall Baptist Hospital in Florida;
- Radu Pescarus, M.D., Foregut Fellow in the Gastrointestinal and Minimally Invasive Surgery Division of Providence Portland Medical Center, presented a poster detailing the pre-clinical use of the Microcutter Xchange 30 in gastrointestinal surgical procedures including endoscopic assisted trans-gastric and trans-anal full thickness resections at the SAGES Annual Meeting in Salt Lake City, Utah;
- The Microcutter Xchange 30 was selected as a finalist in the surgical Equipment, Instruments and Supplies category of the Medical Design Excellence Awards, one of the highest honors in the medical technology industry;
- Began the process of securing value analysis committee (VAC) approval in several hospitals in the United States;
- As of March 31, 2014, secured approval from five hospital VACs who have approved use of the Microcutter Xchange 30 for product evaluation and subsequently have the ability to purchase the Microcutter Xchange 30;
- Increased cumulative worldwide shipments of PAS-Port proximal anastomosis systems to over 36,000 units, with 1,151 units shipped in the fiscal 2014 third quarter;
- Increased cumulative worldwide shipments of C-Port distal anastomosis systems to 14,275 units, with 200 units shipped in the fiscal 2014 third quarter; and,
- Raised $44.5 million in net proceeds from an underwritten public offering of 37,375,000 shares of Cardica’s common stock, offered at a price of $0.85 per share, and 191,474 shares of series A convertible preferred stock, at a price of $85.00 per share.