UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 30, 2013
Cardica, Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware (State or Other Jurisdiction of Incorporation) |
000-51772 (Commission File Number) |
94-3287832 (IRS Employer Identification No.) |
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900 Saginaw Drive, Redwood City, CA (Address of Principal Executive Offices) |
94063 (Zip Code) |
Registrants telephone number, including area code: (650) 364-9975
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition
On April 30, 2013, Cardica, Inc. announced the results of operations for its fiscal quarter and nine months ended March 31, 2013. A copy of Cardicas press release, dated April 30, 2013, announcing these results is attached hereto as Exhibit 99.1.
The information set forth under this Item 2.02, including the exhibit attached hereto, shall not be deemed filed for purposes of Section 18 of the Securities and Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits
Exhibits
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Exhibit No. |
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Description |
99.1 |
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Press release dated April 30, 2013, containing Cardica, Inc.s results of operations for the fiscal quarter and nine months ended March 31, 2013. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Cardica, Inc. | ||
Date: April 30, 2013 | /s/ Robert Y. Newell | |
Robert Y. Newell |
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Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. |
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Description |
99.1 |
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Press release dated April 30, 2013, containing Cardica, Inc.s results of operations for the fiscal quarter and nine months ended March 31, 2013. |
Exhibit 99.1
Contact:
Bob Newell
Vice President, Finance and Chief Financial Officer
(650) 331-7133
investors@cardica.com
CARDICA ANNOUNCES FISCAL 2013 THIRD QUARTER FINANCIAL RESULTS
REDWOOD CITY, Calif. April 30, 2013 -- Cardica, Inc. (Nasdaq: CRDC) today announced financial results for its fiscal third quarter and nine months ended March 31, 2013. Cardicas management will hold a conference call at 4:30 p.m. Eastern Time to discuss the financial results and provide an update on the companys business.
We expect to complete enrollment in our European clinical trial of the MicroCutter XCHANGE 30 device in the weeks ahead, with a U.S. 510(k) submission anticipated in the third quarter of calendar 2013, said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. While making preparations in anticipation of a U.S. launch, pending regulatory clearance, we expect to bring more distributors online in Europe to encourage uptake, expand our experience and extend the reach of this exciting new product.
Recent Highlights and Accomplishments
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Enrolled additional patients in the European clinical trial for the XCHANGE 30, bringing the total number of patients enrolled to 152; |
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Added a second European distributor, Duo-Med, to expand MicroCutter product sales into Belgium, the Netherlands and Luxembourg; |
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Reached 1,000 deployments in more than 350 procedures with the XCHANGE 30 device since May 2012, including procedures such as appendectomies, vascular transections, intestinal and lung resections; |
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Shipped 104 MicroCutter XCHANGE 30 devices and 348 XCHANGE 30 cartridges; |
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Increased cumulative worldwide shipments of PAS-Port® Proximal Anastomosis Systems to over 31,500 units, with 979 units shipped in the fiscal 2013 third quarter; |
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Increased cumulative worldwide shipments of C-Port® Distal Anastomosis Systems to over 13,700 units, with 155 units shipped in the fiscal 2013 third quarter; and, |
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Completed an underwritten public offering of approximately 14 million shares of Cardicas common stock, for a total of $14.1 million in net proceeds. |
Fiscal 2013 Third Quarter and Nine Months Ended March 31, 2013 Financial Results
Total product sales were approximately $0.8 million for the fiscal 2013 third quarter compared to approximately $0.9 million for the same period of 2012. License and development revenue was $84,000 for both the fiscal 2013 and fiscal 2012 third quarters, with license and development revenue from both periods a result of the August 2010 agreement with Intuitive Surgical. Total net revenue was approximately $0.9 million for the fiscal 2013 third quarter compared to $1.0 million for the fiscal 2012 third quarter.
Cost of product sales was approximately $1.1 million for the fiscal 2013 third quarter compared to approximately $1.0 million for the same period of fiscal 2012. Research and development expenses were approximately $2.0 million for both the fiscal 2013 and fiscal 2012 third quarters. Selling, general and administrative expenses were approximately $1.6 million for the fiscal 2013 and fiscal 2012 third quarters.
The net loss for the fiscal 2013 third quarter was approximately $3.9 million, or $0.10 per share, compared with a net loss of approximately $3.7 million, or $0.12 per share, in the fiscal 2012 third quarter.
Total net revenue was approximately $2.6 million for the nine months ended March 31, 2013, compared to approximately $2.7 million for the nine months ended March 31, 2012. Total operating costs and expenses for the nine months ended March 31, 2013, were approximately $14.6 million compared to approximately $12.5 million for the same period of fiscal 2012. Net loss for the nine months ended March 31, 2013, was approximately $12.3 million, or $0.33 per share, compared to approximately $10.0 million, or $0.35 per share for the same period of fiscal 2012.
Cash and short term investments as of March 31, 2013, were approximately $17.0 million compared with $6.7 million at December 31, 2012. As of March 31, 2013, there were approximately 51 million shares of common stock outstanding.
Conference Call Details
To access the live conference call today at 4:30 p.m. Eastern Time via phone, please dial 866-700-6293 from the United States and Canada or 617-213-8835 internationally. The conference ID is 20204428. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately two hours after the call through May 7, 2013, and may be accessed by dialing 888-286-8010 from the United States and Canada or 617-801-6888 internationally. The replay passcode is 73979571.
To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the companys website at www.cardica.com. Please connect to the website at least 15 minutes prior to the presentation to allow for any necessary software downloads.
The webcast is also being distributed through the Thomson StreetEvents Network. Individual investors can listen to the call at www.earnings.com, Thomsons individual investor portal, powered by StreetEvents. Institutional investors can access the call via Thomson StreetEvents at www.streetevents.com, a password-protected event management site.
About Cardica
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica's technology portfolio is intended to minimize operating time and enable minimally-invasive and robot-assisted surgeries. Cardica manufactures and markets its automated anastomosis systems, the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery, and has shipped over 45,200 units throughout the world. In addition, Cardica is developing the Cardica® MicroCutter XCHANGE 30, a cartridge-based microcutter device with a five-millimeter shaft diameter, and the Cardica® MicroCutter XCHANGE 45, a cartridge-based microcutter device with an eight-millimeter shaft. Both MicroCutter devices are designed to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter XCHANGE 30 and XCHANGE 45 products require 510(k) review and are not yet commercially available in the U.S.
Forward-Looking Statements
The statements in this press release regarding Cardicas intention to complete enrollment in its European clinical trial of the MicroCutter XCHANGE 30 device in the weeks ahead, with a U.S. 510(k) submission anticipated in the third quarter of calendar 2013, and that it expects to bring more distributors online in Europe, are "forward-looking statements." The words expect and anticipated are intended to identify these forward-looking statements. There are a number of important factors that could cause Cardicas results to differ materially from those indicated by these forward-looking statements, including: that Cardica may not be successful in its efforts to further develop or commercialize the XCHANGE 30 due to unanticipated technical or other difficulties; that the XCHANGE 30 may face unanticipated development, regulatory, or manufacturing delays; that Cardicas intellectual property rights may not provide adequate protection to enable further development of the XCHANGE 30; that surgeons may not use the XCHANGE 30 correctly, which could cause unfavorable results that may impair the acceptance of the XCHANGE 30 by other surgeons; and that Cardica may not have sufficient funds to develop the XCHANGE 30, as well as other risks detailed from time to time in Cardicas reports filed with the U.S. Securities and Exchange Commission, including its Current Report on Form 10-Q for the quarter ended December 31, 2012. Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. You are encouraged to read Cardicas reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.
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Cardica, Inc.
Statements of Operations
(amounts in thousands except per share amounts)
Three months ended March 31, |
Nine months ended March 31, |
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2013 |
2012 |
2013 |
2012 |
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(unaudited) |
(unaudited) |
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Revenue |
||||||||||||||||
Product sales, net |
$ | 767 | $ | 852 | $ | 2,322 | $ | 2,430 | ||||||||
License and development revenue |
84 | 84 | 252 | 252 | ||||||||||||
Royalty revenue |
17 | 17 | 53 | 53 | ||||||||||||
Total |
868 | 953 | 2,627 | 2,735 | ||||||||||||
Operating costs and expenses |
||||||||||||||||
Cost of product sales |
1,089 | 969 | 2,689 | 2,875 | ||||||||||||
Research and development |
2,022 | 1,960 | 6,848 | 4,999 | ||||||||||||
Selling, general and administrative |
1,593 | 1,644 | 5,040 | 4,668 | ||||||||||||
Total operating costs and expenses |
4,704 | 4,573 | 14,577 | 12,542 | ||||||||||||
Loss from operations |
(3,836 | ) | (3,620 | ) | (11,950 | ) | (9,807 | ) | ||||||||
Interest and other income |
4 | 3 | 11 | 5 | ||||||||||||
Interest expense |
(114 | ) | (105 | ) | (339 | ) | (161 | ) | ||||||||
Net loss |
$ | (3,946 | ) | $ | (3,722 | ) | $ | (12,278 | ) | $ | (9,963 | ) | ||||
Basic and diluted net loss per share |
$ | (0.10 | ) | $ | (0.12 | ) | $ | (0.33 | ) | $ | (0.35 | ) | ||||
Shares used in computing basic and diluted net loss per share |
38,633 | 31,880 | 37,436 | 28,594 |
Balance Sheets
(amounts in thousands)
March 31, 2013 |
June 30, 2012 |
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Assets |
(unaudited) | |||||||
Cash and cash equivalents |
$ | 16,960 | $ | 14,645 | ||||
Accounts receivable |
335 | 299 | ||||||
Inventories |
1,400 | 576 | ||||||
Other assets |
3,627 | 2,622 | ||||||
Total assets |
$ | 22,322 | $ | 18,142 | ||||
Liabilities and stockholders' equity |
||||||||
Accounts payable and other liabilities |
$ | 2,712 | $ | 1,860 | ||||
Deferred revenue |
2,138 | 2,390 | ||||||
Long term debt |
2,720 | 2,532 | ||||||
Total stockholders' equity |
14,752 | 11,360 | ||||||
Total liabilities and stockholders' equity |
$ | 22,322 | $ | 18,142 |
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