QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
For the quarterly period ended September 30, 2011 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
For the transition period from __________ to __________ |
PART I. FINANCIAL INFORMATION
|
||
Item 1. Condensed Financial Statements (unaudited)
|
||
a. Condensed Balance Sheets at September 30, 2011 and June 30, 2011
|
3
|
|
b. Condensed Statements of Operations for the three months ended September 30, 2011 and 2010
|
||
c. Condensed Statements of Cash Flows for the three months ended September 30, 2011 and 2010
|
||
d. Notes to Condensed Financial Statements
|
||
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
|
||
Item 3. Quantitative and Qualitative Disclosures About Market Risk
|
||
Item 4. Controls and Procedures
|
||
PART II. OTHER INFORMATION
|
||
Item 1A. Risk Factors
|
||
Item 6. Exhibits
|
||
SIGNATURES
|
September 30, 2011
|
June 30, 2011
|
||||||
(Unaudited)
|
(Note 1)
|
||||||
Assets
|
|||||||
Current assets
|
|||||||
Cash and cash equivalents
|
$
|
5,912
|
$
|
7,832
|
|||
Short-term investments
|
3,162
|
1,493
|
|||||
Accounts receivable
|
262
|
327
|
|||||
Inventories
|
778
|
840
|
|||||
Prepaid expenses and other current assets
|
289
|
160
|
|||||
Total current assets
|
10,403
|
10,652
|
|||||
Property and equipment, net
|
1,271
|
714
|
|||||
Restricted cash
|
104
|
104
|
|||||
Total assets
|
$
|
11,778
|
$
|
11,470
|
|||
Liabilities and stockholders' equity
|
|||||||
Current liabilities
|
|||||||
Accounts payable
|
$
|
1,100
|
$
|
618
|
|||
Accrued compensation
|
369
|
530
|
|||||
Other accrued liabilities
|
365
|
289
|
|||||
Current portion of deferred revenue
|
738
|
738
|
|||||
Total current liabilities
|
2,572
|
2,175
|
|||||
Note payable and other non-current liabilities
|
2,362
|
433
|
|||||
Total liabilities
|
4,934
|
2,608
|
|||||
Commitments and contingencies
|
|||||||
Stockholders' equity
|
|||||||
Preferred stock, $0.001 par value: 5,000,000 shares authorized: no shares issued and outstanding at September 30, 2011 and June 30, 2011
|
—
|
—
|
|||||
Common stock, $0.001 par value: 65,000,000 shares authorized: 27,071,679 and 26,635,115 shares issued and outstanding at September 30, 2011 and June 30, 2011, respectively
|
27
|
27
|
|||||
Additional paid-in capital
|
134,320
|
133,281
|
|||||
Treasury stock at cost (66,227 shares at September 30, 2011 and June 30, 2011)
|
(596
|
) |
(596
|
) | |||
Accumulated comprehensive loss
|
(3
|
) |
(1
|
) | |||
Accumulated deficit
|
(126,904
|
) |
(123,849
|
) | |||
Total stockholders' equity
|
6,844
|
8,862
|
|||||
Total liabilities and stockholders' equity
|
$
|
11,778
|
$
|
11,470
|
Three months ended
|
|||||||
September 30,
|
|||||||
2011
|
2010
|
||||||
Net revenue
|
|||||||
Product sales, net
|
$
|
767
|
$
|
995
|
|||
License and development revenue
|
84
|
9,025
|
|||||
Royalty revenue
|
19
|
22
|
|||||
Total net revenue
|
870
|
10,042
|
|||||
Operating costs and expenses
|
|||||||
Cost of product sales
|
827
|
944
|
|||||
Research and development
|
1,557
|
1,375
|
|||||
Selling, general and administrative
|
1,541
|
1,495
|
|||||
Total operating costs and expenses
|
3,925
|
3,814
|
|||||
Income (loss) from operations
|
(3,055
|
)
|
6,228
|
||||
Interest income
|
1
|
8
|
|||||
Interest expense
|
—
|
(11
|
)
|
||||
Other income (expense), net
|
(1
|
)
|
(2
|
)
|
|||
Net income (loss)
|
$
|
(3,055
|
)
|
$
|
6,223
|
||
Basic net income (loss) per common share
|
$
|
(0.11
|
)
|
$
|
0.25
|
||
Diluted net income (loss) per common share
|
$
|
(0.11
|
)
|
$
|
0.24
|
||
Shares used in computing net income (loss) per common share
|
|||||||
Basic
|
26,806
|
24,623
|
|||||
Diluted
|
26,806
|
26,000
|
Three months ended
|
|||||||
September 30,
|
|||||||
2011
|
2010
|
||||||
Operating activities:
|
|||||||
Net income (loss)
|
$
|
(3,055
|
)
|
$
|
6,223
|
||
Adjustments to reconcile net cash provided by (used in) operating activities:
|
|||||||
Depreciation and amortization
|
162
|
193
|
|||||
Stock-based compensation expenses
|
136
|
244
|
|||||
Changes in assets and liabilities:
|
|||||||
Accounts receivable
|
65
|
12
|
|||||
Prepaid expenses and other current assets
|
(129
|
)
|
47
|
||||
Inventories
|
62
|
280
|
|||||
Accounts payable and other accrued liabilities
|
558
|
(148
|
)
|
||||
Accrued compensation
|
(161
|
)
|
(87
|
)
|
|||
Deferred revenue
|
(83
|
)
|
963
|
||||
Deferred rent
|
12
|
2
|
|||||
Net cash provided by (used in) operating activities
|
(2,433
|
)
|
7,729
|
||||
Investing activities:
|
|||||||
Purchases of property and equipment
|
(719
|
)
|
(7
|
)
|
|||
Purchases of short-term investments
|
(1,671
|
)
|
—
|
||||
Net cash used in investing activities
|
(2,390
|
)
|
(7
|
)
|
|||
Financing activities:
|
|||||||
Net proceeds from issuance of common stock
|
903
|
2,011
|
|||||
Proceeds from (Repayment of) notes payable
|
2,000
|
(1,400
|
)
|
||||
Net cash provided by financing activities
|
2,903
|
611
|
|||||
Net increase (decrease) in cash and cash equivalents
|
(1,920
|
)
|
8,333
|
||||
Cash and cash equivalents at beginning of period
|
7,832
|
6,561
|
|||||
Cash and cash equivalents at end of period
|
$
|
5,912
|
$
|
14,894
|
Three months ended
|
||||||
September 30,
|
||||||
2011
|
2010
|
|||||
Cost of product sales
|
$
|
12
|
$
|
18
|
||
Research and development
|
39
|
54
|
||||
Selling, general and administrative
|
85
|
172
|
||||
Total
|
$
|
136
|
$
|
244
|
Three months ended
|
||||||||
September 30,
|
||||||||
2011
|
2010
|
|||||||
Numerator:
|
||||||||
Net income (loss)
|
$
|
(3,055
|
)
|
$
|
6,223
|
|||
Denominator:
|
||||||||
Weighted-average common shares outstanding
|
26,806
|
24,623
|
||||||
Less: Weighted-average unvested restricted stock
|
—
|
—
|
||||||
Denominator for basic net income (loss) per common share
|
26,806
|
24,623
|
||||||
Dilutive effect of stock options
|
—
|
403
|
||||||
Dilutive effect of unvested restricted stock awards
|
—
|
43
|
||||||
Dilutive effect of warrants
|
—
|
931
|
||||||
Denominator for diluted net income (loss) per share
|
26,806
|
26,000
|
||||||
Basic net income (loss) per common share
|
$
|
(0.11)
|
$
|
0.25
|
||||
Diluted net income (loss) per common share
|
$
|
(0.11)
|
$
|
0.24
|
September 30,
|
|||||
2011 |
2010
|
||||
Options to purchase common stock
|
3,629
|
1,519
|
|||
Unvested restricted stock awards
|
21
|
—
|
|||
Warrants
|
4,646
|
—
|
|||
Total
|
8,296
|
1,519
|
September 30,
|
||||||||
2011
|
2010
|
|||||||
Net income (loss)
|
(3,055 | ) | 6,223 | |||||
Change in unrealized gain (loss) on investments
|
(2 | ) | — | |||||
Comprehensive income (loss)
|
(3,057 | ) | 6,223 |
Quoted prices in active markets for identical assets or liabilities.
|
||
Level 2 -
|
Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.
|
|
Level 3 -
|
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
As of September 30, 2011
|
||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||
Cash equivalents:
|
||||||||||||||
Money market funds
|
$
|
2,333
|
$
|
—
|
$
|
—
|
$
|
2,333
|
||||||
Short-term investments:
|
||||||||||||||
Corporate debt securities
|
—
|
2,912
|
—
|
2,912
|
||||||||||
Federal agency bond
|
—
|
250
|
—
|
250
|
||||||||||
Total assets at fair value
|
$
|
2,333
|
$
|
3,162
|
$
|
—
|
$
|
5,495
|
As of June 30, 2011
|
||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||
Cash equivalents:
|
||||||||||||||
Money market funds
|
$
|
4,016
|
$
|
—
|
$
|
—
|
$
|
4,016
|
||||||
Short-term investments:
|
||||||||||||||
Corporate debt securities
|
—
|
1,243
|
—
|
1,243
|
||||||||||
Federal agency bond
|
—
|
250
|
—
|
250
|
||||||||||
Total assets at fair value
|
$
|
4,016
|
$
|
1,493
|
$
|
—
|
$
|
5,509
|
As of September 30, 2011 | ||||||||||||||||
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair Value
|
|||||||||||||
Available-for-sale securities:
|
||||||||||||||||
Corporate debt securities
|
$ | 2,915 | $ | — | $ | (3 | ) | $ | 2,915 | |||||||
Federal agency bond
|
$ | 250 | — | — | 250 | |||||||||||
Total
|
$ | 3,165 | $ | — | $ | (3 | ) | $ | 3,162 |
As of June 30, 2011 | ||||||||||||||||
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair Value
|
|||||||||||||
Available-for-sale securities:
|
||||||||||||||||
Corporate debt securities
|
$ | 1,244 | $ | — | $ | (1 | ) | $ | 1,243 | |||||||
Federal agency bond
|
250 | — | — | 250 | ||||||||||||
Total
|
$ | 1,494 | $ | — | $ | (1 | ) | $ | 1,493 |
September 30,
2011
|
June 30,
2011
|
|||||
Raw materials
|
$
|
286
|
$
|
341
|
||
Work in progress
|
236
|
112
|
||||
Finished goods
|
256
|
387
|
||||
$
|
778
|
$
|
840
|
Fiscal year ending June 30,
|
Operating
Leases
|
||||
2012 (remaining nine months)
|
$
|
476
|
|||
2013
|
652
|
||||
2014
|
688
|
||||
2015
|
728
|
||||
2016
|
124
|
||||
Total minimum lease payments
|
$
|
2,668
|
Contractual Obligations:
|
Total
|
Less Than
1 Year
|
1-3
Years
|
4-5
Years
|
More Than
5 Years
|
|||||||||||||||
Operating lease obligations
|
$ | 2,668 | $ | 476 | $ | 2,068 | $ | 124 | $ | — | ||||||||||
Notes payable, including interest
|
2,500 | 75 | 300 | 2,125 | — | |||||||||||||||
Total
|
$ | 5,168 | $ | 551 | $ | 2,368 | $ | 2,249 | $ | — |
Three months ended
|
|||||||
September 30,
|
|||||||
2011
|
2010
|
||||||
Net cash provided by (used in) operating activities
|
$
|
(2,433
|
)
|
$
|
7,729
|
||
Net cash used in investing activities
|
(2,390
|
)
|
(7
|
)
|
|||
Net cash provided by financing activities
|
2,903
|
611
|
|
●
|
the extent of our ongoing research and development programs and related costs, including costs related to the continued development of the MicroCutter XPRESS 30, the MicroCutter XCHANGE 30 and additional potential products in our anticipated MicroCutter product line;
|
|
|
●
|
our ability to enter into additional license, development and/or collaboration agreements with respect to our technology, and the terms thereof;
|
|
|
●
|
market acceptance and adoption of our current products or future products that we may commercialize;
|
|
●
|
our level of revenue;
|
|
●
|
costs associated with our sales and marketing initiatives and manufacturing activities;
|
|
●
|
costs and timing of obtaining and maintaining FDA and other regulatory clearances and approvals for our products and potential additional products;
|
|
|
●
|
securing, maintaining and enforcing intellectual property rights and the costs thereof;
|
|
●
|
the extent to which we access additional capital from Century, or under the Purchase Agreement with Aspire Capital, or under the ATM Agreement with MLV; and
|
|
●
|
the effects of competing technological and market developments.
|
|
●
|
achievement of broad acceptance for our current products or future products that we may commercialize;
|
|
●
|
achievement of U.S. regulatory clearance or approval for additional products; and
|
|
●
|
successful sales, manufacturing, marketing and distribution of our products.
|
|
●
|
the extent of our ongoing research and development programs and related costs, including costs related to the continued development of the MicroCutter XPRESS 30, the MicroCutter XCHANGE 30 and additional potential products in our anticipated MicroCutter product line;
|
|
●
|
our ability to enter into additional license, development and/or collaboration agreements with respect to our technology, and the terms thereof;
|
|
●
|
market acceptance and adoption of our current products or future products that we may commercialize;
|
|
●
|
our level of revenue;
|
|
●
|
costs associated with our sales and marketing initiatives and manufacturing activities;
|
|
●
|
costs and timing of obtaining and maintaining FDA and other regulatory clearances and approvals for our products and potential additional products;
|
|
●
|
securing, maintaining and enforcing intellectual property rights and the costs thereof;
|
|
●
|
the extent to which we access additional capital from Century, or under the Purchase Agreement with Aspire Capital, or under the ATM Agreement with MLV; and
|
|
●
|
the effects of competing technological and market developments.
|
|
●
|
the extent of our ongoing research and development programs and related costs, including costs related to the continued development of the MicroCutter XPRESS 30, the MicroCutter XCHANGE 30 and additional potential products in our anticipated MicroCutter product line;
|
|
●
|
our ability to enter into additional license, development and/or collaboration agreements with respect to our technology, and the terms thereof;
|
|
●
|
market acceptance and adoption of our current products or future products that we may commercialize;
|
|
●
|
our level of revenue;
|
|
●
|
costs associated with our sales and marketing initiatives and manufacturing activities;
|
|
●
|
costs and timing of obtaining and maintaining FDA and other regulatory clearances and approvals for our products and potential additional products;
|
|
●
|
securing, maintaining and enforcing intellectual property rights and the costs thereof;
|
|
●
|
the extent to which we access capital from Century, or under the Purchase Agreement with Aspire Capital, or under the ATM Agreement with MLV; and
|
|
●
|
the effects of competing technological and market developments.
|
|
●
|
warning letters, fines, injunctions, consent decrees and civil penalties;
|
|
●
|
customer notifications, repair, replacement, refunds, recall or seizure of our products;
|
|
●
|
operating restrictions, partial suspension or total shutdown of production;
|
|
●
|
delay in processing marketing applications for new products or modifications to existing products;
|
|
●
|
withdrawing approvals that have already been granted; and
|
|
●
|
criminal prosecution.
|
|
●
|
the FDA or other regulatory authorities suspend or place on hold a clinical trial, or do not approve a clinical trial protocol or a clinical trial;
|
|
●
|
the data and safety monitoring committee of a clinical trial recommends that a trial be placed on hold or suspended;
|
|
●
|
patients do not enroll in clinical trials at the rate we expect;
|
|
●
|
patients are not followed-up at the rate we expect;
|
|
●
|
clinical trial sites decide not to participate or cease participation in a clinical trial;
|
|
●
|
patients experience adverse side effects or events related to our products;
|
|
●
|
patients die or suffer adverse medical effects during a clinical trial for a variety of reasons, which may not be related to our product candidates, including the advanced stage of their disease and other medical problems;
|
|
●
|
third-party clinical investigators do not perform our clinical trials on our anticipated schedule or consistent with the clinical trial protocol and good clinical practices, or other third-party organizations do not perform data collection and analysis in a timely or accurate manner;
|
|
●
|
regulatory inspections of our clinical trials or manufacturing facilities may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials if investigators find us not to be in compliance with regulatory requirements;
|
|
●
|
third-party suppliers fail to provide us with critical components that conform to design and performance specifications;
|
|
●
|
the failure of our manufacturing processes to produce finished products that conform to design and performance specifications;
|
|
●
|
changes in governmental regulations or administrative actions;
|
|
●
|
the interim results of the clinical trial are inconclusive or negative;
|
|
●
|
pre-clinical or clinical data is interpreted by third parties in different ways; or
|
|
●
|
our trial design, although approved, is inadequate to demonstrate safety and/or efficacy.
|
|
●
|
reduced product size;
|
|
●
|
ease of use;
|
|
●
|
product quality and reliability;
|
|
●
|
multi-fire capability;
|
|
●
|
device cost-effectiveness;
|
|
●
|
degree of articultaion;
|
|
●
|
surgeon relationships; and
|
|
●
|
sales and marketing capabilities.
|
|
●
|
improved patient outcomes;
|
|
●
|
access to and acceptance by leading physicians;
|
|
●
|
product quality and reliability;
|
|
●
|
ease of use;
|
|
●
|
device cost-effectiveness;
|
|
●
|
training and support;
|
|
●
|
novelty;
|
|
●
|
physician relationships; and
|
|
●
|
sales and marketing capabilities.
|
|
●
|
maintaining product yields;
|
|
●
|
maintaining quality control and assurance;
|
|
●
|
providing component and service availability;
|
|
●
|
maintaining adequate control policies and procedures; and
|
|
●
|
hiring and retaining qualified personnel.
|
|
●
|
export restrictions and controls relating to technology;
|
|
●
|
the availability and level of reimbursement within prevailing foreign healthcare payment systems;
|
|
●
|
pricing pressure that we may experience internationally;
|
|
●
|
required compliance with existing and changing foreign regulatory requirements and laws;
|
|
●
|
laws and business practices favoring local companies;
|
|
●
|
longer payment cycles;
|
|
●
|
difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;
|
|
●
|
political and economic instability;
|
|
●
|
potentially adverse tax consequences, tariffs and other trade barriers;
|
|
●
|
international terrorism and anti-American sentiment;
|
|
●
|
difficulties and costs of staffing and managing foreign operations; and
|
|
●
|
difficulties in enforcing intellectual property rights.
|
|
●
|
completion of development and commercial launch of our MicroCutter products, and the timing thereof;
|
|
●
|
market acceptance and adoption of our products;
|
|
●
|
regulatory clearance or approvals of or other regulatory developments with rest to our products;
|
|
●
|
volume and timing of orders for our products;
|
|
●
|
changes in earnings estimates, investors' perceptions, recommendations by securities analysts or our failure to achieve analysts' earnings estimates;
|
|
●
|
quarterly variations in our or our competitors' results of operations;
|
|
●
|
general market conditions and other factors unrelated to our operating performance or the operating performance of our competitors;
|
|
●
|
the announcement of new products or product enhancements by us or our competitors;
|
|
●
|
announcements related to patents issued to us or our competitors and to litigation; and
|
|
●
|
developments in our industry.
|
|
●
|
completion of development, and commercialization, of our MicroCutter products, and the timing thereof;
|
|
●
|
FDA or other regulatory clearance or approval of our products;
|
|
●
|
demand for our products;
|
|
●
|
the performance of third-party contract manufacturers and component suppliers;
|
|
●
|
our ability to develop sales and marketing capabilities;
|
|
●
|
our ability to develop, introduce and market new or enhanced versions of our products on a timely basis; and
|
|
●
|
our ability to obtain and protect proprietary rights.
|
|
●
|
limit who may call a special meeting of stockholders;
|
|
●
|
establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon at stockholder meetings;
|
|
●
|
prohibit cumulative voting in the election of our directors, which would otherwise permit less than a majority of stockholders to elect directors;
|
|
●
|
prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; and
|
|
●
|
provide our board of directors with the ability to designate the terms of and issue a new series of preferred stock without stockholder approval.
|
Exhibit
No.
|
Description.
|
|
3.1
|
Amended and Restated Certificate of Incorporation of Cardica, Inc.
Ö
|
|
3.2
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc. (1)
|
|
3.3
|
Certificate of Correction of Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc. (2)
|
|
3.4
|
Amended and Restated Bylaws of Cardica, Inc. (3)
|
|
4.1
|
Warrant dated March 17, 2000 exercisable for 36,870 shares of common stock (on a pre-split basis).
Ö
|
|
4.2
|
Warrant dated October 31, 2002 exercisable for 180,052 shares of common stock (on a pre-split basis).
Ö
|
|
4.3
|
Form of Warrant dated June 2007. (4)
|
|
4.4
|
Form of Warrant dated September 30, 2009. (5)
|
|
10.35
|
At The Market Issuance Sales Agreement, dated August 3, 2011, by and between Cardica, Inc., and McNicoll, Lewis & Vlak LLC. (6)
|
|
10.36
|
Distribution Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
|
|
10.37
|
Secured Note Purchase Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
|
|
10.38
|
Security Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
|
|
10.39
|
Form of Secured Promissory Note to Century Medical, Inc.
|
|
31.1
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
31.2
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
32.1*
|
Certification required by Rule 13a-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).
|
|
101.INS#
|
XBRL Instance Document.
|
|
101.SCH#
|
XBRL Taxonomy Extension Schema Document.
|
|
101.CAL#
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
101.DEF#
|
XBRL Taxonomy Extension Definition.
|
|
101.LAB#
|
XBRL Taxonomy Extension Labels Linkbase Document.
|
|
101.PRE#
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
Ö
|
Filed as exhibits to the Company's Registration Statement on Form S-1 filed with the Securities and Exchange Commission on November 4, 2005, as amended, and incorporated herein by reference.
|
|
*
|
The certification attached as Exhibit 32.1 accompanying this Quarterly Report on Form 10-Q is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Cardica, Inc., under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q and irrespective of any general incorporation language contained in any such filing.
|
|
†
#
|
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment. Omitted portions of this exhibit have been filed separately with the Securities and Exchange Commission.
Pursuant to applicable securities laws and regulations, Cardica, Inc. is deemed to have complied with the reporting obligation relating to the submission of interactive data files in such exhibits and is not subject to liability under any anti-fraud provisions of the federal securities laws as long as Cardica, Inc. has made a good faith attempt to comply with the submission requirements and promptly amend the interactive data files after becoming aware that the interactive data files fail to comply with the submission requirements. In accordance with Rule 406T of Regulation S-T, the information in these exhibits is furnished and deemed not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
|
|
(1)
|
Filed as an exhibit to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 15, 2010 and incorporated herein by reference.
|
|
(2)
|
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 16, 2010 and incorporated herein by reference.
|
|
(3)
|
Filed as an exhibit to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on August 19, 2008 and incorporated herein by reference.
|
|
(4)
|
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 13, 2007 and incorporated herein by reference.
|
|
(5)
|
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 29, 2009 and incorporated herein by reference.
|
|
(6)
|
Filed as an exhibit to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on August 4, 2011 and incorporated herein by reference.
|
Date: November 9, 2011
|
/s/ Bernard A. Hausen
|
|
Bernard A. Hausen, M.D., Ph.D.
|
||
Date: November 9, 2011
|
/s/ Robert Y. Newell
|
|
Robert Y. Newell
|
||
Exhibit
No.
|
Description.
|
|
3.1
|
Amended and Restated Certificate of Incorporation of Cardica, Inc.
Ö
|
|
3.2
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc. (1)
|
|
3.3
|
Certificate of Correction of Certificate of Amendment of Amended and Restated Certificate of Incorporation of Cardica, Inc. (2)
|
|
3.4
|
Amended and Restated Bylaws of Cardica, Inc. (3)
|
|
4.1
|
Warrant dated March 17, 2000 exercisable for 36,870 shares of common stock (on a pre-split basis).
Ö
|
|
4.2
|
Warrant dated October 31, 2002 exercisable for 180,052 shares of common stock (on a pre-split basis).
Ö
|
|
4.3
|
Form of Warrant dated June 2007. (4)
|
|
4.4
|
Form of Warrant dated September 30, 2009. (5)
|
|
10.35
|
At The Market Issuance Sales Agreement, dated August 3, 2011, by and between Cardica, Inc., and McNicoll, Lewis & Vlak LLC. (6)
|
|
10.36
|
Distribution Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
|
|
10.37
|
Secured Note Purchase Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
|
|
10.38
|
Security Agreement by and between Cardica, Inc. and Century Medical, Inc. dated September 2, 2011.†
|
|
10.39
|
Form of Secured Promissory Note to Century Medical, Inc.
|
|
31.1
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
31.2
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
32.1*
|
Certification required by Rule 13a-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).
|
|
101.INS#
|
XBRL Instance Document.
|
|
101.SCH#
|
XBRL Taxonomy Extension Schema Document.
|
|
101.CAL#
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
101.DEF#
|
XBRL Taxonomy Extension Definition.
|
|
101.LAB#
|
XBRL Taxonomy Extension Labels Linkbase Document.
|
|
101.PRE#
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
Ö
|
Filed as exhibits to the Company's Registration Statement on Form S-1 filed with the Securities and Exchange Commission on November 4, 2005, as amended, and incorporated herein by reference.
|
|
*
|
The certification attached as Exhibit 32.1 accompanying this Quarterly Report on Form 10-Q is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Cardica, Inc., under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q and irrespective of any general incorporation language contained in any such filing.
|
|
†
#
|
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment. Omitted portions of this exhibit have been filed separately with the Securities and Exchange Commission.
Pursuant to applicable securities laws and regulations, Cardica, Inc. is deemed to have complied with the reporting obligation relating to the submission of interactive data files in such exhibits and is not subject to liability under any anti-fraud provisions of the federal securities laws as long as Cardica, Inc. has made a good faith attempt to comply with the submission requirements and promptly amend the interactive data files after becoming aware that the interactive data files fail to comply with the submission requirements. In accordance with Rule 406T of Regulation S-T, the information in these exhibits is furnished and deemed not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
|
|
(1)
|
Filed as an exhibit to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 15, 2010 and incorporated herein by reference.
|
|
(2)
|
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 16, 2010 and incorporated herein by reference.
|
|
(3)
|
Filed as an exhibit to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on August 19, 2008 and incorporated herein by reference.
|
|
(4)
|
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 13, 2007 and incorporated herein by reference.
|
|
(5)
|
Filed as an exhibit to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 29, 2009 and incorporated herein by reference.
|
|
(6)
|
Filed as an exhibit to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on August 4, 2011 and incorporated herein by reference.
|
Distribution Agreement
by and between
Cardica, Inc.
a Delaware Corporation
and
Century Medical, Inc.
a Japanese Corporation
Dated as of September 2, 2011
|
1.1
|
“Competing Products”
|
1.2
|
“Contract Year”
|
1.3
|
“First Commercial Sale”
|
1.4
|
“Initial Term”
|
1.5
|
“Note Agreement”
|
1.6
|
“Party” or “Parties”
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 1 | |
Century Medical, Inc. | Initial AH |
1.7
|
“Premarketing Term”
|
1.8
|
“Products”
|
1.9
|
“Territory”
|
2.1
|
Appointment as DISTRIBUTOR by COMPANY.
|
2.2
|
Subdistributors.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 2 | |
Century Medical, Inc. | Initial AH |
3.1
|
Consideration for Distribution Rights.
|
3.2
|
Term.
|
4.1
|
Duties of DISTRIBUTOR.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 3 | |
Century Medical, Inc. | Initial AH |
4.2
|
Product Approvals.
|
5.1
|
Duties of COMPANY.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 4 | |
Century Medical, Inc. | Initial AH |
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 5 | |
Century Medical, Inc. | Initial AH |
6.1
|
DISTRIBUTOR’s Expenses.
|
6.2
|
COMPANY’s Expenses.
|
7.1
|
Records and Reports.
|
7.2
|
Adverse Experience Reporting.
|
7.3
|
Recall.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 6 | |
Century Medical, Inc. | Initial AH |
8.1
|
Purchase Prices and Terms.
|
8.2
|
Risk of Loss, Deliveries.
|
8.3
|
Acceptance and Cancellation of Orders.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 7 | |
Century Medical, Inc. | Initial AH |
8.4
|
Product Specifications.
|
8.5
|
Taxes.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 8 | |
Century Medical, Inc. | Initial AH |
8.6
|
Purchase Levels.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 9 | |
Century Medical, Inc. | Initial AH |
9.1
|
Claim, Suit or Action.
|
9.2
|
Product Liability Insurance.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 10 | |
Century Medical, Inc. | Initial AH |
10.1
|
Warranties.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 11 | |
Century Medical, Inc. | Initial AH |
10.2
|
Rejection of Products.
|
11.1
|
Trademark License.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 12 | |
Century Medical, Inc. | Initial AH |
11.2
|
Duty to Preserve Confidentiality.
|
11.3
|
Proprietary.
|
12.1
|
Indemnity.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 13 | |
Century Medical, Inc. | Initial AH |
12.2
|
Infringing Products.
|
13.1
|
Cancellation for Cause.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 14 | |
Century Medical, Inc. | Initial AH |
13.2
|
Obligations upon Cancellation or Termination.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 15 | |
Century Medical, Inc. | Initial AH |
If Change in Control termination occurs during:
|
Then the Change of Control Termination Fee shall be equal to:
|
Multiplied by a factor of
|
Period from the Effective Date up to the end of Contract Year 3
|
Termination not permitted due to a Change in Control (defined below).
|
|
Contract Years 4 or 5
|
DISTRIBUTOR’s gross profit from the Products in the twelve (12) month period immediately preceding termination of this Agreement
|
[ * ]
|
the Renewal Period
|
[ * ]
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 16 | |
Century Medical, Inc. | Initial AH |
14.1
|
Force Majeure.
|
14.2
|
Relationship between Parties.
|
14.3
|
Successors, Nonassignability.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 17 | |
Century Medical, Inc. | Initial AH |
14.4
|
Survival of Obligations.
|
14.5
|
Remedies.
|
14.6
|
Notices.
|
14.7
|
Disputes.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 18 | |
Century Medical, Inc. | Initial AH |
14.8
|
Unenforceable Terms.
|
14.9
|
Waivers.
|
14.10
|
Governing Law; Headings.
|
14.11
|
Entire Agreement, Modification.
|
14.12
|
Further Assurances.
|
14.13
|
Schedule.
|
14.14
|
Counterparts.
|
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 19 | |
Century Medical, Inc. | Initial AH |
By:
|
/s/ Bernard Hausen | ||
Name:
|
Bernard Hausen, MD | ||
Title:
|
President & CEO |
By:
|
/s/ Akira Hoshino | ||
Name:
|
Akira Hoshino | ||
Title:
|
President & CEO |
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page- 20 | |
Century Medical, Inc. | Initial AH |
Distribution Agreement |
September 2, 2011
|
||
Cardica, Inc. | Initial BH | page-2 1 | |
Century Medical, Inc. | Initial AH |
1.
|
Amount and Terms of the Secured Loan
|
2.
|
The Closing
s
|
4.
|
Representations and Warranties of the Purchaser
|
5.
|
Events of Default; Remedies; Covenants
|
6.
|
Conditions to Closing
|
7.
|
Miscellaneous
|
If to the Company:
|
Cardica, Inc.
900 Saginaw Drive
Redwood City, California 94063
Telephone No.: (650) 364-9975
Facsimile No.: (650) 364-3134
Attention: Robert Y. Newell
|
With a copy to:
|
Cooley LLP
3175 Hanover Street
Palo Alto, California 94304
Telephone No.: (650) 843-5000
Facsimile No.: (650) 849-7400
Attention: Suzanne Sawochka Hooper, Esq.
|
If to the Purchaser:
|
Century Medical, Inc.
1-11-2 Osaki, Shinagawa-ku
Tokyo 141-8588, Japan
Telephone No.: +81-3-3491-1552
Facsimile No.: +81-3-3491-0577
Attention: Mr. Shunzo Saegusa
or such other address as may be designated in writing hereafter, in the same manner, by such Person.
|
With a copy to:
|
O’Melveny & Myers LLP
Meiji Yasuda Seimei Bldg., 11F
2-1-1 Marunouchi, Chiyoda-ku
Tokyo 100-0005, Japan
Facsimile No.: +81-3-5293-2780
Attention: Dale Araki, Esq.
|
Company:
|
||
Cardica, Inc.
|
||
By:
|
/s/ Bernard Hausen | |
Name:
|
Bernard Hausen, MD | |
Title:
|
President & CEO |
Purchaser:
|
||
Century Medical, Inc.
|
||
By:
|
/s/ Akira Hoshino | |
Name:
|
Akira Hoshino | |
Title:
|
President & CEO |
Address Of Grantor
900 Saginaw Drive
Redwood City, CA 94063
|
Cardica, Inc.
, as Grantor
By:
/s/ Bernard Hausen
Printed Name:
Bernard Hausen, MD
Title:
President
|
Taxpayer Identification Number of Grantor
94-3287832
|
Jurisdiction of Organization of Grantor
Delaware
|
Accepted And Acknowledged By:
Century Medical, Inc.
By:
/s/ Akira Hoshino
Printed Name:
Akira Hoshino
Title:
President & CEO
|
|
Entity
|
Address
|
Cardica, Inc.
|
900 Saginaw Drive
Redwood City, CA 94063
|
Patent Number
|
Title
|
|
1
|
6,371,964
|
Trocar for Use in Deploying an Anastomosis Device and Method of Performing Anastomosis
|
2
|
6,402,764
|
Everter and Threadthrough System for Attaching Graft Vessel to Anastomosis Device
|
3
|
6,419,681
|
Implantable Medical Device Such as an Anastomosis Device
|
4
|
6,428,550
|
Sutureless Closure and Deployment System for Connecting Blood Vessels
|
5
|
6,461,320
|
Method and System for Attaching a Graft to a Blood Vessel
|
6
|
6,471,713
|
System for Deploying an Anastomosis Device and Method of performing anastomosis
|
7
|
6,537,288
|
Implantable Medical Device Such as an Anastomosis Device
|
8
|
6,652,541
|
Method of Sutureless Closure for Connecting Blood Vessels
|
9
|
6,666,832
|
Surgical Measurement Tool
|
10
|
6,673,088
|
Tissue Punch
|
11
|
6,719,769
|
Integrated Anastomosis Tool with Graft Vessel Attachment Device and Cutting Device
|
12
|
6,786,914
|
Sutureless Closure and Deployment System for Connecting Blood Vessels
|
13
|
6,821,286
|
System for Preparing a Graft Vessel for Anastomosis
|
14
|
6,893,449
|
Device for Cutting and Anastomosing Tissue
|
15
|
6,955,679
|
Everter and Threadthrough System for Attaching Graft Vessel to Anastomosis Device
|
16
|
6,962,595
|
Integrated Anastomosis System
|
17
|
7,004,949
|
Method and System for Attaching a Graft to a Blood Vessel
|
18
|
7,014,618
|
Surgical Measurement Tool
|
19
|
7,029,482
|
Integrated Anastomosis System
|
20
|
7,041,110
|
Method and System for Attaching a Graft to a Blood Vessel
|
21
|
7,048,751
|
Implantable Medical Device Such as an Anastomosis Device
|
22
|
7,172,608
|
Sutureless Closure and Deployment System for Connecting Blood Vessels
|
23
|
7,175,637
|
Sutureless Closure and Deployment System for Connecting Blood Vessels
|
24
|
7,223,274
|
Method of Performing Anastomosis
|
25
|
7,309,343
|
Method for Cutting tissue
|
26
|
7,335,216
|
Tool for Creating an Opening in Tissue
|
27
|
7,357,807
|
Integrated Anastomosis Tool with Graft Vessel Attachment Device and Cutting Device
|
28
|
7,427,261
|
System for Preparing a Graft Vessel for Anastomosis
|
29
|
7,455,677
|
Anastomosis Device Having a Deployable Section
|
30
|
7,468,066
|
Trocar for Use in Deploying an Anastomosis Device and Method of Performing Anastomosis
|
31
|
7,520,885
|
Functional Package for an Anastomosis Procedure
|
32
|
7,611,523
|
Method for Sutureless Connection of Vessels
|
33
|
8,012,164
|
Method and Apparatus for Creating an Opening in the Wall of a Tubular Vessel
|
34
|
DE69934319T2
|
Method and System for Attaching a Graft to a Blood Vessel
|
35
|
ES2277445
|
Method and System for Attaching a Graft to a Blood Vessel
|
36
|
68251BE/2007 (Italy)
|
Method and System for Attaching a Graft to a Blood Vessel
|
37
|
DE 100 84 618
|
Trocar for Use in Deploying an Anastomosis Device and Method of Performing Anastomosis
|
38
|
DE 100 84 620
|
Sutureless Closure and Deployment System for Connecting Blood Vessels
|
39
|
EP 1105069
|
Method and System for Attaching a Graft to a Blood Vessel
|
No. SN-1
Up to U.S. $4,000,000
|
Redwood City, CA
_________, 2011
|
Cardica, Inc.
|
||||
By: /s/
|
||||
Name:
|
||||
Title:
|
Agreed to and Accepted: | ||||
Century Medical, Inc. | ||||
By: /s/
|
||||
Name:
|
||||
Title:
|
Advance No.
|
Date of Advance or Payment
|
Amount of Advance
|
1
|
_____, 2011
|
U.S. $_________
|
Date: November 9, 2011
|
/s/ Bernard A. Hausen, M.D., Ph.D.
|
||
Bernard A. Hausen, M.D., Ph.D.
President, Chief Executive Officer, Chief Medical
Officer and Director
(Principal Executive Officer)
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Date: November 9, 2011
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/s/ Robert Y. Newell
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Robert Y. Newell
Vice President, Finance, Chief Financial Officer and Secretary
(Principal Financial Officer)
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1.
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The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2011, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
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2.
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The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Bernard A. Hausen, M.D., Ph.D.
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/s/ Robert Y. Newell
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Bernard A. Hausen, M.D., Ph.D.
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Robert Y. Newell
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Chief Executive Officer
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Chief Financial Officer
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