x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2002 |
¨ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from
to
|
Delaware |
56-1959623 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification
No.) |
5250 Greens Dairy Road, Raleigh, North Carolina |
27616 | |
(Address of principal executive offices) |
(Zip Code) |
Class |
Outstanding at November 12, 2002 | |
Common Stock, par value $0.01 per share |
13,548,297 |
Page Number | ||||
PART I: |
FINANCIAL INFORMATION |
|||
Item 1 |
Condensed Financial Statements |
|||
3 | ||||
4 | ||||
5 | ||||
6 | ||||
Item 2 |
8 | |||
Item 3 |
13 | |||
Item 4 |
13 | |||
PART II: |
OTHER INFORMATION |
|||
Item 6 |
14 |
September 30, 2002 |
December 31, 2001 |
|||||||
(unaudited) |
||||||||
Assets |
||||||||
Cash and cash equivalents |
$ |
295 |
|
$ |
2,914 |
| ||
Short-term investments |
|
14,301 |
|
|
8,925 |
| ||
Accounts receivable |
|
2,531 |
|
|
1,985 |
| ||
Inventories |
|
993 |
|
|
1,246 |
| ||
Prepaid expenses |
|
468 |
|
|
263 |
| ||
|
|
|
|
|
| |||
Total current assets |
|
18,588 |
|
|
15,333 |
| ||
Furniture, fixtures and equipment, net |
|
5,945 |
|
|
6,181 |
| ||
Intangible assets, net |
|
3,004 |
|
|
2,707 |
| ||
Long-term investments |
|
924 |
|
|
1,119 |
| ||
|
|
|
|
|
| |||
Total assets |
$ |
28,461 |
|
$ |
25,340 |
| ||
|
|
|
|
|
| |||
Liabilities and Stockholders Equity |
||||||||
Accounts payable |
$ |
1,630 |
|
$ |
1,206 |
| ||
Accrued expenses |
|
2,299 |
|
|
2,355 |
| ||
Deferred revenue |
|
1,467 |
|
|
1,182 |
| ||
Capital lease obligations |
|
40 |
|
|
333 |
| ||
Short-term debt obligations |
|
|
|
|
936 |
| ||
|
|
|
|
|
| |||
Total current liabilities |
|
5,436 |
|
|
6,012 |
| ||
Other accrued liabilities |
|
480 |
|
|
100 |
| ||
Deferred revenue |
|
1,889 |
|
|
1,981 |
| ||
Long-term debt obligations |
|
486 |
|
|
|
| ||
|
|
|
|
|
| |||
Total liabilities |
|
8,291 |
|
|
8,093 |
| ||
|
|
|
|
|
| |||
Commitments and Contingencies |
|
|
|
|
|
| ||
Preferred Stock, $.01 par value. Authorized 2,000 shares; none issued or outstanding |
|
|
|
|
|
| ||
Common Stock, $.01 par value. Authorized 35,000 shares; 13,547 and 13,508 shares issued and outstanding,
respectively |
|
135 |
|
|
135 |
| ||
Additional paid-in capital |
|
49,059 |
|
|
48,521 |
| ||
Accumulated deficit |
|
(29,024 |
) |
|
(31,409 |
) | ||
|
|
|
|
|
| |||
Total stockholders equity |
|
20,170 |
|
|
17,247 |
| ||
|
|
|
|
|
| |||
Total liabilities and stockholders equity |
$ |
28,461 |
|
$ |
25,340 |
| ||
|
|
|
|
|
|
Three Months Ended September 30, |
Nine Months Ended September 30, | |||||||||||
2002 |
2001 |
2002 |
2001 | |||||||||
Product sales |
$ |
5,643 |
$ |
4,687 |
$ |
16,196 |
$ |
12,652 | ||||
License and product development revenues |
|
258 |
|
186 |
|
762 |
|
546 | ||||
|
|
|
|
|
|
|
| |||||
Total revenues |
|
5,901 |
|
4,873 |
|
16,958 |
|
13,198 | ||||
Cost of products sold |
|
1,472 |
|
1,466 |
|
4,749 |
|
3,799 | ||||
|
|
|
|
|
|
|
| |||||
Gross profit |
|
4,429 |
|
3,407 |
|
12,209 |
|
9,399 | ||||
|
|
|
|
|
|
|
| |||||
Research, development and regulatory affairs expenses |
|
1,574 |
|
1,443 |
|
4,917 |
|
4,178 | ||||
General and administrative expenses |
|
2,259 |
|
1,356 |
|
5,056 |
|
4,120 | ||||
|
|
|
|
|
|
|
| |||||
Total operating expenses |
|
3,833 |
|
2,799 |
|
9,973 |
|
8,298 | ||||
|
|
|
|
|
|
|
| |||||
Income from operations |
|
596 |
|
608 |
|
2,236 |
|
1,101 | ||||
Interest income, net |
|
82 |
|
87 |
|
226 |
|
314 | ||||
|
|
|
|
|
|
|
| |||||
Income before income taxes |
|
678 |
|
695 |
|
2,462 |
|
1,415 | ||||
Provision for income taxes |
|
98 |
|
11 |
|
77 |
|
21 | ||||
|
|
|
|
|
|
|
| |||||
Net income |
$ |
580 |
$ |
684 |
$ |
2,385 |
$ |
1,394 | ||||
|
|
|
|
|
|
|
| |||||
Shares used in computation of net income per common share: |
||||||||||||
Basic |
|
13,542 |
|
13,484 |
|
13,531 |
|
13,459 | ||||
|
|
|
|
|
|
|
| |||||
Diluted |
|
13,719 |
|
13,814 |
|
13,834 |
|
13,767 | ||||
|
|
|
|
|
|
|
| |||||
Net income per common share: |
||||||||||||
Basic |
$ |
0.04 |
$ |
0.05 |
$ |
0.18 |
$ |
0.10 | ||||
|
|
|
|
|
|
|
| |||||
Diluted |
$ |
0.04 |
$ |
0.05 |
$ |
0.17 |
$ |
0.10 | ||||
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
||||||||
2002 |
2001 |
|||||||
Cash flows from operating activities: |
||||||||
Net income |
$ |
2,385 |
|
$ |
1,394 |
| ||
Adjustments to reconcile net income to net cash provided by operating activities: |
||||||||
Depreciation and amortization expense |
|
907 |
|
|
805 |
| ||
Loss on disposals of fixed assets |
|
1 |
|
|
58 |
| ||
Loss on abandonment of patents |
|
210 |
|
|
95 |
| ||
Change in accounts receivable |
|
(546 |
) |
|
(1,612 |
) | ||
Change in inventories |
|
253 |
|
|
(569 |
) | ||
Change in prepaid expenses |
|
(205 |
) |
|
205 |
| ||
Change in accounts payable and accrued expenses |
|
748 |
|
|
236 |
| ||
Change in deferred revenue |
|
193 |
|
|
(391 |
) | ||
|
|
|
|
|
| |||
Net cash provided by operating activities |
|
3,946 |
|
|
221 |
| ||
|
|
|
|
|
| |||
Cash flows from investing activities: |
||||||||
Purchases of furniture, fixtures and equipment |
|
(582 |
) |
|
(513 |
) | ||
Investment in intangible assets |
|
(597 |
) |
|
(1,121 |
) | ||
Purchases of investments |
|
(7,715 |
) |
|
(6,106 |
) | ||
Proceeds from the sale of investments |
|
2,534 |
|
|
6,602 |
| ||
|
|
|
|
|
| |||
Net cash used by investing activities |
|
(6,360 |
) |
|
(1,138 |
) | ||
|
|
|
|
|
| |||
Cash flows from financing activities: |
||||||||
Repayment of debt |
|
(450 |
) |
|
(401 |
) | ||
Net proceeds from sale of common stock |
|
538 |
|
|
673 |
| ||
Payments under capital lease obligations |
|
(293 |
) |
|
(237 |
) | ||
|
|
|
|
|
| |||
Net cash provided (used) by financing activities |
|
(205 |
) |
|
35 |
| ||
|
|
|
|
|
| |||
Decrease in cash and cash equivalents |
|
(2,619 |
) |
|
(882 |
) | ||
Cash and cash equivalents at beginning of period |
|
2,914 |
|
|
1,382 |
| ||
|
|
|
|
|
| |||
Cash and cash equivalents at end of period |
$ |
295 |
|
$ |
500 |
| ||
|
|
|
|
|
|
1. |
Organization |
2. |
Significant Accounting Policies |
3. |
Income Taxes |
4. |
Inventories |
September 30, 2002 |
December 31, 2001 | |||||
Packaging |
$ |
423 |
$ |
451 | ||
Raw materials |
|
64 |
|
61 | ||
Work-in-process |
|
239 |
|
309 | ||
Finished goods |
|
267 |
|
425 | ||
|
|
|
| |||
$ |
993 |
$ |
1,246 | |||
|
|
|
|
5. |
Net Income Per Common Share |
|
our expectations with respect to increases in operating expenses; |
|
expectations with respect to increases in research and development and general and administrative expenses in order to develop new products, manufacture
commercial quantities of products and fund additional clinical studies; |
|
expectations with respect to the development, manufacturing and approval of new products; |
|
expectations with respect to incurring additional capital expenditures to expand our manufacturing capabilities; |
|
expectations with respect to generating revenue or maintaining profitability; |
|
our ability to enter into additional marketing agreements and the ability of our existing marketing partners to successfully commercialize products
incorporating our technologies; |
|
the sufficiency of our existing cash, cash equivalents and investments to finance our capital requirements for at least 12 months; and
|
|
expectations with respect to future capital requirements. |
|
a decline in the level of demand for our products; |
|
developments by competitors; |
|
our inability to obtain regulatory clearances; |
|
general economic conditions and specifically, conditions in the health care industry; |
|
our ability to protect our proprietary products, know-how and manufacturing processes; |
|
our inability to obtain adequate supply of raw materials; |
|
the failure to enter into definitive marketing agreements; |
|
unanticipated cash requirements to support current operations or research and development; and |
|
our ability to attract and retain key personnel. |
|
our ability to manufacture and commercialize successfully our lead product, DERMABOND adhesive; |
|
the progress of our research and product development programs for future nonabsorbable and absorbable products, including clinical studies;
|
|
the effectiveness of product commercialization activities and marketing agreements for our future products, including the scale-up of manufacturing capabilities
for increased capacity in anticipation of product commercialization and development and progress of sales and marketing efforts; |
|
our ability to maintain existing marketing agreements, including our agreement with Ethicon for DERMABOND adhesive, and establish and maintain new marketing
agreements; |
|
our ability to achieve product development milestones; |
|
the costs involved in preparing, filing, prosecuting, defending and enforcing intellectual property rights and complying with regulatory requirements;
|
|
the effect of competing technological and market developments; |
|
timely receipt of regulatory clearances and approvals; |
|
general acceptance of our products by the medical community and consumers; and |
|
general economic conditions. |
Exhibit 10.1 - |
Employment Agreement, dated as of August 29, 2002, between Daniel A. Pelak and the Company |
Exhibit 10.2 - |
Defense Agreement, dated as of August 29, 2002, between Daniel A. Pelak and the Company |
Exhibit 99.1 - |
Certification of Chief Executive Officer |
Exhibit 99.2 - |
Certification of Chief Financial Officer |
CLOSURE MEDICAL CORPORATION | ||||||||
Date: November 14, 2002 |
By: |
/s/ Daniel A. Pelak | ||||||
Daniel A. Pelak President and Chief Executive Officer |
Date: November 14, 2002 |
By: |
/s/ Benny Ward | ||||||
Benny Ward Vice President of Finance and
Chief Financial Officer |
1. |
I have reviewed this quarterly report on Form 10-Q of Closure Medical Corporation; |
2. |
Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report. |
4. |
The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-14 and 15d-14) for the registrant and have: |
a) |
designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries*, is
made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; |
b) |
evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly
report (the Evaluation Date); and |
c) |
presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the
Evaluation Date; |
5. |
The registrants other certifying officer and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit
committee of registrants board of directors (or persons performing the equivalent function): |
a) |
all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process,
summarize and report financial data and have identified for the registrants auditors any material weakness in internal controls; and |
b) |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and
|
6. |
The registrants other certifying officer and I have indicated in this quarterly report whether or not there were significant changes in internal controls
or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
|
* |
The reference is only to Closure Medical Corporation, which has no subsidiaries. |
Date: November 14, 2002 |
By: |
/s/ Daniel A. Pelak | ||||||
Daniel A. Pelak President and Chief Executive
Officer |
1. |
I have reviewed this quarterly report on Form 10-Q of Closure Medical Corporation; |
2. |
Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report. |
4. |
The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-14 and 15d-14) for the registrant and have: |
a. |
designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries*, is
made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; |
b. |
evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly
report (the Evaluation Date); and |
c. |
presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the
Evaluation Date; |
5. |
The registrants other certifying officer and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit
committee of registrants board of directors (or persons performing the equivalent function): |
a. |
all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process,
summarize and report financial data and have identified for the registrants auditors any material weakness in internal controls; and |
b. |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and
|
6. |
The registrants other certifying officer and I have indicated in this quarterly report whether or not there were significant changes in internal controls
or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
|
* |
The reference is only to Closure Medical Corporation, which has no subsidiaries. |
Date: November 14, 2002 |
By: |
/s/ Benny Ward | ||||||
Benny Ward Vice President of Finance and Chief Financial Officer |