SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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
OR
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____ to ____
Commission file number 0-22885
TRIPATH IMAGING, INC.
| Delaware | 56-1995728 | |
|
|
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| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
| 780 Plantation Drive, Burlington, North Carolina | 27215 | |
| (Address of principal executive offices) | (Zip Code) |
(336) 222-9707
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date.
| Class | Outstanding at November 4, 2002 | |||
| Common Stock, $.01 par value | 37,480,297 | |||
TriPath Imaging, Inc.
Table of Contents
| Page | ||
| Part I. Financial Information | ||
| Item 1. Condensed Consolidated Financial Statements (Unaudited) | 2 | |
Condensed
consolidated balance sheets As of September 30, 2002 and
December 31, 2001. |
2 | |
Condensed consolidated statements of operations for the three months and nine months
ended September 30, 2002 and 2001. |
3 | |
Condensed consolidated statements of cash flows For the nine months ended
September 30, 2002 and 2001. |
4 | |
Notes
to unaudited condensed consolidated financial statements |
5 | |
| Item 2. Managements Discussion and Analysis of Financial Condition And Results of Operations | 10 | |
| Item 3. Quantitative and Qualitative Disclosures About Market Risk | 23 | |
| Item 4. Controls and Procedures | 23 | |
| Part II. Other Information | ||
| Item 1. Legal Proceedings | 23 | |
| Item 6. Exhibits and Reports on Form 8-K | 24 | |
| Signatures | 25 | |
| Certifications | 26 |
1
Part I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements:
TriPath Imaging, Inc.
| September 30, | December 31, | |||||||||
| 2002 | 2001 | |||||||||
Assets |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ | 35,598 | $ | 53,477 | ||||||
Short-term investments |
| 2,499 | ||||||||
Accounts receivable, net |
9,186 | 9,581 | ||||||||
Inventory, net |
11,209 | 10,718 | ||||||||
Other current assets |
842 | 1,079 | ||||||||
Total current assets |
56,835 | 77,354 | ||||||||
Customer-use assets, net |
6,357 | 6,089 | ||||||||
Property and equipment, net |
4,276 | 2,362 | ||||||||
Other assets |
2,218 | 916 | ||||||||
Intangible assets |
9,414 | 10,027 | ||||||||
Total assets |
$ | 79,100 | $ | 96,748 | ||||||
Liabilities and stockholders equity |
||||||||||
Current liabilities: |
||||||||||
Accounts payable |
$ | 3,924 | $ | 4,411 | ||||||
Accrued expenses |
4,555 | 4,116 | ||||||||
Deferred revenue and customer deposits |
1,068 | 730 | ||||||||
Deferred research and development funding |
2,479 | 2,479 | ||||||||
Current portion of long-term debt |
1,522 | 2,720 | ||||||||
Other current liabilities |
2,475 | | ||||||||
Total current liabilities |
16,023 | 14,456 | ||||||||
Long-term debt, less current portion |
17 | 790 | ||||||||
Other long-term liabilities |
826 | 4,210 | ||||||||
Stockholders equity: |
||||||||||
Common stock, $0.01 par value; 98,000,000 shares authorized;
37,479,595 and 37,304,738 shares issued and outstanding at
September 30, 2002 and December 31, 2001, respectively |
375 | 373 | ||||||||
Additional paid-in capital |
283,430 | 283,396 | ||||||||
Accumulated other comprehensive loss |
(31 | ) | (59 | ) | ||||||
Deferred compensation |
(123 | ) | | |||||||
Accumulated deficit |
(221,417 | ) | (206,418 | ) | ||||||
Total stockholders equity |
62,234 | 77,292 | ||||||||
Total liabilities and stockholders equity |
$ | 79,100 | $ | 96,748 | ||||||
See accompanying notes to condensed consolidated financial statements
2
TriPath Imaging, Inc.
Condensed Consolidated Statements of Operations
| Three months ended | Nine months ended | ||||||||||||||||
| September 30, | September 30, | ||||||||||||||||
| 2002 | 2001 | 2002 | 2001 | ||||||||||||||
Sales |
$ | 9,826 | $ | 5,250 | $ | 26,521 | $ | 20,690 | |||||||||
Cost of sales |
3,886 | 2,248 | 10,925 | 10,000 | |||||||||||||
Gross profit |
5,940 | 3,002 | 15,596 | 10,690 | |||||||||||||
Operating expenses: |
|||||||||||||||||
Research and development |
2,073 | 1,880 | 6,334 | 5,304 | |||||||||||||
Regulatory |
1,000 | 517 | 2,092 | 1,542 | |||||||||||||
Sales and marketing |
4,741 | 5,120 | 15,490 | 12,314 | |||||||||||||
General and administrative |
2,474 | 3,127 | 7,027 | 7,004 | |||||||||||||
| 10,288 | 10,644 | 30,943 | 26,164 | ||||||||||||||
Operating loss |
(4,348 | ) | (7,642 | ) | (15,347 | ) | (15,474 | ) | |||||||||
Interest income |
191 | 650 | 804 | 1,962 | |||||||||||||
Interest expense, including amortization
of non-cash debt issuance costs under
term loan agreement |
(123 | ) | (502 | ) | (456 | ) | (1,345 | ) | |||||||||
Net loss |
$ | (4,280 | ) | $ | (7,494 | ) | $ | (14,999 | ) | $ | (14,857 | ) | |||||
Net loss per common share (basic and
diluted) |
$ | (0.11 | ) | $ | (0.21 | ) | $ | (0.40 | ) | $ | (0.43 | ) | |||||
Weighted-average common shares
outstanding |
37,480 | 36,141 | 37,433 | 34,861 | |||||||||||||
See accompanying notes to condensed consolidated financial statements.
3
TriPath Imaging, Inc.
Condensed Consolidated Statements of Cash Flows
| Nine months ended | |||||||||
| September 30, | |||||||||
| 2002 | 2001 | ||||||||
Operating activities |
|||||||||
Net loss |
$ | (14,999 | ) | $ | (14,857 | ) | |||
Adjustments to reconcile net loss to net cash used in
operating activities: |
|||||||||
Depreciation and amortization |
2,861 | 3,276 | |||||||
Non-cash interest expense |
169 | 670 | |||||||
Gain on disposal of fixed asset |
(5 | ) | (9 | ) | |||||
Amortization of deferred research and development |
(1,859 | ) | (413 | ) | |||||
Other non-cash items |
950 | 1,276 | |||||||
Change in operating assets and liabilities: |
|||||||||
Accounts and notes receivable |
(875 | ) | 1,481 | ||||||
Inventory |
(2,420 | ) | (1,255 | ) | |||||
Accounts payable and other current liabilities |
(65 | ) | (2,213 | ) | |||||
Other |
554 | (542 | ) | ||||||
Net cash used in operating activities |
(15,689 | ) | (12,586 | ) | |||||
Investing activities |
|||||||||
Purchases of property and equipment |
(2,460 | ) | (521 | ) | |||||
Disposals of property and equipment |
5 | 9 | |||||||
Maturities of short-term investments |
2,499 | | |||||||
Other |
| 136 | |||||||
Net cash provided by (used in) investing activities |
44 | (376 | ) | ||||||
Financing activities |
|||||||||
Proceeds from issuance of stock |
| 17,806 | |||||||
Proceeds from exercise of stock options |
234 | 776 | |||||||
Payments on long-term debt |
(2,489 | ) | (2,475 | ) | |||||
Outside funding of research and development |
| 6,198 | |||||||
Other |
| (29 | ) | ||||||
Net cash (used in) provided by financing activities |
(2,255 | ) | 22,276 | ||||||
Effect of exchange rate changes on cash |
21 | (64 | ) | ||||||
Net (decrease) increase in cash and cash equivalents |
(17,879 | ) | 9,250 | ||||||
Cash and cash equivalents at beginning of period |
53,477 | 54,340 | |||||||
Cash and cash equivalents at end of period |
$ | 35,598 | $ | 63,590 | |||||
See accompanying notes to condensed consolidated financial statements
4
TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared by TriPath Imaging, Inc. in accordance with generally accepted accounting principles for interim financial information and applicable Securities and Exchange Commission regulations for interim financial information. These financial statements do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. The balance sheet at December 31, 2001 has been derived from the audited financial statements at that date, but does not include all the information and footnotes required by generally accepted accounting principles for complete financial statements. The accompanying unaudited condensed consolidated financial statements reflect all adjustments (consisting of normal, recurring accruals) which, in the opinion of management, are necessary for a fair presentation of the results for the interim periods presented. The results of operations for such periods are not necessarily indicative of the results expected for the full year or for any future periods. The accompanying condensed consolidated financial statements and related notes should be read in conjunction with our audited consolidated financial statements and notes included in our Annual Report on Form 10-K (File No. 0-22885) for the year ended December 31, 2001.
Reclassifications
Certain amounts, specifically those attributable to our TriPath Oncology segment (see Note 7) and to our accounting for health care costs, in the accompanying condensed consolidated financial statements have been reclassified to more accurately reflect research and development and general and administrative expenses. These reclassifications had no effect on current, or previously, reported net loss or stockholders equity.
2. Inventory
Inventory consists of the following:
| September 30, | December 31, | |||||||
| 2002 | 2001 | |||||||
Raw materials |
$ | 8,102 | $ | 7,442 | ||||
Work-in-process |
432 | 275 | ||||||
Finished goods |
2,675 | 3,001 | ||||||
| $ | 11,209 | $ | 10,718 | |||||
Instruments |
$ | 9,886 | $ | 9,628 | ||||
Reagents and consumables |
1,323 | 1,090 | ||||||
| $ | 11,209 | $ | 10,718 | |||||
For the three months ended September 30, 2002 and 2001, reclassifications of $150 and $296, respectively, occurred between customer-use assets, property and equipment, and inventory. For the nine months ended September 30, 2002 and 2001, such reclassifications were $1,712 and $1,418, respectively.
5
Tripath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except per share amounts)
3. Net Loss Per Share of Common Stock
Per share information is based upon the weighted-average number of shares of common stock outstanding during the period. We incurred losses during all periods presented. As a result, options and warrants were not used to compute diluted loss per share since the effect would be anti-dilutive. Accordingly, there is no difference between basic and diluted loss per share in the periods presented.
4. Long-Term Debt
Included in current and long-term debt are the remaining outstanding balances on a $7,000 subordinated term loan, which we obtained from a syndicate of lenders in February 2000 to finance operations. As of September 30, 2002, the balance outstanding was $1,458, all classified as current. The loan, which is collateralized by substantially all of our assets, accrues interest at a rate equal to the U.S. Treasury Note plus 8%. Accrued interest was due monthly for the first six months of each draw, at which time the outstanding principal balance became payable over a thirty-month term. In connection with this term loan, we issued to the lenders warrants to purchase 223,253 shares of our common stock. Using a Black-Scholes pricing model, the warrants were valued upon issuance at $675, which represented non-cash debt issuance costs. These warrants, which expire in 2007, were recorded as additional paid-in capital and the resulting debt issuance costs are being amortized on a straight-line basis to interest expense over the three-year term of the loan. These warrants have a weighted average exercise price of $4.70 and were exercisable upon issuance.
5. Line of Credit
In February 2000, we obtained a $5,000 working capital facility with Silicon Valley Bank. The outstanding balance is limited to an amount equal to 80% of eligible accounts receivable. The line commitment was renewed for an additional one-year term in January 2002. At September 30, 2002, there was no outstanding balance on the line of credit. In August 2002, a letter of credit for $1,500 was issued against this line to secure operating lease financing in connection with certain facility related capital expenditures. The line bears interest at the banks prime rate plus 1/2% and is collateralized by substantially all of our assets. The line of credit carries customary covenants, including the maintenance of a minimum modified quick ratio, minimum tangible net worth and other requirements.
During August 2002, we obtained a $1,500 lease line of credit (lease line) from Bank of America. This lease line is secured by a letter of credit against our line of credit with Silicon Valley Bank discussed above. This lease line carries three-year lease terms for items acquired under it and financing charges based on three-year constant Treasury Maturities. The lease line will be used as an alternative source of capital to secure operating leases for assets, primarily equipment. As of September 30, 2002, there were $301 of assets leased under this lease line.
6. Other Liabilities
We have recorded a short-term contingent liability of $2,475 in accordance with the provisions of Financial Accounting Standards Board (FASB) Statement of Financial Accounting Standards (SFAS) No. 5, Accounting for Contingencies, on the basis that the likelihood of a future event occurring is probable and reasonably estimable. This contingency relates to our obligation to pay a third party, who received 180,000 shares of our common stock in January 2001 under a settlement agreement, an amount in cash equal to the difference between the market price of our common stock on a specified date in January 2003 and a predetermined target price. The aggregate amount of such obligation will in no event
6
TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except per share amounts)
exceed $2,880. An amount of $1,525, attributable to this contingent liability, was accrued under other long-term liabilities at December 31, 2001.
We entered into a series of agreements with Becton, Dickinson and Company (BD) on July 31, 2001, to develop and commercialize molecular diagnostics and pharmacogenomic tests for cancer as part of the ongoing strategic alliance between BD and Millennium Pharmaceuticals, Inc. (Millennium). We have accounted for the transaction in accordance with the provisions of SFAS No. 68, Research and Development Arrangements. In connection with the transaction, we recorded $6,198 in deferred research and development (R&D) funding, which will be amortized against such expenses over thirty months on a straight line basis. During the three and nine months ended September 30, 2002, $620 and $1,859, respectively, of amortization was recorded against R&D expenses. Included in current and other long-term liabilities are the unamortized balances of $2,479 and $826, respectively.
7. Operations by Industry Segment
Description of Products and Services by Segment
We develop, manufacture, market and sell proprietary products for cancer detection, diagnosis, staging, and treatment selection. We are using our proprietary technologies and know-how to create an array of products designed to improve the clinical management of cancer. We currently operate in two business segments: Commercial Operations, which centers its efforts on cervical cancer screening, and TriPath Oncology, which is focused on the development of molecular diagnostic and pharmacogenomic tests for malignant melanoma and cancers of the cervix, breast, ovary, colon, and prostate.
Results by Segment
TriPath Oncology began operations on July 31, 2001. The results, by segment, for the three and nine months ended September 30, 2002 and 2001, are as follows:
| Three Months Ended September 30, 2002 | ||||||||||||||
| Commercial | TriPath | |||||||||||||
| Operations | Oncology | Total | ||||||||||||
Sales |
$ | 9,826 | $ | | $ | 9,826 | ||||||||
Cost of sales |
3,886 | | 3,886 | |||||||||||
Gross profit |
5,940 | | 5,940 | |||||||||||
Operating expenses: |
||||||||||||||
Research and development |
491 | 1,582 | 2,073 | |||||||||||
Regulatory |
871 | 129 | 1,000 | |||||||||||
Sales and marketing |
4,521 | 220 | 4,741 | |||||||||||
General and administrative |
1,490 | 984 | 2,474 | |||||||||||
Total operating expenses |
7,373 | 2,915 | 10,288 | |||||||||||
Operating loss |
$ | (1,433 | ) | $ | (2,915 | ) | $ | (4,348 | ) | |||||
7
TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except per share amounts)
Results by Segments, continued
| Three Months Ended September 30, 2001 | ||||||||||||||
| Commercial | TriPath | |||||||||||||
| Operations | Oncology | Total | ||||||||||||
Sales |
$ | 5,250 | $ | | $ | 5,250 | ||||||||
Cost of sales |
2,248 | | 2,248 | |||||||||||
Gross profit |
3,002 | | 3,002 | |||||||||||
Operating expenses: |
||||||||||||||
Research and development |
1,135 | 745 | 1,880 | |||||||||||
Regulatory |
517 | | 517 | |||||||||||
Sales and marketing |
5,120 | | 5,120 | |||||||||||
General and administrative |
2,484 | 643 | 3,127 | |||||||||||
Total operating expenses |
9,256 | 1,388 | 10,644 | |||||||||||
Operating loss |
$ | (6,254 | ) | $ | (1,388 | ) | $ | (7,642 | ) | |||||