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 March 31, 2003
OR
( ) 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 | |
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| (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 by checkmark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). 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 May 6, 2003 | |||
Common Stock, $.01 par value |
37,537,940 | |||
TriPath Imaging, Inc.
Table of Contents
Part I. Financial Information |
|||||
Item 1. Condensed Consolidated Financial Statements (Unaudited) |
2 | ||||
Condensed consolidated balance sheets
As of March 31, 2003 and December 31, 2002 |
2 | ||||
Condensed consolidated statements of operations for the three
months ended March 31, 2003 and 2002 |
3 | ||||
Condensed consolidated statements of cash flows
For the three months ended March 31, 2003 and 2002 |
4 | ||||
Notes to condensed consolidated financial statements |
5 | ||||
Item 2. Managements Discussion and Analysis of Financial Condition
And Results of Operations |
11 | ||||
Item 3. Quantitative and Qualitative Disclosures About Market Risk |
20 | ||||
Item 4. Controls and Procedures |
21 | ||||
Part II. Other Information |
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Item 1. Legal Proceedings |
21 | ||||
Item 6. Exhibits and Reports on Form 8-K |
21 | ||||
Signatures |
22 | ||||
Certifications |
23 | ||||
Exhibit
Index |
25 | ||||
1
Part I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements:
TriPath Imaging, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except share and per share amounts)
| March 31, | December 31, | |||||||||
| 2003 | 2002 | |||||||||
Assets |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ | 27,879 | $ | 32,571 | ||||||
Accounts receivable, net |
10,042 | 9,370 | ||||||||
Inventory, net |
10,286 | 10,973 | ||||||||
Other current assets |
1,437 | 477 | ||||||||
Total current assets |
49,644 | 53,391 | ||||||||
Customer use assets, net |
6,894 | 6,357 | ||||||||
Property and equipment, net |
3,983 | 4,063 | ||||||||
Other assets |
864 | 930 | ||||||||
Intangible assets |
9,006 | 9,210 | ||||||||
Total assets |
$ | 70,391 | $ | 73,951 | ||||||
Liabilities and stockholders equity |
||||||||||
Current liabilities: |
||||||||||
Accounts payable |
$ | 3,585 | $ | 2,341 | ||||||
Accrued expenses |
6,423 | 5,436 | ||||||||
Deferred revenue and customer deposits |
1,020 | 1,103 | ||||||||
Deferred research and development funding |
2,066 | 2,479 | ||||||||
Current portion of long-term debt |
355 | 785 | ||||||||
Other current liabilities |
| 2,410 | ||||||||
Total current liabilities |
13,449 | 14,554 | ||||||||
Long-term debt, less current portion |
11 | 13 | ||||||||
Other long-term liabilities |
| 207 | ||||||||
Stockholders equity: |
||||||||||
Common stock, $0.01 par value; 98,000,000 shares authorized;
37,537,940 and 37,454,234 shares issued and outstanding at
March 31, 2003 and December 31, 2002, respectively |
375 | 375 | ||||||||
Additional paid-in capital |
283,514 | 283,396 | ||||||||
Deferred compensation |
(72 | ) | (78 | ) | ||||||
Accumulated deficit |
(226,832 | ) | (224,482 | ) | ||||||
Accumulated other comprehensive loss |
(54 | ) | (34 | ) | ||||||
Total stockholders equity |
56,931 | 59,177 | ||||||||
Total liabilities and stockholders equity |
$ | 70,391 | $ | 73,951 | ||||||
See accompanying notes to condensed consolidated financial statements
2
TriPath Imaging, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
| Three months ended | |||||||||
| March 31, | |||||||||
| 2003 | 2002 | ||||||||
Revenues |
$ | 11,147 | $ | 7,563 | |||||
Cost of revenues |
3,878 | 3,247 | |||||||
Gross profit |
7,269 | 4,316 | |||||||
Operating expenses: |
|||||||||
Research and development |
1,957 | 1,920 | |||||||
Regulatory |
1,183 | 494 | |||||||
Sales and marketing |
4,106 | 5,476 | |||||||
General and administrative |
2,528 | 1,890 | |||||||
| 9,774 | 9,780 | ||||||||
Operating loss |
(2,505 | ) | (5,464 | ) | |||||
Interest income |
168 | 344 | |||||||
Interest expense, including amortization
of non-cash debt issuance costs under
term loan agreement |
(13 | ) | (181 | ) | |||||
Net loss |
$ | (2,350 | ) | $ | (5,301 | ) | |||
Net loss per common share (basic and
diluted) |
$ | (0.06 | ) | $ | (0.14 | ) | |||
Weighted-average common shares
outstanding |
37,509 | 37,415 | |||||||
See accompanying notes to condensed consolidated financial statements.
3
TriPath Imaging, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands, except share and per share amounts)
| Three months ended | |||||||||
| March 31, | |||||||||
| 2003 | 2002 | ||||||||
Operating activities |
|||||||||
Net loss |
$ | (2,350 | ) | $ | (5,301 | ) | |||
Adjustments to reconcile net loss to net cash used in
operating activities: |
|||||||||
Depreciation and amortization |
1,067 | 972 | |||||||
Amortization of non-cash debt issuance costs |
| 56 | |||||||
Loss on disposal of fixed asset |
9 | | |||||||
Amortization of deferred research and development |
(620 | ) | (620 | ) | |||||
Other non-cash items |
| 324 | |||||||
Change in operating assets and liabilities: |
|||||||||
Accounts receivable |
(666 | ) | (64 | ) | |||||
Inventory |
(760 | ) | (650 | ) | |||||
Accounts payable and other current liabilities |
(281 | ) | (1,825 | ) | |||||
Other |
(893 | ) | 394 | ||||||
Net cash used in operating activities |
(4,494 | ) | (6,714 | ) | |||||
Investing activities |
|||||||||
Purchases of property and equipment |
(62 | ) | (688 | ) | |||||
Maturities of short-term investments |
| 1,000 | |||||||
Other |
196 | | |||||||
Net cash provided by investing activities |
134 | 312 | |||||||
Financing activities |
|||||||||
Proceeds from short term debt |
318 | | |||||||
Proceeds from exercise of stock options |
118 | 179 | |||||||
Payments on long-term debt and leases |
(750 | ) | (829 | ) | |||||
Net cash used in financing activities |
(314 | ) | (650 | ) | |||||
Effect of exchange rate changes on cash |
(18 | ) | 2 | ||||||
Net decrease in cash and cash equivalents |
(4,692 | ) | (7,050 | ) | |||||
Cash and cash equivalents at beginning of period |
32,571 | 53,477 | |||||||
Cash and cash equivalents at end of period |
$ | 27,879 | $ | 46,427 | |||||
See accompanying notes to condensed consolidated financial statements
4
TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except share and per share amounts)
March 31, 2003
| 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 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, 2002 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, 2002.
Reclassifications
Certain amounts for the prior period, specifically those attributable to our TriPath Oncology segment (see Note 8) 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 previously reported net loss or stockholders equity.
| 2. | Inventory |
Inventory consists of the following:
| March 31, | December 31, | |||||||
| 2003 | 2002 | |||||||
Raw materials |
$ | 6,772 | $ | 6,934 | ||||
Work-in-process |
1,841 | 629 | ||||||
Finished goods |
1,673 | 3,410 | ||||||
| $ | 10,286 | $ | 10,973 | |||||
Instruments |
$ | 8,983 | $ | 9,761 | ||||
Reagents and consumables |
1,303 | 1,212 | ||||||
| $ | 10,286 | $ | 10,973 | |||||
For the three months ended March 31, 2003 and 2002, reclassifications of $1,445 and $1,124, respectively, occurred between customer-use assets, property and equipment, and inventory.
5
TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except share and 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 March 31, 2003, the balance outstanding was $58, 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 January 2003, 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. At March 31, 2003, there was no outstanding balance on the line of credit. 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.
In August 2002, we obtained a $1,500 lease line of credit 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 March 31, 2003, there were $1,224 of assets leased under this lease line.
In April 2003, we obtained a $2,500 lease line of credit from General Electric Capital Corporation. This lease line carries three-year lease terms for items acquired under it. The lease line will be used as an alternative source of capital to secure operating leases for assets, primarily equipment.
| 6. | Other Liabilities |
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
6
TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except share and per share amounts)
research and development (R&D) funding, which will be amortized against such expenses over thirty months on a straight line basis. During the three months ended March 31, 2003, $620 of amortization was recorded against R&D expenses. Included in current liabilities is the unamortized balance of $2,066.
| 7. | Stock Based Compensation |
We account for stock options issued to employees in accordance with APB Opinion No. 25, Accounting for Stock Issued to Employees (APB 25). Under APB 25, no compensation expense is recognized for stock or stock options issued with an exercise price equivalent to the fair value of our Common Stock. For stock options granted at exercise prices below the deemed fair value, we record deferred compensation expense for the difference between the exercise price of the shares and the deemed fair value. Any resulting deferred compensation expense is amortized ratably over the vesting period of the individual options.
In October 1995, the FASB issued SFAS No. 123, Accounting for Stock Based Compensation (SFAS 123). For companies that continue to account for stock based compensation arrangements under APB 25, SFAS 123 requires disclosure of the pro forma effect on net income (loss) and earnings (loss) per share as if the fair value based method prescribed by SFAS 123 had been applied.
In December 2002, the FASB issued SFAS No. 148, Accounting for Stock Based CompensationTransition and Disclosurean amendment of FASB Statement No. 123 (SFAS 148). This Statement amends FASB Statement No. 123, Accounting for Stock Based Compensation, to provide alternative methods of transition for a voluntary change to the fair value based method of accounting for stock based employee compensation. In addition, this Statement amends the disclosure requirements of Statement 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock based employee compensation and the effect of the method used on reported results (see below).
Had compensation cost for our stock options been determined based on the fair value at the date of grant consistent with the provisions of SFAS 123, with respect to our Equity Incentive Plans and our Employee Stock Purchase Plan, our pro forma net loss and net loss per share would have been as follows:
| Three Months Ended | |||||||||
| March 31, | |||||||||
| 2003 | 2002 | ||||||||
Net loss: |
|||||||||
As reported |
$ | (2,350 | ) | $ | (5,301 | ) | |||
Pro forma |
$ | (3,153 | ) | $ | (6,083 | ) | |||
Net loss per common
share (basic & diluted): |
|||||||||
As reported |
$ | (0.06 | ) | $ | (0.14 | ) | |||
Pro forma |
$ | (0.08 | ) | $ | (0.16 | ) | |||
7
TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except share and per share amounts
| 8. | Operations by Industry Segment |
Description of Products and Services by Segment
We create solutions that redefine the early detection and clinical management of cancer. Specifically, 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 have developed and marketed an integrated solution for cervical cancer screening and other products that deliver image management, data handling, and prognostic tools for cell diagnosis, cytopathology and histopathology. We have created new opportunities and applications for our proprietary technology by applying recent advances in genomics, biology, and informatics to develop new molecular diagnostic and pharmacogenomic products and services for malignant melanoma and cancers of the cervix, breast, ovary, colon and prostate.
We are organized into two operating units: (1) Commercial Operations, through which we manage the market introduction, sales, service, manufacturing and ongoing development of our products; and (2) TriPath Oncology, our wholly-owned subsidiary through which we manage the development of molecular diagnostic and pharmacogenomic products and services for cancer.
Results by Segment
The results, by segment, for the three months ended March 31, 2003 and 2002, are as follows:
| Three Months Ended March 31, 2003 | ||||||||||||||
| Commercial | TriPath | |||||||||||||
| Operations | Oncology | Total | ||||||||||||
Sales |
$ | 11,014 | $ | 133 | $ | 11,147 | ||||||||
Cost of sales |
3,862 | 16 | 3,878 | |||||||||||
Gross profit |
7,152 | 117 | 7,269 | |||||||||||
Operating expenses: |
||||||||||||||
Research and development |
517 | 1,440 | 1,957 | |||||||||||
Regulatory |
1,038 | 145 | 1,183 | |||||||||||
Sales and marketing |
3,921 | 185 | 4,106 | |||||||||||
General and administrative |
1,529 | 999 | 2,528 | |||||||||||
Total operating expenses |
7,005 | 2,769 | 9,774 | |||||||||||
Operating income / (loss) |
$ | 147 | $ | (2,652 | ) | $ | (2,505 | ) | ||||||
8
TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except share and per share amounts)
| Three Months Ended March 31, 2002 | ||||||||||||||
| Commercial | TriPath | |||||||||||||
| Operations | Oncology | Total | ||||||||||||
Sales |
$ | 7,563 | $ | | $ | 7,563 | ||||||||
Cost of sales |
3,247 | | 3,247 | |||||||||||
Gross profit |
4,316 | | 4,316 | |||||||||||
Operating expenses: |
||||||||||||||
Research and development |
624 | 1,296 | 1,920 | |||||||||||
Regulatory |
371 | 123 | 494 | |||||||||||
Sales and marketing |
5,299 | 177 | 5,476 | |||||||||||
General and administrative |
1,057 | 833 | 1,890 | |||||||||||
Total operating expenses |
7,351 | 2,429 | 9,780 | |||||||||||
Operating loss |
$ | (3,035 | ) | $ | (2,429 | ) | $ | (5,464 | ) | |||||
All sales were generated from external customers. There were no inter-segment revenues. Sales to external customers in the TriPath Oncology segment were $133 during the three months ended March 31, 2003 and were attributable to services sold. Sales to external customers in the Commercial Operations segment for the three months ended March 31, 2003 and 2002 include the following:
| Three Months Ended, | |||||||||
| March 31, 2003 | March 31, 2002 | ||||||||
Instruments |
$ | 1,077 | $ | 1,419 | |||||
Reagents |
8,372 | 4,756 | |||||||
Fee-per-use and other |
1,565 | 1,388 | |||||||
Total sales |
$ | 11,014 | $ | 7,563 | |||||
At March 31, 2003, we had accounts and notes receivable of $2,036 from a company which disclosed to us its intention to exit the cervical cytology business. The contract we have with this customer was a multi-year agreement that included commitments for reagents and disposables. As we were unable to reach a mutually acceptable settlement under our agreement through negotiations with that company, we filed suit against that company in February 2003 in state court in North Carolina to enforce our rights under the agreement. We believe the defendant company to be credit-worthy and able to satisfy any judgment we may obtain against it. We expect no material adverse financial impact on our results of operations or financial position, although this litigation will result in additional costs to us that we may be unable to recover.
Depreciation and amortization expense for the three months ended March 31, 2003 and 2002 amounted to $1,012, and $960, respectively, for the Commercial Operations segment and $55 and $12, respectively, for the TriPath Oncology segment. The TriPath Oncology segment also amortized $620 of deferred R&D funding against R&D expenses for each of the three-month periods ended March 31, 2003 and 2002.
As of March 31, 2003, the TriPath Oncology segment had total assets of $1,780 and the Commercial Operations segment had total assets of $68,611.
9
TriPath Imaging, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(In thousands, except share and per share amounts)
| 9. | Recently Issued Accounting Standards |
In August 2001, the FASB issued SFAS No. 143, Accounting for Asset Retirement Obligations (SFAS 143). SFAS 143 requires an entity to record a liability for an obligation associated with the retirement of an asset at the time that the liability is incurred by capitalizing the cost as part of the carrying value of the related asset and depreciating it over the remaining useful life of that asset. The standard became effective for us beginning January 1, 2003. The adoption of SFAS 143 had no impact on our results of operations or financial position.
In April 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities (SFAS 146). SFAS 146 addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force (EITF) Issue No. 94-3,