UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
ý |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 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 000-23541
NANOGEN, INC.
(Exact name of Registrant as specified in its charter)
| Delaware | 33-0489621 | |
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
10398 Pacific Center Court, San Diego, CA |
92121 |
|
| (Address of principal executive offices) | (Zip code) |
(858) 410-4600
(Registrant's telephone number, including area code)
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 ý NO o
As of August 12, 2002, 21,942,999 shares of the Registrant's Common Stock were outstanding.
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Page |
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| PART I. | FINANCIAL INFORMATION | |||
Item 1. |
Financial Statements: |
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Consolidated Balance Sheets at June 30, 2002 and December 31, 2001 |
3 |
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Consolidated Statements of Operations for the Three and Six Months ended June 30, 2002 and 2001 |
4 |
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Consolidated Statements of Cash Flows for the Six Months ended June 30, 2002 and 2001 |
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Notes to Consolidated Financial Statements |
6 |
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Item 2. |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
13 |
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Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
30 |
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PART II: |
OTHER INFORMATION |
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Item 1. |
Legal Proceedings |
31 |
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Item 2. |
Changes in Securities |
31 |
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Item 4. |
Submission of Matters to a Vote of Security Holders |
31 |
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Item 6. |
Exhibits and Reports on Form 8-K |
32 |
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SIGNATURES |
33 |
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EXHIBIT INDEX |
34 |
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2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
NANOGEN, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
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June 30, 2002 |
December 31, 2001 |
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|---|---|---|---|---|---|---|---|---|---|
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(unaudited) |
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| ASSETS | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 11,089 | $ | 10,455 | |||||
| Short-term investments | 40,638 | 57,069 | |||||||
| Receivables, net | 2,189 | 4,380 | |||||||
| Inventories, net | 5,220 | 4,688 | |||||||
| Other current assets | 2,266 | 2,473 | |||||||
| Total current assets | 61,402 | 79,065 | |||||||
| Property and equipment, net | 5,391 | 5,386 | |||||||
| Acquired technology rights, net | 5,365 | 4,183 | |||||||
| Other assets, net | 1,030 | 1,158 | |||||||
| Restricted cash | 114 | 299 | |||||||
| $ | 73,302 | $ | 90,091 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 1,073 | $ | 1,051 | |||||
| Accrued liabilities | 5,056 | 4,916 | |||||||
| Deferred revenue | 353 | 522 | |||||||
| Current portion of capital lease obligations | 890 | 1,060 | |||||||
| Total current liabilities | 7,372 | 7,549 | |||||||
Capital lease obligations, less current portion |
1,256 |
1,755 |
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| Other long-term liabilities | 1,662 | 1,675 | |||||||
| Total long-term liabilities | 2,918 | 3,430 | |||||||
Minority interest in consolidated subsidiary |
2,990 |
4,183 |
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Stockholders' equity: |
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| Convertible preferred stock, $.001 par value, 5,000,000 shares authorized; no shares issued and outstanding at June 30, 2002 and December 31, 2001 | | | |||||||
| Common stock, $.001 par value, 50,000,000 shares authorized; 21,942,999 and 21,616,172 shares issued and outstanding at June 30, 2002 and December 31, 2001, respectively | 22 | 22 | |||||||
| Additional paid-in capital | 199,380 | 198,387 | |||||||
| Accumulated other comprehensive income | 1,252 | 1,253 | |||||||
| Deferred compensation | (153 | ) | (336 | ) | |||||
| Notes receivable from officers | (1,013 | ) | (984 | ) | |||||
| Accumulated deficit | (139,466 | ) | (123,413 | ) | |||||
| Total stockholders' equity | 60,022 | 74,929 | |||||||
| $ | 73,302 | $ | 90,091 | ||||||
See accompanying notes.
3
NANOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
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Three months ended June 30, |
Six months ended June 30, |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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2002 |
2001 |
2002 |
2001 |
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| Revenues: | ||||||||||||||
| Sales | $ | 1,104 | $ | 302 | $ | 1,916 | $ | 531 | ||||||
| Sponsored research | 313 | 2,055 | 626 | 4,401 | ||||||||||
| Contracts and grants | 534 | 358 | 942 | 723 | ||||||||||
| Total revenues | 1,951 | 2,715 | 3,484 | 5,655 | ||||||||||
Operating expenses: |
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| Cost of product sales | 836 | 230 | 1,393 | 400 | ||||||||||
| Research and development | 4,575 | 4,414 | 8,855 | 9,199 | ||||||||||
| Selling, general and administrative | 5,744 | 5,406 | 10,716 | 10,192 | ||||||||||
| Litigation and settlement of patent matter | | 5,511 | | 6,309 | ||||||||||
| Total operating expenses | 11,155 | 15,561 | 20,964 | 26,100 | ||||||||||
| Loss from operations | (9,204 | ) | (12,846 | ) | (17,480 | ) | (20,445 | ) | ||||||
Interest income, net |
556 |
1,092 |
1,285 |
2,418 |
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| Other income (loss) | 127 | 4 | 142 | (2 | ) | |||||||||
| Net loss | $ | (8,521 | ) | $ | (11,750 | ) | $ | (16,053 | ) | $ | (18,029 | ) | ||
| Net loss per sharebasic and diluted | $ | (0.39 | ) | $ | (0.56 | ) | $ | (0.74 | ) | $ | (0.87 | ) | ||
| Number of shares used in computing net loss per sharebasic and diluted | 21,650 | 20,847 | 21,635 | 20,802 | ||||||||||
See accompanying notes.
4
NANOGEN, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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Six months ended June 30, |
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|---|---|---|---|---|---|---|---|---|---|---|
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2002 |
2001 |
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| Operating activities: | ||||||||||
| Net loss | $ | (16,053 | ) | $ | (18,029 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||
| Accrual for settlement of litigation | | 5,000 | ||||||||
| Depreciation and amortization | 2,021 | 1,542 | ||||||||
| Amortization (accretion) related to short-term investments | 18 | (35 | ) | |||||||
| Stock-based compensation expense | 44 | 294 | ||||||||
| Interest capitalized on notes receivables from officers | (29 | ) | (32 | ) | ||||||
| Minority interest in loss of consolidated subsidiary | (983 | ) | | |||||||
| Gain on sale of short-term investments | (163 | ) | | |||||||
| Changes in operating assets and liabilities: | ||||||||||
| Receivables | 2,191 | (91 | ) | |||||||
| Inventories | (532 | ) | (1,945 | ) | ||||||
| Other assets | 95 | (1,783 | ) | |||||||
| Accounts payable | 21 | (601 | ) | |||||||
| Accrued liabilities | (11 | ) | (1,176 | ) | ||||||
| Deferred revenue | (169 | ) | (209 | ) | ||||||
| Net cash used in operating activities | (13,550 | ) | (17,065 | ) | ||||||
Investing activities: |
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| Purchase of short-term investments | (6,268 | ) | (17,552 | ) | ||||||
| Proceeds from sale and maturities of short-term investments | 22,216 | | ||||||||
| Purchase of equipment | (955 | ) | (30 | ) | ||||||
| Purchase of technology rights | (812 | ) | | |||||||
| Net cash provided by (used in) investing activities | 14,181 | (17,582 | ) | |||||||
Financing activities: |
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| Principal payments on capital lease obligations, net | (857 | ) | (859 | ) | ||||||
| Issuance of common stock, net of repurchases | 311 | 595 | ||||||||
| Proceeds from restricted cash balances | 185 | | ||||||||
| Net cash used in financing activities | (361 | ) | (264 | ) | ||||||
| Effect of exchange rate changes | 364 | | ||||||||
| Net increase (decrease) in cash and cash equivalents | 634 | (34,911 | ) | |||||||
| Cash and cash equivalents at beginning of period | 10,455 | 55,330 | ||||||||
| Cash and cash equivalents at end of period | $ | 11,089 | $ | 20,419 | ||||||
| Supplemental disclosure of cash flow information: | ||||||||||
| Interest paid | $ | 92 | $ | 198 | ||||||
| Supplemental schedule of noncash investing and financing activities: | ||||||||||
| Equipment acquired under capital leases | $ | 167 | $ | 983 | ||||||
| Unrealized gain (loss) on short-term investments | $ | (627 | ) | $ | 592 | |||||
| Accrued fee for purchase of technology rights | $ | 225 | $ | | ||||||
| Common stock issued in connection with purchase of license rights | $ | 750 | $ | | ||||||
| Common stock issued in connection with employee benefit plan, net of forfeitures | $ | 101 | $ | 144 | ||||||
| Options issued to non-employees | $ | (38 | ) | $ | | |||||
See accompanying notes.
5
NANOGEN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
June 30, 2002
1. Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States of America for complete financial statements. The consolidated balance sheet as of June 30, 2002, consolidated statements of operations for the three and six months ended June 30, 2002 and 2001, and the consolidated statements of cash flows for the six months ended June 30, 2002 and 2001 are unaudited, but include all adjustments (consisting of normal recurring adjustments) which the Company considers necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented. The results of operations for the three and six months ended June 30, 2002 shown herein are not necessarily indicative of the results that may be expected for the year ending December 31, 2002.
For more complete financial information, these financial statements, and notes thereto, should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2001 included in the Nanogen, Inc. Annual Report on Form 10-K for the year ended December 31, 2001, filed with the Securities and Exchange Commission.
Net Loss per Share
The Company computes net loss per share in accordance with SFAS No. 128, "Earnings per Share." Under the provisions of SFAS No. 128, basic net income (loss) per share is computed by dividing the net income (loss) available to common stockholders for the period by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted average number of common shares outstanding during the period and dilutive common shares outstanding computed using the treasury stock method. The weighted average common shares outstanding during the period does not include those shares issued pursuant to the exercise of stock options prior to vesting and shares issued under the Company's 401K benefit plan prior to vesting. Due to the losses incurred by the Company during the three and six months ended June 30, 2002 and 2001, common stock equivalents resulting from the assumed exercise of outstanding stock options and warrants have been excluded from the computation of diluted net loss per share as their effect would be anti-dilutive.
Recent Accounting Pronouncements
In July 2001, the Financial Accounting Standards Board ("FASB") issued FASB Statements Nos. 141 and 142 (FAS 141 and FAS 142), "Business Combinations" and "Goodwill and Other Intangible Assets." FAS 141 replaces APB 16 and eliminates pooling-of-interests accounting prospectively. It also provides guidance on purchase accounting related to the recognition of intangible assets and accounting for negative goodwill. FAS 142 changes the accounting for goodwill from an amortization method to an impairment-only approach. Under FAS 142, goodwill will be tested annually and whenever events or circumstances occur indicating that goodwill might be impaired. FAS 141 and FAS 142 are effective for all business combinations completed after June 30, 2001. Upon adoption of FAS 142, amortization of goodwill recorded for business combinations consummated prior to July 1, 2001 will cease, and intangible assets acquired prior to July 1, 2001 that do not meet the criteria for recognition under
6
FAS 141 will be reclassified to goodwill. Companies are required to adopt FAS 141 and 142 beginning in fiscal 2002. The adoption of these standards did not result in a material impact on the Company's results of operations and financial position.
In August 2001, the FASB issued FAS 144, "Accounting for the Impairment or Disposal of Long-Lived Assets." FAS 144 replaces FAS 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of." The FASB issued FAS 144 to establish a single accounting model, based on the framework established in FAS 121, as FAS 121 did not address the accounting for a segment of a business accounted for as a discontinued operation under APB 30, "Reporting The Results of OperationsReporting The Effects of Disposal of a Segment of a Business, and Extraordinary Unusual and Infrequently Occurring Events and Transactions." FAS 144 also resolves significant implementation issues related to FAS 121. Companies are required to adopt FAS 144 for fiscal years beginning after December 15, 2001, but early adoption is permitted. The adoption of these standards did not have a material impact on the Company's results of operations and financial position.
In June 2002, the Financial Accounting Standards Board issued Statement No. 146, or SFAS No. 146, "Accounting for Costs Associated with Exit or Disposal." SFAS No. 146 addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies EITF Issue No. 94-3, "Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring)." The principal difference between Statement 146 and Issue 94-3 relates to Statement 146's requirements for recognition of a liability for a cost associated with an exit or disposal activity. Statement 146 requires that a liability for a cost associated with an exit or disposal activity be recognized when the liability is incurred. Under Issue 94-3, a liability for an exit cost as generally defined in Issue 94-3 was recognized at the date of an entity's commitment to an exit plan. The provisions of this Statement 146 are effective for exit or disposal activities that are initiated after December 31, 2002, with early application encouraged. We do not expect that the adoption of SFAS No. 146 will have a material impact on the consolidated financial statements.
2. Inventories
Inventories consist of the following (in thousands):
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June 30, 2002 |
December 31, 2001 |
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|---|---|---|---|---|---|---|---|
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(unaudited) |
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| Raw materials | $ | 1,252 | $ | 796 | |||
| Work in process | 1,110 | 1,436 | |||||
| Finished goods | 4,793 | 3,956 | |||||
| 7,155 | 6,188 | ||||||
| Reserve for excess and obsolete | (1,935 | ) | (1,500 | ) | |||
| $ | 5,220 | $ | 4,688 | ||||
Finished goods includes $2.9 million and $2.0 million of NanoChip® Molecular Biology Workstations ("NanoChip® Workstations") at June 30, 2002 and December 31, 2001, respectively, that are installed at customer sites where title has not transferred to the customer. The majority of these instruments are placed at customer sites under Development Site Agreements. Under these arrangements a NanoChip® Workstation is placed at a customer site for a period normally between six and twelve months for the purpose of developing content and optimizing assays which may result in the creation or enhancement of intellectual property that the Company may license in the future. The
7
customer has the option to purchase the NanoChip® Workstation during the period of the arrangement or at its expiration. The Company classifies this inventory as consignment inventory and includes this within finished goods. The Company accrues refurbishment costs for each unit included in consignment inventory for the purpose of resale in the event the unit is returned under this arrangement. In addition, the Company has recorded a reserve related to the older production units which may be deemed obsolete or sold to the customer at a discount due to the depreciation of the unit during the development site period. This reserve totaled $1.4 million and $982,000 at June 30, 2002 and December 31, 2001, respectively.
The Company's manufacturing agreement with Hitachi, Ltd. ("Hitachi") requires that the Company provide annual purchase commitments to Hitachi for NanoChip® Workstations. As of June 30, 2002, the Company had commitments to purchase approximately $3.1 million in NanoChip® Workstations through March 31, 2003. At June 30, 2002, the inventory under our purchase commitment with Hitachi is within our expected usage levels based upon current and estimated future demands.
3. Licensed Technology
The Company has acquired various licenses to technologies which are incorporated into certain of the Company's current products or products under development. The Company capitalizes fees paid in conjunction with the acquisition of these licenses and amortizes them over the expected life of the product. In June 2002, the Company issued 254,151 shares of the Company's common stock valued at $750,000 to a licensor in exchange for license rights. In April 2002, the Company issued a warrant exercisable through April 12, 2007 to purchase 50,000 shares of the Company's common stock at a per share price of $4.10, the fair market value on the effective date of the agreement. The warrant has a term of five years, and was issued in return for license rights.
4. Comprehensive Loss
SFAS No. 130, Reporting Comprehensive Income, requires the Company to report, in addition to net income (loss), comprehensive income (loss) and its components. A summary is as follows (in thousands):
| |
Three months ended June 30, |
Six months ended June 30, |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| |
2002 |
2001 |
2002 |
2001 |
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| Comprehensive loss: | |||||||||||||
Net unrealized gain/(loss) |
$ |
(127 |
) |
$ |
36 |
$ |
(627 |
) |
$ |
862 |
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| Cumulative currency translation adjustment | 479 | | 626 | | |||||||||
| Net loss | (8,521 | ) | (11,750 | ) | (16,053 | ) | (18,029 | ) | |||||
| Comprehensive loss | $ | (8,169 | ) | $ | (11,714 | ) | $ | (16,054 | ) | $ | (17,167 | ) | |
5. Collaborative Alliances
Hitachi, Ltd.
In January 2000, the Company executed an agreement with Hitachi, Ltd., effective as of December 15, 1999, for the full-scale commercial manufacturing and distribution of the NanoChip® Molecular Biology Workstation in specified research markets. Hitachi, Ltd.'s Instrument Group
8
provides technology and technical support to aid in the manufacturing of the NanoChip® Molecular Biology Workstation's components.
Hitachi, Ltd. has the right to be the sole distributor of Hitachi, Ltd. produced NanoChip® Molecular Biology Workstations in Japan. Hitachi, Ltd. also has the non-exclusive right to distribute NanoChip® Cartridges in Japan. Under this arrangement, the Company receives a royalty for NanoChip® Molecular Biology Workstations sold by Hitachi, Ltd. in Japan. The Company retains the right to distribute, directly or through others, Hitachi, Ltd. produced NanoChip® Molecular Biology Workstations outside of Japan. In addition, the Company manufactures NanoChip® Cartridges at its San Diego, California facility for distribution worldwide. The Company also retains the right to form other manufacturing and distribution agreements.
In July 2000, the Company executed a ten-year agreement with Hitachi, Ltd., Nissei Sangyo Co. Ltd. and Hitachi Instruments Service Co. Ltd. of Japan (collectively, "Hitachi") to develop, manufacture and distribute additional potential products based on the parties' proprietary technologies, potentially including, among other things, reduced-size instruments for genetic testing, integrated amplification and point-of-care detection. The agreement provides that the parties will jointly determine which projects to prioritize over the term of the agreement. The agreement may be terminated before its expiration by either party, subject to certain restrictions. Pursuant to the terms of the agreement, Hitachi and the Company each may contribute, toward the research and development efforts of the Company, up to $28.5 million in cash over the ten-year period. At a minimum the Company is required to contribute on an annual basis funding for its own general technology development in an amount equal to or greater than payments made by Hitachi. In addition, the Company is liable to repay to Hitachi fifty percent of all funding provided by Hitachi over an indefinite period of time. Payment amounts are determined as a percentage of the Company's gross NanoChip® Cartridge sales until the liability is paid in full. Furthermore, Hitachi made an equity investment in the Company by purchasing 74,590 shares of the Company's common stock worth approximately $2.0 million pursuant to a private sale by the Company based on a per share price of $26.813 (the fair market value as of the signing date of the Hitachi agreement). Hitachi has the right to be the exclusive distributor of collaboration products in Japan and, based upon the attainment of minimum sales targets to be mutually agreed upon, in other Asian countries. The Company retains the exclusive right to distribute collaboration products outside of these countries.
Sponsored research revenue recognized under this agreement totaled $313,000 and $626,000 for the three and six months ended June 30, 2002, respectively, and $250,000 and $500,000 for the three and six months ended June 30, 2001, respectively. In accordance with SFAS No. 68, the Company records sponsored research revenue under this arrangement as expenses are incurred not exceeding scheduled payments under the agreement. The amount owed to Hitachi for proceeds received under this agreement was $1.6 million at June 30, 2002 and December 31, 2001. The Company records a long-term liability for fifty percent of the funds received from Hitachi upon the receipt of such funds. The current portion of the long-term liability remains immaterial as payment amounts due under this obligation are determined as a percentage of the Company's gross NanoChip® Cartridge sales which have not been significant to date, as such, the entire balance of this liability is classified as long-term.
Aventis Research and Technologies
In September 1999, the Company entered into two technology development programs with Aventis Research and Technologies, an affiliate of Hoechst AG ("Aventis"), which focused on the development of gene expression tools utilizing electronic bioarrays and the development of high throughput screening tools for kinase analyses. In total, the two programs provided $11.9 million in funding to the
9
Company through December 31, 2001. Under these programs, the Company demonstrated quantitative, multiplexed and reliable gene expression monitoring on a Nanogen electronic microarray system. Additionally, the Company delivered an electronic hybridization-based gene expression prototype detection system as well as a prototype system for analyzing protein kinases. This prototype system was sold during the fourth quarter of 2001 to an affiliate of Aventis. All project milestones established under these arrangements were completed as of December 31, 2001 at which time the agreements expired. The Company does not expect to receive additional funding for these projects.
Revenue was primarily recognized under these agreements as expenses were incurred, and totaled $1.8 million and $3.9 million for the three and six months ended June 30, 2001. No revenue was recognized during 2002 as these projects were completed as of December 31, 2001.
In June 2001, the Company entered into agreements with Aventis to create a new company, Nanogen Recognomics GmbH ("Nanogen Recognomics"). The company was established to develop new products and applications for the NanoChip® System. Nanogen Recognomics is sixty percent owned by the Company and forty percent owned by Aventis and is based in Frankfurt, Germany. Aventis provided the first $5 million of funding for the operations of the new company and also contributed intellectual property in the form of eighteen patents (recorded based on the estimated fair value at the date of the agreement). The Company is required to spend an aggregate of $5.5 million, at the rate of $1.1 million per year beginning April 1, 2001, for its own general technology development which benefits the commercialization and development of potential Nanogen Recognomics products. In addition, Nanogen Recognomics will own several patent applications filed jointly by the Company and Aventis. The Company has licensed certain aspects of its NanoChip® technology to the new company and will seek to commercialize new products and applications developed by Nanogen Recognomics. Aventis retains the right to utilize the former Aventis patent portfolio in fields outside of Nanogen Recognomics. In conjunction with the agreement to form Nanogen Recognomics, the Company issued a warrant to Aventis to purchase 315,863 shares of common stock exercisable through July 17, 2006 at an agreed upon price of $9.828 per share. The value of this warrant, as determined by the Black-Scholes valuation model, was equal to $1.2 million, is included in other assets in the accompanying consolidated financial statements and is being amortized over a two and a half year period, the estimated period for which the $5 million in funding will provide for operating expenses.
The results of operations for Nanogen Recognomics are fully consolidated in the financial statements included herein, as such, there is no off-balance sheet component. The total operating loss of Nanogen Recognomics is reflected as a reduction of the "minority interest in consolidated subsidiary" liability account and totaled $422,000 and $983,000 for the three and six months ended June 30, 2002, respectively, and none for the three and six months ended June 30, 2001, respectively.
6. Litigation
In July 2001, the Company entered into a settlement agreement with Motorola, Genometrix, and MIT concluding the declaratory judgment action by the Company against Motorola, Genometrix and MIT and Motorola's counterclaim against the Company. In connection with the settlement, the Company has secured a license from Motorola to certain claims of the "939 Patent. In exchange, the Company made a one-time payment of $2.5 million in cash and issued 416,666 shares of the Company's common stock (valued at approximately $2.5 million based upon a per share price of $6.00, the fair market value on the date of settlement) to the parties involved. The settlement does not include any cross-licensing provisions of the Company's technology to Motorola, Genometrix or MIT. The lawsuit and the counterclaim have now been dismissed. For the three and six months ended June 30, 2001
10
costs associated with the litigation of the Motorola patent matter totaled $5.5 million and $6.3 million, respectively.
In November 2000, the Company filed a complaint against CombiMatrix Corp. ("CombiMatrix") and Dr. Donald Montgomery in the United States District Court for the Southern District of California. Dr. Montgomery is a former company employee now affiliated with CombiMatrix. The Company's complaint alleges that the naming of Dr. Montgomery as the sole inventor on U.S. Patent No. 6,093,302, entitled "Electrochemical Solid Phase Synthesis" (the "302 patent"), and assignment of the "302 patent to CombiMatrix were incorrect and that the invention was made by company employees. The complaint also alleges that inventions disclosed in the patent were the Company's trade secrets and that CombiMatrix and Dr. Montgomery misappropriated these trade secrets by their actions, including publishing those trade secrets in patent applications. The Company's complaint seeks correction of inventorship, assignment of rights in the patent to the Company, an injunction preventing disclosure of trade secrets and damages for trade secret misappropriation.
In December 2000, CombiMatrix and Dr. Montgomery filed a motion to dismiss the Company's complaint. In January 2001, the motion was denied as to all claims except a claim for conversion, as to which the motion was granted without prejudice. The Company elected not to amend its complaint as to the conversion claim. In March 2001, CombiMatrix and Dr. Montgomery answered the Company's complaint, asserted various affirmative defenses and filed a counterclaim for breach of contract against the Company for unspecified damages allegedly arising from the filing of the complaint at a time when CombiMatrix had announced its intent to make an initial public offering of its shares. The counterclaim asserts that the Company, by filing its complaint, breached a settlement agreement entered into between the Company and Dr. Montgomery in 1996. In May 2001, the Company filed a motion to dismiss CombiMatrix's counterclaim, which was denied on July 27, 2001.
In April 2002, the Company filed a motion for leave to amend its complaint to add a cause of action against Dr. Montgomery for fraudulent inducement to enter into a 1996 settlement agreement with the Company and to add to its claims against CombiMatrix and Dr. Montgomery an additional patent that was recently issued to CombiMatrix. In June 2002, the court permitted the Company to amend its complaint to include the additional claim and additional patent.
In July 2002, the Court denied a partial summary judgment motion made by CombiMatrix and Dr. Montgomery relating to certain of the Company's claims. In their motion for summary judgment, CombiMatrix and Dr. Montgomery argued that certain trade secrets that the Company contends Dr. Montgomery misappropriated were not delineated in the prior settlement agreement between Dr. Montgomery and the Company, and as a result, the Company was precluded from bringing its claims. The Court, however, disagreed with CombiMatrix's and Dr. Montgomery's interpretation of the settlement agreement. The Court ruled that the settlement agreement, in which Dr. Montgomery agreed not to misappropriate any of the Company's trade secrets, was not limited to the specific trade secrets mentioned therein. The Court also rejected CombiMatrix's and Dr. Montgomery's contention that the settlement agreement released Dr. Montgomery from all claims except for those arising out of that agreement.
No assurances can be given that the Company will prevail in the lawsuit or that we can successfully defend ourselves against the counterclaim. The Company is expending considerable financial resources and managerial efforts prosecuting the lawsuit and defending against Dr. Montgomery's and CombiMatrix's counterclaim. The Company may not prevail in the action, which could have a material adverse effect on the Company if the Court determines that as a result of any action by Nanogen, it must compensate CombiMatrix or Dr. Montgomery for any alleged damages they suffered as a result. Discovery is currently ongoing in this lawsuit and trial is scheduled for November 2002.
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7. Subsequent Event
On July 26, 2002, the Compensation Committee of the Board of Directors ("the Compensation Committee") approved the issuance of employee retention options for 969,500 shares of the Company's common stock. The options were issued to the Company's employees and the employees of the Company's subsidiary, Nanogen Europe B.V. pursuant to the Company's 1997 Stock Incentive Plan, as amended. Each incentive stock option grant will be 50% vested on January 1, 2003 and 50% will vest ratably over the period January 1, 2003 through July 26, 2004.
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Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
This report includes forward-looking statements about our business and results of operations that are subject to risks and uncertainties that could cause our actual results to vary materially from those reflected in the forward-looking statements. These risks and uncertainties include possible delays in the introduction of new products, customer acceptance of existing products, price competition, the actions of competitors, infringement of intellectual property rights and licenses of the Company or others, the effects of government regulation, both foreign and domestic, availability of funded research and government contracts and grants, preservation of productive relationships with our manufacturer and collaborator Hitachi and our distributors, ability to manage our capital resources and other factors. Words such as "believes," "anticipates," "plans," "estimates," "future," "could," "may," "should," "expect," "envision," "potentially," variations of such words and similar expressions are intended to identify such forward-looking statements. Factors that could cause or contribute to these differences include those discussed below under the caption "Factors that May Affect Results" and elsewhere in this Quarterly Report on Form 10-Q and which are described in our Annual Report on Form 10-K for the year ended December 31, 2001. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We disclaim any intent or obligation to update these forward-looking statements.
Overview
It is our goal to become a leading provider of molecular diagnostic tests. We integrate advanced microelectronics and molecular biology into a core technology platform with potentially broad and diverse commercial applications. Our primary areas of focus have been in genomics and biomedical research, medical diagnostics, forensics and drug discovery. The first application we have developed, the NanoChip® System, is an integrated bioassay system consisting of the NanoChip® Molecular Biology Workstation and the NanoChip® Cartridge. The NanoChip® Workstation is comprised of two automated instruments and the NanoChip® Cartridge, a consumable cartridge, which incorporates a proprietary microchip (the "NanoChip® Electronic Microarray"). The NanoChip® System provides a flexible tool for the rapid identification and precision analysis of biological test samples containing charged molecules.
Since commencing operations in 1993, we have applied substantially all of our resources to our research and development programs. We have incurred losses since inception and, as of June 30, 2002, had an accumulated deficit of $139.5 million. We expect to continue to incur significant losses over at least the next few years as we attempt to further commercialize our products as well as expand the menu of applications for our current products.
We introduced our first two products into the marketplace in 2000, and our third product in March 2002. While we recognized revenue from product sales during the years ended December 31, 2001 and 2000, our main sources of revenues during these fiscal years were payments under our sponsored research agreements, contracts and grants. However, during the three and six months ended June 30, 2002 our revenue base has begun to shift from primarily sponsored research revenues to product revenues. We anticipate that this shift in our revenue base will continue as we introduce new products to the marketplace and if our instrument and consumable revenues grow. We believe our future operating results may be subject to quarterly fluctuations due to a variety of factors, including, but not limited to, market acceptance of the NanoChip® System and potential products under development, the type of acquisition program our potential customers may choose, whether and when new products, such as the Analyte Specific Reagent ("ASR") for Cystic Fibrosis are successfully developed and introduced by us or our competitors, and the achievement of milestones under our collaborative agreements with Hitachi and various government agencies. The recognition of revenue under contracts, grants and sponsored research agreements will be subject to significant fluctuations in
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both timing and amount and therefore our results of operations for any period may not be comparable to the results of operations for any other period.
Critical Accounting Policies and Estimates
This Management's Discussion and Analysis of Financial Condition and Results of Operations discusses our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, we evaluate our estimates and judgements, including those related to bad debts, inventories, investments, intangible assets, service obligations, contingencies and litigation. We base our estimates and judgements on historical experience and on various other factors that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.
We believe the following critical accounting policies, among others, affect our more significant judgements and estimates used in the preparation of our consolidated financial statements:
Revenue recognition
Revenue from the sale of NanoChip® Molecular Biology Workstations and of NanoChip® Cartridges is generally recognized upon shipment (f.o.b. shipping point) and transfer of title. In transactions where a right-of-return exists, revenue is deferred until acceptance has occurred and the period for the right-of-return has lapsed. The NanoChip® Molecular Biology Workstation is generally sold with a one year maintenance contract. The fair value of the maintenance service is recorded as deferred revenue and recognized ratably over the maintenance period included in the customer contract. The fair value of the maintenance service is determined based on the cost of the service plus an industry accepted profit margin for comparable service on similar types of products. We provide for the estimated cost of product maintenance at the time revenue is recognized. We also recognize revenue from the sale of our NanoChip® System under reagent rental transactions whereby customers pay a premium for our consumable products over a number of years that is intended to cover the sales price of the NanoChip® Workstation. Under these arrangements, the customer typically commits to purchasing a fixed number of consumable products on a periodic basis. Revenue under reagent rental transactions is recognized as consumable products are shipped or consumed, over a period of generally two to five years, depending on the specific customer arrangement. We also offer our NanoChip® Molecular Biology Workstations to customers under programs, such as Development Site arrangements, where title of the NanoChip® Workstation does not transfer to the customer. Transactions under these types of programs do not result in the recognition of revenue, however, if the customer opts to purchase the NanoChip® Workstation at any time, sales revenue is recognized upon receipt of a purchase order. Sales revenue is subject to fluctuation due to the type of acquisition program our customers may choose.
Sponsored research and contract and grant revenue are generally recorded as the costs and expenses to perform the research are incurred. Under certain arrangements revenue is recorded ratably over the term of the arrangement as funding is provided for contractually on a scheduled basis. Payments received in advance under these arrangements are recorded as deferred revenue until the expenses are incurred. Continuation of certain sponsored research and contracts and grants are dependent upon our achieving specific contractual milestones.
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Bad debts
We maintain reserves for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. If the financial condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances would be required.
Inventory
We reduce the carrying value of our inventory, including NanoChip® Molecular Biology Workstations placed under Development Site arrangements (consigned inventory), for estimated obsolescence or non-marketability based upon assumptions about future demand, supply, market conditions and new product introductions. We often rely on our own and third party forecasted demand for various of our products and the accuracy of such forecasts may depend on a number of factors, including but not limited to, government reports and recommendations for certain genetic testing, regulatory burdens, competitive products, the nature and effectiveness of our products, the timing and extent of the introduction of our products into the marketplace and other factors. If actual demand, supply or market conditions are less favorable than those projected by us, additional inventory write-downs may be required.
Intangible Assets
We have capitalized the costs related to acquired technology rights, such as rights to specific genetic markers, as intangible assets. The determination of related estimated useful lives and whether or not these assets are impaired involves significant judgments. Changes in strategy and/or market conditions could significantly impact these judgments and require adjustments to recorded asset balances.