SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| þ | 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 |
0-22025
|
AASTROM BIOSCIENCES, INC.
| Michigan |
94-3096597 |
|
| (State or other jurisdiction of incorporation or organization) |
(I.R.S. employer identification no.) |
|
| 24 Frank Lloyd Wright Dr. P.O. Box 376 Ann Arbor, Michigan |
48106 |
|
| (Address of principal executive offices) | (Zip code) |
(734) 930-5555
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.
þ Yes o No
Indicate the number of shares outstanding of each of the issuers classes of common stock as of the latest practicable date.
| COMMON STOCK, NO PAR VALUE (Class) |
47,904,479 Outstanding at November 12, 2002 |
TABLE OF CONTENTS
| Page | ||||
PART I - |
FINANCIAL INFORMATION |
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Item 1. |
Financial Statements |
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| a) | Consolidated Condensed Balance Sheets as of June 30, 2002 and September 30, 2002 | 3 |
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| b) | Consolidated Condensed Statements of Operations for the three months ended September 30, 2001 and 2002 and for the period from March 24, 1989 (Inception) to September 30, 2002 | 4 |
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| c) | Consolidated Condensed Statements of Cash Flows for the three months ended September 30, 2001 and 2002 and for the period from March 24, 1989 (Inception) to September 30, 2002 | 5 |
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| d) |
Notes to Consolidated Condensed Financial Statements
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6 |
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Item 2. |
Managements Discussion and Analysis of Financial Condition and Results of Operations | 9 |
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Item 3. |
Quantitative and Qualitative Disclosures About Market Risk | 25 |
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Item 4. |
Controls and Procedures
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25 |
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PART II |
OTHER INFORMATION |
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Item 1. |
Legal Proceedings
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26 |
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Item 2. |
Changes in Securities and Use of Proceeds
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26 |
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Item 3. |
Defaults Upon Senior Securities
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26 |
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Item 4. |
Submission of Matters to a Vote of Security Holders
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26 |
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Item 5. |
Other Information
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26 |
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Item 6. |
Exhibits and Reports on Form 8-K
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26 |
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SIGNATURES
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27 |
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CERTIFICATIONS
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28 |
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EXHIBIT INDEX
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31 |
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2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
AASTROM BIOSCIENCES, INC.
(a development stage company)
CONSOLIDATED CONDENSED BALANCE SHEETS
| June 30, | September 30, | |||||||||
| 2002 | 2002 | |||||||||
| (Unaudited) | ||||||||||
Assets |
||||||||||
CURRENT ASSETS: |
||||||||||
Cash and cash equivalents |
$ | 8,605,000 | $ | 6,930,000 | ||||||
Short-term investments |
1,000,000 | 1,000,000 | ||||||||
Receivables, net |
120,000 | 117,000 | ||||||||
Inventory, net |
1,397,000 | 1,485,000 | ||||||||
Other current assets |
225,000 | 504,000 | ||||||||
Total current assets |
11,347,000 | 10,036,000 | ||||||||
PROPERTY, NET |
206,000 | 178,000 | ||||||||
Total assets |
$ | 11,553,000 | $ | 10,214,000 | ||||||
Liabilities and Shareholders Equity |
||||||||||
CURRENT LIABILITIES: |
||||||||||
Accounts payable and accrued expenses |
$ | 589,000 | $ | 668,000 | ||||||
Accrued employee expenses |
161,000 | 167,000 | ||||||||
Total current liabilities |
750,000 | 835,000 | ||||||||
SHAREHOLDERS EQUITY: |
||||||||||
Common stock, no par value; shares authorized
100,000,000; shares issued and outstanding
43,726,557 and 45,934,129, respectively |
104,600,000 | 105,628,000 | ||||||||
Deficit accumulated during the development stage |
(93,797,000 | ) | (96,249,000 | ) | ||||||
Total shareholders equity |
10,803,000 | 9,379,000 | ||||||||
Total liabilities and shareholders equity |
$ | 11,553,000 | $ | 10,214,000 | ||||||
The accompanying notes are an integral part of these financial statements.
3
AASTROM BIOSCIENCES, INC.
(a development stage company)
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
| March 24, 1989 | ||||||||||||||
| Three months ended | (Inception) to | |||||||||||||
| September 30, | September 30, | |||||||||||||
| 2001 | 2002 | 2002 | ||||||||||||
REVENUES: |
||||||||||||||
Product sales and rentals |
$ | | $ | 7,000 | $ | 375,000 | ||||||||
Research and development agreements |
| | 2,020,000 | |||||||||||
Grants |
151,000 | 86,000 | 5,914,000 | |||||||||||
Total revenues |
151,000 | 93,000 | 8,309,000 | |||||||||||
COSTS AND EXPENSES: |
||||||||||||||
Cost of product sales and rentals |
40,000 | 88,000 | 1,560,000 | |||||||||||
Research and development |
1,207,000 | 1,385,000 | 82,886,000 | |||||||||||
Selling, general and administrative |
919,000 | 1,113,000 | 25,223,000 | |||||||||||
Total costs and expenses |
2,166,000 | 2,586,000 | 109,669,000 | |||||||||||
LOSS FROM OPERATIONS |
(2,015,000 | ) | (2,493,000 | ) | (101,360,000 | ) | ||||||||
OTHER INCOME (EXPENSE): |
||||||||||||||
Other income |
| | 1,237,000 | |||||||||||
Interest income |
122,000 | 41,000 | 5,109,000 | |||||||||||
Interest expense |
| | (267,000 | ) | ||||||||||
Total other income |
122,000 | 41,000 | 6,079,000 | |||||||||||
NET LOSS |
$ | (1,893,000 | ) | $ | (2,452,000 | ) | $ | (95,281,000 | ) | |||||
| COMPUTATION OF NET LOSS APPLICABLE TO COMMON SHARES: | ||||||||||||||
NET LOSS |
$ | (1,893,000 | ) | $ | (2,452,000 | ) | ||||||||
NET LOSS PER COMMON SHARE |
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(Basic and Diluted) |
$ | (.05 | ) | $ | (.05 | ) | ||||||||
Weighted average number of common
shares outstanding |
39,934,000 | 44,886,000 | ||||||||||||
The accompanying notes are an integral part of these financial statements.
4
AASTROM BIOSCIENCES, INC.
(a development stage company)
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
| March 24, 1989 | ||||||||||||||||
| Three months ended | (Inception) to | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2001 | 2002 | 2002 | ||||||||||||||
OPERATING ACTIVITIES: |
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Net loss |
$ | (1,893,000 | ) | $ | (2,452,000 | ) | $ | (95,281,000 | ) | |||||||
Adjustments to reconcile net loss to net cash used for
operating activities: |
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Depreciation and amortization |
32,000 | 28,000 | 3,355,000 | |||||||||||||
Loss on property held for resale |
| | 110,000 | |||||||||||||
Amortization of discounts and premiums on investments |
| | (543,000 | ) | ||||||||||||
Stock compensation expense |
| 159,000 | 823,000 | |||||||||||||
Inventory write downs and reserves |
40,000 | 88,000 | 1,317,000 | |||||||||||||
Stock issued pursuant to license agreement |
| | 3,300,000 | |||||||||||||
Changes in assets and liabilities: |
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Receivables |
19,000 | 3,000 | (141,000 | ) | ||||||||||||
Inventory |
(174,000 | ) | (176,000 | ) | (2,802,000 | ) | ||||||||||
Other current assets |
(211,000 | ) | (279,000 | ) | (504,000 | ) | ||||||||||
Accounts payable and accrued expenses |
(120,000 | ) | 79,000 | 668,000 | ||||||||||||
Accrued employee expenses |
(15,000 | ) | 6,000 | 167,000 | ||||||||||||
Net cash used for operating activities |
(2,322,000 | ) | (2,544,000 | ) | (89,531,000 | ) | ||||||||||
INVESTING ACTIVITIES: |
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Organizational costs |
| | (73,000 | ) | ||||||||||||
Purchase of short-term investments |
(4,500,000 | ) | | (62,124,000 | ) | |||||||||||
Maturities of short-term investments |
| | 61,667,000 | |||||||||||||
Capital purchases |
(18,000 | ) | | (2,796,000 | ) | |||||||||||
Proceeds from sale of property held for resale |
| | 400,000 | |||||||||||||
Net cash used for investing activities |
(4,518,000 | ) | | (2,926,000 | ) | |||||||||||
FINANCING ACTIVITIES: |
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Issuance of preferred stock |
| | 51,647,000 | |||||||||||||
Issuance of common stock |
6,841,000 | 869,000 | 45,432,000 | |||||||||||||
Repurchase of common stock |
| | (49,000 | ) | ||||||||||||
Payments received for stock purchase rights |
| | 3,500,000 | |||||||||||||
Payments received under shareholder notes |
| | 31,000 | |||||||||||||
Principal payments under capital lease obligations |
| | (1,174,000 | ) | ||||||||||||
Net cash provided by financing activities |
6,841,000 | 869,000 | 99,387,000 | |||||||||||||
NET INCREASE (DECREASE) IN CASH AND
CASH EQUIVALENTS |
1,000 | (1,675,000 | ) | 6,930,000 | ||||||||||||
CASH AND CASH EQUIVALENTS AT
BEGINNING OF PERIOD |
10,659,000 | 8,605,000 | | |||||||||||||
CASH AND CASH EQUIVALENTS AT
END OF PERIOD |
$ | 10,660,000 | $ | 6,930,000 | $ | 6,930,000 | ||||||||||
The accompanying notes are an integral part of these financial statements.
5
AASTROM BIOSCIENCES, INC.
(A development stage company)
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
1. Organization
Aastrom Biosciences, Inc. (Aastrom) was incorporated in March 1989 (Inception), began employee-based operations in 1991, and is in the development stage. We operate our business in one reportable segment research and product development, conducted both on our own behalf and in connection with various collaborative research and development agreements with others, involving the development and sale of processes and products for the ex vivo production of human cells for use in cell and ex vivo gene therapy.
Successful future operations are subject to several technical and business risks, including satisfactory product development, obtaining regulatory approval and market acceptance for our products and our continued ability to obtain future funding.
The Company is subject to certain risks related to the operation of its business and development of its products and product candidates. While available cash and investments are expected to finance currently planned activities into the first quarter of fiscal year 2004 it will need to raise additional funds in order to complete its product development programs and commercialize its new product candidates. The Company cannot be certain that such funding will be available on favorable terms, if at all. Some of the factors that will impact the Companys ability to raise additional capital and its overall success include, the rate and degree of progress for its product development programs, the liquidity and volatility of its equity securities, regulatory and manufacturing requirements and uncertainties, technological developments by competitors and other factors. If the Company cannot raise such funds, it may not be able to develop or enhance products, take advantage of future opportunities, or respond to competitive pressures or unanticipated requirements, which would negatively impact its business, financial condition and results of operations.
The Company is currently pursuing additional sources of financing. If the Company cannot obtain additional funding prior to the end of the third quarter of fiscal year 2003, it will make substantial reductions in the scope and size of its operations, and may curtail activities currently planned to be resumed, in order to conserve cash until such funding is obtained.
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2. Basis of Presentation
The condensed consolidated financial statements included herein have been prepared by us without audit according to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States have been omitted pursuant to such rules and regulations. The financial statements reflect, in the opinion of management, all adjustments necessary to present fairly the financial position and results of operations as of and for the periods indicated. The results of operations for the three months ended September 30, 2002, are not necessarily indicative of the results to be expected for the full year or for any other period.
The consolidated financial statements include the accounts of Aastrom and its wholly-owned subsidiary, Zellera AG (Zellera), which is located in Berlin, Germany (collectively, the Company). All significant inter-company transactions and accounts have been eliminated in consolidation.
These financial statements should be read in conjunction with the audited financial statements and the notes thereto included in our 2002 Annual Report on Form 10-K, as filed with the Securities and Exchange Commission.
3. Shareholders Equity
We obtained additional equity of $869,000 during the three months ended September 30, 2002 and issued 2,208,000 common shares in these transactions. These equity financings were transacted under our November 16, 2001 shelf registration and our Employee Stock Purchase Plan.
4. Net Loss Per Common Share
Net loss per common share is computed using the weighted-average number of common shares outstanding during the period. Common equivalent shares are not included in the per share calculation where the effect of their inclusion would be anti-dilutive. The aggregate number of common equivalent shares that have been excluded from the computations of net loss per common share for the periods ended September 30, 2001 and 2002 is approximately 6,152,000 and 8,611,000, respectively.
5. Recent Accounting Developments
In July 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities, which requires the liability for a disposal obligation to be recognized and measured at its fair value when the entity ceases using the leased property in operation. The FASB decided the same approach should apply for similar disposal obligations associated with other preexisting firmly committed contracts. Additionally, SFAS No. 146 would require severance pay in many cases to be recognized over time rather than up front. If the benefit arrangement requires employees to render future services beyond a defined
7
minimum retention period, a liability should be recognized as employees render service over the future service period. If the benefit arrangement does not require employees to render future service beyond the minimum retention period, a liability should not be recognized at the date the termination is communicated to employees. SFAS No. 146 is effective for disposable activities initiated after December 31, 2002. The FASBs new rules on liabilities for disposal obligations reconsiders the guidance in 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) and addresses the issue separately from the scope of SFAS No. 144. We have not determined the impact on our financial statements.
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Overview of Aastrom
We are pioneering the development of human cell therapy technologies intended for a broad range of medical applications based on our patented process and device capabilities for manufacturing proprietary cell mixtures. Our lead cell therapeutic product areas under development include: Tissue Repair Cells (TRCs), Therapeutic Cells (TCs), and Cell Culture Devices. TRCs are cells that lead to the construction of normal tissue such as bone. TCs are cells that can act like drugs, such as a therapeutic vaccine for cancer or viruses. Cell culture devices have been developed by Aastrom to produce our TRCs and TCs, but they can also be sold to authorized third parties as stand-alone products.
Our business model builds on two complementary components: (i) proprietary procedures and devices to enable certain types of stem cells and other types of human cells to be produced with excellent biological capabilities as compared with standard cell culture approaches; and (ii) the AastromReplicell System clinical platform that is designed to standardize and enable an effective commercialization pathway for bringing therapeutic cell production to medical practice. The AastromReplicell System consists of an instrumentation platform, to be either sold to a hospital or other centralized facility, or alternatively, used by Aastrom, that can operate a variety of single-use cell production kits that are specific to the desired medical application. Each cell product is produced using a specific type of kit. The kit and the cell product produced with the kit share a common identifying nomenclature such as DC-I, DCV-I, OC-I, OCG-I, SC-I and CB-I. Through this product configuration, we intend either directly to commercialize cells for therapeutic use, or to enable customers or potential collaborators with the capability to produce cells for therapeutic applications through sale of the AastromReplicell System instruments and kits. This approach is intended to provide a product pathway for each cell therapy that is similar to a pharmaceutical product including regulatory approval, reimbursement, marketing and pricing. We believe that the design of the AastromReplicell System will allow us to develop additional cell therapy products to provide standardization for a number of emerging cell therapies being developed by other researchers.
We have different TRC products in active development, including: SC-I bone marrow cells for bone marrow transplantation application; CB-I cells for cord blood stem cell transplantation application; OC-I cells for severe osteoporosis; and OCG-I cells for bone grafting applications. For the TC product areas, we are investigating immune system dendritic cells, a type of blood cell that has the ability to stimulate an immune response against specific targets as a potential new treatment for cancer and viral diseases. We have developed the DC-I and DCV-I device products, and intend to use them for our own TC products, as well as to sell them to many clinical researchers and centers that are developing dendritic cell-based vaccines designed to treat cancer and other disorders. We have obtained approval to affix the CE Mark to the DC-I and DCV-I kits, as well as the AastromReplicell System, allowing us to market and sell these products in Europe, through our German subsidiary, Zellera AG. We also are marketing
9
the DC-I and DCV-I device products to U.S. clinical and research groups that are developing dendritic cell-based cancer vaccines. The development of our own proprietary vaccines may be pursued pending additional grant funding or strategic partnerships.
Our SC-I and CB-I TRC products have received CE Mark approval allowing us to begin commercialization activities in Europe, through our German subsidiary, Zellera AG, and are in Phase III-Type clinical studies in the U.S. However, we do not believe there is a current market for the CB-I product in Europe, and will be several years before any U.S. approvals may be received, or for the markets to develop for this product. Although able to be sold in Europe, the SC-I product will have to undergo various clinical evaluations at initial customer sites in order to generate the data necessary for reimbursement of the product. This year we established relationships at several European centers for these sites to generate this clinical data.
More recently we have initiated a development program for the production of bone-forming TRCs in the AastromReplicell System (our OC line of TRCs). The OC-I cell product is being developed for the treatment of patients with degenerative bone diseases such as osteoporosis, for which a Phase I/II-Pilot clinical study is in process in the U.S. Our OCG-I cell product is being developed for bone grafting applications, and we are developing a clinical trial plan for this product
Our therapeutic cell development efforts to date have focused on using our technology to grow larger quantities of the desired therapeutic cells from small starting amounts of cells or a tissue. Our cell production processes are based on using the natural reproductive capabilities of cells outside the body (ex vivo), without various cloning approaches. Our programs currently use bone marrow, cord blood and blood cells as starting sources of cells. As such, federal support or other factors relating to embryonal research have no direct impact on our current product programs.
Since our inception, we have been in the development stage and engaged in research and product development, conducted principally on our own behalf, but also in connection with various collaborative research and development agreements with others. We commenced our initial pilot-scale product launch in Europe of the AastromReplicell Cell Production System with the SC-I kit in April 1999. At approximately this same time, data was released at international meetings that resulted in the majority of the patients who would otherwise have been candidates for the SC-I product, to no longer require the use of the product. This loss of market for the SC-I caused us to reorganize our operations and suspend all marketing activities in October 1999, pending the receipt of additional financing and reorganization. While weve initiated marketing activities for the CE Marked SC-I, DC-I and the DCV-I products, we do not expect to generate positive cash flows from our consolidated operations for at least the next several years and then only if more significant product sales commence. Until that time, we expect that our revenue sources will be limited to grant revenue and research funding, milestone payments and licensing fees from potential future corporate collaborators. To date, we have financed our operations through public and private sales of our equity securities. As a development-stage company, we have never been profitable and do not anticipate having net
10
income unless and until significant product sales commence, which is unlikely to occur until we obtain significant additional funding. Through September 30, 2002, we have accumulated losses of approximately $95 million. There can be no assurance that we will be able to achieve profitability on a sustained basis, if at all, obtain the required funding, or complete a corporate partnering or acquisition transaction.
Critical Accounting Policies
There are several accounting policies that we believe are significant to the presentation of our consolidated financial statements. The most significant accounting policies include those related to inventory and revenue recognition.
Inventory. We value our inventory that consists primarily of finished components of our lead product, the AastromReplicell Cell Production System, at the lower of cost (specific identification using first in, first out) or market. Furthermore, we regularly review inventory quantities on hand and record a provision to write down obsolete and excess inventory to its estimated net realizable value. Based on the aging of inventory at each period end, we utilize a systematic approach to determine our reserve for obsolete and excess inventory. Under this systematic approach, inventory that is less than twelve months old, based on the receipt date, will be carried at full value. Inventory quantities in excess of twelve months old are reserved over a six-month period, until the items are either sold or fully reserved. We feel this approach is appropriate given our limited product sales history and the risk associated with our ability to recover the inventory as we are still in the process of establishing our product market. Future technological changes, new product development and actual sales results could result in additional obsolete and excess inventory on hand. This could have a significant impact on the value of our inventory and our reported operating results.
Revenue recognition. We generate revenue from grants and research agreements, collaborative agreements and product sales. Revenue from grants and research agreements is recognized on a cost reimbursement basis consistent with the performance requirements of the related agreements. Revenue from collaborative agreements is recognized when the scientific or clinical results stipulated in the agreement have been met and there are no other ongoing obligations on our part. Revenue from product sales is recognized when title to the product transfers and there are no remaining obligations that will affect the customers final acceptance of the sale, generally after installation and training. If there are remaining obligations, including training or installation, revenue is recognized upon completion of these obligations. Revenue from licensing fees under licensing agreements is recognized as revenue when there are no future performance obligations remaining with respect to such fees. Payments received before all obligations are fulfilled are classified as deferred revenue.
Accounts receivable. We make estimates evaluating collectibility of accounts receivable. We continuously monitor collections and payments from our customers and maintain an allowance for estimated credit losses based on any specific customer collection issues we have identified. While such credit issues have not been significant, there is no assurance that we will continue to experience the same credit losses in the future.
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The summary of significant accounting policies should be read in conjunction with our consolidated financial statements and related notes and this discussion of our results of operations.
Results of Operations
Revenues for the quarter ended September 30, 2002 were $93,000, which consisted of grant revenues and product sales and rentals, compared to revenues of $151,000 f