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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.


(Exact name of registrant as specified in its charter)
     
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


(Registrant’s telephone number, including area code)


(Former name, former address and former fiscal year, if changed since last report)

     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 issuer’s 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

PART I — FINANCIAL INFORMATION
Item 1. Financial Statements
CONSOLIDATED CONDENSED BALANCE SHEETS
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
PART II — OTHER INFORMATION
Item 1. Legal Proceedings
Item 2. Changes in Securities and Use of Proceeds
Item 3. Defaults Upon Senior Securities
Item 4. Submission of Matters to a Vote of Security Holders
Item 5. Other Information
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
CERTIFICATIONS
EXHIBITS
EXHIBIT 99.1
EXHIBIT 99.2


Table of Contents

AASTROM BIOSCIENCES, INC.
Quarterly Report on Form 10-Q
September 30, 2002

TABLE OF CONTENTS

         
        Page
       
PART I -
FINANCIAL INFORMATION
 
 
Item 1.
Financial Statements
 
 
 
a) Consolidated Condensed Balance Sheets as of June 30, 2002 and September 30, 2002  
3
 
 
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
 
 
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
 
 
d)
Notes to Consolidated Condensed Financial Statements
 
6
 
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations  
9
 
Item 3.
Quantitative and Qualitative Disclosures About Market Risk  
25
 
Item 4.
Controls and Procedures
 
25
 
PART II
OTHER INFORMATION
 
 
Item 1.
Legal Proceedings
 
26
 
Item 2.
Changes in Securities and Use of Proceeds
 
26
 
Item 3.
Defaults Upon Senior Securities
 
26
 
Item 4.
Submission of Matters to a Vote of Security Holders
 
26
 
Item 5.
Other Information
 
26
 
Item 6.
Exhibits and Reports on Form 8-K
 
26
 
SIGNATURES
 
27
 
CERTIFICATIONS
 
28
 
EXHIBIT INDEX
 
31

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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.

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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
                       
(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.

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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:
                       
   
Net loss
  $ (1,893,000 )   $ (2,452,000 )   $ (95,281,000 )
   
Adjustments to reconcile net loss to net cash used for operating activities:
                       
     
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:
                       
       
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:
                       
   
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:
                       
   
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.

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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 Company’s 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

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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 FASB’s 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. Management’s 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

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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 we’ve 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

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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 customer’s 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