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United States
Securities and Exchange Commission

Washington, D.C. 20549

Form 10-Q

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended December 31, 2003

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:           000-49867

CTI MOLECULAR IMAGING, INC.

(exact name of registrant as specified in its charter)
         
Delaware   62-1377363
(State of Incorporation)
  (I.R.S. Employer Identification No.)
         
810 Innovation Drive, Knoxville, Tennessee 37932
(Address of Principal Executive Offices)
  (Zip Code)

(Registrant’s Telephone Number, Including Area Code): (865) 218-2000

Not Applicable
(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 proceeding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes x No o

APPLICABLE ONLY TO CORPORATE ISSUERS

As of February 2, 2004, the registrant had outstanding 45,426,459 shares of common stock, par value $0.01.



 


TABLE OF CONTENTS

CONDENSED CONSOLIDATED BALANCE SHEETS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
NOTES TO CONDENSED CONSOLIDATED 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
SIGNATURE
EX-31.1 SECTION 302 CERTIFICATION OF THE CEO
EX-31.2 SECTION 302 CERTIFICATION OF THE CFO
EX-32.1 SECTION 906 CERTIFICATION OF THE CEO
EX-32.2 SECTION 906 CERTIFICATION OF THE CFO


Table of Contents

CTI Molecular Imaging, Inc.
Quarterly Report on Form 10-Q

Table of Contents

             
        Page
       
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS     3  
    PART I
Financial Information
       
Item 1.   Condensed Consolidated Financial Statements (unaudited):        
    Condensed Consolidated Balance Sheets at December 31, 2003 and September 30, 2003     4  
    Condensed Consolidated Statements of Operations for the Three Months Ended December 31, 2003 and 2002     5  
    Condensed Consolidated Statements of Cash Flows for the Three Months Ended December 31, 2003 and 2002     6  
    Notes to Condensed Consolidated Financial Statements     7  
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations     19  
Item 3.   Quantitative and Qualitative Disclosures About Market Risk     43  
Item 4.   Controls and Procedures     43  
    PART II
Other Information
       
Item 1.   Legal Proceedings     44  
Item 2.   Changes in Securities and Use of Proceeds     45  
Item 3.   Defaults Upon Senior Securities     45  
Item 4.   Submission of Matters to a Vote of Security Holders     45  
Item 5.   Other Information     45  
Item 6.   Exhibits and Reports on Form 8-K     46  
SIGNATURE     47  
CERTIFICATIONS     48  
EXHIBIT INDEX     50  

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CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS

     This report contains “forward-looking statements.” Forward-looking statements relate to expectations, beliefs, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts or that necessarily depend upon future events. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential,” and similar expressions. Specifically, this report contains, among others, forward-looking statements about:

    our expectations regarding financial condition or results of operations for periods after December 31, 2003;
 
    our critical accounting policies;
 
    the timing of the exercisability of the Siemens option to purchase an additional ownership interest in CTI PET Systems, Inc. (CPS) and the effect of the Siemens option, or its exercise, on our business;
 
    our expectations regarding the size and growth of the market for our products and services and the market acceptance of CTI’s products and services;
 
    our business strategies and our ability to grow our business;
 
    competition, pricing, the seasonality of capital equipment sales, the timing of orders from and shipments to distribution partners and customers, and the availability of financing services for customers;
 
    our ability to enhance existing, or develop new, products and services and the impact of any such enhancements or developments;
 
    the development and timing of new applications for PET and the impact of any such new applications;
 
    the implementation or interpretation of current or future regulations and legislation;
 
    the number and scope of procedures involving our products and services for which third-party reimbursement is available and the reimbursement levels of third-party payors;
 
    our ability to maintain contracts and relationships with key suppliers, customers, distributors or research and development collaboration partners;
 
    our ability to maintain our existing, or to develop additional, valuable intellectual property rights; and
 
    our future sources of and needs for liquidity and capital resources.

     The forward-looking statements contained in this report reflect our current views about future events, are based on assumptions and are subject to known and unknown risks and uncertainties. Many important factors could cause actual results or achievements to differ materially from any future results or achievements expressed in or implied by our forward-looking statements. Many of the factors that will determine future events or achievements are beyond our ability to control or predict. Important factors that could cause actual results or achievements to differ materially from the results or achievements reflected in our forward-looking statements include, among other things, the factors discussed in Part I, Item 2 of this report under the sub-heading “Factors Affecting Operations and Future Results.”

     You should read this report, the information incorporated by reference into this report and the documents filed as exhibits to this report completely and with the understanding that our actual future results or achievements may be materially different from what we expect or anticipate.

     The forward-looking statements contained in this report reflect our views and assumptions only as of the date this report is signed. Except as required by law, we assume no responsibility for updating any forward-looking statements.

     We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

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CTI MOLECULAR IMAGING, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS

                     
        December 31,   September 30,
    2003   2003
   
 
(In thousands, except share and per share data)   (unaudited)        
ASSETS
               
Current assets:
               
 
Cash and cash equivalents
  $ 44,429     $ 49,978  
 
Accounts receivable — trade, less allowance for doubtful accounts of $3,345 at December 31, 2003 and $3,475 at September 30, 2003
    46,406       72,240  
 
Accounts receivable — related party, less allowance for doubtful accounts of $186 at at December 31, 2003 and September 30, 2003
    37,090       42,430  
 
Inventories
    90,015       70,852  
 
Deferred tax asset
    19,705       17,751  
 
Prepaid expenses and other current assets
    6,779       7,691  
 
 
   
     
 
   
Total current assets
    244,424       260,942  
 
 
   
     
 
Property and equipment, net
    113,736       107,293  
Goodwill
    25,076       25,040  
Other assets
    27,900       31,773  
 
 
   
     
 
   
Total assets
  $ 411,136     $ 425,048  
 
 
   
     
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Current liabilities:
               
 
Cash management clearing
  $ 6,266     $ 12,017  
 
Accounts payable
    32,723       34,490  
 
Current maturities of long-term debt and capital lease obligations
    4,056       5,501  
 
Accrued payroll and benefits
    11,662       16,708  
 
Customer advances — trade
    8,180       6,537  
 
Customer advances — related party
    887       326  
 
Accrued warranty expense
    5,052       5,262  
 
Income taxes payable
          3,724  
 
Other accrued expenses
    2,059       3,884  
 
 
   
     
 
   
Total current liabilities
    70,885       88,449  
 
 
   
     
 
Deferred revenues
    1,735       2,332  
Deferred tax liability
    9,739       8,999  
Long-term debt and capital lease obligations, less current maturities
    19,185       18,688  
 
 
   
     
 
   
Total liabilities
    101,544       118,468  
 
 
   
     
 
Commitments and contingencies (Note 5)
               
Minority interest
    47,255       46,727  
Shareholders’ equity:
               
 
Preferred stock, Series C, $.01 par value, 50,000 shares authorized, no shares issued or outstanding at December 31, 2003 and September 30, 2003 (Note 11)
           
 
Common stock, $.01 par value; 500,000,000 shares authorized, 46,453,371 shares issued and 44,621,406 shares outstanding at December 31, 2003; 46,290,459 shares issued and 44,458,494 shares outstanding at September 30, 2003
    465       463  
 
Additional paid-in capital
    244,831       243,400  
 
Retained earnings
    21,925       21,207  
 
Unearned compensation
    (3,995 )     (4,516 )
 
Other comprehensive income — currency translation adjustment
    74       262  
 
Treasury stock, at cost, 1,831,965 shares
    (963 )     (963 )
 
 
   
     
 
   
Total shareholders’ equity
    262,337       259,853  
 
 
   
     
 
   
Total liabilities and shareholders’ equity
  $ 411,136     $ 425,048  
 
 
   
     
 

     The accompanying notes are an integral part of these condensed consolidated financial statements.

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CTI MOLECULAR IMAGING, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

                     
        Three Months Ended
        December 31,
       
    2003   2002
   
 
(In thousands, except share and per share data)   (unaudited)
Revenues (1)
  $ 74,107     $ 60,559  
Cost of revenues (2) (3)
    43,735       32,646  
 
   
     
 
   
Gross margin
    30,372       27,913  
 
   
     
 
Operating expenses:
               
 
Selling, general and administrative expenses (3)
    15,260       12,204  
 
Research and development expenses (3)
    10,190       6,629  
 
Stock-based compensation expense
    511       556  
 
   
     
 
   
Total operating expenses
    25,961       19,389  
 
   
     
 
Income from operations
    4,411       8,524  
Interest expense, net
    485       76  
Other income
    (595 )     (441 )
 
   
     
 
   
Income before income taxes and minority interest
    4,521       8,889  
 
   
     
 
Provision (benefit) for income taxes:
               
 
Current
    2,880       3,500  
 
Deferred
    (1,181 )     (8 )
 
   
     
 
 
    1,699       3,492  
 
   
     
 
Income before minority interest
    2,822       5,397  
Amount applicable to minority interest, net of taxes
    2,105       2,013  
 
   
     
 
   
Net income
  $ 717     $ 3,384  
 
   
     
 
Earnings per share (Note 2):
               
 
Basic
  $ 0.02     $ 0.08  
 
Diluted
  $ 0.02     $ 0.07  
Weighted average shares:
               
 
Basic
    44,331,007       42,103,795  
 
Diluted
    46,321,070       46,660,775  
 
(1) Includes revenues through related parties
  $ 33,471     $ 25,254  
(2) Includes cost of revenues through related parties
  $ 22,479     $ 14,674  
(3) Excludes stock-based compensation expense as follows:
               
   
Cost of revenues
  $ 56     $ 66  
   
Selling, general and administrative expenses
    348       389  
   
Research and development expenses
    107       101  
 
   
     
 
 
  $ 511     $ 556  
 
   
     
 

     The accompanying notes are an integral part of these condensed consolidated financial statements.

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CTI MOLECULAR IMAGING, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

                         
            Three Months Ended
            December 31,
           
            2003   2002
           
 
(In thousands, except share and per share data)   (unaudited)
Cash flows provided by operating activities:
               
 
Net income
  $ 717     $ 3,384  
 
Adjustments to reconcile net income to net cash provided by operating activities:
               
   
Minority interest in income of subsidiaries
    2,105       2,013  
   
Depreciation and amortization
    3,984       2,575  
   
Accretion of discount on marketable securities
          (31 )
   
Deferred tax benefit
    (1,181 )     (8 )
   
Provision for bad debts
    190       340  
   
Equity in income of equity investees
    (78 )     (122 )
   
Stock-based compensation expense
    511       556  
   
Loss on disposal of machinery and equipment
    33        
   
Tax benefit realized from exercises of employee stock options
    320        
   
Changes in operating assets and liabilities:
               
     
Accounts receivable
    30,130       17,856  
     
Inventories
    (20,713 )     (11,856 )
     
Prepaid expenses and other current assets
    459       305  
     
Accounts payable
    (1,766 )     (1,250 )
     
Accrued payroll and benefits
    (5,045 )     (4,033 )
     
Customer advances
    2,204       261  
     
Accrued warranty expense
    (210 )     (794 )
     
Income taxes payable
    (4,139 )     (5,513 )
     
Other accrued expenses
    (1,825 )     (564 )
 
 
   
     
 
       
Net cash provided by operating activities
    5,696       3,119  
 
 
   
     
 
Cash flows used in investing activities:
               
 
Additions to property and equipment
    (10,055 )     (8,099 )
 
Purchase of marketable securities
          (6,095 )
 
Proceeds from sale of marketable securities
          6,750  
 
Proceeds from the sale of other assets
    4,781        
 
Additions to other assets
    (84 )     (78 )
 
 
   
     
 
       
Net cash used in investing activities
    (5,358 )     (7,522 )
 
 
   
     
 
Cash flows (used in) provided by financing activities:
               
 
(Decrease) increase in cash management clearing
    (5,751 )     1,661  
 
Proceeds from exercise of stock options
    314       1,464  
 
Proceeds from issuance of common stock
    808       1,287  
 
Issuance of long-term debt
          321  
 
Principal payments on long-term debt and capital lease obligations
    (947 )     (947 )
 
Draws on line of credit
    7,785       16,992  
 
Payments under line of credit
    (7,785 )     (16,421 )
 
 
   
     
 
       
Net cash (used in) provided by financing activities
    (5,576 )     4,357  
 
 
   
     
 
Effect of foreign currency exchange rates on cash and cash equivalents
    (311 )     489  
 
 
   
     
 
Net (decrease) increase in cash and cash equivalents
    (5,549 )     443  
Cash and cash equivalents, beginning of year
    49,978       84,553  
 
 
   
     
 
Cash and cash equivalents, end of period
  $ 44,429     $ 84,996  
 
 
   
     
 

     The accompanying notes are an integral part of these condensed consolidated financial statements.

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CTI MOLECULAR IMAGING, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited, in thousands, except share and per share data)

1.     Organization and Presentation

     The unaudited condensed consolidated financial statements include the accounts of CTI Molecular Imaging, Inc. (CTI) and all of its subsidiaries (the Company). All of the subsidiaries are wholly owned except for CTI PET Systems, Inc. (CPS) in which CTI owns 50.1%. The balance of CPS is owned by Siemens Medical Solutions USA, Inc. (Siemens).

     The Company’s products and services can be broadly classified into three principal categories: Positron Emission Tomography (PET) scanners, detector materials, and other PET products and services. CPS manages the development, production and distribution of the ECAT® line of PET scanners. Detector Materials develops and manufactures detector materials used in PET scanners manufactured by CPS. CTI Solutions includes the production and distribution of radiopharmaceuticals and the direct sale and service by CTI of PET scanners, cyclotron systems, workstations and other PET related products. The CTI Solutions segment was formed effective October 1, 2003 and reflects the combination of the former CTI Services and PETNET segments, which previously were separately reported.

2.     Summary of Significant Accounting Policies

     Interim Financial Statements — The unaudited condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the SEC). Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These financial statements should be read in conjunction with the financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K filed with the SEC on December 23, 2003. Information in the accompanying condensed consolidated financial statements and notes to the financial statements for the three month periods ended December 31, 2003 and 2002 are unaudited. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of financial position, results of operations and cash flows for the periods presented have been included. Operating results for the three month period ended December 31, 2003 are not necessarily indicative of the results that may be expected for the year ending September 30, 2004 or any future period.

     Principles of Consolidation — All significant intercompany balances and transactions have been eliminated. The Company periodically enters into arrangements in which it holds a majority of the equity ownership. In some instances, the Company also has influence over a majority of the board of directors or managers. The Company determines accounting for these investments under Statement of Financial Accounting Standard (SFAS) No. 94 and Accounting Principles Board (APB) Opinion No. 18 and, where appropriate, evaluates its and the minority shareholders’ participating rights in accordance with Emerging Issues Task Force (EITF) Issue 96-16 to determine whether consolidation or equity method accounting is appropriate in each case.

     CTI owns a majority interest in CPS. Under the terms of the CPS operating agreement, CTI has influence over a majority of the board of directors. Decisions deemed participating rights, including approval of operating budgets and management compensation, are determined by a majority vote of the board of directors. The board of directors of CPS consists of two directors selected by CTI, two directors selected by Siemens, and a fifth director selected by Siemens from a list of persons selected by CTI. Neither Siemens nor any member of the board of directors of CPS who was selected or nominated by Siemens has any substantive participating or veto rights with regard to significant operating, budget, capital and other decisions. CPS is consolidated in the Company’s financial statements.

     CTI Solutions through our subsidiary, PETNET Pharmaceuticals, Inc. (PETNET), owns 90.0% and 51.0% interests in radiopharmacies in Denver and Houston, respectively. Under the terms of the Denver and Houston radiopharmacy operating agreements, CTI Solutions has control over all significant operating decisions and these radiopharmacies are consolidated in our financial statements. CTI Solutions accounted for the Houston joint venture

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under the equity method in the financial statements for the three months ended December 31, 2002 in accordance with EITF 96-16. In March 2003, an amendment to the joint venture agreement was adopted that removed the participating rights of the minority partner. Accordingly, CTI Solutions is now deemed to have control over the significant operating decisions of the joint venture and the entity is consolidated in the Company’s financial statements effective March 1, 2003.

     In cases where the minority shareholder is deemed to have “veto rights” or has equal representation on the board of directors, the Company accounts for these investments using the equity method as the Company does not have control over significant operating decisions. The Company has invested in four radiopharmacies that are accounted for under the equity method. The Company is assessing the potential impact of FASB Interpretation No. 46, Consolidation of Variable Interest Entities, an interpretation of Accounting Research Bulletin No. 51. See the Recent Accounting Pronouncements section of this note below.

     Revenue Recognition — The Company records revenues in accordance with the guidance of the SEC’s Staff Accounting Bulletin No. 104 (SAB 104), which supercedes SAB 101 in order to encompass EITF Issue 00-21, Revenue Arrangements with Multiple Deliverables (EITF 00-21). Revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the contract price is fixed or determinable, and collectibility is reasonably assured. No right of return privileges are granted to customers after shipment.

     The Company accounts for sales of scanning equipment and related installation and associated training services as multiple-element arrangements. The Company recognizes revenue for the elements separately as (i) the sales of the equipment, installation and training services represent separate earnings processes, (ii) revenue is allocated among the elements based on the fair value of the elements and (iii) installation and associated training are not deemed essential to the functionality of the equipment (as other companies are available to provide the installation and associated training services and are sometimes employed by CTI to do so). The Company determines the value of the equipment and installation and training services based on sales of the equipment both with and without installation and training. The Company derives its revenues from sales of scanners, calibration sources, spare parts, detector materials, cyclotrons, radiopharmaceuticals and the provision of services on equipment sold, including site planning and installation, repair and maintenance, training, technical support and assistance with licensing. Revenues derived from the sale of scanners, calibration sources, spare parts, and detector materials are recognized upon either shipment or arrival at destination depending on shipment terms.

  &nbs