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SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2004

 

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Commission file number 0-21982

 

Diametrics Medical, Inc.


Incorporated pursuant to the Laws of Minnesota

 

Internal Revenue Service — Employer Identification No. 41-1663185

 

3050 Centre Pointe Drive, Suite 150, Roseville, Minnesota 55113

(651) 639-8035

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.  Yes x  No ¨

 

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

 

As of April 30, 2004, 29,222,993 shares of Common Stock were outstanding.


Table of Contents

Diametrics Medical, Inc.

 

Part I — FINANCIAL INFORMATION


   Page

Item 1.

  

Consolidated Financial Statements (unaudited)

    
    

Consolidated Statements of Operations: Three Months Ended March 31, 2004 and 2003

   3
    

Consolidated Balance Sheets as of March 31, 2004 and December 31, 2003

   4
    

Consolidated Statements of Cash Flows: Three Months Ended March 31, 2004 and 2003

   5
    

Notes to Consolidated Financial Statements

   6

Item 2.

  

Management’s Discussion and Analysis of Results of Operations and Financial Condition

   15

Item 3.

  

Quantitative and Qualitative Disclosure About Market Risk

   23

Item 4.

  

Controls and Procedures

   24

Part II — OTHER INFORMATION


    

Item 1.

  

Legal Proceedings

   24

Item 2.

  

Changes in Securities

   24

Item 3.

  

Defaults Upon Senior Securities

   24

Item 4.

  

Submission of Matters to a Vote of Security Holders

   25

Item 5.

  

Other Information

   25

Item 6.

  

Exhibits and Reports on Form 8-K

   25

Signatures

   26


Table of Contents

PART I – FINANCIAL INFORMATION

 

Item 1.   Consolidated Financial Statements (unaudited)

 

DIAMETRICS MEDICAL, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

    

Three Months Ended

March 31,


 
     2004

    2003

 

Net revenue

   $ 651,016     $ 737,212  

Cost of revenue

     610,920       619,486  

 

Gross profit

     40,096       117,726  

 

Operating expenses:

                

Research and development

     371,668       589,719  

Selling, general and administrative

     1,324,094       1,536,768  

 

Total operating expenses

     1,695,762       2,126,487  

 

Operating loss

     (1,655,666 )     (2,008,761 )

Interest income

     4,761       7,486  

Interest expense

     (381,191 )     (138,527 )

Other expense, net

     (123,855 )     1,498  

 

Net loss before discontinued operations

     (2,155,951 )     (2,138,304 )

 

Discontinued operations:

                

Loss from discontinued operations

           (752,317 )

Gain on sale of discontinued operations

     557,052        

 

Income (loss) from discontinued operations

     557,052       (752,317 )

 

Net loss

     (1,598,899 )     (2,890,621 )

Beneficial conversion feature—preferred stock dividend

     (665,994 )      

Net loss available to common shareholders

   $ (2,264,893 )   $ (2,890,621 )

 

Basic and diluted net loss per common share:

                

Net loss from continuing operations

   $ (0.10 )   $ (0.08 )

Discontinued operations:

                

Loss from discontinued operations

           (0.03 )

Gain on sale of discontinued operations

     0.02        

 

Net income (loss) from discontinued operations

     0.02       (0.03 )

 

Net loss

   $ (0.08 )   $ (0.11 )

 

Weighted average number of common shares outstanding

     28,498,626       26,835,451  

 

 

See accompanying notes to consolidated financial statements.

 

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DIAMETRICS MEDICAL, INC.

CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

 

    

March 31,

2004


    December 31,
2003


 

ASSETS

                

Current assets:

                

Cash and cash equivalents

   $ 845,052     $ 315,176  

Restricted cash

           720,169  

Accounts receivable, net

     441,330       464,402  

Inventories

     1,416,754       1,450,824  

Prepaid expenses and other current assets

     206,109       298,167  

 

Total current assets

     2,909,245       3,248,738  

 

Property and equipment

     7,406,489       7,249,524  

Less accumulated depreciation and amortization

     (5,620,948 )     (5,390,497 )

 
       1,785,541       1,859,027  

 

Other assets

     76,600       85,234  

 
     $ 4,771,386     $ 5,192,999  

 

LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)

                

Current liabilities:

                

Accounts payable

   $ 1,402,336     $ 1,097,069  

Accrued expenses

     815,249       794,148  

Deferred credits and revenue

     7,435       826,359  

Capital lease obligations and other borrowings

     144,873       169,861  

 

Total current liabilities

     2,369,893       2,887,437  

 

Long-term liabilities:

                

Convertible senior secured fixed rate notes (net of discount of $1,434,672 and $1,667,858 at March 31, 2004 and December 31, 2003, respectively)

     5,865,328       5,632,142  

Long-term liabilities, excluding current portion

     32,596       48,736  

Accrued retirement plan benefit

     2,495,260       2,495,260  

 

Total liabilities

     10,763,077       11,063,575  

 

Shareholders’ equity (deficit):

                

Preferred stock, $.01 par value: 5,000,000 authorized, 17,500 and 7,500 shares issued and outstanding at March 31, 2004 and December 31, 2003, respectively

     175       75  

Common stock, $.01 par value: 100,000,000 authorized, 29,222,993 and 27,456,209 shares issued and outstanding at March 31, 2004 and December 31, 2003, respectively

     292,230       274,562  

Additional paid-in capital

     152,613,913       150,612,474  

Accumulated deficit

     (155,121,486 )     (152,856,593 )

Deferred compensation

     (53,543 )     (93,699 )

Accumulated other comprehensive loss

     (3,722,980 )     (3,807,395 )

 

Total shareholders’ deficit

     (5,991,691 )     (5,870,576 )

 
     $ 4,771,386     $ 5,192,999  

 

 

See accompanying notes to consolidated financial statements.

 

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DIAMETRICS MEDICAL, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

    

Three Months Ended

March 31,


 
     2004

    2003

 

Cash flows from operating activities:

                

Net loss

   $ (1,598,899 )   $ (2,890,621 )

Adjustments to reconcile net loss to net cash used in continuing operating activities:

                

Loss from discontinued operations

           752,317  

Gain on sale of discontinued operations

     (557,052 )      

Depreciation and amortization

     211,487       175,012  

Accretion of convertible senior secured fixed rate notes

     233,186        

Expense related to warrant repricing

     90,674        

Stock-based compensation

     40,156       103,089  

Changes in operating assets and liabilities (net of effect of operations sold):

                

Accounts receivable

     23,072       (190,570 )

Inventories

     34,070       211,193  

Prepaid expenses and other current assets

     92,058       122,266  

Accounts payable

     305,268       86,605  

Accrued expenses

     21,101       (192,060 )

Deferred credits and revenue

     (100,000 )      

 

Net cash used in continuing operating activities

     (1,204,879 )     (1,822,769 )

 

Cash flows from investing activities:

                

Purchases of property and equipment

     (76,401 )     (180,951 )

Release of escrowed proceeds on sale of business

     720,169        

Recognition of deferred gain on sale of business

     (718,924 )      

 

Net cash used in investing activities

     (75,156 )     (180,951 )

 

Cash flows from financing activities:

                

Principal payments on borrowings and capital leases

     (41,129 )     (56,317 )

Net proceeds from the issuance of preferred stock and common stock warrants

     1,262,539        

Net proceeds from the issuance of common stock

           10,203  

 

Net cash provided by (used in) financing activities

     1,221,410       (46,114 )

 

Net cash provided by (used in) discontinued operations

     557,052       (431,027 )

Effect of exchange rate changes on cash and cash equivalents

     31,449       (31,136 )

 

Net increase (decrease) in cash and cash equivalents

     529,876       (2,511,997 )

Cash and cash equivalents at beginning of period

     315,176       3,964,791  

 

Cash and cash equivalents at end of period

   $ 845,052     $ 1,452,794  

 

Supplemental disclosure of cash flow information:

                

Cash paid during the period for interest

   $ 11,971     $ 12,527  

 

 

Supplemental disclosure of noncash investing and financing activities:

 

  -   As further described in note 2, effective January 16, 2004, the Company completed a $1.5 million financing through the sale of 15,000 shares of Series F convertible preferred stock. A beneficial conversion feature embedded in the preferred stock was calculated at $665,994 and was recorded as a noncash charge to retained earnings and treated as a reconciling item on the Statements of Operations to adjust the reported net loss to “net loss available to common shareholders.”

 

  -   The Company entered into capital lease obligations for equipment of $18,977 during the three months ended March 31, 2003.

 

See accompanying notes to consolidated financial statements.

 

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DIAMETRICS MEDICAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2004

(UNAUDITED)

 

(1)   UNAUDITED FINANCIAL STATEMENTS

The interim consolidated financial statements of Diametrics Medical, Inc. (the “Company”) are unaudited and have been prepared by the Company in accordance with accounting principles generally accepted in the United States of America for interim financial information, pursuant to the rules and regulations of the Securities and Exchange Commission. Pursuant to such rules and regulations, certain financial information and footnote disclosures normally included in the financial statements have been condensed or omitted. However, in the opinion of management, the financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the interim periods presented. Operating results for these interim periods are not necessarily indicative of results to be expected for the entire year, due to seasonal, operating and other factors.

 

Prior-year results of operations for the Company’s discontinued intermittent testing business have been reported as discontinued operations. This reclassification had no effect on the Company’s previously reported consolidated financial position, net loss or cash flows.

 

The Company has identified certain of its significant accounting policies that it considers particularly important to the portrayal of the Company’s results of operations and financial position and which may require the application of a higher level of judgment by the Company’s management, and as a result are subject to an inherent level of uncertainty. These are characterized as “critical accounting policies” and address the accounting for and classification of debt and equity instruments, revenue recognition and accounts receivable, inventories, foreign currency translation and transactions, impairment of long-lived assets and retirement plan funding, each more fully described under “Management’s Discussion and Analysis of Results of Operations and Financial Condition” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2003. No other changes to the Company’s critical accounting policies have been made during the quarter ended March 31, 2004.

 

These statements should be read in conjunction with the financial statements and related notes which are part of the Company’s Annual Report on Form 10-K for the year ended December 31, 2003.

 

(2)   SERIES F CONVERTIBLE PREFERRED STOCK FINANCING

On January 16, 2004, the Company completed the sale in a private placement of 15,000 shares of Series F convertible preferred stock at a price of $100 per share, resulting in aggregate gross proceeds to the Company of $1.5 million. An additional $1.5 million may be funded at the discretion of the purchasers, following shareholder approval received in late April 2004 of an increase in the number of authorized shares of the Company’s common stock to accommodate a second tranche of the Series F preferred stock. Each share of preferred stock is convertible at any time into common stock at 75% of the volume weighted average trading price of the lowest three inter-day trading prices of the common stock for the five consecutive trading days preceding the conversion date, but at an exercise price of no more than $.25 per share and no less than $.20 per share. However, if the Company’s six-month cash flow through June 30, 2004 is 20% less than projected, the floor conversion price will decrease to $.15 per share. Five-year warrants were also issued to purchase an aggregate of 6,000,000 shares of the Company’s common stock at the lower of $.35 per share or the average of the lowest ten inter-day closing prices of the Company’s common stock on the Over-the-Counter Bulletin Board during the 10 trading days immediately preceding the exercise date. Proceeds from the interim financing are being used to help meet the Company’s near-term funding requirements for support of its operations, as the Company continues to pursue longer-term financing by mid 2004 in order to sustain the development of its continuous monitoring business and explore additional applications of its technology.

 

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DIAMETRICS MEDICAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (continued)

March 31, 2004

(UNAUDITED)

 

Accounting for this transaction falls primarily under EITF 98-5, “Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios,” and EITF 00-27, “Application of Issue 98-5 to Certain Convertible Instruments.” The Company allocated the net investor proceeds of $1,350,000 from the issuance of the Series F convertible preferred stock to the preferred stock and associated warrants based upon their estimated relative fair values. The resulting fair value allocations of $665,994 and $684,006 for the preferred stock and warrants, respectively, were recorded as equity in the first quarter 2004. The beneficial conversion feature embedded in the preferred stock was calculated at $665,994 and was limited to the fair value allocated to the preferred stock. The beneficial conversion feature of $665,994 was treated as a deemed dividend to preferred shareholders, and was charged to retained earnings, with the offsetting credit to additional paid-in-capital. Additionally, the Company treated the beneficial conversion feature of $665,994 as a reconciling item on the statement of operations to adjust its reported net loss to “net loss available to common shareholders,” which is used in the numerator in the loss per share calculation for the quarter ended March 31, 2004. The Company classified the warrants issued in connection with the Series F preferred stock financing as equity rather than debt based upon an assessment of the Company’s contractual obligations for registration of the related common shares issuable upon exercise of the warrants as provided under EITF 00-19, “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock.”

 

(3)   DISCONTINUED OPERATIONS

On September 29, 2003, the Company completed the sale of substantially all of the assets used in the Company’s intermittent testing business to International Technidyne Corporation (“ITC”), a wholly owned subsidiary of Thoratec Corporation, for approximately $5.2 million in cash and the assumption of certain liabilities, including trade payables of approximately $583,000. Of the $5.2 million cash payment, $758,000 was placed in escrow and restricted from the Company’s use for 180 days to cover excess trade payables assumed by ITC, any shortfall in collected receivables or any indemnification claims. The carrying value of assets sold to ITC approximated $3 million, and ITC assumed liabilities of the intermittent testing business totaling $669,000. As prescribed by SFAS No. 144, “Accounting for the Impairment of Long-lived Assets,” the Company began reporting the results of operations of the intermittent testing business as discontinued operations effective with the quarter ended September 30, 2003, for all periods presented. Upon completion of the sale transaction in September 2003, the Company recorded a gain on the sale of the intermittent testing business of $1.8 million. In late March 2004, sale proceeds remaining in escrow and deferred for recognition were released to the Company, amounting to approximately $713,000. After deducting transaction costs of $156,000, an additional gain on the sale of discontinued operations was recognized in the first quarter 2004 of approximately $557,000.

 

Following are summary operating results of the intermittent testing business, included in discontinued operations in the Company’s Consolidated Statements of Operations for the three months ended March 31, 2003:

 

    

Three Months Ended

March 31, 2003


 

Revenue

   $ 1,439,455  

Gross profit

   $ 301,195  

Net loss

   $ (752,317 )

 

(4)   CONVERTIBLE SENIOR SECURED FIXED RATE NOTES

Effective April 7, 2003, the Company completed the renegotiation of the terms of its $7.3 million Convertible Senior Secured Fixed Rate Notes due August 4, 2003, to extend repayment of the notes to August 4, 2005. In exchange for the extension of repayment, the Company agreed to reduce the conversion price for $6.9 million principal value of the notes from $8.40 to $3.51 per share, and to use

 

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DIAMETRICS MEDICAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (continued)

March 31, 2004

(UNAUDITED)

 

50% of the net proceeds in excess of $10 million received prior to August 4, 2005 from the issuance of any equity securities to pay down the principal value of the notes. In addition, the Company issued the note holders five-year warrants for 4,255,837 shares of its common stock at an exercise price of $.94 per share. This transaction requires accounting treatment prescribed under EITF 96-19, “Debtors Accounting for a Modification or Exchange of Debt Instruments.” As such, the modified notes and associated warrants were recorded in the second quarter 2003 as debt and equity, respectively, at their respective individual fair values of $5 million and $800,000. The $7.3 million carrying value of the original notes was retired, and the residual amount of $1.5 million was recorded in the second quarter 2003 in other income as a gain on modification of the notes. The Company will accrete the initial $5 million carrying value of the modified notes to their redemption value of $7.3 million over the remaining term of the notes using the effective interest method at an effective interest rate of approximately 17%. This will result in the recording of $2.3 million of additional interest expense over the remaining term of the notes, of which $233,186 was recorded in the three months ended March 31, 2004.

 

In January 2004, the note holders agreed to further amend the Note Purchase Agreement effective December 30, 2003 to defer the timing of interest payments due for the fourth quarter 2003 and the first quarter 2004, amounting to approximately $256,000, to June 30, 2004, and to reduce the exercise price of the warrants from $.94 per share to $.34 per share. The reduction in the exercise price resulted in an increase in the fair value of the warrants of $90,674, which was recorded as a charge to other income with an offsetting credit to additional paid-in capital in the first quarter 2004.

 

(5)   LIQUIDITY

The accompanying financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities and other commitments in the normal course of business. The report of the Company’s independent auditors pertaining to the Company’s consolidated financial statements for the year ended December 31, 2003 contained an explanatory paragraph expressing substantial doubt about the Company’s ability to continue as a going concern as a result of recurring losses and negative cash flows. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that may be necessary if the Company is unable to continue as a going concern.

 

The Company incurred a consolidated net loss of $1,598,899 for the three months ended March 31, 2004, preceded by a consolidated net loss of $8,479,145 (including net losses from continuing operations of $8,240,168) for the year ended December 31, 2003, and has incurred net losses since inception. The net loss for the quarter is net of a $557,000 gain recognized upon the release in late March 2004 of escrowed proceeds from the Company’s sale of its intermittent testing business effective September 29, 2003.

 

The Company’s aggregate cash balance (including the impact of restricted cash) decreased by approximately $190,000 during the three months ended March 31, 2004 to $845,000. Primarily impacting the reduction in cash during the first quarter 2004 was a net loss from operations excluding noncash items of $1.6 million, partially offset by net proceeds of $1.3 million from the issuance during the first quarter of Series F convertible preferred stock.

 

As discussed in “Discontinued Operations” under note 3 to the consolidated financial statements, on September 29, 2003, the Company completed the sale of substantially all of the assets used in the operation of the Company’s intermittent testing business to ITC. Gross proceeds received at closing amounted to $4,420,000, of which approximately $389,000 was used to pay accrued interest due on the Company’s Convertible Senior Secured Fixed Rate Notes. Proceeds from the sale also included approximately $758,000 placed in escrow by ITC and restricted from the Company’s use for 180 days to cover excess trade payables assumed by ITC, any shortfall in collected receivables or any indemnification claims. In late March 2004, sales proceeds remaining in escrow were released to the Company, amounting to $713,000. Effective upon the sale of the Company’s intermittent testing business, the holders of the Company’s Series E preferred stock elected to exercise their option to put back to the Company 50% of their original $1.5 million investment plus a return of 1% per month. As a

 

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DIAMETRICS MEDICAL, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (continued)

March 31, 2004

(UNAUDITED)

 

result, in October 2003, the Company redeemed $750,000 in value of the Series E preferred stock, with cash payments of $790,250 including accrued interest. Additionally, the Company made payments of approximately $600,000 after the completion of the sale transaction for accrued retention bonuses earned by employees and accrued vacation pay for employees transferring to ITC or leaving the Company. Also, as part of changes made to reduce the cost structure of the Company’s continuing operations, the Company made payments after the closing of the sale for severance and related costs of approximately $659,000.

 

As more fully discussed under note 2 to the consolidated financial statements, on January 16, 2004, the Company completed the sale in a private placement of 15,000 shares of Series F convertible preferred stock at a price of $100 per share, resulting in aggregate gross proceeds to the Company of $1.5 million. An additional $1.5 million may be funded at the discretion of the purchasers, following shareholder approval of an increase in the number of authorized shares of the Company’s common stock to accommodate a second tranche of the Series F preferred stock. Five-year warrants were also issued to purchase an aggregate of 6,000,000 shares of the Company’s common stock at the lower of $.35 per share or a defined average trading price preceding exercise, providing a potential source of future funding. Proceeds from this financing are being used to help meet the Company’s near-term funding requirements for support of its operations, as the Company continues to pursue longer-te