UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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(Mark One) |
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ý QUARTERLY REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES |
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For the quarterly period ended March 31, 2004 |
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OR |
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o TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES |
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For the transition period from to |
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Commission file number 0-15360 |
BIOJECT MEDICAL TECHNOLOGIES INC.
(Exact name of registrant as specified in its charter)
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Oregon |
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93-1099680 |
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(State or other jurisdiction of incorporation |
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(I.R.S. Employer |
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211 Somerville Road, Route 202 North, |
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07921 |
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(Address of principal executive offices) |
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(Zip Code) |
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Registrant’s telephone number, including area code: (908) 470-2800 |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ý No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes o No ý
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
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Common Stock without par value |
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13,539,771 |
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(Class) |
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(Outstanding at May 10, 2004) |
BIOJECT MEDICAL TECHNOLOGIES INC.
FORM 10-Q
INDEX
1
PART 1 - FINANCIAL INFORMATION
BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES
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March 31, |
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December 31, |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
7,382,011 |
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$ |
6,893,686 |
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Short-term marketable securities |
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1,991,941 |
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2,259,424 |
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||
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Accounts receivable, net of allowance for doubtful accounts of $2,795 and $3,000 |
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1,697,926 |
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1,299,979 |
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||
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Receivable from related party, current portion |
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55,519 |
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74,025 |
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Inventories |
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1,665,651 |
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1,387,865 |
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Other current assets |
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293,777 |
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227,243 |
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||
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Total current assets |
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13,086,825 |
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12,142,222 |
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|
|
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Long-term marketable securities |
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267,496 |
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3,086,624 |
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||
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Restricted funds |
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1,500,000 |
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1,500,000 |
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||
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Property and equipment, net of accumulated depreciation of $4,337,672 and $4,173,195 |
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4,872,862 |
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4,759,671 |
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||
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Other assets, net |
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1,020,901 |
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979,589 |
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Total assets |
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$ |
20,748,084 |
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$ |
22,468,106 |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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Current liabilities: |
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Current portion of long-term debt |
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$ |
272,992 |
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$ |
175,000 |
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Accounts payable |
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1,337,371 |
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1,113,923 |
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||
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Accrued payroll |
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563,152 |
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432,744 |
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Other accrued liabilities |
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197,067 |
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464,964 |
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Deferred revenue |
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67,140 |
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434,119 |
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Total current liabilities |
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2,437,722 |
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2,620,750 |
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Long-term liabilities: |
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Long-term lease payable |
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74,362 |
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81,969 |
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Long-term debt |
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1,227,008 |
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1,325,000 |
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Deferred revenue |
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467,862 |
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484,646 |
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Commitments |
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Shareholders’ equity: |
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Preferred stock, no par value, 10,000,000 shares |
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authorized; issued and outstanding: |
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|
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Series A Convertible - 0 shares at March 31, 2004 and 952,738 shares at December 31, 2003, $15 stated value |
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— |
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17,149,000 |
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Series C Convertible - 0 shares at March 31, 2004 and 391,830 at December 31, 2003, no stated value |
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— |
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2,400,000 |
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Common stock, no par, 100,000,000 shares authorized; issued and outstanding 13,530,137 and 10,820,481 shares at March 31, 2004 and December 31, 2003 , respectively |
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108,423,332 |
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88,777,145 |
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||
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Accumulated deficit |
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(91,882,202 |
) |
(90,370,404 |
) |
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Total shareholders’ equity |
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16,541,130 |
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17,955,741 |
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Total liabilities and shareholders’ equity |
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$ |
20,748,084 |
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$ |
22,468,106 |
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The accompanying notes are an integral part of these consolidated financial statements.
2
BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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For the Three Months Ended March 31, |
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2004 |
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2003 |
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Revenue: |
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Net sales of products |
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$ |
2,006,258 |
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$ |
783,697 |
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License and technology fees |
|
999,699 |
|
316,785 |
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||
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3,005,957 |
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1,100,482 |
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|
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Operating expenses: |
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Manufacturing |
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1,802,033 |
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928,997 |
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Research and development |
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1,496,843 |
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1,139,896 |
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Selling, general and administrative |
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1,283,330 |
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1,336,675 |
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||
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Total operating expenses |
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4,582,206 |
|
3,405,568 |
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Operating loss |
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(1,576,249 |
) |
(2,305,086 |
) |
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Interest income |
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82,116 |
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90,773 |
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Interest expense |
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(17,665 |
) |
(791 |
) |
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64,451 |
|
89,982 |
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Net loss allocable to common shareholders |
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$ |
(1,511,798 |
) |
$ |
(2,215,104 |
) |
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|
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Basic and diluted net loss per common share |
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$ |
(0.12 |
) |
$ |
(0.21 |
) |
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|
|
|
|
|
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Shares used in per share calculations |
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12,488,035 |
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10,648,355 |
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The accompanying notes are an integral part of these consolidated financial statements.
3
BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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For the Three Months Ended March 31, |
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2004 |
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2003 |
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Cash flows from operating activities: |
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Net loss allocable to common shareholders |
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$ |
(1,511,798 |
) |
$ |
(2,215,104 |
) |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Compensation expenses related to fair value of stock or stock options |
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54,316 |
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25,607 |
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Stock contriubted to 401(k) plan |
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17,871 |
|
66,308 |
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Contributed capital for services |
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25,000 |
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— |
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Depreciation and amortization |
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185,477 |
|
127,814 |
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||
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Forgiveness of related party receivable |
|
18,506 |
|
18,506 |
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||
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Changes in operating assets and liabilities: |
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|
|
|
|
||
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Accounts receivable |
|
(397,947 |
) |
152,263 |
|
||
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Inventories |
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(277,786 |
) |
(390,085 |
) |
||
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Other current assets |
|
(66,534 |
) |
(14,021 |
) |
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Accounts payable |
|
222,643 |
|
148,238 |
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||
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Accrued payroll |
|
130,408 |
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39,581 |
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Other accrued liabilities |
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(267,897 |
) |
(31,116 |
) |
||
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Deferred revenue |
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(383,763 |
) |
282,944 |
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||
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Net cash used in operating activities |
|
(2,251,504 |
) |
(1,789,065 |
) |
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|
|
|
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Cash flows from investing activities: |
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|
|
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Maturity of marketable securities |
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3,086,611 |
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6,557,447 |
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Capital expenditures |
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(277,668 |
) |
(332,893 |
) |
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Other assets |
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(62,312 |
) |
(54,551 |
) |
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Net cash provided by investing activities |
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2,746,631 |
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6,170,003 |
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Cash flows from financing activities: |
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|
|
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Payments made on capital lease obligations |
|
(6,802 |
) |
(4,162 |
) |
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Net cash used in financing activities |
|
(6,802 |
) |
(4,162 |
) |
||
|
|
|
|
|
|
|
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Increase in cash and cash equivalents |
|
488,325 |
|
4,376,776 |
|
||
|
|
|
|
|
|
|
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Cash and cash equivalents: |
|
|
|
|
|
||
|
Beginning of period |
|
6,893,686 |
|
8,895,687 |
|
||
|
End of period |
|
$ |
7,382,011 |
|
$ |
13,272,463 |
|
|
|
|
|
|
|
|
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Supplemental disclosure of cash flow information: |
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|
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Cash paid for interest |
|
$ |
14,430 |
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$ |
847 |
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|
|
|
|
|
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Supplemental non-cash information |
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|
|
|
|
||
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Conversion of preferred stock to common |
|
$ |
19,549,000 |
|
$ |
— |
|
The accompanying notes are an integral part of these consolidated financial statements.
4
BIOJECT MEDICAL TECHNOLOGIES INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 1. Basis of Presentation
The financial information included herein for the three month periods ended March 31, 2004 and 2003 is unaudited; however, such information reflects all adjustments consisting only of normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of the financial position, results of operations and cash flows for the interim periods. The financial information as of December 31, 2003 is derived from Bioject Medical Technologies Inc.’s 2003 Annual Report on Form 10-K. The interim consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in Bioject’s 2003 Annual Report on Form 10-K. The results of operations for the interim period presented are not necessarily indicative of the results to be expected for the full year.
Inventories are stated at the lower of cost or market. Cost is determined in a manner which approximates the first-in, first out (FIFO) method. Costs utilized for inventory valuation purposes include labor, materials and manufacturing overhead. Net inventories consist of the following:
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|
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March 31, 2004 |
|
December 31, 2003 |
|
||
|
Raw materials and components |
|
$ |
841,599 |
|
$ |
677,390 |
|
|
Work in process |
|
222,148 |
|
80,991 |
|
||
|
Finished goods |
|
601,904 |
|
629,484 |
|
||
|
|
|
$ |
1,665,651 |
|
$ |
1,387,865 |
|
The following common stock equivalents were excluded from the diluted loss per share calculations, as their effect would have been antidilutive:
|
|
|
Three Months Ended March 31, |
|
||
|
|
|
2004 |
|
2003 |
|
|
Stock options and warrants |
|
4,454,785 |
|
3,547,091 |
|
|
Convertible preferred stock |
|
— |
|
2,689,136 |
|
|
Total |
|
4,454,785 |
|
6,236,227 |
|
We account for stock options using the intrinsic value method as prescribed by Accounting Principles Board (APB) Opinion No. 25, “Accounting for Stock Issued to Employees.” Pursuant to Statement of Financial Accounting Standards (SFAS) No. 148 “Accounting for Stock-Based Compensation - Transition and Disclosure,” we have computed, for pro forma disclosure purposes, the impact on net loss and net loss per share as if we had accounted for our stock-based compensation plans in accordance with the fair value method prescribed by SFAS No. 123 “Accounting for Stock-Based Compensation” as follows:
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Three Months Ended March 31, |
|
2004 |
|
2003 |
|
||
|
Net loss, as reported |
|
$ |
(1,511,798 |
) |
$ |
(2,215,104 |
) |
|
Add - stock-based employee compensation expense included in reported net loss |
|
54,316 |
|
25,607 |
|
||
|
Deduct - total stock-based employee compensation expense determined under the fair value based method for all awards |
|
(296,932 |
) |
(589,228 |
) |
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|
Net loss, pro forma |
|
$ |
(1,754,414 |
) |
$ |
(2,778,725 |
) |
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Basic and diluted net loss per share: |
|
|
|
|
|
||
|
As reported |
|
$ |
(0.12 |
) |
$ |
(0.21 |
) |
|
Pro forma |
|
$ |
(0.14 |
) |
$ |
(0.26 |
) |
5
To determine the fair value of stock-based awards granted during the periods presented, we used the Black-Scholes option pricing model and the following weighted average assumptions:
|
Three Months Ended March 31, |
|
2004 |
|
2003 |
|
|
Risk-free interest rate |
|
3.0 |
% |
3.0 |
% |
|
Expected dividend yield |
|
0 |
% |
0 |
% |
|
Expected lives |
|
5 years |
|
5 years |
|
|
Expected volatility |
|
98 |
% |
114 |
% |
On March 30, 2004, we converted our $1.5 million loan agreement with U.S. Bank into a 5-year term loan. Interest on the note is fixed at 4.73% per annum. Monthly payments, which include principal and interest, total approximately $28,000. At March 31, 2004, $1.5 million was outstanding under this agreement and we had a $1.5 million certificate of deposit collateralizing the loan amount.
In February 2004, Elan Pharmaceuticals Investments, Ltd. converted all 952,738 shares it held of our Series A preferred stock into a total of 1,905,476 shares of our common stock and all 391,830 shares it held of our Series C preferred stock into a total of 783,660 shares of our common stock. Following these conversions, we no longer have any Series A or Series C preferred stock outstanding. Elan still holds a Series P warrant exercisable for 505,334 shares of our common stock at a price of $7.50 per share, which expires on June 30, 2006.
In March 2004, we signed a second license and supply agreement with Merial. Under terms of the agreement, we will provide Merial with an exclusive license for use of a modified version of our Vitajet® needle-free injector system for use in veterinary clinics to administer vaccines for the companion animal market. This new contract expands Merial’s use of our needle-free injection systems and includes product licensing and royalty payments on Merial’s vaccines utilizing the needle-free delivery systems in companion animals. The product is expected to be commercialized in 2005.
Forward Looking Statements
This Quarterly Report on Form 10-Q contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning future financial results, prospects for future strategic corporate relationships, current corporate partners, prospects for sales of our products into new, high leverage markets and generally heightened prospects for the adoption and use of needle-free technology. Such forward looking statements (often, but not always, using words or phrases such as “expects” or “does not expect,” “is expected,” “anticipates” or “does not anticipate,” “plans,” “estimates” or “intends,” or stating that certain actions, events or results “may,” “could,” “would,” “should,” “might” or “will” be taken, occur or be achieved) involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward looking statements. Such risks, uncertainties and other factors include, without limitation, such risks as the risk that our products, including the cool.click™, the SeroJet™ or the Vial Adapter, will not be accepted by the market, the risk that we will be unable to enter into additional strategic corporate licensing and supply agreements or maintain existing agreements to commercialization, the fact that our business has never been profitable and may never be profitable, uncertainties related to the time required to complete research and development and obtain necessary clinical data and government clearances, the risk that we may be unable to produce our products at a unit cost necessary for the products to be competitive in the market and the risk that we may be unable to comply with the extensive government regulations
6
applicable to our business. Readers of this Form 10-Q are referred to our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2003, for further discussions of factors which could affect future results.
Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. We assume no obligation to update forward-looking statements if conditions or management’s estimates or opinions should change, even if new information becomes available or other events occur in the future.
Overview
We develop needle-free injection systems that improve the way patients take medications and vaccines.
Our long-term goal is to become the leading supplier of needle-free injection systems to the pharmaceutical and biotech industries. In 2004, we will continue to focus our business development efforts on new and existing licensing and supply agreements with leading pharmaceutical and biotechnology companies. By bundling customized needle-free delivery systems with partners’ injectable medications and vaccines, we can enhance demand for these products in the healthcare provider and end user markets.
In 2004, our clinical research efforts will continue to be aimed primarily at clinical research collaborations in the areas of vaccines and drug delivery. Currently, we are involved in collaborations with 22 institutions.
In 2004, our other research and development efforts will focus on moving our 0.5 mL and our 1.0 mL Iject® from the clinical phase to the production phase, which includes bringing on line our sterile fill capabilities. In addition, we continue to work on product improvements to existing devices and development of products for our strategic partners.
Revenues and results of operations have fluctuated and can be expected to continue to fluctuate significantly from quarter to quarter and from year to year. Various factors may affect quarterly and yearly operating results including: i) the length of time to close product sales; ii) customer budget cycles; iii) the implementation of cost reduction measures; iv) uncertainties and changes in product sales due to third party payer policies and proposals relating to healthcare cost containment; v) the timing and amount of payments under licensing and technology development agreements; and vi) the timing of new product introductions by us and our competitors.
We do not expect to report net income in 2004.
7
Results of Operations
The consolidated financial data for the three-month periods ended March 31, 2004 and 2003 are presented in the following table:
|
Three Months Ended March 31, |
|
2004 |
|
2003 |
|
||
|
Revenue: |
|
|
|
|
|
||
|
Net sales of products |
|
$ |
2,006,258 |
|
$ |
783,697 |
|
|
Licensing and technology fees |
|
999,699 |
|
316,785 |
|
||
|
|
|
3,005,957 |
|
1,100,482 |
|
||
|
Operating expenses: |
|
|
|
|
|
||
|
Manufacturing |
|
1,802,033 |
|
928,997 |
|
||
|
Research and development |
|
1,496,843 |
|
1,139,896 |
|
||
|
Selling, general and administrative |
|
1,283,330 |
|
1,336,675 |
|
||
|
Total operating expenses |
|
4,582,206 |
|
3,405,568 |
|
||
|
Operating loss |
|
(1,576,249 |
) |
(2,305,086 |
) |
||
|
|
|
|
|
|
|
||
|
Interest income |
|
82,116 |
|
90,773 |
|
||
|
Interest expense |
|
(17,665 |
) |
(791 |
) |
||
|
Net loss allocable to common shareholders |
|
$ |
(1,511,798 |
) |
$ |
(2,215,104 |
) |
|
Basic and diluted net loss per common share |
|
$ |
(0.12 |
) |
$ |
(0.21 |
) |
|
Shares used in per share calculations |
|
12,488,035 |
|
10,648,355 |
|
||
The $1.2 million, or 156%, increase in product sales in the first quarter of 2004 compared to the first quarter of 2003 is due to increased sales of our Vial Adapter product to Amgen and increased sales to Serono of the cool.click product.
The $683,000, or 216%, increase in license and technology fees in the first quarter of 2004 compared to the first quarter of 2003 is due to the recognition of $768,000 pursuant to the terms of the production and companion animal license and supply agreement we have with Merial and our revenue recognition policies. We currently have active licensing and/or development agreements with Serono and Merial.
Manufacturing expense is made up of the cost of products sold and manufacturing overhead expense related to excess manufacturing capacity. The $873,000, or 94%, increase in our manufacturing costs is related to the increase in product sales discussed above.
Research and development costs include labor, materials and costs associated with clinical studies incurred in the research and development of new products and modifications to existing products. The increase in research and development expense in the first quarter of 2004 compared to the first quarter of 2003 primarily relates to an increase of $314,000 in costs incurred in relation to moving our 0.5 mL Iject® from the clinical phase to the production phase, including expenses related to the automated sterile fill capabilities.
The $53,000, or 4.0%, decrease in selling, general and administrative expenses is due primarily to a $134,000 reduction in recruiting fees, offset in part by a $32,000 increase payroll and payroll related expenses. Selling, general and administrative expense in the first quarter of 2004 includes non-cash charges totaling $63,000 related to restricted stock grants to employees and consultants.
Interest income decreased to $82,000 in the first quarter of 2004 compared to $91,000 in the first quarter of 2003 due primarily to lower interest rates and lower cash and investment balances in 2004 compared to 2003. The lower cash and investment balances are due to the fact that we have not raised any capital since December 2001 and, therefore, have been utilizing existing cash and investment balances for operations.
Interest expense increased to $18,000 in the first quarter of 2004 compared to $800 in the first quarter of 2003 due to our $1.5 million outstanding term loan with U.S. Bank, which was not outstanding during the first quarter of 2003.
8
Liquidity and Capital Resources
Since our inception in 1985, we have financed our operations, working capital needs and capital expenditures primarily from private placements of securities, the exercise of stock options and warrants, proceeds received from our initial public offering in 1986, proceeds received from a public offering of common stock in November 1993, licensing and technology revenues and revenues from sales of products.
Total cash, cash equivalents, short and long-term marketable securities and restricted funds at March 31, 2004 were $11.1 million compared to $13.7 million at December 31, 2003. Included in this amount is $1.5 million of restricted funds which secures our loan with U.S. Bank that we used for capital equipment. Working capital at March 31, 2004 was $10.6 million compared to $9.5 million at December 31, 2003.
The overall decrease in cash, cash equivalents and short and long-term marketable securities during the first quarter of 2004 resulted primarily from $2.3 million used in operations, $278,000 used for capital expenditures and $62,000 used for other investing activities, primarily patent applications.
Net accounts receivable increased to $1.7 million at March 31, 2004 from $1.3 million at December 31, 2003 due primarily to increased product sales. Included in the balance at March 31, 2004, was $550,000 due from Serono related to cool.click sales and $455,000 due from Amgen related to Vial Adapter sales, of which $185,000 was past due and collected in April 2004.
Receivable from related party, totaling $56,000 at March 31, 2004, relates to a three-year, non-interest bearing loan to our Chief Executive Officer related to his relocation from Oregon to New Jersey. The note is being forgiven over the three-year term of the note, beginning January 2002, so long as he remains our Chief Executive Officer.
Inventories increased to $1.7 million at March 31, 2004 from $1.4 million at December 31, 2003 and primarily include raw materials and finished goods for the Vial Adapter and the cool.click™ product line. In April 2004, we moved to a new manufacturing facility, which allowed us to expand our manufacturing lines in order to have adequate manufacturing capacity to fulfill our projected Iject® and other product requirements for 2004 and beyond. We built an additional $250,000 of inventory in the first quarter of 2004 prior to our April 2004 move in order to ensure an uninterrupted supply to our customers.
Capital expenditures of $278,000 in the first quarter of 2004 were primarily for the purchase of production automation for sterile fill for our Iject® disposable product and capital expenditures related to our facilities move. We anticipate spending up to a total of $2.0 million in 2004 for production molds, manufacturing capabilities and our facilities move.
Accounts payable increased to $1.3 million at March 31, 2004 from $1.1 million at December 31, 2003 due primarily to inventory purchases and purchases related to capital expenditures late in the quarter.
Other accrued liabilities decreased to $197,000 at March 31, 2004 from $465,000 at December 31, 2003 due primarily to a $200,000 payment we made related to outsourced manufacturing space that is being prepared for our sterile fill capabilities.
Deferred revenue totaled $535,000 at March 31, 2004 compared to $919,000 at December 31, 2003. The balance at March 31, 2004 represents amounts received from Serono pursuant to a license agreement and a non-refundable deposit received from a potential licensing partner. In the first quarter of 2004, we recognized $268,000, which was deferred at December 31, 2003, related to our license and supply agreement with Merial.
On March 30, 2004, we converted our $1.5 million loan agreement with U.S. Bank into a 5-year term loan. Interest on the note is fixed at 4.73% per annum. Monthly payments, which include principal and
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interest, total approximately $28,000. At March 31, 2004, $1.5 million was outstanding under this agreement and we had a $1.5 million certificate of deposit collateralizing the loan amount.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
We reaffirm the critical accounting policies and estimates as reported in our Form 10-K for the year ended December 31, 2003, which was filed with the Securities and Exchange Commission on March 24, 2004.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to market risk for changes in interest rates on our investment portfolio and on our $1.5 million 5-year term loan with U.S. Bank.
We mitigate the risk in our investment portfolio by diversifying investments among high credit quality securities in accordance with our investment policy. As of March 31, 2004, our investment portfolio included cash, cash equivalents and marketable corporate debt securities (excluding $1.5 million of restricted funds) of $4.8 million and federal government debt securities of $4.8 million. The debt securities are subject to interest rate risk, and will decline in value if interest rates increase. Due to the short duration of our investment portfolio, an immediate 10 percent increase in interest rates would not have a material effect on our financial condition or results of operations.
The fair market value of our long-term fixed interest rate debt is subject to interest rate risk. Generally, the fair market value of fixed interest rate debt will increase as interest rates fall and decrease as interest rates rise. The interest rate changes affect the fair market value but do not impact earnings or cash flows. At March 31, 2004, we had $1.5 million of long-term fixed interest rate debt outstanding at an interest rate of 4.73% per annum.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Our management has evaluated, under the supervision and with the participation of our President and Chief Executive Officer and Chief Financial Officer, the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report pursuant to Rule 13a-15(b) under the Securities Exchange Act of 1934 (the “Exchange Act”). Based on that evaluation, our President and Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective in ensuring that information required to be disclosed in our Exchange Act reports is (1) recorded, processed, summarized and reported in a timely manner, and (2) accumulated and communicated to our management, including our President and Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting that occurred during our last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
The following exhibits are filed herewith and this list is intended to constitute the exhibit index:
31.1 Certification of James C. O’Shea pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 Certification of John Gandolfo pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certification of James C. O’Shea pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2 Certification of John Gandolfo pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(b) Reports on Form 8-K
We filed one report on Form 8-K during the quarter ended March 31, 2004, dated March 3, 2004 and filed March 4, 2004 pursuant to Item 12. “Results of Operations and Financial Condition,” regarding our financial results for our quarter and year ended December 31, 2003.
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Date: May 12, 2004 |
BIOJECT MEDICAL TECHNOLOGIES INC. |
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(Registrant) |
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/s/ JAMES O’SHEA |
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James O’Shea |
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Chairman of the Board, Chief Executive Officer |
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and President (Principal Executive Officer) |
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/s/ JOHN GANDOLFO |
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John Gandolfo |
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Chief Financial Officer and Vice President of Finance |
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(Principal Financial and Accounting Officer) |
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