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 March 31, 2010
OR
¨ | 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 000-15360
BIOJECT MEDICAL TECHNOLOGIES INC.
(Exact name of registrant as specified in its charter)
| | |
Oregon | | 93-1099680 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| |
20245 SW 95th Avenue Tualatin, Oregon | | 97062 |
(Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (503) 692-8001
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 has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ¨ No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definition of “accelerated filer,” “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
| | | | | | |
Large accelerated filer | | ¨ | | Accelerated filer | | ¨ |
| | | |
Non-accelerated filer | | ¨ (Do not check if a smaller reporting company) | | Smaller reporting company | | x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.
| | |
Common Stock without par value | | 17,808,944 |
(Class) | | (Outstanding at May 12, 2010) |
BIOJECT MEDICAL TECHNOLOGIES INC.
FORM 10-Q
INDEX
1
PART 1 - FINANCIAL INFORMATION
Item 1. | Financial Statements |
BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
| | | | | | | | |
| | March 31, 2010 | | | December 31, 2009 | |
ASSETS | | | | | | | | |
Current assets: | | | | | | | | |
Cash | | $ | 463,112 | | | $ | 1,146,318 | |
Accounts receivable, net of allowance for doubtful accounts of $5,149 and $5,149 | | | 909,031 | | | | 899,311 | |
Inventories | | | 855,853 | | | | 867,676 | |
Other current assets | | | 25,024 | | | | 20,951 | |
| | | | | | | | |
Total current assets | | | 2,253,020 | | | | 2,934,256 | |
| | |
Property and equipment, net of accumulated depreciation of $7,465,357 and $7,343,888 | | | 948,619 | | | | 1,070,088 | |
Other assets, net | | | 1,265,874 | | | | 1,251,838 | |
| | | | | | | | |
Total assets | | $ | 4,467,513 | | | $ | 5,256,182 | |
| | | | | | | | |
| | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | | | | | |
Current liabilities: | | | | | | | | |
Short-term notes payable | | $ | — | | | $ | 124,758 | |
Accounts payable | | | 713,588 | | | | 949,963 | |
Accrued payroll | | | 163,144 | | | | 163,512 | |
Derivative liabilities | | | 39,983 | | | | 32,451 | |
Other accrued liabilities | | | 705,448 | | | | 690,663 | |
Deferred revenue | | | 269,526 | | | | 276,272 | |
| | | | | | | | |
Total current liabilities | | | 1,891,689 | | | | 2,237,619 | |
| | |
Long-term liabilities: | | | | | | | | |
Deferred revenue | | | 1,268,171 | | | | 1,222,427 | |
Other long-term liabilities | | | 349,139 | | | | 348,161 | |
| | |
Commitments | | | | | | | | |
| | |
Shareholders’ equity: | | | | | | | | |
Preferred stock, no par value, 10,000,000 shares authorized: | | | | | | | | |
Series D Convertible - 2,086,957 shares issued and outstanding at March 31, 2010 and December 31, 2009, liquidation preference of $1.15 per share | | | 1,878,768 | | | | 1,878,768 | |
Series E Convertible - 3,308,392 shares issued and outstanding at March 31, 2010 and December 31, 2009, liquidation preference of $1.37 per share | | | 5,478,466 | | | | 5,478,466 | |
Series F Convertible - 8,314 shares issued and outstanding at March 31, 2010 and December 31, 2009, liquidation preference of $75 per share | | | 723,025 | | | | 720,018 | |
Series G Convertible - 92,448 shares issued and outstanding at March 31, 2010 and December 31, 2009, liquidation preference of $13 per share | | | 1,227,251 | | | | 1,205,034 | |
Common stock, no par value, 100,000,000 shares authorized; 17,729,111 shares issued and outstanding at March 31, 2010 and December 31, 2009 | | | 114,408,261 | | | | 114,355,059 | |
Accumulated deficit | | | (122,757,257 | ) | | | (122,189,370 | ) |
| | | | | | | | |
Total shareholders’ equity | | | 958,514 | | | | 1,447,975 | |
| | | | | | | | |
Total liabilities and shareholders’ equity | | $ | 4,467,513 | | | $ | 5,256,182 | |
| | | | | | | | |
The accompanying notes are an integral part of these consolidated financial statements.
2
BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| | | | | | | | |
| | For the Three Months Ended March 31, | |
| | 2010 | | | 2009 | |
Revenue: | | | | | | | | |
Net sales of products | | $ | 1,091,368 | | | $ | 1,857,546 | |
Licensing and technology fees | | | 96,354 | | | | 127,690 | |
| | | | | | | | |
| | | 1,187,722 | | | | 1,985,236 | |
| | |
Operating expenses: | | | | | | | | |
Manufacturing | | | 808,906 | | | | 1,143,131 | |
Research and development | | | 372,369 | | | | 436,874 | |
Selling, general and administrative | | | 513,847 | | | | 581,035 | |
| | | | | | | | |
Total operating expenses | | | 1,695,122 | | | | 2,161,040 | |
| | | | | | | | |
Operating loss | | | (507,400 | ) | | | (175,804 | ) |
| | |
Interest income | | | 2,205 | | | | 3,104 | |
Interest expense | | | (29,936 | ) | | | (50,118 | ) |
Change in fair value of derivative liabilities | | | (7,532 | ) | | | (1,421 | ) |
| | | | | | | | |
| | | (35,263 | ) | | | (48,435 | ) |
| | | | | | | | |
Net loss | | | (542,663 | ) | | | (224,239 | ) |
Preferred stock dividends | | | (25,224 | ) | | | (12,471 | ) |
| | | | | | | | |
Net loss allocable to common shareholders | | $ | (567,887 | ) | | $ | (236,710 | ) |
| | | | | | | | |
Basic and diluted net loss per common share allocable to common shareholders | | $ | (0.03 | ) | | $ | (0.01 | ) |
| | | | | | | | |
Shares used in per share calculations | | | 17,729,111 | | | | 16,613,432 | |
| | | | | | | | |
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)
| | | | | | | | |
| | For the Three Months Ended March 31, | |
| | 2010 | | | 2009 | |
Cash flows from operating activities: | | | | | | | | |
Net loss | | $ | (542,663 | ) | | $ | (224,239 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | |
Compensation expense related to fair value of stock-based awards | | | 53,202 | | | | 85,590 | |
Stock contributed to 401(k) plan | | | — | | | | 21,562 | |
Depreciation and amortization | | | 149,369 | | | | 164,265 | |
Other non-cash interest expense | | | 25,242 | | | | 39,069 | |
Change in fair value of derivative instruments | | | 7,532 | | | | 1,421 | |
Change in deferred revenue | | | 38,998 | | | | 37,149 | |
Change in deferred rent | | | 2,483 | | | | 40,282 | |
Changes in operating assets and liabilities: | | | | | | | | |
Accounts receivable, net | | | (9,720 | ) | | | (994,089 | ) |
Inventories | | | 11,823 | | | | 119,358 | |
Other current assets | | | (4,073 | ) | | | 14,638 | |
Accounts payable | | | (236,375 | ) | | | 317,905 | |
Accrued payroll | | | (368 | ) | | | 7,952 | |
Other accrued liabilities | | | 14,785 | | | | 208,358 | |
| | | | | | | | |
Net cash used in operating activities | | | (489,765 | ) | | | (160,779 | ) |
| | |
Cash flows from investing activities: | | | | | | | | |
Other assets | | | (41,936 | ) | | | (28,633 | ) |
| | | | | | | | |
Net cash used in investing activities | | | (41,936 | ) | | | (28,633 | ) |
| | |
Cash flows from financing activities: | | | | | | | | |
Principal payments made on short and long-term debt | | | (150,000 | ) | | | (165,000 | ) |
Payments made on capital lease obligations | | | (1,505 | ) | | | (3,829 | ) |
| | | | | | | | |
Net cash used in financing activities | | | (151,505 | ) | | | (168,829 | ) |
| | | | | | | | |
| | |
Decrease in cash and cash equivalents | | | (683,206 | ) | | | (358,241 | ) |
| | |
Cash and cash equivalents: | | | | | | | | |
Beginning of period | | | 1,146,318 | | | | 1,351,892 | |
| | | | | | | | |
End of period | | $ | 463,112 | | | $ | 993,651 | |
| | | | | | | | |
| | |
Supplemental disclosure of cash flow information: | | | | | | | | |
Cash paid for interest | | $ | 2,210 | | | $ | 9,767 | |
| | |
Supplemental disclosure of non-cash information: | | | | | | | | |
Preferred stock dividend to be settled in Series F or Series G preferred stock | | $ | 25,224 | | | $ | 12,471 | |
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 and Going Concern
The financial information included herein for the three-month periods ended March 31, 2010 and 2009 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, 2009 is derived from Bioject Medical Technologies Inc.’s 2009 Annual Report on Form 10-K for the year ended December 31, 2009. The interim consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in Bioject’s 2009 Annual Report on Form 10-K. The results of operations for the interim periods presented are not necessarily indicative of the results to be expected for the full year.
Due to our limited amount of additional committed capital, recurring losses, negative cash flows and accumulated deficit, the report of our independent registered public accounting firm for the year ended December 31, 2009 expressed substantial doubt about our ability to continue as a going concern.
We have historically suffered recurring operating losses and negative cash flows from operations. As of March 31, 2010, we had an accumulated deficit of $122.8 million with total shareholders’ equity of $1.0 million. Our consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, assuming that we will continue as a going concern.
At March 31, 2010, we had a cash balance of $0.5 million and we had working capital of $0.4 million.
In March 2010, we repaid the remaining $150,000 of debt we had outstanding and, as of March 31, 2010, we did not have any debt outstanding.
We continue to monitor our cash and have previously taken measures to reduce our expenditure rate, including temporary salary reductions and rent deferrals. In addition, we delayed capital and maintenance expenditures and restructured our debt. However, if we do not enter into an adequate number of licensing, development and supply agreements with up-front payments or increase sales to current customers or markets during the second quarter of 2010, we may need to do one or more of the following to raise additional resources, or reduce our cash requirements:
| • | | secure additional short-term debt financing; |
| • | | secure additional long-term debt financing; |
| • | | secure additional equity financing; |
| • | | secure a strategic partner; or |
| • | | reduce our operating expenditures. |
While management is committed to working on a number of strategic options and alternatives intended to keep us as a going concern, there is no assurance that we will be successful.
Note 2. Inventories
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. Inventories, net of valuation reserves of $602,000 and $622,000 at March 31, 2010 and December 31, 2009, respectively, consisted of the following:
| | | | | | |
| | March 31, 2010 | | December 31, 2009 |
Raw materials and components | | $ | 498,102 | | $ | 496,208 |
Work in process | | | 32,007 | | | 132,537 |
Finished goods | | | 325,744 | | | 238,931 |
| | | | | | |
| | $ | 855,853 | | $ | 867,676 |
| | | | | | |
5
Note 3. Net Loss Per Common Share
The following common stock equivalents were excluded from the diluted net loss per share calculations, as their effect would have been antidilutive:
| | | | |
| | Three Months Ended March 31, |
| | 2010 | | 2009 |
Stock options, restricted stock and warrants | | 2,907,733 | | 3,023,641 |
Convertible preferred stock | | 15,471,549 | | 6,226,749 |
Series E payment-in-kind dividends | | 550,516 | | 550,516 |
Series F payment-in-kind dividends | | 133,263 | | 62,112 |
Series G payment-in-kind dividends | | 195,519 | | — |
$1.25 million convertible debt | | — | | 716,667 |
$600,000 convertible debt | | — | | 800,000 |
Accrued interest on $600,000 convertible debt | | — | | 83,463 |
| | | | |
Total | | 19,258,580 | | 11,463,148 |
| | | | |
Note 4. Product Sales and Concentrations
Product sales to customers accounting for 10% or more of our product sales were as follows:
| | | | | | |
| | Three Months Ended March 31, | |
| | 2010 | | | 2009 | |
Serono | | 33 | % | | 42 | % |
Ferring | | 29 | % | | 11 | % |
Merial | | 27 | % | | 30 | % |
At March 31, 2010, accounts receivable from Serono, Ferring and Merial represented 35%, 19% and 38%, respectively, of the accounts receivable balance. No other customers accounted for 10% or more of our accounts receivable as of March 31, 2010.
Note 5. Fair Value Measurements
Factors used in determining the fair value of our financial assets and liabilities are summarized into three broad categories:
| • | | Level 1 – quoted prices in active markets for identical securities; |
| • | | Level 2 – other significant observable inputs, including quoted prices for similar securities, interest rates, prepayment speeds, credit risk, etc.; and |
| • | | Level 3 – significant unobservable inputs, including our own assumptions in determining fair value. |
The inputs or methodology used for valuing securities are not necessarily an indication of the risk associated with investing in those securities.
Certain of our convertible debt and equity agreements include derivative liabilities. These instruments were recorded at fair value and are marked to market each period. The fair value of each of these instruments is determined using the Black-Scholes valuation model.
Following are the disclosures related to our financial assets and (liabilities) (in thousands):
| | | | | | |
| | March 31, 2010 |
| | Fair Value | | | Input Level |
Warrants issued in connection with $1.5 million bridge loan | | $ | (39,983 | ) | | Level 3 |
6
| | | | | | | | |
| | Warrants issued in connection with March 2006 $1.5 million bridge loan | | | $1.25 million convertible debt conversion feature(1) | |
Black- Scholes Assumptions | | | | | | | | |
Risk-free interest rate | | | 0.43 | % | | | — | |
Expected dividend yield | | | 0.00 | % | | | — | |
Contractual term (years) | | | 0.44 | | | | — | |
Expected volatility | | | 258 | % | | | — | |
| | |
Certain Other Information | | | | | | | | |
Fair value at December 31, 2009 | | $ | (30,039 | ) | | $ | (2,412 | ) |
Change in fair value | | | (9,944 | ) | | | 2,412 | |
| | | | | | | | |
Fair value at March 31, 2010 | | $ | (39,983 | ) | | $ | — | |
| | | | | | | | |
(1) | The $1.25 million convertible debt was paid off during the first quarter of 2010 and, accordingly, there is no value attributable to the conversion feature at March 31, 2010. |
Note 6. Other Current Liabilities
Included in other current liabilities was $628,000 and $618,000 at March 31, 2010 and December 31, 2009, respectively, related to prepaid inventory and credits for Serono.
Note 7. Recent Accounting Guidance Not Yet Adopted
ASU 2010-17
In April 2010, the FASB issued ASU 2010-17, “Revenue Recognition – Milestone Method,” which provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for research or development transactions. Research or development arrangements frequently include payment provisions whereby a portion or all of the consideration is contingent upon milestone events such as successful completion of phases in a drug study or achieving a specific result from the research or development efforts. An entity often recognizes these milestone payments as revenue in their entirety upon achieving the related milestone, commonly referred to as the milestone method. The amendments in ASU 2010-17 are effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Early adoption is permitted. While we are still analyzing the provisions of ASU 2010-17, we believe that our current practices are consistent with the guidance in ASU 2010-17 and, accordingly, we do not expect the adoption of the provisions of ASU 2010-17 to have any effect on our financial position, results of operations or cash flows.
ASU 2010-06
Accounting Standards Update (“ASU”) 2010-06, “Improving Disclosures about Fair Value Measurements,” requires new disclosures about recurring or nonrecurring fair-value measurements including significant transfers into or out of Level 1 and Level 2 fair-value classifications. It also requires information on purchases, sales, issuances and settlements on a gross basis in the reconciliation of Level 3 fair-value assets and liabilities. These disclosures are required for fiscal years beginning on or after December 15, 2009. The ASU also clarifies existing fair-value measurement disclosure guidance about the level of disaggregation, inputs and valuation techniques, which are required to be implemented in fiscal years beginning on or after December 15, 2010. Since the requirements of this ASU only relate to disclosure, the adoption of the guidance will not have any effect on our financial position, results of operations or cash flows.
7
ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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 cash requirements. 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, the risk that we may not enter into anticipated licensing, development or supply agreements, the risk that we may not achieve the milestones necessary for us to receive payments under our development agreements, the risk that our products will not be accepted by the market, the risk that we will be unable to obtain needed debt or equity financing on satisfactory terms, or at all, risks related to the general economic environment and uncertainties in the financial markets, uncertainties related to our dependence on the continued performance of strategic partners and technology and uncertainties related to the time required for us or our strategic partners to complete research and development and obtain necessary clinical data and government clearances. See also Part II, Item 1A, Risk Factors.
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 are an innovative developer and manufacturer of needle-free injection therapy systems (“NFITS”).
Our NFITS work by forcing liquid medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure medication that penetrates the skin, depositing the medication in the tissue beneath. 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 January 2010, we established a strategic alliance with MPI Research, a leading pre-clinical research organization with experience in the development of injectable therapeutics. The strategic alliance creates a preferred partnership relationship, which allows us to gain access to a range of capabilities and resources needed for us to explore our drug+device opportunities, including access to pharmacologic, analytical, safety and other preclinical testing resources available at MPI Research. The strategic alliance offers MPI Research the opportunity to provide our needle-free technology as an alternate delivery option to current drug/biologic manufacturers who may be interested in seeking a more highly competitive and differentiable drug+device brand. We believe this alliance also increases the possibility that we may be able to secure government sponsored grants or funding directed at improvements in drug+device or vaccine+device based treatments, which could also lead to potential new drug+device combinations.
In March 2010, we met the final milestone in our license, development and supply agreement with Merial Ltd, for their new state-of-the-art spring-powered device for feline leukemia and canine melanoma vaccinations for companion animals and we initiated the first product shipments of the new device to Merial at the end of the first quarter.
8
Although revenues for the first quarter of 2010 were lower than the same time period last year, we are undertaking actions related to both revenue and cash management in an attempt to improve our results. Such actions include the hiring of a new National Sales Manager who is focusing on increasing sales of our devices to the military and public health sectors. We are also exploring new options for funding of technologies to support the needs of the developing world and are targeting potential federally funded programs with our device technology in order to deliver new benefits for emergency preparedness and biodefense.
Also in March 2010, we repaid the remaining $150,000 of debt we had outstanding and, at March 31, 2010, we did not have any debt outstanding.
We do not expect to report net income in 2010.
GOING CONCERN AND CASH REQUIREMENTS FOR THE NEXT TWELVE-MONTH PERIOD
See Note 1 of Notes to Consolidated Financial Statements included in Part I, Item 1 of this Form 10-Q.
CONTRACTUAL PAYMENT OBLIGATIONS
A summary of our contractual commitments and obligations as of March 31, 2010 was as follows:
| | | | | | | | | | | | | | | |
| | Payments Due By Period |
Contractual Obligation | | Total | | Remainder of 2010 | | 2011 and 2012 | | 2013 and 2014 | | 2015 and beyond |
Operating leases and deferred rent(1) | | $ | 2,027,056 | | $ | 312,273 | | $ | 936,991 | | $ | 777,792 | | $ | — |
Capital leases | | | 17,863 | | | 11,490 | | | 6,373 | | | — | | | — |
Purchase order commitments(2) | | | 416,208 | | | 416,208 | | | — | | | — | | | — |
| | | | | | | | | | | | | | | |
| | $ | 2,461,127 | | $ | 739,971 | | $ | 943,364 | | $ | 777,792 | | $ | — |
| | �� | | | | | | | | | | | | | |
(1) | Operating leases and deferred rent includes $110,000 of deferred rent due beginning January 2011, or sooner if certain events occur. |
(2) | Purchase order commitments generally relate to future raw material inventory purchases, research and development projects and other operating expenses. However, $88,000 of the 2010 purchase order commitments is for capital equipment purchases for the benefit and ownership of a customer. While we are contractually obligated to make the purchases, the funds are generally provided to us by our customer in advance of delivery and prior to our payment for the purchases. |
RESULTS OF OPERATIONS
The consolidated financial data for the three-month periods ended March 31, 2010 and 2009 are presented in the following table:
| | | | | | | | |
Three Months Ended March 31, | | 2010 | | | 2009 | |
Revenue: | | | | | | | | |
Net sales of products | | $ | 1,091,368 | | | $ | 1,857,546 | |
License and technology fees | | | 96,354 | | | | 127,690 | |
| | | | | | | | |
| | | 1,187,722 | | | | 1,985,236 | |
Operating expenses: | | | | | | | | |
Manufacturing | | | 808,906 | | | | 1,143,131 | |
Research and development | | | 372,369 | | | | 436,874 | |
Selling, general and administrative | | | 513,847 | | | | 581,035 | |
| | | | | | | | |
Total operating expenses | | | 1,695,122 | | | | 2,161,040 | |
| | | | | | | | |
Operating loss | | | (507,400 | ) | | | (175,804 | ) |
| | |
Interest income | | | 2,205 | | | | 3,104 | |
Interest expense | | | (29,936 | ) | | | (50,118 | ) |
Change in fair value of derivative liabilities | | | (7,532 | ) | | | (1,421 | ) |
| | | | | | | | |
Net loss | | | (542,663 | ) | | | (224,239 | ) |
Preferred stock dividends | | | (25,224 | ) | | | (12,471 | ) |
| | | | | | | | |
Net loss allocable to common shareholders | | $ | (567,887 | ) | | $ | (236,710 | ) |
| | | | | | | | |
Basic and diluted net loss per common share allocable to common shareholders | | $ | (0.03 | ) | | $ | (0.01 | ) |
| | | | | | | | |
Shares used in per share calculations | | | 17,729,111 | | | | 16,613,432 | |
| | | | | | | | |
9
Revenue
Product sales decreased $766,000, or 41%, in the first quarter of 2010 compared to the first quarter of 2009 primarily due to the following:
| • | | A decrease in sales to Serono from $785,000 to $360,000, or 54%, in the first quarter of 2010 compared to the first quarter of 2009 due to reductions in their forecast; |
| • | | A decrease in sales to Merial from $557,000 to $293,000, or 47%, in the first quarter of 2010 compared to the first quarter of 2009, due to the timing of orders; |
| • | | A decrease in sales to the military from $112,000 to $47,000, or 58%, in the first quarter of 2010 compared to the first quarter of 2009; and |
| • | | The completion of a grant project for the Centers for Disease Control, which resulted in $137,000 of revenue in the first quarter of 2009 and no revenue in the first quarter of 2010. |
These decreases were partially offset by an increase in sales to Ferring Pharmaceuticals of $107,000, or 51%, from $208,000 to $315,000 in the first quarter of 2010 compared to the first quarter of 2009.
We currently have supply agreements or commitments with Serono, Merial, Ferring Pharmaceuticals and the U.S. federal government. Our agreement with Serono expires in December 2010.
License and technology fees recognized in accordance with our agreements were as follows:
| | | | | | |
Three Months Ended March 31, | | 2010 | | 2009 |
Merial | | $ | 42,011 | | $ | 38,263 |
Serono | | | 18,991 | | | 42,082 |
Royalty fees | | | 25,352 | | | 26,186 |
Other | | | 10,000 | | | 8,659 |
Vical | | | — | | | 12,500 |
| | | | | | |
| | $ | 96,354 | | $ | 127,690 |
| | | | | | |
We currently have an active licensing and development agreement, which includes commercial product supply provisions, with Merial.
Manufacturing Expense
Manufacturing expense is made up of the cost of products sold and manufacturing overhead expense related to excess manufacturing capacity.
Manufacturing expense decreased $334,000, or 29%, in the first quarter of 2010 compared to the first quarter of 2009 primarily due to lower product sales.
Research and Development
Research and development costs include labor, materials and costs associated with clinical studies or incurred in the research and development of new products and modifications to existing products.
Research and development expense decreased $65,000, or 15%, in the first quarter of 2010 compared to the first quarter of 2009 primarily due to the timing of expenses related to on-going projects.
Current significant projects include the next generation spring-powered device.
Selling, General and Administrative
Selling, general and administrative costs include labor, travel, outside services and overhead incurred in our sales, marketing, management and administrative support functions.
Selling, general and administrative expense decreased $67,000, or 12%, in the first quarter of 2010 compared to the first quarter of 2009 primarily due to the expiration of a consulting arrangement and lower stock-based compensation costs.
10
Interest Expense
Interest expense included the following:
| | | | | | |
| | Three Months Ended March 31, |
| | 2010 | | 2009 |
Contractual interest expense | | $ | 4,694 | | $ | 9,767 |
Amortization of debt issuance costs | | | — | | | 17,086 |
Accretion of $1.25 million convertible debt | | | 25,242 | | | 23,265 |
| | | | | | |
| | $ | 29,936 | | $ | 50,118 |
| | | | | | |
Change in Fair Value of Derivative Liabilities
Our derivative liability is recorded at fair value and marked to market each period. The fair value is determined using the Black-Scholes valuation model.
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 warrants, loans, proceeds received from our initial public offering in 1986, proceeds received from a public offering of common stock in 1993, licensing and technology revenues and revenues from sales of products.
Total cash at March 31, 2010 was $0.5 million compared to $1.1 million at December 31, 2009. We had working capital of $0.4 million at March 31, 2010 compared to $0.7 million at December 31, 2009. Our debt retirement costs were $150,000 in the first quarter of 2010 to pay off the remaining balance on our convertible loan, which was paid in March 2010. Following the repayment of this outstanding debt, we did not have any debt outstanding. However, even with the sale of Series G Preferred shares and the related cash investment in December 2009, given our current cash balance, our March 2010 debt repayment and our current rate of cash usage, if no new licensing, development or supply agreements with significant up-front payments are entered into or there is no significant increase in product sales in the second quarter of 2010, we anticipate that we will be unable to continue operations beyond the second quarter of 2010, unless we obtain additional debt or equity financing.
The overall decrease in cash during the first quarter of 2010 resulted from $490,000 of cash used in operating activities, $152,000 used for principal payments on debt and capital leases and $42,000 used for patent activity.
Net accounts receivable were $0.9 million at both March 31, 2010 and December 31, 2009. Receivables from three different customers accounted for a total of 92% of our accounts receivable balance at March 31, 2010, with individual accounts totaling 38%, 35% and 19%, respectively. For the customer representing 38% of our balance at March 31, 2010, $64,000 related to equipment purchased on their behalf compared to $0.5 million at December 31, 2009. Of the accounts receivable due at March 31, 2010, $859,000 was collected prior to the filing of this Form 10-Q. Historically, we have not had collection problems related to our accounts receivable.
Inventories were $0.9 million at both March 31, 2010 and December 31, 2009.
We did not have any capital expenditures in the first quarter of 2010. We anticipate spending up to a total of $50,000 in 2010 for production molds for current research and development projects.
Accounts payable decreased $0.2 million to $0.7 million at March 31, 2010, compared to $0.9 million at December 31, 2009, primarily due to payments for equipment purchases for the customer mentioned above.
Other accrued liabilities were $0.7 million at both March 31, 2010 and December 31, 2009. Included in the balance at both March 31, 2010 and December 31, 2009 was $0.6 million of inventory credits that Serono could begin taking against current invoices or require repayment at any time.
11
Derivative liabilities of $40,000 at March 31, 2010 reflect the fair value of warrants issued in connection with a March 2006 $1.5 million bridge loan. The fair value of the derivative liabilities is adjusted on a quarterly basis using the Black-Scholes valuation model, with changes in fair value being recorded as a non-cash component of earnings.
Deferred revenue of $1.5 million at March 31, 2010 included $1.4 million received from Merial and $0.1 million received from Serono.
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, 2009, which was filed with the Securities and Exchange Commission on March 30, 2010.
OFF-BALANCE SHEET ARRANGEMENTS
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
RECENT ACCOUNTING GUIDANCE NOT YET ADOPTED
See Note 7 of Notes to Consolidated Financial Statements included in Part I, Item 1 of this Form 10-Q.
ITEM 4T. | 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 principal 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 principal 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 principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Changes in 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.
PART II
In addition to the other information contained in this Form 10-Q, the following risk factors should be considered carefully in evaluating our business. Our business, financial condition, or results of operations could be materially adversely affected by any of these risks. Please note that additional risks not presently known to us or that we currently deem immaterial may also impair our business and operations.
We need to obtain funding in the second quarter of 2010 to continue operations. Sufficient funding may not be available to us and, if available, may be subject to conditions and the unavailability of funding could adversely affect our business and cause us to cease operations.At March 31, 2010, cash was $0.5 million and we had working capital of $0.4 million. We continue to monitor
12
our cash and have previously taken measures to reduce our expenditure rate and delay capital and maintenance expenditures. However, even with the closing of the Series G Preferred Stock transaction in the fourth quarter of 2009, if we do not enter into an adequate number of licensing development and supply agreements with upfront payments or increase sales to current customers or markets, we expect that we will need to do one or more of the following to provide additional resources during the second quarter of 2010:
| • | | secure additional short-term debt financing; |
| • | | secure additional long-term debt financing; |
| • | | secure additional equity financing; |
| • | | secure a strategic partner; or |
| • | | reduce our operating expenditures. |
This situation could be exacerbated if Serono uses its inventory credits against invoices or requires repayment of those credits. While management continues to work on a number of strategic options and alternatives to keep Bioject operating, there are no assurances that we will be successful. Financing may not be available to us on acceptable terms or at all. If we are unable to obtain additional resources, our business could be adversely affected and we could be forced to cease operations.
We have a history of losses and may never be profitable. Since our formation in 1985, we have incurred significant annual operating losses and negative cash flow. At March 31, 2010, we had an accumulated deficit of $122.8 million and net working capital of $0.4 million. Due to our lack of additional committed capital, recurring losses, negative cash flows and accumulated deficit, the report of our independent registered public accounting firm dated March 30, 2010 expressed substantial doubt about our ability to continue as a going concern. We may never be profitable, which could have a negative effect on our stock price, our business and our ability to continue operations. Our revenues are derived from licensing and technology fees and from product sales. We sell our products to strategic partners, who market our products under their brand name, and to end-users such as public health clinics for vaccinations and the military for mass immunizations. We have not attained profitability at these sales levels. We may never be able to generate significant revenues or achieve profitability. Now and in the future, we will require substantial additional financing. Such financing may not be available on terms acceptable to us, or at all, which would have a material adverse effect on our business. Any future equity financing could result in significant dilution to shareholders.
Our preferred stock has a liquidation preference and, as a result, if we are sold or liquidated, holders of common stock could receive nothing. We have outstanding shares of Series D Preferred Stock, Series E Preferred Stock, Series F Preferred Stock and Series G Preferred Stock. Under the terms of the preferred stock, if we are sold or liquidated, the holders of these shares would be entitled to receive approximately $9.3 million, at March 31, 2010, prior to any payments to the holders of common stock. Accordingly, if we are sold or liquidated, holders of common stock could receive nothing.
If our products are not accepted by the market, our business could fail. Our success will depend on market acceptance of our needle-free injection drug delivery systems and on market acceptance of other products under development. If our products do not achieve market acceptance, our business could fail. Currently, the dominant technology used for intramuscular and subcutaneous injections is the hollow-needle syringe, which has a cost per injection that is significantly lower than that of our products. Our products may be unable to compete successfully with needle-syringes.
We may be unable to enter into additional strategic corporate licensing and distribution agreements or maintain existing agreements, which could cause our business to suffer. A key component of our sales and marketing strategy is to enter into licensing and supply arrangements with leading pharmaceutical and biotechnology companies for whose products our technology provides either increased medical effectiveness or a higher degree of market acceptance. Historically, these agreements have taken a long time to finalize, and the current economic environment may extend that period even further. If we cannot enter into these agreements on terms favorable to us or at all, our business may suffer.
13
In prior years, several agreements have been canceled by our partners prior to completion. These agreements were canceled for various reasons, including, but not limited to, costs related to obtaining regulatory approval, unsuccessful pre-clinical vaccine studies, changes in vaccine development and changes in business development strategies. These agreements resulted in significant short-term revenue. However, none of these agreements developed into the long-term revenue stream anticipated by our strategic partnering strategy.
We may be unable to enter into future licensing or supply agreements with major pharmaceutical or biotechnology companies. Even if we enter into these agreements, they may not result in sustainable long-term revenues which, when combined with revenues from product sales, could be sufficient for us to operate profitably.
Our new drug+device strategy is currently suspended and is subject to a number of risks and uncertainties and, as a result, we may not be successful in implementing the strategy.In 2007, we announced a new component of our business strategy pursuant to which we plan to attempt to secure rights to injectable medications to sell in combination with our products under our own brand. Successfully implementing this strategy is subject to a number of risks. We may not be successful in securing rights to medications we are interested in combining with our products. Even if successful in securing rights, these products would be subject to FDA approval, and it will be our responsibility to obtain such approval. This approval may not be obtained or may take a significant period of time to obtain. In addition, there is a risk that our device will not work for the new drug indication. We may also need to raise additional funds to finance this new strategy, and there is no assurance such funds will be available to us on acceptable terms or at all. We do not have experience manufacturing or marketing to end-users drug+device combinations. In addition, these new products may not be accepted by the market. Further, due to our current liquidity situation, we have temporarily suspended implementation of this strategy. Accordingly, there is no assurance that our new strategy will be successfully implemented, and failure to successfully implement the strategy could negatively affect our business.
We have amended our lease agreement for rent deferrals and, if we default under our lease agreement in the future, our landlord could terminate our lease, which would adversely affect our business.In November 2008, we negotiated a $15,000 rent deferral for each of November 2008, December 2008 and January 2009 and, in March 2009, we entered into an agreement pursuant to which we deferred $12,000 of rent for each of February, March and April 2009. On July 8, 2009, we entered into another amendment to our lease agreement, effective June 30, 2009, pursuant to which we deferred $12,000 of rent for each of May and June 2009. Absent certain triggering events causing the deferred rent to be due sooner, we will be required to start repaying the deferred rent in January 2011, when it is to be repaid in twelve equal installments, plus accrued interest. If we are unable to make the payments under the lease when due, including the deferred rent payments, or are unable to negotiate additional rent deferrals, our landlord could declare an event of default and terminate our lease, which would have a material adverse effect on our business.
We must retain qualified personnel in a competitive marketplace, or we may not be able to grow our business.Our success depends upon the personal efforts and abilities of our senior management. We may be unable to retain our key employees, namely our management team, or to attract, assimilate or retain other highly qualified employees. Although we have implemented workforce and salary reductions, there remains substantial competition for highly skilled employees. Our key employees are not bound by agreements that could prevent them from terminating their employment at any time. If we fail to attract and retain key employees, our business could be harmed.
We depend on a few significant customers.Our top three customers accounted for 89% of our total product sales in the first quarter of 2010. If any of these customers delays, reduces or ceases ordering our products or services, our business would be negatively affected.
Our common stock is listed on the Over-the-Counter Bulletin Board, which may impair the price at which our common stock trades, the liquidity of the market for our common stock and our ability to obtain additional funding.The Over-the-Counter Bulletin Board is an electronic quotation service maintained by the Financial Industry Regulatory Authority. As a consequence of this listing, the ability of a stockholder to sell our common stock, the price obtainable for our common stock and our ability to obtain additional funding may be materially impaired.
14
We have limited manufacturing experience, and may be unable to produce our products at the unit costs necessary for the products to be competitive in the market, which could cause our financial condition to suffer. We have limited experience manufacturing our products in commercially viable quantities. We have increased our production capacity for the Biojector® 2000 system and the Vitajet® product line through automation of, and changes in, production methods, in order to achieve savings through higher volumes of production. If we are unable to achieve these savings, our results of operations and financial condition could suffer. The current cost per injection of the Biojector® 2000 system and Vitajet® product line is substantially higher than that of traditional needle-syringes, our principal competition. In order to reduce costs, a key element of our business strategy has been to reduce the overall manufacturing cost through automating production and packaging. There can be no assurance that we will achieve sales and manufacturing volumes necessary to realize cost savings from volume production at levels necessary to result in significant unit manufacturing cost reductions. Failure to do so will continue to make competing with needle-syringes on the basis of cost very difficult and will adversely affect our financial condition and results of operations. We may be unable to successfully manufacture devices at a unit cost that will allow the product to be sold profitably. Failure to do so would adversely affect our financial condition and results of operations.
We are subject to extensive government regulation and must continue to comply with these regulations or our business could suffer.Our products and manufacturing operations are subject to extensive government regulation in both the U.S. and abroad. If we cannot comply with these regulations, we may be unable to distribute our products, which could cause our business to suffer or fail. In the U.S., the development, manufacture, marketing and promotion of medical devices are regulated by the Food and Drug Administration (“FDA”) under the Federal Food, Drug, and Cosmetic Act (“FFDCA”). The FFDCA provides that new pre-market notifications under Section 510(k) of the FFDCA are required to be filed when, among other things, there is a major change or modification in the intended use of a device or a change or modification to a legally marketed device that could significantly affect its safety or effectiveness. A device manufacturer is expected to make the initial determination as to whether the change to its device or its intended use is of a kind that would necessitate the filing of a new 510(k) notification. The FDA may not concur with our determination that our current and future products can be qualified by means of a 510(k) submission or that a new 510(k) notification is not required for such products.
Future changes to manufacturing procedures could require that we file a new 510(k) notification. Also, future products, product enhancements or changes, or changes in product use may require clearance under Section 510(k), or they may require FDA pre-market approval (“PMA”) or other regulatory clearances. PMAs and regulatory clearances other than 510(k) clearance generally involve more extensive prefiling testing than a 510(k) clearance and a longer FDA review process. It is current FDA policy that pre-filled syringes are evaluated by the FDA by submitting a Request for Designation (“RFD”) to the Office of Combination Products (“OCP”). The pharmaceutical or biotechnology company with which we partner is responsible for the submission to the OCP, although we will have this responsibility with respect to drug+device combinations produced by us under our new strategy. A pre-filled syringe meets the FDA’s definition of a combination product, or a product comprised of two or more regulated components, i.e. drug/device. The OCP will assign a center with primary jurisdiction for a combination product (CDER, CDRH) to ensure the timely and effective pre-market review of the product. Depending on the circumstances, drug and combination drug/device regulation can be much more extensive and time consuming than device regulation.
FDA regulatory processes are time consuming and expensive. Product applications submitted by us may not be cleared or approved by the FDA. In addition, our products must be manufactured in compliance with Good Manufacturing Practices, as specified in regulations under the FFDCA. The FDA has broad discretion in enforcing the FFDCA, and noncompliance with the FFDCA could result in a variety of regulatory actions ranging from product detentions, device alerts or field corrections, to mandatory recalls, seizures, injunctive actions and civil or criminal penalties. If we were to have a recall of our product in the field, it could negatively affect our results of operations, financial position and cash flows.
15
Sales of our products, including the Iject® pre-filled syringe, are dependent on regulatory approval being obtained for the product’s use with a given drug to treat a specific condition. It is the responsibility of the strategic partner producing the drug to obtain this approval. The failure of a partner to obtain regulatory approval or to comply with government regulations after approval has been received could harm our business. In order for a strategic partner to sell our devices for delivery of its drug to treat a specific condition, the partner must first obtain government approval. This process is subject to extensive government regulation both in the U.S. and abroad. As a result, sales of our products, including the Iject® product, to any strategic partner are dependent on that partner’s ability to obtain regulatory approval. Accordingly, delay or failure of a partner to obtain that approval could cause our financial results to suffer. In addition, if a partner fails to comply with governmental regulations after initial regulatory approval has been obtained, sales to that partner may cease, which could cause our financial results to suffer.
If we cannot meet international product standards, we will be unable to distribute our products outside of the United States, which could cause our business to suffer.Distribution of our products in countries other than the U.S. may be subject to regulation in those countries. Failure to satisfy these regulations would impact our ability to sell our products in these countries and could cause our business to suffer.
We have received the following certifications from Underwriters Laboratories (“UL”) that our products and quality systems meet the applicable requirements, which allows us to label our products with the CE Mark and sell them in the European Community and non-European Community countries.
| | | | |
Certificate | | Issue Date | | Date Renewed |
ISO 13485:2003 and CMDCAS | | February 2006 | | January 2009 |
EC Certificate – Needle-free Injection Systems and Accessories (Biojector® 2000, cool.click®, ZetaJet™) | | March 2007 | | January 2010 |
EC Certificate – Vial Adapters and Reconstitution Kits | | March 2007 | | January 2009 |
If we are unable to continue to meet the standards of ISO 13485 or CE Mark certification, it could have a material adverse effect on our business and cause our financial results to suffer.
If the healthcare industry limits coverage or reimbursement levels, the acceptance of our products could suffer.The price of our products exceeds the price of needle-syringe combinations and, if coverage or reimbursement levels are reduced, market acceptance of our products could be harmed. The healthcare industry is subject to changing political, economic and regulatory influences that may affect the procurement practices and operations of healthcare facilities. During the past several years, the healthcare industry has been subject to increased government regulation of reimbursement rates and capital expenditures. Among other things, third party payers are increasingly attempting to contain or reduce healthcare costs by limiting both coverage and levels of reimbursement for healthcare products and procedures. Because the price of the Biojector® 2000 system exceeds the price of a needle-syringe, cost control policies of third party payers, including government agencies, may adversely affect acceptance and use of the Biojector® 2000 system. In addition, on March 23, 2010 the Patient Protection and Affordable Care Act was signed into law and, commencing in 2013, the legislation imposes a 2.3% excise tax on sales of medical devices. As this new law is implemented over the next 2-3 years, we will be in a better position to ascertain its impact on our business.
We depend on outside suppliers for manufacturing.Our current manufacturing processes for the Biojector® 2000 jet injector and disposable syringes as well as manufacturing processes to produce our modified Vitajets® consist primarily of assembling component parts supplied by outside suppliers. Some of these components are currently obtained from single sources, with some components requiring significant production lead times. In the past, we have experienced delays in the delivery of certain components. We may experience delays or interruptions in the future, including suppliers suspending or ceasing operations, and these delays or interruptions could have a material adverse effect on our financial condition and results of operations.
16
Manufacturing difficulties could delay product shipments to customers.Delays in receiving approval for the manufacture of customers’ products or delays related to internal manufacturing difficulties could delay the timing of shipments to customers and negatively affect our results of operations, financial position and cash flows.
If we are unable to manage our growth, our results of operations could suffer.If our products achieve market acceptance or if we are successful in entering into significant product supply agreements with major pharmaceutical or biotechnology companies, we expect to experience rapid growth. Such growth would require expanded customer service and support, increased personnel, expanded operational and financial systems, and implementing new and expanded control procedures. We may be unable to attract sufficient qualified personnel or successfully manage expanded operations. As we expand, we may periodically experience constraints that would adversely affect our ability to satisfy customer demand in a timely fashion. Failure to manage growth effectively could adversely affect our financial condition and results of operations.
We may be unable to compete in the medical equipment field, which could cause our business to fail.The medical equipment market is highly competitive and competition is likely to intensify. If we cannot compete, our business will fail. Our products compete primarily with traditional needle-syringes, “safety syringes” and also with other alternative drug delivery systems. In addition, manufacturers of needle-syringes, as well as other companies, may develop new products that compete directly or indirectly with our products. There can be no assurance that we will be able to compete successfully in this market. A variety of new technologies (for example, transdermal patches) are being developed as alternatives to injection for drug delivery. While we do not believe such technologies have significantly affected the use of injection for drug delivery to date, there can be no assurance that they will not do so in the future. Many of our competitors have longer operating histories as well as substantially greater financial, technical, marketing and customer support resources.
We are dependent on a single technology, and if it cannot compete or find market acceptance, our business will suffer.Our strategy has been to focus our development and marketing efforts on our needle-free injection technology. Focus on this single technology leaves us vulnerable to competing products and alternative drug delivery systems. If our technology cannot find market acceptance or cannot compete against other technologies, business will suffer. We perceive that healthcare providers’ desire to minimize the use of the traditional needle-syringe has stimulated development of a variety of alternative drug delivery systems such as “safety syringes,” jet injection systems, nasal delivery systems and transdermal diffusion “patches.” In addition, pharmaceutical companies frequently attempt to develop drugs for oral delivery instead of injection. While we believe that for the foreseeable future there will continue to be a significant need for injections, alternative drug delivery methods may be developed which are preferable to injection.
We rely on patents and proprietary rights to protect our technology.We rely on a combination of trade secrets, confidentiality agreements and procedures and patents to protect our proprietary technologies. We have been granted a number of patents in the U.S. and several patents in other countries covering certain technology embodied in our current jet injection system and certain manufacturing processes. Additional patent applications are pending in the U.S. and certain foreign countries. The claims contained in any patent application may not be allowed, or any patent or our patents collectively may not provide adequate protection for our products and technology. In the absence of patent protection, we may be vulnerable to competitors who attempt to copy our products or gain access to our trade secrets and know-how. In addition, the laws of foreign countries may not protect our proprietary rights to this technology to the same extent as the laws of the U.S. We believe we have independently developed our technology and attempt to ensure that our products do not infringe the proprietary rights of others.
17
If a dispute arises concerning our technology, we could become involved in litigation that might involve substantial cost. Such litigation might also divert substantial management attention away from our operations and into efforts to enforce our patents, protect our trade secrets or know-how or determine the scope of the proprietary rights of others. If a proceeding resulted in adverse findings, we could be subject to significant liabilities to third parties. We might also be required to seek licenses from third parties in order to manufacture or sell our products. Our ability to manufacture and sell our products might also be adversely affected by other unforeseen factors relating to the proceeding or its outcome.
If our products fail or cause harm, we could be subject to substantial product liability, which could cause our business to suffer.Producers of medical devices may face substantial liability for damages in the event of product failure or if it is alleged the product caused harm. We currently maintain product liability insurance and, to date, have experienced one product liability claim. There can be no assurance, however, that we will not be subject to a number of such claims, that our product liability insurance would cover such claims, or that adequate insurance will continue to be available to us on acceptable terms in the future. Our business could be adversely affected by product liability claims or by the cost of insuring against such claims.
There are a large number of shares eligible for sale into the public market, which may reduce the price of our common stock.The market price of our common stock could decline as a result of sales of a large number of shares of our common stock in the market, or the perception that such sales could occur. We have a large number of shares of common stock outstanding and available for resale. These sales also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate. There are also a large number of shares of common stock issuable upon conversion of our outstanding preferred stock and exercise of warrants. In addition, as of March 31, 2010, we had approximately 763,000 shares of common stock available for future issuance under our stock incentive plan. As of March 31, 2010, options to purchase approximately 332,000 shares of common stock were outstanding and approximately 157,000 restricted stock units were outstanding and will be eligible for sale in the public market from time to time subject to vesting.
Our stock price may be highly volatile, which increases the risk of securities litigation.The market for our common stock and for the securities of other small market-capitalization companies has been highly volatile in recent years. This increases the risk of securities litigation relating to such volatility. We believe that factors such as quarter-to-quarter fluctuations in financial results, new product introductions by us or our competition, public announcements, changing regulatory environments, sales of common stock by certain existing shareholders, substantial product orders and announcement of licensing or product supply agreements with major pharmaceutical or biotechnology companies could contribute to the volatility of the price of our common stock, causing it to fluctuate dramatically. General economic trends such as recessionary cycles and changing interest rates may also adversely affect the market price of our common stock.
Concentration of ownership could delay or prevent a change in control or otherwise influence or control most matters submitted to our shareholders.Certain funds affiliated with Life Sciences Opportunities Fund II (Institutional), L.P. (collectively, the “LOF Funds”) and its affiliates currently own shares of Series D Preferred Stock, Series E Preferred Stock, Series G Preferred Stock and warrants to purchase common stock representing in aggregate approximately 43.5% of our outstanding voting power (assuming exercise of the warrants). As a result, the LOF Funds and their affiliates have the potential to control matters submitted to a vote of shareholders, including a change of control transaction, which could prevent or delay such a transaction.
18
The following exhibits are filed herewith and this list is intended to constitute the exhibit index:
| | |
Exhibit No. | | Description |
3.1 | | 2002 Restated Articles of Incorporation of Bioject Medical Technologies Inc., as amended. Incorporated by reference to Form 8-K dated November 15, 2004 and filed November 19, 2004. |
| |
3.1.1 | | Articles of Amendment to 2002 Restated Articles of Incorporation. Incorporated by reference to Form 8-K dated May 30, 2006 and filed June 5, 2006. |
| |
3.1.2 | | Articles of Amendment to 2002 Restated Articles of Incorporation. Incorporated by reference to Exhibit 3.1 in the Form 8-K filed January 23, 2008. |
| |
3.1.3 | | Articles of Amendment to 2002 Restated Articles of Incorporation. Incorporated by reference to Form 8-K filed with the Securities and Exchange Commission on December 21, 2009. |
| |
3.2 | | Second Amended and Restated Bylaws of Bioject Medical Technologies, Inc. Incorporated by reference to Form 8-K filed July 5, 2007. |
| |
4.1 | | Form of Rights Agreement dated as of July 1, 2002 between the Company and American Stock Transfer & Trust Company, including Exhibit A, Terms of the Preferred Stock, Exhibit B, Form of Rights Certificate, and Exhibit C, Summary of the Right To Purchase Preferred Stock. Incorporated by reference to Form 8-K dated July 2, 2002. |
| |
4.1.1 | | First Amendment, dated October 8, 2002, to Rights Agreement dated July 1, 2002 between Bioject and American Stock Transfer & Trust Company. Incorporated by reference to registration statement on Form 8-A/A filed with the Commission on October 8, 2002. |
| |
4.1.2 | | Second Amendment, dated November 15, 2004, to Rights Agreement dated July 1, 2002 between Bioject and American Stock Transfer & Trust Company. Incorporated by reference to Form 8-K dated November 15, 2004. |
| |
4.1.3 | | Third Amendment to Rights Agreement, dated March 8, 2006, between Bioject Medical Technologies Inc. and American Stock Transfer & Trust Company. Incorporated by reference to Form 8-K dated March 3, 2006 and filed March 9, 2006. |
| |
4.1.4 | | Fourth Amendment to Rights Agreement, dated November 20, 2007, between Bioject Medical Technologies Inc. and American Stock Transfer & Trust Company. Incorporated by reference to Form 8-K dated December 19, 2007 and filed December 20, 2007. |
| |
4.1.5 | | Fifth Amendment to Rights Agreement, dated January 8, 2010, between Bioject Medical Technologies Inc. and American Stock Transfer & Trust Company. Incorporated by reference to Form 8-K dated January 8, 2010 and filed January 14, 2010. |
| |
31.1 | | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934. |
| |
31.2 | | Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934. |
| |
32.1 | | Certification of Chief Executive Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350. |
| |
32.2 | | Certification of Principal Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350. |
19
SIGNATURES
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.
| | | | | | |
Date: May 14, 2010 | | | | | | BIOJECT MEDICAL TECHNOLOGIES INC. |
| | | | | | (Registrant) |
| | | |
| | | | | | /s/ RALPH MAKAR |
| | | | | | Ralph Makar |
| | | | | | President and Chief Executive Officer |
| | | | | | (Principal Executive Officer) |
| | | |
| | | | | | /s/ CHRISTINE M. FARRELL |
| | | | | | Christine M. Farrell |
| | | | | | Vice President of Finance |
| | | | | | (Principal Financial and Accounting Officer) |
20