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 |
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For the quarterly period ended June 30, 2002 OR | |||
[ ] |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period from __________ to __________ |
Commission file number 0-15360
BIOJECT MEDICAL TECHNOLOGIES INC.
Oregon (State or other jurisdiction of incorporation or organization) |
93-1099680 (I.R.S. Employer Identification No.) |
|
211 Somerville Road, Route 202 North, Bedminster, NJ (Address of principal executive offices) |
07921 (Zip Code) |
Registrants telephone number, including area code: (908) 470-2800
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 the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date.
Common Stock without par value | 10,598,826 | |
(Class) | (Outstanding at August 8, 2002) |
BIOJECT MEDICAL TECHNOLOGIES INC.
FORM 10-Q
INDEX
Page | ||||||
PART I FINANCIAL INFORMATION | ||||||
Item 1. | Financial Statements | |||||
Consolidated Balance Sheets June 30, 2002 (unaudited) and March 31, 2002 | 2 | |||||
Consolidated Statements of Operations Three Months Ended June 30, 2002 and 2001 (unaudited) | 3 | |||||
Consolidated Statements of Cash Flows Three Months Ended June 30, 2002 and 2001 (unaudited) | 4 | |||||
Notes to Consolidated Financial Statements | 5 | |||||
Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations | 6 | ||||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 9 | ||||
PART II OTHER INFORMATION | ||||||
Item 2. | Changes in Securities and Use of Proceeds | 9 | ||||
Item 6. | Exhibits and Reports on Form 8-K | 9 | ||||
Signatures | 10 |
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
BIOJECT MEDICAL TECHNOLOGIES INC.
AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
June 30, | March 31, | ||||||||||
2002 | 2002 | ||||||||||
(unaudited) | |||||||||||
ASSETS |
|||||||||||
Current assets: |
|||||||||||
Cash and cash equivalents |
$ | 7,309,947 | $ | 7,612,766 | |||||||
Short-term marketable securities |
3,823,877 | 3,593,060 | |||||||||
Accounts receivable, net of allowance for doubtful
accounts of $26,000 and $14,000 |
805,083 | 1,666,969 | |||||||||
Receivable from related party, current portion |
50,000 | 50,000 | |||||||||
Inventories, net |
1,289,098 | 1,460,913 | |||||||||
Other current assets |
337,910 | 225,438 | |||||||||
Total current assets |
13,615,915 | 14,609,146 | |||||||||
Long-term marketable securities |
14,479,652 | 15,751,774 | |||||||||
Receivable from related party |
75,000 | 100,000 | |||||||||
Property and equipment, net of accumulated depreciation
of $3,509,116 and $3,416,333 |
2,590,496 | 2,314,586 | |||||||||
Other assets |
728,018 | 693,925 | |||||||||
Total assets |
$ | 31,489,081 | $ | 33,469,431 | |||||||
LIABILITIES AND SHAREHOLDERS EQUITY |
|||||||||||
Current liabilities: |
|||||||||||
Accounts payable |
$ | 353,784 | $ | 614,856 | |||||||
Accrued payroll |
311,919 | 353,662 | |||||||||
Other accrued liabilities |
102,363 | 143,168 | |||||||||
Deferred revenue |
67,140 | 83,808 | |||||||||
Total current liabilities |
835,206 | 1,195,494 | |||||||||
Long-term liabilities: |
|||||||||||
Long-term lease payable |
2,781 | 5,519 | |||||||||
Deferred revenue |
285,323 | 302,399 | |||||||||
Shareholders equity: |
|||||||||||
Preferred stock, no par value, 10,000,000 shares
authorized; issued and outstanding: |
|||||||||||
Series A
Convertible 952,738 shares at June 30, 2002
and March 31, 2002, $15 stated value |
17,149,000 | 17,149,000 | |||||||||
Series C
Convertible 391,830 shares at June 30, 2002
and March 31, 2002, no stated value |
2,400,000 | 2,400,000 | |||||||||
Common stock, no par, 100,000,000 shares authorized;
issued and outstanding 10,598,826 and 10,572,435
shares at June 30, 2002 and March 31, 2002 |
88,187,301 | 87,989,718 | |||||||||
Accumulated deficit |
(77,370,530 | ) | (75,572,699 | ) | |||||||
Total shareholders equity |
30,365,771 | 31,966,019 | |||||||||
Total liabilities and shareholders equity |
$ | 31,489,081 | $ | 33,469,431 | |||||||
The accompanying notes are an integral part of these consolidated financial statements.
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BIOJECT MEDICAL TECHNOLOGIES INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months Ended | ||||||||||
June 30, | ||||||||||
2002 | 2001 | |||||||||
Revenue: |
||||||||||
Net sales of products |
$ | 679,456 | $ | 491,372 | ||||||
Licensing/technology fees |
366,122 | 128,661 | ||||||||
1,045,578 | 620,033 | |||||||||
Operating expenses: |
||||||||||
Manufacturing |
1,069,863 | 599,946 | ||||||||
Research and development |
792,974 | 528,841 | ||||||||
Selling, general and administrative |
1,215,930 | 850,999 | ||||||||
Total operating expenses |
3,078,767 | 1,979,786 | ||||||||
Operating loss |
(2,033,189 | ) | (1,359,753 | ) | ||||||
Interest income |
235,562 | 255,125 | ||||||||
Other loss |
(204 | ) | | |||||||
235,358 | 255,125 | |||||||||
Loss before income taxes |
(1,797,831 | ) | (1,104,628 | ) | ||||||
Provision for income taxes |
| | ||||||||
Loss from operations before preferred stock dividend |
(1,797,831 | ) | (1,104,628 | ) | ||||||
Preferred stock dividend |
| (305,690 | ) | |||||||
Net loss allocable to common shareholders |
$ | (1,797,831 | ) | $ | (1,410,318 | ) | ||||
Basic and diluted net loss per common share |
$ | (0.17 | ) | $ | (0.16 | ) | ||||
Shares used in per share calculations |
10,588,757 | 8,803,181 | ||||||||
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 | |||||||||||
June 30, | |||||||||||
2002 | 2001 | ||||||||||
Cash flows from operating activities: |
|||||||||||
Net loss allocable to common shareholders |
$ | (1,797,831 | ) | $ | (1,410,318 | ) | |||||
Adjustments to reconcile net loss to net cash used in
operating activities: |
|||||||||||
Non-cash expenses related to stock, stock option and
warrant issuances |
136,488 | 127,266 | |||||||||
Depreciation and amortization |
132,600 | 95,459 | |||||||||
Preferred stock dividends |
| 305,690 | |||||||||
Changes in operating assets and liabilities: |
|||||||||||
Accounts receivable |
861,886 | (88,269 | ) | ||||||||
Inventories |
171,815 | (429,897 | ) | ||||||||
Other current assets |
(112,472 | ) | 28,015 | ||||||||
Accounts payable |
(261,214 | ) | 240,382 | ||||||||
Accrued payroll |
(41,743 | ) | 6,904 | ||||||||
Other accrued liabilities |
(40,805 | ) | (13,948 | ) | |||||||
Deferred revenue |
(33,744 | ) | (16,785 | ) | |||||||
Net cash used in operating activities |
(985,020 | ) | (1,155,501 | ) | |||||||
Cash flows from investing activities: |
|||||||||||
Purchase of marketable securities |
| (992,172 | ) | ||||||||
Maturity of marketable securities |
1,041,305 | 3,050,000 | |||||||||
Capital expenditures |
(368,693 | ) | (91,433 | ) | |||||||
Proceeds from sale of capital equipment |
| 692 | |||||||||
Other assets |
(48,910 | ) | (41,026 | ) | |||||||
Net cash provided by investing activities |
623,702 | 1,926,061 | |||||||||
Cash flows from financing activities: |
|||||||||||
Payments made on capital lease obligations |
(2,596 | ) | (2,461 | ) | |||||||
Cash proceeds from sale of common stock |
61,095 | 15,277,791 | |||||||||
Net cash provided by financing activities |
58,499 | 15,275,330 | |||||||||
Increase (decrease) in cash and cash equivalents |
(302,819 | ) | 16,045,890 | ||||||||
Cash and cash equivalents: |
|||||||||||
Beginning of period |
7,612,766 | 6,254,544 | |||||||||
End of period |
$ | 7,309,947 | $ | 22,300,434 | |||||||
The accompanying notes are an integral part of these consolidated financial statements.
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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 June 30, 2002 and 2001 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 March 31, 2002 is derived from Bioject Medical Technologies Inc.s 2002 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 Biojects 2002 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.
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. Net inventories consist of the following:
June 30, 2002 | March 31, 2002 | |||||||
Raw materials and components |
$ | 693,814 | $ | 917,785 | ||||
Finished goods |
595,284 | 543,128 | ||||||
$ | 1,289,098 | $ | 1,460,913 | |||||
Note 3. Net Loss Per Share
The following common stock equivalents are excluded from the diluted loss per share calculations, as their effect would have been antidilutive:
Three Months Ended June 30, | |||||||||
2002 | 2001 | ||||||||
Stock options and warrants |
3,210,491 | 2,877,649 | |||||||
Convertible preferred stock |
2,689,136 | 2,640,896 | |||||||
Total |
5,899,627 | 5,518,545 | |||||||
Note 4. Subsequent Event Shareholder Rights Plan
On July 1, 2002, Biojects board of directors adopted a shareholder rights agreement. To implement the agreement, Bioject issued a dividend of one right for each share of its common stock held by shareholders of record as of the close of business on July 19, 2002.
The purpose of the rights agreement is to obtain maximum value for shareholders in the event of an unsolicited acquisition attempt. The agreement was not adopted in response to any efforts to acquire the Company and the Company is not aware of any such efforts.
Each right initially entitles shareholders to purchase a fractional share of Biojects preferred stock for $50.00. However, the rights are not immediately exercisable and will become exercisable only if certain events related to an unsolicited acquisition attempt occur. For example, unless earlier redeemed for $0.001 per right, when a person or group acquires 15% or more of Biojects common stock, all rights holders (except the person or group who acquired the triggering amount of shares) will be able to exercise their rights for shares of Bioject having a value of twice the rights then-current exercise price.
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ITEM 2. MANAGEMENTS 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 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, 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 our products, including the cool.click or the SeroJet, 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, 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, obtaining 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 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 March 31, 2002, 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 managements 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 industry. In fiscal 2003, we will 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 fiscal 2003, our clinical research efforts will be aimed primarily at clinical research collaborations in the areas of vaccines and drug delivery. Currently, we are involved in collaborations with approximately 30 institutions.
In fiscal 2003, our other research and development efforts will be primarily focused on the development of the smaller, lighter Iject II and development of products for our strategic partners. The Iject II has been modeled using a more streamlined design, thus making it more cost effective to manufacture while retaining the same flexibility and performance characteristics of the original Iject.
6
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 from operations in fiscal 2003.
Results of Operations
Quarter Ended June 30, 2002 Compared to Quarter Ended June 30, 2001
Product sales increased to $679,000 in the first quarter of fiscal 2003 from $491,000 in the first quarter of fiscal 2002, primarily due to increased sales of B2000 syringes and vial adapters to new and existing customers and the cool.click, which is sold to Serono for use with Saizen, Seronos pediatric human growth hormone.
License and development fees increased to $366,000 in the first quarter of fiscal 2003 from $129,000 in the first quarter of fiscal 2002. We currently have licensing and/or development agreements with Serono and Alkermes.
Manufacturing expense is made up of the cost of products sold and manufacturing overhead expense related to excess manufacturing capacity. Manufacturing expense increased to $1.1 million in the first quarter of fiscal 2003 from $600,000 in the first quarter of fiscal 2002. The increased manufacturing expense in the first quarter of fiscal 2003 compared to the first quarter of fiscal 2002 is primarily due to production of the cool.click for Seronos U.S. customers and for their worldwide launch of the cool.click and the increase in manufacturing overhead due to increased payroll and related expenses.
Research and development expense increased to $793,000 in the first quarter of fiscal 2003 from $529,000 in the first quarter of fiscal 2002. The increase in the first quarter of fiscal 2003 compared to the first quarter of fiscal 2002 is primarily due to increased payroll and related expenses and expenses associated with research collaborations and the development of the Iject II disposable product, and various other new product developments and improvements.
Selling, general and administrative expenses increased to $1.2 million in the first quarter of fiscal 2003 from $851,000 in the first quarter of fiscal 2002. Approximately $258,000 of the increase resulted from increases in payroll and related expenses due to the addition of two executive officers in the second and third quarters of fiscal 2002 and the addition a Vice President of Business Development in the first quarter of fiscal 2003.
Preferred stock dividends were zero in the first quarter of fiscal 2003 compared to $306,000 in the first quarter of fiscal 2002 due to changes made to the terms of our Series A Preferred Stock in the third quarter of fiscal 2002.
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. Net proceeds received from issuance of securities from inception through June 30, 2002 totaled approximately $100 million.
7
Total cash, cash equivalents and short and long-term marketable securities at June 30, 2002 were $25.6 million compared to $27.0 million at March 31, 2002. Working capital at June 30, 2002 was $12.8 million compared to $13.4 million at March 31, 2002.
Net accounts receivable decreased to $805,000 at June 30, 2002 from $1.7 million at March 31, 2002 due primarily to the timing of payments received from Serono. Included in the balance at June 30, 2002, was $353,000 due from Serono.
Inventories decreased to $1.3 million at June 30, 2002 from $1.5 million at March 31, 2002 due to the timing of production and shipments made in the first quarter of fiscal 2003.
Accounts payable decreased to $354,000 at June 30, 2002 from $615,000 at March 31, 2002 due primarily to the timing of payments made and decreased inventory purchases.
Receivable from related party, current and long-term, totaling $125,000 at June 30, 2002 relates to a three-year, non-interest bearing loan to our Chief Executive Officer, related to his relocation assistance 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 Biojects Chief Executive Officer.
Capital expenditures totaled $369,000 in the first quarter of fiscal 2003, primarily for the purchase of production molds for manufacturing and office equipment for the New Jersey office. We anticipate spending up to a total of $2.0 million in fiscal 2003, primarily for production automation for sterile fill of our Iject disposable product and other manufacturing and office equipment.
NEW ACCOUNTING PRONOUNCEMENTS
Asset Retirements and Impairment or Disposal of Long Lived Assets
In August 2001, the FASB approved SFAS No. 143, Accounting for Asset Retirement Obligations, which addresses the financial accounting and reporting for obligations associated with the retirement of tangible long-lived assets and the associated asset retirement costs. In October 2001, the FASB approved SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets, which supersedes SFAS No. 121, Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed of (SFAS 121) and the accounting and reporting provisions of APB No. 30, Reporting the Results of Operations Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions for the disposal of a segment of a business. SFAS No. 144 retains many of the fundamental provisions of SFAS No. 121, but resolves certain implementation issues. The provisions of SFAS Nos. 143 and 144 were adopted April 1, 2002 and did not have a significant impact on our financial position or results of operations.
In July 2002, the FASB approved SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities. SFAS No. 146 addresses the financial accounting and reporting for obligations associated with an exit activity, including restructuring, or with a disposal of long-lived assets. Exit activities include, but are not limited to, eliminating or reducing product lines, terminating employees and contracts and relocating plant facilities or personnel. SFAS No. 146 specifies that a company will record a liability for a cost associated with an exit or disposal activity only when that liability is incurred and can be measured at fair value. Therefore, commitment to an exit plan or a plan of disposal expresses only managements intended future actions and, therefore, does not meet the requirement for recognizing a liability and the related expense. SFAS No. 146 is effective prospectively for exit or disposal activities initiated after December 31, 2002, with earlier adoption encouraged. The Company does not anticipate that the adoption of SFAS No. 146 will have a material effect on its financial position or results of operations.
CRITICAL ACCOUNTING POLICIES
Our critical accounting policies have not changed since the disclosure included in our Annual Report on Form 10-K for the year ended March 31, 2002.
8
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
None.
PART II
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
On June 1, 2002, we issued a warrant to MedaCorp in exchange for consulting services exercisable for 15,000 shares of our common stock at an exercise price of $4.85 per share. The warrant is immediately exercisable and expires June 1, 2005. In issuing this warrant, we relied on an exemption from the registration requirements pursuant to Section 4(2) of the Securities Act of 1933.
On July 1, 2002, our board of directors adopted a shareholder rights agreement. To implement the agreement, we issued a dividend of one right for each share of our common stock held by shareholders of record as of the close of business on July 19, 2002.
Each right initially entitles shareholders to purchase a fractional share of Bioject preferred stock for $50.00. However, the rights are not immediately exercisable and will become exercisable only if certain events related to an unsolicited acquisition attempt occur. For example, unless earlier redeemed for $0.001 per right, when a person or group acquires 15% or more of our common stock, all rights holders (except the person or group who acquired the triggering amount of shares) will be able to exercise their rights for shares of Bioject having a value of twice the shareholder rights then-current exercise price.
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:
10.1 | Second Amendment to Lease dated April 22, 2002, by and between Bridgeport Woods Business Park, LLC and Bioject, Inc. | |
10.2 | Lease Extension Agreement dated June 5, 2002, by and between Earl J. Itel and Lois Itel Trust and Bioject, Inc. | |
99.1 | Certification of the Chief Executive Officer | |
99.2 | Certification of the Chief Financial Officer |
(b) Reports on Form 8-K
There was one report on Form 8-K filed during the quarter ended June 30, 2002. On May 10, 2002 a report on Form 8-K was filed pursuant to Item 4, Changes in Registrants Certifying Accountant. This Report on Form 8-K was amended on May 16th, May 22nd and May 24th.
In addition, one report on Form 8-K was filed on July 2, 2002 pursuant to Item 5. Other Events and Regulation FD Disclosure, regarding the adoption by the board of directors of a rights agreement.
9
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: August 8, 2002 |
BIOJECT MEDICAL TECHNOLOGIES INC. (Registrant) |
|
/s/ JAMES OSHEA | ||
|
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James OShea Chairman of the Board, Chief Executive Officer and President (Principal Executive Officer) |
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/s/ JOHN GANDOLFO | ||
|
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John Gandolfo Chief Financial Officer and Vice President of Finance (Principal Financial and Accounting Officer) |
10