10-Q 1 a05-18583_110q.htm QUARTERLY REPORT PURSUANT TO SECTIONS 13 OR 15(D)

 

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D. C. 20459

 

FORM 10-Q

 

QUARTERLY REPORT UNDER SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE QUARTER ENDED September 30, 2005

 

COMMISSION FILE NUMBER 0-20970

 

VISION-SCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

13-3430173

(State or other jurisdiction of
incorporation or organization)

 

(IRS Employer
Identification Number)

 

 

 

9 Strathmore Road, Natick, MA

 

01760

(Address of principal executive offices)

 

(Zip Code)

 

(508) 650-9971

(Registrant’s telephone number, including area code)

 

None

(Former name, former address, and

former fiscal year if changed since last report)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the 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 requirement for the past 90 days.

 

Yes  ý         No  o

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

 

Yes  o         No  ý

 

Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act).

 

Yes  o         No  ý

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of October 31, 2005.

 

Common Stock, par value of $.01

 

35,129,377

(Title of Class)

 

(Number of Shares)

 

 



 

VISION-SCIENCES, INC.

TABLE OF CONTENTS

 

Part I.

Financial Information

 

 

 

 

 

 

Item 1.

Financial Statements

 

 

 

 

 

 

 

Consolidated Balance Sheets

 

 

 

 

 

 

 

Consolidated Statements of Operations

 

 

 

 

 

 

 

Consolidated Statement of Stockholders’ Equity and Comprehensive Loss

 

 

 

 

 

 

 

Consolidated Statements of Cash Flows

 

 

 

 

 

 

 

Notes to Consolidated Financial Statements

 

 

 

 

 

 

Item 2.

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

 

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

 

 

 

 

 

 

Item 4.

Controls and Procedures

 

 

 

 

 

Part II.

Other Information

 

 

 

 

 

 

Item 4.

Submission of Matters to a Vote of Stockholders

 

 

 

 

 

 

Item 6.

Exhibits

 

 

 

 

 

 

Signatures

 

 

 

 

 

 

Exhibits

 

 

2



 

PART I - FINANCIAL INFORMATION

 

Item 1: FINANCIAL STATEMENTS

 

VISION-SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

September 30,
2005

 

March 31,
2005

 

ASSETS

 

 

 

 

 

Current Assets:

 

 

 

 

 

Cash and cash equivalents

 

$

7,724,411

 

$

9,868,586

 

Accounts receivable, net of allowance for doubtful accounts of $136,209 and $70,097, respectively

 

1,336,125

 

1,662,486

 

Inventories

 

2,573,651

 

1,876,824

 

Prepaid expenses and deposits

 

51,607

 

61,964

 

Total current assets

 

11,685,794

 

13,469,860

 

 

 

 

 

 

 

Property and Equipment, at cost:

 

 

 

 

 

Machinery and equipment

 

4,620,351

 

4,427,047

 

Furniture and fixtures

 

242,735

 

242,406

 

Leasehold improvements

 

579,032

 

573,780

 

 

 

5,442,118

 

5,243,233

 

Less-Accumulated depreciation and amortization

 

4,242,993

 

4,040,060

 

 

 

1,199,125

 

1,203,173

 

 

 

 

 

 

 

Other assets, net of accumulated amortization of $56,955 and $53,815, respectively

 

71,676

 

74,816

 

Total assets

 

$

12,956,595

 

$

14,747,849

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

Current portion of note payable

 

$

25,406

 

$

24,431

 

Accounts payable

 

695,706

 

637,408

 

Accrued expenses

 

1,010,211

 

1,213,577

 

Total current liabilities

 

1,731,323

 

1,875,416

 

 

 

 

 

 

 

Long-term portion of note payable

 

17,903

 

31,089

 

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

Common stock, $.01 par value—
Authorized—50,000,000 shares
Issued and outstanding—35,108,401 shares at September 30, 2005 and 34,998,877 shares at March 31, 2005

 

351,083

 

349,988

 

Additional paid-in capital

 

75,262,121

 

74,987,548

 

Accumulated deficit

 

(64,405,835

)

(62,496,192

)

Total stockholders’ equity

 

11,207,369

 

12,841,344

 

Total liabilities and stockholders’ equity

 

$

12,956,595

 

$

14,747,849

 

 

See accompanying notes to consolidated financial statements.

 

3



 

VISION-SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three Months Ended
September 30,

 

Six Months Ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

2,301,552

 

$

2,031,438

 

$

4,834,510

 

$

4,808,219

 

Cost of sales

 

1,807,204

 

1,780,599

 

3,730,022

 

3,474,815

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

494,348

 

250,839

 

1,104,488

 

1,333,404

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative expenses (1)

 

1,119,817

 

844,622

 

2,065,186

 

1,841,057

 

Research and development expenses (1)

 

442,375

 

308,548

 

939,439

 

648,743

 

Stock-based compensation

 

49,684

 

33,526

 

99,369

 

67,052

 

Loss from operations

 

(1,117,528

)

(935,857

)

(1,999,506

)

(1,223,448

)

 

 

 

 

 

 

 

 

 

 

Interest income

 

41,093

 

7,389

 

86,880

 

16,074

 

Interest expense

 

(851

)

(1,298

)

(1,817

)

(2,701

)

Other income, net

 

(1,260

)

 

4,800

 

3,659

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(1,078,546

)

$

(929,766

)

$

(1,909,643

)

$

(1,206,416

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.03

)

$

(0.03

)

$

(0.05

)

$

(0.04

)

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic and diluted net loss per common share

 

35,092,438

 

30,925,047

 

35,070,300

 

30,880,365

 

 


(1)                                  Excludes non-cash stock-based compensation, as follows:

 

Research and development expenses

 

$

109

 

$

109

 

$

219

 

$

219

 

Selling, general and administrative expenses

 

49,575

 

33,417

 

99,150

 

66,833

 

Total

 

$

49,684

 

$

33,526

 

$

99,369

 

$

67,052

 

 

See accompanying notes to consolidated financial statements.

 

4



 

VISION-SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY

and COMPREHENSIVE LOSS

(Unaudited)

 

 

 

Common Stock

 

 

 

 

 

Total

 

Total

 

 

 

Number
of Shares

 

$.01
Par Value

 

Additional
Paid-in-Capital

 

Accumulated
Deficit

 

Stockholders’
Equity

 

Comprehensive
Loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, March 31, 2005

 

34,998,877

 

$

349,988

 

$

74,987,548

 

$

(62,496,192

)

$

12,841,344

 

 

 

Exercise of stock options, net

 

109,524

 

1,095

 

119,335

 

 

120,430

 

 

 

Receipt of subscription receivable for shares sold February 2005, net

 

 

 

 

 

55,869

 

 

 

55,869

 

 

 

Compensation expense related to non-employee non-qualified stock options

 

 

 

 

 

92,775

 

 

92,775

 

 

 

Compensation expense related to employee non-qualified stock options

 

 

 

 

 

6,594

 

 

 

6,594

 

 

 

Net loss

 

 

 

 

(1,909,643

)

(1,909,643

)

$

(1,909,643

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

$

(1,909,643

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance September 30, 2005

 

35,108,401

 

$

351,083

 

$

75,262,121

 

$

(64,405,835

)

$

11,207,369

 

 

 

 

See accompanying notes to consolidated financial statements.

 

5



 

VISION-SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Six Months Ended
September 30, 2005

 

Six Months Ended
September 30, 2004

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(1,909,643

)

$

(1,206,416

)

Adjustments to reconcile net loss to net cash used for operating activities:

 

 

 

 

 

Depreciation and amortization

 

206,073

 

124,349

 

Stock compensation for non-qualified options

 

99,369

 

67,052

 

Changes in assets and liabilities:

 

 

 

 

 

Accounts receivable

 

326,361

 

638,710

 

Inventories

 

(696,827

)

(403,219

)

Prepaid expenses and deposits

 

10,357

 

(550

)

Accounts payable

 

58,298

 

15,250

 

Accrued expenses

 

(203,366

)

(117,781

)

 

 

 

 

 

 

Net cash used for operating activities

 

(2,109,378

)

(882,605

)

 

 

 

 

 

 

Cash flows used for investing activities

 

 

 

 

 

Purchase of property and equipment, net

 

(198,885

)

(398,961

)

Increase in other assets

 

 

(14,437

)

 

 

 

 

 

 

Net cash used for investing activities

 

(198,885

)

(413,398

)

 

 

 

 

 

 

Cash flows provided by (used for) financing activities:

 

 

 

 

 

Payments on note payable for computer equipment

 

(12,211

)

(8,532

)

Proceeds from acceptances payable to a bank

 

 

4,378

 

Proceeds from the sale of common stock, net

 

55,869

 

 

Exercise of stock options, net

 

120,430

 

302,262

 

Net cash provided by financing activities

 

164,088

 

298,108

 

 

 

 

 

 

 

Net decrease in cash and cash equivalents

 

(2,144,175

)

(997,895

)

Cash and cash equivalents, beginning of period

 

9,868,586

 

2,714,941

 

Cash and cash equivalents, end of period

 

$

7,724,411

 

$

1,717,046

 

 

 

 

 

 

 

Supplemental Disclosure of Cash Flow Information:

 

 

 

 

 

Cash paid during the period for interest

 

$

1,817

 

$

2,701

 

 

 

 

 

 

 

Supplemental Disclosure of Non-cash Items from Financing Activities:

 

 

 

 

 

 

 

 

 

 

 

Fair market value of non-qualified options granted in the period

 

$

 

$

241,832

 

 

See accompanying notes to consolidated financial statements.

 

6



 

VISION-SCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

1.                                      Basis of Presentation

 

The consolidated financial statements included herein have been prepared by Vision-Sciences, Inc. and subsidiaries (the “Company”) in accordance with accounting principles generally accepted in the United States of America, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission and include, in the opinion of management, all adjustments (consisting only of normal and recurring adjustments) that the Company considers necessary for a fair presentation of such information.  Certain information and footnote disclosures normally included in financial statements have been condensed or omitted pursuant to such rules and regulations.  The Company believes, however, that its disclosures are adequate to make the information presented not misleading.  These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s latest annual report to stockholders.  The results for the interim periods presented are not necessarily indicative of results to be expected for the full fiscal year.

 

2.                                      Summary of Significant Accounting Policies

 

The accompanying consolidated financial statements reflect the application of certain accounting policies described below:

 

a.                                       Principles of Consolidation: The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries.  All material intercompany accounts and transactions have been eliminated in consolidation.

 

b.                                      Cash Equivalents: Cash equivalents consist of a money market account at a bank, and investments in commercial paper.  Cash equivalents are short-term highly liquid investments with original maturities of less than three months, and are carried at amortized cost, which approximates market value.

 

c.                                       Inventories:  Inventories are stated at the lower of cost or market using the first-in, first-out (FIFO) method and consist of the following:

 

 

 

September 30,
2005

 

March 31,
2005

 

 

 

 

 

(audited)

 

Raw materials

 

$

1,636,300

 

$

1,166,946

 

Work-in-process

 

287,723

 

253,449

 

Finished goods

 

649,628

 

456,429

 

 

 

$

2,573,651

 

$

1,876,824

 

 

Work-in-process and finished goods inventories consist of material, labor, and manufacturing overhead.

 

7



 

d.                                      Depreciation and Amortization: The Company provides for depreciation and amortization using the straight-line method in amounts that allocate the cost of the assets to operations over their estimated useful lives as follows:

 

Asset Classification

 

Estimated
Useful Life

 

Machinery and Equipment

 

3-5 Years

 

Furniture and Fixtures

 

5 Years

 

 

Leasehold improvements are amortized over the shorter of their estimated useful lives or the lives of the leases.

 

e.                                       Basic and Diluted Net Loss Per Common Share: Basic and diluted net loss per common share is based on the weighted average number of common shares outstanding.  Shares of common stock issuable pursuant to outstanding stock options have not been considered, as their effect would be antidilutive.

 

f.                                         Revenue Recognition: The following must occur before the Company recognizes revenue: (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services have been rendered, (3) the price is fixed or determinable, (4) collectibility is reasonably assured and (5) the fair value of undelivered elements, if any, exists.  To date the Company has not entered into any multiple element arrangements.  The Company recognizes revenue when title passes to the customer, generally upon shipment of products F.O.B. shipping point.  Since September 2003, the Company’s medical segment has distributed all of its products for the Ear-Nose-Throat (“ENT”) market in the U.S.A. and Canada through an agreement (the “Medtronic Agreement”) with Medtronic Xomed, Inc. (“Medtronic Xomed”).  The initial term of the Medtronic Agreement was three years, renewable thereafter annually, unless terminated by either party.

 

During the fiscal year ended March 31, 2005 (“FY 05”), the Company and Medtronic Xomed modified the Medtronic Agreement to provide for a rebate to Medtronic Xomed for sales of ENT EndoSheaths to new customers who commit to large purchases.  The rebate program was designed to run for one year to September 30, 2005.  The Company accounts for this modification under Emerging Issues Task Force (“EITF”) 01-9, Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products).  As of September 30, 2005, the Company has provided for rebates of approximately $62,000.  The Company expects to terminate the rebate program in the three months ending December 31, 2005.

 

8



 

Since December 2004, the Company’s medical segment has distributed all of its products for the urology market in the U.S.A. and Canada through an agreement (the “MGU Agreement”) with Medtronic USA, Inc. (“MGU”).  The term of the MGU Agreement is through March 31, 2006, renewable for successive one-year periods unless either party notifies the other party in writing at least 90 days prior to the end of any term that it does not want to renew.

 

Neither the Medtronic Agreement nor the MGU Agreement provide for any contingencies, nor provide any terms related to product acceptance or warranty that are different from the normal terms provided by the Company to its other customers.

 

g.                                      Foreign Currency Transactions: In accordance with Statement of Financial Accounting Standard (“SFAS”) No. 52, Foreign Currency Translation, the Company charges foreign currency exchange gains or losses, in connection with its purchases of products from vendors in Japan, to operations, and charges foreign exchange translation gains and losses to retained earnings.

 

h.                                      Income Taxes: The Company accounts for income taxes under the liability method in accordance with SFAS No. 109, Accounting for Income Taxes.  Under SFAS No. 109, deferred tax assets or liabilities are computed based upon the differences between the financial statement and income tax bases of assets and liabilities as measured by the enacted tax rates.

 

The Company has recorded a valuation allowance equal to its net deferred tax asset due to the uncertainty of realizing the benefit of this asset.

 

i                                             Accounting for Options Issued to Non-employees:  During the fiscal year ended March 31, 2005, the Company granted options to purchase 150,000 shares of the Company’s Common Stock to non-employees.  The fair value of these options measured at the option grant dates was approximately $371,000, determined using the Black-Scholes option-pricing model, and is being recorded as an expense over the vesting period.  The assumptions used in the Black-Scholes option-pricing model by the Company were as follows:

 

Risk-free interest rate

 

.93% - 1.36%

 

 

 

Expected dividend yield

 

 

 

 

Expected lives

 

5 years

 

 

 

Expected volatility

 

79% - 83%

 

 

 

Weighted average value grants per share

 

$3.81

 

9



 

During the three months ended September 30, 2005 and 2004, the Company recognized $46,387 and $30,229, respectively, of expense related to such options.  During the six months ended September 30, 2005 and 2004, the Company recognized $92,775 and $60,458, respectively, of expense related to such options.

 

j.                                          Employee Stock-based Compensation Arrangements: The Company accounts for its stock-based compensation arrangements for employees and independent directors using the intrinsic value method under the provisions of Accounting Principles Board (“APB”) Opinion No. 25, Accounting for Stock Issued to Employees, and Financial Interpretation No. (“FIN”) 44.  The Company does not recognize stock-based compensation cost when the options granted have an exercise price equal to, or greater than, the market value of the underlying common stock on the date of the grant.  The Company does recognize stock-based employee compensation cost when the options granted have an exercise price less than the market value of the underlying common stock on the date of the grant.

 

In June 2003, the Company granted options to purchase 1,295,000 shares of common stock to its employees at an exercise price of $1.04 per share.  The fair market value of the common stock on the date of grant was $1.09 per share.  As a result, the Company has recognized compensation expense for the difference between the fair market value and the option price over the life of the options.  In each of the three months and six months ended September 30, 2005, and 2004, the Company recognized $3,297 and $6,594, respectively, of expense related to these options as stock-based compensation in the consolidated statements of operations.

 

In the three months ended September 30, 2005, the Company granted non-qualified options to purchase 4,000 shares of the Company’s Common Stock to each of three of its independent directors, as provided for in the Company’s 2003 Director Option Plan.  The options were granted at exercise prices equal to the fair market value of the underlying common stock on the dates of grant.

 

10



 

In accordance with the Financial Accounting Standards Board (“FASB”) Statement No. 148, Accounting for Stock-Based Compensation – Transition and Disclosure, beginning in the quarter ending March 31, 2003, the Company adopted the disclosure requirements of FASB No. 148.  Had compensation expense for all stock option grants to employees and independent directors been determined under the fair value method at the grant dates, consistent with the method prescribed by SFAS No. 123, the Company’s net loss would have been increased to the pro forma amounts indicated as follows:

 

 

 

Three Months Ended
September 30,

 

Six Months Ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

Net loss – as reported

 

$

(1,078,546

)

$

(929,766

)

$

(1,909,643

)

$

(1,206,416

)

Stock-based employee compensation – as reported

 

3,297

 

3,297

 

6,594

 

6,594

 

Pro forma stock-based employee compensation

 

(146,493

)

(103,500

)

(265,662

)

(198,000

)

Net loss - pro forma

 

$

(1,221,742

)

$

(1,029,969

)

$

(2,168,711

)

$

(1,397,822

)

 

 

 

 

 

 

 

 

 

 

Net loss per share – as reported

 

$

(.03

)

$

(.03

)

$

(0.05

)

$

(0.04

)

Stock-based employee compensation – as reported

 

 

 

 

 

Pro forma stock-based employee compensation

 

 

 

(0.01

)

(0.01

)

Net loss per share - pro forma

 

$

(.03

)

$

(.03

)

$

(0.06

)

$

(0.05

)

 

k.                                       New Accounting Standards:  In November 2004, the FASB issued SFAS No. 151, Inventory Costs, an amendment of ARB No. 43, Chapter 4.  SFAS No. 151 amends the guidance in ARB No. 43, Chapter 4, Inventory Pricing, to clarify the accounting for abnormal amounts of idle facility expense, freight, handling costs and spoilage.  This statement requires that those items be recognized as current period charges regardless of whether they meet the criterion of “so abnormal” which was the criterion specified in ARB No. 43.  In addition, this Statement requires that allocation of fixed production overheads to the cost of production be based on normal capacity of the production facilities.  This pronouncement is effective for fiscal years beginning after June 15, 2005.  The Company has not yet assessed the impact of adopting this new standard.

 

11



 

In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment.  SFAS 123R is a revision of SFAS No. 123, Accounting for Stock-Based Compensation and supersedes APB No. 25, Accounting for Stock Issued to Employees, and its related implementation guidance.  SFAS 123R requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values.  The pro forma disclosures previously permitted under SFAS 123 no longer will be an alternative to financial statement recognition.  The Company is required to adopt SFAS 123R in the first quarter of the fiscal year ending March 31, 2007, beginning April 1, 2006.  Under SFAS 123R, the Company must determine the appropriate fair value model to be used for valuing share-based payments, the amortization method for compensation costs and the transition method to be used at date of adoption. The transition methods include prospective and retrospective adoption options.

 

Under the retroactive option, prior periods may be restated either as of the beginning of the year of adoption or for all periods presented.  The prospective method requires that compensation expense be recorded for all unvested stock options and restricted stock at the beginning of the first quarter of adoption of SFAS 123R, while the retroactive method would record compensation expense for all unvested stock options and restricted stock beginning with the first period restated.  The Company is evaluating the requirements of SFAS 123R and expects that the adoption of SFAS 123R may have a material impact on its consolidated results of operations and earnings per share.  The Company has not yet determined the method of adoption or the effect of adopting SFAS 123R, and it has not determined whether the adoption will result in amounts that are similar to the current pro forma disclosures under SFAS 123.

 

12



 

3.                                      3BY Ltd.

 

In June 2003, the Company entered into a Contract Manufacturing Agreement, a Loan Agreement and a Pledge Agreement (collectively, the “3BY Agreements”) with Three BY Ltd., an Israeli company (“3BY”).  The 3BY Agreements provided for, among other things, the manufacture of certain of the Company’s products by 3BY, and a loan of up to $267,500 by the Company to 3BY for the purchase and installation of certain manufacturing equipment by 3BY, at 3BY’s facility, to be used to manufacture certain of the Company’s products.  3BY completed the purchase and installation of the manufacturing equipment, and the Company began receiving commercial production from 3BY in the three months ending September 30, 2004.  On October 1, 2004, according to terms in the Loan Agreement, 3BY and the Company agreed that the Company would take title to the manufacturing equipment, in lieu of 3BY retaining title and paying back the advance.

 

In May 2005, the Company decided to bring the manufacturing of these products back to its Natick, MA plant, due to the inability to exert sufficient control over the manufacturing processes to have the confidence level necessary for its product quality.  In addition, the costs savings anticipated have not been attained.  On October 2, 2005, the Company and 3BY entered into a Termination and Settlement Agreement (the “Termination Agreement”) pursuant to which the Company and 3BY terminated the 3BY Agreements.  Included in the Termination Agreement is a provision for the Company to purchase from 3BY 180,000 units of the Company’s basic ENT Slide-On EndoSheath at a price that represents an increase of approximately $62,000 in total, compared to the price paid prior to termination.  The Company expects this purchase order will be completed over six to nine months.  In addition, the Company will pay 3BY $16,700 for costs related to equipment purchased by 3BY.  After completion of the purchase order, the equipment owned by the Company located at 3BY will be returned to the Company’s Natick, MA plant.  To date, the Company does not believe these assets are impaired based upon their intended use.  However, depending upon the demand for the Company’s products that utilize this equipment, and the Company’s ability to reconfigure the equipment to manufacture other products, the Company may incur a charge for impairment in the future related to this equipment which is valued at approximately $330,000 at September 30, 2005.

 

13



 

4.                                      Segment Information

 

The Company has three reportable segments – medical, industrial and corporate.  The medical segment designs, manufactures and sells EndoSheaths and sells endoscopes to users in the health care industry.  The industrial segment designs, manufactures and sells borescopes to a variety of users, primarily in the aircraft engine manufacturing and aircraft engine maintenance industries.  In addition, the industrial segment manufactures and repairs endoscopes for the medical segment.  The corporate segment consists of certain administrative expenses applicable to the Company as a whole.

 

All segments follow the accounting policies described in the summary of significant accounting policies.  The Company evaluates segment performance based upon operating income.  Identifiable assets are those used directly in the operations of each segment.  Corporate assets include cash, marketable securities and the assets of Vision-Sciences, Ltd.  Data regarding management’s view of the Company’s segments are provided in the following tables.

 

14



 

Three months ended September 30,

 

Medical

 

Industrial

 

Corporate

 

Adjustments

 

Total

 

2005

 

 

 

 

 

 

 

 

 

 

 

Sales to external customers

 

$

1,706,980

 

$

594,572

 

$

 

$

 

$

2,301,552

 

Intersegment sales

 

 

587,102

 

 

(587,102

)

 

Operating income (loss)

 

(735,852

)

(13,474

)

(368,202

)

 

(1,117,528

)

Interest income (expense), net

 

 

 

40,242

 

 

40,242

 

Depreciation and amortization

 

92,960

 

8,862

 

 

 

101,822

 

Other significant non-cash items:

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

46,575

 

62

 

3,047

 

 

49,684

 

Expenditures for fixed assets

 

80,789

 

8,044

 

 

 

88,833

 

 

 

 

 

 

 

 

 

 

 

 

 

2004

 

 

 

 

 

 

 

 

 

 

 

Sales to external customers

 

$

1,130,315

 

$

901,123

 

$

 

$

 

$

2,031,438

 

Intersegment sales

 

 

330,253

 

 

(330,253

)

 

Operating income (loss)

 

(615,701

)

(51,737

)

(268,419

)

 

(935,857

)

Interest income (expense), net

 

 

 

6,091

 

 

6,091

 

Depreciation and amortization

 

54,386

 

11,596

 

1,506

 

 

67,488

 

Other significant non-cash items:

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

30,416

 

63

 

3,047

 

 

33,526

 

Expenditures for fixed assets

 

227,078

 

17,491

 

 

 

244,569

 

 

Six months ended September 30,

 

Medical

 

Industrial

 

Corporate

 

Adjustments

 

Total

 

2005

 

 

 

 

 

 

 

 

 

 

 

Sales to external customers

 

$

3,616,309

 

$

1,218,201

 

$

 

$

 

$

4,834,510

 

Intersegment sales

 

 

1,415,893

 

 

(1,415,893

)

 

Operating income (loss)

 

(1,348,375

)

(27,516

)

(623,615

)

 

(1,999,506

)

Interest income (expense), net

 

 

 

85,063

 

 

85,063

 

Depreciation and amortization

 

182,403

 

23,670

 

 

 

206,073

 

Other significant non-cash items:

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

93,150

 

125

 

6,094

 

 

99,369

 

Expenditures for fixed assets

 

183,015

 

15,870

 

 

 

198,885

 

Total assets

 

3,741,647

 

1,842,183

 

7,810,366

 

(437,601

)

12,956,595

 

 

 

 

 

 

 

 

 

 

 

 

 

2004

 

 

 

 

 

 

 

 

 

 

 

Sales to external customers

 

$

3,107,645

 

$

1,700,574

 

$

 

$

 

$

4,808,219

 

Intersegment sales

 

 

977,214

 

 

(977,214

)

 

Operating income (loss)

 

(605,442

)

(31,443

)

(586,563

)

 

(1,223,448

)

Interest income (expense), net

 

 

 

13,373

 

 

13,373

 

Depreciation and amortization

 

98,769

 

22,568

 

3,012

 

 

124,349

 

Other significant non-cash items:

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

60,832

 

126

 

6,094

 

 

67,052

 

Expenditures for fixed assets

 

376,811

 

22,150

 

 

 

398,961

 

Total assets

 

2,664,864

 

1,594,733

 

1,806,008

 

(280,818

)

5,784,787

 

 

15



 

Item 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Executive Summary

 

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.  Examples of forward-looking statements include statements about expectations about future financial results, future products and future sales of new and existing products, future expenditures, and capital resources to meet anticipated requirements.  Without limiting the foregoing, the words “believes”, “anticipates”, “plans”, “expects”, and similar expressions are intended to identify forward-looking statements.  These forward-looking statements involve risks and uncertainties, and our actual results may differ significantly from those discussed in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, the availability of capital resources, the availability of third-party reimbursement, government regulation, the availability of supplies, competition, technological difficulties, the continuation of our contracts with Medtronic Xomed and MGU, general economic conditions and other risks detailed in our most recent Annual Report on Form 10-K and any subsequent periodic filings made with the Securities and Exchange Commission.  We do not undertake an obligation to update our forward-looking statements to reflect future events or circumstances.

 

We develop, manufacture and sell flexible endoscope products for the medical device and industrial device markets.  We operate in three reporting segments, medical, industrial and corporate.

 

Medical Segment

 

The medical segment supplies flexible endoscopes and disposable Slide-On™ EndoSheath® Systems (“EndoSheaths”) to the ENT, gastrointestinal (“GI”), urology and pulmonary markets.  Health-care providers use EndoSheaths to cover the insertion tube of flexible endoscopes, such as ENT endoscopes, Trans-Nasal Esophagoscopes (“TNE”), sigmoidoscopes, cystoscopes and bronchoscopes.  We have designed the EndoSheaths to allow the health-care providers to process patients economically by permitting the providers to minimize reprocessing the endoscopes between procedures.  In addition, the EndoSheaths ensure a sterile insertion tube for each patient procedure.

 

Our strategy in the medical segment is comprised of three components: a) improve sales distribution, b) lower manufacturing costs and c) increase the number of new product offerings.

 

Sales Distribution

 

Since September 19, 2003, we have been distributing all of our products for the ENT market in the U.S.A. and Canada through Medtronic Xomed as part of the Medtronic Agreement. The initial term of the Medtronic Agreement is three years.  Thereafter, the Medtronic Agreement is automatically renewed for successive one-year periods, unless terminated by either party upon advance written notice.  Under the Medtronic Agreement, we have granted Medtronic Xomed exclusive distribution rights in the U.S.A. and Canada to market and sell our ENT and TNE EndoSheaths and endoscopes to ENT practitioners.  Medtronic Xomed fulfilled certain minimum purchase requirements for the initial twelve-month period of the term.  The Medtronic Agreement resulted in an increase in sales of our ENT EndoSheaths and ENT endoscopes due to the quantities of endoscopes and EndoSheaths purchased by Medtronic Xomed in the initial twelve-month period.  In the second year (“Year 2”) of the Medtronic Agreement, Medtronic

 

16



 

purchased fewer units of ENT endoscopes and ENT EndoSheaths than in the initial period, due to the build up of inventory that resulted from the purchases in the initial period.  During Year 2, we and Medtronic Xomed began a rebate program, whereby we agreed to pay Medtronic a cash rebate for ENT EndoSheaths they sold to new users who committed to a large annual purchase. As of September 30, 2005, we recorded a reserve of approximately $62,000 for the rebate program.  As of September 30, 2005, Medtronic Xomed had reduced their excess inventory, and had ordered ENT EndoSheaths at an annual rate of over 150,000 units.  We expect we will terminate the rebate program during the three months ending December 31, 2005.

 

In addition, in December 2004, we signed the MGU Agreement with MGU, the gastro-urology division of Medtronic, Inc., granting MGU exclusive rights to distribute our new cystoscope with Slide-On EndoSheath System to urologists in the U.S.A. and Canada.  The term of the MGU Agreement is through March 31, 2006, renewable for successive one-year periods unless either party notifies the other party in writing at least 90 days prior to the end of any term that it does not want to renew.  The total purchase commitment for cystoscopes and Slide-On EndoSheaths is $1,965,000, of which $353,500 was to be delivered in the fiscal year ended March 31, 2005 (“FY 05”), and the remainder in the fiscal year ending March 31, 2006 (“FY 06”).  There can be no assurance that MGU will purchase the total commitment by March 31, 2006.

 

We believe the marketing and sales capabilities of Medtronic Xomed and MGU have facilitated and will continue to facilitate the introduction of new products to the ENT and urology markets by allowing quicker market acceptance of these products than if we marketed them ourselves.  As a result of these agreements, the success of our ENT and urology product lines is substantially dependent upon the success of the marketing and sales activities of Medtronic Xomed and MGU, over which we have limited control.  We have retained our domestic network of independent sales representatives for the GI and pulmonary product lines.  Also, we have retained our own international network of distributors for all our medical product lines.

 

Cost Reduction

 

During FY 06, we plan to implement reductions in the cost of materials and labor across our endoscope and EndoSheath product lines by examining and updating our material costs and labor processes.  In addition, we are working on a development project for a new low-cost EndoSheath that we expect will result in a new EndoSheath design and machinery that will automate many of the processes performed in the manufacture of EndoSheaths.  Our plan is to have this development project result in new machinery that we expect will be in place during the second half of the fiscal year ending March 31, 2007 (“FY 07”).

 

17



 

New Products

 

In May 2005, we received clearance from the FDA to market our new ENT-3000 portable endoscope with battery-powered LED light source.  During FY 06, our product development plans include a feasibility model of a new Trans-Esophageal Echo based cardioversion product to treat atrial fibrillation, and a thoracic surgery flexible endoscope with three-dimensional imaging.  We also are continuing our design efforts for a new low-cost EndoSheath concept, described in Cost Reduction above.  In addition, we are designing a new family of smaller sized “D-shaped” proprietary endoscopes for use with our EndoSheaths that incorporate channels, and a new family of videoscopes with a distal tip CCD based camera.  We also plan to investigate other potential products for the gastrointestinal and bariatric surgery markets.

 

Industrial Segment

 

The industrial segment designs, manufactures and sells flexible endoscopes, termed borescopes, for industrial users, and manufactures and repairs flexible endoscopes for the medical segment.  The industrial segment users consist primarily of companies in the aircraft engine manufacturing and maintenance markets and the defense market.

 

Corporate Segment

 

The corporate segment consists of certain administrative and business development activities applicable to the Company as a whole.

 

18



 

Critical Accounting Policies and Estimates

 

This discussion and analysis of our financial condition and results of operations is based upon our Consolidated Financial Statements, which have been prepared in accordance with accounting principles generally accepted in the United States.  See the Notes to the Consolidated Financial Statements included elsewhere herein.  Certain of our accounting policies require the application of judgment in selecting the appropriate assumptions for calculating financial estimates.  By their nature these judgments are subject to an inherent degree of uncertainty.  We periodically evaluate the judgments and estimates used for our critical accounting policies to ensure that such judgments and estimates are reasonable for our interim and year-end reporting requirements.  These judgments and estimates are based upon our historical experience, current trends and information available from other sources, as appropriate.  If different conditions result from those assumptions used in our judgment, the results could be materially different from our estimates.  Our critical accounting policies include the following:

 

Revenue Recognition

 

We recognize revenue in accordance with SEC Staff Accounting Bulletin No. 104, Revenue Recognition in Financial Statements and EITF 00-21, Revenue Arrangements with Multiple Deliverables. These pronouncements require that five basic criteria must be met before revenue can be recognized: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred or services rendered; (3) the fee is fixed and determinable; (4) collectibility is reasonably assured and (5) the fair value of undelivered elements, if any, exists.  Determination of criterion (4) is based on management’s judgment regarding the collectibility of invoices for products and services delivered to customers.  Should changes in conditions cause management to determine these criteria are not met for certain future transactions, revenue recognized for any reporting period could be adversely affected.

 

We account for the rebate we granted to Medtronic Xomed in accordance with EITF 01-9, Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products).  This pronouncement requires that a vendor recognize rebates as a reduction of revenue based on a systematic and rational allocation of the cost of honoring rebates earned and claimed to each of the underlying revenue transactions that result in progress by the customer toward earning the rebate.  Accordingly, as of September 30, 2004, we recognized an allowance of $39,000 for the estimated rebate that would accrue to Medtronic Xomed for sales of ENT EndoSheaths that were in Medtronic Xomed’s inventory at that date that would be sold to new customers under the rebate program.  Subsequent to September 30, 2004, we recognize revenue on sales of ENT EndoSheaths to Medtronic Xomed, net of an estimated sales allowance related to that rebate program.  Measurement of the total rebate is based on the estimated number of customers that will ultimately earn rebates under the offer.  Determination of the number of customers that will earn rebates and the amount of those rebates is based on management’s judgment.  We review our estimates of the number of customers that will earn benefits under the rebate program each fiscal quarter.  If different conditions result from those assumptions used in our judgment, the results could be materially different from our estimates.

 

19



 

Options Issued to Non-employees

 

We account for non-qualified options issued to non-employees as equity instruments, in accordance with the provisions of EITF 96-18.  Fair values for these non-qualified options are derived from pricing models that consider current market and contractual prices for the underlying financial instruments, as well as time value, yield curve and volatility factors underlying the positions.  Pricing models and their underlying assumptions impact the amount and timing of the value of these non-qualified options, and the use of different pricing models or assumptions could produce different financial results.  We use the Black-Scholes option-pricing model for determining the value of non-qualified options issued to non-employees, and we expense that value over the vesting period of the non-qualified options.

 

We account for certain non-qualified options granted to employees and independent members of our Board of Directors to purchase our common stock in accordance with APB Opinion No. 25, Accounting for Stock Issued to Employees.  If the fair market value of the underlying stock at the date of grant is greater than the option price, we recognize compensation expense for the difference between the market price and the option price over the vesting period of the options.

 

Income Taxes

 

Under our income tax policy, we record the estimated future tax effects of temporary differences between the tax bases of assets and liabilities and amounts recorded in the accompanying consolidated balance sheets, as well as operating loss and tax credit carryforwards.  The evaluation of the recoverability of any tax assets recorded on the balance sheet is subject to significant judgment.  We have provided valuation allowances for all our deferred tax assets to date.

 

Results of Operations

 

Net Sales

 

Q2 06 Compared to Q2 05

 

Net sales for the three months ended September 30, 2005 (“Q2 06”) were $2,301,552, an increase of $270,114, or 13%, compared to the three-month period ended September 30, 2004 (“Q2 05”).  During Q2 06, net sales of the medical segment increased by $576,665, or 51%, to $1,706,980, and net sales of the industrial segment decreased by $306,551, or 34%, to $594,572, compared to Q2 05.  In the medical segment, the net sales and changes in net sales by market were as follows ($000’s):

 

Market

 

Q2 06

 

Q2 05

 

Increase
(Decrease)

 

Percent

 

ENT

 

$

1,253

 

$

906

 

$

347

 

38

%

Urology

 

155

 

72

 

83

 

115

%

Other

 

299

 

152

 

147

 

97

%

Total

 

$

1,707

 

$

1,130

 

$

577

 

51

%

 

20



 

Medical Sales – ENT Market

 

Net sales to the ENT market include products for domestic and international customers as follows:

 

ENT Market

 

Q2 06

 

Q2 05

 

Increase
(Decrease)

 

Percent

 

Domestic

 

$

 638

 

$

557

 

$

 81

 

15

%

International

 

615

 

349

 

266

 

76

%

Total ENT

 

$

1,253

 

$

906

 

$

347

 

38

%

 

We further delineate products sold to the domestic ENT market as follows:

 

ENT Products

 

Q2 06

 

Q2 05

 

Increase
(Decrease)

 

Percent

 

Slide-On EndoSheaths

 

$

258

 

$

266

 

$

(8

)

(3

)%

Endoscopes

 

380

 

291

 

89

 

31

%

Total Domestic ENT

 

$

638

 

$

557

 

$

81

 

15

%

 

The primary reason for the increase in sales of products to the domestic ENT market was the initial shipment of our new ENT-3000 endoscope with the re-chargeable battery-powered LED light source to Medtronic Xomed, our exclusive distributor of ENT products in the U.S. and Canada.  Total sales to Medtronic Xomed in Q2 06 were $0.765 million, an increase of approximately $0.139 million, or 22%, compared to $0.626 million in Q2 05, due primarily to the sales of ENT-3000 referred to above.  Also during Q2 06, Medtronic Xomed purchased 34,830 ENT Slide-On EndoSheaths (“ENT SOS”).  During Q2 06, Medtronic Xomed began re-ordering ENT SOS at an annual rate of approximately 180,000 units.  From this activity and discussions with Medtronic Xomed, we believe their excess inventory of ENT SOS has been sold, and we expect to do a final accounting for any rebate owed Medtronic Xomed in our fiscal quarter ending December 31, 2005 (“Q3 06”).  In Q2 06, we recorded sales discounts of approximately $11,000 as part of the rebate program, resulting in cumulative reserves of approximately $62,000.

 

Although Medtronic Xomed has not purchase the required number of ENT EndoSheaths to maintain their exclusivity under the Medtronic Agreement, we have not exercised our right to terminate their exclusivity, as we believe their sales of our products will continue to improve, and we currently believe they represent the best alternative for us to distribute our current line of ENT products and drive product acceptance of new ENT products in the domestic market.

 

21



 

In FY 06, we and Medtronic Xomed plan to introduce a more attractive pricing program, allowing the price for all new purchases to decline in steps.  The first 150,000 units of ENT EndoSheaths purchased by Medtronic Xomed will be at the contract price; the next 100,000 will be at the contract price less $1.50 per unit; units over 250,000 will be at the contract price less $2.00 per unit.  The purpose of this price schedule is to allow Medtronic Xomed to penetrate the market for large institutions and sell ENT EndoSheaths to them at prices those institutions find reasonable.  In addition, we and Medtronic Xomed are having discussions to establish additional new programs that will increase the sales of our ENT and TNE products.

 

As a result of the Medtronic Agreement, the success of our ENT product lines are substantially dependent upon the success of the marketing and sales activities of Medtronic Xomed over which we have limited control.

 

Unit sales of ENT EndoSheaths in Q2 06 to the domestic market were 34,830, an increase of 1,350, or 4% compared to the 33,480 units sold in Q2 05.  The increase in unit sales was directly related to the reduction of inventory that had built-up at Medtronic Xomed during the first year of the Medtronic Agreement.  Unit sales of ENT endoscopes, which include our ENT-2000, ENT-1000 and ENT-3000 models, in Q2 06 were 108, an increase of 69, or 177%, compared to the unit sales of 39 in Q2 05.  The increase was due primarily to initial shipments of 40 units of the ENT-3000, and higher demand for the ENT-2000.

 

We further delineate products sold to the international ENT market as follows:

 

ENT Products

 

Q2 06

 

Q2 05

 

Increase
(Decrease)

 

Percent

 

Slide-On EndoSheaths

 

$

509

 

$

237

 

$

272

 

115

%

Endoscopes

 

106

 

112

 

(6

)

(5

)%

Total International

 

$

615

 

$

349

 

$

266

 

76

%

 

The increase in net sales to international distributors is primarily due to higher unit volume of ENT SOS.  Unit sales of ENT SOS to the international distributors were 79,460 in Q2 06, an increase of 43,246 units, compared to sales in Q2 05.  The increase in sales was due to higher demand, especially in Europe, and to sales of ENT SOS to new distributors in the Middle East.  We expect unit demand from international distributors to continue at this rate for the remainder of FY 06.

 

22



 

Unit sales of ENT endoscopes in Q2 06 to international distributors were 25, compared to 27 in Q2 05.  In addition, we sold 2 TNE Therapeutic (“TNE Bx”) endoscopes to our international distributors in Europe.  We are in the early stages of selling TNE endoscopes to our distributors, and we plan to increase our sales of this product by increasing the number of distributors in countries where we do not have representation.  However, there can be no assurance we will be able to consummate these agreements on terms that are beneficial to us. Also, we expect sales of the TNE endoscopes will improve after we release the new smaller D-shaped fiberscope and new videoscope in FY 07.

 

Sales of endoscopes are dependent upon a variety of factors, including the timing requirements of end users, foreign exchange rates, sales promotions of international competitors and other factors.

 

Medical Sales – Urology

 

The increase in sales of urology products reflects primarily increased shipments of our new Flexible Cystoscope (“CST-2000”) with Slide-On EndoSheath System to MGU, offset partially by lower shipments to international distributors.  We sold approximately $140,000 of CST-2000 and Slide-On EndoSheaths to MGU in Q2 06, and approximately $15,000 to international distributors.  We expect sales of the CST-2000 to MGU will be approximately the same in the fiscal quarter ending December 31, 2005 compared to sales in Q2 06, but to increase in the fiscal quarter ending March 31, 2006.  This is due to the time required to train MGU sales personnel and to the time needed by the MGU sales representatives to penetrate the urology market.  However, there can be no assurance that these sales goals will be met.

 

We believe the CST-2000 and EndoSheath System can significantly enhance the practice efficiency of urologists by allowing them to avoid the tedious and time-consuming reprocessing of conventional cystoscopes, and presents the significant benefit of a sterile insertion tube for each patient.  In addition, the use of our CST-2000 with Slide-On EndoSheath System avoids the need to reprocess endoscopes with harsh chemicals, one of which has been contraindicated for use on patients with bladder cancer.

 

Industrial Segment

 

The decrease in net sales of the industrial segment was due to higher demand in the market for video borescopes, compared to our line of fiber borescopes, and lower demand for repairs of fiber borescopes.

 

6 Months 06 Compared to 6 Months 05

 

Net sales for the six months ended September 30, 2005 (“6M 06”) were $4,834,510, an increase of $26,291, or 0.5%, compared to net sales of $4,808,219 for the 6 months ended September 30, 2004 (“6M 05”).  In 6M 06, sales of the medical segment were $3,616,309, an increase of $508,664, or 16%, compared to net sales of $3,107,645 in 6M 05.  Also in 6 M 06, sales of the industrial segment were $1,218,201, a decrease of $482,373, or 28%, compared to net sales of $1,700,574 in 6M 05.  In the medical segment, net sales and changes in net sales by market were as follows ($000’s):

 

23



 

Market

 

6M 06

 

6M 05

 

Increase
(Decrease)

 

Percent

 

ENT

 

$

2,443

 

$

2,544

 

$

(101

)

(4

)%

Urology

 

503

 

95

 

408

 

429

%

Other

 

670

 

469

 

201

 

43

%

Total

 

$

3,616

 

$

3,108

 

$

508

 

16

%

 

Medical Sales – ENT Market

 

Sales to the ENT market include products for the domestic and international customers as follows:

 

ENT Market

 

6M 06

 

6M 05

 

Increase
(Decrease)

 

Percent

 

Domestic

 

$

1,194

 

$

1,577

 

$

(383

)

(24

)%

International

 

1,249

 

967

 

282

 

29

%

Total ENT

 

$

2,443

 

$

2,544

 

$

(101

)

(4

)%

 

We further delineate products sold to the domestic ENT market as follows:

 

ENT Products

 

6M 06

 

6M 05

 

Increase
(Decrease)

 

Percent

 

Slide-On EndoSheaths

 

$

429

 

$

950

 

$

(521

)

(55

)%

Endoscopes

 

765

 

627

 

138

 

22

%

Total Domestic ENT

 

$

1,194

 

$

1,577

 

$

(383

)

(24

)%

 

The primary reason for the lower sales of ENT EndoSheaths to the domestic market in 6M 06 compared to 6M 05 was the build-up of inventory at Medtronic Xomed during FY 05.  As discussed above, we believe this build-up has been sold through to end users, and that comparisons of sales of ENT EndoSheaths to Medtronic Xomed will be positive going forward.  The primary reason for the increase in sales of ENT endoscopes was the sales to Medtronic Xomed of our new ENT-3000 in Q2 06.

 

We further delineate products sold to the international ENT market as follows:

 

ENT Products

 

6M 06

 

6M 05

 

Increase
(Decrease)

 

Percent

 

Slide-On EndoSheaths

 

$

942

 

$

758

 

$

184

 

24

%

Endoscopes

 

307

 

209

 

98

 

47

%

Total International

 

$

1,249

 

$

967

 

$

282

 

29

%

 

The primary reason for the increase in sales of ENT SOS to international distributors was higher demand, especially in Europe.  In addition, we established new distributors in the Middle East for our ENT SOS.  The increase in sales of endoscopes was caused primarily by higher sales in the three months ended June 30, 2005 (“Q1 06”) of our ENT-1000, the small diameter ENT endoscope.

 

24



 

Medical Sales –Urology Market

 

The increase in sales of products to the urology market was primarily due to shipments of our new CST-2000 with Slide-On EndoSheath System to MGU, and secondarily to international distributors.  We sold approximately $460,000 of CST-2000 and Slide-On EndoSheaths to MGU and $43,000 to international distributors.

 

Industrial Segment

 

The decrease in sales of the industrial segment was due primarily to higher demand in the market for video borescopes, compared to our line of fiber borescopes.

 

Gross Profit

 

Q2 06 Compared to Q2 05

 

Gross profit was $494,348 in Q2 06, an increase of $243,509, compared to gross profit in Q2 05.  Gross profit increased by approximately $127,000 in the medical segment, and by approximately $117,000 in the industrial segment.  Gross profit in the medical segment increased due to higher volume of sales of ENT SOS sold to international distributors.  This increase was partially offset by a write down of approximately $138,000 of inventory, primarily to reflect the excess of the cost over the market value of our Slide-On cystoscope EndoSheath.  We are working to redesign this EndoSheath to result in lower manufacturing costs.  Based upon current estimates, we believe there is sufficient inventory of the current EndoSheath at MGU and our Natick facility to last for approximately one year.

 

We are in the process of developing a new EndoSheath concept and automated equipment to manufacture our EndoSheaths at significantly lower manufacturing costs than our current costs.  We now expect this automation equipment to be in place at the last half of FY 07.

 

In the industrial segment, the increase in gross profit was due primarily to lower fixed costs for personnel.

 

6M 06 Compared to 6M 05

 

Gross profit was $1,104,488 in 6M 06, a decrease of $228,916, compared to gross profit in 6M 05. Gross profit decreased by approximately $304,000 in the medical segment and increased by approximately $75,000 in the industrial segment. The decrease in the medical segment was due primarily to the lower unit volume of ENT EndoSheaths sold to the domestic market in Q1 06. As stated above, we expect sales of ENT EndoSheaths to the domestic market to increase in the subsequent fiscal quarters of FY 06.

 

The increase in gross profit in the industrial segment was primarily due to the lower fixed costs for personnel in Q2 06.

 

Operating Expenses

 

Selling, General and Administrative Expenses

 

Q2 06 Compared to Q2 05

 

The increase in selling, general and administrative (“SG&A”) expenses was due primarily to an increase in the charges by our outside public accounting firm of $50,000, higher costs related to severance of approximately $61,000 and higher spending for recruiting fees for new personnel of $30,000.  In addition, we incurred a higher charge for the provision for doubtful accounts in the industrial segment of approximately $72,000.

 

6M 06 Compared to 6M 05

 

The increase in SG&A expenses was due primarily to the items listed above, offset partially by lower spending for product promotion in Q1 06.  Expenses for the promotion of our ENT and urology products are incurred primarily by our exclusive distributors, Medtronic Xomed and MGU.

 

25



 

Research and Development Expenses

 

Q2 06 Compared to Q2 05

 

The increase in research and development (“R&D”) expenses was due primarily to additional spending for materials and personnel hired to work on developing new products and manufacturing methods for the medical segment.  We expect R&D expenses will continue to be higher in FY 06, compared to FY 05, as we increase our efforts to develop new products for medical markets, both those that will utilize the technology inherent in our EndoSheaths, and other products for the medical market.

 

6M 06 Compared to 6M 05

 

The increase in R&D expenditures was due to the same reasons as noted above.

 

Stock-based Compensation Expenses

 

We incurred stock-based compensation costs during FY 06 and FY 05, due primarily to grants in April 2004 and July 2004 of non-qualified options to purchase 100,000 shares and 50,000 shares, respectively, of our Common Stock to an outside consultant.  These grants were in accordance with an agreement entered into with that consultant in January 2003.  The value of the non-qualified options were determined to be approximately $371,000, using the Black-Scholes option-pricing model, and are being recorded in our statements of operations over the vesting period of the options.  We recorded $46,387 and $92,775 of expense in Q2 06 and 6M 06, respectively, related to these non-qualified options.  In addition, during the three months ended June 30, 2003, the compensation committee of our board of directors authorized the issuance of non-qualified options to purchase 1,295,000 shares of common stock to certain of our employees.  These options were priced below the fair market price of our common stock on the date of grant.  Accordingly, we are recognizing compensation expense totaling approximately $65,000 from June 2003 through December 2007, the vesting period of these options.  In Q2 06 and 6M 06, we incurred $3,297 and $6,594, respectively, of expense related to these options in our statements of operations.

 

Operating Income (Loss)

 

Operating income (loss) by segment was as follows ($000’s):

 

Segment

 

Q2 06

 

Q2 05

 

Change

 

6M 06

 

6M 05

 

Change

 

Medical

 

$

(736

)

$

(616

)

$

(120

)

$

(1,348

)

$

(605

)

$

(743

)

Industrial

 

(14

)

(52

)

38

 

(27

)

(31

)

4

 

Corporate

 

(368

)

(268

)

(100

)

(624

)

(587

)

(37

)

Total

 

$

(1,118

)

$

(936

)

$

(182

)

$

(1,999

)

$

(1,223

)

$

(776

)

 

In the medical segment, the higher gross profit was more than offset by higher spending for SG&A and R&D, resulting in a higher loss in Q2 06, compared to Q2 05.  For 6M 06, compared to 6M 05, the lower gross profit in Q1 06 combined with higher spending for R&D resulted in a higher loss.

 

26



 

In the industrial segment, the higher gross profit was partially offset by the increased provision for bad debts, resulting in a lower loss in Q2 06, compared to Q2 05.  For 6M 06, compared to 6M 05, the higher gross profit was approximately equal to the higher charge for bad debts, resulting in a lower loss.

 

In the corporate segment, the higher spending for professional fees and severance costs resulted in higher losses in Q2 06, compared to Q2 05, and in the 6M 06, compared to 6M 05.

 

Liquidity and Capital Resources

 

At September 30, 2005, our principal source of liquidity was working capital of approximately $10 million, including $7.7 million in cash and cash equivalents.   We have pledged $125,000 to support acceptances payable to banks, as we incur them when we purchase inventory using letters of credit.

 

We also have an agreement with a bank, which includes a revolving line of credit under which we may borrow up to $1,000,000, net of up to $250,000 of any outstanding letters of credit and banker’s acceptances.  Borrowings under this loan arrangement must be fully cash collateralized.  The agreement also stipulates that when we achieve positive cash flow, as defined in the agreement, we will be eligible to negotiate changes to this loan arrangement that may include changing the borrowing base for revolving loans, and the release of the pledged cash collateral.

 

Our cash and cash equivalents decreased by approximately $2,144,000 in the six months ended September 30, 2005, due primarily to cash used for operations of approximately $2,109,000 and cash used for investing activities of approximately $199,000.  These uses were offset by the exercise of stock options by employees and non-employees totaling approximately $120,000, and the receipt of a subscription receivable from one of the investors in our sale of common shares in February 2005 of approximately $56,000, net.  We expect that our current balance of cash and cash equivalents will be sufficient to fund our operations for the next twelve months.

 

We have incurred losses since our inception, and losses are expected to continue at least during FY 06.  We have funded the losses principally with the proceeds from public and private equity financings.  The private equity financings have included sales of new common stock to two employees who are also directors, to a hedge fund, to other independent directors and to independent private individuals.

 

We expect total spending for property and equipment to be approximately $850,000 for FY 06.  This amount could be higher depending upon the terms we negotiate for the purchase of the equipment we are designing to manufacture our new low-cost EndoSheath.  We expect to obtain long-term financing for this purchase, but there can be no assurance such financing will be available to us, or available on terms acceptable to us.

 

We conduct our operations in certain leased facilities.  These leases expire on various dates through August 31, 2010.  In addition, we have operating leases for certain office equipment.  These leases expire on various dates through June 2007.  The following chart summarizes our contractual obligations as of September 30, 2005.

 

Contractual Obligation

 

Total

 

Due within 1 year

 

Due in 1-3 years

 

Operating leases

 

$

1,240,390

 

$

375,726

 

$

864,664

 

Capital lease

 

43,309

 

25,406

 

17,903

 

 

27



 

We have no off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

28



 

Item 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

In the normal course of business, we are subject to the risks associated with fluctuations in interest rates and changes in foreign currency exchange rates.

 

Interest and Market Risk

 

We currently invest our excess cash in a money market account at our bank.  We have not used derivative financial instruments in our investment portfolio.  We attempt to limit our exposure to interest rate and credit risk by placing our investments with high-quality financial institutions and have established investment guidelines relative to diversification and maturities designed to maintain safety and liquidity.

 

Investments in both fixed-rate and floating-rate interest earning instruments carry a degree of interest rate risk.  Fixed-rate securities may have their fair market value adversely impacted due to a rise in interest rates, while floating-rate securities may produce less income than expected if interest rates decline.  Due in part to these factors, our future investment income may fall short of expectations due to changes in interest rates, or we may suffer losses in principal if forced to sell securities which have seen a decline in market value due to changes in interest rates.

 

Foreign Currency Exchange

 

We face exposure, due to purchases of raw materials from Japanese suppliers, to adverse movements in the value of the Japanese Yen.  This exposure may change over time, and could have a materially adverse effect on our financial results.  We may attempt to limit this exposure by purchasing forward contracts, as required.  Most of our Japanese Yen liabilities are settled within 90 days of receipt of materials.  At September 30, 2005, our liabilities relating to Japanese Yen were approximately $9,000.

 

29



 

Item 4.  CONTROLS AND PROCEDURES

 

a)            Evaluation of Disclosure Controls and Procedures.

 

Based on an evaluation of our disclosure controls and procedures (as defined in Rules 13a-14(c) and 15d-14(c) under the Securities Exchange Act of 1934), the chief executive officer and chief financial officer have concluded that our disclosure controls and procedures as of the end of the three months ended September 30, 2005, are effective.

 

b)            Changes in Internal Controls Over Financial Reporting.

 

There were no changes in our internal controls over financial reporting that occurred during the fiscal quarter ended September 30, 2005 that have materially affected, or are reasonable likely to materially affect, our internal controls over financial reporting.

 

30



 

PART II - OTHER INFORMATION

 

Item 4.  Submission of Matters to a Vote of Stockholders

 

We held the 2005 Annual General Meeting of Shareholders (the “Annual Meeting”) on July 25, 2005.  At the Annual Meeting, the following actions were taken:

 

1.               The stockholders elected Katsumi Oneda and Ron Hadani as Class II directors to serve for a three-year term.  Holders of 22,127,476 shares of Common Stock voted for and holders of 125,473 shares of Common Stock withheld votes for Mr. Oneda.  Holders of 22,118,111 shares of Common Stock voted for and holders of 134,838 shares of Common Stock withheld votes for Mr. Hadani.  In addition to Messrs. Oneda and Hadani, Messers Lewis C. Pell, Kenneth W. Anstey and John J. Wallace continue to serve on the Board of Directors.  On August 12, 2005 Mr. William F. Doyle resigned as a member of the Board of Directors of the Company.

 

2.               The stockholders ratified an amendment to the Company’s 2000 Stock Incentive Plan (the “Plan”) to increase the number of share of Common Stock that may be issued pursuant to awards granted under the Plan from 4,000,000 to 4,500,000.  Holders of 22,044,635 shares of Common Stock voted for, holders of 206,254 shares of Common Stock voted against and holders of 2,060 shares of Common Stock abstained from voting to increase the number of shares that may be issued pursuant to awards granted under the Plan.

 

Item 6.  Exhibits

 

Exhibits

 

 

 

31.1

 

Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a), promulgated under the Securities Exchange Act of 1934, as amended.

 

 

 

31.2

 

Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a), promulgated under the Securities Exchange Act of 1934, as amended.

 

 

 

32

 

Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

31



 

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.

 

VISION-SCIENCES, INC.

 

 

Date: November 14, 2005

/s/ Ron Hadani

 

 

Ron Hadani

 

President, CEO (Duly Authorized Officer)

 

 

 

 

Date: November 14, 2005

/s/ James A. Tracy

 

 

James A. Tracy

 

Vice President Finance, Chief Financial Officer and
Controller (Principal Financial Officer and Principal
Accounting Officer)

 

32