UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
(Mark One) |
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x
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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 March 31, 2004 | ||
o |
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: 0-18338
I-FLOW CORPORATION
| Delaware | 33-0121984 | |
| (State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) |
| 20202 Windrow Drive, Lake Forest, CA | 92630 | |
| (Address of Principal Executive Offices) | (Zip Code) |
(949) 206-2700
(Registrants Telephone Number, Including Area Code)
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 o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes x No o
As of May 1, 2004 there were 21,429,168 shares of common stock outstanding.
I-FLOW CORPORATION
FORM 10-Q
FOR THE QUARTER ENDED MARCH 31, 2004
Table of Contents
| Page |
||||||||
| Part I: Financial Information | ||||||||
| Item 1. | Financial Statements (Unaudited) | |||||||
| Condensed Consolidated Balance Sheets | 1 | |||||||
| Condensed Consolidated Statements of Operations and Comprehensive Operations | 2 | |||||||
| Condensed Consolidated Statements of Cash Flows | 3 | |||||||
| Notes to Condensed Consolidated Financial Statements | 4 | |||||||
| Item 2. | Management's Discussion and Analysis of Financial Condition and Results of Operations | 9 | ||||||
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 15 | ||||||
| Item 4. | Controls and Procedures | 15 | ||||||
| Part II: Other Information | ||||||||
| Item 1. | Legal Proceedings | 16 | ||||||
| Item 5. | Other Information | 16 | ||||||
| Item 6. | Exhibits and Reports on Form 8-K | 22 | ||||||
| Signatures | 23 | |||||||
| EXHIBIT 31.1 | ||||||||
| EXHIBIT 31.2 | ||||||||
| EXHIHBIT 32.1 | ||||||||
I-FLOW CORPORATION
| March 31, | December 31, | |||||||
| 2004 |
2003 |
|||||||
ASSETS |
||||||||
CURRENT ASSETS: |
||||||||
Cash and cash equivalents |
$ | 12,761,000 | $ | 15,185,000 | ||||
Accounts receivable, less allowance for doubtful accounts of
$1,897,000
and $1,698,000 at March 31, 2004 and December 31, 2003, respectively |
11,953,000 | 12,392,000 | ||||||
Inventories, net |
6,361,000 | 6,815,000 | ||||||
Prepaid expenses and other current assets |
627,000 | 652,000 | ||||||
Deferred taxes |
4,926,000 | 3,546,000 | ||||||
Total current assets |
36,628,000 | 38,590,000 | ||||||
Property, net |
7,691,000 | 6,744,000 | ||||||
Goodwill |
2,639,000 | 2,639,000 | ||||||
Other intangible assets, net |
1,239,000 | 1,214,000 | ||||||
Other long-term assets |
147,000 | 147,000 | ||||||
Deferred taxes |
2,562,000 | 2,562,000 | ||||||
TOTAL |
$ | 50,906,000 | $ | 51,896,000 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
CURRENT LIABILITIES: |
||||||||
Accounts payable |
$ | 2,456,000 | $ | 3,134,000 | ||||
Accrued payroll and related expenses |
3,008,000 | 2,961,000 | ||||||
Income taxes payable |
257,000 | 236,000 | ||||||
Other liabilities |
741,000 | 792,000 | ||||||
Total current liabilities |
6,462,000 | 7,123,000 | ||||||
COMMITMENTS AND CONTINGENCIES |
||||||||
STOCKHOLDERS EQUITY: |
||||||||
Preferred stock $0.001 par value; 5,000,000 shares
authorized; no shares issued and outstanding |
| | ||||||
Common stock $0.001 par value; 40,000,000 shares
authorized; 18,417,894 and 18,305,787 shares
issued and outstanding at March 31, 2004
and December 31, 2003, respectively |
61,243,000 | 60,049,000 | ||||||
Accumulated other comprehensive loss |
(215,000 | ) | (192,000 | ) | ||||
Accumulated deficit |
(16,584,000 | ) | (15,084,000 | ) | ||||
Net stockholders equity |
44,444,000 | 44,773,000 | ||||||
TOTAL |
$ | 50,906,000 | $ | 51,896,000 | ||||
See accompanying notes to condensed consolidated financial statements.
1
I-FLOW CORPORATION
| Three Months Ended | ||||||||
| March 31, |
||||||||
| 2004 |
2003 |
|||||||
Revenues: |
||||||||
Net product sales |
$ | 9,906,000 | $ | 7,105,000 | ||||
Net rental income and other |
4,263,000 | 3,030,000 | ||||||
Total revenues |
14,169,000 | 10,135,000 | ||||||
Cost of revenues: |
||||||||
Product cost of revenues |
3,522,000 | 2,579,000 | ||||||
Rental cost of revenues |
1,160,000 | 876,000 | ||||||
Total cost of revenues |
4,682,000 | 3,455,000 | ||||||
Gross Profit |
9,487,000 | 6,680,000 | ||||||
Operating expenses: |
||||||||
Selling and marketing |
7,683,000 | 3,803,000 | ||||||
General and administrative |
3,617,000 | 2,459,000 | ||||||
Product development |
579,000 | 502,000 | ||||||
Total operating expenses |
11,879,000 | 6,764,000 | ||||||
Operating loss |
(2,392,000 | ) | (84,000 | ) | ||||
Interest income, net |
36,000 | 8,000 | ||||||
Loss from continuing operations before
income taxes |
(2,356,000 | ) | (76,000 | ) | ||||
Income tax benefit |
(856,000 | ) | (32,000 | ) | ||||
Loss from continuing operations |
(1,500,000 | ) | (44,000 | ) | ||||
Income from discontinued operations,
net of tax |
| 61,000 | ||||||
Net income (loss) |
$ | (1,500,000 | ) | $ | 17,000 | |||
Loss per share from continuing operations: |
||||||||
Basic and diluted |
$ | (0.08 | ) | $ | | |||
Net income (loss) per share: |
||||||||
Basic and diluted |
$ | (0.08 | ) | $ | | |||
Comprehensive Operations: |
||||||||
Net income (loss) |
$ | (1,500,000 | ) | $ | 17,000 | |||
Foreign currency translation loss |
(23,000 | ) | (72,000 | ) | ||||
Comprehensive loss |
$ | (1,523,000 | ) | $ | (55,000 | ) | ||
See accompanying notes to condensed consolidated financial statements.
2
I-FLOW CORPORATION
| Three Months Ended | ||||||||
| March 31, |
||||||||
| 2004 |
2003 |
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||||
Net income (loss) |
$ | (1,500,000 | ) | $ | 17,000 | |||
Income from discontinued operations |
| (61,000 | ) | |||||
Adjustments to reconcile net income (loss)
to net cash provided by (used in) operating activities: |
||||||||
Deferred taxes |
(877,000 | ) | | |||||
Depreciation and amortization |
737,000 | 422,000 | ||||||
Stock based compensation |
269,000 | 153,000 | ||||||
Provision for doubtful accounts receivable |
621,000 | (29,000 | ) | |||||
Provision for inventory obsolescence |
373,000 | 68,000 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
(183,000 | ) | (502,000 | ) | ||||
Inventories |
82,000 | (429,000 | ) | |||||
Prepaid expenses and other current assets |
10,000 | (374,000 | ) | |||||
Accounts payable, accrued payroll and related expenses |
(630,000 | ) | 985,000 | |||||
Income taxes payable |
21,000 | 17,000 | ||||||
Other liabilities |
(50,000 | ) | (2,000 | ) | ||||
Net cash provided by (used in) operating activities from
continuing operations |
(1,127,000 | ) | 265,000 | |||||
Net cash used in operating activities from discontinued operations |
| (56,000 | ) | |||||
Net cash provided by (used in) operating activities |
(1,127,000 | ) | 210,000 | |||||
CASH FLOWS FROM INVESTING ACTIVITIES: |
||||||||
Property acquisitions |
(1,620,000 | ) | (913,000 | ) | ||||
Patent acquisitions |
(100,000 | ) | (46,000 | ) | ||||
Net cash used in investing activities from continuing operations |
(1,720,000 | ) | (959,000 | ) | ||||
Net cash used in investing activities from discontinued operations |
| (26,000 | ) | |||||
Net cash used in investing activities |
(1,720,000 | ) | (985,000 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||||
Revolving line of credit borrowings |
| 300,000 | ||||||
Principal payments on notes payable |
(1,000 | ) | (36,000 | ) | ||||
Proceeds from exercise of stock options and warrants |
421,000 | 169,000 | ||||||
Net cash provided by financing activities |
420,000 | 433,000 | ||||||
Effect of exchange rates on cash |
3,000 | (78,000 | ) | |||||
NET DECREASE IN CASH AND CASH EQUIVALENTS |
(2,424,000 | ) | (420,000 | ) | ||||
CASH AND CASH EQUIVALENTS AT BEGINNING OF
PERIOD |
15,185,000 | 1,700,000 | ||||||
CASH AND CASH EQUIVALENTS AT END OF PERIOD |
$ | 12,761,000 | $ | 1,280,000 | ||||
SUPPLEMENTAL CASH FLOW INFORMATION: |
||||||||
Interest paid |
$ | | $ | 2,000 | ||||
Income taxes paid |
$ | | $ | | ||||
See accompanying notes to condensed consolidated financial statements.
3
I-FLOW CORPORATION
1. Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation The accompanying unaudited condensed consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) that, in the opinion of management, are necessary to present fairly the financial position of I-Flow Corporation and its subsidiaries (the Company) at March 31, 2004, the results of its operations and cash flows for the three-month periods ended March 31, 2004 and 2003. Certain information and footnote disclosures normally included in financial statements have been condensed or omitted pursuant to rules and regulations of the Securities and Exchange Commission although the Company believes that the disclosures in the financial statements are adequate to make the information presented not misleading.
The financial statements included herein should be read in conjunction with the financial statements of the Companys Annual Report on Form 10-K for the year ended December 31, 2003 filed with the Securities and Exchange Commission on March 15, 2004.
The Company sold Spinal Specialties, Inc., a wholly owned subsidiary (Spinal Specialties), on November 1, 2003 to Integra LifeSciences Holdings Corporation for approximately $6,000,000 in cash and net proceeds of approximately $5,000,000.
The Company has restated its financial statements for the three-month period ended March 31, 2003 to present the operations of Spinal Specialties as discontinued operations. Reported in income from discontinued operations, net of tax, for the three months ended March 31, 2003 are net product sales from Spinal Specialties of $1,029,000, income before taxes of $105,000, and income tax expense of $44,000.
Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles necessarily requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates.
New Accounting Pronouncements In January 2003, the FASB issued FIN 46, Consolidation of Variable Interest Entities. In general, a variable interest entity is a corporation, partnership, trust or any other legal structure used for business purposes that either (a) does not have equity investors with voting rights or (b) has equity investors that do not provide sufficient financial resources for the entity to support its activities. FIN 46 requires a variable interest entity to be consolidated by a company if that company is subject to a majority of the risk of loss from the variable interest entitys activities or entitled to receive a majority of the entitys residual returns or both. The consolidation requirements of FIN 46 apply immediately to variable interest entities created after January 31, 2003. With respect to variable interest entities created before January 31, 2003, in December 2003 the FASB issued FIN 46R which, among other things, revised the implementation date to first fiscal years or interim periods ending after March 15, 2004, with the exception of Special Purpose Entities (SPE). The consolidated requirements apply to all SPEs in the first fiscal year or interim period ending after December 15, 2003. As the Company has determined that it does not have any SPEs to which these interpretations apply, the Company adopted FIN46R in the first quarter of 2004 and such adoption did not have a material impact on its financial statements.
4
In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (SFAS 150). SFAS 150 establishes standards for how an issuer classifies and measures certain financial instruments with characteristics of both debt and equity and requires an issuer to classify the following instruments as liabilities in its balance sheet:
| | a financial instrument issued in the form of shares that is mandatorily redeemable and embodies an unconditional obligation that requires the issuer to redeem it by transferring its assets at a specified or determinable date or upon an event that is certain to occur; |
| | a financial instrument, other than an outstanding share, that embodies an obligation to repurchase the issuers equity shares, or is indexed to such an obligation, and requires the issuer to settle the obligation by transferring assets; and |
| | a financial instrument that embodies an unconditional obligation that the issuer must settle by issuing a variable number of its equity shares if the monetary value of the obligation is based solely or predominantly on (1) a fixed monetary amount, (2) variations in something other than the fair value of the issuers equity shares, or (3) variations inversely related to changes in the fair value of the issuers equity shares. |
In November 2003, the FASB issued FASB Staff Position (FSP) No. 150-3 which deferred the effective dates for applying certain provisions of SFAS 150 related to mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests for public and nonpublic entities.
For public entities, SFAS 150 is effective for mandatorily redeemable financial instruments entered into or modified after May 31, 2003 and is effective for all other financial instruments as of the first interim period beginning after June 15, 2003.
For mandatorily redeemable noncontrolling interests that would not have to be classified as liabilities by a subsidiary under the exception in paragraph 9 of SFAS 150, but would be classified as liabilities by the parent, the classification and measurement provisions of SFAS 150 are deferred indefinitely. For other mandatorily redeemable noncontrolling interests that were issued before November 5, 2003, the measurement provisions of SFAS 150 are deferred indefinitely. For those instruments, the measurement guidance for redeemable shares and noncontrolling interests in other literature shall apply during the deferral period.
The adoption of the other provisions of SFAS 150 did not have a material impact on the Companys consolidated financial statements.
Accounting for Stock-Based Compensation The Company accounts for employee stock options using the intrinsic value method in accordance with Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and FASB Interpretation No. 28, Accounting for Stock Appreciation Rights and Other Variable Stock Option or Award Plans, and has adopted the disclosure-only alternative of SFAS 123, Accounting for Stock-Based Compensation. Stock options issued to consultants and vendors are accounted for at fair value.
5
Because the Company has adopted the disclosure-only provisions of SFAS 123, no compensation cost has been recognized for stock option grants to employees and non-employee directors with exercise prices equal to the fair market value of the underlying shares at the grant date. Had compensation cost for the Companys option plans been determined based on the fair value of the options at the grant date consistent with the provisions of SFAS 123, the Companys net income (loss) and net income (loss) per share would have been the pro forma amounts indicated below:
| Three Months Ended March 31, |
||||||||
| (Amounts in thousands, except per share amounts) |
2004 |
2003 |
||||||
Net income (loss) as reported |
$ | (1,500 | ) | $ | 17 | |||
Stock-based employee compensation included in net
income (loss), net of tax |
$ | 133 | $ | 56 | ||||
Total stock-based employee compensation expense
determined under fair value based method for all
awards, net of tax |
$ | (876 | ) | $ | (182 | ) | ||
Net loss pro forma |
$ | (2,243 | ) | $ | (109 | ) | ||
Basic earnings (loss) per share as reported |
$ | (0.08 | ) | $ | | |||
Basic earnings (loss) per share pro forma |
$ | (0.12 | ) | $ | (0.01 | ) | ||
Diluted earnings (loss) per share as reported |
$ | (0.08 | ) | $ | | |||
Diluted earnings (loss) per share pro forma |
$ | (0.12 | ) | $ | (0.01 | ) | ||
The amounts in the above table related to stock-based employee compensation included in net income (loss), net of tax relate to employee stock options only and exclude compensation expense related to consultant stock options and restricted stock.
The fair value of each option grant is estimated on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions used for grants during the three months ended March 31, 2004 and 2003: no dividend yield; expected volatility 94% in 2003 and 90% in 2004; risk-free interest rate of 3.04% in 2003 and 3.64% in 2004; and expected lives of 5 years.
Reclassifications Certain prior year amounts have been reclassified to conform to the presentation at March 31, 2004.
2. Inventories
Inventories consisted of the following:
| March 31, | December 31, | |||||||
| 2004 |
2003 |
|||||||
Raw Materials |
$ | 5,046,000 | $ | 5,368,000 | ||||
Work in Process |
1,345,000 | 765,000 | ||||||
Finished Goods |
2,493,000 | 2,838,000 | ||||||
Reserve for Obsolescence |
(2,523,000 | ) | (2,156,000 | ) | ||||
Total |
$ | 6,361,000 | $ | 6,815,000 | ||||
3. Earnings (Loss) Per Share
Basic net income (loss) per share is computed using the weighted average number of common shares outstanding during the periods presented, excluding unvested restricted stock which the Company has a right to repurchase in the event of early termination of employment of 65,000 shares and 84,500 shares as of March 31, 2004 and 2003, respectively.
6
Diluted net income (loss) per share is computed using the weighted average number of common and potential common shares outstanding during the periods utilizing the treasury stock method for stock options, warrants and unvested restricted stock, if dilutive.
The following is a reconciliation between the number of shares used in the basic and diluted net income (loss) per share calculations:
| Three Months Ended March 31, |
||||||||
| (Amounts in thousands) |
2004 |
2003 |
||||||
Net income (loss) |
$ | (1,500 | ) | $ | 17 | |||
Basic net income (loss) per share |
||||||||
Weighted average number of common shares outstanding |
18,282 | 15,434 | ||||||
Effect of dilutive securities: |
||||||||
Stock options and unvested restricted stock |
| | ||||||
Diluted net income (loss) per share |
||||||||
Weighted average number of common and common
equivalent shares outstanding |
18,282 | 15,434 | ||||||
Options to purchase 1,000 and 1,860,533 shares of common stock have been excluded from the treasury stock method of calculation for diluted weighted average common shares for the three-month periods ended March 31, 2004 and 2003, respectively, as their exercise prices exceeded the average market price of the Companys common stock for these periods and their effect would be anti-dilutive.
4. Other Intangible Assets
Amortizable intangible assets included in the accompanying condensed consolidated balance sheets are as follows:
| As of March 31, 2004 |
||||||||||||
| Carrying | Accumulated | |||||||||||
| Amount |
Amortization |
Net |
||||||||||
Patents |
$ | 2,027,000 | $ | 788,000 | $ | 1,239,000 | ||||||
| As of December 31, 2003 |
||||||||||||
| Carrying | Accumulated | |||||||||||
| Amount |
Amortization |
Net |
||||||||||
Patents |
$ | 1,960,000 | $ | 746,000 | $ | 1,214,000 | ||||||
The Company amortizes patents over a period of seven years. Amortization expense for the three months ended March 31, 2004 was $74,000 compared to $72,000 for the same period in the prior year. Amortization expense of intangible assets recorded as of March 31, 2004 is expected to be approximately $245,000 in each of the next five fiscal years.
5. Stockholders Equity
During September 2003, the Company sold 1,666,740 shares of common stock at $7.50 per share with net proceeds to the Company of $11,563,000. In connection with the sale of the common stock, the Company granted the investors warrants to purchase 250,011 shares of common stock with an exercise price of $10.00 per share. The estimated fair value of these warrants on the grant date was $1,272,000 as calculated by the Black-Scholes pricing model. These warrants are fully exercisable and expire five years from the date of grant. As of March 31, 2004, warrants to purchase 225,111 shares of common stock were outstanding. The following weighted average assumptions were used to calculate the fair value of these warrants using the Black-Scholes pricing model: contractual life of five years; stock volatility of 87%; risk-free interest rate of 2.730%; and no dividends during the term.
7
6. Operating Segments and Revenue Data
The Company operates in two reportable operating segments: the manufacturing and marketing of medical infusion pumps (the Manufacturing and Marketing operating segment) and the rental and third party billing of electronic medical infusion pumps that are manufactured by companies other than I-Flow Corporation (the Rentals operating segment.) The Manufacturing and Marketing operating segment consists of two major market segments, the IV Infusion Therapy market segment and Regional Anesthesia market segment. The Rentals operating segment consists of the activities of InfuSystem, Inc., which provides infusion pumps for chemotherapy to the Oncology Infusion Services market segment.
Operating segment information is as follows for the three-month periods ended March 31, 2004 and 2003.
| Manufacturing and | ||||||||||||
| (Amounts in thousands) |
Marketing |
Rentals |
Consolidated |
|||||||||
Three months ended March 31, 2004 |
||||||||||||
Revenues |
$ | 9,906 | $ | 4,263 | $ | 14,169 | ||||||
Operating income (loss) |
(3,292 | ) | 900 | (2,392 | ) | |||||||
Assets |
38,827 | 12,079 | 50,906 | |||||||||
Depreciation and amortization |
369 | 368 | 737 | |||||||||
Property additions |
524 | 1,096 | 1,620 | |||||||||
Three months ended March 31, 2003 |
||||||||||||
Revenues |
$ | 7,105 | $ | 3,030 | $ | 10,135 | ||||||
Operating income (loss) |
(747 | ) | 663 | (84 | ) | |||||||
Assets |
23,374 | 11,448 | 34,822 | |||||||||
Depreciation and amortization |
331 | 91 | 422 | |||||||||
Property additions |
373 | 540 | 913 | |||||||||
The Company had a major customer which accounted for 9% and 13% of the total revenues for the three month periods ended March 31, 2004 and 2003, respectively.
7. Guarantees and Indemnifications
From time to time, the Company enters into certain types of contracts that contingently require the Company to indemnify parties against third party claims. These contracts primarily relate to: (i) divestiture and acquisition agreements, under which the Company may provide customary indemnifications to either (a) purchasers of the Companys businesses or assets or (b) entities from which the Company is acquiring assets or businesses; (ii) certain real estate leases, under which the Company may be required to indemnify property owners for environmental and other liabilities and other claims arising from the Companys use of the leased premises; (iii) certain agreements with the Companys officers, directors and employees, under which the Company may be required to indemnify such persons for liabilities arising out of their relationship with the Company; and (iv) license, consulting, distribution and purchase agreements with the Companys customers and other parties, under which the Company may be required to indemnify such parties for intellectual property infringement claims, product liability claims and other claims arising from the Companys provision of products or services to such parties.
The terms of such obligations vary. Generally, a maximum obligation arising out of these types of agreements is not explicitly stated and, therefore, the overall maximum amount of these obligations cannot be reasonably estimated. Historically, the Company has not been obligated to make significant payments for these obligations. The Company had not issued any significant indemnities, commitments or guarantees during the three-month periods ended March 31, 2004 and 2003 requiring recognition, thus, no liabilities have been recorded.
8. Subsequent Event
On April 19, 2004, the Company completed a public offering of 2,990,000 shares of common stock, of which 390,000 shares were issued pursuant to the exercise of the underwriters over-allotment option. The shares were sold at a price to the public of $15.50 per share resulting in net proceeds to the Company of approximately $43,000,000.
8
Item 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking Statements
Statements by the Company in this report and in other reports and statements released by the Company are and will be forward-looking in nature and express the Companys current opinions about trends and factors that may impact future operating results. Statements that use words such as believes, anticipates, or expects or use similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ materially from those expected, and readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to republish revised forward-looking statements to reflect the occurrence of unanticipated or subsequent events. Readers are also urged to carefully review and consider the various disclosures made by the Company in this report that seek to advise interested parties of the risks and other factors that affect the Companys business. Interested parties should also review the Companys reports on Forms 10-K, 10-Q and 8-K and other reports that are periodically filed with the Securities and Exchange Commission. The risks affecting the Companys business include, among others: implementation of our direct sales strategy; dependence on our suppliers and distributors; reliance on the success of the home health care industry; our continuing compliance with applicable laws and regulations, such as the Food, Drug and Cosmetic Act, and the FDAs concurrence with our managements subjective judgment on compliance issues; the reimbursement system currently in place and future changes to that system; competition in the industry; economic and political conditions in foreign countries; currency exchange rates; inadequacy of booked reserves; technological changes; and product availability and acceptance. All forward-looking statements, whether made in this release or elsewhere, should be considered in context with the various disclosures made by the Company about its business.
Critical Accounting Policies
I-Flow prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States. Accordingly, the Company is required to make estimates, judgments and assumptions that the Company believes are reasonable based on the information available. These estimates and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. The critical accounting policies which the Company believes are the most important to aid in fully understanding and evaluating its reported financial results are:
Revenue Recognition
The Company recognizes revenue from product sales at the time of shipment and passage of title. The Company offers the right of return for defective products and continuously monitors and tracks product returns. The Company records a provision for the estimated amount of future returns based on historical experience and any notification received of pending returns. Although such returns have historically been insignificant, the Company cannot guarantee that it will continue to experience the same return rates as it has in the past. Any significant increase in product returns could have a material adverse impact on the Companys operating results for the period or periods in which the returns materialize.
The Company recognizes rental revenues from medical pumps over the term of the related agreement, generally on a month-to-month basis. Pump rentals are billed at the Companys established rates, which often differ from contractually allowable rates provided by third party payors such as Medicare, Medicaid and commercial insurance carriers. The Company records net rental revenues at the estimated realizable amounts from patients and third party payors. The Company experiences significant extended payment terms with certain of these third party payors, but it continuously monitors reimbursement rates of the third party payors and the timing of such payments. Any change in reimbursement or collection rates could have a material negative impact on the Companys operating results for the period or periods in which the change is identified.
Accounts Receivable
The Company performs various analyses to evaluate accounts receivable balances. It records an allowance for bad debts based on the estimated collectibility of the accounts such that the recorded amounts reflect estimated net
9
realizable value. The Company applies specified percentages to the accounts receivable agings to estimate the amount that will ultimately be uncollectible and therefore should be reserved. The percentages are increased as the accounts age. If the actual uncollected amounts are less than the previously estimated allowance, a favorable adjustment would result. If the actual uncollected amounts significantly exceed the estimated allowance, the Companys operating results would be significantly and adversely affected.
Inventories
The Company values inventory at the lower of the actual cost to purchase or manufacture the inventory and the current estimated market value of the inventory. The Company regularly reviews inventory quantities on hand and records a provision for excess and obsolete inventory on specifically identified items based primarily upon the estimated forecast of product demand and production requirements for the next two years. A significant increase in the demand for the Companys products could result in a short-term increase in the cost of inventory purchases while a significant decrease in demand could result in an increase in the amount of excess inventory quantities on hand. Additionally, the Companys estimates of future product demand may prove to be inaccurate and thus the Company may have understated or overstated the provision required for excess and obsolete inventory. In the future, if inventory is determined to be overvalued, the Company would be required to recognize such costs in cost of goods sold at the time of such determination. Likewise, if inventory is determined to be undervalued, the Company may have over-reported cost of goods sold in previous periods and would be required to recognize additional operating income at the time of sale. Therefore, although the Company seeks to ensure the accuracy of its forecasts of future product demand, any significant unanticipated changes in demand or technological developments could have a significant impact on the value of its inventory and reported operating results.
Deferred Taxes
The Company recognizes deferred tax assets and liabilities based on the differences between the financial statement carrying amounts and the tax bases of assets and liabilities. The Company regularly reviews its deferred tax assets for recoverability and establishes a valuation allowance based on historical taxable income, projected future taxable income and the expected timing of the reversals of existing temporary differences. If the Company operates at a profit in the future and generates sufficient future taxable income, it could be required to reverse the current valuation allowance against the deferred tax assets which would result in a substantial decrease in the Companys effective tax rate. Likewise, if the Company is unable to operate at a profit and unable to generate sufficient future taxable income, it could be required to establish an additional valuation allowance against all or a significant portion of its deferred tax assets, resulting in a substantial increase in the Companys effective tax rate and a material adverse impact on operating results.
Intangible Assets
Statement of Financial Accounting Standards No. 142, Goodwill and Other Intangible Assets (SFAS 142), required the Company to cease amortizing goodwill and indefinite life intangibles effective January 1, 2002. The Companys business combinations have at various times resulted in the acquisition of goodwill and other intangible assets, which may affect the amount of future period amortization expense and impairment expense that the Company may incur. The determination of the value of such intangible assets requires management to make estimates and assumptions that affect its consolidated financial statements. The Company reviews the recoverability of the carrying value of goodwill on an annual basis or more frequently if an event occurs or circumstances change to indicate that an impairment of goodwill has possibly occurred. The Company compares fair value of its reporting units to their carrying value, as well as other factors, to determine whether or not any potential impairment of goodwill exists. If a potential impairment exists, an impairment loss is recognized to the extent the carrying value of goodwill exceeds the difference between the fair value of the reporting unit and the fair value of its other assets and liabilities. The Company cannot guarantee that there will be no impairment in the future. See Note 4 to Condensed Consolidated Financial Statements.
Divestiture of Spinal Specialties
The Company sold Spinal Specialties, Inc., a wholly owned subsidiary (Spinal Specialties), on November 1, 2003 to Integra LifeSciences Holdings Corporation for approximately $6,000,000 in cash and net proceeds of approximately $5,000,000.
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The net income of Spinal Specialties prior to divestiture is presented in the Companys operations as income from discontinued operations, net of tax. Reported in income from discontinued operations, net of tax, for the three months ended March 31, 2003 are net product sales from Spinal Specialties of $1,029,000, income before taxes of $105,000 and income tax expense of $44,000.
Overview
We design, develop and market technically advanced, low-cost drug delivery systems and services that provide life-enhancing, cost-effective solutions for pain relief and intravenous infusion therapy. We focus on three distinct markets: Regional Anesthesia, IV Infusion Therapy and Oncology Infusion Services. Our products are used in hospitals, ambulatory surgery centers, physicians offices and patients homes.
Our strategic focus for future growth is on the Regional Anesthesia market and, more specifically, on our pain relief products marketed under our ON-Q brand. We intend to continue to expand our sales and marketing efforts to further penetrate the United States post-surgical pain relief market for our ON-Q products.
Results of Operations
Revenue
Net revenues during the three-month period ended March 31, 2004 were $14,169,000 compared to $10,135,000 for the same period in the prior year, representing an increase of 40%. Net product revenues increased 39% to $9,906,000 during the three months ended March 31, 2004 compared to the same period in the prior year. Rental income, comprised of the revenues of the Companys InfuSystem subsidiary, increased by 41% to $4,263,000 for the three months ended March 31, 2004 from $3,030,000 for the same period in the prior year.
The Companys product revenues from the Manufacturing and Marketing operating segment during the three months ended March 31, 2004 and 2003 were generated in two primary market segments: Regional Anesthesia and IV Infusion Therapy. Regional Anesthesia product revenues increased by 90% to $5,721,000 during the three months ended March 31, 2004 compared to $3,015,000 for the same period in the prior year. This increase resulted from increased market penetration by the Companys ON-Q® PainBuster® Post-Operative Pain Relief System. Regional anesthesia products include the ON-Q® PainBuster® Post-Operative Pain Relief System, the ON-Q® C-bloc® Continuous Nerve Block System and the SoakerTM Catheter.
IV Infusion Therapy product sales, which included the Companys intraveneous elastomeric pumps, mechanical infusion devices and electronic infusion pumps and disposables, increased 2% to $4,185,000 for the three months ended March 31, 2004 from $4,090,000 for the same period in the prior year.
Revenues from the Rental operating segment provided by the Companys InfuSystem subsidiary within the Oncology Infusion Services market increased 41% to $4,263,000 for the three months ended March 31, 2004 from $3,030,000 for the same period in the prior year. This increase resulted primarily from the increased clinical usage of new chemotherapy drugs and protocols requiring the use of continuous intravenous pump services.
Cost of Revenue
The Company incurred cost of sales of $4,682,000 during the three-month period ended March 31, 2004 compared to $3,455,000 for the comparable period in the prior year. This represents an increase of 36%. This increase is primarily due to higher sales volume. As a percentage of net product sales, product cost of revenues decreased by approximately one percentage point compared to the same period in the prior year. This decrease was due to increased sales of higher-margin products, including the Companys ON-Q® PainBuster® Post-Operative Pain Relief System, during the three-month period ended March 31, 2004. As a percentage of rental revenues, rental cost of revenue decreased by approximately two percentage points compared to the same period in the prior year due to reduced direct operating costs.
Selling and Marketing Expenses
Selling and marketing expenses for the three-month period ended March 31, 2004 increased over the same period in the prior year by $3,880,000, or 102%. As a percentage of net revenues, selling and marketing expenses increased
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by 17 percentage points for the three-month period ended March 31, 2004 over the comparable period in the prior year. This increase was primarily attributable to increases in salaries and commissions ($2,184,000), increases in travel and entertainment expenses ($483,000), increases in training costs ($292,000) and other costs related to the expansion of the Companys direct sales force. The increase also consisted of increased marketing expenses ($186,000) related to the Companys ON-Q® PainBuster® Post-Operative Pain Relief System.
General and Administrative Expenses
General and administrative expenses for the three-month period ended March 31, 2004 increased by $1,158,000, or 47%, compared to the comparable period in the prior year. This increase included increased bad debt provision primarily for the Companys Infusystem subsidiary ($506,000), increased compensation expenses ($163,000), general insurance expenses ($55,000), consulting fees ($24,000) and investor relations expenses ($19,000), as well as overall increases due to growth of the Company. As a percentage of net revenues, general and administrative expenses increased by approximately one percentage point for the three-month period ended March 31, 2004 compared to the same period in the prior year.
Product Development Expenses
Product development expenses for the three-month period ended March 31, 2004 increased by $77,000, or 15%, compared to the same period in the prior year, primarily due to increased salaries and wages and consulting fees. The Company will continue to incur product development expenses as it continues its efforts to introduce new and improved technology and cost-efficient products into the market. Product development expenses as a percentage of net revenues for the three-month period ended March 31, 2004 decreased by approximately one percentage point compared to the same period in the prior year, primarily due to higher sales levels.
Income Taxes
During the three-month period ended March 31, 2004, the Company recorded an income tax benefit of $856,000 compared to an income tax benefit of $32,000 for the same period in the prior year. The Companys effective tax rate for the three-month period ended March 31, 2004 was 36.3% compared to 42.1% for the same period in the prior year, due to changes in deductible amortization of intangible assets and changes in consolidated state tax rates.
Liquidity and Capital Resources
During the three-month period ended March 31, 2004, cash of $1,127,000 was used in operating activities consisting of a net loss of $1,500,000 partially offset by net non-cash expenses of $1,123,000, less net changes in operating assets and liabilities of $750,000, primarily related to a decrease in accounts payable and accrued liabilities due to timing of payments to vendors.
During the three-month period ended March 31, 2004, cash of $1,720,000 was used in investing activities, compared to $985,000 for the same period in the prior year. The expenditures in the three-month period ended March 31, 2004 consisted of $1,620,000 used to acquire capital equipment, including electronic infusion pumps for the Companys rental business segment, computer equipment, purchased software, leasehold improvements, furniture, fixtures, tooling and equipment for use in the Companys operations and a net outflow related to the acquisition of other assets, primarily patents, of $100,000.
During the three-month period ended March 31, 2004, net cash of $420,000 was provided by financing activities consisting primarily of $421,000 in proceeds from the exercise of stock options and warrants to purchase common stock.
As of March 31, 2004, the Company had cash and cash equivalents of $12,761,000, net accounts receivable of $11,953,000 and net working capital of $30,167,000. Management believes the Companys funds, together with possible borrowings on its existing lines of credit and other bank loans, are sufficient to provide for its short and long-term needs for operations as currently projected. The Company may decide to sell additional equity securities or increase its borrowings in order to fund or increase its expenditures for selling and marketing, to fund increased product development, or for other purposes. On April 19, 2004, the Company completed a public offering of 2,990,000 shares of common stock which resulted in net proceeds to the Company of approximately $43,000,000. See Note 8 to the Condensed Consolidated Financial Statements.
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The Company has a working capital line of credit with Silicon Valley Bank which expires on April 30, 2005. Under the line of credit, the Company may borrow up to the lesser of $4,000,000 or the sum of 80% of eligible accounts receivable plus 25% of eligible inventory, as defined, at the banks prime rate (4.0% at March 31, 2004). As of March 31, 2004, there were funds available for borrowing of $3,700,000 and no outstanding borrowings.
The Companys InfuSystem subsidiary has a revolving line of credit with a bank under which it may borrow up to the lesser of $3,500,000 or 80% of eligible accounts receivable, as defined, at the banks prime rate less 0.25% (3.75% at March 31, 2004). There were no outstanding borrowings under the line of credit as of March 31, 2004 and there were funds available for borrowing of $3,500,000. The credit line expires on June 30, 2004. In addition, InfuSystem has a loan facility under which it ma