SECURITIES AND EXCHANGE COMMISSION
_____________
FORM 10-Q
| [X] | Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. |
For the quarterly period ended June 30, 2003.
| [ ] | Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. |
For the transition period from ______ to ______
Commission file number 0-28440
ENDOLOGIX, INC.
| Delaware (State or other jurisdiction of incorporation or organization) |
68-0328265 (I.R.S.Employer Identification Number) |
13900 Alton Parkway, Suite 122, Irvine, California 92618
(Address of principal executive offices)
Registrants telephone number, including area code (949) 595-7200
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes [X] No [ ]
Indicate by a check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act).
Yes [ ] No [X]
On August 5, 2003, the Registrant had outstanding approximately 27,946,000 shares of Common Stock of $.001 par value, which is the Registrants only class of Common Stock.
ENDOLOGIX, INC.
Form 10-Q
June 30, 2003
TABLE OF CONTENTS
| Page | ||||
| Part I. | Financial Information | |||
| Item 1. | Condensed Consolidated Financial Statements (Unaudited) | |||
| Condensed consolidated balance sheets at December 31, 2002 and June 30, 2003 | 3 | |||
| Condensed consolidated statements of operations for the three and six months ended June 30, 2002 and 2003 | 4 | |||
| Condensed consolidated statements of cash flows for the six months ended June 30, 2002 and 2003 | 5 | |||
| Notes to condensed consolidated financial statements | 6 | |||
| Item 2. | Managements discussion and analysis of financial condition and results of operations | 19 | ||
| Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 28 | ||
| Item 4. | Controls and Procedures | 28 | ||
| Part II. | Other Information | |||
| Items 1 through 6. | 29 | |||
| Signatures | 31 | |||
| Exhibit Index | 32 | |||
ENDOLOGIX, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share amounts)
(Unaudited)
| December 31, | June 30, | |||||||||
| 2002 | 2003 | |||||||||
ASSETS |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ | 2,606 | $ | 2,416 | ||||||
Marketable securities available-for-sale |
5,053 | 4,405 | ||||||||
Accounts receivable, net |
622 | 193 | ||||||||
Other receivables |
1,004 | 726 | ||||||||
Inventories |
2,043 | 2,172 | ||||||||
Other current assets |
431 | 335 | ||||||||
Total current assets |
11,759 | 10,247 | ||||||||
Property and equipment, net |
185 | 141 | ||||||||
Marketable securities available-for-sale |
2,051 | 363 | ||||||||
Goodwill (Note 8) |
3,602 | 3,602 | ||||||||
Other intangibles, net of accumulated amortization of $819
and $1,522, respectively (Note 8) |
15,939 | 15,236 | ||||||||
Other assets |
371 | 375 | ||||||||
Total Assets |
$ | 33,907 | $ | 29,964 | ||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||||
Current liabilities: |
||||||||||
Accounts payable and accrued expenses |
$ | 2,348 | $ | 1,732 | ||||||
Total current liabilities |
2,348 | 1,732 | ||||||||
Minority interest |
83 | | ||||||||
Total liabilities |
2,431 | 1,732 | ||||||||
Commitments and contingencies
|
||||||||||
Stockholders equity: |
||||||||||
Convertible preferred stock, $.001 par value;
5,000 shares authorized, no shares issued and
outstanding |
| | ||||||||
Common stock, $.001 par value; 30,000 shares authorized,
24,314 and 24,373 shares issued and outstanding at
December 31, 2002 and June 30, 2003, respectively |
24 | 24 | ||||||||
Additional paid-in capital |
99,495 | 99,574 | ||||||||
Accumulated deficit |
(68,004 | ) | (70,847 | ) | ||||||
Treasury stock, at cost, 227 and 495 shares at
December 31, 2002 and June 30, 2003, respectively |
(205 | ) | (661 | ) | ||||||
Accumulated other comprehensive income |
166 | 142 | ||||||||
Total stockholders equity |
31,476 | 28,232 | ||||||||
Total Liabilities and Stockholders Equity |
$ | 33,907 | $ | 29,964 | ||||||
See accompanying notes
3
ENDOLOGIX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
| 2002 | 2003 | 2002 | 2003 | ||||||||||||||||
Revenue: |
|||||||||||||||||||
Product |
$ | 140 | $ | 295 | $ | 140 | $ | 785 | |||||||||||
License |
1,800 | 694 | 3,568 | 1,366 | |||||||||||||||
Total revenue |
1,940 | 989 | 3,708 | 2,151 | |||||||||||||||
Cost of product revenue |
83 | 108 | 152 | 365 | |||||||||||||||
Gross profit |
1,857 | 881 | 3,556 | 1,786 | |||||||||||||||
Operating expenses: |
|||||||||||||||||||
Research, development and clinical |
1,699 | 1,715 | 2,716 | 3,561 | |||||||||||||||
Marketing and sales |
133 | 154 | 133 | 437 | |||||||||||||||
General and administrative |
693 | 697 | 1,091 | 835 | |||||||||||||||
Charge for acquired in-process
research and development |
4,438 | | 4,438 | | |||||||||||||||
Minority interest |
(7 | ) | 1 | (15 | ) | (16 | ) | ||||||||||||
Total operating expenses |
6,956 | 2,567 | 8,363 | 4,817 | |||||||||||||||
Loss from operations |
(5,099 | ) | (1,686 | ) | (4,807 | ) | (3,031 | ) | |||||||||||
Other income (expense): |
|||||||||||||||||||
Interest income |
185 | 46 | 411 | 200 | |||||||||||||||
Gain (loss) on sale of assets |
58 | (11 | ) | 92 | (8 | ) | |||||||||||||
Other expense |
(6 | ) | (2 | ) | (10 | ) | (4 | ) | |||||||||||
Total other income |
237 | 33 | 493 | 188 | |||||||||||||||
Net loss |
($ | 4,862 | ) | ($ | 1,653 | ) | ($ | 4,314 | ) | ($ | 2,843 | ) | |||||||
Basic and diluted net loss per share |
($ | 0.28 | ) | ($ | 0.07 | ) | ($ | 0.29 | ) | ($ | 0.12 | ) | |||||||
Shares used in computing basic and
diluted net loss per share |
17,081 | 23,915 | 15,133 | 23,981 | |||||||||||||||
See accompanying notes
4
ENDOLOGIX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
| Six Months Ended June 30, | ||||||||||||
| 2002 | 2003 | |||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
($4,314 | ) | ($2,843 | ) | ||||||||
Adjustments to reconcile net loss to net cash
provided by (used in) operating activities: |
||||||||||||
Depreciation and amortization |
130 | 752 | ||||||||||
Amortization of deferred compensation |
(12 | ) | 44 | |||||||||
Charge for acquired in-process research
and development |
4,438 | | ||||||||||
Bad debt expense (recovery) |
5 | (50 | ) | |||||||||
Loss (gain) on sale of assets |
(55 | ) | 18 | |||||||||
Minority interest in losses of subsidiary |
(8 | ) | (16 | ) | ||||||||
Forgiveness of officer loan |
137 | | ||||||||||
Change in (net of effects of acquisition): |
||||||||||||
Trade accounts receivable |
166 | 479 | ||||||||||
Inventories |
72 | (129 | ) | |||||||||
Other receivables and other assets |
791 | 370 | ||||||||||
Accounts payable and accrued expenses |
(643 | ) | (616 | ) | ||||||||
Deferred revenue |
(40 | ) | | |||||||||
Net cash provided by (used in) operating activities |
667 | (1,991 | ) | |||||||||
Cash flows provided by investing activities: |
||||||||||||
Purchases of available-for-sale securities |
(6,529 | ) | (728 | ) | ||||||||
Sales of available-for-sale securities |
12,691 | 3,035 | ||||||||||
Purchase of (former) Endologix, net of cash acquired of $2,097 |
(3,214 | ) | | |||||||||
Final distribution to subsidiary minority interest shareholder |
| (67 | ) | |||||||||
Capital expenditures for property and equipment
|
(27 | ) | (7 | ) | ||||||||
Net cash provided by investing activities |
2,921 | 2,233 | ||||||||||
Cash flows provided by (used in) financing activities: |
||||||||||||
Proceeds from sale of common stock under employee stock
purchase plan |
14 | 35 | ||||||||||
Proceeds from exercise of common stock options |
40 | | ||||||||||
Purchases of treasury stock |
| (456 | ) | |||||||||
Net cash provided by (used in) financing activities |
54 | (421 | ) | |||||||||
Effect of exchange rate changes on cash and cash equivalents |
12 | (11 | ) | |||||||||
Net increase (decrease) in cash and cash equivalents |
3,654 | (190 | ) | |||||||||
Cash and cash equivalents, beginning of period |
3,327 | 2,606 | ||||||||||
Cash and cash equivalents, end of period |
$ | 6,981 | $ | 2,416 | ||||||||
Supplemental disclosure of non-cash operating activities:
In May 2002, the Company acquired all of the common stock of (former) Endologix (Note 8). The following is a summary of the transaction as of June 30, 2002:
Fair value of assets acquired, including intangible assets |
$ | 25,664 | |||
Acquired in-process research and development |
4,501 | ||||
Cash paid |
(5,311 | ) | |||
Merger consideration payable |
(3,830 | ) | |||
Common stock issued |
(18,637 | ) | |||
Liabilities assumed |
$ | 2,387 | |||
See accompanying notes
5
ENDOLOGIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
1. Business and Basis of Presentation
Endologix, Inc. (formerly named Radiance Medical Systems, Inc. referred to as Endologix or the Company) was incorporated in California in March 1992 and reincorporated in Delaware in June 1993. In May 2002, the Company merged with privately held Endologix, Inc., and changed its name to Endologix, Inc.
The Company is engaged in the development, manufacture, sales and marketing of minimally invasive therapies for the treatment of vascular disease. The Companys primary focus is the development of the PowerLink System, a catheter-based alternative treatment for abdominal aortic aneurysms, or AAA. AAA is a weakening of the wall of the aorta, the largest artery of the body. Once AAA develops, it continues to enlarge and if left untreated becomes increasingly susceptible to rupture. Prior to the restructuring in September 2001 (Note 10) and the merger in May 2002 (Note 8), the Company was developing proprietary devices to deliver radiation to prevent the recurrence of blockages in arteries following balloon angioplasty, vascular stenting, arterial bypass surgery and other interventional treatments of blockages in coronary and peripheral arteries. The Company also manufactured, licensed and sold angioplasty catheters and stent products primarily through medical device distributors. The Company operates in a single business segment.
For the six months ended June 30, 2003, the Company incurred a net loss of $2.8 million. As of June 30, 2003, the Company had an accumulated deficit of approximately $70.8 million. The Company believes that current cash and cash equivalents, marketable securities and cash generated by operations will be sufficient to meet anticipated cash needs for operating and capital expenditures through at least December 31, 2004. Unanticipated reductions in royalty revenue, failure of the market to accept the products, or failure to reduce certain discretionary expenditures, if necessary, could have a material adverse effect on the Companys ability to achieve the intended business objectives.
The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the unaudited six-month period ended June 30, 2003 are not necessarily indicative of results that may be expected for the
6
ENDOLOGIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
year ending December 31, 2003 or any other period. For further information, including information on significant accounting policies and use of estimates, refer to the consolidated financial statements and footnotes thereto included in the Companys Annual Report on Form 10-K for the year ended December 31, 2002.
2. Stock-Based Compensation
The Company has elected to follow Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25), and related interpretations in accounting for its employee stock options because the alternative fair value accounting provided for under SFAS No. 123 (SFAS No. 123), Accounting for Stock-Based Compensation, and amended by SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure, requires use of option valuation models that were not developed for use in valuing employee stock options. Under the provisions of APB 25, the Company recognizes compensation expense only to the extent that the exercise price of the Companys employee stock options is less than the market price of the underlying stock on the date of grant. SFAS No. 123 requires the presentation of pro forma information as if the Company has accounted for its employee stock options granted under the fair value method. The fair value for these options was estimated at the date of grant using the Black-Scholes option-pricing model. The Black-Scholes model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility.
Because the Companys employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in managements opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options.
In calculating the pro forma information, the fair value was estimated at the date of grant using a Black-Scholes option pricing model with the following weighted-average assumptions: risk-free interest rate of 2.7% and 2.1%; a dividend yield of 0% and 0%; volatility of the expected market price of the Companys common stock of 80.0% and 81.0%; and a weighted-average expected life of the options of 5.0 years and 5.0 years for the second quarter and first six months of 2002 and 2003, respectively.
7
ENDOLOGIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
For purposes of pro forma disclosures, the estimated fair value of the options is amortized to expense over the options vesting period. The Companys pro forma information for the quarters ended June 30, 2002 and 2003 follows:
| 2002 | 2003 | ||||||||
Net loss, as
reported |
$ | (4,862 | ) | $ | (1,653 | ) | |||
Deduct: Total stock-based employee compensation expense
determined under fair value based method for all awards,
net of related tax effects |
(90 | ) | (44 | ) | |||||
Pro forma net
loss |
$ | (4,952 | ) | $ | (1,697 | ) | |||
Earnings per share: |
|||||||||
Basic and diluted-as reported |
$ | (0.28 | ) | $ | (0.07 | ) | |||
Basic and diluted-pro forma |
$ | (0.29 | ) | $ | (0.07 | ) | |||
The Companys pro forma information for the six month periods ended June 30, 2002 and 2003 follows:
| 2002 | 2003 | ||||||||
Net loss, as
reported |
$ | (4,314 | ) | $ | (2,843 | ) | |||
Deduct: Total stock-based employee compensation expense
determined under fair value based method for all awards,
net of related tax effects |
(180 | ) | (122 | ) | |||||
Pro forma net
loss |
$ | (4,494 | ) | $ | (2,965 | ) | |||
Earnings per share: |
|||||||||
Basic and diluted-as reported |
$ | (0.29 | ) | $ | (0.12 | ) | |||
Basic and diluted-pro forma |
$ | (0.30 | ) | $ | (0.12 | ) | |||
The Company accounts for non-employee stock-based awards, in which goods or services are the consideration received for the stock options issued, in accordance with the provisions of SFAS No. 123 and related interpretations. Compensation expense for non-employee stock-based awards is recognized in accordance with FASB Interpretation 28, Accounting for Stock Appreciation Rights and Other Variable Stock Options or Award Plans, an Interpretation of APB Opinions No. 15 and 25 (FIN 28). Under SFAS No. 123 and FIN 28, the Company records compensation expense based on the then-current fair values of the stock options at each financial reporting date. Compensation recorded during the service period is adjusted in subsequent periods for changes in the stock options fair value until the options vest.
8
ENDOLOGIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
3. Net Income (Loss) Per Share
Net income (loss) per common share is computed using the weighted average number of common shares outstanding during the periods presented. Certain options to purchase shares of the Companys common stock granted under the Companys stock option plan have been excluded from the calculation of diluted earnings per share, as they are anti-dilutive. If anti-dilutive stock options were included for the second quarter of 2002 and 2003, the number of shares used to compute diluted net loss per share would have been increased by approximately 0.1 million shares and 0.4 million shares. In addition, options to purchase 1.3 million shares and 1.1 million shares with an exercise price above the average market price for the first quarter of 2002 and 2003, respectively, were excluded from the computation of diluted loss per share because the effect would have been antidilutive.
If anti-dilutive stock options were included for the first six months of 2002 and 2003, the number of shares used to compute diluted net loss per share would have been increased by approximately 0.1 million shares and 0.3 million shares. In addition, options to purchase 1.7 million shares and 1.1 million shares with an exercise price above the average market price for the first quarter of 2002 and 2003, respectively, were excluded from the computation of diluted loss per share because the effect would have been antidilutive.
4. Inventories
Inventories are stated at the lower of cost, determined on an average cost basis, or market value. Inventories consist of the following:
| December 31, 2002 | June 30, 2003 | |||||||
Raw
materials
|
$ | 1,069 | $ | 1,018 | ||||
Work-in-process
|
174 | 406 | ||||||
Finished
goods
|
800 | 748 | ||||||
| $ | 2,043 | $ | 2,172 | |||||
5. Note Receivable
In February 2001, the Company amended the Assets Sale and Purchase agreement with Escalon Medical Corporation (Escalon) regarding the payment of royalties. As part of this amended agreement, the Company received a prime (4.25% at June 30, 2003) plus one percent interest bearing note receivable for $718, payable in eleven equal quarterly installments from April 2002 to October 2004, representing the remaining minimum
9
ENDOLOGIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(Unaudited)
royalties, on a discounted basis, due for 2001 to 2003. Additional royalties above the minimums will be paid under the amended agreement only if related product sales exceed $3,000 annually. The Company recognizes interest income and license revenue under the $718 note receivable when the payment is received, as collection of this note receivable was not reasonably assured. Accordingly, the note receivable and deferred revenue are not recorded on the condensed consolidated balance sheet.
The Company recognized interest income of $5 and $6 in the second quarter of 2002 and 2003, respectively, under this arrangement. The Co