UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
(Mark One)
| x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2003
OR
| o |
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 No. 0-23930
TARGETED GENETICS CORPORATION
| Washington | 91-1549568 | |
| (State of Incorporation) | (IRS Employer Identification No.) |
1100 Olive Way, Suite 100
Seattle, WA 98101
(Address of principal executive offices, including zip code)
(206) 623-7612
(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 o No x
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date.
| Common Stock, $0.01 par value | 58,424,750 | |
| (Class) | (Outstanding at July 30, 2003) |
TARGETED GENETICS CORPORATION
Quarterly Report on Form 10-Q
For the quarter ended June 30, 2003
TABLE OF CONTENTS
| Page No. | ||||||
| PART I | FINANCIAL INFORMATION | |||||
| Item 1. | Financial Statements | |||||
| a) | Condensed Consolidated Balance Sheets at June 30, 2003 and December 31, 2002 | 1 | ||||
| b) | Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2003 and 2002 | 2 | ||||
| c) | Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2003 and 2002 | 3 | ||||
| d) | Notes to Condensed Consolidated Financial Statements | 4 | ||||
| Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations | 8 | ||||
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 20 | ||||
| Item 4. | Controls and Procedures | 21 | ||||
| PART II | OTHER INFORMATION | |||||
| Item 1. | Legal Proceedings | 22 | ||||
| Item 2. | Changes in Securities and Use of Proceeds | 22 | ||||
| Item 3. | Defaults Upon Senior Securities | 22 | ||||
| Item 4. | Submission of Matters to a Vote of Security Holders | 22 | ||||
| Item 5. | Other Information | 22 | ||||
| Item 6. | Exhibits and Reports on Form 8-K | 22 | ||||
| SIGNATURES | 23 | |||||
| EXHIBIT INDEX | 24 | |||||
i
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
TARGETED GENETICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | December 31, | |||||||||||
| 2003 | 2002 | |||||||||||
| (unaudited) | ||||||||||||
ASSETS |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
$ | 24,752,000 | $ | 12,606,000 | ||||||||
Accounts receivable |
7,000 | 1,170,000 | ||||||||||
Prepaid expenses and other |
573,000 | 452,000 | ||||||||||
Total current assets |
25,332,000 | 14,228,000 | ||||||||||
Property and equipment, net |
4,093,000 | 5,520,000 | ||||||||||
Goodwill, net |
31,649,000 | 31,649,000 | ||||||||||
Other assets |
1,240,000 | 1,316,000 | ||||||||||
Total assets |
$ | 62,314,000 | $ | 52,713,000 | ||||||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||||||
Current liabilities: |
||||||||||||
Accounts payable and accrued expenses |
$ | 1,875,000 | $ | 2,012,000 | ||||||||
Accrued employee expenses |
383,000 | 729,000 | ||||||||||
Accrued restructure expenses |
2,080,000 | 1,202,000 | ||||||||||
Deferred revenue |
5,237,000 | 6,041,000 | ||||||||||
Current portion of long-term obligations and short-term debt |
1,567,000 | 1,298,000 | ||||||||||
Total current liabilities |
11,142,000 | 11,282,000 | ||||||||||
Accrued restructure expenses and deferred rent |
3,555,000 | 2,276,000 | ||||||||||
Long-term obligations |
20,535,000 | 20,494,000 | ||||||||||
Commitments |
||||||||||||
Minority interest in preferred stock of subsidiary |
750,000 | 750,000 | ||||||||||
Series B convertible exchangeable preferred stock |
| 12,015,000 | ||||||||||
Shareholders equity: |
||||||||||||
Preferred stock, $0.01 par value, 6,000,000 shares authorized: |
||||||||||||
Series A preferred stock, 800,000 shares designated, none
issued and outstanding |
| | ||||||||||
Series B convertible preferred stock, 12,015 shares designated,
issued and outstanding |
12,015,000 | | ||||||||||
Common stock, $0.01 par value, 120,000,000 shares authorized,
58,406,210 shares issued and outstanding at June 30, 2003 and
50,566,348 shares at December 31, 2002 |
584,000 | 506,000 | ||||||||||
Additional paid-in capital |
223,227,000 | 207,139,000 | ||||||||||
Accumulated deficit |
(209,494,000 | ) | (201,749,000 | ) | ||||||||
Total shareholders equity |
26,332,000 | 5,896,000 | ||||||||||
Total liabilities and shareholders equity |
$ | 62,314,000 | $ | 52,713,000 | ||||||||
See accompanying notes to condensed consolidated financial statements
1
TARGETED GENETICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Three months ended | Six months ended | |||||||||||||||||
| June 30, | June 30, | |||||||||||||||||
| 2003 | 2002 | 2003 | 2002 | |||||||||||||||
Revenue: |
||||||||||||||||||
Collaborative agreements |
$ | 2,053,000 | $ | 3,818,000 | $ | 7,692,000 | $ | 8,349,000 | ||||||||||
Collaborative agreement with unconsolidated,
majority-owned research and development joint
venture |
| 775,000 | | 1,614,000 | ||||||||||||||
Total revenue |
2,053,000 | 4,593,000 | 7,692,000 | 9,963,000 | ||||||||||||||
Operating expenses: |
||||||||||||||||||
Research and development |
4,327,000 | 7,634,000 | 8,869,000 | 15,931,000 | ||||||||||||||
General and administrative |
1,438,000 | 2,270,000 | 2,774,000 | 4,665,000 | ||||||||||||||
Restructure charges |
2,899,000 | | 3,180,000 | | ||||||||||||||
Equity in net loss of unconsolidated,
majority-owned research and development joint
venture |
| 833,000 | | 1,611,000 | ||||||||||||||
Amortization of acquisition-related intangibles |
| 127,000 | | 253,000 | ||||||||||||||
Total operating expenses |
8,664,000 | 10,864,000 | 14,823,000 | 22,460,000 | ||||||||||||||
Loss from operations |
(6,611,000 | ) | (6,271,000 | ) | (7,131,000 | ) | (12,497,000 | ) | ||||||||||
Investment income |
56,000 | 139,000 | 108,000 | 226,000 | ||||||||||||||
Interest expense |
(360,000 | ) | (305,000 | ) | (722,000 | ) | (572,000 | ) | ||||||||||
Net loss |
$ | (6,915,000 | ) | $ | (6,437,000 | ) | $ | (7,745,000 | ) | $ | (12,843,000 | ) | ||||||
Computation of basic and diluted net loss per common
share: |
||||||||||||||||||
Net loss per common share (basic and diluted) |
$ | (0.13 | ) | $ | (0.15 | ) | $ | (0.15 | ) | $ | (0.29 | ) | ||||||
Shares used in computation of basic and diluted net loss
per common share |
51,694,000 | 44,159,000 | 51,133,000 | 44,148,000 | ||||||||||||||
See accompanying notes to condensed consolidated financial statements
2
TARGETED GENETICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| Six months ended | |||||||||||
| June 30, | |||||||||||
| 2003 | 2002 | ||||||||||
Operating activities: |
|||||||||||
Net loss |
$ | (7,745,000 | ) | $ | (12,843,000 | ) | |||||
Adjustments to reconcile net loss to net cash used in operating activities: |
|||||||||||
Depreciation and amortization |
1,545,000 | 1,612,000 | |||||||||
Non-cash interest expense |
611,000 | 475,000 | |||||||||
Equity in net loss of unconsolidated, majority-owned research and
development joint venture |
| 1,611,000 | |||||||||
Amortization of purchased intangibles |
| 253,000 | |||||||||
Changes in assets and liabilities: |
|||||||||||
Decrease (increase) in accounts receivable |
1,163,000 | (722,000 | ) | ||||||||
Increase in prepaid expenses and other current assets |
(121,000 | ) | (130,000 | ) | |||||||
Decrease in other non-current assets |
76,000 | 77,000 | |||||||||
Decrease in current liabilities |
(183,000 | ) | (617,000 | ) | |||||||
Increase in accrued restructure expenses and deferred rent |
2,157,000 | 102,000 | |||||||||
Decrease in deferred revenue |
(804,000 | ) | (513,000 | ) | |||||||
Increase in accounts receivable from unconsolidated,
majority-owned research and development joint venture |
| (169,000 | ) | ||||||||
Net cash used in operating activities |
(3,301,000 | ) | (10,864,000 | ) | |||||||
Investing activities: |
|||||||||||
Purchases of property and equipment |
(118,000 | ) | (391,000 | ) | |||||||
Investment in unconsolidated, majority-owned research and development
joint venture |
| (1,631,000 | ) | ||||||||
Net cash used in investing activities |
(118,000 | ) | (2,022,000 | ) | |||||||
Financing activities: |
|||||||||||
Net proceeds from issuance of common stock |
16,166,000 | 36,000 | |||||||||
Payments under leasehold improvements and equipment financing arrangements |
(601,000 | ) | (654,000 | ) | |||||||
Loan proceeds from collaborative partners |
| 5,000,000 | |||||||||
Proceeds from leasehold improvements and equipment financing arrangements |
| 591,000 | |||||||||
Net cash provided by financing activities |
15,565,000 | 4,973,000 | |||||||||
Net increase (decrease) in cash and cash equivalents |
12,146,000 | (7,913,000 | ) | ||||||||
Cash and cash equivalents, beginning of period |
12,606,000 | 25,186,000 | |||||||||
Cash and cash equivalents, end of period |
$ | 24,752,000 | $ | 17,273,000 | |||||||
See accompanying notes to condensed consolidated financial statements
3
TARGETED GENETICS CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
| 1. | Basis of Presentation |
The condensed consolidated financial statements included in this quarterly report have been prepared by Targeted Genetics Corporation without audit, according to the rules and regulations of the Securities and Exchange Commission, or SEC. Our condensed consolidated financial statements include the accounts of Targeted Genetics Corporation, our wholly-owned subsidiaries Genovo, Inc. and TGCF Manufacturing Corporation (inactive), and our majority-owned subsidiary, CellExSys, Inc. The condensed consolidated financial statements do not include the accounts of Emerald Gene Systems, Ltd., or Emerald, our unconsolidated, majority-owned research and development joint venture with Elan International Services Ltd., or Elan, because we do not have operating control of Emerald. The operations of Emerald terminated during 2002 and we expect to dissolve the joint venture. All significant inter-company transactions have been eliminated in consolidation. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted in accordance with the SECs rules and regulations. The financial statements reflect, in the opinion of management, all adjustments (which consist solely of normal recurring adjustments) necessary to present fairly our financial position and results of operations as of and for the periods indicated. Certain reclassifications have been made to conform prior year results to the current year presentation.
Our results of operations for the three months ended June 30, 2003, include a $2.9 million restructure charge, which represents our revised estimate of the ongoing lease commitment and associated costs of our Bothell, Washington facility lease. Our results of operations for the three months ended March 31, 2003, include $3.9 million in revenue recognized in connection with the termination of our development collaboration with Wyeth. As a result of these and other factors, we do not believe that our results of operations for the three months and six months ended June 30, 2003 are necessarily indicative of the results to be expected for the full year.
The unaudited condensed consolidated financial statements included in this quarterly report should be read in conjunction with our audited consolidated financial statements and related footnotes included in our annual report on Form 10-K for the year ended December 31, 2002.
| 2. | Impact of New Accounting Pronouncements |
In April 2003, the Financial Accounting Standards Board, or FASB, issued Statement of Financial Accounting Standards, or SFAS, No. 149, Amendment of Statement 133 on Derivative Instruments and Hedging Activities. This statement amends and clarifies financial accounting and reporting for derivative instruments, including certain derivative instruments embedded in other contracts and for hedging activities under SFAS No. 133 and is effective for contracts entered into or modified after June 30, 2003. We do not expect the provisions of SFAS No. 149 to have a significant effect on our financial position or operating results.
In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity. This statement establishes standards for how an issuer classifies and measures certain financial instruments with characteristics of both liabilities and equity and is effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective beginning July 1, 2003. We do not expect the provisions of SFAS No. 150 to have a significant effect on our financial position or operating results.
4
TARGETED GENETICS CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS(Continued)
(Unaudited)
| 3. | Long-Term Obligations |
Long-term obligations consisted of the following:
| June 30, | December 31, | |||||||
| 2003 | 2002 | |||||||
Loan payable to Biogen, due August 2006 |
$ | 10,000,000 | $ | 10,000,000 | ||||
Convertible loans payable to Elan, due July 2005 |
7,950,000 | 7,950,000 | ||||||
Accrued interest payable to Elan, due July 2005 |
1,172,000 | 699,000 | ||||||
Equipment financing obligations |
1,831,000 | 2,383,000 | ||||||
Other long-term obligations |
1,149,000 | 760,000 | ||||||
| 22,102,000 | 21,792,000 | |||||||
Less current portion |
(1,567,000 | ) | (1,298,000 | ) | ||||
| $ | 20,535,000 | $ | 20,494,000 | |||||
Future aggregate principal payments related to long-term obligations are $1.1 million for the remainder of 2003, $800,000 in 2004, $10.1 million in 2005 and $10.1 million in 2006.
Elan has the option to convert principal and unpaid interest outstanding under the loan facility, on a per-draw basis, into shares of our common stock. The applicable fixed conversion prices if Elan elects to convert the loans and interest into shares of our common stock range from $0.49 to $6.11. If Elan had elected to convert the convertible loans and the related interest into our common stock as of June 30, 2003, Elan would have received 3,726,518 shares of our common stock.
We have the option to prepay principal and interest outstanding under our Elan loan facility, in either cash or shares of our common stock. If we elect to prepay outstanding loan amounts with our common stock, the conversion price will equal the lesser of the average closing price of our common stock for a specified period of time before the date of prepayment and the applicable conversion price for each draw. Unless we obtain shareholder approval, we are limited in our ability to issue shares of our common stock to repay amounts outstanding under the loan facility to the extent the repayment caused Elans ownership in our common stock to exceed 19.9% of our then total common shares outstanding. If we elect to prepay the outstanding amounts in cash, we must pay the greater of the amount of principal and interest outstanding or the value of our common stock that Elan would receive upon conversion at the applicable conversion price for each draw, at the then current market price of those shares. In accordance with the terms of the loans payable to Elan, to date, we have elected not to make any cash payments of interest to Elan.
| 4. | Shareholders Equity |
Common Stock Offering
In June 2003, we issued 7,777,778 shares of our common stock in a public offering to institutional investors at a price of $2.25 per share. We expect to use the proceeds from this financing of approximately $16.1 million to fund our ongoing research and development activities and general corporate purposes.
Series B Convertible Preferred Stock
In July 1999, we issued shares of our Series B convertible exchangeable preferred stock, valued at $12 million, to Elan in exchange for our 80.1% interest in Emerald. The Series B preferred stock is convertible until July 2005, at Elans option, into shares of our common stock, at an initial conversion price of $3.32 per share. Compounding dividends accrue semi-annually at 7% per year on the $1,000 per share face value of the preferred stock. Dividends are not paid in cash, but rather result in an increase in the number of shares of common stock issuable upon conversion. The Series B preferred stock and accrued dividends were convertible into 4,604,348 shares of our common stock at June 30, 2003, and unless converted earlier, will automatically convert into approximately 5.5 million shares of our common stock in July 2005. Elan was entitled to exchange the Series B preferred stock for all shares of preferred stock that we hold in Emerald until this exchange right expired on April 21, 2003. As a result of the expiration of the exchange right, we have reclassified the Series B preferred stock from mezzanine equity to shareholders equity.
5
TARGETED GENETICS CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS(Continued)
(Unaudited)
Stock Compensation
As permitted by the provisions of Statement of Financial Accounting Standard (SFAS) No. 123, Accounting for Stock-Based Compensation, we have elected to follow Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations in accounting for employee stock option grants, and we apply the disclosure-only provisions to account for our stock option plans. We do not recognize any compensation expense for options granted to employees because we grant all options at fair market value on the date of grant. Options granted to consultants are recorded as an expense over their vesting term based on their fair value, which is determined using the Black-Scholes method.
If we had elected to recognize compensation expense based on the fair market value at the grant dates for stock options granted, the pro forma net loss and net loss per common share would have been as follows:
| Three months ended | Six months ended | ||||||||||||||||
| June 30, | June 30, | ||||||||||||||||
| 2003 | 2002 | 2003 | 2002 | ||||||||||||||
Net loss: |
|||||||||||||||||
As reported |
$ | (6,915,000 | ) | $ | (6,437,000 | ) | $ | (7,745,000 | ) | $ | (12,843,000 | ) | |||||
Stock-based
compensation
under SFAS 123 |
(366,000 | ) | (956,000 | ) | 15,000 | (2,058,000 | ) | ||||||||||
Pro forma |
$ | (7,281,000 | ) | $ | (7,393,000 | ) | $ | (7,730,000 | ) | $ | (14,901,000 | ) | |||||
Basic net loss per share: |
|||||||||||||||||
As reported |
$ | (0.13 | ) | $ | (0.15 | ) | $ | (0.15 | ) | $ | (0.29 | ) | |||||
Pro forma |
(0.14 | ) | (0.17 | ) | (0.15 | ) | (0.34 | ) | |||||||||
Warrants
During April 2003, warrants to purchase 3,333,333 shares of our common stock expired. At June 30, 2003, warrants to purchase 2,025,141 shares of our common stock were outstanding as follows:
| | In connection with a technology license agreement with Alkermes, Inc., we issued a warrant to Alkermes to purchase 1,000,000 shares of our common stock at an exercise price of $2.50, expiring in June 2007, and a warrant to purchase 1,000,000 shares at an exercise price of $4.16 per share, expiring in June 2009. | ||
| | We have outstanding warrants to purchase a total of 25,141 shares of our common stock related to equipment financing and consulting agreements. These warrants have a weighted average price of $5.46 per share and expire between December 2003 and March 2004. |
| 5. | Net Loss per Common Share |
Net loss per common share is based on the weighted average number of common shares outstanding during the period. Our diluted net loss per common share is the same as our basic net loss per common share because all stock options, warrants and other potentially dilutive securities are antidilutive and therefore excluded from the calculation of diluted net loss per common share.
| 6. | Accrued Restructure Expenses |
During 2002, we restructured our operations to focus our resources on our cystic fibrosis, arthritis and AIDS vaccine product development programs. In connection with this restructuring, we reduced our head count and operating expenses and began to pursue options to sublease, or terminate, the lease on our facility in Bothell, Washington. We had leased the facility in 2000 to accommodate commercial-scale manufacturing of our product candidates. As part of our collaborative development agreements with Celltech and Wyeth, we had financing commitments in place to fund a substantial portion of the construction of this facility. Both of these collaborative development relationships have ended and, as a result, the funding commitments have terminated