UNITED STATES
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 September 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 0-29993
| DELAWARE | 94-3200380 | |
| (State or other jurisdiction of | (I.R.S. Employer Identification Number) | |
| incorporation or organization) |
2483 East Bayshore Road, Suite 100
Palo Alto, CA 94303
(Address of principal executive offices)
(650) 526-6800
(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 checkmark whether registrant is an accelerated filer (as defined in
Rule 12b-2 of Securities Exchange Act of 1934).
Yes o No x
There were 5,253,983 shares of the Companys Common Stock, par value $.001, outstanding as of October 31, 2003.
INTRABIOTICS PHARMACEUTICALS, INC.
FORM 10-Q
QUARTER ENDED September 30, 2003
TABLE OF CONTENTS
| Page | ||||
| PART I. | FINANCIAL INFORMATION | |||
| Item 1. | Financial Statements (unaudited) | |||
| Condensed Balance Sheets as of September 30, 2003 and December 31, 2002 | 3 | |||
| Condensed Statements of Operations for the Three- and Nine-Month Periods Ended September 30, 2003 and 2002 | 4 | |||
| Condensed Statements of Cash Flows for the Nine-Month Periods Ended September 30, 2003 and 2002 | 5 | |||
| Notes to Condensed Financial Statements | 6 | |||
| Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations | 10 | ||
| Item 3. | Quantitative and Qualitative Disclosure About Market Risk | 22 | ||
| Item 4. | Controls and Procedures | 22 | ||
| PART II. | OTHER INFORMATION | |||
| Item 6. | Exhibits and Reports on Form 8-K | 23 | ||
| SIGNATURES | 24 |
2
PART I. FINANCIAL INFORMATION
ITEM I. FINANCIAL STATEMENTS
INTRABIOTICS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS)
| SEPTEMBER 30, | DECEMBER 31, | |||||||||
| 2003 | 2002 | |||||||||
| (Unaudited) | (Note 1) | |||||||||
Assets |
||||||||||
Current assets: |
||||||||||
Cash and cash
equivalents |
$ | 10,061 | $ | 10,170 | ||||||
Restricted cash |
250 | 250 | ||||||||
Short-term investments |
| 2,895 | ||||||||
Prepaid drug substance |
| 2,375 | ||||||||
Prepaid expenses |
467 | 247 | ||||||||
Total current assets |
10,778 | 15,937 | ||||||||
Property and equipment,
net |
31 | 112 | ||||||||
Other assets |
184 | 177 | ||||||||
Total assets |
$ | 10,993 | $ | 16,226 | ||||||
Liabilities and stockholders
equity |
||||||||||
Current liabilities: |
||||||||||
Accounts payable |
$ | 376 | $ | 345 | ||||||
Accrued clinical
liabilities |
128 | | ||||||||
Accrued employee
liabilities |
91 | 135 | ||||||||
Accrued restructuring
charges |
| 64 | ||||||||
Other accrued
liabilities |
244 | 202 | ||||||||
Total current liabilities |
839 | 746 | ||||||||
Stockholders
equity: |
||||||||||
Preferred stock |
1,886 | | ||||||||
Common stock |
3 | 3 | ||||||||
Additional paid-in
capital |
219,244 | 216,466 | ||||||||
Deferred stock
compensation |
(180 | ) | (720 | ) | ||||||
Accumulated deficit |
(210,799 | ) | (200,269 | ) | ||||||
Total stockholders equity |
10,154 | 15,480 | ||||||||
Total liabilities and
stockholdersequity |
$ | 10,993 | $ | 16,226 | ||||||
See accompanying notes.
3
INTRABIOTICS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
| THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||||||
| SEPTEMBER 30, | SEPTEMBER 30, | |||||||||||||||||
| 2003 | 2002 | 2003 | 2002 | |||||||||||||||
Operating expenses: |
||||||||||||||||||
Research and
development |
$ | 3,641 | $ | 3,955 | $ | 5,261 | $ | 17,407 | ||||||||||
General and
administrative |
1,125 | 2,388 | 3,833 | 6,295 | ||||||||||||||
Arbitration settlement |
| | | (3,600 | ) | |||||||||||||
Restructuring and other
charges |
| 5,140 | | 5,231 | ||||||||||||||
Total operating expenses |
4,766 | 11,483 | 9,094 | 25,333 | ||||||||||||||
Operating loss |
(4,766 | ) | (11,483 | ) | (9,094 | ) | (25,333 | ) | ||||||||||
Interest income |
28 | 143 | 99 | 623 | ||||||||||||||
Interest expense |
| (131 | ) | | (397 | ) | ||||||||||||
Other income |
| 200 | | 984 | ||||||||||||||
Net loss |
(4,738 | ) | (11,271 | ) | (8,995 | ) | (24,123 | ) | ||||||||||
Non-cash deemed dividend related to
beneficial conversion
feature of Series A preferred stock |
| | (1,418 | ) | | |||||||||||||
Dividends on Series A preferred
stock |
(70 | ) | | (117 | ) | | ||||||||||||
Net loss applicable to common
stockholders |
$ | (4,808 | ) | $ | (11,271 | ) | $ | (10,530 | ) | $ | (24,123 | ) | ||||||
Basic and diluted net loss per share
applicable to common
stockholders |
$ | (1.46 | ) | $ | (3.59 | ) | $ | (3.22 | ) | $ | (7.99 | ) | ||||||
Shares used to compute basic and diluted
net loss per share
applicable to common stockholders |
3,283 | 3,143 | 3,274 | 3,018 | ||||||||||||||
See accompanying notes.
4
INTRABIOTICS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
| NINE MONTHS ENDED SEPTEMBER 30, | ||||||||||
| 2003 | 2002 | |||||||||
Operating
activities |
||||||||||
Net loss |
$ | (8,995 | ) | $ | (24,123 | ) | ||||
Adjustments to reconcile net loss to net
cash used in operating activities: |
||||||||||
Amortization of deferred stock
compensation |
110 | 848 | ||||||||
Depreciation and
amortization |
81 | 575 | ||||||||
Acquired workforce
amortization |
| 234 | ||||||||
Stock compensation
expense |
411 | 619 | ||||||||
Gain on sale of pre-clinical
programs |
| (975 | ) | |||||||
Change in assets and
liabilities: |
||||||||||
Prepaid expenses |
2,155 | 2,025 | ||||||||
Other assets |
(7 | ) | | |||||||
Accounts payable |
31 | (33 | ) | |||||||
Accrued clinical liabilities |
128 | (222 | ) | |||||||
Accrued employee liabilities |
(44 | ) | (300 | ) | ||||||
Accrued restructuring charges |
(64 | ) | 2,859 | |||||||
Deferred rent |
| 203 | ||||||||
Other accrued liabilities |
(28 | ) | (396 | ) | ||||||
Net cash used in operating
activities |
(6,222 | ) | (18,686 | ) | ||||||
Investing
activities |
||||||||||
Capital expenditures |
| (17 | ) | |||||||
Proceeds from sale of pre-clinical
programs |
| 400 | ||||||||
Maturities of short-term
investments |
2,895 | | ||||||||
Cash received in acquisition of
subsidiary |
| 58 | ||||||||
Net cash provided by investing
activities |
2,895 | 441 | ||||||||
Financing
activities |
||||||||||
Proceeds from issuance of common stock,
net |
6 | 19,472 | ||||||||
Proceeds from issuance of Series A
preferred stock and warrants, net |
3,212 | | ||||||||
Payments on financing
obligations |
| (1,406 | ) | |||||||
Net cash provided by financing
activities |
3,218 | 18,066 | ||||||||
Net decrease in cash and cash
equivalents |
(109 | ) | (179 | ) | ||||||
Cash and cash equivalents at beginning of
period |
10,170 | 27,982 | ||||||||
Cash and cash equivalents at end of
period |
$ | 10,061 | $ | 27,803 | ||||||
Supplemental disclosure of cash flow
information: |
||||||||||
Interest paid |
$ | | $ | 397 | ||||||
Supplemental disclosure of non-cash
information: |
||||||||||
Net deferred stock compensation
(cancellations due to employee termination) |
$ | (430 | ) | $ | (1,076 | ) | ||||
Other assets received from sale of
pre-clinical programs |
$ | | $ | 575 | ||||||
Beneficial conversion feature on
Series A preferred stock |
$ | (1,418 | ) | $ | | |||||
Issuance of common stock dividend on
Series A preferred stock |
$ | (117 | ) | $ | | |||||
Cash flow for acquisition of
subsidiary: |
||||||||||
Acquired workforce |
$ | | $ | 1,694 | ||||||
Other current assets
acquired |
| 297 | ||||||||
Property and equipment
acquired |
| 56 | ||||||||
Liabilities assumed |
| (75 | ) | |||||||
Acquisition costs
incurred |
| (106 | ) | |||||||
Common stock issued |
| (1,924 | ) | |||||||
Cash received in
acquisition |
$ | | $ | (58 | ) | |||||
See accompanying notes.
5
INTRABIOTICS PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note 1. Basis of Presentation and Summary of Significant Accounting Policies
The accompanying condensed financial statements are unaudited and have been prepared by IntraBiotics Pharmaceuticals, Inc. (the Company) in accordance with the rules and regulations of the Securities and Exchange Commission for interim financial information, and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X.
Certain information and footnote disclosures normally included in the Companys annual audited financial statements (as required by accounting principles generally accepted in the United States) have been condensed or omitted. The interim condensed financial statements, in the opinion of management, reflect all adjustments (consisting entirely of normal recurring adjustments) necessary for a fair presentation of the Companys financial position as of September 30, 2003, the results of its operations for the three- and nine-month periods ended September 30, 2003 and 2002 and cash flows for the nine-month periods ended September 30, 2003 and 2002.
The results of operations of the interim periods are not necessarily indicative of the results of operations to be expected for the entire fiscal year. These interim condensed financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2002, which are contained in the Companys Annual Report on Form 10-K/A, and filed with the Securities and Exchange Commission on June 25, 2003. The condensed balance sheet as of December 31, 2002 is derived from such audited financial statements.
Use of estimates
The preparation of financial statements in conformity with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
Recent Accounting Pronouncements
In August 2002, the Financial Accounting Standards Board issued Statement No. 146 (SFAS No. 146), Accounting for Costs Associated with Exit or Disposal Activities. SFAS No. 146 supersedes Emerging Issues Task Force Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs To Exit an Activity (Including Certain Costs Associated with a Restructuring) and requires that a liability for a cost associated with an exit or disposal activity be recognized when the liability is incurred, as opposed to when management is committed to an exit plan. SFAS No. 146 also establishes that the liability should initially be measured and recorded at fair value. This statement is effective for exit or disposal activities initiated after December 31, 2002. The provisions of SFAS No. 146 are required to be applied prospectively after the adoption date to newly initiated exit activities, and may affect the timing of recognizing future restructuring costs, as well as the amounts recognized. The adoption of the statement on January 1, 2003 did not have a material impact on the Companys financial position, results of operations or disclosure.
In November 2002, the FASB issued Interpretation No. 45 (FIN 45), Guarantors Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others. FIN 45 requires that a liability be recorded in the guarantors balance sheet upon issuance of a guarantee. In addition, FIN 45 requires disclosures about the guarantees that an entity has issued. FIN 45 is effective on a prospective basis to guarantees issued or modified after December 31, 2002. The disclosure requirements of FIN 45 are effective for financial statements for interim and annual periods ending after December 31, 2002. The adoption of FIN 45 did not have any impact on the Companys financial position, results of operations or disclosure.
In January 2003, the FASB issued FASB Interpretation No. 46 (FIN 46), Consolidation of Variable Interest Entities, an Interpretation of ARB No. 51. FIN 46 requires certain variable interest entities to be consolidated by the primary beneficiary of the entity if the equity investors in the entity do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. FIN 46 is effective for all new variable interest entities created or acquired after January 31, 2003. For variable interest entities created or acquired prior to February 1, 2003, the provisions of FIN 46, as amended, must be applied for the first interim or annual period ending after December 15, 2003. The adoption of FIN 46 did not have any impact on the Companys financial position, results of operations or disclosure.
6
In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity. SFAS No. 150 requires that certain financial instruments, which under previous guidance were accounted for as equity, must now be accounted for as liabilities. The financial instruments affected include stock with mandatory redemption, certain financial instruments that require or may require the issuer to buy back some of its shares in exchange for cash or other assets and certain obligations that can be settled with shares of stock. SFAS No. 150 is effective for all financial instruments entered into or modified after May 31, 2003 and must be applied to the Companys existing financial instruments effective July 1, 2003, the beginning of the first fiscal period after June 15, 2003. The adoption of SFAS No. 150 did not have a material impact on the Companys financial position, results of operations or disclosure.
Note 2. Stock-Based Compensation
As permitted by Statement of Financial Accounting Standards No. 123 (SFAS 123), Accounting for Stock-Based Compensation, as amended by Statement of Financial Standards No. 148, Accounting for Stock-Based Compensation - Transition and Disclosure, the Company has elected to follow APB 25 and related interpretations in accounting for stock-based employee compensation. Under APB 25, if the exercise price of an employee or director stock option is set equal or in excess of the fair value of the underlying stock on the date of grant, no compensation expense is recognized. If the exercise price of the employee or director stock option is set at less than the fair value of the underlying stock on the grant date, the Company records deferred compensation for the difference. Deferred compensation is amortized on a straight-line basis over the vesting period of the original award, ranging from four to six years.
Options or stock awards issued to non-employees are recorded at their fair value as determined in accordance with SFAS 123, and are recognized over the related service period and are periodically re-measured as the underlying options vest.
The following table illustrates the effect on net loss and net loss per share applicable to common stockholders if the Company had applied the fair value recognition provisions of SFAS 123 to stock-based employee compensation (in thousands, except per share amounts):
| Three Months Ended | Nine Months Ended | ||||||||||||||||
| September 30, | September 30, | ||||||||||||||||
| 2003 | 2002 | 2003 | 2002 | ||||||||||||||
Net loss applicable to common
stockholders, as reported |
$ | (4,808 | ) | $ | (11,271 | ) | $ | (10,530 | ) | $ | (24,123 | ) | |||||
Add: Stock-based employee compensation
expense included in
reported net loss |
300 | 161 | 419 | 848 | |||||||||||||
Deduct: Total stock-based employee
compensation expense
determined under fair value based method for all awards |
(384 | ) | (720 | ) | (1,194 | ) | (1,799 | ) | |||||||||
Pro forma net loss applicable to common
stockholders |
$ | (4,892 | ) | $ | (11,830 | ) | $ | (11,305 | ) | $ | (25,074 | ) | |||||
Net loss per share applicable to common
stockholders: |
|||||||||||||||||
Basic and diluted as
reported |
$ | (1.46 | ) | $ | (3.59 | ) | $ | (3.22 | ) | $ | (7.99 | ) | |||||
Basic and diluted pro forma |
$ | (1.49 | ) | $ | (3.76 | ) | $ | (3.45 | ) | $ | (8.20 | ) | |||||
The fair value for the Companys options was estimated at the date of grant using the Black-Scholes option pricing model for the three- and nine-month periods ended September 30, 2003 and 2002 with the following weighted-average assumptions:
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2003 | 2002 | 2003 | 2002 | |||||||||||||
Risk-free interest rate |
3.20 | % | 3.35 | % | 2.81 | % | 4.08 | % | ||||||||
Volatility |
1.00 | 1.00 | 1.00 | 1.00 | ||||||||||||
Dividend yield |
| | | | ||||||||||||
Expected life of option |
5 years | 5 years | 5 years | 5 years | ||||||||||||
7
Note 3. Comprehensive Loss
Comprehensive loss is solely comprised of the net loss in each period presented.
Note 4. Contractual Commitments
In February 2003, the Company entered into an operating lease agreement for a facility in Palo Alto, California, which expires in June 2004. Under the terms of the lease, the Company is committed to pay an aggregate amount of approximately $84,000 in 2003 and $43,000 in 2004.
Note 5. Stock Options Cancellation and Regrant
In February 2003, the Board of Directors approved a cancellation and re-grant of 321,335 unexercised stock options held by existing employees and directors of the Company. Upon election by the participants, all of the unexercised stock options were cancelled and new stock options were granted in a one-for-one exchange. The re-granted options have an exercise price equal to the closing price of the Companys common stock on the Nasdaq National Market on February 5, 2003, or $2.76 per share, post-split (see Note 8). The options vest over a four-year period and will expire in February 2008 if not previously exercised. Variable accounting is being applied to the re-granted options, starting from the date of re-grant, and the related compensation expense may have a significant impact on the Companys future results of operations. Compensation expense of $285,000 and $309,000 was recorded for these options during the three- and nine-month periods ended September 30, 2003, respectively.
Note 6. Net Loss Per Common Share
Basic and diluted net loss per share applicable to common stockholders is presented in accordance with Financial Accounting Standards Board Statement No. 128, Earnings Per Share, and is calculated using the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share applicable to common stockholders includes the impact of potentially dilutive securities (stock options, warrants and convertible preferred stock). As the Companys potentially dilutive securities were anti-dilutive for all periods, they are not included in the calculations of diluted net loss per share applicable to common stockholders. The total number of shares underlying the stock options, warrants and convertible preferred stock excluded from the calculations of net loss per common share were 3,200,874 and 623,410 for the three-month periods ended September 30, 2003 and 2002, respectively, and 2,991,807 and 385,114 for the nine-month periods ended September 30, 2003 and 2002, respectively.
Note 7. Restructuring and Other Charges
In October 2002, the Company announced a restructuring plan as a result of the failure of its then recently completed phase III clinical trial for the prevention of oral mucositis in cancer patients. This restructuring plan reduced headcount by 26 employees in research and development and general and administration, or 70% of the Companys workforce. In accordance with provisions of EITF 94-3 and related interpretations, the Company recorded restructuring charges of $848,000 for severance costs of which $784,000 were paid as of December 31, 2002. The remaining severance accrual as of December 31, 2002 of $64,000 was paid in January 2003 to employees who left the Company in December 2002. No other charges were expensed in 2003 as a result of the restructuring plan.
Note 8. Reverse Stock Split
On April 3, 2003, the Companys stockholders authorized a 1-for-12 reverse stock split of all outstanding shares of the Companys common stock, which was effected on April 10, 2003. All share and per share amounts have been retroactively adjusted to reflect the stock split for all periods presented.
Note 9. Stockholders Equity
On May 1, 2003, in a private placement transaction, the Company sold 350 shares of a newly created Series A convertible preferred stock (the Preferred Stock), $0.001 par value, and issued warrants to purchase 920,699 shares of common stock, resulting in net cash proceeds of $3.2 million. The primary purpose of completing the private placement was to provide funds for a clinical trial of iseganan HCl for the prevention of ventilator-associated pneumonia (VAP), as well as for other general corporate purposes and working capital.
8
The Preferred Stock is convertible into 1,841,404 shares of common stock at any time, at a conversion price of $1.90 per share, subject to adjustment upon the occurrence of certain events, such as stock splits, payment of dividends to common stockholders, reorganizations, mergers or consolidations. Each share of Preferred Stock automatically converts into shares of common stock on the tenth day after the day that the closing sale price of the Companys common stock on the Nasdaq National Market has reached at least $8.28 and has remained at such level for 20 consecutive trading days, but only after the earlier to occur of (1) the unblinding and the public announcement of the results of the Companys first pivotal clinical trial of iseganan HCl for the prevention of VAP, or (2) the second anniversary of the date the Preferred Stock was first issued. The holders of Preferred Stock are also entitled to receive, but only out of funds legally available for dividends, cumulative dividends payable quarterly, at the annual rate of eight percent of the original issue price of $10,000 on each outstanding share of Preferred Stock. The dividend will be paid in common stock based on the average of the closing sales prices of the common stock on the Nasdaq National Market for the five trading days immediatel