UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Form 10-Q
| þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the quarterly period ended September 30, 2004 |
| 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 000-50447
PHARMION CORPORATION
| Delaware | 84-1521333 | |
| (State or other jurisdiction of | (I.R.S. Employer | |
| incorporation or organization) | Identification No.) |
2525 28th Street, Boulder, Colorado 80304
(Address of principal executive offices)
(720) 564-9100
(Registrants telephone number)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act 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 þ 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 þ
As of November 5, 2004, there were 31,656,158 shares of the Registrants Common Stock outstanding.
PHARMION CORPORATION
TABLE OF CONTENTS
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| Section 302 Certification for President and CEO | ||||||||
| Section 302 Certification for CFO | ||||||||
| Section 906 Certification for President and CEO and CFO | ||||||||
2
PART I
FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
PHARMION CORPORATION
CONSOLIDATED BALANCE SHEETS
(In thousands, except for share amounts)
| September 30, | December 31, | |||||||
| 2004 |
2003 |
|||||||
| (Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 195,129 | $ | 88,542 | ||||
Short-term investments |
115,157 | | ||||||
Accounts
receivable, net of allowances of $1,443 and $819, respectively |
31,473 | 7,992 | ||||||
Inventories |
3,136 | 4,923 | ||||||
Other current assets |
3,990 | 4,122 | ||||||
Total current assets |
348,885 | 105,579 | ||||||
Product rights, net |
28,234 | 30,651 | ||||||
Property and equipment, net |
4,598 | 5,050 | ||||||
Goodwill |
3,586 | 3,652 | ||||||
Other assets |
208 | 541 | ||||||
Total assets |
$ | 385,511 | $ | 145,473 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 3,672 | $ | 4,241 | ||||
Accrued liabilities |
32,611 | 14,800 | ||||||
Total current liabilities |
36,283 | 19,041 | ||||||
Long-term liabilities: |
||||||||
Convertible notes payable |
| 13,374 | ||||||
Deferred tax liability |
3,599 | 3,665 | ||||||
Other long-term liabilities |
1,320 | 4,479 | ||||||
Total long-term liabilities |
4,919 | 21,518 | ||||||
Stockholders equity: |
||||||||
Common stock, $.001 par value; 100,000,000 shares authorized and
31,545,634 and 23,948,636 shares issued and outstanding at September
30, 2004 and December 31, 2003 |
32 | 24 | ||||||
Preferred stock, $0.001, 10,000,000 shares authorized, no shares
issued and outstanding at September 30, 2004 and December 31, 2003 |
| | ||||||
Additional paid-in capital |
482,055 | 222,218 | ||||||
Deferred compensation |
(766 | ) | (1,155 | ) | ||||
Other comprehensive income |
3,693 | 4,386 | ||||||
Accumulated deficit |
(140,705 | ) | (120,559 | ) | ||||
Total stockholders equity |
344,309 | 104,914 | ||||||
Total liabilities and stockholders equity |
$ | 385,511 | $ | 145,473 | ||||
The accompanying notes are an integral part of these consolidated financial statements
3
PHARMION CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except for share and per share amounts)
(Unaudited)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, |
September 30, |
|||||||||||||||
| 2004 |
2003 |
2004 |
2003 |
|||||||||||||
Net sales |
$ | 42,576 | $ | 7,673 | $ | 78,692 | $ | 13,760 | ||||||||
Operating expenses: |
||||||||||||||||
Cost of sales, including royalties of
$9,817 and $1,695 for the three months
ended September 30, 2004 and 2003,
respectively; and royalties of $19,532 and
$1,934 for the nine months ended September
30, 2004 and 2003, respectively |
14,169 | 2,681 | 27,931 | 7,140 | ||||||||||||
Clinical, development and regulatory |
7,383 | 5,436 | 21,116 | 16,897 | ||||||||||||
Selling, general and administrative |
18,592 | 7,867 | 42,808 | 25,479 | ||||||||||||
Product rights amortization |
720 | 613 | 2,160 | 1,259 | ||||||||||||
Total operating expenses |
40,864 | 16,597 | 94,015 | 50,775 | ||||||||||||
Income (loss) from operations |
1,712 | (8,924 | ) | (15,323 | ) | (37,015 | ) | |||||||||
Interest and other income (expense), net |
911 | (290 | ) | 722 | 28 | |||||||||||
Income (loss) before taxes |
2,623 | (9,214 | ) | (14,601 | ) | (36,987 | ) | |||||||||
Income tax expense |
2,978 | 40 | 5,545 | 154 | ||||||||||||
Net loss |
(355 | ) | (9,254 | ) | (20,146 | ) | (37,141 | ) | ||||||||
Less accretion of redeemable convertible
preferred stock to redemption value |
| (2,825 | ) | | (8,474 | ) | ||||||||||
Net loss attributable to common stockholders |
$ | (355 | ) | $ | (12,079 | ) | $ | (20,146 | ) | $ | (45,615 | ) | ||||
Net loss attributable to common
stockholders per common share, basic and
diluted |
$ | (0.01 | ) | $ | (14.35 | ) | $ | (0.75 | ) | $ | (56.10 | ) | ||||
Shares used in computing net loss
attributable to common stockholders per
common share, basic and diluted |
30,381,691 | 841,477 | 26,688,333 | 813,055 | ||||||||||||
Pro forma net loss attributable to common
stockholders per common share assuming
conversion of preferred stock, basic and
diluted |
$ | (0.52 | ) | $ | (2.08 | ) | ||||||||||
Shares used in computing pro forma net loss
attributable to common stockholders per
common share assuming conversion of
preferred stock, basic and diluted |
17,872,433 | 17,844,011 | ||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements
4
PHARMION CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| Nine Months Ended | ||||||||
| September 30, |
||||||||
| 2004 |
2003 |
|||||||
Operating activities |
||||||||
Net loss |
$ | (20,146 | ) | $ | (37,141 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
3,650 | 2,349 | ||||||
Compensation expense related to stock option issuance |
389 | 406 | ||||||
Other |
305 | 181 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable, net |
(23,564 | ) | (3,780 | ) | ||||
Inventories |
1,650 | (2,213 | ) | |||||
Other current assets |
135 | (985 | ) | |||||
Other long-term assets |
332 | 475 | ||||||
Accounts payable |
(528 | ) | 233 | |||||
Accrued liabilities |
18,416 | 2,448 | ||||||
Net cash used in operating activities |
(19,361 | ) | (38,027 | ) | ||||
Investing activities |
||||||||
Purchases of property and equipment |
(996 | ) | (1,965 | ) | ||||
Acquisition of business, net of cash acquired |
(19 | ) | (12,265 | ) | ||||
Purchase of product rights |
| (1,000 | ) | |||||
Purchase of available-for-sale investments |
(131,855 | ) | | |||||
Sale and maturity of available-for-sale investments |
16,308 | | ||||||
Net cash used in investing activities |
(116,562 | ) | (15,230 | ) | ||||
Financing activities |
||||||||
Proceeds from sale of common stock, net of issuance costs |
245,683 | 70 | ||||||
Proceeds from issuance of convertible notes and warrants |
| 14,000 | ||||||
Payment of debt obligations |
(2,950 | ) | (177 | ) | ||||
Net cash provided by financing activities |
242,733 | 13,893 | ||||||
Effect of exchange rate changes on cash and cash equivalents |
(223 | ) | 293 | |||||
Net increase (decrease) in cash and cash equivalents |
106,587 | (39,071 | ) | |||||
Cash and cash equivalents at beginning of period |
88,542 | 62,604 | ||||||
Cash and cash equivalents at end of period |
$ | 195,129 | $ | 23,533 | ||||
Noncash items |
||||||||
Warrants granted in connection with issuance of convertible notes |
| 730 | ||||||
Conversion of debt and accrued interest to common stock |
14,161 | | ||||||
Financed property and equipment acquisitions |
58 | | ||||||
Financed product rights acquisition |
| 8,208 | ||||||
The accompanying notes are an integral part of these consolidated financial statements
5
PHARMION CORPORATION
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
1. NATURE OF BUSINESS
Pharmion Corporation (the Company) was incorporated in Delaware on August 26, 1999 and commenced operations in January 2000. The Company is engaged in the acquisition, development and commercialization of pharmaceutical products for the treatment of oncology and hematology patients. The Companys product acquisition and licensing efforts are focused on both development stage products as well as those approved for marketing. In exchange for distribution and marketing rights, the Company generally grants the seller royalties on future sales and, in some cases, up-front and scheduled cash payments. To date, the Company has acquired the distribution and marketing rights to four products. The Company has established operations in the United States, Europe and Australia. Through a distributor network, the Company can reach the hematology and oncology community in additional countries in the Middle East and Asia.
On September 25, 2003, the Company effected a one for four reverse stock split of its common stock. All share and per share amounts included in these consolidated financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split.
On November 12, 2003, the Company completed an initial public offering (IPO) which resulted in net proceeds of approximately $76.2 million from the issuance of 6,000,000 shares of common stock. In connection with the initial public offering, all of the outstanding shares of the Companys preferred stock were converted into shares of common stock.
On July 7, 2004, the Company completed a public offering of common stock. A total of 5,290,000 shares of common stock were sold at a price to the public of $48.00 per share, resulting in net proceeds to the Company of $238.0 million.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying unaudited consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and pursuant to the rules and regulations of the SEC pertaining to Form 10-Q. All significant intercompany accounts and transactions have been eliminated in consolidation. Certain disclosures required for complete financial statements are not included herein. These statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Companys latest audited annual financial statements, which are included in its 2003 Annual Report on Form 10-K, which has been filed with the SEC.
In the opinion of management, the unaudited interim financial statements reflect all adjustments, which include only normal, recurring adjustments necessary to present fairly the Companys financial position and results of operations and cash flows for the three and nine months ended September 30, 2004 and 2003. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the year ending December 31, 2004 or for any other interim period or for any other future year.
Use of Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting principles 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 expenses during the reporting period. Actual results could differ from those estimates or assumptions. The significant estimates reflected in these financial statements include estimates of chargebacks from distributors, product returns and rebates, inventory impairment and valuation of stock-based compensation.
Revenue Recognition
The Company sells its products to wholesale distributors and directly to hospitals, clinics and retail pharmacies. Revenue from product sales is recognized when ownership of the product is transferred to the customer, the sales price is fixed and determinable, and collectibility is reasonably assured.
6
Revenue is reported net of allowances for chargebacks from distributors, product returns, rebates and prompt payment discounts. Significant estimates are required for determining such allowances and are based on historical data, industry information and information from customers. If actual results are different from estimates, the Company will adjust the allowances at the time such differences become apparent.
Certain governmental health insurance providers as well as hospitals and clinics that are members of group purchasing organizations may be entitled to price discounts and rebates on the Companys products used by those organizations and their patients. As such, the Company must estimate the likelihood that products sold to wholesale distributors will ultimately be subject to a rebate or price discount. This estimate is based on historical trends and industry data on the utilization of the Companys products.
Short-term Investments
Short-term investments consist of investment grade government agency and corporate debt securities due within one year. Investments with maturities beyond one year are classified as short-term based on their highly liquid nature and because such investments represent the investment of cash that is available for current operations. All investments are classified as available-for-sale and are recorded at market value. Unrealized gains and losses are reflected in other comprehensive income.
Inventories
Inventories consist of raw materials and finished goods and are stated at the lower of cost or market, cost being determined under the first-in, first-out method. The Company periodically reviews inventories and any items considered outdated or obsolete are reduced to their estimated net realizable value. The Company estimates reserves for excess and obsolete inventories based on inventory levels on hand, future purchase commitments, product expiration dates and current and forecasted product demand. If an estimate of future product demand suggests that inventory levels are excessive, then inventories are reduced to their estimated net realizable value.
Concentration of Credit Risk
Financial instruments which potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents, short-term investments and accounts receivable. The Company maintains its cash balances in the form of short-term investment grade securities, money market accounts and overnight deposits with financial institutions that management believes are creditworthy. The Company has no financial instruments with off-balance-sheet risk of accounting loss.
The Companys products are sold both to wholesale distributors and directly to hospitals and clinics. Ongoing credit evaluations of customers are performed and collateral is generally not required. The Company maintains a reserve for potential credit losses, and such losses have been within managements expectations. In the nine months ended September 30, 2004 and 2003, revenues generated from the Companys five largest customers in the United States totaled approximately 34% and 29%, respectively, of consolidated net revenues. Revenues generated from international customers were individually less than 5% of consolidated net revenues.
Pro Forma Net Loss Per Share
Immediately prior to the effective date of the Companys initial public offering (November 12, 2003), all of the Companys shares of redeemable convertible preferred stock outstanding converted into an aggregate of 17,030,956 shares of common stock. Unaudited pro forma net loss per share is computed by dividing net loss before accretion of redeemable convertible preferred stock to redemption value by the weighted average number of common shares outstanding, including the pro forma effects of conversion of all outstanding redeemable convertible preferred stock into shares of the Companys common stock as of January 1, 2003.
3. NET LOSS PER COMMON SHARE
The Company applies SFAS No. 128, Earnings per Share, which establishes standards for computing and presenting earnings per share. Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted average number of unrestricted common shares outstanding for the period. Diluted net loss per common share is the same as basic net loss per common share, since the effects of potentially dilutive securities are antidilutive for all periods presented. Potential incremental common shares include shares of common stock issuable upon exercise of stock options and warrants and upon the conversion of redeemable convertible preferred stock and convertible notes outstanding during the period. The potential shares of
7
common stock have not been included in the diluted net loss per share calculation because to do so would be antidilutive. Such shares totaled 2,229,083 and 20,632,148 as of September 30, 2004 and 2003, respectively.
4. LICENSE AGREEMENTS AND PRODUCT RIGHTS
Innohep
In June 2002, the Company entered into an agreement with LEO Pharma A/S for the license of the low molecular weight heparin, Innohep®. Under the terms of the agreement, the Company acquired an exclusive right and license to market and distribute Innohep® in the United States. On the closing date, in exchange for this license, the Company paid $5 million which was capitalized as product rights and is being amortized over the 10 year period during which the Company expects to generate significant revenues. On the closing date, the Company paid an additional $2.5 million which is creditable against royalty payments otherwise due during the period ending March 1, 2005. In addition, the Company is obligated to pay LEO Pharma royalties at the rate of 30% of net sales on annual net sales of up to $20 million and at the rate of 35% of net sales on annual net sales exceeding $20 million, less in each case the Companys purchase price from LEO Pharma of the units of product sold. The agreement has a term of ten years.
Refludan
In May 2002, the Company acquired the exclusive right to market and distribute Refludan® in all countries outside the U.S. and Canada. The Company has paid Schering an aggregate of $8 million and is obligated to make $5 million in additional fixed payments to Schering, payable in quarterly installments of $1 million through the end of 2005. The value of the total cash payments made and the present value of future payments was $12.2 million, which was capitalized to product rights and is being amortized over the 10-year period during which the Company expects to generate revenue. Additional payments of up to $7.5 million will be due Schering upon achievement of certain milestones. Because such payments are contingent upon future events, they are not reflected in the accompanying financial statements. In addition, the Company pays Schering a 14% royalty on net sales of Refludan® (8% in 2003) until the aggregate royalty payments total $12.0 million measured from January 2004. At that time, the royalty rate will be reduced to 6%.
Azacitidine
In 2001, the Company acquired the development and commercialization rights to azacitidine for the treatment of certain bone marrow disorders. Global rights to azacitidine were licensed from Pharmacia Corporation, now part of Pfizer Inc. The Company is responsible for all costs associated with the development, regulatory review, and commercialization of this product.
Under the terms of the Companys agreement with Pfizer, the Company is obligated to pay a royalty of up to 20% on net sales of azacitidine. The license from Pfizer has a term extending for the longer of the last to expire of valid patent claims in any given country or ten years from the first commercial sale of the product in a particular country. In May 2004, the Company received approval from the FDA to market azacitidine under the branded name Vidaza® in the United States. The Company began selling Vidaza on July 1, 2004.
Thalidomide
In 2001, the Company acquired the development and commercialization rights to Thalomid® (thalidomide) in all countries outside the U.S., Canada, and certain Asian countries. The license was purchased from both Celgene Corporation and Penn T Limited, which was acquired by Celgene in October 2004. In the second quarter of 2003, the Company began selling thalidomide on a compassionate use or named patient basis throughout Europe and other international markets while it pursues marketing authorizations in those countries. The Company is responsible for all costs associated with the development, regulatory review, and commercialization of this product.
Under the Companys agreements with Penn and Celgene, the Company will pay a combined royalty of 36% of net sales, less the Companys purchase price from Penn of the units of product sold, on all sales of thalidomide once it is approved by the appropriate health regulatory authority for sale in any country within the Companys licensed territory. Until such approvals are obtained, the combined royalty payment obligations to Celgene and Penn are generally lower than 36%. The Companys royalty payment obligations to Celgene and Penn are also subject to certain minimum yearly payment thresholds. In connection with our ongoing
8
relationship with Celgene, and to further the clinical development of thalidomide, particularly in multiple myeloma, the Company has also agreed to fund an aggregate of $8.0 million of Celgenes clinical trial development costs for clinical studies of thalidomide. As of September 30, 2004 the Company was obligated to pay Celgene an aggregate of $2.8 million in quarterly installments through 2005. The Company issued a warrant to Celgene to purchase 1,701,805 shares of Series B Preferred Stock at $2.09 per share in November 2001 which expires seven years from the date of grant. Immediately prior to the effective date of the IPO, this warrant was converted into the right to purchase 425,452 shares of common stock at an exercise price of $8.36 per share and it was exercised in September 2004. The agreements with Celgene and Penn each have a ten year term running from the date of receipt of the first regulatory approval for thalidomide in the United Kingdom, subject, in the case of the Celgene agreement to Celgene having a right to terminate the agreement if the Company has not obtained that approval by November 2006.
On March 25, 2003, the Company acquired 100% of the outstanding stock of Gophar S.A.S. and its wholly owned subsidiary, Laphal Développement. As part of this purchase, we acquired Laphals thalidomide formulation. A portion of the Laphal purchase price was allocated to the thalidomide product rights. The thalidomide product rights are being amortized over their estimated economic life of 15 years.
The cost value and accumulated amortization associated with Innohep®, Refludan® and Thalidomide is as follows (in thousands):
| As of September 30, 2004 |
As of December 31, 2003 |
|||||||||||||||
| Gross Carrying | Accumulated | Gross Carrying | Accumulated | |||||||||||||
| Amount |
Amortization |
Amount |
Amortization |
|||||||||||||
Amortized product rights: |
||||||||||||||||
Innohep® |
$ | 5,000 | $ | (1,125 | ) | $ | 5,000 | $ | (750 | ) | ||||||
Refludan® |
12,208 | (1,876 | ) | 12,208 | (865 | ) | ||||||||||
Thalidomide |
15,583 | (1,556 | ) | 15,849 | (791 | ) | ||||||||||
Total product rights |
$ | 32,791 | $ | (4,557 | ) | $ | 33,057 | $ | (2,406 | ) | ||||||
5. INVENTORY
Inventory at September 30, 2004 and December 31, 2003 consisted of the following (in thousands):
| September 30, | December 31, | |||||||
| 2004 |
2003 |
|||||||
Raw materials |
$ | 499 | $ | | ||||
Finished goods |
2,637 | 4,923 | ||||||
Total inventory |
$ | 3,136 | $ | 4,923 | ||||
6. CONVERTIBLE NOTES PAYABLE
In April 2003, the Company issued $14 million of 6% convertible notes with interest payable annually. Holders of the notes also received warrants to purchase an aggregate of 424,243 shares of the Companys common stock at a price of $11.00 per share. The value of the warrants was reflected as an additional debt discount to be amortized over the term of the debt or 5 years. Effective March 1, 2004, the $14 million of convertible notes plus accrued interest were converted into 1,342,170 shares of common stock. The remaining unamortized debt discount was recorded as a decrease to equity.
7. STOCK OPTION COMPENSATION
At September 30, 2004, the Company had two stock option plans. The Company has elected to account for stock-based compensation arrangements using the intrinsic value method under the provisions of Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees and its related interpretations. Under this method, when the exercise price is less than the market price for the underlying stock on the date of grant, a non-cash charge to compensation expense is recorded ratably over the term of the option vesting period in an amount equal to the difference between the value calculated using the exercise price and the fair value. The Company uses the fair value method to account for nonemployee stock-based compensation.
During 2003, options were granted to employees and directors at exercise prices that were less than the estimated fair value of the underlying shares of common stock as of the grant date. In accordance with APB 25, deferred compensation expense is being recognized for the excess of the estimated fair value of the Companys common stock as of the grant date over the exercise price of the options and amortized to expense on a straight-line basis over the vesting periods of the related options, which is generally 4 years. The Company recorded compensation expense totaling $388,908 for the nine months ended September 30, 2004.
9
Pro forma information regarding net loss is required by Statement of Financial Accounting Standard No. 123 (SFAS No. 123), Accounting for Stock-Based Compensation, and has been determined as if the Company had accounted for its employee stock options under the fair value method of that statement. The fair value for these options was estimated at the date of grant using the Black-Scholes valuation model.
The effects of applying the fair value method to the results for the three and nine months ended September 30, 2004 and 2003 are (in thousands):
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2004 |
2003 |
2004 |
2003 |
|||||||||||||
Net loss attributable to common shareholders: |
||||||||||||||||
As reported |
$ | (355 | ) | $ | (12,079 | ) | $ | (20,146 | ) | $ | (45,615 | ) | ||||
Plus: stock based compensation recognized under the
intrinsic value method |
94 | 163 | 389 | 406 | ||||||||||||
Less: stock based compensation under fair value method |
(1,259 | ) | (235 | ) | (2,308 | ) | (553 | ) | ||||||||
Pro forma net loss |
$ | (1,520 | ) | $ | (12,151 | ) | $ | (22,065 | ) | $ | (45,762 | ) | ||||
Net loss attributable to common shareholders per
common share: |
||||||||||||||||
As reported (basic and diluted) |
$ | (0.01 | ) | $ | (14.35 | ) | $ | (0.75 | ) | $ | (56.10 | ) | ||||
Pro forma net loss per share (basic and diluted) |
$ | (0.05 | ) | $ | (14.44 | ) | $ | (0.83 | ) | $ | (56.28 | ) | ||||
Option valuation models such as the Black-Scholes value method described above require the input of highly subjective assumptions. 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.
The weighted-average fair value per share was $19.48 and $9.01 for stock options granted in the nine months ended September 30, 2004 and 2003, respectively. The assumptions used to develop the estimated fair value of the options granted utilizing the Black-Scholes pricing model are:
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2004 |
2003 |
2004 |
2003 |
|||||||||||||
Risk-free interest rate |
2.80 | % | 2.80 | % | 2.80 | % | 2.80 | % | ||||||||
Expected stock price volatility |
85 | % | 86 | % | 85 | % | 86 | % | ||||||||
Expected option term until exercise (years) |
5 | 5 | 5 | 5 | ||||||||||||
Expected dividend yield |
0 | % | 0 | % | 0 | % | 0 | % | ||||||||
8. OTHER COMPREHENSIVE LOSS
Total comprehensive loss for the three and nine months ended September 30, 2004 and 2003 was (in thousands):
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, |
September 30, |
|||||||||||||||
| 2004 |
2003 |
2004 |
2003 |
|||||||||||||
Net loss |
$ | (355 | ) | $ | (9,254 | ) | $ | (20,146 | ) | $ | (37,141 | ) | ||||
Other comprehensive income: |
||||||||||||||||
Foreign currency translation |
610 | 435 | (615 | ) | 1,312 | |||||||||||
Unrealized gain (loss) on available for sale securities |
167 | | (78 | ) | | |||||||||||
Comprehensive income (loss) |
$ | 422 | $ | (8,819 | ) | $ | (20,839 | ) | $ | (35,829 | ) | |||||
The foreign currency translation amounts relate to the operating results of our foreign subsidiaries.
9. INCOME TAXES
Income taxes have been provided for using the liability method in accordance with SFAS No. 109, Accounting for Income Taxes. The provision for income taxes reflects managements estimate of the effective tax rate expected to be applicable for the full fiscal year for each country in which we do business. This estimate is re-evaluated by management each quarter based on the Companys estimated tax expense for the year. Income tax expense for the three and nine months ended September 30, 2004 resulted primarily from taxable income generated in certain foreign jurisdictions.
10. COMMITMENTS AND CONTINGENCIES
During the fourth quarter of 2003, the Company filed suit against Lipomed AG, and certain of its distributors, in the UK, Switzerland, Germany and Italy for patent infringement in connection with their sales of thalidomide for the treatment of angiogenesis-mediated disorders, including multiple myeloma, in these countries. The Company was seeking injunctive relief that would have prevented the defendants from making any further sales of thalidomide for the treatment of angiogenesis-mediated disorders, including multiple myeloma, in the four countries in which the Company brought suit, and damages against the defendants. In April 2004, all parties to the litigation agreed to a settlement of all claims. Lipomed agreed to cease selling its thalidomide
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formulation and to not further challenge the validity of the thalidomide patent. The Company agreed to make a 1.25 million payment to Lipomed toward the legal costs incurred by Lipomed in connection with the suit and in consideration of future assistance to be provided to the Company by Lipomed in obtaining regulatory approvals to market Thalidomide Pharmion 50 mg in those countries in which the Company is currently not approved to do so. In addition, the Company entered in to a distribution agreement with Lipomed pursuant to which Lipomed was appointed as the exclusive distributor of Thalidomide Pharmion 50 mg in Switzerland and Austria effective May 1, 2004.
11. GEOGRAPHIC INFORMATION
Domestic and foreign financial information for the three and nine months ended September 30, 2004 and 2003 was (in thousands):
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||
| 2004 |
2003 |
2004 |
2003 |
|||||||||||||||
| United States | Net sales |
$ | 22,496 | $ | 912 | $ | 26,735 | $ | 2,269 | |||||||||
| Foreign entities | Net sales |
20,080 | 6,761 | 51,957 | 11,491 | |||||||||||||
| Total | Net sales |
$ | 42,576 | $ | 7,673 | $ | 78,692 | $ | 13,760 | |||||||||
| United States | Operating income (loss) |
$ | 290 | $ | (5,133 | ) | $ | (16,835 | ) | $ | (23,603 | ) | ||||||
| Foreign entities | Operating income (loss) |
1,422 | (3,791 | ) | 1,512 | (13,412 | ) | |||||||||||
| Total | Operating income (loss) |
$ | 1,712 | $ | (8,924 | ) | $ | (15,323 | ) | $ | (37,015 | ) | ||||||
12. WARRANT EXERCISE
In June 2004, a stock purchase warrant was exercised by a business partner, resulting in the issuance of 44,026 shares of common stock. The option holder utilized the cashless exercise option allowed under the warrant agreement and surrendered 16,580 shares to the Company as consideration for this exercise. In September 2004, a second business partner exercised two stock purchase warrants which resulted in the issuance of 789,089 shares of common stock. Total exercise proceeds received by the Company for the September warrant exercise were $7.6 million.
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with the condensed financial statements and the related notes that appear elsewhere in this document.
FORWARD-LOOKING STATEMENTS
All statements, trend analysis and other information contained in this Form 10-Q that are not historical in nature are forward-looking statements within the meaning of the Private-Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, discussion relative to markets for our products and trends in revenue, gross margins and anticipated expense levels, as well as other statements including words such as anticipate, believe, plan, estimate, expect and intend and other similar expressions. All statements regarding our expected financial position and operating results, business strategy, financing plans, forecast trends relating to our industry are forward-looking statements. These forward-looking statements are subject to business and economic risks and uncertainties, and our actual results of operations may differ materially from those contained in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those mentioned in the discussion below. As a result, you should not place undue reliance on these forward-looking statements. We undertake no obligation to update or revise these forward-looking statements to reflect future events or developments.
Overview
Our goal is to create a global pharmaceutical company focused on in-licensing, developing and commercializing therapeutic products for the treatment of hematology and oncology patients. We were formed in August 1999 and commenced operations in January 2000 with the completion of our first round of equity financing. To date, we have licensed the rights to four products on either a global or regional basis. Three of these products are approved for marketing and are being sold by us, Innohep® in the U.S. and Refludan® in Europe and Australia. The third product, Vidaza®, was approved for marketing in the United States in May 2004 and we began selling it on July 1, 2004. We have filed for approval to market Vidaza in Europe and this submission is under review by European regulatory authorities. We are currently selling the fourth product, Thalidomide, in Europe and other international markets on a compassionate use or named patient basis while we pursue full regulatory marketing approval.