UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2005
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 0-19635
GENTA
INCORPORATED
(Exact name of Registrant as specified in its charter)
| Delaware | 33-0326866 | |
| (State or other
jurisdiction of incorporation or organization) |
(I.R.S. Employer
Identification Number) |
|
| Two Connell Drive
Berkeley Heights, NJ |
07922 | |
| (Address of principal executive offices) | (Zip Code) |
(908)
286-9800
(Registrant's 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 þ | No o |
Indicate
by check mark whether the registrant is an accelerated filer (as defined in
Rule 12b-2 of the Securities Exchange Act of 1934).
| Yes þ | No o |
As of April 29, 2005, the registrant had 95,358,215 shares of common stock outstanding.
Genta
Incorporated
INDEX TO FORM 10-Q
| PART I. | FINANCIAL INFORMATION | |||||
| Item 1. | Financial Statements: | |||||
| Consolidated Balance Sheets at March 31, 2005 | ||||||
| and December 31, 2004 | 3 | |||||
| Consolidated Statements of Operations for the | ||||||
| Three Months Ended March 31, 2005 and 2004 | 4 | |||||
| Consolidated Statements of Cash Flows for the | ||||||
| Three Months Ended March 31, 2005 and 2004 | 5 | |||||
| Notes to Consolidated Financial Statements | 6 | |||||
| Item 2. | Managements Discussion and Analysis of Financial Condition | |||||
| and Results of Operations | 14 | |||||
| Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 20 | ||||
| Item 4. | Controls and Procedures | 20 | ||||
| PART II. | OTHER INFORMATION | |||||
| Item 1. | Legal Proceedings | 22 | ||||
| Item 6. | Exhibits | 22 | ||||
| SIGNATURES | 24 | |||||
| CERTIFICATIONS | 26 | |||||
2
Table of Contents
GENTA
INCORPORATED
CONSOLIDATED BALANCE SHEETS
| (In thousands, except par value data) | ||||||||
| ASSETS | March
31, 2005 |
December
31, 2004 |
||||||
| |
|
|||||||
| (Unaudited) | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,522 | $ | 36,489 | ||||
| Marketable securities (Note 3) | 15,693 | 5,758 | ||||||
| Inventory (Note 4) | 339 | 354 | ||||||
| Prepaid expenses and other current assets | 1,326 | 1,910 | ||||||
| Total current assets | 32,880 | 44,511 | ||||||
| Property and equipment, net (Note 5) | 2,335 | 2,847 | ||||||
| Intangibles, net (Note 6) | 142 | 286 | ||||||
| Prepaid royalties | 1,268 | 1,268 | ||||||
| Other assets | 1,626 | 1,620 | ||||||
| Total assets | $ | 38,251 | $ | 50,532 | ||||
| |
|
|||||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 10,277 | $ | 14,424 | ||||
| Deferred revenues, current portion | 7,790 | 26,228 | ||||||
| Notes payable | 289 | 816 | ||||||
| Short term debt (Note 7) | 4,114 | 7,312 | ||||||
| Total current liabilities and total liabilities | 22,470 | 48,780 | ||||||
| Commitments and contingencies (Note 11) | ||||||||
| Stockholders equity: | ||||||||
| Series A convertible preferred stock, $.001 par value; | ||||||||
| 5,000 shares authorized, 10 shares issued and outstanding, | ||||||||
| liquidation value of $485 at March 31, 2005 and December 31, 2004 | | | ||||||
| Common stock, $.001 par value; 150,000 shares authorized, | ||||||||
| 95,358 shares issued and outstanding at March 31, 2005 | ||||||||
| and December 31, 2004 | 95 | 95 | ||||||
| Additional paid-in capital | 357,714 | 357,714 | ||||||
| Accumulated deficit | (341,959 | ) | (355,984 | ) | ||||
| Deferred compensation | (30 | ) | (41 | ) | ||||
| Accumulated other comprehensive loss | (39 | ) | (32 | ) | ||||
| Total stockholders equity | 15,781 | 1,752 | ||||||
| Total liabilities and stockholders equity | $ | 38,251 | $ | 50,532 | ||||
| |
|
|||||||
See accompanying notes to consolidated financial statements.
3
GENTA
INCORPORATED
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended March 31, | ||||||||
| (In thousands, except per share data) | 2005 | 2004 | ||||||
| |
|
|||||||
| (Unaudited) | ||||||||
| Revenues: | ||||||||
| License fees and royalties | $ | 3,684 | $ | 261 | ||||
| Development funding | 14,754 | 1,049 | ||||||
| Product sales - net | 76 | 372 | ||||||
| Total revenues | 18,514 | 1,682 | ||||||
| Cost of goods sold | 15 | 93 | ||||||
| Gross margin | 18,499 | 1,589 | ||||||
| Costs and expenses: | ||||||||
| Research and development (including non-cash compensation expense | ||||||||
| related to certain stock options issued in 1999 and 2000 of $52 | ||||||||
| for the three months ended March 31, 2004) | 3,870 | 12,353 | ||||||
| Selling, general and administrative (including non-cash compensation | ||||||||
| expense related to certain stock options issued in 1999 and 2000 | ||||||||
| of $11 and $18 for the three months ended March 31, 2005 | ||||||||
| and March 31, 2004, respectively) | 3,986 | 9,224 | ||||||
| Total costs and expenses - gross | 7,856 | 21,577 | ||||||
| Aventis reimbursement | (3,252 | ) | (7,433 | ) | ||||
| Total costs and expenses - net | 4,604 | 14,144 | ||||||
| Other income | 130 | 23 | ||||||
| Net income/(loss) | 14,025 | (12,532 | ) | |||||
| Net income/(loss) per basic and diluted share (Note 9) | $ | 0.15 | $ | (0.16 | ) | |||
| Shares used in computing net income/(loss) per | ||||||||
| basic and diluted share | 95,358 | 76,859 | ||||||
See accompanying notes to consolidated financial statements.
4
GENTA
INCORPORATED
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Three Months Ended March 31, | ||||||||
| (In thousands) | 2005 | 2004 | ||||||
| |
|
|||||||
| (Unaudited) | ||||||||
| Operating activities: | ||||||||
| Net income/(loss) | $ | 14,025 | $ | (12,532 | ) | |||
| Items reflected in net income/(loss) not requiring cash: | ||||||||
| Depreciation and amortization | 663 | 787 | ||||||
| Non-cash reimbursement of research & development expense (Note 7) | (3,252 | ) | | |||||
| Amortization of deferred revenues | (18,438 | ) | (1,309 | ) | ||||
| Compensation expense related to certain stock options issued in 1999 and 2000 | 11 | 70 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | | 7,730 | ||||||
| Inventory (Note 4) | 15 | (6,178 | ) | |||||
| Notes receivable | | (845 | ) | |||||
| Prepaid expenses and other current assets | 584 | 1,099 | ||||||
| Accounts payable and accrued expenses | (4,093 | ) | (3,114 | ) | ||||
| Other assets | (6 | ) | | |||||
| Net cash used in operating activities | (10,491 | ) | (14,292 | ) | ||||
| Investing activities: | ||||||||
| Purchase of marketable securities (Note 3) | (9,942 | ) | (7,281 | ) | ||||
| Maturities and sales of marketable securities (Note 3) | | 33,735 | ||||||
| Purchase of property and equipment | (7 | ) | (1,409 | ) | ||||
| Net cash (used in)/provided by investing activities | (9,949 | ) | 25,045 | |||||
| Financing activities: | ||||||||
| Repayments of note payable | (527 | ) | | |||||
| Deferred financing costs | | (33 | ) | |||||
| Issuance of common stock upon exercise of warrants and options | | 276 | ||||||
| Net cash (used in)/provided by financing activities | (527 | ) | 243 | |||||
| Decrease/(increase) in cash and cash equivalents | (20,967 | ) | 10,996 | |||||
| Cash and cash equivalents at beginning of period | 36,489 | 25,153 | ||||||
| Cash and cash equivalents at end of period | $ | 15,522 | $ | 36,149 | ||||
See accompanying notes to consolidated financial statements
5
GENTA
INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2005
(Unaudited)
| 1. | Organization and Business |
Genta
Incorporated (Genta or the Company) is a biopharmaceutical
company engaged in pharmaceutical (drug) research and development, its sole
reportable segment. The Company is dedicated to the identification, development and
commercialization of novel drugs for the treatment of cancer and related diseases.
The
Company has had recurring operating losses since its inception. Management expects
that such losses will continue at least until its lead product, Genasense®,
receives approval from the U.S. Food and Drug Administration (FDA) for
commercial sale in one or more indications. Achievement of profitability for the
Company is dependent on the timing of Genasense® regulatory approvals in the
U.S. and outside the U.S.
Genta
has completed and announced the results of Phase 3 trials of Genasense in combination
with chemotherapy in the treatment of malignant melanoma, chronic lymphocytic
leukemia (CLL) and multiple myeloma. The Company is currently evaluating
possible regulatory filings in the U.S. and/or Europe for approvals of Genasense in
combination with chemotherapy for the treatment of CLL and malignant melanoma.
In addition to the three Phase 3 trials, the Company is conducting (under its
own sponsorship or in conjunction with various cooperative groups) randomized
trials in non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC),
acute myeloid leukemia (AML) and prostate cancer. Genta is also conducting a
number of non-randomized clinical trials in patients with various types of
cancer, either under its own sponsorship or in collaboration with the National
Cancer Institute (NCI).
Genta
markets Ganite® (gallium nitrate injection) for the treatment of cancer-related
hypercalcemia. In May 2004, the Company eliminated its sales force and
significantly reduced its marketing support for Ganite®.
A
significant source of funds during the last several years has been from the
Companys collaboration with Aventis, a member of the sanofi-aventis Group (Aventis),
regarding the development and commercialization of Genasense®. On November 8,
2004 Aventis gave six-month notice to Genta that it was terminating its
collaborative agreements with the Company. Pursuant to those agreements, Aventis
continued to fund ongoing development activities through the termination notice
period. Although no assurances can be expressed, management believes that at the
current rate of spending, the Company should have sufficient cash funds to maintain
its present operations through 2005. There are a number of alternatives available
to the Company to sustain its operations beyond 2005 should there be a delay in
approval of Genasense®.
The
Company may also seek collaborative agreements, equity financing and other
financing arrangements with potential corporate partners and other sources.
However, there can be no assurance that any such collaborative agreements or
other sources of funding will be available on favorable terms, if at all. The
Company will need substantial additional funds before it can expect to realize
significant product revenue.
6
| 2. | Summary of Significant Accounting Policies |
Basis of
Presentation
The
consolidated financial statements are presented on the basis of accounting
principles generally accepted in the United States. All professional accounting
standards have been considered in preparing the consolidated financial
statements. Such financial statements include the accounts of the Company and
all majority-owned subsidiaries. The preparation of financial statements in
conformity with generally accepted accounting principles requires management to
make certain estimates and assumptions that affect reported earnings, financial
position and various disclosures. Actual results could differ from those
estimates. Certain reclassifications have been made to prior-year amounts to
conform to the current-year presentation. The unaudited condensed consolidated
financial statements and related disclosures have been prepared with the
presumption that users of the interim financial information have read or have
access to the audited financial statements for the preceding fiscal year.
Accordingly, these financial statements should be read in conjunction with the
audited consolidated financial statements and the related notes thereto included
in the Company's Annual Report on Form 10-K for the fiscal year ended December
31, 2004. Results for interim periods are not necessarily indicative of results
for the full year. The Company has experienced significant quarterly fluctuations
in operating results and it expects those fluctuations will continue.
Revenue
Recognition
In
April 2002, the Company entered into a development and commercialization agreement (Collaborative
Agreement) with Aventis. Under the terms of the Collaborative Agreement, the
Company and Aventis would jointly develop and commercialize Genasense® in the
U.S., and Aventis would have exclusive development and marketing rights to the
compound in all countries outside of the U.S. Under the Collaborative
Agreement, Aventis would pay 75% of U.S. New Drug Application (NDA)-directed
development costs incurred by either Genta or Aventis, subsequent to the execution
of the Collaborative Agreement, and 100% of all other development, marketing, and
sales costs incurred within the U.S. and elsewhere as subject to the
Collaborative Agreement. On November 8, 2004 Aventis gave six-month notice to Genta
that it was terminating its Collaborative Agreement with the Company. Under the
terms of the agreement, Aventis continued to fund ongoing development activities
through the termination notice period.
The
Company follows the provisions of the Securities and Exchange Commissions
Staff Accounting Bulletin (SAB) No. 104, Revenue Recognition and Emerging Issues
Task Force (EITF) No. 00-21, Accounting for Revenue Arrangements with Multiple
Deliverables.
In
accordance with EITF No. 00-21 the Company analyzes its multiple element
arrangements to determine whether the elements can be separated and accounted for
individually as separate units of accounting. The Company recognizes license
payments as revenue if the license has stand-alone value and the fair value of the
undelivered items can be determined. If the license is considered to have
stand-alone value but the fair value on any of the undelivered items cannot be
determined, the license payments are recognized as revenue over the period of
performance for such undelivered items or services. The Companys estimate of
the period of performance involves management judgment. Amounts received for
milestones are recognized upon achievement of the milestone, as long as the
milestone is deemed to be substantive and the Company has no other
performance obligations.
The
Company determined that, due to the nature of the ongoing development work
related to its Collaborative Agreement with Aventis, the end of the development
phase and the fair value of the undelivered elements were not determinable.
Accordingly, the Company deferred recognition of the initial licensing fee and
up-front development funding received from Aventis and recognized these payments on
a straight-line basis over the original estimated useful life of the related
first-to-expire patent of 115 months. As a result of the notice of termination of the
agreement with Aventis, the Company determined that the period over which the
remaining deferred revenue should be recognized will be through May 8, 2005. In
accordance with EITF No. 00-21 and SAB No. 104, the Company has reclassified the
remaining deferred revenue as current and will recognize such revenue through May 8,
2005.
7
Genta
recognizes revenue from product sales when title to product and associated risk of
loss has passed to the customer and the Company is reasonably assured of
collecting payment for the sale. All revenue from product sales are recorded net
of applicable allowances for returns, rebates and other applicable discounts and
allowances. The Company allows return of its product for up to twelve months after
product expiration. In December 2004, a wholesaler contacted the Company to return a
significant portion of its inventory of Ganite®. The Company agreed to the return
of this product and recorded a provision for sales returns, as well as provided
for potential returns from other wholesalers. In January 2005, the wholesaler
returned $0.5 million of Ganite®. At March 31, 2005, the Companys
provision for sales returns was $0.8 million.
Research and
Development
Research
and development costs are expensed as incurred, including raw material costs
required to manufacture products for clinical trials. Reimbursements for applicable
Genasense®-related costs, under the Collaborative Agreement, have been recorded
as a reduction to expenses in the Consolidated Statement of Operations.
Cash, Cash
Equivalents and Marketable Securities
The
carrying amounts of cash, cash equivalents and marketable securities approximate
fair value due to the short-term nature of these instruments. Marketable
securities primarily consist of government securities, all of which are
classified as available-for-sale marketable securities. Management determines the
appropriate classification of securities at the time of purchase and reassesses
the classification at each reporting date.
Property and
Equipment
Property and equipment is stated at cost and depreciated on the straight-line method over the estimated useful lives of the assets, ranging from three to five years. Leasehold improvements incurred in the renovation of the Companys current offices are being amortized over the remaining life of the leases. The Companys policy is to evaluate the appropriateness of the carrying value of the undepreciated value of long-lived assets. If such evaluation were to indicate an impairment of assets, such impairment would be recognized by a write-down of the applicable assets. Based on the valuation, no impairment was indicated in accordance with Statement of Financial Accounting Standards