Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 September 30, 2009
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: 0-24274
LA JOLLA PHARMACEUTICAL COMPANY
(Exact name of registrant as specified in its charter)
|
|
|
Delaware
|
|
33-0361285 |
(State or other jurisdiction of
|
|
(I.R.S. Employer |
incorporation or organization)
|
|
Identification No.) |
|
|
|
4365 Executive Drive, Suite 300
|
|
|
San Diego, CA
|
|
92121 |
(Address of principal executive offices)
|
|
(Zip Code) |
Registrants telephone number, including area code: (858) 452-6600
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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See definition of large accelerated filer
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o |
Accelerated filer þ |
Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
The number of shares of the registrants common stock, $0.01 par value per share, outstanding at
November 12, 2009 was 65,722,648.
LA JOLLA PHARMACEUTICAL COMPANY
FORM 10-Q
QUARTERLY REPORT
INDEX
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS UNAUDITED
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(Unaudited) |
|
|
(See Note) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,830 |
|
|
$ |
9,447 |
|
Short-term investments |
|
|
|
|
|
|
10,000 |
|
Prepaids and other current assets |
|
|
746 |
|
|
|
785 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
6,576 |
|
|
|
20,232 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
|
|
|
|
357 |
|
Patent costs and other assets, net |
|
|
|
|
|
|
250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
6,576 |
|
|
$ |
20,839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
692 |
|
|
$ |
4,626 |
|
Accrued clinical/regulatory expenses |
|
|
|
|
|
|
3,957 |
|
Accrued expenses |
|
|
235 |
|
|
|
1,008 |
|
Accrued payroll and related expenses |
|
|
98 |
|
|
|
1,549 |
|
Credit facility |
|
|
|
|
|
|
5,933 |
|
Current portion of obligations under notes payable |
|
|
|
|
|
|
152 |
|
Current portion of obligations under capital leases |
|
|
|
|
|
|
11 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
1,025 |
|
|
|
17,236 |
|
|
|
|
|
|
|
|
|
|
Noncurrent portion of obligations under notes payable |
|
|
|
|
|
|
179 |
|
Noncurrent portion of obligations under capital leases |
|
|
|
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
Commitments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
657 |
|
|
|
555 |
|
Additional paid-in capital |
|
|
427,574 |
|
|
|
418,522 |
|
Accumulated deficit |
|
|
(422,680 |
) |
|
|
(415,687 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
5,551 |
|
|
|
3,390 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
6,576 |
|
|
$ |
20,839 |
|
|
|
|
|
|
|
|
Note: The condensed consolidated balance sheet at December 31, 2008 has been derived from the
audited consolidated financial statements as of that date but does not include all of the
information and disclosures required by U.S. generally accepted accounting principles.
See accompanying notes.
1
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from collaboration agreement |
|
$ |
|
|
|
$ |
|
|
|
$ |
8,125 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(240 |
) |
|
|
14,099 |
|
|
|
9,567 |
|
|
|
38,170 |
|
General and administrative |
|
|
992 |
|
|
|
2,791 |
|
|
|
5,602 |
|
|
|
6,766 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
|
752 |
|
|
|
16,890 |
|
|
|
15,169 |
|
|
|
44,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(752 |
) |
|
|
(16,890 |
) |
|
|
(7,044 |
) |
|
|
(44,936 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
|
54 |
|
|
|
163 |
|
|
|
64 |
|
|
|
653 |
|
Interest expense |
|
|
|
|
|
|
(12 |
) |
|
|
(13 |
) |
|
|
(71 |
) |
Realized loss on investments, net |
|
|
|
|
|
|
(395 |
) |
|
|
|
|
|
|
(1,352 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(698 |
) |
|
$ |
(17,134 |
) |
|
$ |
(6,993 |
) |
|
$ |
(45,706 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.01 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.96 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and
diluted net loss per share |
|
|
65,723 |
|
|
|
55,327 |
|
|
|
62,555 |
|
|
|
47,764 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
2
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
Operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,993 |
) |
|
$ |
(45,706 |
) |
Adjustments to reconcile net loss to net cash used for
operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
116 |
|
|
|
758 |
|
(Gain) loss on write-off/disposal of patents and
property and equipment |
|
|
(326 |
) |
|
|
193 |
|
Share-based compensation expense |
|
|
2,344 |
|
|
|
3,400 |
|
Expense reduction from settlement of vendor obligations |
|
|
(2,645 |
) |
|
|
|
|
Realized loss on investments, net |
|
|
|
|
|
|
1,352 |
|
Amortization of premium on investments |
|
|
|
|
|
|
341 |
|
Change in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaids and other current assets |
|
|
39 |
|
|
|
33 |
|
Accounts payable and accrued liabilities |
|
|
(6,019 |
) |
|
|
491 |
|
Accrued payroll and related expenses |
|
|
(1,451 |
) |
|
|
29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used for operating activities |
|
|
(14,935 |
) |
|
|
(39,109 |
) |
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
Sales of short-term investments |
|
|
10,000 |
|
|
|
24,665 |
|
Net proceeds from sale of patents and property and equipment |
|
|
841 |
|
|
|
43 |
|
Additions to property and equipment |
|
|
(18 |
) |
|
|
(484 |
) |
Increase in patent costs and other assets |
|
|
(6 |
) |
|
|
(179 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
10,817 |
|
|
|
24,045 |
|
|
|
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
Net proceeds from issuance of common stock |
|
|
|
|
|
|
28,263 |
|
Net proceeds from issuance of preferred stock |
|
|
6,810 |
|
|
|
|
|
Payments on credit facility |
|
|
(5,933 |
) |
|
|
|
|
Payments on obligations under notes payable |
|
|
(331 |
) |
|
|
(112 |
) |
Payments on obligations under capital leases |
|
|
(45 |
) |
|
|
(6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
501 |
|
|
|
28,145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(3,617 |
) |
|
|
13,081 |
|
Cash and cash equivalents at beginning of period |
|
|
9,447 |
|
|
|
4,373 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
5,830 |
|
|
$ |
17,454 |
|
|
|
|
|
|
|
|
See accompanying notes.
3
LA JOLLA PHARMACEUTICAL COMPANY
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2009
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of La Jolla Pharmaceutical
Company and its wholly-owned subsidiary (the Company) have been prepared in accordance with U.S.
generally accepted accounting principles (GAAP) for interim financial information and with the
instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all
of the information and disclosures required by GAAP for complete financial statements. In the
opinion of management, all adjustments (consisting of normal recurring accruals, including
restructuring costs and settlement of liabilities) considered necessary for a fair presentation
have been included. Operating results for the three and nine months ended September 30, 2009 are
not necessarily indicative of the results that may be expected for other quarters or the year
ending December 31, 2009. For more complete financial information, these unaudited condensed
consolidated financial statements, and the notes thereto, should be read in conjunction with the
audited consolidated financial statements for the year ended December 31, 2008 included in the
Companys Form 10-K filed with the Securities and Exchange Commission on March 31, 2009.
In
February 2009, the Company announced that an Independent Monitoring Board for the Riquent ® Phase
3 ASPEN study had completed its review of the first interim efficacy analysis and determined that
continuing the study was futile. Based on these results, the Company immediately discontinued the
Riquent Phase 3 ASPEN study and the development of Riquent. The Company had previously devoted
substantially all of its research, development and clinical efforts and financial resources toward
the development of Riquent. In connection with the termination of the clinical trials for Riquent,
the Company subsequently initiated steps to significantly reduce its operating costs, including a
reduction in force, which was effected in April 2009 (see Note 6), and ceased all Riquent
manufacturing and regulatory activities.
In July 2009, the Company announced that, in light of the current alternatives available to the
Company, a wind down of the Companys business would be in the best interests of the Company and
its stockholders. Although the Board of Directors (the Board) approved a Plan of Complete
Liquidation and Dissolution (the Plan of Dissolution) in September 2009, it is subject to
approval by holders of at least a majority in voting power of the Companys outstanding shares. The
Company has called a special meeting of stockholders to vote on the Plan of Dissolution, however to
date, the majority of the Companys stockholders have failed to return
their proxy cards or otherwise indicate their votes with respect to this proposal.
The Company has not changed its basis of accounting as a result of the Boards adoption of the Plan
of Dissolution, given that the Plan of Dissolution cannot be implemented without stockholder
approval. Should the dissolution of the Company pursuant to the Plan of Dissolution be approved by
the required vote of its stockholders, the Company would then change its basis of accounting from
the going concern basis to the liquidation basis. If the
Companys stockholders do not approve the dissolution of the
Company pursuant to the Plan of Dissolution, the Board will explore
what, if any, alternatives are available for the future of the
Company.
The accompanying unaudited condensed consolidated financial statements have been prepared assuming
that the Company will continue as a going concern. This basis of accounting contemplates the
recovery of the Companys assets and the satisfaction of liabilities in the normal course of
business and this does not include any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts and classification of liabilities that
might be necessary should the Company be unable to continue as a going concern or should the
4
dissolution of the Company pursuant to the Plan of Dissolution be approved by the Companys
stockholders. Certain assets, such as prepaid insurance (which represents a significant component
of prepaids and other current assets), could have significantly lower values, or no value, under
the liquidation basis of accounting. While the basis of presentation remains that of a going
concern, the Company has a history of recurring losses from operations, and as of September 30,
2009, the Company had an accumulated deficit of $422,680,000, available cash and cash equivalents
of $5,830,000 and working capital of $5,551,000. These factors, as
well as the Companys current inability to generate future cash
flows and the potential
stockholder approval of the Plan of Dissolution, raise substantial doubt about the Companys
ability to continue as a going concern.
2. Accounting Policies
Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements include the accounts of La
Jolla Pharmaceutical Company and its wholly-owned subsidiary, La Jolla Limited, which was
incorporated in England in October 2004. There have been no significant transactions related to La
Jolla Limited since its inception. La Jolla Limited was formally
dissolved during October 2009 with no resulting accounting
consequences.
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to
make estimates and assumptions that affect the amounts reported in the unaudited condensed
consolidated financial statements and disclosures made in the accompanying notes to the unaudited
condensed consolidated financial statements. Actual results could differ materially from those
estimates.
Recent Accounting Pronouncements
In June 2009, the Financial Accounting Standards Board (FASB) approved the FASB Accounting
Standards Codification (the Codification) when it issued
Statement of Financial Accounting Standards No. 168, The FASB Accounting
Standards Codification and the Hierarchy of Generally Accepted Accounting Principles, which is
included in The Accounting Standards Codification
(ASC) Topic of Generally Accepted Accounting
Principles (the Topic). All existing accounting standard documents, such as FASB, American
Institute of Certified Public Accountants, Emerging Issues Task Force and other related literature,
excluding guidance from the Securities and Exchange Commission (SEC), have been superseded by the
Codification. All other non-grandfathered, non-SEC accounting literature not included in the
Codification has become non-authoritative. The Codification did not change GAAP, but instead
introduced a new structure that combines all authoritative standards into a comprehensive,
topically-organized online database. The Topic is effective for financial statements issued for
interim and annual periods ending after September 15, 2009. The
Topic impacts the Companys
financial statement disclosures as all future references to authoritative accounting literature
will be referenced in accordance with the Codification. As a result of the implementation of the
Codification during the quarter ended September 30, 2009, previous references to accounting
standards and literature are no longer applicable.
Effective
April 1, 2009, the Company implemented The ASC Topic of
Subsequent Events. This
guidance establishes general standards of accounting for and disclosure of events that occur after
the balance sheet date and requires companies to disclose the date through which subsequent events
have been evaluated, as well as whether that date is the date the financial statements were issued
or the date the financial statements were available to be issued.
The ASC Topic of Subsequent Events became effective for
interim or annual periods ending after June 15, 2009 and did not have a material impact on the
Companys unaudited condensed consolidated financial statements for the three and nine months ended
September 30, 2009.
5
Revenue Recognition
On January 4, 2009, the Company entered into a development and commercialization agreement (the
Development Agreement) with BioMarin CF Limited (BioMarin CF), a wholly-owned subsidiary of
BioMarin Pharmaceutical Inc. (BioMarin Pharma). The Development Agreement was terminated on March
27, 2009 following the failure of the Phase 3 ASPEN trial. See Note 4 for further details related
to the Development Agreement.
The Company considers a variety of factors in determining the appropriate method of revenue
recognition under collaborative arrangements, such as whether the elements are separable, whether
there are determinable fair values and whether there is a unique earnings process associated with
each element of a contract.
Net Loss Per Share
Basic and diluted net loss per share is computed using the weighted-average number of common shares
outstanding during the periods. Basic earnings per share (EPS) is calculated by dividing the net
income or loss by the weighted-average number of common shares outstanding for the period, without
consideration for common share equivalents. Diluted EPS is computed by dividing the net income or
loss by the weighted-average number of common share equivalents outstanding for the period
determined using the treasury-stock method. For purposes of this calculation, stock options,
and warrants are considered to be common stock
equivalents and are only included in the calculation of diluted EPS when their effect is dilutive.
Because the Company has incurred a net loss for all periods presented in the unaudited condensed
consolidated statements of operations, stock options and warrants are not included in the
computation of net loss per share because their effect is anti-dilutive. The shares used to
compute basic and diluted net loss per share represent the weighted-average common shares
outstanding.
Comprehensive Loss
Unrealized gains and losses on available-for-sale securities are included in other comprehensive
income (loss). There were no unrealized gains or losses on available-for-sale securities for the
three or nine months ended September 30, 2009, and therefore net loss is equal to comprehensive
loss for these periods. The Companys comprehensive net loss was $17,133,000 and $45,719,000 for
the three and nine months ended September 30, 2008, respectively.
Impairment of Long-Lived Assets and Assets to Be Disposed Of
If indicators of impairment exist, the Company assesses the recoverability of the affected
long-lived assets by determining whether the carrying value of such assets can be recovered through
the undiscounted future operating cash flows.
As a result of the futility determination in the Phase 3 ASPEN trial, the Company discontinued the
Riquent Phase 3 ASPEN study and the development of Riquent. Based on these events, the future cash
flows from the Companys Riquent-related patents are no longer expected to exceed their carrying
values and the assets became impaired as of December 31, 2008. This rendered substantially all of
the Companys laboratory equipment, as well as a large portion of its furniture and fixtures and
computer equipment and software, impaired as of December 31, 2008.
The Company recorded a non-cash charge for the impairment of long-lived assets of $2,810,000 for
the year ended December 31, 2008 to write down the value of the Companys long-lived assets to
their estimated fair values. The Company sold, disposed of, or wrote off all of its remaining long-lived assets during the nine months ended September 30, 2009 for a gain of $326,000.
6
3. Fair Value of Financial Instruments
Fair
value is defined under The ASC Topic of Fair Value Measurements and Disclosures as
the exchange price that would be received for an asset or paid to transfer a liability (an exit
price) in the principal or most advantageous market for the asset or liability in an orderly
transaction between market participants on the measurement date. Valuation techniques used to
measure fair value under The ASC Topic of Fair Value Measurements
and Disclosures must maximize the use of observable inputs and minimize the use
of unobservable inputs. The standard describes a fair value hierarchy based on three levels of
inputs, of which the first two are considered observable and the last unobservable, that may be
used to measure fair value which are the following:
|
|
|
Level 1 Quoted prices in active markets for identical assets or liabilities. |
|
|
|
|
Level 2 Inputs other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or liabilities; quoted
prices in markets that are not active; or other inputs that are observable or
can be corroborated by observable market data for substantially the full term
of the assets or liabilities. |
|
|
|
|
Level 3 Unobservable inputs that are supported by little or no market
activity and that are significant to the fair value of the assets or
liabilities. |
As of September 30, 2009, cash and cash equivalents were comprised of cash in checking accounts.
The Company held no investments as of September 30, 2009.
As of December 31, 2008, cash and cash equivalents were comprised of short-term, highly liquid
investments with maturities of 90 days or less from the date of purchase. Investments were
comprised of available-for-sale securities recorded at estimated fair value determined using level
3 inputs. Unrealized gains and losses associated with the Companys investments, if any, were
reported in stockholders equity.
At December 31, 2008, short-term investments were comprised of $10,000,000 invested in auction rate
securities, which were sold to UBS at par value in January 2009 pursuant to an Auction Rate
Securities Agreement executed in November 2008.
4. Development and Stock Purchase Agreements
On January 4, 2009, the Company entered into the Development Agreement with BioMarin CF, a
wholly-owned subsidiary of BioMarin Pharma, granting BioMarin CF co-exclusive rights to develop and
commercialize Riquent (and certain potential follow-on products) (collectively, Riquent) in the
Territory, and the non-exclusive right to manufacture Riquent anywhere in the world. The
Territory includes all countries of the world except the Asia-Pacific Territory (i.e., all
countries of East Asia, Southeast Asia, South Asia, Australia, New Zealand, and other countries of
Oceania).
Under the terms of the Development Agreement, BioMarin CF paid the Company a non-refundable
commencement payment of $7,500,000 and purchased, through BioMarin Pharma, $7,500,000 of a newly
designated series of preferred stock (the Series B-1 Preferred Stock), pursuant to a related
securities purchase agreement described more fully below.
Following the futile results of the first interim efficacy analysis of Riquent received in February
2009, BioMarin CF elected not to exercise its full license rights to the Riquent program under the
Development Agreement. Thus, the Development Agreement between the parties terminated on March 27,
2009 in accordance with its terms. All rights to Riquent were returned to the Company.
7
Accordingly, the $7,500,000 non-refundable commencement payment received in connection with this
Development Agreement was recorded as revenue in the quarter ended March 2009.
In connection with the Development Agreement, the Company also entered into a securities purchase
agreement, dated as of January 4, 2009 with BioMarin Pharma. In accordance with the terms of the
agreement, on January 20, 2009, the Company sold 339,104 shares of Series B-1 Preferred Stock at a
price per share of $22.1171 and received $7,500,000. On March 27, 2009, in connection with the
termination of the Development Agreement, the Series B-1 Preferred Stock converted into 10,173,120
shares of Common Stock pursuant to the terms of the securities purchase agreement. The total sales
price included a premium over the fair value of the stock issued of $625,000, which was recorded as
revenue in the quarter ended March 31, 2009.
5. Stockholders Equity
Share-Based Compensation
In June 1994, the Company adopted the La Jolla Pharmaceutical Company 1994 Stock Incentive Plan
(the 1994 Plan), under which, as amended, 1,640,000 shares of common stock were authorized for
issuance. The 1994 Plan expired in June 2004 and there were 499,935 options outstanding under the
1994 Plan as of September 30, 2009.
In May 2004, the Company adopted the La Jolla Pharmaceutical Company 2004 Equity Incentive Plan
(the 2004 Plan), under which, as amended, 6,400,000 shares of common stock have been authorized
for issuance. The 2004 Plan provides for the grant of incentive and non-qualified stock options, as
well as other share-based payment awards, to employees, directors, consultants and advisors of the
Company with up to a 10-year contractual life and various vesting periods as determined by the
Companys Compensation Committee or the Board of Directors, as well as automatic fixed grants to
non-employee directors of the Company. As of September 30, 2009, there were a total of 3,315,958
options outstanding under the 2004 Plan and 2,804,822 shares remained available for future grant.
In August 1995, the Company adopted the La Jolla Pharmaceutical Company 1995 Employee Stock
Purchase Plan (the ESPP), under which, as amended, 850,000 shares of common stock are reserved
for sale to eligible employees, as defined in the ESPP. Employees may purchase common stock under
the ESPP every three months (up to but not exceeding 10% of each employees base salary or hourly
compensation, and any cash bonus paid, subject to certain limitations) over the offering period at
85% of the fair market value of the common stock at specified dates. The offering period may not
exceed 24 months. As of September 30, 2009, 833,023 shares of common stock have been issued under
the ESPP and 16,977 shares of common stock are available for future issuance.
Options or stock awards issued to non-employees, other than non-employee directors, are
periodically remeasured as the options vest.
Share-based compensation expense recognized for the three months ended September 30, 2009 and 2008
was $311,000 and $1,119,000, respectively, and $2,344,000 and $3,409,000 for the nine months ended
September 30, 2009 and 2008, respectively. As of September 30, 2009, there was $941,000 of total
unrecognized compensation cost related to non-vested share-based payment awards granted under all
equity compensation plans. Total unrecognized compensation cost will be adjusted for future changes
in estimated forfeitures. The Company expects to recognize this compensation cost over a
weighted-average period of 1.1 years.
The following table summarizes share-based compensation expense related to employee and director
stock options, restricted stock and ESPP purchases by expense category:
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(in thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
Research and development |
|
$ |
|
|
|
$ |
563 |
|
|
$ |
632 |
|
|
$ |
1,565 |
|
General and administrative |
|
|
311 |
|
|
|
556 |
|
|
|
1,712 |
|
|
|
1,844 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
expense included in
operating expenses |
|
$ |
311 |
|
|
$ |
1,119 |
|
|
$ |
2,344 |
|
|
$ |
3,409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company determines the fair value of share-based payment awards on the date of grant using the
Black-Scholes option-pricing model, which is affected by the Companys stock price as well as
assumptions regarding a number of highly complex and subjective variables. Option-pricing models
were developed for use in estimating the value of traded options that have no vesting or hedging
restrictions and are fully transferable. Although the fair value of the employee and director stock
options granted by the Company is determined using an option-pricing model, that value may not be
indicative of the fair value observed in a willing-buyer/willing-seller market transaction.
The Company estimated the fair value of each option grant and ESPP purchase right on the date of
grant using the Black-Scholes option-pricing model with the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
Options: |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Risk-free interest rate |
|
|
|
|
|
|
3.3 |
% |
|
|
0.6 |
% |
|
|
3.2 |
% |
Dividend yield |
|
|
|
|
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility |
|
|
|
|
|
|
106.4 |
% |
|
|
295.0 |
% |
|
|
115.2 |
% |
Expected life (years) |
|
|
|
|
|
|
5.6 |
|
|
|
1.0 |
|
|
|
5.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
ESPP: |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Risk-free interest rate |
|
|
|
|
|
|
1.6 |
% |
|
|
|
|
|
|
1.7 |
% |
Dividend yield |
|
|
|
|
|
|
0.0 |
% |
|
|
|
|
|
|
0.0 |
% |
Volatility |
|
|
|
|
|
|
54.5 |
% |
|
|
|
|
|
|
65.8 |
% |
Expected life (months) |
|
|
|
|
|
|
3.0 |
|
|
|
|
|
|
|
3.0 |
|
There were no purchases under the ESPP for the three or nine months ended September 30, 2009.
There were no options granted in the three months ended September 30, 2009. The weighted-average
fair values of options granted was $1.18 for the three months ended September 30, 2008. The
weighted-average fair values of options granted were $1.72 and $1.71 for the nine months ended
September 30, 2009 and 2008, respectively. For the ESPP, the weighted-average purchase prices were
$0.95 and $1.29 for the three and nine months ended September 30, 2008, respectively.
A summary of the Companys stock option activity and related data for the nine months ended
September 30, 2009 follows:
9
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
|
|
|
|
Weighted- |
|
|
|
Number of |
|
|
Average |
|
|
|
Shares |
|
|
Exercise Price |
|
Balance at December 31, 2008 |
|
|
5,626,960 |
|
|
$ |
6.80 |
|
Granted |
|
|
691,875 |
|
|
$ |
1.73 |
|
Exercised |
|
|
|
|
|
$ |
|
|
Forfeited or expired |
|
|
(2,502,942 |
) |
|
$ |
5.23 |
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009 |
|
|
3,815,893 |
|
|
$ |
6.91 |
|
|
|
|
|
|
|
|
|
6. Restructuring Costs
In connection with the termination of the clinical trials for Riquent, the Company ceased all
manufacturing and regulatory activities related to Riquent and initiated steps to significantly
reduce its operating costs, including a reduction of force, resulting in the termination of 74
employees who received notification in February 2009 and were terminated in April 2009. The
Company recorded a charge of approximately $1,048,000 in the quarter ended March 31, 2009, of which
$668,000 was included in research and development and $380,000 was included in general and
administrative expense. The $1,048,000 was paid in May 2009.
7. Commitments and Contingencies
The Company leased two adjacent buildings in San Diego, California covering a total of
approximately 54,000 square feet. Both building leases expired in July 2009. Pursuant to one of the
leases, the Company was responsible for completing modifications to the leased building prior to
lease expiration. In July 2009, approximately $315,000 was paid in accordance with the lease
provisions upon lease expiration and exit of the buildings.
The Company renewed certain of its liability insurance policies in March 2009 covering future
periods.
In addition, the Company early terminated its operating leases during the quarter ended June 30,
2009, and as a result paid a termination fee of $100,000 in September 2009. There were no operating
leases remaining as of September 30, 2009.
8. Settlement of Liabilities
During the nine months ended September 30, 2009, the Company negotiated settlements related to
accounts payable obligations and accrued liabilities with a majority of its vendors. These
negotiations resulted in reductions to accounts payable obligations and accrued liabilities from
those amounts originally invoiced and accrued of approximately $765,000 and $2,645,000 for the
three and nine months ended September 30, 2009, respectively, which were recorded as expense
reductions upon the execution of the settlement agreements. As a result of these settlements,
during the quarter ended September 30, 2009 there were decreases of $711,000 and $54,000 to
research and development and general and administrative expenses, respectively. During the nine
months ended September 30, 2009 there were decreases of $2,499,000 and $146,000 to research and
development and general and administrative expenses, respectively.
In April 2009, the Company settled its notes payable obligations at face value.
10
9. Subsequent Events
No events subsequent to September 30, 2009 that require disclosure have occurred. The Company
evaluated subsequent events for disclosure through the time of filing on November 13, 2009, which
represents the date the financial statements were issued.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking Statements
The forward-looking statements in this report involve significant risks, assumptions and
uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to
differ materially from our current expectations. Forward-looking statements include those that
express a plan, belief, expectation, estimation, anticipation, intent, contingency, future
development or similar expression. The analysis of the data from our Phase 3 ASPEN trial of Riquent
showed that the trial did not reach statistical significance with respect to its primary endpoint,
delaying time to renal flare or for either secondary endpoint, improvement in proteinuria or time
to major SLE flare and we decided to stop the study as well as the
further development of Riquent. Accordingly, you should not rely upon
forward-looking statements as predictions of future events. The outcome of the events described in
these forward-looking statements are subject to the risks, uncertainties and other factors
described in Managements Discussion and Analysis of Financial Condition and Results of
Operations and in the Risk Factors contained in our Annual Report on Form 10-K for the year
ended December 31, 2008, and in other reports and registration statements that we file with the
Securities and Exchange Commission from time to time and as updated in Part II, Item 1.A. Risk
Factors contained in this Quarterly Report on Form 10-Q. We expressly disclaim any intent to
update forward-looking statements.
Overview and Recent Developments
Since our inception in May 1989, we have devoted substantially all of our resources to the
research and development of technology and potential drugs to treat antibody-mediated diseases. We
have never generated any revenue from product sales and have relied on public and private offerings
of securities, revenue from collaborative agreements, equipment financings and interest income on
invested cash balances for our working capital.
On January 4, 2009, we entered into a development and commercialization agreement (the
Development Agreement) with BioMarin CF Limited (BioMarin CF), a wholly-owned subsidiary of
BioMarin Pharmaceutical Inc. (BioMarin Pharma). Under the terms of the Development Agreement,
BioMarin CF was granted co-exclusive rights to develop and commercialize Riquent in the United
States, Europe and all other territories of the world, excluding the Asia Pacific region, and the
non-exclusive right to manufacture Riquent anywhere in the world. In connection with the
Development Agreement, we also entered into a securities purchase agreement with BioMarin Pharma.
In January 2009, BioMarin CF paid us a non-refundable commencement payment of $7.5 million pursuant
to the Development Agreement and BioMarin Pharma paid us $7.5 million in exchange for a newly
designated series of our preferred stock pursuant to the securities purchase agreement. As
described below, the Development Agreement was terminated on March 27, 2009.
In February 2009, we were informed by an Independent Monitoring Board for the Riquent Phase 3
ASPEN study that the monitoring board completed its review of the first interim efficacy analysis
of Riquent and determined that continuing the study was futile. We subsequently unblinded the data
and found that there was no statistical difference in the primary endpoint, delaying time to renal
flare, between the Riquent-treated group and the placebo-treated group, although there was a
significant difference in the reduction of antibodies to double-stranded DNA.
11
Based on these results, we immediately discontinued the Riquent Phase 3 ASPEN study and the
further development of Riquent. We had previously devoted substantially all of our research,
development and clinical efforts and financial resources toward the development of Riquent. In
connection with the termination of our clinical trials for Riquent, we subsequently initiated steps
to significantly reduce our operating costs, including a reduction in force, which was effected in
April 2009. We also ceased the manufacture of Riquent at our former facility in San Diego,
California, as well as all regulatory activities associated with Riquent. We recorded a charge of
approximately $1.1 million in the quarter ended March 31, 2009, of which $0.7 million was included
in research and development and $0.4 million was included in general and administrative expense.
This amount was paid in May 2009.
Following the futile results of the first interim efficacy analysis of Riquent, BioMarin CF
elected to not exercise its full license rights to the Riquent program under the Development
Agreement. Thus, the Development Agreement between the parties terminated on March 27, 2009 in
accordance with its terms. Pursuant to the Securities Purchase Agreement between us and BioMarin
Pharma, the Companys Series B-1 preferred shares purchased by BioMarin Pharma were automatically
converted into 10,173,120 shares of common stock upon the termination of the Development Agreement.
Additionally, all rights to Riquent were returned to us.
In January 2009, we sold all of our auction rate securities to our broker-dealer, UBS A.G.
(UBS) at par value of $10.0 million. As of December 31, 2008, we had previously recognized a
total impairment charge of $2.3 million as a result of the illiquidity of these securities, which
was fully offset by a realized gain of $2.3 million from UBSs repurchase agreement that provided
for a put option on these securities. Following the sale of these investments, we no longer hold
any auction-rate securities.
In July 2009, we announced that, in light of the current alternatives available to us, a wind
down of our business would be in the best interests of our stockholders. Although the Board of
Directors (the Board) approved a Plan of Complete Liquidation and Dissolution (the Plan of
Dissolution) in September 2009, it is subject to approval by holders of at least a majority in
voting power of our outstanding shares. We have called a special meeting of stockholders to vote on
the Plan of Dissolution however, to date, the majority of our
stockholders failed to return their proxy cards or otherwise indicate their votes with respect to
this proposal prior to the start of these stockholders meetings.
We have not changed our basis of accounting as a result of the Boards adoption of the Plan of
Dissolution, given that the Plan of Dissolution cannot be implemented without stockholder approval.
Should the dissolution of the Company pursuant to the Plan of Dissolution be approved by the
required vote of our stockholders, we would then change our basis of accounting from the going
concern basis to the liquidation basis. If our stockholders do not
approve the dissolution of the Company pursuant to the Plan of
Dissolution, the Board will explore what, if any, alternatives are
available for the future of the Company.
During September 2009, Thomas H. Adams, Ph.D., James N. Topper, M.D., Ph.D. and Martin P.
Sutter each resigned from our Board and all committees and related positions thereof. The
resignations of Drs. Adams and Topper and Mr. Sutter from the Board did not involve any
disagreement with the Company.
During September 2009, the Board approved the termination of the Amended and Restated Rights
Agreement, dated December 2, 2008, by and between the Company and American Stock Transfer & Trust
Co., LLC, as amended (the Rights Agreement) effective as of September 23, 2009. The Rights
Agreement was terminated in connection with the Boards approval of the liquidation and dissolution
of the Company.
During September 2009, we received a notice from the Nasdaq Stock Market indicating that we
are not in compliance with Nasdaq Marketplace Rule 5550(a)(2) (the Minimum Bid Price Rule)
because, for 30 consecutive days, the bid price of our common stock has closed below the
12
minimum
level of $1.00 per share. In accordance with Nasdaq Marketplace Rules, we have
been provided 180 calendar days, or until March 15, 2010, to regain compliance with the Minimum Bid
Price Rule. Although this notification has no effect on the current listing of our common stock, if
we do not regain compliance with the Minimum Bid Price Rule by March 15, 2010, Nasdaq will notify
us that our common stock will be delisted from the Nasdaq Stock Market.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based on
our unaudited condensed consolidated financial statements, which have been prepared in accordance
with United States generally accepted accounting principles. The preparation of these consolidated
financial statements requires us to make estimates and judgments that affect the reported amounts
of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and
liabilities. We evaluate our estimates on an ongoing basis, including those related to stock-based
compensation . We base our estimates on historical experience and on other assumptions that we
believe to be reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not readily apparent from
other sources. Actual results may differ materially from these estimates under different
assumptions or conditions.
We believe the following critical accounting policies involve significant judgments and
estimates used in the preparation of our condensed consolidated financial statements (see also Note
1 to our unaudited condensed consolidated financial statements included in Part I).
Revenue Recognition
We consider a variety of factors in determining the appropriate method of revenue recognition
under collaborative arrangements, such as whether the elements are separable, whether there are
determinable fair values and whether there is a unique earnings process associated with each
element of a contract.
Impairment and useful lives of long-lived assets
We regularly review our long-lived assets for impairment. Our long-lived assets include costs
incurred to file our patent applications. We evaluate the recoverability of long-lived assets by
measuring the carrying amount of the assets against the estimated undiscounted future cash flows
associated with them. At the time such evaluations indicate that the future undiscounted cash flows
of certain long-lived assets are not sufficient to recover the carrying value of such assets, the
assets are adjusted to their fair values. The estimation of the undiscounted future cash flows
associated with long-lived assets requires judgment and assumptions that could differ materially
from the actual results.
For the year ended December 31, 2008, as a result of the futility determination in the ASPEN
trial, we recorded a non-cash charge for the impairment of long-lived assets of $2.8 million to
write down the value of our long-lived assets to their estimated fair values. We disposed of or
wrote off all of our remaining long-lived assets during the nine months ended September 30, 2009
for a gain of $0.3 million.
Share-Based Compensation
Share-based compensation expense was approximately $2.3 million and $3.4 million for the nine
months ended September 30, 2009 and 2008, respectively. As of September 30, 2009, there was
approximately $0.9 million of total unrecognized compensation cost related to non-vested
share-based payment awards granted under all equity compensation plans. Total unrecognized
compensation cost will be adjusted for future changes in estimated forfeitures. We
currently expect to recognize the remaining unrecognized compensation cost over a
weighted-average period of 1.1 years.
13
Option-pricing models were developed for use in estimating the value of traded options that
have no vesting or hedging restrictions and are fully transferable. Because the employee and
director stock options granted by us have characteristics that are significantly different from
traded options, and because changes in the subjective assumptions can materially affect the
estimated value, in our opinion the existing valuation models may not provide an accurate measure
of the fair value of the employee and director stock options granted by us. Although the fair value
of the employee and director stock options granted by us is determined using an option-pricing
model that value may not be indicative of the fair value observed in a willing-buyer/willing-seller
market transaction.
Recent Accounting Pronouncements
In June 2009, the Financial Accounting Standards Board (FASB) approved the FASB Accounting
Standards Codification (the Codification) when it issued
Statement of Financial Accounting Standards No. 168, The FASB Accounting
Standards Codification and the Hierarchy of Generally Accepted Accounting Principles, which is
included in The Accounting Standards Codification
(ASC) Topic of Generally Accepted Accounting
Principles (the Topic). All existing accounting standard documents, such as FASB, American
Institute of Certified Public Accountants, Emerging Issues Task Force and other related literature,
excluding guidance from the Securities and Exchange Commission (SEC), have been superseded by the
Codification. All other non-grandfathered, non-SEC accounting literature not included in the
Codification has become non-authoritative. The Codification did not change GAAP, but instead
introduced a new structure that combines all authoritative standards into a comprehensive,
topically organized online database. The Topic is effective for financial statements issued for
interim and annual periods ending after September 15, 2009. The
adoption of the Topic impacts our
financial statement disclosures as all future references to authoritative accounting literature
will be referenced in accordance with the Codification. As a result of the implementation of the
Codification during the quarter ended September 30, 2009, previous references to accounting
standards and literature are no longer applicable.
Effective
April 1, 2009, we implemented The ASC Topic of Subsequent Events. This
guidance established general standards of accounting for and disclosure of events that occur after
the balance sheet date and requires companies to disclose the date through which subsequent events
have been evaluated, as well as whether that date is the date the financial statements were issued
or the date the financial statements were available to be issued.
The ASC Topic of Subsequent Events became effective for
interim or annual periods ending after June 15, 2009 and did not have a material impact on our
unaudited condensed consolidated financial statements for the three and nine months ended September
30, 2009.
Results of Operations
For the nine months ended September 30, 2009, revenue increased to $8.1 million as a result of
the Development Agreement entered into with BioMarin CF in January 2009. The Development Agreement
was terminated in March 2009 following the negative results from our Riquent Phase 3 ASPEN study.
There were no revenues for the three months ended September 30, 2009 and 2008 or the nine months
ended September 30, 2008.
During the nine months ended September 30, 2009, we negotiated settlements related to accounts
payable obligations and accrued liabilities with a majority of our vendors to preserve our
remaining cash and other assets. These negotiations resulted in a reduction of approximately $2.6
million to accounts payable obligations and accrued liabilities from amounts originally invoiced
and accrued, which were recorded upon the execution of the settlement agreements. As a result of
these settlements, during the nine months ended September 30, 2009, there were
decreases of $2.5 million and $0.1 million to research and development and general and
administrative expenses, respectively.
14
For the three and nine months ended September 30, 2009, research and development expenses
decreased to ($0.2) million and $9.6 million, respectively, from $14.1 million and $38.2 million,
respectively, for the same periods in 2008 as a result of the discontinuation of the Riquent Phase
3 ASPEN study, salary and benefits decreases due to the termination of all research personnel and
the settlement of accounts payable obligations and accrued liabilities noted above. For the nine
months ended September 30, 2009, this decrease was partially offset by an increase in termination
expense, mainly relating to severance, of approximately $0.7 million recorded as of March 31, 2009,
as a result of the termination of 64 research and development personnel in April 2009. We expect
minimal research and development expenditures going forward as we wind down our operations.
For the three and nine months ended September 30, 2009, general and administrative expenses
decreased to $1.0 million and $5.6 million, respectively, from $2.8 million and $6.8 million for
the same periods in 2008. The decreases in general and administrative expenses are primarily the
result of decreases in consulting and legal expense for the three and nine months ended September
30, 2009 of $1.2 million and $0.9 million, respectively. In addition, during April 2009, 10 general
and administrative personnel were terminated, resulting in salary and benefits decreases for the
three and nine months ended September 30, 2009 of $0.7 million and $0.6 million, respectively. The
decrease in general and administrative expense for the nine months ended September 30, 2009 was
partially offset by an increase in termination expense recorded as of March 31, 2009 relating to
severance of approximately $0.3 million as a result of the termination of personnel in April 2009.
We expect decreased general and administrative expenditures going forward as we wind down our
operations.
Interest
and other income, net, decreased to less than $0.1 million for the three and nine months ended
September 30, 2009, from $0.2 million and $0.6 million, respectively, for the same periods in 2008.
These decreases are primarily due to moving all short-term investments to non-interest bearing cash accounts
during the quarter ended March 31, 2009.
Realized loss on investments, net, of $0.4 million and $1.4 million for the three and nine
months ended September 30, 2008 primarily consisted of the other-than-temporary impairment loss on
our auction rate securities recorded during the nine months ended September 30, 2008. These
securities were sold to UBS at par value in January 2009 with no realized loss on investments.
Liquidity and Capital Resources
From inception through September 30, 2009, we have incurred a cumulative net loss of
approximately $422.7 million and have financed our operations through public and private offerings
of securities, revenues from collaborative agreements, equipment financings and interest income on
invested cash balances. From inception through September 30, 2009, we have raised approximately
$410.8 million in net proceeds from sales of equity securities.
At September 30, 2009, we had $5.8 million in cash and cash equivalents as compared to $19.4
million of cash, cash equivalents and short-term investments at December 31, 2008. Our working
capital at September 30, 2009 was $5.6 million, as compared to $3.0 million at December 31, 2008.
The decrease in cash, cash equivalents and short-term investments resulted from the use of our
financial resources to fund our clinical trial and manufacturing activities until their termination
in 2009 and for other general corporate purposes. This decrease was partially offset by the
non-refundable commencement payment of $7.5 million received from BioMarin CF under the Development
Agreement and the proceeds of $7.5 million from the sale of 339,104 shares of our preferred stock
to BioMarin Pharma under the Securities Purchase Agreement in January 2009.
15
At September 30, 2009, all of our contractual obligations have been either paid in full or
settlement amounts have been accrued as of September 30, 2009. We expect to pay all remaining
outstanding obligations by December 31, 2009.
On July 31, 2009, our two building leases expired. Pursuant to the lease for one of these
buildings, we were responsible for completing modifications to the leased building prior to lease
expiration. In July 2009, approximately $315,000 was paid in accordance with the lease provisions.
We exited the buildings upon the expiration of the leases in July 2009.
As discussed above, we have presented a plan of liquidation and dissolution to our
stockholders in our Proxy distributed to our stockholders on or about October 7, 2009. As noted in
the Proxy, if the dissolution of the Company pursuant to the Plan of Dissolution is approved by the
stockholders and implemented, we project that there will be between $0.028 and $0.045 per share
available for distribution to stockholders.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current
or future effect on our consolidated financial condition, changes in our consolidated financial
condition, expenses, consolidated results of operations, liquidity, capital expenditures or capital
resources.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We do not utilize derivative financial instruments, derivative commodity instruments or other
market risk sensitive instruments, positions or transactions in any material fashion. We currently
do not invest in any securities that are materially and directly affected by foreign currency
exchange rates or commodity prices.
At September 30, 2009, all of our cash and cash equivalents consisted of cash. At December
31, 2008, all of our investment securities, which consisted of money market funds, U.S. Treasury
bills and asset-backed student loan auction rate securities, were classified as available-for-sale
and were therefore reported on the balance sheet at market value.
ITEM 4. CONTROLS AND PROCEDURES
Our management, with the participation of our principal executive officer and principal
financial officer, evaluated the effectiveness of our disclosure controls and procedures as of
September 30, 2009. The term disclosure controls and procedures, as defined in Rules 13a-15(e)
and 15d-15(e) under the Securities Exchange Act of 1934, as amended (Exchange Act), means
controls and other procedures of a company that are designed to ensure that information required to
be disclosed by a company in the reports that it files or submits under the Exchange Act is
recorded, processed, summarized and reported, within the time periods specified in the Securities
and Exchange Commissions rules and forms. Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that information required to be disclosed by
a company in the reports that it files or submits under the Exchange Act is accumulated and
communicated to the companys management, including its principal executive and principal financial
officers, as appropriate to allow timely decisions regarding required disclosure. Management
recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives and management necessarily applies its
judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on
the evaluation of our disclosure controls and procedures as of September 30, 2009, our principal
executive officer and principal financial officer
concluded that, as of such date, the Companys disclosure controls and procedures were
effective at the reasonable assurance level.
16
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and
15d-15(f) under the Exchange Act) occurred during the quarter ended September 30, 2009 that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
PART II. OTHER INFORMATION
ITEM 1.A. Risk Factors
No material changes to risk factors as previously disclosed in our Annual Report on Form 10-K
for the year ended December 31, 2008 have occurred, other than those set forth in our Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2009 and June 30, 2009, our proxy statement
filed with the Securities and Exchange Commission on October 1, 2009 and as set forth below.
II. RISK FACTORS RELATED SPECIFICALLY TO OUR STOCK.
Our common stock is at risk of being delisted from The Nasdaq Stock Market. If it is
delisted, our stock price and the liquidity of our common stock would be impacted.
In September 2009, we received a notice from the Nasdaq Stock Market indicating that the Company is
not in compliance with Nasdaq Marketplace Rule 5550(a)(2) (the Minimum Bid Price Rule) because,
for 30 consecutive days, the bid price for our common stock has closed below the minimum level of
$1.00 per share. Our stock continues to trade below $1.00 per share, resulting in a strong
likelihood that Nasdaq will commence delisting proceedings. Delisting from the Nasdaq Stock Market
would significantly affect the ability of investors to trade our securities and would negatively
affect the value and liquidity of our common stock.
ITEM 6. EXHIBITS
|
|
|
Exhibit |
|
|
Number |
|
Description |
31.1*
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
31.2*
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.1*
|
|
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
17
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
La Jolla Pharmaceutical Company
|
|
Date: November 13, 2009 |
/s/ Deirdre Y. Gillespie
|
|
|
Deirdre Y. Gillespie, M.D. |
|
|
President and Chief Executive
Officer
(On behalf of the Registrant) |
|
|
|
|
|
|
/s/ Gail A. Sloan
|
|
|
Gail A. Sloan |
|
|
Vice President of Finance and Secretary
(As Principal Financial and Accounting Officer) |
|
18
LA JOLLA PHARMACEUTICAL COMPANY
INDEX TO EXHIBITS
|
|
|
Exhibit |
|
|
Number |
|
Description |
31.1
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
31.2
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.1
|
|
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
19