UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2003
or
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number: 0-21699
VIROPHARMA INCORPORATED
(Exact Name of Registrant as Specified in its Charter)
Delaware |
94-2347624 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
405 Eagleview Boulevard
Exton, Pennsylvania 19341
(Address of Principal Executive Offices and Zip Code)
610-458-7300
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirement for the past 90 days: Yes x No ¨
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act): Yes ¨ No x
Number of shares outstanding of the issuers Common Stock, par value $.002 per share, as of May 8, 2003: 25,933,096 shares.
INDEX
2
(A Development Stage Company)
Consolidated Balance Sheets
(unaudited)
December 31, 2002 and March 31, 2003
December 31, 2002 |
March 31, 2003 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ |
15,987,056 |
|
$ |
11,987,553 |
| ||
Short-term investments |
|
142,294,488 |
|
|
132,695,079 |
| ||
Notes receivable from officers-current |
|
88,743 |
|
|
88,743 |
| ||
Other current assets |
|
3,447,928 |
|
|
3,143,774 |
| ||
Total current assets |
|
161,818,215 |
|
|
147,915,149 |
| ||
Equipment and leasehold improvements, net |
|
8,515,248 |
|
|
8,087,052 |
| ||
Notes receivable from officers-noncurrent |
|
88,743 |
|
|
67,558 |
| ||
Debt issue costs, net |
|
2,612,366 |
|
|
2,387,412 |
| ||
Other assets |
|
496,185 |
|
|
94,458 |
| ||
Total assets |
$ |
173,530,757 |
|
$ |
158,551,629 |
| ||
Liabilities and Stockholders Equity |
||||||||
Current liabilities: |
||||||||
Loans payable-current |
$ |
116,667 |
|
$ |
83,379 |
| ||
Accounts payable |
|
979,909 |
|
|
539,424 |
| ||
Due to partners |
|
693,778 |
|
|
693,866 |
| ||
Accrued expenses and other current liabilities |
|
6,739,353 |
|
|
3,901,549 |
| ||
Deferred revenue-current |
|
516,667 |
|
|
563,636 |
| ||
Total current liabilities |
|
9,046,374 |
|
|
5,781,854 |
| ||
Loans payable-noncurrent |
|
8,334 |
|
|
|
| ||
Convertible subordinated notes |
|
134,900,000 |
|
|
129,900,000 |
| ||
Deferred revenue-noncurrent |
|
1,765,278 |
|
|
1,550,000 |
| ||
Total liabilities |
|
145,719,986 |
|
|
137,231,854 |
| ||
Commitments and Contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred stock, par value $.001 per share. 5,000,000 shares authorized; Series A convertible participating preferred stock; no shares issued and outstanding |
|
|
|
|
|
| ||
Series A junior participating preferred stock; 200,000 shares designated; no shares issued and outstanding |
|
|
|
|
|
| ||
Common stock, par value $.002 per share. Authorized 100,000,000 shares; issued and outstanding 25,933,096 at December 31, 2002 and at March 31, 2003 |
|
51,866 |
|
|
51,866 |
| ||
Additional paid-in capital |
|
248,782,497 |
|
|
248,782,497 |
| ||
Deferred compensation |
|
(435,093 |
) |
|
(412,538 |
) | ||
Accumulated other comprehensive loss |
|
(2,086,601 |
) |
|
(1,753,349 |
) | ||
Deficit accumulated during the development stage |
|
(218,501,898 |
) |
|
(225,348,701 |
) | ||
Total stockholders equity |
|
27,810,771 |
|
|
21,319,775 |
| ||
Total liabilities and stockholders equity |
$ |
173,530,757 |
|
$ |
158,551,629 |
| ||
See accompanying notes to consolidated financial statements.
3
(A Development Stage Company)
Consolidated Statements of Operations
(unaudited)
Three months ended March 31, 2002 and 2003 and the
period from December 5, 1994 (Inception) to March 31, 2003
Three months ended |
Period from |
|||||||||||
2002 |
2003 |
|||||||||||
Revenues: |
||||||||||||
License fee and milestone revenue |
$ |
538,462 |
|
$ |
168,309 |
|
$ |
14,886,364 |
| |||
Grant revenue |
|
|
|
|
|
|
|
526,894 |
| |||
Other revenue |
|
|
|
|
34,000 |
|
|
237,400 |
| |||
Total revenues |
|
538,462 |
|
|
202,309 |
|
|
15,650,658 |
| |||
Continuing operating expenses incurred in the development stage: |
||||||||||||
Research and development |
|
13,520,299 |
|
|
5,665,967 |
|
|
195,181,449 |
| |||
Acquisition of technology rights |
|
|
|
|
|
|
|
16,500,000 |
| |||
Marketing |
|
3,214,246 |
|
|
|
|
|
23,360,873 |
| |||
General and administrative |
|
2,437,278 |
|
|
2,347,896 |
|
|
43,290,270 |
| |||
Total operating expenses |
|
19,171,823 |
|
|
8,013,863 |
|
|
278,332,592 |
| |||
Gain on repurchase of debt |
|
|
|
|
2,805,337 |
|
|
30,699,597 |
| |||
Interest income |
|
2,115,765 |
|
|
306,050 |
|
|
35,424,620 |
| |||
Interest expense |
|
2,910,715 |
|
|
2,146,636 |
|
|
35,131,547 |
| |||
Loss from continuing operations |
|
(19,428,311 |
) |
|
(6,846,803 |
) |
|
(231,689,264 |
) | |||
Discontinued operations: |
||||||||||||
Income (loss) from discontinued sales operations |
|
(2,048,404 |
) |
|
|
|
|
6,340,563 |
| |||
Net loss |
$ |
(21,476,715 |
) |
$ |
(6,846,803 |
) |
$ |
(225,348,701 |
) | |||
Basic and diluted loss per share from continuing operations |
$ |
(0.86 |
) |
$ |
(0.27 |
) |
||||||
Basic and diluted loss per share from discontinued sales operations |
$ |
(0.09 |
) |
$ |
|
|
||||||
Basic and diluted net loss per share |
$ |
(0.95 |
) |
$ |
(0.27 |
) |
||||||
Shares used in computing basic and diluted loss per share amounts |
|
22,675,388 |
|
|
25,726,726 |
|
||||||
See accompanying notes to consolidated financial statements.
4
(A Development Stage Company)
Consolidated Statements of Cash Flows
(unaudited)
Three months ended March 31, 2002 and 2003 and the
period from December 5, 1994 (Inception) to March 31, 2003
Three months ended |
Period from (Inception) |
|||||||||||
2002 |
2003 |
|||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ |
(21,476,715 |
) |
$ |
(6,846,803 |
) |
$ |
(225,348,701 |
) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Non-cash gain on sale of sales force |
|
|
|
|
|
|
|
(15,410,000 |
) | |||
Non-cash gain on repurchase of convertible subordinated notes |
|
|
|
|
(2,875,000 |
) |
|
(31,599,875 |
) | |||
Write-off of deferred financing costs on repurchase of notes |
|
|
|
|
69,663 |
|
|
900,278 |
| |||
Non-cash write-off of fixed assets |
|
|
|
|
|
|
|
1,517,172 |
| |||
Non-cash acquisition of technology rights |
|
|
|
|
|
|
|
16,500,000 |
| |||
Non-cash compensation expense |
|
106,614 |
|
|
22,555 |
|
|
1,683,109 |
| |||
Non-cash warrant value |
|
|
|
|
|
|
|
153,751 |
| |||
Non-cash consulting expense |
|
|
|
|
|
|
|
46,975 |
| |||
Non-cash interest expense |
|
204,615 |
|
|
155,291 |
|
|
2,437,727 |
| |||
Depreciation and amortization expense |
|
624,206 |
|
|
713,725 |
|
|
6,546,194 |
| |||
Changes in assets and liabilities: |
||||||||||||
Other current assets |
|
378,920 |
|
|
304,154 |
|
|
(3,143,774 |
) | |||
Notes receivable from officers |
|
89,804 |
|
|
21,185 |
|
|
(156,301 |
) | |||
Due (to) from partners |
|
(844,127 |
) |
|
(88 |
) |
|
693,866 |
| |||
Other assets |
|
(97,116 |
) |
|
48,558 |
|
|
(94,458 |
) | |||
Accounts payable |
|
278,858 |
|
|
(440,485 |
) |
|
539,424 |
| |||
Deferred revenue |
|
(538,461 |
) |
|
(168,309 |
) |
|
2,113,636 |
| |||
Accrued expenses and other current liabilities |
|
7,474,688 |
|
|
(2,837,804 |
) |
|
13,901,549 |
| |||
Other liabilities |
|
(10,000,000 |
) |
|
|
|
|
10,000,000 |
| |||
Net cash used in operating activities |
|
(23,798,714 |
) |
|
(11,833,182 |
) |
|
(218,719,428 |
) | |||
Cash flows from investing activities: |
||||||||||||
Purchase of equipment and leasehold improvements |
|
(1,172,618 |
) |
|
(285,529 |
) |
|
(16,346,955 |
) | |||
Proceeds from sale equipment |
|
|
|
|
|
|
|
196,537 |
| |||
Purchases of short-term investments |
|
(51,963,486 |
) |
|
(33,801,065 |
) |
|
(1,058,154,236 |
) | |||
Sales of short-term investments |
|
|
|
|
|
|
|
9,680,414 |
| |||
Maturities of short-term investments |
|
85,099,073 |
|
|
44,086,895 |
|
|
914,025,393 |
| |||
Net cash provided by (used in) investing activities |
|
31,962,969 |
|
|
10,000,301 |
|
|
(150,598,847 |
) | |||
Cash flows from financing activities: |
||||||||||||
Net proceeds from issuance of preferred stock |
$ |
|
|
$ |
|
|
$ |
27,242,143 |
| |||
Net proceeds from issuance of common stock |
|
37,951 |
|
|
|
|
|
198,816,016 |
| |||
Preferred stock cash dividends |
|
|
|
|
|
|
|
(1,254,294 |
) | |||
Proceeds from loans payable and milestone advance |
|
|
|
|
|
|
|
2,100,000 |
| |||
Payment of loans payable |
|
(50,000 |
) |
|
(41,622 |
) |
|
(2,016,621 |
) | |||
Payment on repurchase of convertible subordinated notes |
|
|
|
|
(2,125,000 |
) |
|
(18,500,125 |
) | |||
Proceeds received on notes receivable |
|
|
|
|
|
|
|
1,625 |
| |||
Gross proceeds from notes payable |
|
|
|
|
|
|
|
180,692,500 |
| |||
Issuance costs on notes payable |
|
|
|
|
|
|
|
(5,725,416 |
) | |||
Payment of notes payable |
|
|
|
|
|
|
|
(50,000 |
) | |||
Net cash provided by (used in) financing activities |
|
(12,049 |
) |
|
(2,166,622 |
) |
|
381,305,828 |
| |||
Net increase (decrease) in cash and cash equivalents |
|
8,152,206 |
|
|
(3,999,503 |
) |
|
11,987,553 |
| |||
Cash and cash equivalents at beginning of period |
|
9,826,879 |
|
|
15,987,056 |
|
|
|
| |||
Cash and cash equivalents at end of period |
$ |
17,979,085 |
|
$ |
11,987,553 |
|
$ |
11,987,553 |
| |||
5
Supplemental disclosure of non-cash transactions: |
||||||||
Conversion of Note Payable to Series A and Series B Preferred Stock |
|
|
|
642,500 |
| |||
Conversion of mandatorily redeemable convertible preferred stock to common shares |
|
|
|
16,264,199 |
| |||
Notes issued for 828,750 common shares |
|
|
|
1,625 |
| |||
Deferred compensation |
106,614 |
|
|
2,222,158 |
| |||
Forfeiture of restricted stock |
|
|
|
126,511 |
| |||
Accretion of redemption value attributable to mandatorily redeemable converted preferred stock |
|
|
|
1,616,445 |
| |||
Conversion of milestone advance to loan payable |
|
|
|
1,000,000 |
| |||
Unrealized gains (losses) on available for sale securities |
(1,153,339 |
) |
333,252 |
(1,753,349 |
) | |||
Issuance of common stock to Aventis Pharmaceuticals Inc. |
|
|
|
4,590,000 |
| |||
Settlement of milestone advances to Aventis Pharmaceuticals Inc. |
|
|
|
20,000,000 |
| |||
Supplemental disclosure of cash flow information: |
||||||||
Cash paid for interest |
5,416,400 |
|
4,047,000 |
31,684,443 |
|
See accompanying notes to consolidated financial statements.
6
(A Development Stage Company)
Notes to Consolidated Financial Statements
(1) Organization and Business Activities
ViroPharma Incorporated (a development stage company) commenced operations on December 5, 1994. ViroPharma Incorporated and its subsidiary (the Company or ViroPharma) is a development stage pharmaceutical company engaged in the discovery and development of new antiviral medicines.
The Company is devoting substantial effort towards conducting drug discovery and development, raising capital, conducting clinical trials, and pursuing regulatory approval for products under development. The only revenues from product sales that the Company has earned are detailing fees from discontinued sales operations during the first eight months of 2002 for detailing products owned by Aventis Pharmaceuticals Inc. The Company has earned no significant revenue or product sales and has not achieved profitable operations or positive cash flow from continuing operations. The Companys deficit accumulated during the development stage aggregated $225,348,701 through March 31, 2003. There is no assurance that profitable operations can ever be achieved, and even if achieved, could be sustained on a continuing basis. Effective on August 31, 2002, the Company discontinued its sales force operations related to two products owned by Aventis Pharmaceuticals Inc. (Aventis) and all related sales administration activities.
The Company plans to continue to finance its operations with a combination of stock issuances and debt issuances, as available, license payments, payments from strategic research and development arrangements when and if agreed upon milestones are achieved and, in the longer term, revenues from product sales or collaborations, if its planned products are commercialized. There are no assurances, however, that the Company will be successful in obtaining regulatory approval for any of its product candidates or in obtaining an adequate level of financing needed for the long-term development and commercialization of its product candidates.
Basis of Presentation
The financial information at March 31, 2003 and for the three months ended March 31, 2002 and 2003, is unaudited but includes all adjustments (consisting only of normal recurring adjustments) which, in the opinion of management, are necessary to state fairly the financial information set forth therein in accordance with accounting principles generally accepted in the United States of America. The interim results are not necessarily indicative of results to be expected for the full fiscal year. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2002 included in the Companys Annual Report on Form 10-K filed with the Securities and Exchange Commission.
Reclassification
Certain prior year amounts have been reclassified to conform to the current year presentation.
(2) Comprehensive Income (loss)
In the Companys annual consolidated financial statements, comprehensive income (loss) is presented as a separate financial statement. For interim consolidated financial statements, the Company is permitted to disclose the information in the footnotes to the consolidated financial statements. The disclosures are required for comparative purposes. The only comprehensive income (loss) item the Company has is unrealized gains and losses on available for sale securities. The following reconciles net loss to comprehensive loss for the three-months ended March 31, 2002 and 2003:
2002 |
2003 |
|||||||
Net loss |
$ |
(21,476,715 |
) |
$ |
(6,846,803 |
) | ||
Other comprehensive income (loss): |
||||||||
Unrealized gains (losses) on available for sale securities |
|
(1,153,339 |
) |
|
333,252 |
| ||
Comprehensive loss |
$ |
(22,630,054 |
) |
$ |
(6,513,551 |
) | ||
(3) Convertible Subordinated Note Repurchases
During 2002, the Board of Directors of ViroPharma approved a convertible note repurchase program to spend up to $20.0 million to purchase a portion of the $180.0 million principal amount of its 6% convertible subordinated notes due in 2007. As of March 31, 2003, the Company had purchased $50.1 million of principal amount of its 6% convertible subordinated
7
ViroPharma Incorporated
(A Development Stage Company)
Notes to Consolidated Financial Statements(continued)
notes due in 2007 under this program. As a result of these purchases, the Company has reduced its annual interest expense by approximately $3.0 million. During the quarter ended March 31, 2003, the Company recognized a $2.8 million gain, after the write-off of $0.1 million of related deferred financing costs related to the purchase of $5.0 million of principal amount of these notes. The gain was classified as other income. As of March 31, 2003, the Company may, in its discretion, spend up to $1.5 million to purchase additional convertible subordinated notes in the open market or in privately negotiated transactions from time to time as market conditions warrant.
(4) Stock Compensation
The Company accounts for its stock option plans in accordance with the provisions of Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees and related interpretations. As such, compensation cost is measured on the date of grant for fixed options as the excess of the current market price of the underlying stock over the exercise price. Such compensation amounts are amortized over the respective vesting periods of the option grant. Any charge to operations for variable options with performance criteria is affected each reporting period by changes in the fair value of our common stock. The Company adopted the disclosure provisions of SFAS No. 123, Accounting for Stock-Based Compensation, which permits entities to provide pro forma net income (loss) and pro forma earnings (loss) per share disclosures for employee stock option grants as if the fair-value based method defined in SFAS No. 123 had been applied.
In December 2002, the FASB issued SFAS No. 148, Accounting for Stock-Based CompensationTransition and Disclosure, an amendment of FASB Statement No. 123. This Statement amended FASB Statement No. 123, Accounting for Stock-Based Compensation, to provide alternative methods of transition for a voluntary change to the fair value method of accounting for stock-based employee compensation. In addition, this Statement amended the disclosure requirements of Statement No. 123 to require prominent disclosures in both annual and interim financial statements.
Compensation expense for options granted to non-employees is determined in accordance with SFAS No. 123, and related interpretations, as the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. Compensation expense for options granted to non-employees is re-measured each period as the underlying options vest.
The Company applies APB Opinion No. 25 in accounting for its stock options granted to employees and directors. Had the Company determined compensation cost for options granted to employees and directors based on the fair value at the grant date under SFAS No. 123, the Companys net loss and net loss per share would have been increased to the pro forma amounts under SFAS No. 123 indicated below:
For the three months ended, March 31, |
||||||||
2002 |
2003 |
|||||||
Net loss: |
||||||||
As reported |
$ |
(21,476,715 |
) |
$ |
(6,846,803 |
) | ||
Add: stock-based employee compensation expense included in net loss |
|
|
|
|
|
| ||
Deduct: total stock-based employee compensation expense determined under the fair value-based method for all employee and director awards |
|
(3,026,196 |
) |
|
(2,074,197 |
) | ||
Pro forma under SFAS No. 123 |
$ |
(24,502,911 |
) |
$ |
(8,921,000 |
) | ||
Net loss per share: |
||||||||
Basic and diluted: |
||||||||
As reported |
$ |
(0.95 |
) |
$ |
(0.27 |
) | ||
Pro forma under SFAS No. 123 |
|
(1.08 |
) |
|
(0.35 |
) |
(5) Restructuring
In August 2002, the Company adopted a restructuring plan to establish the foundation for its future growth.
Continuing Operations
As part of its restructuring plan, the Company terminated 33 employees within the development, commercial operations, and administration departments of the Company. In August 2002, the Company accrued $1.2 million in expenses associated with this portion of its restructuring plan, which primarily was comprised of employee severance costs
8
ViroPharma Incorporated
(A Development Stage Company)
Notes to Consolidated Financial Statements(continued)
associated with downsizing. This charge was included in the operating expenses of the Company in the third quarter of 2002. As of March 31, 2003, the Company has paid $1.0 million of termination benefits associated with the termination of 33 employees. During the quarter ended March 31, 2003, the Company reduced its severance estimate by $0.05 million to reflect actual costs that it incurred, and other than the revision, there were no other changes to the accrued restructuring liability. As of March 31, 2003, $0.2 million of the restructuring accrual remained.
Discontinued Operations
On September 1, 2002, Aventis acquired the Companys sales force, which totaled nearly 200 people, for $15.41 million, which was recorded as a gain in September 2002. There were no costs related to this transaction.
There was no activity related to the former sales force operations during 2003. During the quarter ended March 31, 2002, the loss from operations of the sales force of the Company totaled $2.0 million. This loss included detailing fee revenue of $6.0 million, and $8.0 million in sales force operational costs. During 2002, the Company incurred a restructuring charge of $2.2 million related to discontinuing the sales operations, primarily for severance, and as of March 31 2003, the Company has paid $2.1 million of this charge.
Aventis Termination Agreement
Under the agreement ending their collaboration to co-develop and co-promote Picovir®, Aventis returned Picovir® to the Company, and both parties received mutual releases of all obligations without incurring termination fees. Aventis compensated the Company for Aventis share of development and commercial expenses through July 2002 and the Companys detailing fees through August 2002, and the Company has returned to Aventis advance milestone payments of $20.0 million. Aventis also purchased 3 million shares of the Companys common stock with a fair market value of $4.59 million. In accordance with the terms of the aforementioned agreements, the Company and Aventis offset all amounts due to each other with respect to the settlement, purchase of stock and sale of the sales force.
As a result of the termination of the Aventis agreement during August of 2002, the Company accelerated the recognition of the remaining $4.0 million of deferred revenue related to the $5.0 million up-front payment received in September 2001.
In September 2001, the Company entered into a collaboration to co-develop and co-promote Picovir® in the United States with Aventis. As part of the agreement, the Company received an initial payment of $25.0 million from Aventis. $5.0 million of the initial payment received was reflected in Deferred revenue, and was recognized as revenue on a straight-line basis through July 31, 2002 based on the then estimated performance period ending December 31, 2005. At March 31, 2002, $20.0 million of the initial payment was reflected in Accrued expenses. From September 2001 to July 31, 2002, the Company and Aventis shared the cost of preparing for the commercial launch of Picovir® and the continued marketing and commercialization efforts: 55 percent by Aventis and 45 percent by ViroPharma. Additionally, the agreement calls for Aventis to fund 50 percent of the Companys research and development efforts for the use of Picovir® in the treatment of adult and pediatric viral respiratory infection (VRI). At March 31, 2003, the Company was not due any payment under these cost sharing provisions. For the quarter ended March 31, 2002, approximately $3.3 million and $0.3 million were reflected as reductions of Picovir® research and development and sales and marketing costs, respectively.
(6) Litigation
In March and May 2002, we and certain of our directors were named as defendants in purported class actions filed in the United States District Court for the Eastern District of Pennsylvania. In July 2002, these actions were consolidated into a single complaint which also named certain of our officers as defendants. The plaintiffs in these actions have alleged that certain statements by us about Picovir® were misleading. A judgment against us could materially exceed the coverage which may be available under our directors and officers liability insurance. The Company filed a motion to dismiss this action in August 2002. In April 2003, the court granted in part and denied in part our motion to dismiss the consolidated complaint. We are vigorously defending ourselves against this action and believe we have meritorious defenses against these claims. While it is not feasible to predict the outcome of this claim at this time, the ultimate resolution of this action could require substantial payment by the us which could have a material adverse effect on our financial position and liquidity, and the resolution of this matter during a specific period could have a material adverse effect on the quarterly or annual operating results for that period. To date no liability related to this matter has been reflected in our consolidated balance sheet.
9
IMPORTANT INFORMATION ABOUT FORWARD-LOOKING STATEMENTS
Our disclosure and analysis in this report contains some forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as anticipate, estimate, expect, project, intend, plan, believe and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. These forward-looking statements include the statements in this report on Form 10-Q about:
| our plan to advance a compound from HCV-371, our lead HCV compound, into additional studies in HCV-infected patients by late-2003; |
| our plan to advance at least one additional HCV compound into human clinical trials by the end of 2003; |
| our plan to evaluate an intranasal approach for using Picovir® to treat the common cold, including our consideration of conducting a study to evaluate the antiviral activity of our intranasal formulation of Picovir®; |
| our plan not to fund additional significant clinical development of Picovir® for the treatment of the common cold without a new partner; |
| our purchase of a portion of our convertible subordinated notes; |
| our expectation that our most significant sources of our near-term operating expenses will be discovery and development activities with our hepatitis C program, the exploration of alternatives regarding the future development of Picovir® for the treatment of life-threatening chronic meningoencephalitis in patients with agammaglobulinemia or hypogammaglobulinemia caused by primary immune deficiency (CEMA), and business development activities seeking new opportunities to expand our pipeline; |
| our expectation that our monthly expenses and operating losses in 2003 should be lower than we experienced during the first eight months of 2002; and |
| our expectation that our available cash, cash equivalents and short term investments at March 31, 2003 will be sufficient to fund our planned business operations and debt service requirements through 2005. |
Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. There can be no assurance that:
| we will be able to continue or complete our current clinical studies of HC-371; |
| HC-371 will demonstrate antiviral activity; |
| we will, or will be able to, achieve the development milestones for our HCV program during the timeframe described in this quarterly report on form 10-Q, or at all; |
| we will, or we will be able to, purchase additional convertible subordinated debts at prices favorable to us or at all; |
| we will develop, or will be successful in developing, Picovir® to treat CEMA patients or any other serious or life threatening enteroviral infection; |
| we will conduct a study to evaluate the antiviral activity of an intranasal formulation of Picovir®, or that we will be successful in developing a viable intranasal formulation of Picovir®, for the treatment of the common cold; |
| we will be successful in engaging a partner for the development and commercialization of an intranasal formulation of Picovir®; |
| our research and development plan will not change from our current focus on HCV, CEMA and products that we may be able to in-license through business development efforts; |
| we will be able to acquire new research and development opportunities to expand our pipeline; |
| our actual average monthly cash expenses in 2003 will reflect our anticipated spending levels during those periods; or |
| our available cash, cash equivalents and short term investments at March 31, 2003 will be sufficient to fund our planned business operations and debt service requirements through 2005. |
Our actual expenses over the period described in this quarterly report on Form 10-Q may vary depending on a variety of factors, including: the actual cost of conducting clinical trials; the outcome of clinical trials in our HCV program, and our resulting right to receive or obligation to pay milestone payments under collaborations relating to those programs; our ability to develop Picovir® for CEMA patients and the cost of that development program; our ability to continue with, or attract a development and commercialization partner for, an intranasal formulation of Picovir®; the cost of conducting a study to evaluate the antiviral activity of an intranasal formulation of Picovir®, if we decide to conduct such a study; the actual face amount of our convertible subordinated notes that we are able or willing to acquire, if any; the resulting reduction in interest expense associated with the purchase of such convertible subordinated notes, if any; costs associated with litigation; and the cost of exploring and investing in other strategic opportunities. Conducting clinical trials for investigational pharmaceutical products are subject to risks and uncertainties. There can be no assurance that planned clinical trials can be initiated, or that planned or ongoing clinical trials can be successfully concluded or concluded in accordance with our anticipated schedule. In addition, in the future, we may not be able to maintain our listing on the Nasdaq Stock Market.
10
These and other risks and uncertainties that could affect our actual results are discussed in greater detail in this report and in our other filings with the Securities and Exchange Commission. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, events, levels of activity, performance, or achievements. We do not assume responsibility for the accuracy and completeness of the forward-looking statements other than as required by applicable law.
We do not undertake any duty to update after the date of this report any of the forward-looking statements in this report to conform them to actual results.
You should read this report on Form 10-Q in combination with the Managements Discussion and Analysis of Financial Condition and Results of Operations, the description of our business and the discussion of our risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2002.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We have not been profitable since inception and have incurred a cumulative net loss of $225,348,701 through March 31, 2003. Losses have resulted principally from costs incurred in research and development activities, general and administrative expenses and sales and marketing expenses. We expect to incur additional operating losses over the next several years.
Since inception, we have devoted substantially all of our resources to our research, sales and marketing and product development programs. In the first eight months of 2002, we earned detailing fees of approximately $17.2 million for promoting Nasacort® AQ and Allegra®, two products owned by Aventis Pharmaceuticals Inc. (Aventis). We stopped promoting Nasacort® AQ and Allegra® at the end of August 2002. As a result of the sale of our sales force, we will earn no future revenue from detailing Aventis or other products and we have accounted for all Nasacort® AQ and Allegra® promotion related activities as discontinued sales operations. We have generated no revenues from sales of our own products and have been dependent upon funding primarily from equity and debt financing.
ViroPharma and Wyeth are conducting a phase 1 clinical study to evaluate our lead HCV product candidate, HCV-371. If the data from this study are supportive, the companies plan to advance HCV-371 into additional studies in HCV-infected patients in late-2003. We cannot assure you that data from our ongoing phase 1 clinical study for HCV-371 will warrant advancing this compound into additional studies in HCV-infected patients. ViroPharma and Wyeth are advancing several distinct compound classes shown to inhibit viral replication activities in preclinical studies, and expect at least one additional compound to enter human trials by the end of 2003.
In March 2003, we submitted an application for Orphan Drug designation for oral Picovir® in the treatment of life-threatening chronic enteroviral meningoencephalitis in patients with agammaglobulinemia or hypogammaglobulinemia caused by primary immune deficiency (CEMA). Since August 1996, we have made Picovir® available on an open label basis for patients with severe or life-threatening diseases caused by picornaviruses. CEMA patients comprise a portion of the patients enrolled in our compassionate use program. In addition, we are continuing to explore ways to maximize the value of Picovir® by evaluating an intranasal approach to treating the common cold. ViroPharma is in discussions with potential partners for this program. While we do not intend to fund significant clinical development of Picovir® for the treatment of the common cold without a partner, we may conduct a study intended to evaluate the antiviral activity of an intranasal formulation of Picovir®.
In January 2003, we announced that we have decided to discontinue the development of our phase 1 and pre-clinical RSV compounds. This decision was based on the combination of the cost of advancing the program and the timeframe to commercialization. We are actively seeking to out license our RSV assets.
In order to improve our capital structure and reduce annual interest expense, in 2002 our board of directors approved a convertible subordinated note repurchase program to spend up to $20.0 million to purchase a portion of our outstanding 6% convertible subordinated notes due 2007. Through March 31, 2003, we have purchased an aggregate of $50.1 million in principal amount of our convertible notes for approximately $18.5 million. In May 2003, our board of directors instructed us to continue to assess and pursue alternatives to reduce the outstanding principal amount of our convertible subordinated notes, including but not limited to the purchase of such notes. In connection with this effort, our board of directors delegated to the note repurchase committee of the board the authority to spend up to an additional $40.0 million in cash to purchase such notes from time to time during the period that continues through 2007, the maturity date of the notes. However, this delegation of authority does not obligate us to effect cash purchases of these notes, and we may not engage in any further note purchases. If we decide to purchase additional convertible subordinated notes, we may, in our discretion, purchase these notes in the open market or in privately negotiated transactions from time to time as market conditions warrant.
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Our ability to achieve profitability is dependent on developing and obtaining regulatory approvals for our product candidates, successfully commercializing such product candidates (which may include entering into collaborative agreements for product development and commercialization), and securing contract manufacturing services and distribution and logistics services. We will need to raise substantial additional funds to continue our business activities and fund our debt service obligations beyond 2005.
In March and May 2002, we and certain of our directors were named as defendants in purported class actions filed in the United States District Court for the Eastern District of Pennsylvania. In July 2002, these actions were consolidated into a single complaint which also named certain of our officers as defendants. The plaintiffs in these actions have alleged that certain statements by us about Picovir® were misleading. A judgment against us could materially exceed the coverage which may be available under our directors and officers liability insurance. We filed a motion to dismiss this action in August 2002. In April 2003, the court granted in part and denied in part our motion to dismiss the consolidated complaint. We are vigorously defending ourselves against this action and believe we have meritorious defenses against these claims. While it is not feasible to predict the outcome of this claim at this time, the ultimate resolution of this action could require substantial payment by the us which could have a material adverse effect on our financial position and the resolution of this matter during a specific period could have a material adverse effect on the quarterly or annual operating results for that period. To date no liability related to this matter has been reflected in our consolidated balance sheet.
Critical Accounting Policies
Our consolidated financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the United States of America. Preparing consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. These estimates and assumptions are affected by the application of our accounting policies. Critical policies and practices are both most important to the portrayal of a companys financial condition and results of operations, and require managements most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effects of matters that are inherently uncertain. Due to the nature of our business and our stage of development, we do not currently face the many complex or subjective judgments that face companies that are further along in their life cycle that may be necessary in applying accounting policies. Our decision to apply APB Opinion No. 25 to account for our stock option plans rather than SFAS No. 123 is one area where our practice could be construed to be critical. Had we applied SFAS No. 123 our net loss allocable to common shareholders in the first quarter of 2002 and 2003 would have been increased by approximately $3.0 million, and $2.1 million, respectively.
Liquidity and Capital Resources
We commenced operations in December 1994. We are a development stage company and, other than detailing fees from discontinued sales operations earned in the first eight months of 2002 for promoting products owned by Aventis, we have not generated revenues from product sales. The cash flows used in operations historically have been applied to research and development activities, supporting Picovir® marketing, general and administrative expenses, and servicing of our debt. We expect that the most significant sources of our near-term operating expenses will be discovery and development activities with our hepatitis C program, the exploration of alternatives regarding the future development of Picovir® for the treatment of life-threatening chronic meningoencephalitis in patients with agammaglobulinemia or hypogammaglobulinemia caused by primary immune deficiency (CEMA), and business development activities seeking new opportunities to expand our pipeline. While we do not intend to fund any significant clinical development of Picovir® for the treatment of the common cold without a partner, we may conduct a study intended to evaluate the antiviral activity of an intranasal formulation of Picovir®. In January 2003, we announced that we decided to discontinue our respiratory syncytial virus (RSV) program based on the combination of the cost of advancing the program and the timeframe to commercialization. We are actively seeking to out license our RSV assets.
Through March 31, 2003, we have used approximately $218.7 million of cash in operating activities. We invest our cash in short-term investments. Through March 31, 2003, we have used approximately $150.6 million in investing activities, including $134.4 million in short-term investments and $16.2 million in equipment purchases and new construction. Through March 31, 2003, we have financed our operations primarily through private and public offerings of common stock, a convertible subordinated notes offering, private placements of redeemable preferred stock, two bank loans and equipment lease lines totaling approximately $381.3 million, net of approximately $18.5 million used to repurchase $50.1 million in principal amount of our 6% convertible subordinated notes due 2007.
During the quarter ended March 31, 2003 we used approximately $11.8 million of cash in operating activities. We invest our cash in short-term investments. For the quarter ended March 31, 2003, cash provided by investing activities was approximately $10.0 million, including $10.3 million from short-term investments, net of $0.3 million in equipment purchases. For the quarter ended March 31, 2003, we have used approximately $2.2 million of cash in financing activities, which primarily relates to $2.1 million in cash used to repurchase $5.0 million in principal amount of our 6% convertible
12
subordinated notes due 2007. At March 31, 2003, we had cash and cash equivalents and short-term investments aggregating approximately $144.7 million.
Future contractual obligations and commercial commitments at March 31, 2003 are as follows:
Payments due by period | |||||||||||||||
Contractual Obligations |
Total |
Less than |
2-3 years |
4-5 years |
More than | ||||||||||
(in millions) | |||||||||||||||
Long-Term Debt |
$ |
129.9 |
$ |
0.0 |
$ |
0.0 |
$ |
129.9 |
$ |
0.0 | |||||
Capital Lease Obligations |
|
0.0 |
|
0.0 |
|
0.0 |
|
0.0 |
|
0.0 | |||||
Operating Leases |
|
17.1 |
|
1.8 |
|
3.6 |
|
3.5 |
|
8.2 | |||||
Purchase Obligations |
|
0.0 |
|
0.0 |
|
0.0 |
|
0.0 |
|
0.0 | |||||
Other Long-Term Liabilities Reflected on the Registrants Balance Sheet under GAAP |
|
0.0 |
|
0.0 |
|
0.0 |
|
0.0 |
|
0.0 | |||||
Total |
$ |
147.0 |
$ |
1.8 |
$ |
3.6 |
$ |
133.4 |
$ |
8.2 | |||||
We lease our corporate and research and development facilities under an operating lease expiring in 2008. We also have the right, under certain circumstances, to purchase the facility. We completed our final expansion of this facility in October 2002. Rent and operating expenses have increased approximately $0.5 million per year, commencing in November 2002. We also lease approximately 30,000 square feet of additional office space, which has resulted in an annual increase in rent expense of approximately $0.6 million starting in September 2002. The term of the lease is fifteen years. We are currently exploring several potential opportunities, including subleasing, related to its use. We cannot be certain that we will find a use for the facility or that we will be able to sublease the facility on favorable terms or at all.
In August 2002, we and Aventis mutually agreed to end our collaboration to co-develop and co-promote Picovir®. Under the agreement, Aventis returned Picovir® to us, and both parties received mutual releases of all obligations without incurring termination fees. Aventis has compensated us for their share of development and commercial expenses through July 2002 and our detailing fees through August 2002, and we returned to Aventis advance milestone payments of $20.0 million. Aventis also purchased 3 million shares of our common stock with a fair market value of $4.59 million. In a separate agreement, Aventis acquired our sales force for a payment to us of approximately $15.41 million. The sales force promoted products from the Aventis respiratory portfolio, Nasacort® AQ and the Allegra® family, through August 31, 2002. In accordance with the terms of the aforementioned agreements, we and Aventis offset all amounts due to each other with respect to the settlement, purchase of stock and sale of the sales force.
As a result of our restructuring in August 2002, particularly the termination of our co-promotion and co-development agreement with Aventis and our decision not to fund any additional significant clinical development of Picovir® for the treatment of the common cold without a new partner, we expect our monthly expenses and operating losses in 2003 to be lower than we experienced during the first eight months of 2002. Our expected decreases in expenses and operating losses would be due to lower development, marketing, sales and general and administrative expenses.
In June 2002, we announced that we and Wyeth extended the screening phase of our HCV drug discovery, development and commercialization agreement for up to an additional two years. We will continue to fund the development of additional compounds under our collaboration agreement with Wyeth. Wyeth pays a substantial portion of the collaborations HCV research and development expenses.
Our ability to achieve profitability is dependent on developing and obtaining regulatory approvals for our product candidates, successfully commercializing such product candidates (which may include entering into collaborative agreements for product development and commercialization), and securing contract manufacturing, distribution and logistics, sales and marketing services.
In order to improve our capital structure and reduce annual interest expense, in 2002 our board of directors approved a convertible note repurchase program to spend up to $20.0 million to purchase a portion of the $180.0 million principal amount of our convertible subordinated notes. We have remaining convertible subordinated notes payable in the principal amount of $129.9 million as of March 31, 2003. These notes bear interest at 6% per annum and become due in March 2007. Through March 31, 2003, we have purchased an aggregate of $50.1 million in principal amount of our convertible subordinated notes for approximately $18.5 million. In May 2003, our board of directors instructed us to continue to assess and pursue alternatives to reduce the outstanding principal amount of our convertible subordinated notes, including but not limited to the purchase of such notes for up to an additional $40.0 million in cash during the period that continues through 2007, the maturity date of the
13
convertible subordinated notes. We may, in our discretion, purchase additional notes in the open market or in privately negotiated transactions from time to time as market conditions warrant. There can be no assurance that we will be able to purchase any additional notes at prices favorable to us, or at all. As a result of our repurchase of $50.1 million in principal amount of our outstanding 6% convertible subordinated notes our annual interest expense will be reduced by approximately $3.0 million.
We expect that our available cash, cash equivalents and short term investments at March 31, 2003 will be sufficient to fund our planned business operations and debt service requirements through 2005. We expect that we will need to raise substantial additional funds to continue our business activities and fund our debt service and other obligations beyond 2005. To obtain this financing, we intend to access the public or private equity or debt markets or enter into additional arrangements with corporate collaborators to whom we may issue shares of our stock. We have an effective Form S-3 universal shelf registration statement filed with the Securities and Exchange Commission for the potential additional issuance of up to approximately $212.0 million of our securities. The registration statement provides us with the flexibility to determine the type of security we choose to sell, including common stock, preferred stock, warrants and debt securities, as well as the ability to time such sales when market conditions are favorable. In order for us to issue securities registered on this registration statement we must either have an aggregate market value of the voting and non-voting common equity excluding shares held by our affiliates of $75 million or more, or we must file a post effective amendment to the registration statement on Form S-2 or S-1.
If we raise additional capital by issuing equity securities, the terms and prices for these financings may be much more favorable to the new investors than the terms obtained by our existing stockholders. These financings also may significantly dilute the ownership of existing stockholders.
Additional financing, however, may not be available on acceptable terms from any source as a result of, among other factors, our failure to achieve regulatory approval of Picovir®, our inability to generate revenue through our existing collaborative agreements, the existence of pending litigation involving allegations of securities fraud, and our inability to file, prosecute, defend and enforce any patent claim and or other intellectual property rights. If sufficient additional financing is not available, we may need to delay, reduce or eliminate current research and development programs, or reduce or eliminate other aspects of our business.
Additionally, Wyeth is required to purchase our common stock at the time of completion of certain product development events pursuant to the terms of our collaboration agreement. However, in the event we are not able to successfully achieve the product development or regulatory approval events, this additional financing would not be available to us.
Results of Operations
Quarters ended March 31, 2003 and 2002
For the quarter ended March 31, 2003, we reported a net loss of $6.8 million compared to a net loss of $21.5 million for the same period in 2002. Net loss per share for the quarter ended March 31, 2003 was $0.27 per share, basic and diluted, compared to $0.95 per share, basic and diluted for the same period in 2002.
Our loss from continuing operations for the quarter ended March 31, 2003 decreased to approximately $6.8 million from a loss of approximately $19.4 million for the same period in 2002. During the first quarter of 2003, we purchased $5.0 million of face value of our outstanding 6% convertible subordinated notes due 2007 for $2.1 million, resulting in a gain of approximately $2.8 million after the write-off of $0.1 million in related deferred financing costs. Loss per share from continuing operations for the quarter ended March 31, 2003 was $0.27 per share, basic and diluted, compared to a loss per share from continuing operations of $0.86 per share, basic and diluted, in the same period in 2002.
Revenues were approximately $0.2 million for the quarter ended March 31, 2003, compared to approximately $0.5 million during the same period in 2002. During the quarter ended March 31, 2003, we recognized license fee and milestone revenue of approximately $0.2 million from advance payments received under our collaboration with Wyeth, compared to recognizing license fee and milestone revenue of approximately $0.5 million from advance payments received under our collaboration agreements with Wyeth and Aventis during the same period in 2002. The revenue recognized from our collaboration with Wyeth was lower in the first quarter of 2003 because the performance period over which we recognized the Wyeth deferred revenue was increased to reflect the extension of the screening phase of the agreement in June 2002.
Research and development expenses decreased approximately $7.8 million to $5.7 million in the first quarter of 2003 from $13.5 million in the first quarter of 2002. In the first quarter of 2003, we experienced a $3.9 million reduction in development expenses related to Picovir®, a $2.5 million reduction in development expenses related to our RSV program that we discontinued in January 2003, a $1.0 million reduction in development compensation expenses, a $0.4 million reduction in discovery expenses, and a $0.2 million reduction in employee related expenses, in each case when compared to
14
the same expenses incurred during the first quarter of 2002. This reduction in expenses during the first quarter of 2003 costs was slightly offset by an increase of $0.2 million in costs related to our Wyeth collaboration. During the quarter ended March 31, 2003 we were engaged in phase 1 clinical trials and discovery research in our hepatitis C program, a variety of clinical and regulatory activities related to our efforts to pursue the development of Picovir® (pleconaril) for the treatment of serious and life-threatening diseases caused by enteroviral infections, preclinical activities related to developing an intranasal formulation of Picovir® for the treatment of the common cold and discovery research. In comparison, during the first quarter of 2002 our primary research and development focus related to Picovir® for the treatment of the common cold in adults, including preparing for an FDA Advisory Committee meeting for Picovir®, manufacturing validation batches of Picovir® and conducting clinical trials in other common cold indications and in respiratory syncytial virus disease.
During the quarter ended March 31, 2003, we had no marketing expenses. During the same period in 2002, we incurred $3.2 million in marketing expenses related to Picovir® as a result of our joint marketing efforts with Aventis Pharmaceuticals Inc.
General and administrative expenses for the quarter ended March 31, 2003 of approximately $2.3 million decreased $0.1 million from $2.4 million in the same period in 2002. This decrease was primarily due to a reduction in personnel related costs. During the first quarter of 2003, we spent $0.2 million on business development activities for which comparable activities were not performed during the same period in 2002.
Interest income for the quarter ended March 31, 2003 of $0.3 million decreased by $1.8 million when compared to interest income of $2.1 million during the same period in the prior year. This decrease in interest income is due from lower invested balances and lower interest rates. Interest expense for the quarter ended March 31, 2003 decreased $0.8 million to $2.1 million. This decrease in interest expense is due to the repurchase of $50.1 million in principal amount of our outstanding 6% convertible subordinated notes due 2007 in the second half of 2002 and first quarter of 2003.
During the third quarter of 2002, we terminated our co-promotion and co-development agreement with Aventis Pharmaceuticals Inc., discontinued our sales force operations and sold our sales force to Aventis. We had no income or loss from discontinued sales operations for the quarter ended March 31, 2003 compared to a loss of approximately $2.0 million for the same period in 2002. Costs associated with the discontinued sales operations for the same period in 2002 related primarily to sales force start-up activities and the detailing of two of Aventiss products. The loss from discontinued sales operations for the quarter ended March 31, 2002 is net of $6.0 million in detailing fees received by us for detailing activities during that period. Basic and diluted loss per share from discontinued sales operations for the quarter ended March 31, 2002 was $0.09 per share.
As of March 31, 2003, ViroPharma had approximately $144.7 million in cash, cash equivalents and short-term investments. Also, at March 31, 2003 the annualized weighted average nominal interest rate on our short-term investments was approximately 1.4%.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
Our holdings of financial instruments are comprised of a mix of U.S. corporate debt, government securities and commercial paper. All such instruments are classified as securities available for sale. Our debt security portfolio represents funds held temporarily pending use in our business and operations. We manage these funds accordingly. Our primary investment objective is the preservation of principal, while at the same time maximizing the generation of investment income. We seek reasonable assuredness of the safety of principal and market liquidity by investing in cash equivalents (such as Treasury bills and money market funds) and fixed income securities (such as US government and agency securities, municipal securities, taxable municipals, and corporate notes) while at the same time seeking to achieve a favorable rate of return. Our market risk exposure consists principally of exposure to changes in interest rates. Our holdings are also exposed to the risks of changes in the credit quality of issuers. Historically, we have typically invested in financial instruments with maturities less than one year. The carrying amount and the annualized weighted average nominal interest rate of our investment portfolio at March 31, 2003 was approximately $132.7 million and approximately 1.4%, respectively.
At March 31, 2003, we had outstanding $129.9 million of 6% convertible subordinated notes due 2007. The notes are convertible into shares of our common stock at a price of $109 per share, subject to certain adjustments. The notes bear interest at a rate of 6% per annum, payable semi-annually in arrears, and can be redeemed by us, at certain premiums over the principal amount, at any time on or after March 6, 2003. At March 31, 2003, the market value of our convertible subordinated notes was approximately $62.8 million, based on quoted market prices. The fair value of our convertible subordinated notes is dependant upon, among other factors, the fair value of our common stock and prevailing market interest rates.
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ITEM 4. Controls and Procedures
(a) Under the supervision and with the participation of our management, including our chief executive officer and principal financial officer, we conducted an evaluation of our disclosure controls and procedures, as such term is defined under Rule 13a-14(c) promulgated under the Securities Exchange Act of 1934, as amended (the Exchange Act), within 90 days of the filing date of this report. Based on their evaluation, our principal executive officer and principal accounting officer concluded that our disclosure controls and procedures are effective.
(b) There have been no significant changes (including corrective actions with regard to significant deficiencies or material weaknesses) in our internal controls or in other factors that could significantly affect these controls subsequent to the date of the evaluation referenced in paragraph (a) above.
16
In March and May 2002, we and certain of our directors were named as defendants in purported class actions filed in the United States District Court for the Eastern District of Pennsylvania. In July 2002, these actions were consolidated into a single complaint which also named certain of our officers as defendants. The plaintiffs in these actions have alleged that certain statements by us about Picovir® were misleading. A judgment against us could materially exceed the coverage which may be available under our directors and officers liability insurance. We filed a motion to dismiss this action in August 2002. In April 2003, the court granted in part and denied in part our motion to dismiss the consolidated complaint. We are vigorously defending ourselves against this action and believe we have meritorious defenses against these claims.
ITEM 6. Exhibits and Reports on Form 8-K
(a) | List of Exhibits: |
10.32 | Form of Change of Control Agreement between ViroPharma and certain of its employees. |
99.1 | Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
(b) | Reports on Form 8-K: |
We filed the following Current Reports on Form 8-K during the quarter ended March 31, 2003:
(i) | We filed a Current Report on Form 8-K dated March 25, 2003 to report, pursuant to Item 5, a set of Frequently Asked Questions describing information that experience has demonstrated to be often requested by analysts and investors, and the answers to these questions. |
(ii) | We filed a Current Report on Form 8-K dated February 25, 2003 to report, pursuant to Item 5, our financial results for the fourth quarter and fiscal year ended December 31, 2002. |
(iii) | We filed a Current Report on Form 8-K dated February 24, 2003 to report, pursuant to Item 5, a set of Frequently Asked Questions describing information that experience has demonstrated to be often requested by analysts and investors, and the answers to these questions. |
(iv) | We filed a Current Report on Form 8-K dated January 3, 2003 to report, pursuant to Item 5, the initiation of Phase 1 hepatitis C trials and an update on our product pipeline and convertible notes. |
17
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.
VIROPHARMA INCORPORATED | ||||||||
Date: May 12, 2003 |
By: |
/s/ MICHEL DE ROSEN | ||||||
Michel de Rosen | ||||||||
By: |
/s/ VINCENT J. MILANO | |||||||
Vincent J. Milano |
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I, Michel de Rosen, President, Chief Executive Officer and Chairman of the Board of Directors of the registrant, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of ViroPharma Incorporated; |
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; |
4. | The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: |
a) | designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; |
b) | evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and |
c) | presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. | The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function): |
a) | all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and |
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and |
6. | The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
/s/ MICHEL DE ROSEN |
Michel de Rosen |
May 12, 2003
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I, Vincent J. Milano, Vice President, Chief Financial Officer and Treasurer of the registrant, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of ViroPharma Incorporated; |
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; |
4. | The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: |
a) | designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; |
b) | evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and |
c) | presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. | The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function): |
a) | all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and |
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and |
6. | The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
/s/ VINCENT J. MILANO |
Vincent J. Milano |
May 12, 2003
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Exhibit Index
Exhibit |
Description | |
10.32 |
Form of Change of Control Agreement between ViroPharma and certain of its employees. | |
99.1 |
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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