UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2002
OR
[ ] | 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: 0-19825
SCICLONE PHARMACEUTICALS, INC.
California | 94-3116852 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. employer Identification no.) |
901 Mariners Island Blvd., Suite 205, San Mateo, California | 94404 | |
(Address of principal executive offices) | (Zip code) |
(650) 358-3456
(Registrants telephone number, including area code)
Not Applicable
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes [X] No [ ]
As of September 30, 2002, 36,876,397 shares of the registrants Common Stock, no par value, were issued and outstanding.
SCICLONE PHARMACEUTICALS, INC.
INDEX
PAGE NO. | ||||||
PART I. |
FINANCIAL INFORMATION |
|||||
Item 1. |
Condensed Consolidated Financial Statements (Unaudited) |
|||||
Condensed Consolidated Balance Sheets as of September 30,
2002 and December 31, 2001 |
3 | |||||
Condensed Consolidated Statements of Operations for the
Three-month and Nine-month periods ended September 30,
2002 and 2001 |
4 | |||||
Condensed Consolidated Statements of Cash Flows for the
Nine-month periods ended September 30, 2002 and 2001 |
5 | |||||
Notes to Condensed Consolidated Financial Statements |
6 | |||||
Item 2. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
9 | ||||
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
26 | ||||
Item 4. |
Controls and Procedures |
26 | ||||
PART II. |
OTHER INFORMATION |
|||||
Item 6. |
Exhibits and Reports on Form 8-K |
27 | ||||
Signatures |
29 | |||||
Certifications |
29 |
2
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
SCICLONE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
ASSETS
September 30, | December 31, | ||||||||
2002 | 2001 | ||||||||
(unaudited) | (Note 1) | ||||||||
Current assets: |
|||||||||
Cash and cash equivalents |
$ | 23,528,000 | $ | 15,518,000 | |||||
Restricted short-term investments |
633,000 | 633,000 | |||||||
Other short-term investments |
345,000 | 317,000 | |||||||
Accounts receivable, net |
9,009,000 | 8,792,000 | |||||||
Inventories |
3,326,000 | 4,059,000 | |||||||
Prepaid expenses and other current assets |
897,000 | 1,333,000 | |||||||
Total current assets |
37,738,000 | 30,652,000 | |||||||
Property and equipment, net |
119,000 | 167,000 | |||||||
Intangible assets, net |
785,000 | 1,091,000 | |||||||
Other assets |
169,000 | 186,000 | |||||||
Total assets |
$ | 38,811,000 | $ | 32,096,000 | |||||
LIABILITIES AND SHAREHOLDERS EQUITY |
|||||||||
Current liabilities: |
|||||||||
Accounts payable |
$ | 2,533,000 | $ | 1,575,000 | |||||
Accrued compensation and employee benefits |
841,000 | 960,000 | |||||||
Accrued clinical trials expense |
771,000 | 296,000 | |||||||
Accrued professional fees |
645,000 | 633,000 | |||||||
Deferred revenue |
895,000 | | |||||||
Other accrued expenses |
298,000 | 258,000 | |||||||
Total current liabilities |
5,983,000 | 3,722,000 | |||||||
Deferred revenue |
1,342,000 | | |||||||
Convertible notes payable |
5,600,000 | 5,600,000 | |||||||
Shareholders equity: |
|||||||||
Common stock, no par value; 75,000,000
shares authorized; 36,876,397 and
32,474,150 shares issued and outstanding at
September 30, 2002 and December 31, 2001,
respectively |
156,240,000 | 145,713,000 | |||||||
Accumulated other comprehensive income |
45,000 | 39,000 | |||||||
Accumulated deficit |
(130,399,000 | ) | (122,978,000 | ) | |||||
Total shareholders equity |
25,886,000 | 22,774,000 | |||||||
Total liabilities and shareholders equity |
$ | 38,811,000 | $ | 32,096,000 | |||||
See notes to condensed consolidated financial statements
3
SCICLONE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three months ended | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2002 | 2001 | 2002 | 2001 | ||||||||||||||
Product sales |
$ | 4,298,000 | $ | 3,580,000 | $ | 12,294,000 | $ | 9,943,000 | |||||||||
Contract revenue |
224,000 | | 448,000 | | |||||||||||||
Total revenue |
4,522,000 | 3,580,000 | 12,742,000 | 9,943,000 | |||||||||||||
Cost of product sales |
918,000 | 714,000 | 2,525,000 | 1,948,000 | |||||||||||||
Gross profit |
3,604,000 | 2,866,000 | 10,217,000 | 7,995,000 | |||||||||||||
Operating expenses: |
|||||||||||||||||
Research and development |
2,110,000 | 3,390,000 | 8,407,000 | 6,717,000 | |||||||||||||
Sales and marketing |
2,217,000 | 2,256,000 | 6,291,000 | 7,184,000 | |||||||||||||
General and administrative |
960,000 | 749,000 | 2,907,000 | 2,532,000 | |||||||||||||
Total operating expenses |
5,287,000 | 6,395,000 | 17,605,000 | 16,433,000 | |||||||||||||
Loss from operations |
(1,683,000 | ) | (3,529,000 | ) | (7,388,000 | ) | (8,438,000 | ) | |||||||||
Interest and investment income |
100,000 | 174,000 | 252,000 | 672,000 | |||||||||||||
Interest and investment expense |
(91,000 | ) | (90,000 | ) | (271,000 | ) | (243,000 | ) | |||||||||
Other income (expense), net |
2,000 | 3,272,000 | (13,000 | ) | 3,492,000 | ||||||||||||
Net loss |
$ | (1,672,000 | ) | $ | (173,000 | ) | $ | (7,420,000 | ) | $ | (4,517,000 | ) | |||||
Basic and diluted net loss per share |
$ | (0.05 | ) | $ | (0.01 | ) | $ | (0.22 | ) | $ | (0.14 | ) | |||||
Weighted average shares used in computing
basic and diluted net loss per share |
36,869,133 | 32,429,345 | 34,365,118 | 32,272,682 | |||||||||||||
See notes to condensed consolidated financial statements
4
SCICLONE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Nine months ended | ||||||||||
September 30, | ||||||||||
2002 | 2001 | |||||||||
Operating activities: |
||||||||||
Net loss |
$ | (7,420,000 | ) | $ | (4,517,000 | ) | ||||
Adjustments to reconcile net loss to net cash used in
operating activities: |
||||||||||
Depreciation and amortization |
421,000 | 399,000 | ||||||||
Changes in operating assets and liabilities: |
||||||||||
Accounts receivable, net |
(217,000 | ) | (606,000 | ) | ||||||
Inventories |
733,000 | (575,000 | ) | |||||||
Prepaid expenses and other current assets |
436,000 | (358,000 | ) | |||||||
Accounts payable and other accrued expenses |
998,000 | (868,000 | ) | |||||||
Accrued compensation and employee benefits |
(119,000 | ) | (51,000 | ) | ||||||
Accrued clinical trials expense |
475,000 | 772,000 | ||||||||
Accrued professional fees |
12,000 | (15,000 | ) | |||||||
Deferred revenue |
2,237,000 | | ||||||||
Net cash used in operating activities |
(2,444,000 | ) | (5,819,000 | ) | ||||||
Investing activities: |
||||||||||
Purchase of property and equipment |
(49,000 | ) | (45,000 | ) | ||||||
Payment on purchase of marketable securities |
(23,000 | ) | (343,000 | ) | ||||||
Net cash used in investing activities |
(72,000 | ) | (388,000 | ) | ||||||
Financing activities: |
||||||||||
Proceeds from issuance of convertible note |
| 1,600,000 | ||||||||
Proceeds from issuance of common stock, net of
financing costs |
10,526,000 | 849,000 | ||||||||
Net cash provided by financing activities |
10,526,000 | 2,449,000 | ||||||||
Net increase (decrease) in cash and cash equivalents |
8,010,000 | (3,758,000 | ) | |||||||
Cash and cash equivalents, beginning of period |
15,518,000 | 21,981,000 | ||||||||
Cash and cash equivalents, end of period |
$ | 23,528,000 | $ | 18,223,000 | ||||||
See notes to condensed consolidated financial statements
5
SCICLONE PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(unaudited)
1. | Basis of Presentation | |
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles consistent with those applied in, and should be read in conjunction with, the audited financial statements for the year ended December 31, 2001 included in the Companys Form 10-K as filed with the Securities and Exchange Commission. The interim financial information reflects all normal recurring adjustments which are, in the opinion of management, necessary for a fair presentation of the results for the interim periods presented and are not necessarily indicative of results for subsequent interim periods or for the full year. The condensed consolidated balance sheet data at December 31, 2001 is derived from the audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. Certain prior year amounts have been reclassified to conform to the current period presentation. | ||
2. | Significant Accounting Policies | |
Revenue Recognition | ||
The Company recognizes revenue from product sales at the time of shipment and recognizes contract/grant revenue when services have been performed. There are no significant customer acceptance requirements or post shipment obligations on the part of the Company. Sales to importing agents or distributors are recognized at time of shipment when title to the product is transferred to them, and they do not have contractual rights of return except under limited terms regarding product quality. However, the Company will replace products that have expired or are deemed to be damaged or defective when delivered. Payments by the importing agents and distributors are not contingent upon sale to the end user by the importing agents or distributors. Contract revenue for research and development is recorded as earned based on the performance requirements of the contract. Nonrefundable contract fees for which no further performance obligations exist, and there is no continuing involvement by the Company, are recognized on the earlier of when the payments are received or when collection is assured. Revenue associated with substantive performance milestones is recognized based upon the achievement of the milestones, as defined in the respective agreements. Revenue under research and development cost reimbursement contracts is recognized as the related costs are incurred. | ||
Net Loss Per Share | ||
Net loss per share is computed using the weighted average number of shares of common stock outstanding. Common equivalent shares from stock options and warrants are excluded, as their effect is antidilutive. |
6
Recent Accounting Pronouncements | ||
The Company adopted Financial Accounting Standards Board Statement of Financial Accounting Standards No. 142, Goodwill and Other Intangible Assets, on January 1, 2002. There has been no impact on the Companys operating results from the adoption of this standard. | ||
3. | Comprehensive Loss | |
For the three-month periods ended September 30, 2002 and 2001, the Companys total comprehensive loss amounted to $(1,690,000) and $(223,000), respectively. For the nine-month periods ended September 30, 2002 and 2001, the Companys total comprehensive loss amounted to $(7,414,000) and $(4,503,000), respectively. | ||
4. | Available-For-Sale Securities | |
The following is a summary of available-for sale securities at September 30, 2002 and December 31, 2001: |
Gross | Estimated | ||||||||||||
Amortized | Unrealized | Fair | |||||||||||
Cost | Gains | Value | |||||||||||
September 30, 2002: |
|||||||||||||
Certificate of deposit |
$ | 882,000 | $ | | $ | 882,000 | |||||||
U.S. government obligations |
17,447,000 | | 17,447,000 | ||||||||||
Corporate equity securities |
51,000 | 45,000 | 96,000 | ||||||||||
$ | 18,380,000 | $ | 45,000 | $ | 18,425,000 | ||||||||
December 31, 2001: |
|||||||||||||
Certificate of deposit |
$ | 865,000 | $ | | $ | 865,000 | |||||||
Corporate obligations |
10,858,000 | 6,000 | 10,864,000 | ||||||||||
Corporate equity securities |
51,000 | 33,000 | 84,000 | ||||||||||
$ | 11,774,000 | $ | 39,000 | $ | 11,813,000 | ||||||||
As of September 30, 2002, the available-for-sale securities are included as follows: $17,447,000 in cash and cash equivalents; $633,000 in restricted short-term investments and $345,000 in other short-term investments. | ||
5. | Inventories | |
The following is a summary of inventories at September 30, 2002 and December 31, 2001: |
September 30, | December 31, | |||||||
2002 | 2001 | |||||||
Raw materials |
$ | 2,464,000 | $ | 2,759,000 | ||||
Work in progress |
478,000 | 1,269,000 | ||||||
Finished goods |
464,000 | 431,000 | ||||||
Reserve |
(80,000 | ) | (400,000 | ) | ||||
$ | 3,326,000 | $ | 4,059,000 | |||||
7
6. | Prepaid Expenses | |
The Companys prepaid expenses consist of payments to third party institutions conducting or managing our clinical trials and to insurance companies for business liability coverage. | ||
7. | Intangible Assets | |
The following is a summary of intangible assets at September 30, 2002 and December 31, 2001: |
September 30, | December 31, | |||||||
2002 | 2001 | |||||||
Intangible product rights |
$ | 2,456,000 | $ | 2,456,000 | ||||
Accumulated amortization |
(1,671,000 | ) | (1,365,000 | ) | ||||
$ | 785,000 | $ | 1,091,000 | |||||
ZADAXIN® product rights that the Company acquired are being amortized over six years beginning in September 1998. Amortization expense for the three-month and nine-month periods ended September 30, 2002 and 2001 was $102,000 and $307,000, respectively, for both years. Amortization expense for the years ended December 31, 2002, 2003 and 2004 is expected to be $409,000, $409,000 and $273,000, respectively. The Company reassesses the useful life of these assets in accordance with current facts and circumstances. The Companys policy is to identify and record impairment losses, as circumstances dictate, on intangible product rights when events and circumstances indicate that the assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets. The Company to date has not identified any changes in useful life or impairment losses on these assets. | ||
8. | Minimum Purchase Requirements | |
The Company does not have any minimum purchase requirements under its contract manufacturing supply agreements for ZADAXIN and CPX. | ||
9. | Deferred Revenue | |
In January 2002, the Company received $2,685,000 from its European partner, Sigma-Tau under the terms of our collaborative agreement announced in late December 2001. This receipt has been recorded as deferred revenue and will be recognized as contract revenue over the next three years starting in April 2002, the estimated time to complete the ZADAXIN hepatitis C U.S. clinical program and anticipated FDA regulatory filings. For the three-month and nine-month periods ended September 30, 2002, the Company recognized $224,000 and $448,000, respectively as contract revenue. |
8
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Special Note Regarding Forward-Looking Statements
This Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based on our current expectations, estimates and projections about our industry, managements beliefs and certain assumptions made by us. Words such as anticipates, expects, intends, plans, believes or similar expressions are intended to identify forward-looking statements including those statements we make regarding the timing and outcome of clinical trials, anticipated sales and cost of product sales, allocation of financial resources to certain trials and programs, reliance on third-party collaborators and research and development, sales and marketing, general and administrative and operating expense levels. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors including, but not limited to, those described under the caption Risk Factors in this Form 10-Q. We undertake no obligation to revise or update publicly any forward-looking statements for any reason.
Overview
SciClone Pharmaceuticals, Inc. (SciClone or the Company) is a biopharmaceutical company and its lead product ZADAXIN, an Immune System Enhancer, is in two phase 3 hepatitis C clinical trials in the U.S., a phase 3 hepatitis B clinical trial in Japan, a phase 2 malignant melanoma clinical trial in Europe, and two phase 2 liver cancer trials in the U.S. ZADAXIN has been approved for sale by the ministries of health in over 30 countries and is marketed in China and selected other countries outside the U.S. ZADAXIN has been administered to more than 10,000 patients in both clinical and commercial use, alone and in combination with anti-viral and anti-cancer drugs, without producing any ZADAXIN related significant side effects or toxicities.
Results of Operations
Total Revenue
Product sales were $4,298,000 and $12,294,000 for the three-month and nine-month periods ended September 30, 2002, as compared to $3,580,000 and $9,943,000 for the corresponding periods in 2001. The growth was largely due to increased sales of ZADAXIN to our importers in China.
Contract revenue was $224,000 and $448,000 for the three-month and nine-month periods ended September 30, 2002, respectively, as compared to none in 2001. The contract revenue we recognized in 2002 was in connection with funds we received from Sigma-Tau. These funds have been recorded as deferred revenue and are being recognized as contract revenue over three years starting in April 2002, the estimated time to complete the ZADAXIN U.S. hepatitis C clinical trial program and anticipated FDA regulatory filings.
9
For the three-month and nine-month periods ended September 30, 2002, all of our product sales were derived from sales of ZADAXIN, and in each period, China accounted for approximately 88% of this revenue. Sales emphasis is concentrated in China because, as our most developed market, marketing expenditures are more likely to result in sales and profits compared to newer markets, which require investment and development spending.
Cost of Product Sales
Cost of product sales were $918,000 and $2,525,000 for the three-month and nine-month periods ended September 30, 2002 as compared to $714,000 and $1,948,000 for the corresponding periods in 2001 with the increase being primarily due to higher product sales. We expect cost of product sales to vary from quarter to quarter, depending upon the level of ZADAXIN sales, the absorption of fixed product-related costs, and any charges associated with excess or expiring finished product inventory.
Research and Development
Research and development expenses were $2,110,000 and $8,407,000 for the three-month and nine-month periods ended September 30, 2002, as compared to $3,390,000 and $6,717,000 for the corresponding periods in 2001. The decrease in the three-month period ended September 30, 2002 was primarily due to higher expenses in 2001 for the clinical trial in Japan and the impact of the refinement of our clinical trial accrual estimates relating to our U.S. ZADAXIN hepatitis C trials. The revisions to our estimates reduced research and development expenses in the third quarter of 2002 by $625,000. The increase in the nine-month period ended September 30, 2002 related to higher expenses in 2002 for our late-stage clinical programs for ZADAXIN in the U.S. The initiation and continuation of ZADAXIN clinical trials have had, and will continue to have, the largest and most significant effect on our research and development expenses. Expenses related to grants to institutions that conduct the clinical trials on our behalf are accrued based on the level of patient enrollment and activity according to the protocol. In general, these expenses will be higher for the initial and final months of a patients scheduled 18 months of treatment and observation. Fees to the clinical research organization (CRO) managing the trials and laboratory and other direct expenses are recognized in the period they are incurred. We expect that the current level of spending on and the projected costs to complete our ZADAXIN clinical trials in the U.S. will require us to seek additional capital resources. Our research and development spending is focused almost exclusively on ZADAXIN, and we expect this to continue unless and until we obtain additional resources which could be applied to our other product candidates. In general, we expect product research and development expenses to increase in absolute dollars over the next several years and to vary quarter to quarter as we pursue our strategy of initiating additional preclinical and clinical trials and testing, acquiring product rights, and expanding regulatory activities.
Sales and Marketing
Sales and marketing expenses were $2,217,000 and $6,291,000 for the three-month and nine-month periods ended September 30, 2002, as compared to $2,256,000 and $7,184,000 for the corresponding periods in 2001. The decrease in the 2002 nine-month period was related to lower promotional and advertising expenses. We expect our sales and marketing expenses to
10
vary quarter to quarter and to increase in the next several years as we expect to expand our commercialization and marketing efforts and pursue additional strategic collaborations.
General and Administrative
General and administrative expenses were $960,000 and $2,907,000 for the three-month and nine-month periods ended September 30, 2002, as compared to $749,000 and $2,532,000 for the corresponding periods in 2001. The increases were primarily related to increased legal expenses. In the near term, we expect general and administrative expenses to vary quarter to quarter and to increase over the next several years as we augment our general and administrative activities and resources to support increased expenditures on preclinical and clinical trials and testing, and regulatory, pre-commercialization and marketing activities.
Interest and Investment Income
Interest and investment income was $100,000 and $252,000 for the three-month and nine-month periods ended September 30, 2002, as compared to $174,000 and $672,000 for the corresponding periods in 2001. The decrease was primarily due to lower interest rates.
Interest and Investment Expense
Interest and investment expense was $91,000 and $271,000 for the three-month and nine-month periods ended September 30, 2002, as compared to $90,000 and $243,000 for the corresponding periods in 2001.
Other Income (Expense), net
Other income (expense), net, was $2,000 and $(13,000) for the three-month and nine-month periods ended September 30, 2002, as compared to $3,272,000 and $3,492,000 for the corresponding periods in 2001. The higher other income amount in 2001 was due to a repayment of a loan that had previously been written off.
Liquidity and Capital Resources
At September 30, 2002 and 2001, we had $24,506,000 and $19,096,000, respectively, in cash, cash equivalents and short-term investments, $633,000 of which was restricted cash at each date. Our short-term investments consist primarily of short term U.S. government and agency obligations.
Net cash used by us in operating activities amounted to $2,444,000 for the nine-month period ended September 30, 2002. Net cash used in operating activities in the 2002 period was less than our net loss for that period primarily due to the receipt of a payment from Sigma-Tau of $2,685,000 for a clinical trial collaboration which increased deferred revenue balances by $2,237,000, depreciation and amortization, increases in accrued clinical trials expense, increases in accounts payable and decreases in prepaid expenses and inventories, partially offset by increases in accounts receivable.
11
Net cash used by us in investing activities amounted to $72,000 for the nine-month period ended September 30, 2002 and related primarily to the purchase of $49,000 in property and equipment.
Net cash provided by financing activities amounted to $10,526,000 for the nine-month period ended September 30, 2002. Net cash provided by financing activities consisted of $494,000 related to exercises of outstanding options under our employee stock option plans, $118,000 for the issuance of common stock under our employee stock purchase plan and gross proceeds of $10,630,000 from the offering of our common stock in June 2002, less $716,000 in financing-related costs.
Our contractual obligations and other commitments as of September 30, 2002 were as follows:
Payments Due by Period | ||||||||||||||||||||
Contractual | Less than 1 | |||||||||||||||||||
Obligations | Total | year | 1-3 years | 4-5 years | After 5 years | |||||||||||||||
Long Term Debt |
$ | 5,600,000 | $ | | $ | | $ | 5,600,000 | $ | | ||||||||||
Operating Leases |
5,347,000 | 1,339,000 | 2,712,000 | 1,296,000 | | |||||||||||||||
Total Contractual Cash Obligations |
$ | 10,947,000 | $ | 1,339,000 | $ | 2,712,000 | $ | 6,896,000 | $ | |
Amount of Commitment Expiration Per Period | ||||||||||||||||||||
Other Commercial | Total Amounts | Less than 1 | ||||||||||||||||||
Commitments | Committed | year | 1-3 years | 4-5 years | After 5 years | |||||||||||||||
Letter of Credit |
$ | 633,000 | $ | 633,000 | | | |
None of our officers or directors were involved in any related party transactions with the Company in the three-month and nine-month periods ended September 30, 2002.
Management intends to give priority use of the Companys financial resources to ZADAXIN clinical programs in the United States. Management believes our existing capital resources and interest on funds available are adequate to maintain our current and planned operations through 2003. We will need to obtain additional capital to support our long-term product development. Assuming approval of ZADAXIN by the U.S. FDA and other regulatory authorities, we may also require additional capital for our commercialization programs. The need, timing and amount of additional funding will depend upon numerous factors, including the level of ZADAXIN sales, the timing and amount of manufacturing costs related to ZADAXIN, the availability of complementary products, technologies and businesses, the initiation and continuation of preclinical and clinical trials and testing, particularly ZADAXIN trials in the U.S. and Japan, the timing of regulatory approvals, developments in relationships with existing or future collaborative parties and the status of competitive products. In the event we need to raise additional financing, the unavailability or the inopportune timing of any financing could prevent or delay our long-term product development and commercialization programs, either of which would severely hurt our business.
Risk Factors
You should carefully consider the risks described below, in addition to the other information in this report on Form 10-Q, before making an investment decision. Each of these
12
risk factors could adversely affect our business, financial condition, and operating results as well as adversely affect the value of an investment in our common stock.
Our phase 3 clinical trials in the U.S. for the approval of ZADAXIN in combination with pegylated interferon for the treatment of hepatitis C may fail, which will harm our business.
Currently, there is no U.S. FDA approved therapy for hepatitis C patients who have failed to respond to prior therapy with interferon plus ribavirin or with interferon alone. We designed phase 3 clinical trials based on the use of ZADAXIN in combination with pegylated interferon to address this medical need. There can be no assurances that the results from our previous hepatitis C studies which enabled us to produce this design will carryover to the trials involving a combination of ZADAXIN and pegylated interferon and any resulting data may be insufficient or inadequate to demonstrate appropriate efficacy under FDA guidelines. In addition, insufficient data resulting from the clinical trials would also adversely affect our ability to market and sell ZADAXIN in markets where it is approved for sale. We have begun enrolling patients in both of the phase 3 trials in our hepatitis C clinical program in the U.S.; however, there are trials being conducted by competitors seeking to enroll similar patients and competition for appropriate patients for these clinical trials is significant. We may not be able to enroll patients quickly enough to meet our timing expectations for completing the trial which would delay the preparation of a new drug application (NDA); or we may not be able to fully enroll the studies or patient drop out rates could be higher than anticipated, either of which could weaken the quality of an NDA. Our hepatitis C clinical trials have been designed to show that the combination of ZADAXIN and pegylated interferon adds a significant clinical benefit when compared to the use of pegylated interferon alone in the treatment of hepatitis C. However, the independent use of the pegylated form of interferon may perform better than anticipated which could weaken the quality of an NDA. ZADAXIN has been used both clinically and commercially in thousands of patients without producing any reported ZADAXIN related significant side effects or toxicities, and the pegylated interferon used in the clinical trials has been approved by the FDA and has documented adverse side effects. Should the combination therapy of ZADAXIN and pegylated interferon cause significant new or to a greater degree the same adverse side effects, our clinical trials could be delayed, patients may drop out at a greater than anticipated rate, we may be forced to halt the trials, or the FDA may reject an NDA on safety issues. If any of the foregoing occurs, our efforts to market and sell ZADAXIN in combination with pegylated interferon will be impaired, and our business will suffer.
We rely on third parties to manufacture our clinical trial product. Deficiencies in their work could delay or harm our trials or the approval process and harm our business.
We manufacture the ZADAXIN used in our phase 3 trials under cGMP guidelines and under our direct manufacturing and quality control using third party cGMP manufacturers and suppliers. If unanticipated deficiencies in these manufacturers or suppliers occur, this could create a delay in the assembling of a timely and acceptable NDA. Although all of the ZADAXIN and pegylated interferon planned to be used in the hepatitis C clinical trials has already been manufactured and received, any recall of either product by a manufacturer could delay the clinical trials or detract from the integrity of the trial data. If any of the foregoing occurs, our
13
efforts to market and sell ZADAXIN in combination with pegylated interferon will be impaired, and our business will suffer.
We may not be able to successfully develop or commercialize our products.
Many of our products are in the development stage and will require the commitment of substantial resources, devoted to extensive research, development, preclinical testing, clinical trials, manufacturing scale-up and regulatory approval prior to being ready for sale. We cannot assure you that commercially viable products will result from these efforts. We face significant technological risks inherent in developing these products. We may also abandon some or all of our proposed products before they become commercially viable. We have limited experience in conducting and managing U.S. clinical trials and we rely, in part, on third parties, particularly clinical research organizations and our development partners, to assist us in managing and monitoring clinical trials. Our reliance on these third parties may result in delays in completing, or failure to complete, these clinical trials if third parties fail to fulfill their obligations to us. If any of our products, even if developed and approved, cannot be successfully commercialized in a timely manner, our business will be harmed and the price of our stock may decline.
We have not yet sold any product other than ZADAXIN. We have experienced difficulties with the formulation of CPX which has delayed its further development. Our future revenue growth depends on increased market acceptance and commercialization of ZADAXIN in additional countries, particularly in the U.S., Europe and Japan. If we fail to successfully market ZADAXIN, or if we cannot commercialize this drug in the U.S. and other additional markets, our revenue and operating results will suffer. Our future revenue will also depend in part on our ability to develop other commercially viable and accepted products; however, until we obtain additional resources, substantially all of our resources are focused on the development of ZADAXIN. Market acceptance of our products will depend on many factors, including our ability to convince prospective customers and prospective strategic partners that our products are an attractive alternative to other treatments and therapies, and manufacture products in sufficient quantities with acceptable quality and at an acceptable cost. Failure to do so will hurt our operations.
If we fail to satisfy and comply with governmental regulations or if government regulations change, our business may suffer.
All new drugs, including our products, which have been developed or are under development, are subject to extensive and rigorous regulation by the FDA, and comparable agencies in state and local jurisdictions and in foreign countries. These regulations govern, among other things, the development, testing, manufacturing, labeling, storage, pre-market approval, importation, advertising, promotion, sale and distribution of our products. These regulations change from time to time and new regulations may be adopted. For example, in prior years, legislation has been introduced in the U.S. Congress that would restrict the duration of the marketing exclusivity of an orphan drug. There can be no assurances that this type of legislation will not be reintroduced and passed into law, or that the benefits of the existing statute will remain in effect. Our failure to satisfy and comply with regulations adopted by the FDA, and comparable agencies in state and local jurisdictions and in foreign countries, may delay or stop approval of our drugs. In particular, such failure can, among other things, result in warning
14
letters, fines, suspensions of regulatory approvals, product recalls or seizures, operating restrictions, injunctions, total or partial suspension of production, civil penalties, and criminal prosecutions. Furthermore, additional government regulation may be established or imposed by legislation or otherwise, which could prevent or delay regulatory approval of ZADAXIN or any of our other future products. Adverse events related to our products in any of our existing or future markets could cause regulatory authorities to withdraw market approval for such products, if any, or prevent us from receiving market approval in the future. There is no assurance that ZADAXIN, or any of our other products, will demonstrate efficacy sufficient to obtain approval by the FDA or its counterpart regulatory agencies in other countries.
Satisfaction of government regulations may take several years and the time needed to satisfy them varies substantially, based on the type, complexity and novelty of the pharmaceutical product. As a result, government regulation may cause us to delay the introduction of, or prevent us from marketing, our existing or potential products for a considerable period of time and to impose costly procedures upon our activities. If regulatory approval of our products is granted, such approval may impose limitations on the indicated uses for which our products may be marketed.
If we fail to obtain regulatory approvals for our products in countries where we have targeted regulatory approval, we may not be able to sustain or increase our revenues and our stock price may decline.
The research, preclinical and clinical development, manufacturing, marketing and sale of ZADAXIN and our other drug candidates are subject to extensive regulation by governmental authorities. ZADAXIN and any other products we may sell in countries outside the U.S. must be approved by the foreign counterparts of the FDA before they can be sold in any jurisdiction. Obtaining regulatory approval is time-consuming and expensive. In some countries where we are contemplating marketing and selling ZADAXIN, the regulatory approval process for drugs that have not been previously approved in countries with established clinical trial review procedures is uncertain, and this may delay or prevent the grant of regulatory approvals for ZADAXIN. In addition, to secure these regulatory approvals, we will need, among other things, to demonstrate favorable results from additional clinical trials of ZADAXIN. Even if we are able to complete the clinical trials we have sponsored or are planning in a timely or cost effective manner, these trials may not fulfill the applicable regulatory approval criteria, in which case we will not be able to obtain regulatory approval in these countries. There can be no assurance that we will ultimately obtain regulatory approvals in our targeted countries in a timely and cost-effective manner or at all. Our failure to obtain the required regulatory approvals so that we can develop, market and sell our products in countries where we currently do not have such rights will limit our revenues.
In addition, adverse results that occur in our clinical trials could result in restrictions on the use of ZADAXIN, which may also hurt our business.
We will need to obtain additional capital to support our long-term product development and commercialization programs.
Our ability to achieve and sustain operating profitability depends in large part on our ability to commence, execute and complete clinical programs for, and obtain additional
15
regulatory approvals for ZADAXIN and other drug candidates, particularly in the U.S., Europe and Japan, increase ZADAXIN sales in existing markets, and launch ZADAXIN in new markets. We cannot assure you that we will ever achieve more significant levels of sales or that we will receive additional ZADAXIN market approvals.
Our current sales levels of ZADAXIN are not expected to generate all the funds we anticipate will be needed to support our current plans for product development including our U.S. phase 3 clinical trials for ZADAXIN. We will need to obtain additional financing to support our product development and commercialization programs. We may seek additional funds through public and private stock offerings, arrangements with corporate partners, borrowings under lease lines of credit or other sources. If we cannot raise the necessary funds, we will have to reduce our capital expenditures, curtail or delay our phase 3 clinical trials, scale back our development of new products, reduce our workforce and out-license to others products or technologies that we otherwise would seek to commercialize ourselves, any of which may harm our business and cause our stock price to fall.
The amount of capital we will need will depend on many factors, including: the timing, location, scope and results of ongoing and planned preclinical studies and clinical trials; the cost of manufacturing or obtaining preclinical and clinical materials; the timing and cost involved in applying for and obtaining FDA and international regulatory approvals; whether we elect to establish additional partnering arrangements for development, sales, manufacturing, and marketing of our products; the level of future ZADAXIN sales; expense levels for our international sales and marketing efforts; our ability to establish and maintain strategic arrangements for development, sales, manufacturing and marketing of our products; competing technological and market developments; the costs involved in filing, prosecuting and enforcing patent claims; whether any or all of our outstanding convertible notes are converted to common stock; and whether any or all of our outstanding common stock warrants are exercised and the timing and amount of these exercises.
Many of the foregoing factors are not within our control. If we need to raise additional funds and such funds are not available on reasonable terms, we may be required to delay or cancel our product development and commercialization programs. Any additional equity financing will be dilutive to shareholders, and any debt financing, if available, may include restrictive covenants.
We have a history of operating losses and an accumulated deficit. We expect to continue to incur losses in the near term and may never achieve profitability.
We have experienced significant operating losses since our inception and as of September 30, 2002, we had an accumulated deficit of approximately $130 million. We expect our operating expenses to increase over the next several years as we plan to dedicate substantially all of our resources to expanding our development, testing and marketing capabilities, particularly in the U.S., and we may never achieve profitability. Our failure to achieve profitability may cause our stock price to decline.
16
Our revenue is dependent on the sale of ZADAXIN in foreign countries, particularly China, and if we experience difficulties in our foreign sales efforts, our financial condition will be harmed.
Our product revenue in the near term is highly dependent on the sale of ZADAXIN in foreign countries. If we experience difficulties in our foreign sales efforts, our business will suffer and our financial condition will be harmed. Substantially all of our ZADAXIN sales are to customers in China. Sales of ZADAXIN in China may be limited due to its low average personal income, lack of patient cost reimbursement, poorly developed infrastructure, and existing and potential competition from other products, including generics. We are currently in the process of renewing our importation permit to allow us to continue to sell our product to the importers in China. Our business would be severely harmed if we were unable to renew the permit or if the renewal process were prolonged and we were not granted an exemption to make periodic shipments into China. In China ZADAXIN is sold as an imported finished product. The attractiveness of the ZADAXIN market may encourage local companies to introduce lower priced locally manufactured generic competitive products. If this occurs, there could be a negative impact on the price and the volume of ZADAXIN sold to this country and this would harm our business.
In addition, our ZADAXIN sales and operations in other parts of Asia, as well as in Latin America and the Middle East, are subject to a number of risks, including: difficulties and delays in obtaining pricing approvals and reimbursement, product health registrations and importation permits; unexpected changes in regulatory requirements; difficulties in staffing and managing foreign operations; long payment cycles; difficulties in accounts receivable collection; difficulties in enforcing our proprietary rights; currency fluctuations; adverse or deteriorating economic conditions; and potential adverse tax consequences.
We do not have product sales in the U.S. with which to offset any decrease in our revenue from ZADAXIN sales in Asia, Latin America and the Middle East. In addition, some countries in these regions, including China, regulate pharmaceutical prices and pharmaceutical importation. These regulations may reduce prices for ZADAXIN to levels significantly below those that would prevail in an unregulated market, limit the volume of product which may be imported and sold, or place high import duties on the product, any of which may limit the growth of our revenues or cause them to decline.
Because of Chinas tiered method of importing and distributing finished pharmaceutical products, our quarterly results may vary substantially from one period to the next.
China uses a tiered method to import and distribute finished pharmaceutical products. At each port of entry, and prior to moving the product forward to the distributors, government licensed importing agents must process and evaluate each shipment to determine whether such shipment satisfies Chinas quality assurance requirements. In order to efficiently manage this process, the importing agents place relatively few orders from time to time over any six month period and each order is typically for large quantities. Therefore, our sales to an importing agent can vary substantially from quarter to quarter depending on the size and timing of the orders, which has in the past and may in the future cause our quarterly results to fluctuate. Because we use four importing agents in China, our account receivable from any one importing agent is
17
material and if we were unable to collect receivables from any importer, our business and cash-flow would be adversely affected, at least in the short term.
We have limited sales, marketing and distribution capabilities, which may adversely affect our ability to successfully commercialize our products.
We currently have limited sales, marketing and distribution capabilities, and we anticipate that we will be relying on third-party collaborators to sell, market and distribute our products for the foreseeable future. If our arrangements with these third parties are not successful, or if we are unable to enter into additional third-party arrangements, we may need to substantially expand our sales, marketing and distribution force. Our efforts to expand may not succeed, or we may lack sufficient resources to expand in a timely manner, either of which will harm our operating results. In addition, if we are able to further expand our sales, marketing and distribution capabilities, we will begin competing with other companies that have experienced and well funded operations. If we cannot successfully compete with these larger companies, our revenues may not grow and our business may suffer.
If we are not able to establish and maintain adequate manufacturing and supply relationships, the development and sale of our products could be impaired.
To be successful, our products must be manufactured in commercial quantities, in compliance with regulatory requirements and at an acceptable cost. We may not be able to maintain the long-term manufacturing relationships we currently have with our suppliers and we anticipate changes will be needed if our volume requirements increase. Manufacturing interruptions could significantly delay clinical development of potential products and reduce third-party or clinical researcher interest and support of proposed trials. These interruptions could also impede commercialization of our products, including sales of ZADAXIN in approved markets, and impair our competitive position. Any of these developments would harm our business.
In some countries, a manufacturing change may require additional regulatory approvals. If we do not obtain the required regulatory approvals for a manufacturing change in a timely fashion, new ZADAXIN marketing approvals may be delayed or sales may be interrupted until the manufacturing change is approved. Either of these results would harm our business.
In addition, manufacturing, supply and quality control problems may arise as we, either alone or with subcontractors, attempt to scale-up our manufacturing procedures. We may not be able to scale-up in a timely manner or at a commercially reasonable cost, either of which could cause delays or pose a threat to the ultimate commercialization of our products and harm our business.
If we do not obtain rights to additional products from third parties, our prospects for future revenue may decline.
We are only actively pursuing clinical development of ZADAXIN at this time. If we do not devote additional resources to CPX or advance SCV-07 and DAX, the other products to which we have in-licensed rights, from preclinical into clinical development, we may lose the
18
rights to these products. We may also have a shortage of drugs to develop and commercialize if we do not license or otherwise acquire rights to additional drugs. Any shortage in the number of drugs that we are able to develop and commercialize may reduce our prospects for future revenue.
Commercialization of some of our products depends on collaborations with others. If our collaborators are not successful, or if we are unable to find future collaborators, we may not be able to properly develop and commercialize our products.
We depend in part on our distributors and business partners to develop and/or promote our drugs, and if they are not successful in their efforts or fail to do so, our business will suffer. We generally do not have control over the amount and timing of resources that our business partners devote to ZADAXIN and they have not always performed as or when expected. If they do not perform their obligations as we expect, particularly obligations regarding clinical trials, our development expenses would increase and the development and/or sale of our products could be limited or delayed, which could hurt our business and cause our stock price to decline. In addition, our relationships with these companies may not be successful. Disputes may arise over ownership rights to intellectual property, know-how or technologies developed with our collaborators, and we may not be able to negotiate similar additional arrangements in the future to develop and commercialize ZADAXIN or other products.
If we fail to protect our products, technologies and trade secrets, we may not be able to successfully use, manufacture, market or sell our products, or we may fail to advance or maintain our competitive position.
Our success depends significantly on our ability to obtain and maintain meaningful patent protection for our products and technologies, to preserve our trade secrets and to avoid infringing on the proprietary rights of third parties. Our pending patent applications may not result in the issuance of patents in the future. Our patents or patent applications may not have priority over others applications. Our existing patents and additional patents, if any, that issued, may not provide a competitive advantage to us or may be invalidated or circumvented by our competitors. Others may independently develop similar products or design around patents issued or licensed to us. Patents issued to, or patent applications filed by, other companies could harm our ability to use, manufacture, market or sell our products or maintain our competitive position with respect to our products. Although many of our patents relating to ZADAXIN have expired, we have rights to other patents and patent applications relating to ZADAXIN under exclusive licenses. If we breach the terms of any of these licenses, we could lose our rights to these patents and patent applications.
Our commercial success also depends in part on us not infringing valid, enforceable patents or proprietary rights of third parties, and not breaching any licenses that may relate to our technologies and products. We are aware of third-party patents that may relate to our products. It is possible that we may unintentionally infringe these patents or other patents or proprietary rights of third parties. We may in the future receive notices claiming infringement from third parties as well as invitations to take licenses under third-party patents. Any legal action against us or our collaborative partners claiming damages and seeking to enjoin commercial activities relating to our products and processes affected by third-party rights may require us or our
19
collaborative partners to obtain licenses in order to continue to manufacture or market the affected products and processes. Our efforts to defend against any of these claims, even if unmeritorious, would require us to devote resources and attention that could have been directed to our operations and growth plans. In addition, these actions may subject us to potential liability for damages. We or our collaborative partners may not prevail in a patent action and any license required under a patent may not be made available on commercially acceptable terms, or at all.
Pharmaceuticals are either not patentable or have only recently become patentable in some of the countries in which we have exclusive rights to ZADAXIN. Past enforcement of intellectual property rights in many of these countries has been limited or non-existent. Future enforcement of patents and proprietary rights in many other countries will likely be problematic or unpredictable. Moreover, the issuance of a patent in one country does not assure the issuance of a similar patent in another country. Claim interpretation and infringement laws vary by nation, so the extent of any patent protection is uncertain and may vary in different jurisdictions.
If we make any acquisitions, we will incur a variety of costs and may never realize the anticipated benefits.
If appropriate opportunities become available, we may attempt to acquire products, product candidates or businesses that we believe fit strategically with our business. We currently have no commitments or agreements with respect to material acquisitions. If we do undertake any transaction of this sort, the process of integrating an acquired product, product candidate or business may result in operating difficulties and expenditures and may absorb significant management attention that would otherwise be available for our ongoing business development plans. Moreover, we may never realize the anticipated benefits of any acquisition. Future acquisitions could result in in-process research and development expenses, potentially dilutive issuances of equity securities, the incurrence of debt, contingent liabilities and/or amortization or impairment of goodwill or other intangible assets, which could adversely affect our business, financial condition and results of operations.
We may lose market share or otherwise fail to compete effectively in the intensely competitive biopharmaceutical industry.
Competition in the biopharmaceutical industry is intense and we expect that competition to increase. Our success depends on our ability to compete. We believe that the principal competitive factors in this industry include the efficacy, safety, price, therapeutic regimen, manufacturing quality assurance, and patents associated with a given drug. Our competitors include biopharmaceutical companies, biotechnology firms, universities and other research institutions, both in the U.S. and abroad, that are actively engaged in research and development of products in the therapeutic areas we are pursuing, particularly hepatitis C, hepatitis B, and cancer. Competitors are currently marketing drugs for hepatitis C, hepatitis B and cancer, or have products in late-stage clinical trials.
Most of our competitors, particularly large biopharmaceutical companies, have substantially greater financial, technical, regulatory, manufacturing, marketing and human resource capabilities than we do. Most of them also have extensive experience in undertaking the preclinical and clinical testing and in obtaining the regulatory approvals necessary to market
20
drugs. Additional mergers and acquisitions in the pharmaceutical industry may result in even more resources being concentrated with our competitors. Where comparable products are marketed by other companies, price is a competitive factor. Increased competitive pressure could lead to intensified price-based competition resulting in lower prices and margins, which would hurt our operating results.
We currently rely on sales of ZADAXIN outside of the U.S. as a treatment for hepatitis C and hepatitis B and certain cancers as our primary source of product revenue. Several large biopharmaceutical companies have substantial commitments to alpha interferon, an approved drug for treating hepatitis B and hepatitis C, and to lamivudine, an approved drug to treat hepatitis B. We cannot assure you that we will compete successfully against our competitors or that our competitors, or potential competitors, will not develop drugs or other treatments for hepatitis C, hepatitis B, cancer, and other diseases that will be superior to ours.
In the U.S., our product ZADAXIN is being evaluated in combination with pegylated interferon for the treatment of hepatitis C patients who have failed to respond to prior therapy with interferon plus ribavirin or with interferon alone. Other companies are researching, developing, or marketing other products for use in combination with pegylated interferons for clinical indications including HCV and HBV. Such competitive products include ribavirin, allegedly improved ribavirin molecules and other products not yet in late stage clinical trials such as therapeutic vaccines and reverse transcriptase inhibitors. Our clinical trials may not show ZADAXIN to have advantages over such existing or future competitive products nor to have clinically significant synergistic value.
We believe that we can position ZADAXIN as a complementary rather than competitive drug to many therapies, but cannot guarantee that we will be successful in this endeavor. We expect continuing advancements in and increasing awareness of the use of immune system enhancer therapy to fight cancer and infectious diseases and that this development may create new competitors. We cannot assure you that we will be able to successfully compete with any such competitors.
Legislative actions, higher insurance cost and potential new accounting pronouncements are likely to impact our future financial position and results of operations.
There have been regulatory changes, including the Sarbanes-Oxley Act, and there may be potential new accounting pronouncements or regulatory rulings, which will have an impact on our future financial position and results of operations. The Sarbanes-Oxley Act and other rule changes and proposed legislative initiatives following the Enron bankruptcy are likely to increase general and administrative costs. In addition, insurers are likely to increase rates as a result of high claims rates over the past year and our rates for our various insurance policies are likely to increase. Further, proposed initiatives could result in changes in accounting rules, including legislative and other proposals to account for employee stock options as an expense. These and other potential changes could materially increase the expenses we report under generally accepted accounting principles, and adversely affect our operating results.
Future changes in financial accounting standards may cause adverse unexpected revenue fluctuations and affect our reported results of operations.
21
A change in accounting policies can have a significant effect on our reported results and may even affect our reporting of transactions completed before the change is effective. New pronouncements and varying interpretations of pronouncements have occurred with frequency and may occur in the future. Changes to existing rules or the questioning of current practices may adversely affect our reported financial results or the way we conduct our business.
Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses.
Changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002, new SEC regulations and Nasdaq Stock Market rules, are creating uncertainty for companies such as ours. We are committed to maintaining high standards of corporate governance and public disclosure. As a result, we intend to invest all reasonably necessary resources to comply with evolving standards, and this investment may result in increased general and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities.
If third-party reimbursement is not available or patients cannot otherwise pay for ZADAXIN, we may not be able to successfully market ZADAXIN.
Our ability to successfully commercialize our products may depend in part on the extent to which coverage and reimbursement to patients for our products will be available from government health care programs, private health insurers and other third party payors or organizations. Significant uncertainty exists as to the reimbursement status of new therapeutic products, such as ZADAXIN, and we cannot assure you that third party insurance coverage and reimbursement will be available for therapeutic products we might develop. In most of the emerging markets in which we sell ZADAXIN or intend to sell ZADAXIN, reimbursement for ZADAXIN under government or private health insurance programs is not yet widely available. The failure to obtain third-party reimbursement for our products, particularly in the U.S., Europe and Japan, will harm our business. In the U.S., proposed health care reforms could limit the amount of third-party reimbursement available for our products. We cannot assure you that additional limitations will not be imposed in the future on drug coverage and reimbursement. In many emerging markets where we have marketing rights to ZADAXIN, government resources and per capita income may be so low that our products will be prohibitively expensive. In these countries, we may not be able to market our products on economically favorable terms, if at all.
Efforts by governmental and third-party payors to contain or reduce health care costs could cause us to reduce the prices at which we market our drugs, which will reduce our gross margins and may harm our business. Various governments and third-party payors are trying to contain or reduce the costs of health care through various means. We expect that there will continue to be a number of legislative proposals to implement government controls. The announcement of proposals or reforms could cause us to reduce the prices at which we market our drugs, which will reduce our gross margins and may harm our business.
22
If the current economic slowdown in the U.S. causes the economies of other countries, particularly those in Asia, Latin America and the Middle East to experience a slowdown or recession, our business will suffer.
The U.S. is the worlds largest consumer and as such, the current economic slowdown in the U.S. may adversely affect the economies of other countries, including the developing countries in Asia, Latin America and the Middle East from which we derive all of our revenues. If the economic conditions in the U.S. continue or worsen, these developing countries may also experience an economic slowdown or recession, which would likely result in a decrease of sales of ZADAXIN. Any decrease in sales of ZADAXIN would harm our operating results, delay our efforts to achieve profitability, and likely cause our stock price to decline.
If we lose key personnel or are unable to attract and retain additional, highly skilled personnel required for the expansion of our activities, our business will suffer.
We are highly dependent upon our ability to attract and retain qualified personnel because of the specialized, scientific and international nature of our business. There is intense competition for qualified management, scientific and technical personnel in the pharmaceutical industry, and we may not be able to attract and retain the qualified personnel we need to grow and develop our business globally. In addition, numerous key responsibilities at SciClone are assigned to a small number of individuals. If we were unable to attract and retain qualified personnel as needed or promptly replace those employees who are critical to our product development and commercialization, the development and commercialization of our products would adversely be affected. At this time, we do not maintain key person life insurance on any of our key personnel.
We may be subject to product liability lawsuits and our insurance may be inadequate to cover damages.
Clinical trials or marketing of any of our current and potential products may expose us to liability claims from the use of these products. We currently carry product liability insurance. However, we cannot be certain that we will be able to maintain insurance on acceptable terms for clinical and commercial activities or that the insurance would be sufficient to cover any potential product liability claim or recall. If we fail to have sufficient coverage, our business, results of operations and cash flows could be adversely affected.
If we are unable to comply with environmental laws and regulations, our business may be harmed.
We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous materials and waste products. We currently maintain a supply of hazardous materials at our facilities. In the event of an accident, we could be liable for any damages that result, and the liability could exceed our resources. While we outsource our research and development programs involving the controlled use of biohazardous materials, if in the future we conduct these programs ourselves, we might be required to incur significant cost to comply with the environmental laws and regulations.
23
The price of our common stock has experienced substantial volatility and may fluctuate due to factors beyond our control.
U.S. and global economies have weakened due to the effects and uncertainties caused by the events of September 2001 which may result in a decrease in our revenues and cause our stock price to decline. Further, high profile corporate governance and accounting problems and resulting corporate failures have eroded investor confidence. In the wake of these events, U.S. and global capital markets have experienced a period of extreme volatility, and this may continue for some time.
In addition, there has been significant volatility in the market prices for publicly traded shares of pharmaceutical and biotechnology companies, including ours. The following factors may have an adverse impact on the market price of our common stock: significant negative changes in the major equity market indices; announcements of technical or product developments by us or our competitors; governmental regulation; health care legislation; public announcements regarding advances in the treatment of the disease states that we are targeting; public announcements from government officials relating to the biotechnology or pharmaceutical industries; patent or proprietary rights developments; changes in third-party reimbursement policies for our products; and fluctuations in our operating results. We cannot assure you that the price of our common stock will remain at or exceed current levels.
If the current war on terrorism causes economic slowdowns in the economies of certain countries our business will suffer.
The United States and its allied nations are aggressively attacking terrorism with military and economic actions. If these actions lead to economic slowdowns in the economies of developing countries in Asia, Latin America and the Middle East from which we currently derive all of our product revenue, then our sales could decrease. Any decrease in sales would harm our operating results, delay our efforts to achieve profitability, and likely cause our stock price to decline.
Our indebtedness may result in future liquidity problems.
As of September 30, 2002, we had $5.6 million in convertible notes payable, of which $4.0 million were issued in the quarter ended December 31, 2000 and $1.6 million were issued in the quarter ended March 31, 2001. This indebtedness, or additional debt we may incur to fund our operations, may make it more difficult for us to obtain additional financing. The outstanding notes are payable five years after issuance unless converted into common stock at the sole discretion of the holder. If we are unable to satisfy our debt service requirements, substantial liquidity problems could result which would negatively impact our future prospects. As of September 30, 2002 we had cash, cash equivalents and short-term investments of $24.5 million.
Substantial sales of our stock or convertible securities may impact the market price of our common stock.
As of September 30, 2002, stock options for 5,115,282 shares of common stock were outstanding, of which options for 3,595,474 shares were exercisable. Also outstanding as of the
24
same date were warrants exercisable for 1,970,500 shares of common stock and two issues of notes convertible into a total of 684,140 shares of common stock. In addition, the note holder has the right to purchase senior unsecured convertible notes due December 2005 and March 2006. If issued, the additional notes will bear no interest (zero coupon) and will be convertible into 684,140 shares of our common stock. Upon exercise of options or warrants, or conversion of the notes, these issued shares of common stock will be freely tradable.
Future sales of substantial amounts of our common stock could adversely affect the market price of our common stock. Similarly, if we raise additional funds through the issuance of common stock or securities convertible into or exercisable for common stock, the percentage ownership of our shareholders will be reduced and the price of our common stock may fall.
Issuing preferred stock with rights senior to those of our common stock could adversely affect holders of common stock.
Our charter documents give our board of directors the authority to issue series of preferred stock without a vote or action by our shareholders. The board also has the authority to determine the terms of preferred stock, including price, preferences and voting rights. The rights of holders of our common stock may be adversely affected by the rights granted to holders of preferred stock. For example, a series of preferred stock may be granted the right to receive a liquidation preference a pre-set distribution in the event of a liquidation that would reduce the amount available for distribution to holders of common stock. In addition, the issuance of preferred stock could make it more difficult for a third party to acquire a majority of our outstanding voting stock. As a result, common shareholders could be prevented from participating in transactions that would offer an optimal price for their shares.
25
Item 3. Quantitative and Qualitative Disclosures About Market Risk
The primary objective of our investment activities is to preserve principal while at the same time maximizing yields without significantly increasing risk. To achieve this objective, we invest in highly liquid and high quality U.S. government and agency obligations. Our investments in U.S. government and agency obligations are subject to interest rate risk. To minimize the exposure due to an adverse shift in interest rates, we invest in short term securities and maintain an average maturity of less than one year. A hypothetical 60 basis point increase in interest rates would result in an approximate $82,791 decrease (0.6%) in fair value of our available-for-sale securities.
The potential change noted above is based on sensitivity analyses performed on our financial positions at September 30, 2002. Actual results may differ materially.
Item 4. Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our filings under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commissions rules and forms, and that such information is accumulated and communicated to management, including the Chief Executive Officer and the Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Our Chief Executive Officer and the Chief Financial Officer, with the assistance of other members of our management, have evaluated our disclosure controls and procedures as defined in Rule 13a-14(c) under the Securities Exchange Act of 1934, within 90 days of the filing date of this report, and have concluded based on that evaluation that those disclosure controls and procedures are effective. Since the date of that evaluation, 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 those controls.
26
PART II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
Exhibit Number | Description | |
3(i).1(1) | Restated Articles of Incorporation. | |
3(i).2(2) | Certificate of Amendment of Restated Articles of Incorporation. | |
3(i).3(3) | Certificate of Determination. | |
3(i).4(4) | Certificate of Determination Regarding the terms of the Series C Preferred Stock. | |
3(ii).1(1) | Bylaws. | |
3(ii).2(2) | Certificate of Amendment of Bylaws. | |
4.1(3) | Rights Agreement dated as of July 25, 1997 between the Registrant and Chase Mellon Shareholder Services, L.L.C. | |
4.2(5)* | 6% Convertible Note dated as of December 7, 2000 by the Registrant in favor of UBS AG, London Branch. | |
4.3(5)* | Option Agreement dated as of October 26, 2000 by and between the Registrant and UBS AG, London Branch. | |
4.4(5)* | Amendment No. 1 to Option Agreement dated as of December 19, 2000 by and between the Registrant and UBS AG, London Branch. | |
4.5(6)* | 6% Convertible Note dated as of March 21, 2001 by the Company in favor of UBS AG, London Branch. | |
4.6(6)* | Option Agreement dated as of February 16, 2001 by and between the Company and UBS AG, London Branch. | |
4.7(6)* | Amendment No. 1 to Option Agreement dated as of March 21, 2001 by and between the Company and UBS AG, London Branch. | |
99.1(7) | Certification of Chief Executive Officer. | |
99.2(7) | Certification of Chief Financial Officer. |
* | Certain information in this exhibit has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request under 17 C.F.R. Sections 200, 80(b)(4), 200.83 and 230.46. | |
(1) | Incorporated by reference from the Companys Registration Statement on Form S-l (No. 33-45446), declared effective by the Commission on March 17, 1992. | |
(2) | Incorporated by reference from the Companys Registration Statement on Form S-8 (No. 33-66832) filed with the Commission on August 3, 1993. | |
(3) | Incorporated by reference from the Companys current Report on Form 8-K filed on October 14, 1997. |
27
(4) | Incorporated by reference from the Companys Annual Report on Form 10-K for the year ended December 31, 1997. | |
(5) | Incorporated by reference from the Companys Annual Report on Form 10-K for the year ended December 31, 2000. | |
(6) | Incorporated by reference from the Companys Quarterly Report on Form 10-Q on May 15, 2001. | |
(7) | Filed herewith. |
(b) | Reports on Form 8-K |
None.
28
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SCICLONE PHARMACEUTICALS, INC. (Registrant) |
Date: November 7, 2002 | /s/ Richard A. Waldron Richard A. Waldron Chief Financial Officer (Principal Financial & Accounting Officer) |
29
CERTIFICATIONS
I, Donald R. Sellers, certify that:
1. I have reviewed this quarterly report on Form 10-Q of SciClone Pharmaceuticals, Inc. (the registrant);
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;
30
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.
Date: November 7, 2002 | /s/ Donald R. Sellers Donald R. Sellers Chief Executive Officer |
I, Richard A. Waldron, certify that:
1. I have reviewed this quarterly report on Form 10-Q of SciClone Pharmaceuticals, Inc. (the registrant);
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
31
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.
Date: November 7, 2002 | /s/ Richard A. Waldron Richard A. Waldron Chief Financial Officer (Principal Financial & Accounting Officer) |
32