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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, 2007
¨ | 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 0-23272
NPS PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware | 87-0439579 | |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) |
383 Colorow Drive, Salt Lake City, Utah | 84108-1256 | |
(Address of Principal Executive Offices) | (Zip Code) |
(801) 583-4939
(Registrant’s Telephone Number, Including Area Code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for at least the past 90 days. YES x NO ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer ¨ Accelerated Filer x Non-accelerated filer ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ¨ NO x
The number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date is as follows:
Class | Outstanding at May 8, 2007 | |
Common Stock $.001 par value | 46,340,685 |
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Page No. | ||||
Item 1. | Financial Statements (unaudited) | |||
Condensed Consolidated Balance Sheets | 3 | |||
Condensed Consolidated Statements of Operations | 4 | |||
Condensed Consolidated Statements of Cash Flows | 5 | |||
Notes to Condensed Consolidated Financial Statements | 6 | |||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 10 | ||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 24 | ||
Item 4. | Controls and Procedures | 24 | ||
Item 1. | Legal Proceedings | 26 | ||
Item 1A. | Risk Factors | 26 | ||
Item 5. | Other Information | 26 | ||
Item 6. | Exhibits | 26 | ||
27 |
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FINANCIAL INFORMATION
Item 1. | Financial Statements. |
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
March 31, 2007 | December 31, 2006 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 32,157 | $ | 36,244 | ||||
Marketable investment securities | 99,798 | 109,908 | ||||||
Restricted cash and cash equivalents | 2 | 21,921 | ||||||
Accounts receivable | 9,984 | 15,534 | ||||||
Other current assets | 4,685 | 6,082 | ||||||
Total current assets | 146,626 | 189,689 | ||||||
Plant and equipment: | ||||||||
Building | 15,010 | 15,010 | ||||||
Equipment | 14,200 | 16,567 | ||||||
Leasehold improvements | 3,029 | 3,029 | ||||||
32,239 | 34,606 | |||||||
Less accumulated depreciation and amortization | 13,038 | 14,757 | ||||||
Net plant and equipment | 19,201 | 19,849 | ||||||
Goodwill, net of accumulated amortization | 9,414 | 9,333 | ||||||
Debt issuance costs, net of accumulated amortization | 4,934 | 5,569 | ||||||
Other assets | 300 | 300 | ||||||
$ | 180,475 | $ | 224,740 | |||||
Liabilities and Stockholders’ Equity (Deficit) | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 18,005 | $ | 24,665 | ||||
Deferred revenue | 1,081 | 758 | ||||||
Current installments of notes payable and lease financing obligation | 6,465 | 19,044 | ||||||
Total current liabilities | 25,551 | 44,467 | ||||||
Notes payable | 339,987 | 346,690 | ||||||
Lease financing obligation | 18,843 | 18,843 | ||||||
Deferred revenue | 5,667 | 5,045 | ||||||
Other liabilities | 3,014 | 2,939 | ||||||
Total liabilities | 393,062 | 417,984 | ||||||
Stockholders’ equity (deficit): | ||||||||
Common stock | 47 | 46 | ||||||
Additional paid-in capital | 679,116 | 677,474 | ||||||
Deferred compensation | — | — | ||||||
Accumulated other comprehensive loss: | ||||||||
Net unrealized loss on marketable investment securities | (203 | ) | (326 | ) | ||||
Foreign currency translation | (1,531 | ) | (1,566 | ) | ||||
Accumulated deficit | (890,016 | ) | (868,872 | ) | ||||
Total stockholders’ deficit | (212,587 | ) | (193,244 | ) | ||||
$ | 180,475 | $ | 224,740 | |||||
See accompanying notes to condensed consolidated financial statements.
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NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
(Unaudited)
Three Months Ended March 31, | ||||||||
2007 | 2006 | |||||||
Revenues: | ||||||||
Product sales | $ | 1,127 | $ | 428 | ||||
Royalties, milestones, and license fees | 8,864 | 5,655 | ||||||
Total revenues | 9,991 | 6,083 | ||||||
Operating expenses: | ||||||||
Cost of goods sold | 952 | — | ||||||
Cost of royalties | 1,047 | 454 | ||||||
Research and development | 10,242 | 21,208 | ||||||
Selling, general and administrative | 6,570 | 18,898 | ||||||
Restructuring charges | 7,114 | — | ||||||
Total operating expenses | 25,925 | 40,560 | ||||||
Operating loss | (15,934 | ) | (34,477 | ) | ||||
Other income (expense): | ||||||||
Interest income | 1,970 | 2,579 | ||||||
Interest expense | (7,144 | ) | (6,635 | ) | ||||
Loss on disposition of equipment | (3 | ) | (2 | ) | ||||
Foreign currency transaction gain (loss) | (33 | ) | 149 | |||||
Other | — | 57 | ||||||
Total other expense, net | (5,210 | ) | (3,852 | ) | ||||
Loss before income tax expense (benefit) | (21,144 | ) | (38,329 | ) | ||||
Income tax expense (benefit) | — | — | ||||||
Net loss | $ | (21,144 | ) | $ | (38,329 | ) | ||
Basic and diluted net loss per common and potential common share | $ | (0.45 | ) | $ | (0.83 | ) | ||
Weighted average common and potential common shares outstanding - basic and diluted | 46,625 | 46,236 |
See accompanying notes to condensed consolidated financial statements.
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NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Three Months Ended March 31, | ||||||||
2007 | 2006 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (21,144 | ) | $ | (38,329 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 1,209 | 1,617 | ||||||
Realized loss on disposition of equipment | 3 | 2 | ||||||
Compensation expense on deferred stock units, restricted stock units and restricted stock | 393 | 588 | ||||||
Compensation expense on stock options and stock appreciation rights | 896 | 5,654 | ||||||
Decrease in operating assets: | ||||||||
Accounts receivable | 5,570 | (1,781 | ) | |||||
Prepaid expenses, other current assets and other assets | 1,506 | 316 | ||||||
Increase (decrease) in operating liabilities: | ||||||||
Accounts payable and other current accrued expenses | (6,700 | ) | (12,124 | ) | ||||
Deferred revenue | 883 | 163 | ||||||
Other liabilities | 60 | 907 | ||||||
Net cash used in operating activities | (17,324 | ) | (42,987 | ) | ||||
Cash flows from investing activities: | ||||||||
Sales and maturities of marketable investment securities | 56,216 | 38,153 | ||||||
Purchases of marketable investment securities | (45,991 | ) | (12,949 | ) | ||||
Acquisitions of equipment and leasehold improvements | (20 | ) | (807 | ) | ||||
Proceeds from sale of fixed assets | 24 | 6 | ||||||
Net cash provided by investing activities | 10,229 | 24,403 | ||||||
Cash flows from financing activities: | ||||||||
Principal payments on notes payable and under lease financing obligation | (19,282 | ) | (1,345 | ) | ||||
Proceeds from issuance of common stock | 353 | 788 | ||||||
Decrease in restricted cash and cash equivalents | 21,919 | 1,101 | ||||||
Net cash provided by financing activities | 2,990 | 544 | ||||||
Effect of exchange rate changes on cash | 18 | (41 | ) | |||||
Net decrease in cash and cash equivalents | (4,087 | ) | (18,081 | ) | ||||
Cash and cash equivalents at beginning of period | 36,244 | 98,712 | ||||||
Cash and cash equivalents at end of period | $ | 32,157 | $ | 80,631 | ||||
Supplemental Disclosures of Cash Flow Information: | ||||||||
Cash paid for interest | $ | 15,423 | $ | 4,395 | ||||
Supplemental Schedule of Noncash Investing and Financing Activities: | ||||||||
Unrealized gains (losses) on marketable investment securities | 123 | (54 | ) |
See accompanying notes to condensed consolidated financial statements.
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NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
(1) | Basis of Presentation |
The accompanying unaudited condensed consolidated financial statements included herein have been prepared by NPS Pharmaceuticals, Inc. (NPS) in accordance with the rules and regulations of the United States Securities and Exchange Commission (SEC). The condensed consolidated financial statements are comprised of the financial statements of NPS and all its subsidiaries in which it owns a majority voting interest including a variable interest entity in which the Company is the primary beneficiary, collectively referred to as the Company. In management’s opinion, the interim financial data presented includes all adjustments (consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated. All monetary amounts are reported in U.S. dollars unless specified otherwise. Certain information required by accounting principles generally accepted in the United States of America has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the three months ended March 31, 2007 are not necessarily indicative of the results that may be expected for any future period or the year ending December 31, 2007.
These condensed consolidated financial statements should be read in conjunction with the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Quantitative and Qualitative Disclosures About Market Risk” sections of this Quarterly Report and the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2006, included in the Company’s 2006 Annual Report on Form 10-K filed with the SEC.
The preparation of the condensed consolidated financial statements requires management to make estimates and assumptions relating to reporting of assets and liabilities and the disclosure of contingent assets and liabilities to prepare these condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with accounting principles generally accepted in the United States of America. Actual results could differ from these estimates. Certain prior year amounts have been reclassified to conform with the current year presentation.
(2) | Loss Per Common Share |
Basic loss per common share is the amount of loss for the period applicable to each share of common stock outstanding during the reporting period. Diluted loss per common share is the amount of loss for the period applicable to each share of common stock outstanding during the reporting period and to each share that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares.
Potential common shares of approximately 11.8 million and 11.5 million during the three months ended March 31, 2007 and 2006, respectively, that could potentially dilute basic earnings per share in the future were not included in the computation of diluted loss per share because to do so would have been anti-dilutive for the periods presented. Potential dilutive common shares for the three months ended March 31, 2007 and 2006 include approximately 5.2 million common shares related to convertible debentures and 6.6 million and 6.3 million, shares, respectively, related to stock options, stock appreciation rights, and restricted stock units.
(3) | Operating Segments |
The Company is engaged in the discovery, development, and commercialization of pharmaceutical products, and in its current state of development, considers its operations to be a single reportable segment. Financial results of this reportable segment are presented in the accompanying condensed consolidated financial statements. The Company’s subsidiaries operating outside of the United States of America had long-lived assets, including goodwill, of approximately $9.9 million and $9.8 million, respectively, as of March 31, 2007 and December 31, 2006. The Company recognized non-United States revenue of $1.6 million and $2.4 million, respectively, during the three months ended March 31, 2007 and 2006. Substantially all of the Company’s revenues for the three months ended March 31, 2007 and 2006 were from two and three licensees, respectively, of the Company. As of March 31, 2007 and December 31, 2006, the majority of the Company’s accounts receivable balances were from two licensees and four licensees, respectively.
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(4) | Comprehensive Loss |
The components of the Company’s comprehensive loss are as follows, in thousands:
Three months ended March 31, | ||||||||
2007 | 2006 | |||||||
Other comprehensive loss: | ||||||||
Gross unrealized gain (loss) on marketable investment securities | $ | 123 | $ | (54 | ) | |||
Reclassification for realized loss on marketable investment securities | — | — | ||||||
Net unrealized gain (loss) on marketable investment securities | 123 | (54 | ) | |||||
Foreign currency translation gain (loss) | 35 | (207 | ) | |||||
Net loss | (21,144 | ) | (38,329 | ) | ||||
Comprehensive loss | $ | (20,986 | ) | $ | (38,590 | ) | ||
(5) | Long-term Debt Obligations |
The following table reflects the carrying value of our long-term debt obligations under our various financing arrangements as of March 31, 2007 and December 31, 2006 (in thousands):
March 31, 2007 | December 31, 2006 | |||||
Convertible notes payable | $ | 192,000 | $ | 192,000 | ||
Secured notes payable | 154,452 | 173,734 | ||||
Lease financing obligation | 18,843 | 18,843 | ||||
Total borrowings | 365,295 | 384,577 | ||||
Less current position | 6,465 | 19,044 | ||||
Total long-term debt obligations | $ | 358,830 | $ | 365,533 | ||
(a) | Convertible Notes Payable |
In July 2003, the Company completed a private placement of $192.0 million in 3.0% Convertible Notes due June 15, 2008 (Convertible Notes). The Company received net proceeds from these Convertible Notes of approximately $185.9 million, after deducting costs associated with the offering. The Convertible Notes accrue interest at an annual rate of 3.0% payable semiannually in arrears on June 15 and December 15 of each year, beginning December 15, 2003. Accrued interest on the Convertible Notes was approximately $1.7 million as of March 31, 2007. The holders may convert all or a portion of the Convertible Notes into common stock at any time on or before June 15, 2008. The Convertible Notes are convertible into common stock at a conversion price of $36.59 per share, subject to adjustment in certain events. The Convertible Notes are unsecured senior debt obligations and rank equally in right of payment with all existing and future unsecured senior indebtedness. On or after June 20, 2006, the Company may redeem any or all of the Convertible Notes at redemption prices of 100% of their principal amount, plus accrued and unpaid interest through the day preceding the redemption date. Upon the occurrence of a “fundamental change,” as defined in the indenture governing the Convertible Notes, holders of the Convertible Notes may require the Company to redeem all or a part of the Convertible Notes at a price equal to 100% of the principal amount, plus accrued and unpaid interest and liquidated damages, if any. The Company has filed a registration statement with the United States Securities and Exchange Commission covering the resale of the Convertible Notes and common stock issuable upon conversion of the Convertible Notes. The Company incurred debt issuance costs of $6.1 million, which are being amortized over a five-year period. The effective interest rate on the Convertible Notes, including debt issuance costs, is 3.6%.
Under the Registration Rights Agreement for the Convertible Notes, the Company could be subject to liquidated damages if the effectiveness of the registration statement covering the Convertible Notes is not maintained, or if the Company fails to perform certain other registration related performance obligations, at any time prior to the redemption of the Convertible Notes, the repayment of the Convertible Notes or certain corporate events as defined in the Convertible Notes agreement. The Company believes the likelihood of such an event occurring is remote and, as such, the Company has not recorded a liability as of March 31, 2007. In the unlikely event that it becomes probable that the Company would have to pay liquidated damages under the Registration Rights Agreement until a shelf registration statement, post effective amendment thereto, or prospectus supplement covering the Convertible Notes is again effective, or filed in the case of a prospectus supplement, the potential liquidated damages would be 0.5% of the aggregate principal amount of such Convertible Notes or 0.5% of the conversion price for common stock that has been issued upon conversion of a Convertible Note. Such liquidated damages would accrue from the date the Company was required to file such registration statement or prospectus supplement until the date the registration statement or prospectus supplement was actually filed.
(b) | Secured Notes Payable |
In December 2004, the Company completed a private placement of $175.0 million in Secured 8.0% Notes due March 30, 2017 (Secured Notes). The Company received net proceeds from the issuance of the Secured Notes of approximately $169.3 million, after deducting costs associated with the offering. The Secured Notes accrue interest at an annual rate of 8.0% payable quarterly in arrears on March 30, June 30, September 30 and December 30 of each year (Payment Date). The Secured Notes are
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secured by certain royalty and related rights of the Company under its agreement with Amgen. Additionally, the only source for interest payments and principal repayment of the Secured Notes is limited to royalty and milestone payments received from Amgen plus any amounts available in the restricted cash reserve account and earnings thereon as described later. The Secured Notes are non-recourse to NPS Pharmaceuticals, Inc. Payments of principal will be made on March 30 of each year commencing March 30, 2006, to the extent there is sufficient revenue available for such principal payment. As of March 31, 2007, the outstanding principal balance on the Secured Notes was $154.5 million. In connection with the issuance of the Secured Notes, the Company was required to place $14.2 million of the Secured Notes proceeds into a restricted cash reserve account to pay any shortfall of interest payments through December 30, 2006. The remaining amount in the restricted cash reserve account after December 30, 2006 was used to repay principal on March 30, 2007. In the event the Company receives royalty and milestone payments under its agreement with Amgen above certain specified amounts, a redemption premium on principal repayment will be owed. The redemption premium ranges from 0% to 41.5% of principal payments, depending on the annual net sales of Sensipar by Amgen. As of March 31, 2007, the Company classified $6.5 million of the Secured Notes as current based on royalty payments accrued during the three months ended March 31, 2007 less estimated redemption premiums. The Company may repurchase, in whole but not in part, the Secured Notes on any Payment Date at a premium ranging from 0% to 41.5% of outstanding principal, depending on the preceding four quarters’ sales of Sensipar by Amgen. The Company is accruing the estimated redemption premiums over the estimated life of the debt of six years using the “effective interest-rate” method. Accrued interest on the notes was approximately $620,000 as of March 31, 2007 which represents the Company’s estimate of the redemption premium. The Company incurred debt issuance costs of $5.7 million, which are also being amortized using the “effective interest-rate” method. The effective interest rate on the Secured Notes, including debt issuance costs and estimated redemption premiums, is approximately 11.3%.
(c) | Lease Financing Obligations |
In December 2005, the Company completed a sale-leaseback transaction with BioMed Realty, L.P., or BioMed Realty, a Maryland limited partnership, in which the Company agreed to sell its 93,000 square foot laboratory and office building located in Salt Lake City, Utah for $19.0 million and lease back the property under a 15-year lease. Net proceeds from the sale were $19.0 million. Under the terms of the lease the Company agreed to pay a base rent of $158,000 per month for the first three years of the lease. After year three, the Company’s rent increases at the rate of 2.75% per year for the remainder of the lease term. The lease is a triple-net lease and, as a result, the Company will continue to pay all costs associated with the building, including costs for maintenance and repairs, property taxes, insurance, and lease payments of $203,000 per year under the ground lease with the University of Utah. Under the terms of the sale, the Company assigned its 40-year ground lease with the University of Utah to BioMed Realty. Upon the expiration of the lease term, the Company has the right to (i) extend the lease for two separate five year periods, each at the current fair-market-rental value of the building, or (ii) purchase the building for 115% of its then fair-market-value. As the lease agreement in the sale-leaseback transaction contains a purchase option by the Company, SFAS No. 98,Accounting for Leases, requires the Company to account for the transaction as a financing, deferring the gain on the sale of $4.3 million. The effective interest rate on the lease financing obligation is 10.3%. Principal payments will commence in 2012. See also Note 10.
(6) | Restructuring Charges |
On June 12, 2006 as a result of the uncertainty with respect to the regulatory approval of PREOS®, the Company announced an initiative to restructure operations (the 2006 Restructuring Plan). Under the 2006 Restructuring Plan, NPS reduced its worldwide workforce, including employees and contractors, by approximately 250 positions, eliminated all commercial sales and related field based activities, terminated its agreement with Allergan Inc. to promote Restasis® Ophthalmic Emulsion to rheumatologists and closed and plans to sell the Company’s technical operations facility in Mississauga, Ontario, Canada within the next six months. The reduction in workforce involved all functional disciplines including selling, general and administrative employees as well as research and development personnel.
The charge related to the 2006 Restructuring Plan during the three months ended March 31, 2007 and 2006 was a credit of $19,000 and zero, respectively. Associated severance payments related to the 2006 Restructuring Plan were paid primarily in the second and third quarters of 2006 for severed United States employees and are anticipated to be paid by January 31, 2008 for severed Canadian employees.
On March 14, 2007, the Company announced an initiative to restructure operations and to reduce its work force from 196 employees to approximately 35 employees by the end of 2007 (the 2007 Restructuring Plan). Under the 2007 Restructuring Plan, the Company will close its operations in Toronto, Canada and Salt Lake City, Utah. These steps are part of the Company’s strategy to
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transition to an organization that will rely primarily on outsourcing research, development and clinical trial activities and manufacturing operations, as well as other functions critical to its business. The Company believes this approach enhances its ability to focus on late stage product opportunities, preserve cash, allocate resources rapidly to different projects and reallocate internal resources more effectively.
The charge related to the 2007 Restructuring Plan during the three months ended March 31, 2007 was $7.1 million. The charge during the three months ended March 31, 2007 was comprised of $6.4 million in severance related cash expenses, $435,000 for accelerated vesting of options under existing employee severance agreements and retirement plan and $269,000 for accelerated vesting of restricted stock units under employee retention plans. Associated severance payments are anticipated to be paid by December 31, 2007 for severed United States employees and are anticipated to be paid by December 31, 2008 for severed Canadian employees. Total anticipated restructuring charges as a result of the 2007 Restructuring Plan are estimated to be between $11.0 and $16.0 million.
A summary of accrued restructuring costs is as follows (in thousands):
December 31, 2006 | Charges | Cash | Non-Cash | March 31, 2007 | ||||||||||||||
2006 Restructuring Plan: | ||||||||||||||||||
Severance | $ | 607 | $ | (19 | ) | $ | (410 | ) | $ | — | $ | 178 | ||||||
2007 Restructuring Plan: | ||||||||||||||||||
Severance | — | 7,139 | (1,149 | ) | (704 | ) | 5,286 | |||||||||||
$ | — | $ | 7,120 | $ | (1,559 | ) | $ | (704 | ) | $ | 5,464 | |||||||
(7) | Income Taxes |
In July 2006, the Financial Accounting Standards Board, or FASB, issued FASB Interpretation No. 48,Accounting for Uncertainty in Income Taxes, or FIN 48. FIN No. 48 is an interpretation of FASB Statement No. 109,Accounting for Income Taxes. FIN No. 48 seeks to reduce the diversity in practice associated with certain aspects of measurement and recognition in accounting for income taxes. In addition, FIN No. 48 provides guidance on derecognition, classification, interest and penalties, and accounting in interim periods and requires expanded disclosure with respect to the uncertainty in income taxes. The Company is subject to the provisions of FIN No. 48 as of January 1, 2007. The Company believes that its income tax filing positions and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position. Therefore, no reserves for uncertain income tax positions have been recorded pursuant to FIN No. 48. In addition, the Company did not record a cumulative effect adjustment related to the adoption of FIN No. 48.
The Company’s policy for recording interest and penalties associated with audits is to record such items as a component of income before taxes. Penalties and interest paid or received are recorded in interest expense or interest income, respectively. During the three months ended March 31, 2007, the Company did not record any interest income or interest expense and penalties related to the settlement of audits for certain prior periods.
Tax years 2003 through 2006 are subject to examination by the United States Federal and Canadian Federal authorities.
(8) | Commitments and Contingencies |
The Company has agreed to indemnify, under certain circumstances, certain manufacturers and service providers from and against any and all losses, claims, damages or liabilities arising from services provided by such manufacturers and service providers or from any use, including clinical trials, or sale by the Company or any Company agent of any product supplied by the manufacturers. The Company has entered into long-term agreements with various third-party contract manufacturers for the production and packaging of drug product and vials. Under the terms of these various contracts, we are required to purchase certain minimum quantities of drug product each year.
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(9) Legal Proceedings
A consolidated shareholders’ securities class action lawsuit is currently pending against the Company and certain of its present and former officers and directors in the United States District Court for the District of Utah, Central Division. The consolidated complaint asserts that, during the class period, the Company and the individual defendants made false and misleading statements to the investing public concerning PREOS. The consolidated complaint alleges that false and misleading statements were made during the class period concerning the efficacy of PREOS as a treatment for postmenopausal osteoporosis, the potential market for PREOS, the dangers of hypercalcemic toxicity as a side effect of injectable PREOS, and the prospects of FDA approval of the Company’s New Drug Application for injectable PREOS. The consolidated complaint seeks compensatory damages in an unspecified amount, unspecified equitable or injunctive relief, and an award of an unspecified amount for plaintiff’s costs and attorneys fees. Additionally, on August 22, 2006, a shareholder of NPS filed a shareholder derivative action against certain of the Company’s present and former officers and directors. This action, which names the Company as a nominal defendant but is asserted on the company’s behalf, is pending in the Third Judicial District Court of Salt Lake County, State of Utah. The derivative complaint asserts allegations similar to those asserted in the securities class action described above. The derivative complaint also seeks compensatory damages in an unspecified amount, unspecified equitable or injunctive relief and an award of an unspecified amount for plaintiff’s costs and attorneys fees.
The Company and related defendants intend to vigorously defend themselves in both of these actions. The Company believes the claims are without merit and has filed a motion to dismiss the securities class action and has filed a motion to dismiss the shareholder derivative action. Although the company and related defendants are optimistic about their motions being granted, no assurances can be given in this regard. The Company maintains insurance for actions of this nature, which it believes is adequate.
(10) Subsequent Events
On May9, 2007, the Company signed an Agreement of Purchase and Sale to repurchase from BioMed Realty its 93,000 square foot laboratory and office building located in Salt Lake City, Utah, for $20.0 million. Under the terms of the Agreement of Purchase and Sale, the 15-year lease obligation of the Company to BioMed Realty will be terminated. The Company expects the closing to occur on or before June 30, 2007.
On May 9, 2007, the Company signed an Agreement of Purchase and Sale with Transglobe Property Management Services Ltd. in Trust to sell its land and 85,795 square foot laboratory and office building located in Mississauga, Ontario, Canada for $4.8 million Cdn. The Company expects the closing to occur on or before June 30, 2007.
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
Cautionary Statement Regarding Forward-Looking Statements
The following discussion should be read in conjunction with the accompanying unaudited Condensed Consolidated Financial Statements and related notes appearing elsewhere in this report. This Quarterly Report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management’s judgment regarding future events. In many cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “plan,” “expect,” “anticipate,” “estimate,” “predict,” “intend,” “potential” or “continue” or the negative of these terms or other words of similar import, although some forward-looking statements are expressed differently. All statements other than statements of historical fact included in this report and the documents incorporated by reference into this report regarding our financial position, business strategy and plans or objectives for future operations are forward-looking statements. Without limiting the broader description of forward-looking statements above, we specifically note that statements regarding potential drug candidates, their potential therapeutic effect, the possibility of obtaining regulatory approval, our ability or the ability of our collaborators to manufacture and sell any products, market acceptance, or our ability to earn a profit from sales or licenses of any drug candidate are all forward-looking in nature. We cannot guarantee the accuracy of the forward-looking statements, and you should be aware that results and events could differ materially and adversely from those contained in the forward-looking statements due to a number of factors, including:
• | Our ability to outsource activities critical to the advancement of our product candidates and manage those companies to whom such activities are outsourced; |
• | our ability to secure additional funds; |
• | the successful continuation of our strategic collaborations, our and our collaborators’ ability to successfully complete clinical trials, commercialize products and receive required regulatory approvals and the length, time and cost of obtaining such regulatory approvals; |
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• | competitive factors; |
• | our ability to maintain the level of our expenses consistent with our internal budgets and forecasts; |
• | the ability of our contract manufacturers to successfully produce adequate supplies of our product candidates and drug delivery devices to meet clinical trial and commercial launch requirements for us and our partners; |
• | changes in our relationships with our collaborators; |
• | variability of our royalty, license and other revenues; |
• | our ability to enter into and maintain agreements with current and future collaborators on commercially reasonable terms; |
• | the demand for securities of pharmaceutical and biotechnology companies in general and our common stock in particular; |
• | uncertainty regarding our patents and patent rights; |
• | compliance with current or prospective governmental regulation; |
• | technological change; and |
• | general economic and market conditions. |
You should also consider carefully the statements set forth in Item 1A of this Quarterly Report entitled “Risk Factors” as well as the statements set forth in Item 1A of our Annual Report on Form 10-K for the fiscal year-ended December 31, 2006, entitled “Risk Factors,” which address these and additional factors that could cause results or events to differ materially from those set forth in the forward-looking statements. All subsequent written and oral forward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by the applicable cautionary statements. We have no plans to update these forward-looking statements.
Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to all such reports are available, free of charge, on our Internet website under “Investor Relations—SEC Filings,” as soon as reasonably practicable after we file electronically such reports with, or furnish such reports to, the SEC. Our Internet website address is http://www.npsp.com. Information on our website does not constitute a part of this Quarterly Report on Form 10-Q.
Overview
We are a biopharmaceutical company focused on the development and commercialization of small molecule drugs and recombinant proteins. Our current portfolio of approved drugs and product candidates are primarily for the treatment of bone and mineral disorders, gastrointestinal disorders and central nervous system disorders. Our product portfolio consists of one U.S. Food and Drug Administration, or FDA, approved product, another product candidate that has been granted marketing approval in Europe and is the subject of an approvable letter from the FDA in response to a new drug application we filed in May 2005, a product candidate that is presently the subject of a pivotal Phase III clinical study, and other product candidates in various stages of clinical development and preclinical development. Though we independently develop many of our product candidates, we have entered into collaboration agreements for several of our programs.
In March 2007, we announced that we were restructuring the company and reducing our work force from 196 employees to approximately 35 employees by the end of 2007. In conjunction with the reduction in force we are also closing our operations in Toronto, Canada and Salt Lake City, Utah. We determined that the restructuring was necessary in light of the additional clarity that has been reached with respect to the regulatory path forward for PREOS®. After meetings and discussions with the FDA, the regulatory path forward for PREOS® will be longer and require more capital than we initially expected. As a result, we have adopted a strategy to transition the company to an organization that will rely primarily on outsourcing research, development and clinical trial activities and manufacturing operations, as well as other functions critical to our business. We believe this approach enhances our ability to focus on our late stage product opportunities, including additional indications with our lead product candidates, preserve cash, allocate resources rapidly to different programs, and reallocate internal resources more effectively.
In June 2006, we announced an initiative to restructure operations by significantly reducing cash burn, reprioritizing our development portfolio, and leveraging our proprietary research and development assets. In connection with this restructuring, we reduced our worldwide workforce, including employees and contractors, by approximately 250 positions, eliminated all commercial sales and related field based activities, terminated our agreement with Allergan, Inc. to co-promote Allergan’s proprietary drug, Restasis® Ophthalmic Emulsion to rheumatologists, and determined to sell our technical operations facility in Mississauga, Ontario, Canada.
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We have incurred cumulative losses from inception through March 31, 2007 of approximately $890.0 million, net of cumulative revenues from research and license agreements of approximately $171.2 million. We expect to continue to incur significant operating losses over at least the next several years as we continue our current and anticipated development projects. Activities that will increase our operating losses include: seeking approval to market PREOS® in the U.S. from the FDA; the conduct of current and future clinical trials with teduglutide and potentially PREOS®; clinical and commercial manufacturing for teduglutide, PREOS®, and PREOTACT®; and, contractual commitments to fund research activities in our metabotropic glutamate receptor program.
Approved Products and Product Candidates Undergoing Regulatory Review
Our FDA approved product, cinacalcet HCl, is being marketed in the U.S. and the European Union for the treatment of secondary hyperparathyroidism in chronic kidney disease patients on dialysis and for the treatment of elevated calcium levels in patients with parathyroid carcinoma. We have licensed to Amgen worldwide rights to cinacalcet HCl, with the exception of Japan, China, North and South Korea, Hong Kong and Taiwan, where we have licensed such rights to Kirin Brewery, Ltd., or Kirin. Amgen developed and is marketing cinacalcet HCl in the U.S. under the brand name Sensipar® and in Europe under the brand name Mimpara®. Kirin filed a new drug application, or NDA, with the Japanese Pharmaceuticals and Medical Devices Agency in February 2006 for approval to market cinacalcet HCl in Japan for the treatment of patients with secondary hyperparathyroidism who are on dialysis. Both Amgen and Kirin have contractually committed to pay us royalties on their sales of cinacalcet HCl.
The European Commission has granted marketing authorization for PREOS® for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The marketing authorization is valid in all 25 member states of the European Union, or EU. We have granted to Nycomed Danmark ApS, or Nycomed, the exclusive right to market and sell PREOS® in Europe. Nycomed is marketing PREOS® in Europe under the brand name PREOTACT®. Nycomed has launched PREOTACT® in Denmark, Germany, the United Kingdom, Italy, Spain, Greece, Netherlands and Austria. In May 2005, we filed an NDA for PREOS® with the FDA seeking approval to market PREOS® in the U.S. On March 9, 2006, we received notification from the FDA that the PREOS® NDA is approvable. Additional information regarding the approvable letter and our proposed path forward for PREOS® is provided below under the caption “Major Research and Development Projects.”
Major Research and Development Projects
Our major research and development projects involve teduglutide and PREOS®. We and our corporate licensees also have other significant ongoing research and development activities with our proprietary compounds, including our work with AstraZeneca on metabotropic glutamate receptors, the development of calcilytic compounds by GlaxoSmithKline, the development of glycine reuptake inhibitors by Janssen and other proprietary clinical research programs.
Teduglutide. Teduglutide is an analog of glucagon-like peptide 2, a naturally occurring hormone that regulates proliferation of the cells lining the small intestine. We are independently investigating teduglutide as a potential treatment for short bowel syndrome, and other indications, including Crohn’s disease, chemotherapy-induced enteritis, necrotizing enterocolitis and various other gastrointestinal diseases.
We have completed enrollment of patients in a pivotal Phase III clinical study in adult short bowel syndrome patients to measure the ability of teduglutide to reduce a patient’s dependency on total parenteral nutrition. We expect top line results of the Phase III study in the second half of 2007.If the results of the Phase III study are positive we expect to file an NDA with the FDA for approval to market teduglutide for the treatment of short bowel syndrome.
A Phase IIa proof-of-concept clinical study to evaluate the possible utility of teduglutide in the treatment of patients with Crohn’s disease has been completed. Based on the results of that study we are advancing the clinical development of teduglutide for Crohn’s disease. We are conducting a safety and dose escalation study with teduglutide as part of our clinical development plan for this drug candidate.
We have reviewed encouraging findings from preclinical studies with teduglutide demonstrating the drug’s potential to prevent necrotizing enterocolitis and chemotherapy-induced enteritis/febrile neutropenia. We believe both indications represent serious unmet medical needs that may be addressed by teduglutide therapy, and are exploring the conduct of clinical studies in each of these indications.
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During the three months ended March 31, 2007 and 2006, we incurred $3.3 million and $5.1 million, respectively, in the research and development of this product candidate, including costs associated with the manufacture of clinical supplies of teduglutide. We have incurred costs of approximately $114.2 million since we assumed development obligations of this product candidate under our acquisition of Allelix Biopharmaceuticals Inc., or Allelix, in December 1999.
Our development administration overhead costs are included in total research and development expense for each period, but are not allocated among our various projects.
The goal of our teduglutide development program is to obtain marketing approval from the FDA, and analogous international agencies. We will consider the project substantially complete if we obtain those approvals even though subsequent to that time we might incur additional expenses in conducting additional clinical trials and follow-up studies. Before we can obtain such marketing approvals we will need to complete pivotal clinical trials with satisfactory results and submit an NDA to the FDA. We are unable to estimate the costs to completion or the completion date for the teduglutide program because of the on-going work with respect to the pivotal Phase III trial in adults with short bowel syndrome, the early stage of the clinical trials for other indications such as Crohn’s disease, necrotizing enterocolitis and chemotherapy-induced enteritis/febrile neutropenia, the risks associated with the clinical trial process, including the risks that patient enrollment in the clinical trials may be slow, that we may repeat, revise or expand the scope of future trials or conduct additional clinical trials not presently planned to secure marketing approvals, and the additional risks identified herein. We cannot predict when material cash inflows from our teduglutide program will commence, if ever, because of the many risks and uncertainties relating to the completion of clinical trials, receipt of marketing approval from the applicable regulatory agency, acceptance in the marketplace, and the availability of sufficient funds to complete development of the product. To date, we have not received any revenues from product sales of teduglutide. The risks and uncertainties associated with completing the development of teduglutide on schedule, or at all, include but are not limited to the following:
• | Teduglutide may not be shown to be safe and efficacious in the pivotal and on-going clinical trials; |
• | We may be unable to obtain regulatory approval of the drug on a timely basis, or at all; |
• | We may be unable to secure adequate clinical and commercial supplies of teduglutide in order to complete preclinical studies, clinical trials and initiate commercial launch upon approval; and |
• | We may not have adequate funds to complete the development of teduglutide, and may not be successful in securing a corporate partner to share in the costs associated with the development and commercialization of this drug candidate. |
A failure to obtain marketing approval for teduglutide or to timely complete development and obtain regulatory approval would likely have the following results on our operations, financial position and liquidity:
• | We would not earn any sales revenue from teduglutide, which would increase the likelihood that we would need to obtain additional financing for our other development efforts; |
• | Our reputation among investors might be harmed, which might make it more difficult for us to obtain equity capital on attractive terms or at all; and |
• | Our profitability would be delayed and our business and stock price may be aversely affected. |
PREOS®. PREOS® is our brand name for recombinant, full length, human parathyroid hormone that we are developing as a potential treatment for post-menopausal osteoporosis. During the three months ended March 31, 2007 and 2006 we incurred $1.7 million and $4.3 million, respectively, in the research and development of this product candidate, including costs associated with the manufacture of clinical and commercial supplies of PREOS® but exclusive of commercial supply cost of PREOTACT®. We have incurred costs of approximately $343.4 million since we assumed development obligations for this product candidate under our acquisition of Allelix in December 1999.
Our development administration overhead costs are included in total research and development expense for each period, but are not allocated among our various projects.
The goal of our PREOS® development program is to obtain marketing approval from the FDA and analogous international agencies. We will consider the project substantially complete if we obtain those approvals even though subsequent to that time we might incur additional expenses in conducting additional clinical trials and follow-up studies. The European Commission has granted marketing authorization for PREOS® in Europe. The marketing authorization is valid in all 25 member states of the EU. We have granted to Nycomed the exclusive right to market and sell PREOS® in Europe. Nycomed is marketing PREOS® in Europe under the brand name PREOTACT®. Nycomed has launched PREOTACT® in Denmark, Germany, the United Kingdom, Italy, Spain, Greece, Netherlands and Austria.
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We submitted an NDA for PREOS® to the FDA in May 2005. On March 9, 2006, we received notification from the FDA that the PREOS® NDA is approvable. In the approvable letter, the FDA indicated that our pivotal Phase III study with PREOS® demonstrated significant fracture risk reductions in post menopausal women with osteoporosis, but noted a higher incidence of hypercalcemia with PREOS® compared to placebo. The FDA expressed concern regarding hypercalcemia associated with the proposed daily dose of PREOS® and requested additional clinical information. The FDA also requested additional information regarding the reliability and use of the injection device for delivery of PREOS®. Since receiving the approvable letter from the FDA, we have had further communications with the FDA including an in person meeting in May 2006 with senior staff from the FDA’s Division of Endocrine and Metabolism Drug Products. During the meeting, the FDA proposed that we generate additional clinical data through the conduct of a new clinical trial in order to adequately address the hypercalcemia issue raised in the approvable letter. Since receiving the approvable letter we have been carefully evaluating the regulatory path forward for PREOS®. We have submitted a new clinical trial protocol for PREOS® to the FDA to support U.S. registration. After multiple communications with the FDA we believe the protocol design is now finalized. The clinical study under the protocol is a 12-month bone-mineral density bridging study designed to evaluate the relative efficacy and safety of PREOS® as compared to placebo in women with post-menopausal osteoporosis. We have concluded at this time that we will not initiate the study until we secure additional funding for the study from a corporate or financial partner. There is no assurance that we will secure additional funding on acceptable terms or at all.
We are currently supporting an investigator led study to explore the use of PREOS® program as a hormone replacement therapy to treat hypoparathyroidism. This is a condition in which patients do not produce adequate levels of parathyroid hormone, resulting in lower than normal levels of calcium in the blood. Hypoparathyroidism can result in hypocalcemia, vitamin D deficiency, hypercalciuria and brittle bones of poor quality.
Because of the on-going work with respect to the PREOS® program, the FDA review process, the risks associated with the drug approval process, including the risk that we may have to repeat, revise or expand the scope of clinical trials or conduct additional clinical trials not presently planned to secure marketing approvals and the initiation of commercial manufacturing activities, and the additional risks identified herein, we are unable to estimate the costs to completion or the completion date for the PREOS® program. Material cash inflows relating to our PREOS® development program will not commence until after marketing approvals are obtained, and then only if PREOS® finds acceptance in the marketplace. Because of the many risks and uncertainties relating to the receipt of marketing approval from the applicable regulatory agencies and acceptance in the marketplace, the availability of sufficient funds to complete development of the product, we cannot predict when material cash inflows from our PREOS® program will commence, if ever. During the three months ended March 31, 2007, we recognized product sale revenues to Nycomed of $1.1 million, royalty income for PREOTACT® sales by Nycomed of $356,000, and milestone revenue of $69,000. The risks and uncertainties associated with completing the development of PREOS® on a timely basis, or at all, and successfully commercializing PREOS® include but are not limited to the following:
• | We may be unable to obtain regulatory approval of the drug in the United States on a timely basis or at all; |
• | We may be unable to secure adequate commercial supplies of PREOS® and the injection delivery device in order to initiate commercial launch when and if PREOS® is approved; and |
• | We may not have adequate funds to complete the development and prepare for the commercial launch of PREOS® when and if approved in the United States. |
A failure to obtain marketing approval for PREOS®, secure adequate commercial supplies of PREOS®, or secure adequate funds to complete development and prepare for commercial launch would likely have the following results on our operations, financial position and liquidity:
• | We would not earn any U.S. sales revenue from PREOS®, which would increase the likelihood that we would need to obtain additional financing for our other development efforts; |
• | Our reputation among investors might be harmed, which might make it more difficult for us to obtain equity capital on attractive terms or at all; and |
• | Our profitability would be delayed and our business and stock price may be aversely affected. |
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Other Research and Development Programs
Most of the remaining research and development expenses for the three months ended March 31, 2007 and 2006, were generated by various early clinical stage programs, pre-clinical studies and drug discovery programs, including those described below.
Metabotropic Glutamate Receptor Program. Since 1996, we have been working to find compounds that act on targets in the central nervous system called metabotropic glutamate receptors, or mGluRs. We have discovered a number of compounds that activate or inhibit mGluRs and that are highly selective for specific subtypes of mGluRs. Our animal studies with a number of these compounds have demonstrated their potential as drug candidates for the treatment of central nervous system disorders such as chronic pain. Additionally, animal studies with a number of these compounds have demonstrated their potential as drug candidates for the treatment of gastrointestinal disorders such as gastroesophageal reflux disease, or GERD.
In March 2001, we entered into an agreement with AstraZeneca under which we collaborate exclusively in an extensive program around a number of mGluR subtypes. We granted AstraZeneca exclusive rights to commercialize mGluR subtype-selective compounds. Under our agreement, we are required to co-direct the research and pay for an equal share of the preclinical research costs, including capital and a minimum number of personnel, through March 2009, unless earlier terminated by AstraZeneca or us upon six months advance written notice. In connection with our March 2007 restructuring, we plan to outsource our research obligations to a contract research organization. If certain milestones are met, AstraZeneca is required to pay us up to $30.0 million. AstraZeneca is also required to pay us royalties on sales of products that include those compounds. We have the right to co-promote any resulting product in the United States and Canada and to receive co-promotion revenue, if any. Should we elect to co-promote products, in some circumstances we will be required to share in the development and regulatory costs associated with those products, and we may not receive some late-stage milestone payments. AstraZeneca is engaged in Phase I clinical development activities with a compound active at mGluRs licensed from us.
During the three months ended March 31, 2007 and 2006, we incurred $1.0 million and $1.1 million, respectively, in research and development expenses under our collaboration with AstraZeneca.
Our development, administration and overhead costs are included in total research and development expenses for each period, but are not allocated among our various projects.
Calcilytic Compounds. We are pursuing a treatment for osteoporosis that focuses on the discovery and development of orally administered drugs called calcilytic compounds. Calcilytic compounds are small molecule antagonists of the calcium receptors that temporarily increase the secretion of the body’s own parathyroid hormone, which may result in the formulation of new bone. In animal studies, we determined that intermittent increases in circulating levels of parathyroid hormone can be obtained through use of calcilytics.
In 1993, we collaborated with GlaxoSmithKline for research, development and commercialization of calcium receptor active compounds from treatment of osteoporosis and other bone metabolism disorders. We are not expending any significant resources in the program. In December 2000, GlaxoSmithKline initiated a proof-of-concept Phase I clinical trial with a calcilytic compound for which we received a $1.0 million milestone payment. In November 2003, GlaxoSmithKline initiated new Phase I clinical studies with more advanced compounds for which we received an additional $2.0 million milestone payment. GlaxoSmithKline, has successfully completed a proof-of-concept clinical trial in non-osteoporatic, post-menopausal women with a calcilytic compound licensed from us for potential use in osteoporosis. The trial evaluated safety as well as certain surrogate efficacy biomarkers including PTH levels and biomarkers of bone turnover. GlaxoSmithKline continues to advance the calcilytics program and has informed us that they expect to initiate Phase II studies with a compound identified under the collaboration in the second quarter of 2007.
GlaxoSmithKline has paid us a total of $38.7 million for license fees, research support, milestone payments and equity purchases as part of our collaboration. We will receive additional payments of up to an aggregate of $32.0 million, which includes additional milestones under the December 2006 amendment noted below, if certain clinical milestones are achieved. We will also receive royalties on sales of any commercialized products based on compounds identified in the collaboration. In addition to the milestone and royalty payments, we have a limited right to co-promote any products that are developed through our collaboration and to receive co-promotion revenue, if any.
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In December 2006 we entered into an amendment to our agreement with GlaxoSmithKline under which we provided GlaxoSmithKline rights to additional compounds discovered by us. In connection with such amendment GlaxoSmithKline paid us a one time licensing fee of $3.0 million and agreed to pay us additional milestones payments for the achievement of certain clinical milestones with such compounds as well as royalties on sales of such compounds should GlaxoSmithKline commercialize any of such compounds.
Glycine Reuptake Inhibitors. We collaborated with Janssen on glycine reuptake inhibitors to identify prospective drug candidates for schizophrenia and dementia. Janssen has now assumed full responsibility for the development of product candidates identified under the collaboration. We are not expending any significant resources in the program. In November 2001, we received a milestone payment from Janssen as a result of the selection of a pre-clinical compound for further development as a potential treatment for schizophrenia. Janssen has informed us that they have moved a compound from this collaboration into a Phase 1 clinical trial. We will receive additional milestone payments of up to $20.5 million from Janssen, if certain milestones are met and royalties on sales of any drugs developed or sold by Janssen under this collaboration agreement.
Summary of other programs. The goal of our other programs is to discover, synthesize, develop and obtain marketing approval for product candidates. Material cash inflows will not commence until after marketing approvals are obtained, and then only if the product finds acceptance in the marketplace. Currently all compounds are in pre-clinical stages or early clinical stages. In order to obtain marketing approval, we or our corporate licensees, as the case may be, will need to initiate and complete all current and planned clinical trials with satisfactory results and submit a NDA to the FDA. Because of this, and the many risks and uncertainties relating to the completion of clinical trials, receipt of marketing approvals and acceptance in the marketplace, we cannot predict when material cash inflows from these programs will commence, if ever.
Results of Operations
Three Months Ended March 31, 2007 and 2006
The following table summarizes selected operating statement data for the three months ended March 31, 2007 and 2006 (amounts in thousands):
Three months ended March 31, | ||||||||
2007 | 2006 | |||||||
Revenue | $ | 9,991 | $ | 6,083 | ||||
Operating expenses: | ||||||||
Cost of good sold | $ | 952 | $ | — | ||||
% of revenues | 10 | % | — | |||||
Cost of royalties | $ | 1,047 | $ | 454 | ||||
% of revenues | 10 | % | 7 | % | ||||
Research and development | $ | 10,242 | $ | 21,208 | ||||
% of revenues | 103 | % | 349 | % | ||||
Selling, general and administrative | $ | 6,570 | $ | 18,898 | ||||
% of revenues | 66 | % | 311 | % | ||||
Restructuring charges | $ | 7,114 | $ | — |
Revenues. Substantially all our revenues have come from license fees, research and development support payments, milestone payments, product sales and royalty payments from our licensees and collaborators. These revenues fluctuate from quarter to quarter. Our revenues were $10.0 million for the quarter ended March 31, 2007 compared to $6.1 million for the quarter ended March 31, 2006. We recognized revenue under our research and license agreements during the three months ended March 31, 2007 and 2006, respectively, primarily as follows:
• | Under our agreement with Amgen, we recognized revenue of $8.3 million and $3.6 million; |
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• | Under our agreement with Kirin, we recognized revenue of zero and $2.0 million; and |
• | Under our agreement with Nycomed, we recognized revenue of $1.6 million and $443,000. |
The increase in royalty revenue earned from Amgen is due to an increase in sales of cinacalcet HCl since launching in March 2004. The increase in product sales, milestone income and royalty income earned from Nycomed is due primarily to PREOTACT® not being approved in the EU until April 2006. During the three months ended March 31, 2007, we recognized PREOTACT® product sales revenue of $1.1 million, royalty revenue of $356,000 and milestone revenue of $69,000 from Nycomed. During the three months ended March 31, 2006, we recognized PREOTACT® product sales revenue of $428,000 and milestone revenue of $15,000. Additionally, during the three months ended March 31, 2006, we recognized milestone revenue of $2.0 million from Kirin for the filing of a new drug application with the Japanese Pharmaceuticals and Medical Devices Agency in February 2006 for cinacalcet HCl.
Cost of Goods Sold.Our cost of goods sold consists of the cost of inventory, subsequent to the April 2006 approval of PREOTACT® in the EU, for products sales to Nycomed. Costs associated with inventory build that were incurred prior to the EU approval of PREOTACT® have been previously expensed as research and development expense, creating an initial FIFO inventory layer with a carrying value of zero. As inventory is expensed under the FIFO methodology, cost of goods sold as a percentage of product revenue will continue to increase in future periods until the initial zero costed FIFO layer is consumed. We recorded cost of goods sold of $952,000 and zero, respectively, during the three months ended March 31, 2007 and 2006.
Cost of Royalties. Our cost of royalties consists of royalties owed under our agreement with the Brigham and Women’s Hospital on sales of cinacalcet HCl. We recorded cost of royalties of $1.0 million and $454,000, respectively, during the three months ended March 31, 2007 and 2006. The increase in cost of royalties is due to increased sales of cinacalcet HCl by Amgen.
Research and Development. Our research and development expenses arise primarily from compensation and other related costs of our personnel who are dedicated to research and development activities and from the fees paid and costs reimbursed to outside professionals to conduct research, pre-clinical and clinical trials, and to manufacture drug compounds and related supplies prior to FDA approval. Our research and development expenses decreased to $10.2 million for the quarter ended March 31, 2007 from $21.2 million in 2006. The decrease is principally due to a $2.7 million decrease in stock-based compensation, including $630,000 due to severance agreements, a $1.9 million decrease in the costs of advancing our PREOS® clinical program, a $1.9 million decrease in personnel costs due to the 2006 Restructuring Plan, a $1.2 million decrease in costs associated with the manufacture of clinical and commercial supplies of PREOS® and teduglutide, a $1.2 million decrease in the development costs of advancing our teduglutide clinical program and a $835,000 decrease in the development costs of advancing our central nervous system programs.
Selling, General and Administrative. Our selling, general and administrative expenses consist primarily of the costs of our management and administrative staff, business insurance, property taxes, professional fees and market research and promotion activities, including the cost of our sales force through June 2006, for our marketed products and product candidates. Our selling, general and administrative expenses decreased to $6.6 million for the quarter ended March 31, 2007 from $18.9 million for the quarter ended March 31, 2006. The decrease is due primarily to a $7.8 million decrease in pre-launch commercial support, educational and commercial activities, including personnel costs, associated with PREOS® and terminating our sales promotional activities around Kineret® and Restasis® in 2006, a $2.2 million decrease in compensation cost related to stock-based compensation, a $1.6 million decrease in compensation expense due to severance agreements and a $600,000 decrease in other selling, general and administrative costs, including decreases in personnel costs due to the 2006 Restructuring Plan.
Restructuring Charges.Our restructuring charges relate to our initiative to restructure operations which was announced in June 2006, referred to as our 2006 Restructuring Plan, and to our subsequent initiative to further restructure our operations which was announced in March 2007, referred to as our 2007 Restructuring Plan. Under the 2006 Restructuring Plan, we reduced our worldwide workforce, including employees and contractors, by approximately 250 positions, eliminated all commercial sales and related field based activities, terminated our agreement with Allergan Inc. to promote Restasis® Ophthalmic Emulsion to rheumatologists and closed and plan to sell our technical operations facility in Mississauga, Ontario, Canada. The charge related to the 2006 Restructuring Plan during the three months ended March 31, 2007 and 2006, was a credit of $19,000 and zero, respectively, and was comprised primarily of severance related expenses. Under the 2007 Restructuring Plan, we announced that our worldwide workforce would be reduced from 196 employees to approximately 35 employees by the end of 2007. We also announced the closure of our operations in
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Toronto, Canada and Salt Lake City, Utah. The charge related to the 2007 Restructuring Plan during the three months ended March 31, 2007 and 2006, was $7.1 million and zero, respectively, and was comprised primarily of severance related expenses.
Total Other Expense, Net. Our total other expense, net, increased to $5.2 million for the three months ended March 31, 2007 from $3.9 million from the three months ended March 31, 2006. The increase in total other expense, net, for the three months ended March 31, 2007 compared to the same period in the prior year is due primarily to a $609,000 decrease in interest income due to lower average cash, cash equivalent and marketable security balances in 2007, a $509,000 increase in interest expense related to increasing our estimate of the effective interest rate on our Secured Notes for the cash sweep premium and a $182,000 decrease in foreign currency transaction gain/loss.
Liquidity and Capital Resources
The following table summarizes selected financial data (amounts in the thousands):
March 31, 2007 | December 31, 2006 | |||||||
Cash, cash equivalents, and marketable securities | $ | 131,955 | $ | 146,152 | ||||
Total assets | 180,475 | 224,740 | ||||||
Current debt | 6,465 | 19,044 | ||||||
Non-current debt | 358,830 | 365,533 | ||||||
Stockholders’ deficit | $ | (212,587 | ) | $ | (193,244 | ) |
We require cash to fund our operating expenses, to make capital expenditures, acquisitions and investments and to service our debt. We have financed operations since inception primarily through payments received under collaborative research and license agreements, the private and public issuance and sale of equity securities, and the issuance and sale of secured debt, convertible debt and lease financing. As of March 31, 2007, we had recognized $171.2 million of cumulative revenues from payments for research support, license fees, product sales, milestone and royalty payments, $563.0 million from the sale of equity securities for cash, $355.2 million from the sale of secured debt and convertible debt for cash and $19.0 million from the sale of our administration and laboratory building located in Salt Lake City, Utah, in a sale-leaseback transaction. Our principal sources of liquidity are cash, cash equivalents, and marketable investment securities, which totaled $132.0 million at March 31, 2007. Our $192,0 million 3.0% Convertible Notes, or Convertible Notes, mature in June 2008. Our current balance of cash, cash equivalents and marketable securities is not sufficient to repay the outstanding Convertible Notes. We are evaluating specific options to refinance a portion or all of the Convertible Notes as well as options to generate adequate new capital to repay a portion or all of the Convertible Notes. Although we have not selected a specific plan for addressing the maturity of the Convertible Notes, we believe that alternatives will be available to us although no assurances can be made. We plan to address our Convertible Notes by the end of 2007.
The primary objectives for our marketable investment security portfolio are liquidity and safety of principal. Investments are intended to achieve the highest rate of return to us, consistent with these two objectives. Our investment policy limits investments to certain types of instruments issued by institutions with investment grade credit ratings and places restrictions on maturities and concentration by type and issuer.
On May 9, 2007, we signed an Agreement of Purchase and Sale with Transglobe Property Management Services Ltd. in Trust to sell our land and 85,795 square foot laboratory and office building located in Mississauga, Ontario, Canada, for $4.8 million Cdn. We expect the closing to occur on or before June 30, 2007. The sale of this facility is part of our restructuring initiatives which includes a plan to close our Mississauga and Toronto facilities and discontinue all operations in Canada.
In March 2007, we announced that we were restructuring the company and reducing our work force from 196 employees to approximately 35 employees by the end of 2007. In conjunction with the reduction in force we are also closing our operations in Toronto, Canada and Salt Lake City, Utah. We believe the restructuring will enhance our ability to focus on our late stage product opportunities, including additional indications with our lead product candidates, preserve cash, allocate resources rapidly to different programs, and reallocate internal resources more effectively.
In June 2006, as a result of the uncertainty with respect to the regulatory approval of PREOS® by the FDA, we announced an initiative to restructure operations, referred to as our 2006 Restructuring Plan. The primary objective of the 2006 Restructuring Plan was to maximize shareholder value by significantly reducing cash burn, reprioritizing our development portfolio and leveraging our proprietary research and development assets. Under the 2006 Restructuring Plan, we reduced our worldwide workforce, including employees and contractors, by approximately 250 positions, eliminated all commercial sales and related field based activities, terminated our agreement with Allergan, Inc. to co-promote Allergan’s proprietary drug, Restasis® Ophthalmic Emulsion to rheumatologists, and closed and are in the process of selling our technical operations facility in Mississauga, Ontario, Canada.
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In December 2005, we completed a sale-leaseback transaction with BioMed Realty, L.P., or BioMed Realty, a Maryland limited partnership, in which we agreed to sell our 93,000 square foot laboratory and office building located in Salt Lake City, Utah for $19.0 million and lease back the property under a 15-year lease with BMR – 383 Colorow Drive LLC, or BMR, a subsidiary of BioMed Realty. Net proceeds from the sale were $19.0 million after deducting miscellaneous closing expenses. Under the terms of the lease we will pay a base rent of $158,000 per month for the first three years of the lease. After year three, our rent increases at the rate of 2.75% per year for the remainder of the lease. The lease is a triple-net lease and, as a result, we will continue to pay all costs associated with the building, including costs for maintenance and repairs, property taxes, insurance, and lease payments under the ground lease with the University of Utah. Under the terms of the sale, we assigned the 40-year ground lease with the University of Utah to BioMed Realty. Upon the expiration of the lease term, we have the right to (i) extend the lease for two separate five year periods, each at the current fair-market-rental value of the building, or (ii) purchase the building for 115% of its then fair-market-value. On May9, 2007, we signed an Agreement of Purchase and Sale to repurchase from BioMed Realty our 93,000 square foot laboratory and office building located in Salt Lake City, Utah, for $20.0 million. Under the terms of the Agreement of Purchase and Sale, our 15-year lease obligation to BMR will be terminated. We expect the closing to occur on or before June 30, 2007. We intend to sell the Salt Lake City facility as soon as practical after the closing of the transaction with BMR. Our re-purchase and subsequent sale of the building are part of our restructuring initiatives, which include a plan to close our Salt Lake City facility and discontinue all Salt Lake City operations.
In December 2004, we completed a private placement of $175.0 million in Secured 8.0% Notes due March 30, 2017, or Secured Notes. The Company received net proceeds from the issuance of the Secured Notes of approximately $169.3 million, after deducting costs associated with the offering. The Secured Notes accrue interest at an annual rate of 8.0% payable quarterly in arrears on March 30, June 30, September 30 and December 30 of each year. The Secured Notes are secured by certain royalty and related rights under our agreement with Amgen. Additionally, the only source for interest payments and principal repayment of the Secured Notes is limited to royalty and milestone payments received from Amgen plus any amounts available in the restricted cash reserve account and earnings thereon as described later. All payments received by us from Amgen will be applied to the payment of interest and principal on the Secured Notes until such notes are paid in full. The Secured Notes are non-recourse to NPS Pharmaceuticals, Inc. Payments of principal will be made on March 30 of each year, to the extent there is sufficient revenue available for such principal payment. In connection with the issuance of the Secured Notes, we were required to place $14.2 million of the Secured Notes proceeds into a restricted cash reserve account to pay any shortfall of interest payments through December 30, 2006. The remaining amount in the restricted cash reserve as of December 30, 2006 was used to repay principal and redemption premiums on March 30, 2007. In the event we receive royalty and milestone payments under our agreement with Amgen above certain specified amounts, a redemption premium on principal repayment will be owed. The redemption premium ranges from 0% to 41.5% of principal payments, depending on the annual net sales of cinacalcet HCl by Amgen. The Company may repurchase, in whole but not in part, the Secured Notes on any Payment Date at a premium ranging from 0% to 41.5% of outstanding principal, depending on the preceding four quarters’ sales of Sensipar® by Amgen. We are accruing the estimated redemption premiums over the estimated life of the debt of six years using the “effective interest-rate” method. Accrued interest in the notes was approximately $620,000 as of March 31, 2007 which represents our estimate of the redemption premium. We incurred debt issuance costs of $5.7 million, which are also being amortized using the “effective interest-rate” method. The effective interest rate on the Secured Notes, including debt issuance costs and estimated redemption premiums, is approximately 11.3%.
In April 2004, we signed a distribution and license agreement with Nycomed Danmark ApS, or Nycomed, in which we granted Nycomed the exclusive right to develop and market PREOS® in Europe. Nycomed also agreed to make an equity investment in NPS of $40.0 million through the purchase of 1.3 million shares of NPS common stock in the form of a private placement. We closed on the equity investment on July 7, 2004. The agreement also requires Nycomed to pay us up to 20.8 million euros in milestone payments upon regulatory approvals and achievement of certain sales targets to purchase drug product and devices from us and to pay us royalties on product sales. To date, we have earned 5.6 million euros in milestone payments from Nycomed. Nycomed has also committed to participate in fifty percent of the costs incurred in the conduct of certain Phase IIIb clinical trials up to a maximum contribution of 10.4 million euros and to expend at least 10.4 million euros in the conduct of certain Phase IV clinical studies. Under the terms of the agreement, we recognized revenue during the three months ended March 31, 2007 and 2006 of $1.6 million and $443,000, respectively.
In July 2003, we completed a private placement of $192.0 million of our 3.0 % Convertible Notes due June 15, 2008. Interest is payable semi annually in arrears on June 15 and December 15 of each year. Accrued interest on the Convertible Notes was approximately $1.7 million as of March 31, 2007. The holders may convert all or a portion of the Convertible Notes into common stock at any time on or before June 15, 2008. The Convertible Notes are convertible into our common stock at a conversion rate equal to approximately $36.59 per share, subject to adjustment in certain events. The Convertible Notes are unsecured senior debt obligations and rank equally in right of payment with all existing and future unsecured senior indebtedness. On or after June 20, 2006, we may redeem any or all of the Convertible Notes at a redemption price of 100 percent of their principal amount, plus accrued and unpaid interest to the day preceding the redemption date. The Convertible Notes will mature on June 15, 2008 unless earlier converted, redeemed at our option or redeemed at the option of the noteholder upon a “fundamental change”, as described in the
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Convertible Note indenture. Neither we nor any of our subsidiaries are subject to any financial covenants under the indenture. In addition, neither we nor any of our subsidiaries are restricted under the indenture from paying dividends, incurring debt, or issuing or repurchasing our securities.
The following table summarizes our cash flow activity for the three months ended March 31, 2007 and 2006 (amounts in thousands):
Three months ended March 31, | ||||||||
2007 | 2006 | |||||||
Net cash used in operating activities | $ | (17,324 | ) | $ | (42,987 | ) | ||
Net cash provided by investing activities | 10,229 | 24,403 | ||||||
Net cash provided by financing activities | $ | 2,990 | $ | 544 |
Net cash used in operating activities was $17.3 million for the three months ended March 31, 2007 compared to $43.0 million for the three months ended March 31, 2006. The decrease in cash used in operating activities during the three months ended March 31, 2007 compared to same period in the prior year is primarily a result of a decreased net loss in the three months ended March 31, 2007, compared with the same period in the prior year. The net loss decreased $17.2 million during the first quarter of 2007 compared to the first quarter of 2006 due primarily to increased revenues recognized under license agreements and decreases in research and development expenses and selling, general and administrative expenses, offset by restructuring charges associated with our 2007 Restructuring Plan. Additionally, we recorded less non-cash compensation expense of $5.0 million in 2007 related to all equity awards.
Net cash provided by investing activities was $10.2 million for the three months ended March 31, 2007 compared to $24.4 million for the three months ended March 31, 2006. Net cash provided by investing activities during the three months ended March 31, 2007 and 2006 was primarily the result of selling marketable investment securities to fund current operations. Additionally, capital expenditures for the three months ended March 31, 2007 and 2006 were $20,000 and $807,000, respectively.
Net cash provided by financing activities was $3.0 million for the three months ended March 31, 2007 compared to $544,000 for the three months ended March 31, 2006. Cash provided financing activities during the three months ended March 31, 2007 primarily relates to decreases in our restricted cash balances of $21.9 million related to our Secured Notes offset by principal payments of $19.3 million on our Secured Notes. Similarly during the three months ended March 31, 2006, cash was used in financing activities to make principal payments $1.3 million on our Secured Notes offset by decreases in our restricted cash balances of $1.1 million related to our Secured Notes. Additionally, we received cash from the exercise of employee stock options and proceeds from the sale of stock by us pursuant to the employee stock purchase plan. Employee stock option exercises and proceeds from the sale of stock by us pursuant to the employee stock purchase plan provided approximately $353,000 and $788,000, respectively, of cash during the three months ended March 31, 2007 and 2006. Proceeds from the exercise of employee stock options vary from period to period based upon, among other factors, fluctuations in the market value of NPS’s stock relative to the exercise price of such options.
We could receive future milestone payments of up to $94.5 million in the aggregate if each of our current licensees accomplishes the specified research and/or development milestones provided in the respective agreements. In addition, all of the agreements require the licensees to make royalty payments to us if they sell products covered by the terms of our license agreements. However, we do not control the subject matter, timing or resources applied by our licensees to their development programs. Thus, potential receipt of milestone and royalty payments from these licensees is largely beyond our control. Some of the late-stage development milestone payments from AstraZeneca will not be due if we elect a co-promotion option under which we may commercialize products. Further, each of these agreements may be terminated before its scheduled expiration date by the respective licensee either for any reason or under certain conditions.
We have entered into certain research and license agreements that require us to make research support payments to academic or research institutions when the research is performed. Additional payments may be required upon the accomplishment of research milestones by the institutions or as license fees or royalties to maintain the licenses. As of March 31, 2007, we have a total commitment of up to $1.5 million for future research support and milestone payments. Further, depending on the commercial success of certain of our products, we may be required to pay license fees or royalties. For example, we are required to make royalty payments to certain licensors on teduglutide net sales and cinacalcet HCl royalty revenues. We expect to enter into additional sponsored research and license agreements in the future.
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Under our agreement with AstraZeneca, we are required to co-direct the research and pay for an equal share of the preclinical research costs, including capital and a minimum number of personnel through March 2009, unless earlier terminated by AstraZeneca or us upon six months advance written notice. Additionally, we have entered into long-term agreements with certain manufacturers and suppliers that require us to make contractual payment to these organizations. We expect to enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require up-front payments and long-term commitments of cash.
We expect that our existing capital resources including interest earned thereon, will be sufficient to allow us to maintain our current and planned operations through at least the next 12 months. However, our actual needs will depend on numerous factors, including the success of our restructuring and outsourcing initiative, the progress and scope of our internally funded development and commercialization activities; our ability to comply with the terms of our research funding agreements; our ability to maintain existing collaborations; our decision to seek additional collaborators; the success of our collaborators in developing and marketing products under their respective collaborations with us; our success in producing clinical and commercial supplies of our product candidates on a timely basis sufficient to meet the needs of our clinical trials and commercial launch; the costs we incur in obtaining and enforcing patent and other proprietary rights or gaining the freedom to operate under the patents of others; and our success in acquiring and integrating complementary products, technologies or businesses. Our clinical trials may be modified or terminated for several reasons including the risk that our product candidates will demonstrate safety concerns; the risk that regulatory authorities may not approve our product candidates for further development or may require additional or expanded clinical trials to be performed; and the risk that our manufacturers may not be able to supply sufficient quantities of our drug candidates to support our clinical trials or commercial launch, which could lead to a disruption or cessation of the clinical trials or commercial activities. We may also be required to conduct unanticipated clinical trials to obtain regulatory approval of our product candidates. In particular, the FDA proposed that we conduct a new clinical trial for PREOS® in order to provide a complete response to the March 9, 2006 approvable letter. If any of the events that pose these risks comes to fruition, our actual capital needs may substantially exceed our anticipated capital needs and we may have to substantially modify or terminate current and planned clinical trials or postpone conducting future clinical trials. As a result, our business may be materially harmed, our stock price may be adversely affected, and our ability to raise additional capital may be impaired.
We will probably need to raise substantial additional funds to support our long-term product development, and commercialization programs. We regularly consider various fund raising alternatives, including, for example, partnering of existing programs, monetizing of potential revenue streams, debt or equity financing and merger and acquisition alternatives. We may also seek additional funding through strategic alliances, collaborations, or license agreements and other financing mechanisms. There can be no assurance that additional financing will be available on acceptable terms, if at all. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research and development programs, or to obtain funds through arrangements with licensees or others that may require us to relinquish rights to certain of our technologies or product candidates that we may otherwise seek to develop or commercialize on our own.
Critical Accounting Policies and Estimates
Our discussion and analysis of our consolidated financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, including those related to revenue and research and development costs. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We believe the following critical accounting policies affect the significant judgments and estimates used in the preparation of our consolidated financial statements:
• | revenue recognition; |
• | accrual of research and development expenses; |
• | share based payments; and |
• | valuation of long-lived and intangible assets and goodwill. |
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Revenue Recognition. We earn our revenue from research and development support payments, product sales, license fees, milestone payments and royalty payments. As described below, significant management judgment and estimates must be made and used in connection with the revenue recognized in any accounting period. Material differences may result in the amount and timing of our revenue for any period if our management made different judgments or utilized different estimates.
We apply the provisions of Staff Accounting Bulletin No. 104,Revenue Recognition,or SAB No. 104, to all of our revenue transactions and Emerging Issues Task Force, or EITF, Issue No. 00-21,Revenue Arrangements with Multiple Deliverables, to all revenue transactions entered into in fiscal periods beginning after June 15, 2003. We recognize revenue from our research and development support agreements as related research and development costs are incurred and the services are performed. The terms and conditions of our research and development support agreements are such that revenues are earned as the related costs are incurred. The principal costs under these agreements are for personnel employed to conduct research and development under these agreements. We recognize revenue from product sales when persuasive evidence of an arrangement exists, title to product and associated risk of loss has passed to the customer, the price is fixed or determinable, collection from the customer is reasonably assured and we have no further performance obligations. All revenues from product sales are recorded net of the applicable provision for returns in the same period the related sales are recorded. We recognize revenue from milestone payments as agreed upon events representing the achievement of substantive steps in the development process are achieved and where the amount of the milestone payment approximates the value of achieving the milestone. We recognize revenue from up-front nonrefundable license fees on a straight-line basis over the period we have continuing involvement in the research and development project. Royalties from licensees are based on third-party sales of licensed products and are recorded in accordance with the contract terms when third-party results are reliably measurable and collectability is reasonably assured. Cash received in advance of the performance of the related research and development support and for nonrefundable license fees when we have continuing involvement is recorded as deferred income. Where questions arise about contract interpretation, contract performance, or possible breach, we continue to recognize revenue unless we determine that such circumstances are material and/or that payment is not probable.
We analyze our arrangements entered into after June 15, 2003 to determine whether the elements can be separated and accounted for individually or as a single unit of accounting. Allocation of revenue to individual elements which qualify for separate accounting is based on the estimated fair value of the respective elements.
Accrual of Research and Development Expenses.Research and development costs are expensed as incurred and include salaries and benefits; costs paid to third-party contractors to perform research, conduct clinical trials, develop and manufacture drug materials and delivery devices; and associated overhead expenses and facilities costs. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. Invoicing from third-party contractors for services performed can lag several months. We accrue the costs of services rendered in connection with third-party contractor activities based on our estimate of management fees, site management and monitoring costs and data management costs. Differences between actual clinical trial costs from estimated clinical trial costs have not been material and are adjusted for in the period in which they become known.
Share-Based Payments.We grant options to purchase our common stock to our employees and directors under our stock option plans. Eligible employees can also purchase shares of our common stock at 85% of the lower of the fair market value on the first or the last day of each six-month offering period under our employee stock purchase plan. Share-based compensation expense recognized during the three months ended March 31, 2007 and 2006 was $896,000 and $5.7 million respectively. At March 31, 2007, total unrecognized estimated compensation expense related to non-vested stock options, stock appreciation rights, restricted stock and restricted stock units was $18.1 million, which is expected to be recognized over a weighted-average period of 2.01 years.
We determine the value of stock option awards on the date of grant using a Black-Scholes pricing model (Black-Scholes model). The determination of the fair value of share-based payment awards on the date of grant using the Black-Scholes model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. These variables include, but are not limited to, our expected stock price volatility over the term of the awards, actual and projected employee stock option exercise behaviors, risk-free interest rate and expected dividends. If factors change and we employ different assumptions in future periods, the compensation expense that we record may differ significantly from what we have recorded in the current period.
Estimates of share-based compensation expenses are significant to our financial statements, but these expenses are based on option valuation models and will never result in the payment of cash by us. The application of these principles may be subject to further interpretation and refinement over time. There are significant differences among valuation models, and there is a possibility
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that we will adopt different valuation models in the future. This may result in a lack of consistency in future periods and materially affect the fair value estimate of share-based payments. It may also result in a lack of comparability with other companies that use different models, methods and assumptions.
For purposes of estimating the fair value of stock options granted during the three months ended March 31, 2007 and 2006 using the Black-Scholes model, we have made an estimate regarding our stock price volatility (weighted-average of 61.8 % and 53.2%, respectively). We used a combination of historical volatility and the implied volatility of market-traded options in our stock for the expected volatility assumption input to the Black-Scholes model. In calculating the estimated volatility for the three months ended March 31, 2007 and 2006, we weighted implied volatility at zero percent and historical volatility at 100 percent. The risk-free interest rate is based on the yield curve of U.S. Treasury strip securities for a period consistent with the expected life of the option in effect at the time of grant (weighted-average of 4.8% and 4.4%, respectively, for the three months ended March 31, 2007 and 2006). We do not target a specific dividend yield for our dividend payments, but we are required to assume a dividend yield as an input to the Black-Scholes model. The dividend yield assumption is based on our history and expectation of dividend payouts (weighted-average of zero for the three months March 31, 2007 and 2006). The expected term is estimated using historical option exercise information (weighted-average of 3.8 years and 3.4 years, respectively, for the three months ended March 31, 2007 and 2006).
Valuation of Long-lived and Intangible Assets and Goodwill. We assess the impairment of long-lived assets and goodwill whenever events or changes in circumstances indicate that the carrying value may not be recoverable. Factors we consider important which could trigger an impairment review include the following:
• | significant underperformance relative to expected historical or projected future operating results; |
• | significant changes in the manner of our use of the acquired assets or the strategy for our overall business; |
• | significant negative industry or economic trends; |
• | significant decline in our stock price for a sustained period; and |
• | our market capitalization relative to net book value. |
Our balance sheet reflects net long-lived assets of $33.8 million, including net goodwill of $9.4 million on March 31, 2007.
When we determine that the carrying value of long-lived assets may not be recoverable based upon the existence of one or more of the above indicators of impairment, we measure any impairment based on a probability weighted projected discounted cash flow method using a discount rate determined by our management to be commensurate with the risk inherent in our current business model. Provision has been made for any impairment losses related to our long-lived assets.
We perform an annual impairment review of goodwill. We have not determined the existence of any indication of impairment sufficient to require us to adjust our historical measure of the value of such assets.
Recent Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board, or FASB, issued Statement on Financial Accounting Standard No. 157,Fair Value Measurements,or SFAS No. 157. SFAS No. 157 defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair value measurements. SFAS No. 157 applies under other accounting pronouncements that require or permit fair value measurements, the FASB having previously concluded in those accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, SFAS No. 157 does not require any new fair value measurements. SFAS No. 157 is effective for fiscal years beginning after November 15, 2007. We are currently evaluating the impact, if any, the adoption of SFAS No. 157 will have on our consolidated financial position, results of operations and cash flows.
In February 2007, the FASB issued Statement on Financial Accounting Standard No. 159,The Fair Value Option for Financial Assets and Financial Liabilities-including an amendment of FASB Statement No. 115, or SFAS No 159. SFAS No. 159 permits entities to choose to measure many financial instruments and certain other items at fair value that are not currently required to be measured at fair value, with unrealized gains and losses related to these financial instruments reported in earnings at each subsequent reporting date. SFAS No. 159 is effective for first fiscal years beginning after November 15, 2007. We are currently evaluating the impact, if any, the adoption of SFAS No. 159 will have on our consolidated financial position, results of operations and cash flows.
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Item 3. | Quantitative and Qualitative Disclosures About Market Risk. |
Interest Rate Risk. Our interest rate risk exposure results from our investment portfolio, our convertible notes, our secured notes and our lease financing obligation. Our primary objectives in managing our investment portfolio are to preserve principal, maintain proper liquidity to meet operating needs and maximize yields. The securities we hold in our investment portfolio are subject to interest rate risk. At any time, sharp changes in interest rates can affect the fair value of the investment portfolio and its interest earnings. After a review of our marketable investment securities, we believe that in the event of a hypothetical ten percent increase in interest rates, the resulting decrease in fair market value of our marketable investment securities would be insignificant to the financial statements. Currently, we do not hedge these interest rate exposures. We have established policies and procedures to manage exposure to fluctuations in interest rates. We place our investments with high quality issuers and limit the amount of credit exposure to any one issuer and do not use derivative financial instruments in our investment portfolio. We invest in highly liquid, investment-grade securities and money market funds of various issues, types and maturities. These securities are classified as available for sale and, consequently, are recorded on the balance sheet at fair value with unrealized gains or losses reported as accumulated other comprehensive income as a separate component in stockholders’ equity (deficit). Our 3.0 percent Convertible Notes in the principal amount of $192.0 million due June 15, 2008, our 8.0 percent Secured Notes in the principal amount of $154.5 million and our $19.0 million lease obligation each have a fixed interest rate. The fair value of the Convertible Notes is affected by changes in the interest rates and by changes in the price of our common stock. The fair value of the Secured Notes is affected by changes in the interest rates and by historical rates of royalty revenues from cinacalcet HCl sales. The fair value of the lease obligation is affected by changes in the interest rates and by changes in the value of real estate and lease rates in Salt Lake City, Utah.
Foreign Currency Risk. We have research and development operations in Canada. Additionally, we have significant clinical and commercial manufacturing agreements which are denominated in euros. As a result, our financial results could be affected by factors such as a change in the foreign currency exchange rate between the U.S. dollar and the Canadian dollar or euro, or by weak economic conditions in Canada or Europe. When the U.S. dollar strengthens against the Canadian dollar or euros , the cost of expenses in Canada or Europe decreases. When the U.S. dollar weakens against the Canadian dollar or euro, the cost of expenses in Canada or Europe increases. The monetary assets and liabilities in our foreign subsidiary which are impacted by the foreign currency fluctuations are cash, accounts receivable, accounts payable, and certain accrued liabilities. A hypothetical ten percent increase or decrease in the exchange rate between the U.S. dollar and the Canadian dollar or euro from the March 31, 2007 rate would cause the fair value of such monetary assets and liabilities in our foreign subsidiary to change by an insignificant amount. We are not currently engaged in any foreign currency hedging activities.
Item 4. | Controls and Procedures. |
We maintain “disclosure controls and procedures” within the meaning of Rule 13a-15(e) of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Our disclosure controls and procedures, or Disclosure Controls, are designed to ensure that information required to be disclosed by us in the reports we file under the Exchange Act, such as this Annual Report on Form 10-K, is recorded, processed, summarized and reported within the time periods specified in the U.S. Securities and Exchange Commission’s rules and forms. Our Disclosure Controls are also designed to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our Disclosure Controls, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply its judgment in evaluating and implementing possible controls and procedures.
Evaluation of Disclosure Controls and Procedures. As of March 31, 2007, we evaluated the effectiveness of the design and operation of the Company’s disclosure controls and procedures, which was done under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer. Immediately following the Signatures section of this Quarterly Report on Form 10-Q are certifications of our Chief Executive Officer and Chief Financial Officer, which are required in accordance with Rule 13a-14 of the Exchange Act. This Controls and Procedures section includes the information concerning the controls evaluation referred to in the certifications and it should be read in conjunction with the certifications for a more complete understanding of the topics presented. Based on the controls evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the date of their evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports we file or submit under the Securities Exchange Act is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, to allow timely determination regarding required disclosure and that such information is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
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Change in Internal Control over Financial Reporting. No change in our internal control over financial reporting occurred during our most recent fiscal quarter that has materially affected, or is reasonably likely to material affect, our internal control over financial reporting.
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OTHER INFORMATION
Item 1. | Legal Proceedings. |
Information with respect to our legal proceedings is contained in Item 3, Legal Proceedings, of our Annual Report on Form 10-K for the fiscal year-ended December 31, 2006. As of the date of this Quarterly Report on Form 10-Q, there have been no material changes to this information.
Item 1A. | Risk Factors. |
Information with respect to the risks and uncertainties relative to our business is contained in Item 1A, Risk Factors, of our Annual Report on Form 10-K for the fiscal year-ended December 31, 2006. As of the date of this Quarterly Report on Form 10-Q, there have been no material changes to this information.
Item 5. | Other Information. |
Entry Into Material Definitive Agreements
Salt Lake City, Utah Real Property. On May 9, 2007, we entered into an Agreement of Purchase and Sale with BMR-383 Colorow Drive LLC, a Delaware limited liability company, or BMR, pursuant to which we will re-purchase from BMR our 93,000 square foot laboratory and office building located at 383 Colorow Drive, Salt Lake City, Utah. In December 2005, we sold the building to BMR as part of a sale-leaseback transaction and agreed to lease the entire building back under a 15-year lease, referred to as the “building lease.” The building is located on land in the Research Park of the University of Utah and is the subject of a 40-year ground lease with the university, which BMR will assign to us at the closing of the transaction. We intend to sell the building as soon as reasonably practical after the closing of the transaction with BMR. Our re-purchase and subsequent sale of the building are part of our restructuring initiative, which includes a plan to close our Salt Lake City facility and discontinue all Salt Lake City operations.
The purchase price for the building is $20.0 million, which amount we will pay to BMR at closing less any credits, deposits or offsets. Upon signing the agreement, we deposited $250,000 in cash with a third-party escrow agent as earnest money for the building purchase. Under the agreement, the earnest money is refundable to us only if we terminate the agreement prior to closing due to a breach by BMR of its obligations under the agreement. Under the agreement, we agree to release BMR from any liability associated with the environmental, structural or physical condition of the building. The agreement also contains representations and warranties, closing conditions, termination provisions and other provisions which are customary for a transaction of this nature. Upon the closing of the transaction, BMR will return to us a $300,000 security deposit under the building lease and the building lease will terminate.
The foregoing summary does not purport to be complete and is qualified in its entirety by reference to the Agreement of Purchase and Sale and the exhibits thereto, which are attached as Exhibit 10.1 to this Quarterly Report and incorporated by reference in their entirety herein.
Mississauga, Ontario Real Property. On May 9, 2007, we entered into an Agreement of Purchase and Sale with Transglobe Property Management Services Ltd. in Trust, or Transglobe, pursuant to which we will sell our land and 85,795 square foot laboratory and office building located at 6850 Goreway Drive, Mississauga, Ontario. We refer to the land and building as the “property.” Our sale of the property is part of our restructuring initiatives, which include a plan to close our Mississauga and Toronto facilities and discontinue all operations in Canada.
The sales price for the property is $4.8 million Cdn., which amount will be paid to us at closing less any credits, deposits or offsets. Upon signing the agreement, Transglobe deposited $100,000 Cdn. in cash with our Canadian counsel to be held in trust as earnest money for the sale transaction. The agreement contains a 30-day “conditional period” to allow Transglobe to inspect the property, evaluate financial information relating to the property, evaluate title to the property and obtain financing for the transaction. During the conditional period, if Transglobe is not satisfied with its inspection or evaluations, or if Transglobe is unable to secure satisfactory financing, Transglobe may terminate the agreement and will receive a refund of the earnest money. Upon the earlier of Transglobe’s waiver of the conditional period or the expiration of the conditional period without notice of termination from Transglobe, the parties will proceed with the closing under the agreement. The agreement also contains representations and warranties, closing conditions, termination provisions and other provisions which are customary for a transaction of this nature.
The foregoing summary does not purport to be complete and is qualified in its entirety by reference to the Agreement of Purchase and Sale and the exhibits thereto, which are attached as Exhibit 10.2 to this Quarterly Report and incorporated by reference in their entirety herein.
Item 6. | Exhibits. |
(a) | Exhibits: |
Exhibit Number | Description of Document | |
10.1 | Agreement of Purchase and Sale, dated May9, 2007, between NPS Pharmaceuticals, Inc. and BMR-383 Colorow Drive LLC | |
10.2 | Agreement of Purchase and Sale, dated May 9, 2007, between NPS Allelix Corp. and Transglobe Property Management Services Ltd. in Trust | |
31.1 | Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer | |
31.2 | Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer | |
32 | Section 1350 Certification of Periodic Financial Report by the Chief Executive Officer and Chief Financial Officer |
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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.
NPS PHARMACEUTICALS, INC. | ||||
Date: May 9, 2007 | By: | /s/ N. ANTHONY COLES | ||
N. Anthony Coles, | ||||
President and Chief Executive Officer (Principal Executive Officer) | ||||
Date: May 9, 2007 | By: | /s/ GERARD J. MICHEL | ||
Gerard J. Michel, | ||||
Chief Financial Officer (Principal Financial and Accounting Officer) |
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Table of Contents
EXHIBIT INDEX
Exhibit Number | Description of Document | |
10.1 | Agreement of Purchase and Sale, dated May9, 2007, between NPS Pharmaceuticals, Inc. and BMR-383 Colorow Drive LLC | |
10.2 | Agreement of Purchase and Sale, dated May 9, 2007, between NPS Allelix Corp. and Transglobe Property Management Services Ltd. in Trust | |
31.1 | Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer | |
31.2 | Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer | |
32 | Section 1350 Certification of Periodic Financial Report by the Chief Executive Officer and Chief Financial Officer |
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