UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
November 6, 2013 |
Date of Report (Date of earliest event reported) |
NPS PHARMACEUTICALS, INC. |
(Exact name of registrant as specified in its charter) |
Delaware |
0-23272 |
87-0439579 |
(State or other jurisdiction of |
(Commission File Number)
|
(I.R.S. Employer Identification Number) |
550 Hills Drive, 3rd Floor |
Bedminster, NJ 07921 |
(Address of principal executive offices) |
(908) 450-5300 |
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(Registrant’s telephone number, including area code) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
On November 6, 2013, NPS Pharmaceuticals, Inc. issued a press release announcing its operating results for the third quarter of 2013. The text of the press release is furnished as Exhibit 99.1 to this Form 8-K.
The information in Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. | Description | ||
99.1 | Press Release issued by NPS Pharmaceuticals, Inc. on November 6, 2013. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: |
November 6, 2013 |
NPS PHARMACEUTICALS, INC. |
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By: |
/s/ EDWARD STRATEMEIER |
Edward Stratemeier |
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Senior Vice President, General Counsel and |
Exhibit 99.1
NPS Pharmaceuticals Reports Third Quarter 2013 Financial Results and Provides Business Update
-- Full-year net sales guidance increased to $28 to $32 million with $16 million in net sales year to date --
-- Natpara BLA submitted for hypoparathyroidism; market research supports unmet medical need and significant long-term global sales potential --
-- Conference call today at 8:30 AM ET --
BEDMINSTER, N.J.--(BUSINESS WIRE)--November 6, 2013--NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, reported its results for the third quarter.
“We are excited by the continued success of the Gattex launch in the U.S.,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. “We are seeing strong demand and sales have exceeded our expectations so far with 235 patients now on Gattex. We are also pleased to raise our full-year net sales guidance to $28 to $32 million given the favorable results and trends we have seen so far. In addition, recent progress includes data from STEPS 2, which showed that patients can continue to achieve clinically meaningful reductions in parenteral support requirements or even complete independence with Gattex treatment beyond one year. With respect to our international expansion, we are quite proud of the significant progress we have made. The transfer of the Revestive EU Marketing Authorization is complete and we are preparing to initiate pricing and reimbursement discussions early in 2014. We also expect to begin launching our first named-patient programs around the end of this year.”
Dr. Nader added, “We were very pleased with the recent submission of our Biologic License Application for Natpara and we look forward to continuing to work with the FDA to complete its review. Natpara could be the first and only FDA-approved parathyroid hormone replacement therapy for hypoparathyroidism and market research supports the unmet medical need and significant global market potential.”
Recent Highlights
Gattex® (U.S.)/Revestive® (Ex-U.S.) (teduglutide [rDNA origin]) for injection
Natpara® (recombinant human parathyroid hormone 1-84 (rhPTH 1-84))
New indications and product pipeline
Financial results for the third quarter of 2013
“From a financial perspective 2013 continues to be a highly successful year. We have recorded more than $16 million in Gattex sales and our Sensipar royalty stream has contributed more than $76 million in revenues so far this year,” commented Luke M. Beshar, executive vice president and chief financial officer of NPS. “Our financial position and outlook is the strongest in the company’s history. We ended the quarter with $178 million in cash and investments and are well-equipped to support the global commercialization of Gattex and Natpara while pursuing new opportunities for growth.”
Net loss
NPS reported a net loss of $1.1 million or $0.01 per diluted share for the third quarter of 2013 compared to a net loss of $3.3 million or $0.04 per diluted share for the same period of the prior year.
Revenues
Revenues were comprised of net product sales for Gattex, which was launched in the first quarter of 2013, and royalty revenues. Sales of Gattex were $11.0 million for the third quarter of 2013, compared to $0 for the same period of the prior year.
Royalty revenues were $28.1 million for the third quarter of 2013 compared to $27.0 million for the same period of the prior year. NPS earns royalties on (i) Amgen’s sales of Sensipar®/Mimpara® (cinacalcet HCl), (ii) Kyowa Hakko Kirin’s sales of REGPARA® (cinacalcet HCl), and (iii) Janssen Pharmaceuticals’ sales of NUCYNTA® (tapentadol) and NUCYNTA® ER (tapentadol extended-release tablets).
The components of royalties are summarized as follows:
In millions |
Quarter ended |
Nine months ended |
|||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||
Royalty: | |||||||||||||
Sensipar/Mimpara | $25.4 | $23.0 | $76.5 | $65.2 | |||||||||
REGPARA | 2.0 | 2.3 | 5.9 | 6.4 | |||||||||
Preotact | -- | 1.0 | -- | 4.8 | |||||||||
NUCYNTA and other | 0.7 | 0.7 | 2.2 | 2.1 | |||||||||
Total | $28.1 | $27.0 | $84.6 | $78.5 | |||||||||
On November 15, 2013, the company will receive a cash payment of $17.4 million for the Sensipar/Mimpara royalties earned during the third quarter of 2013. The remaining $8 million of Sensipar/Mimpara royalties will be retained to repay a royalty advance received in August 2011 from Amgen. At September 30, 2013, NPS had $54.4 million in long-term, non-recourse debt secured by its Sensipar royalties. The company expects the remaining balance of its Sensipar-secured non-recourse debt to be fully repaid in 2015. After repayment, NPS will receive all of the Sensipar royalties through the March 2018 patent expiry in the U.S. and through the end of 2018 for the rest-of-world.
Research and development
Research and development expenses were relatively consistent at $18.8 million for the third quarter of 2013 compared to $18.0 million for the same period of the prior year.
General and administrative
General and administrative expenses were $17.6 million for the third quarter of 2013 compared to $8.3 million for the same period of the prior year. The increase in general and administrative expenses was primarily due to personnel and other external costs related to the U.S. launch of Gattex.
Interest expense
Interest expense was $3.0 million for the third quarter of 2013 compared to $4.4 million for the same period of the prior year. Interest expense was largely attributable to non-recourse debt secured by the company’s Sensipar/Mimpara, REGPARA, and Preotact (rhPTH 1-84) royalties. The decline in interest expense was primarily due to a reduction in the outstanding principal associated with Sensipar/Mimpara-secured non-recourse debt, as well as lower effective interest rates associated with the REGPARA- and PTH 1-84-secured non-recourse debt.
Cash and investments
The company’s cash, cash equivalents, and marketable investment securities were $178 million at September 30, 2013 compared to $101 million at December 31, 2012.
Long-term debt
All long-term debt on the company’s balance sheet is non-recourse and secured solely by royalties related to Sensipar/Mimpara, REGPARA, and sales of PTH 1-84 in the EU, CIS, and Turkey. After repayment of these obligations, the cash flows from these royalties will revert to NPS in accordance with the terms set forth in each agreement.
The following table reflects the company’s non-recourse debt at September 30, 2013 and December 31, 2012:
In millions |
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September 30, |
December 31, |
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Non-recourse debt: | |||||||
Sensipar/Mimpara-secured | $61.1 | $80.2 | |||||
PTH 1-84-secured (EU, CIS and Turkey) | 42.8 | 42.8 | |||||
REGPARA-secured | 35.2 | 36.3 | |||||
Total non-recourse debt | 139.1 | 159.3 | |||||
Less current portion | 6.7 | 6.3 | |||||
Total long-term non-recourse debt | $132.4 | $153.0 | |||||
Financial guidance
The company financial guidance for 2013, which includes increased Gattex/Revestive net sales guidance, is summarized as follows:
Conference Call Information
NPS will host a conference call beginning today at 8:30 a.m. Eastern Time. To participate in the conference call, dial (866) 318-8618 and use pass code 68040193. International callers may dial +1 (617) 399-5137, using the same pass code. In addition, a live audio of the conference call will be available over the Internet. Interested parties can access the event through the NPS website, http://www.npsp.com.
A replay of the call will be available at (888) 286-8010, with pass code 32541481, until midnight Eastern Time, November 20, 2013. International callers may access the replay by dialing +1 (617) 801-6888, using the same pass code. The webcast will also be available through the NPS website for the same period.
About NPS Pharmaceuticals
NPS Pharmaceuticals is a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide. The company’s lead product, Gattex® (U.S.)/Revestive® (EU) (teduglutide [rDNA origin]) for injection is approved for adult Short Bowel Syndrome (SBS) patients who are dependent on parenteral support. NPS has also developed Natpara® (rhPTH [1-84]) for the treatment of hypoparathyroidism and submitted its Biologic License Application to the U.S. Food and Drug Administration in October 2013.
NPS’ earlier stage pipeline includes NPSP795, a calcilytic compound with potential application in rare disorders involving increased calcium receptor activity, such as autosomal dominant hypocalcemia (ADH). NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Janssen Pharmaceuticals, and Kyowa Hakko Kirin. Additional information about NPS is available through its corporate website, http://www.npsp.com.
“NPS,” “NPS Pharmaceuticals,” “Gattex,” “Natpara,” “Preotact,” and “Revestive” are the company's trademarks.
Disclosure notice
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on the company's current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward looking statements include, but are not limited to, statements concerning the company’s future financial performance and plans for the commercialization of its products. Risks associated to the company's business include, but are not limited to, the risks associated with any failure by the company to successfully commercialize Gattex (teduglutide [rDNA origin]) for injection, including the risk that physicians and patients may not see the advantages of Gattex and may therefore be reluctant to utilize the product, the risk that private and public payers may be reluctant to cover or provide reimbursement for Gattex, risks related to regulatory approvals for Natpara (recombinant human parathyroid hormone 1-84 (rhPTH 1-84)), the risks associated with the company's strategy, global macroeconomic conditions, the impact of changes in management or staff levels, the effect of legislation effecting healthcare reform in the United States, as well as other risk factors described in the company's periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Form 10-Qs. All information in this press release is as of the date of this release and NPS undertakes no duty to update this information, whether as a result of new information, future events or otherwise.
(Financial statements to follow)
NPS Pharmaceuticals and Subsidiaries |
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Three Months Ended | Nine Months Ended | ||||||||||||||
September 30, | September 30, | ||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||
Revenues: | |||||||||||||||
Product sales, net | $11,037 | $ -- | $16,492 | $ -- | |||||||||||
Royalties | 28,129 | 27,012 | 84,613 | 78,453 | |||||||||||
Sale of royalty rights | -- | -- | -- | 25,000 | |||||||||||
Other | 36 | 7 | 36 | 7 | |||||||||||
Total revenues | 39,202 | 27,019 | 101,141 | 103,460 | |||||||||||
Costs and expenses: | |||||||||||||||
Cost of goods sold | 1,077 | -- | 1,615 | -- | |||||||||||
Research and development | 18,798 | 17,957 | 65,381 | 70,797 | |||||||||||
General and administrative | 17,558 | 8,329 | 46,228 | 25,769 | |||||||||||
Total operating expenses | 37,433 | 26,286 | 113,224 | 96,566 | |||||||||||
Operating income (loss) | 1,769 | 733 | (12,083) | 6,894 | |||||||||||
Other (expense) income: | |||||||||||||||
Interest income, net | 108 | 64 | 221 | 224 | |||||||||||
Interest expense | (2,959) | (4,444) | (9,388) | (14,445) | |||||||||||
Other | (5) | 323 | (18) | 795 | |||||||||||
Total other expense, net | (2,856) | (4,057) | (9,185) | (13,426) | |||||||||||
Loss before income tax expense | (1,087) | (3,324) | (21,268) | (6,532) | |||||||||||
Income tax expense | -- | -- | 4 | -- | |||||||||||
Net loss | (1,087) | (3,324) | (21,272) | ($6,532) | |||||||||||
Net loss per common and potential common share: |
|||||||||||||||
Basic | ($0.01) | ($0.04) | ($0.22) | ($0.08) | |||||||||||
Diluted | ($0.01) | ($0.04) | ($0.22) | ($0.08) | |||||||||||
Weighted average common and potential common share: | |||||||||||||||
Basic | 102,227 | 86,947 | 96,034 | 86,910 | |||||||||||
Diluted | 102,227 | 86,947 | 96,034 | 86,910 | |||||||||||
NPS Pharmaceuticals and Subsidiaries |
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September 30, | December 31, | ||||||
2013 | 2012 | ||||||
Assets: | |||||||
Cash, cash equivalents and marketable investment securities | $177,601 | $100,715 | |||||
Account receivable | 31,986 | 30,276 | |||||
Inventory | 27,580 | -- | |||||
Other current assets | 6,446 | 6,060 | |||||
Property and equipment, net | 3,860 | 4,193 | |||||
Goodwill | 9,429 | 9,429 | |||||
Intangibles, net | 19,750 | -- | |||||
Debt issuance costs, net | 361 | 436 | |||||
Total assets | $277,013 | $151,109 | |||||
Liabilities and Stockholders’ Equity (Deficit): | |||||||
Accounts payable and accrued expenses | $24,207 | $23,289 | |||||
Convertible notes | 16,545 | -- | |||||
Current portion of non-recourse debt | 6,670 | 6,278 | |||||
Convertible notes, less current portion | -- | 16,545 | |||||
Non-recourse debt, less current portion* | 132,387 | 153,024 | |||||
Other long-term liabilities | 5,372 | 6,614 | |||||
Total liabilities | 185,181 | 205,750 | |||||
Common stock and additional paid-in capital | 1,122,270 | 954,539 | |||||
Accumulated other comprehensive income | 19 | 5 | |||||
Accumulated deficit | (1,030,457) | (1,009,185) | |||||
Total stockholders' equity (deficit) | 91,832 | (54,641) | |||||
Total liabilities and stockholders' equity (deficit) | $277,013 | $151,109 | |||||
* Non-recourse debt secured by Sensipar®/Mimpara®, Preotact® (rhPTH 1-84), and REGPARA® royalty revenue
CONTACT:
NPS Pharmaceuticals, Inc.
Susan M. Mesco, 908-450-5516
smesco@npsp.com