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
February 18, 2014 |
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 February 18, 2014, NPS Pharmaceuticals, Inc. issued a press release announcing its operating results for the fourth quarter and year ended December 31, 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 February 18, 2014 |
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: |
February 18, 2014 |
NPS PHARMACEUTICALS, INC. |
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By: |
/s/ Jill Thompson |
Jill Thompson |
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Acting General Counsel and Secretary |
Exhibit 99.1
NPS Pharmaceuticals Reports Fourth Quarter and Full-Year 2013 Financial Results and Financial Outlook for 2014
– Gattex® delivers strong performance with 2013 sales of $31.8 million –
– Global Short Bowel Syndrome franchise expected to grow by more than 250% in 2014 --
– Natpara® BLA review underway with PDUFA date of October 24 –
– Conference call today at 5:00 PM ET –
BEDMINSTER, N.J.--(BUSINESS WIRE)--February 18, 2014--NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today reported financial results for 2013 and its financial outlook for 2014.
NPS reported net global product sales of $15.3 million for the fourth quarter of 2013 and $31.8 million for the full year. These results are at the high end of the company’s 2013 guidance of $28 to $32 million in net sales. In February 2013, NPS launched and initiated sales of its first commercial product Gattex® (teduglutide [rDNA origin]) for injection in the US for the treatment of patients with adult Short Bowel Syndrome (SBS) who are dependent on parenteral support. Teduglutide is also approved in the European Union (EU) under the trade name Revestive® and is expected to launch in certain countries in 2014.
“2013 was a transformative year in which we successfully established NPS as a global commercial rare disease company with the US launch of Gattex and the regaining of the ex-US rights to our two products,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. “Looking forward to 2014, we will continue to execute our growth strategy to build a premier global orphan drug business. Our key initiatives are growing Gattex sales in the US, launching Revestive in certain ex-US markets, securing US approval of Natpara for hypoparathyroidism, and building a global pipeline of innovative, ‘first-in’ or ‘best-in’ rare disease therapeutics.”
Gattex® 2013 launch highlights
Other business highlights
Gattex/Revestive (teduglutide) in Short Bowel Syndrome
Natpara® (recombinant human parathyroid hormone [1-84] or rhPTH 1-84) in Hypoparathyroidism
Product pipeline
Financial results
Net income (loss)
NPS reported net income of $7.8 million or $0.07 per diluted share for the fourth quarter of 2013, compared to a net loss of $12.2 million or $0.14 per diluted share for the fourth quarter of 2012. For the full year, NPS reported a net loss of $13.5 million or $0.14 per diluted share in 2013 versus a net loss of $18.7 million or $0.22 per diluted share in 2012.
Revenues
Revenues are comprised of net product sales for Gattex, which was launched in the US in the first quarter of 2013, and royalty revenues. Net sales were $15.3 million for the fourth quarter of 2013 and $31.8 million for the full year compared to $0 for the same periods in the prior year.
Royalty revenues were $39.2 million for the fourth quarter of 2013 and $27.1 million for the fourth quarter of 2012. For the full year, royalty revenues were $123.8 million for 2013 compared with $105.6 million for 2012. 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: |
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In millions |
Quarter ended
December 31, |
Year ended
December 31, |
|||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Royalty: | |||||||||||||||||
Sensipar | $36.4 | $24.0 | $112.9 | $89.3 | |||||||||||||
REGPARA | 2.1 | 2.3 | 8.0 | 8.7 | |||||||||||||
NUCYNTA | 0.7 | 0.8 | 2.9 | 2.8 | |||||||||||||
rhPTH 1-84 | -- | -- | -- | 4.8 | |||||||||||||
Total | $39.2 | $27.1 | $123.8 | $105.6 | |||||||||||||
The company’s fourth quarter 2013 Sensipar/Mimpara royalties included a non-recurring favorable adjustment from Amgen. On February 15, 2014, the company received a cash payment of $22.8 million for the Sensipar/Mimpara royalties earned during the fourth quarter of 2013. Amgen retained $8 million of Sensipar/Mimpara royalties to repay a royalty advance received in August 2011.
Research and development
Research and development expenses were $20.0 million for the fourth quarter of 2013 compared to $24.0 million for the fourth quarter of 2012. For the full year, research and development expenses were $85.4 million for 2013 compared to $94.8 million for 2012. The decrease in 2013 research and development expenses was primarily due to a reduction in clinical development activities for Gattex and Natpara.
Selling, general and administrative
Selling, general and administrative expenses were $21.9 million for the fourth quarter of 2013 compared to $11.2 million for the fourth quarter of 2012. For the full year, selling, general and administrative costs were $68.1 million for 2013 compared to $36.9 million for 2012. The increase in 2013 selling, general and administrative expenses was primarily due to launch and pre-launch activities for Gattex/Revestive and Natpara, respectively, including personnel-related expenses.
Cash and investments
The company’s cash, cash equivalents, and marketable investment securities were approximately $180 million at December 31, 2013 compared with $101 million at December 31, 2012.
Long-term debt
At December 31, 2013, the company’s only recourse debt was $16.5 million in 5.75% convertible notes due in 2014.
All other debt on the company’s balance sheet is non-recourse and secured solely by its royalty rights related to Sensipar/Mimpara, rhPTH 1-84, and REGPARA. 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 December 31, 2013 and 2012:
In millions |
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December 31, 2013 |
December 31, 2012 |
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Non-recourse debt: | |||||||||
Sensipar/Mimpara-secured | $54.4 | $80.2 | |||||||
rhPTH 1-84-secured | 42.8 | 42.8 | |||||||
REGPARA-secured | 35.2 | 36.3 | |||||||
Total non-recourse debt | 132.4 | 159.3 | |||||||
Less current portion | 8.8 | 6.3 | |||||||
Total long-term non-recourse debt | $123.6 | $153.0 | |||||||
2014 Financial guidance
NPS expects to achieve the following financial objectives in 2014:
Conference Call Information
To participate in the conference call, dial (800) 688-0836 and use passcode 71899588. International callers may dial +1 (617) 614-4072, using the same passcode. In addition, a live audio of the conference call will be available over the Internet. Interested parties can access the event through the investors’ calendar of events page on the NPS website at http://www.npsp.com/calendar.
If you are unable to participate in the live call, a replay will be available at (888) 286-8010, with passcode 41017687 until midnight ET, March 4, 2014. International callers may access the replay by dialing +1 (617) 801-6888, using the same passcode. The webcast will also be available through the NPS website for the same period.
About NPS Pharmaceuticals
NPS Pharmaceuticals is a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases. The company’s lead product, Gattex® (teduglutide [rDNA origin]) for injection is approved in the US for adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. In the EU, teduglutide (trade name: Revestive®) is approved for the treatment of adult patients with SBS; patients should be stable following a period of intestinal adaptation after surgery. Teduglutide is not approved for the treatment of pediatric SBS patients. The safety and efficacy of teduglutide in this population is currently being evaluated in a global registration trial.
A Biologics License Application is undergoing FDA review for Natpara® (rhPTH [1-84]) for the treatment of hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone. The Prescription Drug User Fee Act goal date for the Natpara application is October 24, 2014.
NPS’ earlier stage pipeline includes NPSP795, a calcilytic compound with potential application in rare disorders involving increased calcium sensing 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/Revestive (teduglutide [rDNA origin]) for injection, including the risk that physicians and patients may not see the advantages of Gattex/Revestive 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 Condensed Consolidated Statements of Operations (In thousands, except per share data) (Unaudited) |
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Three Months Ended | Twelve months ended | ||||||||||||||
December 31, | December 31, | ||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||
Revenues: | |||||||||||||||
Product sales | $15,260 | $ -- | $31,752 | $ -- | |||||||||||
Royalties | 39,191 | 27,134 | 123,804 | 105,587 | |||||||||||
Sale of royalty rights | -- | -- | -- | 25,000 | |||||||||||
Milestones and license fees | -- | 50 | 36 | 57 | |||||||||||
Total revenues | 54,451 | 27,184 | 155,592 | 130,644 | |||||||||||
Cost of sales | 1,972 | -- | 3,587 | -- | |||||||||||
Cost of license fees | -- | -- | 9 | -- | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 20,040 | 24,042 | 85,421 | 94,839 | |||||||||||
Selling, general and administrative | 21,851 | 11,160 | 68,070 | 36,929 | |||||||||||
Total operating expenses | 41,891 | 35,202 | 153,491 | 131,768 | |||||||||||
Operating income (loss) | 10,588 | (8,018 | ) | (1,495 | ) | (1,124 | ) | ||||||||
Other (expense) income: | |||||||||||||||
Interest income, net | 119 | 68 | 340 | 292 | |||||||||||
Interest expense | (2,550 | ) | (3,753 | ) | (11,938 | ) | (18,198 | ) | |||||||
Other | (211 | ) | (500 | ) | (229 | ) | 295 | ||||||||
Total other expense, net | (2,642 | ) | (4,185 | ) | (11,827 | ) | (17,611 | ) | |||||||
Income (loss) before income tax expense | 7,946 | (12,203 | ) | (13,322 | ) | (18,735 | ) | ||||||||
Income tax expense | 178 | -- | 182 | -- | |||||||||||
Net income (loss) | $7,768 | ($12,203 | ) | ($13,504 | ) | ($18,735 | ) | ||||||||
Net income (loss) per common and potential common share: |
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Basic | $0.08 | ($0.14 | ) | ($0.14 | ) | ($0.22 | ) | ||||||||
Diluted | $0.07 | ($0.14 | ) | ($0.14 | ) | ($0.22 | ) | ||||||||
Weighted average common and potential common share: | |||||||||||||||
Basic | 102,843 | 87,266 | 97,750 | 86,999 | |||||||||||
Diluted | 107,062 | 87,266 | 97,750 | 86,999 |
NPS Pharmaceuticals and Subsidiaries
Condensed Consolidated Balance Sheets (In thousands) (Unaudited) |
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December 31, | December 31, | ||||||||
2013 | 2012 | ||||||||
Assets: | |||||||||
Cash, cash equivalents and marketable investment securities | $180,474 | $100,715 | |||||||
Account receivable | 41,242 | 30,276 | |||||||
Other current assets | 37,036 | 6,060 | |||||||
Property and equipment, net | 4,402 | 4,193 | |||||||
Goodwill | 9,429 | 9,429 | |||||||
Intangibles, net | 19,301 | -- | |||||||
Debt issuance costs, net | 338 | 436 | |||||||
Total assets | $292,222 | $151,109 | |||||||
Liabilities and Stockholders’ Deficit: | |||||||||
Accounts payable and accrued expenses | $33,117 | $23,289 | |||||||
Convertible notes | 16,545 | -- | |||||||
Convertible notes, less current portion | -- | 16,545 | |||||||
Current portion of non-recourse debt | 8,752 | 6,278 | |||||||
Non-recourse debt, less current portion* | 123,635 | 153,024 | |||||||
Other long-term liabilities | 5,283 | 6,614 | |||||||
Total liabilities | 187,332 | 205,750 | |||||||
Common stock and additional paid-in capital | 1,127,523 | 954,539 | |||||||
Accumulated other comprehensive income | 56 | 5 | |||||||
Accumulated deficit | (1,022,689 | ) | (1,009,185 | ) | |||||
Total stockholders' equity (deficit) | 104,890 | (54,641 | ) | ||||||
Total liabilities and stockholders' equity (deficit) | $292,222 | $151,109 | |||||||
* Non-recourse debt secured by Sensipar®/Mimpara®, rhPTH 1-84, and REGPARA® revenue |
CONTACT:
NPS Pharmaceuticals, Inc.
Susan M. Mesco, 908-450-5516
smesco@npsp.com