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 10, 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 incorporation)
|
(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
|
(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 10, 2014, NPS Pharmaceuticals, Inc. (the “Company”) issued a
press release announcing its operating results for the quarter ended
September 30, 2014. The text of the press release is furnished as
Exhibit 99.1 to this Form 8-K.
On November 10, 2014, the Company is holding a previously-scheduled
conference call to discuss its results of operations for the quarter
ended September 30, 2014.
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 of NPS Pharmaceuticals, Inc. dated November 10, 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:
|
November 10, 2014
|
NPS PHARMACEUTICALS, INC.
|
|
|
|
|
|
By:
|
/s/ Christine Mikail
|
|
|
|
Christine Mikail
|
|
|
|
Senior Vice President, Legal Affairs, General
|
|
|
|
Counsel and Corporate Secretary
|
Exhibit 99.1
NPS
Pharma Reports Third-Quarter 2014 Financial Results
Net
global Gattex®/Revestive® sales of $28 million representing sequential
growth of 28 percent
Company
on track to meet full-year financial guidance
Commercial-readiness
activities continue in advance of Natpara’s January 24 PDUFA date
Conference
call today at 4:30 PM ET
BEDMINSTER, N.J.--(BUSINESS WIRE)--November 10, 2014--NPS
Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company
pioneering and delivering innovative therapies that transform the lives
of patients with rare diseases, today reported its results for the
quarter ended September 30, 2014.
NPS Pharma reported net global Gattex®/Revestive® sales
of $28.1 million for the third quarter of 2014, compared to $11.0
million for the same period last year. Based on the company’s
expectations for the remainder of 2014, NPS Pharma currently anticipates
its full-year net sales will be in the lower end of its guidance range
of $100 and $110 million.
“We are pleased with the continued success of Gattex/Revestive, which
has achieved $68 million of net sales so far this year leaving us on
track to deliver more than 200% year-over-year growth,” said Francois
Nader, MD, president and chief executive officer of NPS Pharma. “We
continue to identify new Short Bowel Syndrome patients and grow our
prescriber base leaving us confident in the long-term outlook for
Gattex. Internationally, we are also making important progress.
Revestive is now officially launched in Germany and we filed for orphan
drug designation in Japan.”
Dr. Nader added: “We were very gratified to receive a positive Advisory
Committee vote recommending the approval of Natpara for the long-term
treatment of hypoparathyroidism. We are working with the FDA to finalize
our label and Risk Evaluation and Mitigation Strategy. In parallel, we
are advancing a number of pre-commercial activities to prepare for the
successful launch of Natpara in the second quarter of 2015.”
Financial Results
Net loss
NPS Pharma reported a net loss of $2.1 million or $0.02 per diluted
share for the third quarter of 2014 compared to a net loss of $1.1
million or $0.01 per diluted share for the same period last year.
Revenues
The company’s revenues were comprised of net product sales for
Gattex/Revestive and royalty revenues. Net sales were $28.1 million for
the third quarter of 2014 compared to $11.0 million for the same period
last year. In February 2013, NPS Pharma launched and initiated sales of
Gattex in the U.S. The company recently began commercializing Revestive
in Germany and has obtained published pricing in other EU markets. NPS
Pharma expects to begin to see meaningful sales after it has concluded
its pricing discussions and secured broad-based reimbursement in key EU
markets.
Royalty revenues were $29.1 million for the third quarter of 2014
compared to $28.1 million for the same period last 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
|
|
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
|
|
|
|
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
|
|
|
Royalty:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sensipar
|
|
|
|
$
|
26.5
|
|
$
|
25.4
|
|
|
$
|
81.2
|
|
$
|
76.5
|
|
|
|
|
REGPARA
|
|
|
|
|
2.1
|
|
|
2.0
|
|
|
|
6.4
|
|
|
5.9
|
|
|
|
|
NUCYNTA and other
|
|
|
|
|
0.5
|
|
|
0.7
|
|
|
|
1.9
|
|
|
2.2
|
|
|
|
|
Total
|
|
|
|
$
|
29.1
|
|
$
|
28.1
|
|
|
$
|
89.5
|
|
$
|
84.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
On November 15, 2014, the company will receive a cash payment of $18.5
million for the Sensipar/Mimpara royalties earned during the third
quarter of 2014. The remaining $8.0 million of Sensipar/Mimpara
royalties will be retained to repay a royalty advance received in August
2011 from Amgen. At September 30, 2014, NPS Pharma had $33.5 million in
non-recourse debt secured by its Sensipar royalties.
Research and development
Research and development expenses were $24.5 million for the third
quarter of 2014 as compared to $18.8 million for the same period last
year. The increase was attributable to product development and
regulatory activities.
Selling, general and administrative
Selling, general and administrative expenses were $28.1 million for the
third quarter of 2014 as compared to $17.6 million for the same period
last year. The increase in selling, general and administrative expenses
was primarily due to commercial activities related to Gattex/Revestive
and pre-launch activities for Natpara.
Interest expense
Interest expense was $3.4 million for the third quarter of 2014 compared
to $3.0 million for the same period last year. Interest expense was
largely attributable to non-recourse debt secured by the company’s
Sensipar/Mimpara, rhPTH 1-84, and REGPARA revenues.
Cash and investments
The company’s cash, cash equivalents, and marketable investment
securities were approximately $169.3 million at September 30, 2014
compared to $180.5 million at December 31, 2013.
Non-recourse debt
As of September 30, 2014, all debt on the company’s balance sheet is
non-recourse and secured solely by royalties related to
Sensipar/Mimpara, REGPARA, and worldwide sales, excluding Israel, of PTH
1-84. After repayment of these obligations, the cash flows from these
royalties will revert to NPS Pharma in accordance with the terms set
forth in each agreement.
The following table reflects the company’s non-recourse debt at
September 30, 2014 and December 31, 2013:
|
|
|
|
|
|
|
|
|
|
In millions
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2014
|
|
December 31, 2013
|
|
|
Non-recourse debt:
|
|
|
|
|
|
|
|
|
Sensipar/Mimpara-secured
|
|
|
|
$
|
33.5
|
|
$
|
54.4
|
|
|
PTH 1-84-secured (worldwide, excluding Israel)
|
|
|
|
|
42.8
|
|
|
42.8
|
|
|
REGPARA-secured
|
|
|
|
|
31.0
|
|
|
35.2
|
|
|
Total non-recourse debt
|
|
|
|
|
107.3
|
|
|
132.4
|
|
|
Less current portion
|
|
|
|
|
7.3
|
|
|
8.8
|
|
|
Total long-term non-recourse debt
|
|
|
|
$
|
100.0
|
|
$
|
123.6
|
|
|
|
|
|
|
|
|
|
2014 Financial Guidance
The company currently expects that full-year net sales will be at the
low end of net sales guidance of $100 to $110 million.
The company now expects full-year 2014 operating expenses, excluding the
impact of share-based compensation and cost of goods sold, to be between
$185 and $195 million versus its previous range of $180 to $200 million.
NPS Pharma reported share-based compensation of $11.2 million for the
nine months ended September 30, 2014.
The foregoing financial guidance comprises projections based on numerous
assumptions, all of which are subject to certain risks and
uncertainties. For a discussion of the risks and uncertainties
associated with these forward-looking statements, please see the
disclosure notice below.
Conference Call Information
NPS Pharma will host a conference call beginning today at 4:30 p.m. ET.
To participate in the conference call, dial (877) 576-3758.
International callers may dial +1 (443) 877-4073. 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://ir.npsp.com/events.cfm.
If you are unable to participate in the live call, a replay will be
available at (855) 859-2056, with conference ID: 17738226 until midnight
ET, November 24, 2014. International callers may access the replay by
dialing +1 (404) 537-3406, using the same conference ID. The webcast
will also be available through the NPS website for the same period.
About NPS Pharma
NPS Pharma is a global biopharmaceutical company pioneering and
delivering therapies that transform the lives of patients with rare
diseases. The current therapeutic areas of focus for NPS Pharma are rare
gastrointestinal disease and endocrine disorders. These include Short
Bowel Syndrome, a potentially fatal gastrointestinal disorder in which
patients may have to rely on parenteral nutrition for their survival;
Hypoparathyroidism, a complex endocrine disorder in which the
parathyroid glands are either absent or damaged, and the body produces
insufficient or no parathyroid hormone; and Autosomal Dominant
Hypocalcemia, an ultra-rare, genetic disorder of calcium homeostasis
caused by mutations of the calcium-sensing receptor gene. NPS Pharma is
actively seeking in-licensing opportunities to develop new therapies for
a broad range of rare diseases, and 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. NPS Pharma has operations in the U.S., Canada,
Europe, Latin America and Japan. Learn more at: www.npsp.com
“NPS Pharma” and “NPS Pharmaceuticals” 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,
including statements regarding launch timelines and plans for Natpara,
beliefs or expectations regarding our products in development,
statements concerning the company's plans for international expansion,
beliefs or expectations regarding potential revenue and earnings from
product sales, including beliefs regarding our ability to grow sales,
expectations regarding the market size for our products, including those
in development, and beliefs or expectations regarding our operating
expenses. 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 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 press release and NPS
undertakes no duty to update this information, whether as a result of
new information, future events or otherwise.
|
|
|
|
|
|
|
|
|
|
|
NPS Pharmaceuticals and Subsidiaries
|
Condensed Consolidated Statements of Operations
|
(In thousands, except per share data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
Product sales, net
|
|
|
|
$
|
28,091
|
|
|
$
|
11,037
|
|
|
$
|
67,917
|
|
|
$
|
16,492
|
|
Royalties
|
|
|
|
|
29,109
|
|
|
|
28,129
|
|
|
|
89,450
|
|
|
|
84,613
|
|
License fees
|
|
|
|
|
--
|
|
|
|
36
|
|
|
|
--
|
|
|
|
36
|
|
Total revenues
|
|
|
|
|
57,200
|
|
|
|
39,202
|
|
|
|
157,367
|
|
|
|
101,141
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
|
3,180
|
|
|
|
1,077
|
|
|
|
7,794
|
|
|
|
1,615
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
24,530
|
|
|
|
18,798
|
|
|
|
66,238
|
|
|
|
65,381
|
|
Selling, general and administrative
|
|
|
|
|
28,139
|
|
|
|
17,558
|
|
|
|
79,142
|
|
|
|
46,228
|
|
Total operating expenses
|
|
|
|
|
52,669
|
|
|
|
36,356
|
|
|
|
145,380
|
|
|
|
111,609
|
|
Operating income (loss)
|
|
|
|
|
1,351
|
|
|
|
1,769
|
|
|
|
4,193
|
|
|
|
(12,083
|
)
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
Interest income, net
|
|
|
|
|
97
|
|
|
|
108
|
|
|
|
321
|
|
|
|
221
|
|
Interest expense
|
|
|
|
|
(3,364
|
)
|
|
|
(2,959
|
)
|
|
|
(11,047
|
)
|
|
|
(9,388
|
)
|
Other
|
|
|
|
|
(9
|
)
|
|
|
(5
|
)
|
|
|
298
|
|
|
|
(18
|
)
|
Total other expense, net
|
|
|
|
|
(3,276
|
)
|
|
|
(2,856
|
)
|
|
|
(10,428
|
)
|
|
|
(9,185
|
)
|
Loss before income tax expense
|
|
|
|
|
(1,925
|
)
|
|
|
(1,087
|
)
|
|
|
(6,235
|
)
|
|
|
(21,268
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
|
|
|
|
|
221
|
|
|
|
--
|
|
|
|
495
|
|
|
|
4
|
|
Net loss
|
|
|
|
$
|
(2,146
|
)
|
|
|
($1,087
|
)
|
|
|
($6,730
|
)
|
|
|
($21,272
|
)
|
Net loss per common and potential common share:
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
|
($0.02
|
)
|
|
|
($0.01
|
)
|
|
|
($0.06
|
)
|
|
|
($0.22
|
)
|
Diluted
|
|
|
|
|
($0.02
|
)
|
|
|
($0.01
|
)
|
|
|
($0.06
|
)
|
|
|
($0.22
|
)
|
Weighted average common and potential common share:
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
|
107,312
|
|
|
|
102,227
|
|
|
|
105,924
|
|
|
|
96,034
|
|
Diluted
|
|
|
|
|
107,312
|
|
|
|
102,227
|
|
|
|
105,924
|
|
|
|
96,034
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NPS Pharmaceuticals and Subsidiaries
|
Condensed Consolidated Balance Sheets
|
(In thousands)
|
(Unaudited)
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
|
2014
|
|
2013
|
Assets:
|
|
|
|
|
|
|
Cash, cash equivalents and marketable investment securities
|
|
|
|
$
|
169,347
|
|
|
$
|
180,474
|
|
Account receivable
|
|
|
|
|
38,125
|
|
|
|
41,242
|
|
Inventory
|
|
|
|
|
33,513
|
|
|
|
30,035
|
|
Other current assets
|
|
|
|
|
7,936
|
|
|
|
7,001
|
|
Property and equipment, net
|
|
|
|
|
5442
|
|
|
|
4,402
|
|
Goodwill
|
|
|
|
|
9,429
|
|
|
|
9,429
|
|
Intangibles, net
|
|
|
|
|
17,954
|
|
|
|
19,301
|
|
Other
|
|
|
|
|
469
|
|
|
|
338
|
|
Total assets
|
|
|
|
$
|
282,215
|
|
|
$
|
292,222
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity:
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
|
|
$
|
35,002
|
|
|
$
|
33,117
|
|
Convertible notes
|
|
|
|
|
-
|
|
|
|
16,545
|
|
Current portion of non-recourse debt*
|
|
|
|
|
7,270
|
|
|
|
8,752
|
|
Non-recourse debt, less current portion*
|
|
|
|
|
100,007
|
|
|
|
123,635
|
|
Other long-term liabilities
|
|
|
|
|
9,023
|
|
|
|
5,283
|
|
Total liabilities
|
|
|
|
|
151,302
|
|
|
|
187,332
|
|
|
|
|
|
|
|
|
Common stock and additional paid-in capital
|
|
|
|
|
1,161,965
|
|
|
|
1,127,523
|
|
Accumulated other comprehensive income
|
|
|
|
|
(1,633
|
)
|
|
|
56
|
|
Accumulated deficit
|
|
|
|
|
(1,029,419
|
)
|
|
|
(1,022,689
|
)
|
Total stockholders' equity
|
|
|
|
|
130,913
|
|
|
|
104,890
|
|
Total liabilities and stockholders' equity
|
|
|
|
$
|
282,215
|
|
|
$
|
292,222
|
|
|
|
|
|
|
|
|
* Non-recourse debt secured by Sensipar®/Mimpara®,
rhPTH 1-84, and REGPARA® revenue
|
CONTACT:
NPS Pharmaceuticals, Inc.
Investor:
Susan Mesco, + 1
908-450-5516
smesco@npsp.com
or
Media:
Justine
O’Malley, + 1 908-375-7665
jomalley@npsp.com
Nps (NASDAQ:NPSP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Nps (NASDAQ:NPSP)
Historical Stock Chart
From Jul 2023 to Jul 2024