– 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
–
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
- As of December 31, there were 303
patients on Gattex, which was in line with the company’s guidance
of 275 to 325 patients, and 530 Gattex/Revestive prescriptions were
received.
Other business highlights
Gattex/Revestive (teduglutide) in Short Bowel Syndrome
- NPS has finalized its core value
dossier and is now tailoring it to the relevant ex-US countries.
The company continues to expect to begin pricing/reimbursement
discussions with authorities in selected EU countries during the
first half of 2014.
- The company has initiated named-patient
programs in certain ex-US countries, including Argentina, Turkey,
and Brazil.
- NPS is implementing its clinical and
regulatory strategy for Japan, which includes filing for orphan
drug status in 2014.
- The company continues to expect that it
will begin recognizing meaningful commercial sales from ex-US
territories in the second half of 2014.
- Patient dosing is underway in a global
registration study of pediatric patients with SBS. The 12-week,
open-label study will be conducted at approximately 20 sites
throughout the US and Europe.
- New data from the two-year open-label
STEPS 2 extension study have been submitted to the US Food and Drug
Administration (FDA) and the European Medicines Agency (EMA) for
inclusion in the US and EU prescribing information. The results
from STEPS 2 show that long-term treatment with 30 months of
Gattex/Revestive resulted in clinically meaningful reductions in
parenteral support dependence with a significant percentage of
patients achieving complete independence.
Natpara® (recombinant human parathyroid hormone [1-84] or rhPTH
1-84) in Hypoparathyroidism
- The company’s Biologics License
Application (BLA) for its second product, Natpara in
Hypoparathyroidism, has been accepted by the FDA with a
Prescription Drug User Fee Act (PDUFA) goal date of October 24,
2014. Within the company’s Filing Review Notification, also
referred to as the Day-74 letter, the FDA also informed the company
it is currently planning to hold an advisory committee meeting to
discuss the Natpara BLA.
- NPS expects to submit its Marketing
Authorization Application to the EMA for Natpara in
Hypoparathyroidism this year. The European Commission recently
granted orphan drug designation to Natpara for the treatment of
Hypoparathyroidism. This designation provides marketing exclusivity
in the EU for 10 years after approval.
Product pipeline
- NPS remains on track to initiate a
Phase 2a proof-of-concept study in mid-2014 for NPSP795, a
calcilytic compound with potential application in Autosomal
Dominant Hypocalcemia or ADH, an ultra-rare disorder caused by a
gain-of-function mutation in the calcium-sensing receptor
gene.
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:
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
December 31,
2013
December 31,
2012
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:
- Net Gattex/Revestive sales of between
$110 and $120 million, representing more than 250% growth in the
company’s SBS franchise.
- Operating expenses, excluding cost of
sales and share-based compensation expense, of between $180 and
$200 million. The anticipated increase in 2014 operating expenses
is primarily related to the following investments that NPS is
making to drive continued long-term, global growth:
- The build-out of the company's
infrastructure and core competencies to support the continued
growth of NPS as a global organization.
- The production of pre-launch Natpara
inventory and the establishment of secondary supply-chain
sources.
- The pre-launch initiatives and the
event-driven ramp up of the US commercial infrastructure to support
the successful commercialization of Natpara. Key pre-launch
activities include generating awareness on the burden of
hypoparathyroidism, creating an unbranded platform, deploying a
pre-launch field-based team, and identifying patients.
- The execution of clinical activities
supporting the global development of Gattex/Revestive in pediatric
SBS and NPSP795 in ADH.
- Regulatory activities, including
preparations for an FDA Advisory Committee meeting and key
international regulatory submissions for Natpara in
hypoparathyroidism.
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)
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:
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)
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
NPS Pharmaceuticals, Inc.Susan M. Mesco,
908-450-5516smesco@npsp.com
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