In a release on
"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
Gattex 2013 launch highlights
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
-NPS is implementing its clinical and regulatory strategy for
-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
-New data from the two-year open-label STEPS 2 extension study have been submitted to the
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
-NPS expects to submit its Marketing Authorization Application to the EMA for Natpara in Hypoparathyroidism this year.
-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.
Net income (loss)
NPS reported net income of
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
Royalty revenues were
The company's fourth quarter 2013 Sensipar/Mimpara royalties included a non-recurring favorable adjustment from
Research and development
Research and development expenses were
Selling, general and administrative
Selling, general and administrative expenses were
Cash and investments
The company's cash, cash equivalents, and marketable investment securities were approximately
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.
2014 Financial guidance
NPS expects to achieve the following financial objectives in 2014:
-Net Gattex/Revestive sales of between
-Operating expenses, excluding cost of sales and share-based compensation expense, of between
-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
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In a release on