NPS Pharmaceuticals, Inc.
Q2 2010 Earnings Conference Call
August 4, 2010 17:00 E.T
Francois Nader – President and Chief Executive Officer
Luke Beshar – Senior Vice President and Chief Financial Officer
Susan Mesco – Investor Relations.
Ryan Martins - Barclays Capital
Ann Paul – Citigroup
John Stevenson – Summer Street Research
Leah Hartman – CRT Capital Group
Alan Carr – Needham & Company
Previous Statements by NPSP
» NPS Pharmaceuticals, Inc. Q1 2010 Earnings Call Transcript
» NPS Pharmaceuticals Inc. Q4 2008 Earnings Call Transcript
» NPS Pharmaceuticals, Inc. Q2 2008 Earnings Call Transcript
Good day ladies and gentlemen and welcome to the second quarter 2010 NPS Pharmaceuticals earnings conference call. My name is [Tekia] and I will be your operator for today. At this time, all participants are in a listen-only mode. Later we will conduct a question and answer session. (Operator instructions). As a reminder, this call is being recorded for replay purposes.
I would now like to turn the conference over to Miss. Susan Mesco, director of Investor Relations and Corporate Communications. You may proceed.
Thank you [Tekia] and welcome to today’s conference call to discuss our financial results for the second quarter of 2010. Before we start, let me remind you that today’s call will include forward-looking statements based on current expectations. Such statements represent our judgment as of today and may involve risks and uncertainties. Please refer to our filings with the SEC, which are available from the SEC or our Website for information concerning the risk factors that could affect the company.
Joining me on today’s call are members of our management team, including our President and Chief Executive Officer, Dr. Francois Nader; and our Chief Financial Officer, Luke Beshar. To begin, it is now my pleasure to turn the call over to our Chief Executive Officer, Dr. Nader.
Good afternoon and thank you for joining our second quarter conference call. I’m happy to report that 2010 has been a year of solid execution. Earlier this year we brought in over $90 million of new capital through two very successful transactions. In addition, we recently achieved a key milestone for GATTEX in short bowel syndrome with the completion of patient randomization in STEPS which puts us on track to report top line results early next year.
With two Phase 3 registration programs advancing on our stated timeline, we have delivered on our commitment and we are very well positioned to continue to achieve additional milestones in the months ahead. Turning now to GATTEX as a reminder, STEPS was designed to confirm previously stated findings that GATTEX safely reduces chronic parenteral nutrition dependence of short bowel syndrome patients.
The primary endpoint of STEPS is a 20% or greater reduction in parenteral nutrition requirement at week 20 maintained through week 24. As you recall, the STEPS study design calls for patients to be enrolled and undergo an optimization and stabilization period of up to 16 weeks before being randomized to either GATTEX or Placebo.
Through collaborative efforts between our clinical research team and the investigators, the optimization and stabilization process went better than we originally anticipated specifically with respect to the percentage of patients successfully moving to randomization. We thought a free randomization drop out rate of roughly 27% which is a significant improvement over the 4o% free randomization drop out rate that we saw in our first Phase 3 study. We also adopted a prudent approach and continued enrolling stations in STEPS until the 86
patient was randomized. Once this number was reached we closed enrollment and the additional patients who will complete the optimization and stabilization phase will go directly into our two year open day long continuation study STEP two.
We are very pleased that interest in the continuation study remains high. All of the access STEPS sites are now participating and well over 90% of patients who have completed 24 weeks of therapy in STEPS have elected to roll over into STEP 2. In our clinical studies, we are ramping up a number of activities to support a 2011 FDA regulatory submission for GATTEX in short bowel syndrome.
Manufacturing and CNC related initiatives remain a key focus, including the production of validation and commercial scale batches. The commercialization activities for GATTEX are also progressing as per plan. A key objective of commercializing us is gaining an in depth understanding about potential subscribers
and influences. We are therefore focusing our efforts on physician segmentation, referral patterns and treatment objectives.
We are continuing to broaden our understanding of the impact of short valve syndrome on patients’ medical care and quality of life, with our market research results reinforcing the need for new, safe and effective treatment options and improved patient outcome.
Now I would like to turn to our second Phase 3 registration program, NPSP558 in hypoparathyroidism. As many of you know, NPSP558 is our full length recombinant parathyroid hormone 1-84 that we are developing as a hormone replacement therapy for patients with hypoparathyroidism. As a reminder, hypoparathyroidism is an orphan indication characterized by low serum calcium or hypocalcaemia that can lead to neuromuscular symptoms and bone impairment, as well as to serious complications like brittle bones, tetany, seizures or psychosis.
Since there is no approved treatment for hypoparathyroidism, the condition is currently managed palliatively with high doses of calcium and Vitamin D analog supplements. Over the long term though, calcium supplementation can lead to organ calcification and kidney failure. Therefore the primary endpoint of our registration study is maintaining normal calcaemia while reducing calcium and Vitamin D analog supplementation by at least 50%.
We have now achieved approximately 70% of our enrollment target in our 24 week Phase 3 registration study which is known as REPLACE. We remain on track for full enrollment later this year and top line data in 2011. If approved, NPSP558 would be the first hormone replacement therapy to treat the underlying cause of hypoparathyroidism.