NPSP Pharmaceuticals CEO Discusses Q3 2010 - Earnings Call Transcript
NPSP Pharmaceuticals, Inc. (
)
Q3 2010 Earnings Call
November 2, 2010 08:30 am ET
Executives
Francois Nader – President and Chief Executive Officer
Luke Beshar – Senior Vice President and Chief Financial Officer
Susan Mesco – Investor Relations
Analysts
George Former – Canaccord
John Stevenson – Summer Street Research
Marco Kozul – Thinkequity
Leah Hartman - CRT Capital
Ryan Martin – Barkley’s Capital
Lucy Lung – Citi
Alan Carr – Needham & Company
Presentation
Operator
Compare to:
Previous Statements by NPSP
»
NPS Pharmaceuticals, Inc. Q2 2010 Earnings Conference Call Transcript
»
NPS Pharmaceuticals, Inc. Q1 2010 Earnings Call Transcript
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NPS Pharmaceuticals Inc. Q4 2008 Earnings Call Transcript
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NPS Pharmaceuticals, Inc. Q2 2008 Earnings Call Transcript
Good day, ladies and gentlemen, and welcome to third quarter 2010 NPS Pharmaceuticals earnings conference call. My name is Modesta, and I will be your operator for today. At this time, all participants are in a listen-only mode. (Operator instructions)
I would now like to turn the call over to your host for today, Ms. Susan Mesco, Senior Director of Investor Relations. Please proceed.
Susan Mesco
Thank you, and welcome to today’s our third quarter conference call. 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 and Roger J. Garceau, Chief Medical Officer. In addition, we also have Dr. John Bilezikian, our primary investigator in the US for our phase III REPLACE study joining us today to share his insights on hypoparathyroidism. To begin, it is now my pleasure to turn the call over to our Chief Executive Officer, Dr. Francois Nader.
Francois Nader
Good morning, and thank you for joining our third quarter conference call. Before I begin, I’d like to welcome Dr. Bilezikian on today’s call. As many of you know, Dr. Bilezikian is a recognized expert in hypoparathyroidism. He’s also the Chief of the Division of Endocrinology, Director of the Metabolic Bone Disease Unit, and Professor of Medicine and Pharmacology at Columbia University’s College of Physicians and Surgeons. As our lead investigator in the US for NPSP 558 REPLACE study, we are happy to have Dr. Bilezikian join us on today’s call.
To begin our business update, I’m happy to report that 2010 continues to be marked by strong execution. Our two Phase 3 programs are progressing as planned, with a number of key milestones on the near term horizon, including top line results from our step study of GATTEX in short bowel syndrome, and the randomization of the last patient in our REPLACE study of NPSP558 in hypoparathyroidism.
We also further strengthened our cash position with another very successful financing transaction that brought in more than $44 million. We ended the quarter with $154 million in cash, leaving us well equipped to advance our pipeline.
Turning now to GATTEX, as a reminder, STEPS is our Phase 3 registration study that was designed to confirm previous findings, that GATTEX safely reduces paranteral nutrition requirements of short-bowel syndrome patients. I’m pleased to report that STEPS is on track for last patient, last visit very early next year, and top line results as soon as possible thereafter.
We continue to experience a high level of interest in STEPS 2, our two year continuation study that is open to patients who have participated in STEPS. As of today, of the 54 patients who have completed the 24 weeks of dosing in STEPS, 52 patients have elected to roll over into STEPS 2. In addition, 10 patients went directly into STEPS 2 after completing the optimization and stabilization phase of STEPS. As you may recall, we continued to enroll patients into STEPS until 86 patients were randomized.
Recent market research underscored the favorable market dynamics for short bowel syndrome. We completed a survey of more than 450 US Gastroenterologists and gastrointestinal surgeons, that indicated the leading etiology of short bowel syndrome was Crohn’s Disease, accounting for 35% of the cases, followed by ischemia, at 28%, cancer at 20%, trauma at 9%, bariatric surgery at 8%, and all other accounting for the remaining 8% of the cases.
Over 80% of the physicians surveyed believe there are unmet needs in the treatment of short bowel syndrome. The highest scored unmet need were improving absorption capacity and reducing parenteral nutrition complications. In addition, more than 70% of physicians surveyed confirmed that weaning patients from parenteral nutrition is an important treatment goal.
When presented with the GATTEX profile, 75% of the physicians surveyed indicated they will be early adopters of GATTEX. In the coming months, we will continue to broaden our understanding of prescribers and influencers of the short bowel syndrome market, and we will finalize our commercialization plans. Before turning to NPSP558, I would like to invite Dr. Bilezikian to give us an overview of hypoparathyroidism. Dr. Bilezikian?
Dr. John
Bilezikian
Francois, thank you very much. I appreciate the invitation to join this conference call. As you indicated in your introduction, I have been involved in this study we are going to talk about, REPLACE. Anti-dating the REPLACE study, my group has been interested and committed to the problems of parathyroid hormones in human subjects for about 35 years. Our interest in a disease, hyperparathyroidism is well recognized, and over the past five to ten years, we have turned our attention to the disease of the moment, namely hypoparathyroidism.
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