Santarus CEO Discusses Q3 2010 Results – Earnings Call Transcript
Santarus, Inc. (
)
Q3 2010 Earnings Conference Call
November 8, 2010 4:30 PM ET
Executives
Martha Hough – VP, Finance and IR
Gerry Proehl – President and CEO
Bill Denby – SVP, Commercial Operations
Debbie Crawford – SVP, CFO, Treasurer and Secretary
David Ballard – SVP, Clinical Research and Medical Affairs
Analysts
Scott Henry – ROTH Capital Partners
Ian Sanderson – Cowen and Company
Michael Dinerman – Piper Jaffray
Jelena Ofengein – Stifel Nicolaus & Co.
Presentation
Operator
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Santarus Inc. Q3 2009 Earnings Call Transcript
Welcome to the Santarus Third Quarter 2010 Financial Results Conference Call. (Operator Instructions)
I would now like to turn the conference over to Martha Hough. Please go ahead, ma’am.
Martha Hough
Thank you, Carey. Good afternoon and welcome to today’s call. This is Martha Hough, Vice President of Finance and Investor Relations. Joining me on the call today are Gerry Proehl, President and Chief Executive Officer; Dr. David Ballard, Senior Vice President, Clinical Research and Medical Affairs; Bill Denby, Senior Vice President, Commercial Operations, and Debbie Crawford, Senior Vice President, Chief Financial Officer, Treasurer and Secretary; and will also join us for today’s question-and-answer session.
Earlier today Santarus issued two press releases. The first announced top-line data from our European clinical data with Budesonide MMX and the second announced our third quarter 2010 financial results. If you have not received a copy of these news releases, you can access it on our website at www.santarus.com. A replay of this call also will be available on our website and can be found in the Investor Relations section for the next two weeks.
For today’s call, please keep in mind that risks and uncertainties involved in the company’s business may affect the matters referred to in forward-looking statements made by management during today’s call. As a result, the company’s performance may differ from those expressed in or indicated by such forward-looking statements, which are qualified in their entirety by the cautionary statements contained in the press release and the company’s Securities and Exchange Commission filings.
The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast on August 2, 2010. Santarus undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.
I’ll now turn the call over to Gerry Proehl. Gerry?
Gerry Proehl
Thank you, Martha, and welcome to this afternoon’s call. We are pleased to report that earlier today; we announced positive top-line result from the Budesonide MMX, which was conducted in Europe. In both the U.S. and E.U. Phase III studies, Budesonide MMX 9 milligram achieved statistically significant results for the induction of remission of mild or moderate active ulcerative colitis compared to placebo.
Our next step is to complete the extended use study in second quarter 2011 and then move forward with the submission of an NDA for Budesonide MMX in the second half of 2011. The successful completion of these two Phase III studies is a significant accomplishment for Santarus and Cosmo and I’d like to thank all the colleagues and both companies who contributed to these positive pivotal studies.
We’ve been working hard on all fronts of Santarus over the last few months. Since our last quarterly call, we’ve completed three transaction that support our strategic objective of creating shareholder value by adding an approved product to drive near-term revenue and two development stage products with potential for future revenue growth. We believe these transactions will have a positive impact by leveraging our sales organization and broadening our development pipeline.
We are very busy with the pre-launch activity to prepare for launch in CYCLOSET, a first in class in therapy for type 2 diabetes. CYCLOSET is approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes and it’s the first and only centrally acting dopamine agonist oral anti-diabetic drug approved for the treatment of type 2 diabetes.
We have exclusive U.S. license and distribution rights to CYCLOSET. We believe this product is an excellent fit with our commercial activities for GLUMETZA, which is also indicated for the treatment of patients with type 2 diabetes. We’ve moved very quickly to ramp up manufacturing and to train our sales organization to promote the product. In a few minutes, Bill Denby will discuss our planned promotional messaging and launch activities.
We also have added two promising novel biologic drug candidates to our development pipeline. We believe these drugs offer substantial medium to long-term revenue potential in especially markets that are readily addressable by a small sales organization.
First from Pharming, we obtained North American rights to RHUCIN, which is recombinant human C1 inhibitor that acts to regulate important aspects of human immune response. RHUCIN is an intravenous drug and late stage clinical development in the U.S. for acute attacks of Hereditary Angioedema or HAE, which is cost by C1 inhibitor deficiency.
In two randomized placebo-controlled double-blind studies conducted by Pharming, RHUCIN demonstrated statistically significant and clinically relevant improvement in the primary end point of time, the beginning of relief of symptoms at two dosage strengths.
Pharming recently received European marketing authorization for RUCONEST, RHUCIN’s trade name in Europe for the treatment of acute HAE. RUCONEST has been granted orphan drug and fast track by the FDA for the acute HAE indication. HAE is a serious disease that is characterized by acute attacks of painful and in some cases fatal slowing of soft tissues.
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