Supernus Pharmaceuticals, Inc. (SUPN)

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Supernus Pharmaceuticals, Inc. (SUPN)

Q4 2012 Earnings Call

March 14, 2013, 05:00 pm ET


Jack Khattar - President & CEO

Greg Patrick - CFO


Corey Davis - Jefferies

Ken Cacciatore - Cowen & Company

David Amsellem - Piper Jaffray

Annabel Samimy - Stifel Nicolaus

Jonathan Eckard - Citi



Good afternoon and welcome to the Supernus’ Fourth Quarter and Fiscal Year 2012 Financial Results Conference Call. Please note this event is being recorded.

Before we get started, I would like to remind you that matters discussed on this call contain forward-looking statements that involve risks and uncertainties, including, but not limited to those relating to the commercial efforts related to Oxtellar XR and Trokendi XR. Actual results may differ materially from the results predicted and recorded results should not be considered an indication of future performance.

These and other risk factors are more fully discussed in our annual report on Form 10-K that we expect to file with the SEC by the end of this week and it will be most particularly dealt with under the caption Risk Factors. Supernus disclaims any obligation to update or revise any forward-looking statements made on this call as a result of new information or future developments.

As a reminder, Supernus’ policy is to only provide financial guidance and guidance on corporate goals for the current fiscal year and to provide update or reconfirm its guidance only by issuing press release or filing updated guidance with the SEC in a publicly accessible document. Reference to current cash, cash equivalents and investments are based upon balances as of December 31, 2012. All other guidance including guidance relating to the company's expenses, year-end cash and corporate goals is as of today, March, 14, 2013.

With that, I will hand it over Jack Khattar, President and CEO of Supernus.

Jack Khattar

Thank you. Good afternoon and welcome to our fourth quarter and year-end 2012 financial results and business update conference call. With me today on the call is Greg Patrick, Vice President and Chief Financial Officer of Supernus.

2012 was a very a successful year for Supernus and we are off to a great start in 2013. I would like to summarize the operational and financial accomplishments of 2012 and provide an update on our Oxtellar XR product launch, Trokendi XR in our pipeline. We are very proud of our accomplishments in 2012 and I'll give you some of the highlights.

We transitioned from a development stage private company to a publicly traded commercial pharmaceutical company. Our initial public offering raised gross proceeds totaling $52 million and the follow-on public offering raised an additional $48 million. We built our commercial organization including an experienced sales and marketing team in preparation for the launch of our lead epilepsy product Oxtellar XR, extended-release oxcarbazepine, which was approved by the FDA in October and for which we received confirmation from the FDA that it has been granted three years marketing exclusivity.

In addition, we received tentative approval in June for Trokendi XR, extended-release topiramate and later in October announced that the USPTO issued two patents covering the product. Finally, in 2012 we continued to develop our pipeline through the successful completion of a Phase IIb trial with positive topline results of SPN-810, our novel treatment for impulsive aggression in ADHD patients.

While 2012 was a remarkable and exciting year for us with so many critical accomplishments, we are even more excited about 2013 which started with the launch of our first product Oxtellar XR. While this launch is still in its very early stages, I'll try to shed some light on some early indicators. As you know, Oxtellar XR is a novel once daily extended-release oxcarbazepine. It is an anti-epileptic drug approved as adjunctive therapy in partial seizures in adults and children six to 17 years old. In early 2013, we hired approximately 75 sales representatives and started promoting Oxtellar XR in February.

Starting with distribution, we are very pleased to tell you that all major wholesalers and several regional wholesalers have stocked the product. We also have a pharmacy assistant service that assist our patients in finding a local pharmacy that can quickly order the product and fill their prescription.

Regarding managed care, we have exceeded our expectations with more than 120 million commercial lives already covered. As we expected, coverages with a Tier-3 unrestricted status. In addition to that, we now have 7 million Medicaid lives also covered with no prior authorization or with other authorization. We expect more lives to be added on a state-by-state basis as the various states go through their approval process.

For your reference, anti-epileptic drugs are a protected class where coverage by Medicaid is mandatory and Medicaid represents about 27% of the oxcarbazepine prescriptions in the U.S. So overall, we're very pleased with the managed care situation and we have not encountered any unexpected issues.

Regarding our sales efforts in the field, our sales force is targeting the top six deciles of high prescribing physicians. Initial feedback from the field and I emphasize, initial, given how early in the launch cycle we are has been very encouraging. Our representatives are able to access our target physician audience and are getting sufficient time with them. The message we are delivering in the physician’s office about the benefits of Oxtellar XR seems to resonate well with physicians who are familiar with and are current prescribers of immediate release of oxcarbazepine. In addition, we have started to hear from the field of our positive experiences by patients with Oxtellar XR that are being reported by physicians.

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