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Avanir Pharmaceuticals, Inc (AVNR)

Q3 2011 Earnings Call

August 8, 2011 4:30 p.m. ET


Keith Katkin – President and CEO

Christine Ocampo – VP, Finance

William Sibold – SVP, Chief Commercial Officer

Randall Kaye – SVP, Clinical Research and Medical Affairs, Chief Medical Officer


Ritu Baral – Canaccord Genuity

Thomas Wei – Jeffries

Carol Werther – Summer Street Research Partners


[Abrupt Start]in this area of high unmet medical need.

In addition, we're pleased to recently report on the positive progress we have made on the European Regulatory Filing for NUEDEXTA, which Randall will comment on later during this call.

On the corporate front, I'm pleased to report that the senate special sub committee on aging held a hearing on July 21st, neither Avanir nor NUEDEXTA were mentioned during the hearing and since that issued a briefing letter summarizing with conclusion of their review on the pricing of NUEDEXTA.

Additionally, on the corporate front, we've been building out a world class management team and one of the last building blocks is ahead of research and development. I'm delighted that doctor Joao Siffert has agreed to join the Avanir team. Has experienced across the number of CNS indications will help firmly put us on a path to building out not only the NUEDEXTA franchise, but also help with a new assets to the organization.

Looking forward, we plan to build on our track record of success and leverage our clinical and commercial expertise to continue to deliver shareholder value. Our business development team will be focusing on identifying strategic CNS assets that along with NUEDEXTA can enable us to build the portfolio of innovative products that will enable us to achieve our mission of becoming a leading CNS specialty biopharmaceutical company.

With that introduction, I will now ask Bill to say few words on the commercial activities, Bill?

William Sibold

Thanks Keith and good afternoon everyone. NUEDEXTA the first and only FDA approved treatment for pseudobulbar affect has now been on the market for approximately six months.

During this initial launch phase, we believe we have established the foundation for future growth of the product through the remainder of this year and beyond. Our commercial team is focused on the three main strategic imperative, increasing awareness of PBA and NUEDEXTA, growing prescription numbers, and ensuring access to NUEDEXTA. Our first priority is ensuring that physicians and patients are aware of both PBA and NUEDEXTA, until we launch NUEDEXTA in February, PBA was a widely unrecognized condition.

Thus far, for our pharma guidelines, we have focused our initial efforts on physicians and other healthcare providers and have initiated PBA disease awareness programs with the advocacy groups involved with patients with the underlying neurologic condition associated with PBA.

During the remainder of this calendar year, we will be increasing our patient and caregiver education efforts including rolling out a NUEDEXTA branded advertising campaign, through these programs, we hope to drive patients where appropriate to inquire about treatment of their PBA with NUEDEXTA.

Another high priority is growing NUEDEXTA prescriptions, our sales force is targeting the highest potential neurologist and psychiatrist. During the current quarter, over 23,000 practice calls have been made with our sales reps on average calling on over five practices a day.

Our data clearly demonstrates the impact of field sales force interactions on prescribing behavior. In fact, our data shows that the doctors that have been called on 12 times or more since launch, are three times more likely to write their first prescription for NUEDEXTA then doctors called on six times since launch and as important, these doctors write eight times as many prescriptions for NUEDEXTA.

These data support the increased long-term uptake of NUEDEXTA, as we continue with our launch efforts and get increased accumulative exposure to doctors.

This is further supported by a recently completed survey of doctors were over 80% of respondents said they intend to increase their prescribing of NUEDEXTA in the future.

I'm encouraged by this progress as it affirms our belief that educating physicians takes time and effort, but our promotional activity is having an affect.

We are also piloting a number of initiative to explore how best to prioritize and operationalize against the many significant NUEDEXTA opportunities in various settings of care such as ALS Clinics and long-term care facilities as well as the coverage of less densely populated geographies without a local avenue or sales representative.

For these uncovered geographies, we have been utilizing technology and home office located representatives to officially expand our reach and generate incremental sales.

The third priority area involves ensuring that patients have broad access to NUEDEXTA. Our managed market account team has been meeting with and educating the various payer organizations, recent successes include Blue Shield of California and Health Net who both added NUEDEXTA to their preferred formularies for both the commercial and Medicare Part D books of business, these additions represent approximately 4 million lives with unrestricted access to NUEDEXTA, extending our tier 2 unrestricted coverage for more than 70 million US patients.

We are optimistic that several of the largest Medicare plans currently requiring a letter of medical necessity to cover NUEDEXTA, will choose to cover NUEDEXTA more broadly in 2012 when the new benefit year begins.

Negotiations continue with all large Medicare D plans and are progressing as expected. Looking at prescription trends in numbers, in April a total of 1,140 prescriptions were written of which 826 were new prescriptions. In May a total 1,850 prescriptions were written of which 1,247 were new prescriptions and for June a total of 2,146 prescriptions were written of which 1,328 were new prescriptions.

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