Avanir Pharmaceuticals' CEO Discusses F2Q13 Results - Earnings Call Transcript

| About: Avanir Pharmaceuticals, (AVNR)

Avanir Pharmaceuticals, Inc. (NASDAQ:AVNR)

F2Q13 Earnings Call

May 8, 2013 4:30 PM ET

Executives

Ian Clements – Head, IR

Keith Katkin – President and CEO

Christine Ocampo – VP, Finance

Rohan Palekar – EVP and Chief Commercial Officer

Joao Siffert – Chief Scientific Officer

Analysts

Christopher Marai – Wedbush

Ritu Baral – Canaccord

Carol Werther – Summer Street

Operator

Good day, ladies and gentlemen and welcome to the Avanir Pharmaceuticals’ Fiscal 2013 Second Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will facilitate a question-and-answer session. (Operator Instructions) As a reminder, this conference is being recorded for replay purposes.

I would now like to turn the call over to your host, Dr. Ian Clements, Head of Investor Relations. Please go ahead.

Ian Clements

Thanks, Francis, and good afternoon everybody. I’d like to welcome you to our conference call to discuss our financial and operating results for the fiscal 2013 second quarter.

To discuss these results, commercial and clinical initiatives, I am joined today by several members of our leadership team. Our President and CEO, Keith Katkin will lead the call today by providing a brief strategic overview of our business. After Keith, our Vice President of Finance, Christine Ocampo will review our quarterly results. Our Chief Commercial Officer, Rohan Palekar will highlight NUEDEXTA performance followed by Dr. Joao Siffert, Chief Scientific Officer who will provide the pipeline update. For the Q&A portion of today’s call, we will also be joined by Dr. Randall Kaye, Chief Medical Officer; and Greg Flesher, our Chief Business Officer.

During the course of this conference call, we will be making certain forward-looking statements. These statements are subject to numerous risks and uncertainties and reflect our current expectations and judgments. Examples of these forward-looking statements includes statements relating to our expectations for NUEDEXTA sales and revenue growth including market opportunity, future expense levels, the timing and success of future development of AVP-923 for other indications, the potential approval of NUEDEXTA in new markets, and the timing and success of the development of AVP-786. Actual results could vary materially from the results anticipated by these statements. Investors should read the risk factors set forth in Avanir’s Form 10-K for the year ended September 30, 2012 and periodic reports filed with the Securities and Exchange Commission.

With that said, I will turn the call over to Keith Katkin. Keith?

Keith Katkin

Thanks Ian, and my thanks to each of you for joining us on our call today. We are building a leading mid-cap biopharmaceutical business designed to provide innovative new therapies to patients with high unmet needs. During the past few months, we have made significant progress towards this goal. First, our growing NUEDEXTA PBA franchise in the United States, the number of PBA patients benefiting from NUEDEXTA has steadily grown each month. We continue to see strength in our PBA franchise and deliver record prescriptions, the most recent of which annualized nearly $90 million in gross sales. Second, our pipeline, from a clinical perspective, we continue to make progress in our Phase 2 trials exploring the therapeutic benefit of AVP-923 in Alzheimer’s disease, central neuropathic pain and Parkinson’s disease. Third, from a regulatory perspective, the positive opinion from CHMP and recommendation for a broad PBA level for NUEDEXTA with a key step in the regulatory process toward having the first and only evidence-based treatment for PBA approved in the European Union.

Our primary goal as stated previously is to identify a partner that will broadly commercialize in Europe as well as partner with Avanir to help accelerate follow-on indications. I look forward to keeping you apprised of the progress we make. I am very pleased with the excellent progress we have made over the past quarter and the achievements the organization continues to make.

I will now turn the call over to Christine Ocampo to address our financial results. Christine?

Christine Ocampo

Thanks Keith and good afternoon everyone. In addition to the financial results summarized in the press release issued earlier this afternoon, you can find additional information, including full year information in our upcoming Form 10-Q which will be filed by Friday.

We reported total net revenue for the second fiscal quarter of 2013 of $17.4 million as compared to $10 million for the comparable period in fiscal 2012, a year-over-year growth of approximately 74%. For the second fiscal quarter of 2013, we recorded record gross product sales of NUEDEXTA of $20.8 million and record net sales of NUEDEXTA of $16.5 million. During the quarter ended March 31, 2013, our gross to net discount was 20.7% compared to 19% in the prior quarter. The increase in gross to net discount is primarily attributable to a number of new payor contracts as well as the impact of a 3.3% price increase that became effective as of January 9, 2013.

First quarter wholesale inventories as of March 31, 2013 were estimated to be 3 to 4 weeks. Gross margin on the sales of NUEDEXTA for the first fiscal quarter of 2013 was 94.4%. Research and development expenses were $8.9 million for the quarter ended March 31, 2013, compared with $6.4 million for the same period in the prior year. This includes a one-time milestone payment of $2 million to Concert Pharmaceuticals for advancement of AVP-786 which was accrued in the second fiscal quarter. In the second fiscal quarter of 2013 our R&D spend was primarily attributed to costs associated with our multiple ongoing clinical studies, medical affairs and EMA regulatory expenses.

Selling, general and administrative expenses of $23 million for the fiscal second quarter of 2013 increased from $20.2 million for the corresponding period of the prior year. Sales and marketing expenses for the second quarter were $16.1 million as compared to $14.8 million for the corresponding period of the prior year. The increase in the second quarter was due to the cost of the pilot Direct TV advertising campaign, the primary care pilot and the full impact of the Q1 increase in the sales force.

Total operating expenses excluding cost of goods sold for the quarter were $31.9 million compared with $26.6 million for the comparable quarter in fiscal 2012. For the three months ended March 31, 2013 and 2012 the company recorded $1.8 million and $1.2 million respectively of the share-based compensation expense. Cash used in operations for the quarter ended March 31, 2013 was $9.6 million. Our net loss for the second quarter of fiscal 2013 was $16.5 million or $0.12 per share compared with a net loss of $17 million or $0.13 per share for the same quarter in fiscal 2012.

During the recent quarter, we’ve raised net proceeds of $19.1 million under our aftermarket facility thus as of March 31, 2013, Avanir had total cash, cash equivalents and restricted investments of $70.2 million. We’ve decided to use the ATM during the second fiscal quarter as there was significant in-bound interest from long only institutional funds. With these funds our balance sheet is strong and based on current revenue and expense projections, we believe we have sufficient capital to become a profitable PBA company in the U.S.

Turning to operating expense guidance, with the positive CHMP opinion and higher than anticipated Paragraph 4 litigation expenses and additional commercial initiatives, we now expect our operating expenses to be between $105 million and $115 million excluding cost of sales and non-cash expenses such as FAS 123 and depreciation. And with that summary of our financial results I would like to turn the call over to Rohan. Rohan?

Rohan Palekar

Thanks Christine. The NUEDEXTA franchise continues to perform well as measured by increasing prescriptions, growth in the number of physicians writing NUEDEXTA, and the number of nursing homes using NUEDEXTA for their PBA patients. Two years post-launch, we are pleased that we have maintained a solid growth trajectory with consecutive double-digit revenue growth quarter-on-quarter. Both channels of our business, the institutional and retail are showing robust growth. This growth we believe validates our conviction that there is significant market opportunity in PBA. The institutional business grew 4% versus the previous quarter and represents 53% of our revenue, while the retail business that represents the remaining 47% grew 13% versus the previous quarter.

We have seen continued growth in April and pill counts in the past eight weeks include seven of our all-time weekly highs. Indeed the pill counts, for the most recent eight weeks compared to the previous eight weeks, was up 15%. Taking a deeper dive into our business channels, the institutional growth was impacted early in the quarter due to prior authorization renewals typically observed at the start of the year, a system error at a major payor resulting in lost prior authorizations, and therefore prescriptions, change in the size of prescriptions dispensed due to the Affordable Care Act and changes in our field deployment as we expanded the team. We are now past these issues and comparing the most recent eight weeks versus the previous eight weeks, the institutional business grew robustly up 25%. As you may recollect, we expanded our institutional sales force in the first fiscal quarter and are now seeing the benefits of the added reach. This is consistent with our previous experience, where it takes two to three quarters for new sales reps to hit their stride.

The institutional setting represents a large opportunity and we have the potential significant continued growth as our penetration of estimated PBA patient is only approximately 8%. We expect to grow this business by increasing our nursing home coverage, increasing penetrations within the homes we cover, and lastly by gaining key wins with managed care plans. We are especially pleased with the recent growth in our retail business. As we have discussed, this channel in the long run represents the bigger opportunity given the number of potential patients with PBA. We saw growth across all specialties of the retail business, neurology, psychiatry, and primary care. This growth was driven by increased awareness of PBA had NUEDEXTA among physicians, more targeted efforts by the representatives to focus on high volume dementia, stroke, and TBI physicians, and increased awareness of PBA amongst patients and caregivers.

We have recently completed a national TV campaign to educate patients and caregivers about PBA and to encourage them to sign up for information and talk to their doctor. We are extremely pleased with the response we observed. Over the 10-week campaign, we had roughly 300,000 visitors to our website, pbafacts.com, or call the toll free hotline and tens of thousands sign up to receive more information on PBA and NUEDEXTA. These results reinforce our belief that PBA is widely prevalent and often is under-diagnosed. We anticipate in the coming months that many of these people will talk to the doctor and could be placed on NUEDEXTA. We have built a strong foundation for NUEDEXTA with the PBA franchise and are optimistic about the growth we expect to see in the coming months. Further, this foundation will set us up well for the additional program that we expect to launch in the future with NUEDEXTA and AVP-786. To discuss these programs in greater detail, I will turn the call over to Joao. Joao?

Joao Siffert

Thanks Rohan. So, once again, the team has done an outstanding job in moving multiple clinical programs forward and reaching important regulatory milestones in the last quarter. First, regarding the status of our marketing authorization for NUEDEXTA in Europe, as reported in late April, we received a positive CHMP opinion for approval of NUEDEXTA in Europe. This positive opinion from the CHMP and recommendation for a broad PBA label for NUEDEXTA is the key in the regulatory process toward having the first and only evidence-based treatment for PBA approved in the European Union. We will continue to work with the European Medicines Agency and the European Commission towards the marketing authorization, so the patients suffering from PBA have ready access to NUEDEXTA in Europe. We anticipate an approval from the European Commission of approximately three months. Second, with respect to progress in our pipeline, recently we had a pre-IND meeting with a neurology division of the FDA to discuss the development path for AVP-786. We had a productive discussion with the FDA and we’ll update you once we have received the official minutes of the meeting.

Turning to the PRIME study, which is assessing the safety and benefit of AVP-923 in central neuropathic pain associated with multiple sclerosis. It is nearing the enrollment target of 200 patients. The top line results are expected in the fourth calendar quarter of 2013. As a reminder, the PRIME efficacy measure is the standard Likert scale for measuring pain from 0 to 10. And we are also assessing a number of interesting secondary endpoints, including spasticity, cognition, and others.

Our ongoing study assessing AVP-923 for the treatment of agitation in patients with Alzheimer’s disease is also well underway with approximately 35 actively enrolling patients. Interest in this study remains high and the study conduct has continued to progress smoothly. We expect top line data in the first half of 2014. The third Phase 2 study to assess AVP-923 in treating levodopa-induced dyskinesia in patients with Parkinson’s disease will begin enrollment in the coming months, first in Canada and then the U.S.

I’ll now turn back over to Keith for some closing statements. Keith?

Keith Katkin

Thanks, Joao. The achievements made in the last three months by the team have been quite remarkable. It’s a testament to having a dedicated team, one that is focused on the success of the company. I firmly believe that the hard work and perseverance coupled with high-quality are now bearing fruit for the company as we enter the next stage toward becoming a mid-cap biopharmaceutical company. With the robust and growing commercial franchise, the positive opinion from the CHMP and a broad CNS pipeline, we are well-positioned to achieve this goal.

So, looking ahead to the next few months, we will have continued growth in our NUEDEXTA business. We will enroll the first patient into the Phase 2 study of levodopa induced dyskinesia in Parkinson’s disease. We will complete enrollment in our Phase 2 trial studying AVP-923 for central naturopathic pain in multiple sclerosis and we anticipate receiving EU approval from the European Commission. As we entered the fall of 2013, we’ll bring to a conclusion our litigation with the ANDA filers, and we’ll have top line data from the PRIME Phase 2 study. And finally in the first half of calendar 2014, we will be getting ready to share a top line data from our two Phase 2 studies, the agitation in Alzheimer’s disease study and the levodopa-induced dyskinesia in Parkinson’s disease study.

In closing, Avanir is well on its way to becoming a leading mid-cap specialty biopharmaceutical company. We have a rare combination of an FDA-approved product and that provides significant benefits for patients with PBA that is generating meaningful cash flows and significant number of additional development opportunities, and a commercial R&D infrastructure that allows us to capitalize on all of these opportunities.

With that, I’d now like to open the call up for questions. Operator?

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) Your first question is from the line of Christopher Marai from Wedbush. You may proceed.

Christopher Marai – Wedbush

Hi, good afternoon. Thanks for taking my question. I was wondering if you could comment a little bit here on the NUEDEXTA franchise profitability. I recall last quarter that reached cash flow breakeven or just wondering where profitability is there on the franchise. And then further if you could comment a little bit about when you expect Avanir company as a whole to be profitable?

Keith Katkin

Sure. I’ll comment on Avanir as a whole and then I will turn it over to Rohan to talk about the NUEDEXTA franchise. So, first looking at the Avanir as a whole and our march towards profitability, I am really excited about the position we are in right now. When you look at our cash balance of approximately $70 million and you combine that with our revenue and expense projections, when we look at Avanir as a NUEDEXTA company in PBA in the U.S., we believe that we have sufficient cash in order to become profitable. As we look forward to all of the other potential indications for NUEDEXTA and AVP-786, if we have success with those programs, so success in agitation, success in neuropathic pain, or success in Parkinson’s induced or levodopa-induced Parkinson’s dyskinesia. Certainly, that would cause us to reassess our capital needs. However, we will be doing that on the back of success and likely have a number of different financing alternatives with that positive data in hand. And let me turn over to Rohan to talk a little bit about the franchise profitability right now.

Rohan Palekar

So, the NUEDEXTA franchise in the last quarter was very close to being profitable, and this quarter as Christine mentioned we had a couple of one-time expense items, including two of the pilot programs we ran for the DRTV campaign and the primary care pilot. As those one-time expenses move off, clearly this franchise is profitable and we anticipate growing that profitability over the upcoming quarters.

Christopher Marai – Wedbush

Great, thanks very helpful. Congratulations on a great quarter.

Keith Katkin

Thanks.

Operator

Your next question comes from the line of Ritu Baral from Canaccord. You may proceed.

Ritu Baral – Canaccord

Hi, guys. Thanks for taking the question. Can you address who you are or the structure of your ideal European partnership because I understand correctly that ideally it would cover additional indications and potentially even 786?

Keith Katkin

Yeah, no I think your understanding is correct. We are really looking for a partner that has – that really has a two different components. First is obviously the ability and a track record of success commercializing products I hope in the European Union, but I would say equally as important we are looking for someone that has the shared vision for NUEDEXTA and potentially 786 and really sees all of the potential indications for those products and as willing to really participate in not only the commercialization within Europe, but also participate in the clinical development programs for NUEDEXTA and 786, because we believe there is obviously a significant potential in those programs and that’s a key aspect to the companies that we are looking at.

Ritu Baral – Canaccord

And at this point have you ruled out any European commercial presence in Europe for Avanir?

Keith Katkin

No, given the obviously the recommendation for approval from the CHMP has come very recently. We have had a lot of inbound activity and a lot of interest. So, certainly we haven’t ruled anyone out at this point in time given how recent the news is?

Ritu Baral – Canaccord

I mean, have you guys ruled out yourself having any part of the commercial presence sort of heat on the ground over there?

Keith Katkin

Got it. No, certainly we haven’t ruled that out as we believe that the value of NUEDEXTA and PBA is extraordinarily high and also the value of all of the potential future indications for NUEDEXTA and 786 is extremely high. We would be remiss if we weren’t preparing ourselves also for the possibility that we may not be able to get economic terms that we think makes sense to do a partnership. So, certainly, we are talking steps to do, look at reimbursement pricing, and exactly what it would take to commercialize NUEDEXTA ourselves within Europe.

Ritu Baral – Canaccord

Got it. And just following up on 786, I know you are waiting for the meeting minutes to give us color, but could you let us know sort of the topics covered during the pre-IND meeting with FDA, was it PKPD, was it safety?

Keith Katkin

It was a pre-IND meeting. So, you can imagine that covered everything that would be appropriate to cover in a pre-IND meeting, but obviously we chose our works pretty carefully in terms of the prepared comments, and we’ll go into more detail as to what happened at the meeting in the outcome when we received the minutes, and we do plan on putting out a press release once we receive the minutes from the FDA.

Ritu Baral – Canaccord

Got it. And last question I’ll hop back in the queue. The two pilot sales initiatives mentioned the DTC and the other one which escapes me right now, what were your main take away as to the success of those pilot programs and is it something that you guys plan on expanding going forward is part of the commercial plan.

Rohan Palekar

Ritu, this is Rohan. So the primary care pilot is still ongoing so this was the pilot where in certain markets guided additional representatives to call on internal medicine physician. So that one just kicked off early this quarter it’s a much longer pilot and we will really be looking at whether we can change the sales trends in that specialty. The other pilot, which I discuss the results of which was the DRTV or the Direct Response TV pilot the preliminary results are very encouraging and we are now in the process of analyzing the data. The beauty of DRTV is you can draw a very clear return on investment because you know how many of those patients actually ended up going on NUEDEXTA and we will really take a critical look at analyzing that and if the ROI is positive we would consider moving forward with additional investment into additional consumer in DRTV efforts.

Ritu Baral – Canaccord

Great, thanks for taking the question.

Rohan Palekar

Good bye, Ritu.

Operator

Your next question will come from the line of Charles Duncan with Piper Jaffray. You may proceed.

Unidentified Analyst

Hi guys. This is Roy in for Charles. Thanks for taking my question. First question I wonder if you can going to a little more detail about why the Paragraph IV expense were higher in the quarter?

Keith Katkin

Sure. As you can imagine Roy, that’s ongoing litigation. So, it’s difficult for us to go into any great detail in terms of what’s driving the expense we can say is that obviously this is the priority for the organization we will spend what we need to spend and fully expect that we will prevail in the litigation.

Unidentified Analyst

Okay, thank you. And kind of off the cuff question on 786 I’m just wondering if it make sense to delay the Phase 2 in dyskinesia if you plan to use 786 in that indication I’m assuming you are going to run for Phase 2 and 3 each indication just wondering about the costs there what make sense developmentally?

Keith Katkin

Sure. As you may recall the dyskinesia studies is being funded by the Michael J. Fox Foundation. And so since its external funding part of the agreement that we would use NUEDEXTA in that clinical study that said I should remind everyone that if you recall that the PK curve 786 versus NUEDEXTA the once we presented on the last call I mean essentially they were super impossible so essentially by using NUEDEXTA you are essentially using 786 as well as we believe that these will be inter changeable as we move forward with our clinical development program.

Unidentified Analyst

Okay, excited to hear the minutes. Thanks.

Operator

Your next question will come from the line of Carol Werther from Summer Street. You may proceed.

Carol Werther – Summer Street

Thanks for taking my questions. So do you have any sense of how many patients what the discontinuation rate is, once the patients start NUEDEXTA?

Rohan Palekar

Carol, this is Rohan, so that’s the tough number to get at exactly what percentage discontinue what we do know is at about six months which is an internal we are tracking as we have over half of the patients still on NUEDEXTA which compares pretty favorably when you look at other CNS drug.

Carol Werther – Summer Street

Okay. And can you comment at all why the EU recommended both doses when we only got one in the U.S.?

Joao Siffert

Yes, Joao here. The second time around, of course we get a little better and also the process and use slightly different, right taking into account all of the member states and so forth. So, it’s both in terms of the effort and what we have known from collectively over the years about NUEDEXTA as well as the reviewer sort of the portfolio if you will of all of the countries. There is the higher dose gives you potential increase flexibility for dosing more individual basis for each patient, so it allows you to increase the dose those who tolerate it. It may not be fully benefiting and also there are some potential advantages regarding some quality of life type health outcome data which appears more favorable for the higher doses in some patients. So, this is – I think this is an important win too for Avanir and for the prescribers for that matter.

Carol Werther – Summer Street

I think it’s great. And can you give us some guidance on what you think the discounting might be gross to net in the second half of fiscal year?

Christine Ocampo

Hi Carol. This is Christine what we have said in the past is that we expect our gross to net discounts to fall within about 20% to 25% and that it will just depend on where we fall, will depend on how aggressive we decide to be with the payor contracts.

Carol Werther – Summer Street

Okay, great. Thank you very much.

Keith Katkin

Thank you.

Operator

Your next question is a follow-up from the line of Ritu Baral from Canaccord. You may begin.

Ritu Baral – Canaccord

Thanks guys. Keith do you think that the better label I guess the broader label than you had expected and the additional doses will give you better pricing power in Europe and how are you looking at that pricing landscape given what we’ve seen with other MS-related drugs Ampyra and the challenges there?

Keith Katkin

Yeah I will provide some commentary and then I will turn it over to Rohan to add additional commentary as he is leading the commercialization planning within Europe. So, I think in – obviously in general we are extremely pleased I do think as Joao said getting both doses was very important for Europe not only for patients, but also as we look at the reimbursement landscape. If you look at the NUEDEXTA clinical data and you look at the 3010 dose in particular, there are a lot of quality of life related benefits that are visible in that data and I think which will translate very well to pricing and reimbursement, also important to consider a significant burden of illness, the fact that there are no existing treatments that are currently approved.

And if you want to compare and contrast to some other products like the ones that you mentioned I think one thing NUEDEXTA certainly has going forward is the very higher percentage of patients which observe clinical efficacy. So, if you look at the clinical studies in excess of 85% of patients have what’s deemed a clinical response which we defined is about 30% reduction in episode counts. If you compare and contract that to other recent CNS products that in which the benefit was arguably marginal and only in a small percentage of patients we think that we will be able to have a very good position as it relates to pricing and reimbursement. With that I will turn it, nope I will not turn to Rohan because he thinks that I did a good job.

Rohan Palekar

I think that’s the idea.

Keith Katkin

So, I hope that answers your question.

Ritu Baral – Canaccord

Great and last question on the dyskinesia trial, why start that in Canada and then move it to the U.S.?

Keith Katkin

So, there – we have sites both in Canada and U.S. and that’s to do with the timing of IRB review that’s all that is Canadians happened to be more efficient than some of the U.S. sites. But that should – the difference in the rollout should be pretty close couple of months and months or a couple of months apart.

Ritu Baral – Canaccord

Great. Alright thanks guys. I appreciate taking the questions.

Keith Katkin

Thanks Ritu.

Operator

At this time there are no other questions. I would like to turn the call back over to Dr. Ian Clements for your closing remarks.

Ian Clements

Thanks Francis. Thanks everybody for joining us today and your continued interest in Avanir. We look forward to continuing to provide updates on the progress that we are making here at Avanir. If you have any further questions or would like to discuss any portion of the results from today, you can call me on 949-389-6700. Thank you.

Operator

And ladies and gentlemen this concludes your presentation. You may now disconnect. Have a great day.

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