Ian Clements - Head, IR
Keith Katkin - President & CEO
Rohan Palekar - CCO
Christine Ocampo - VP, Finance
Dr. Joao Siffert - SVP, Research and Development
Charles Duncan - JMP Securities
Ritu Baral - Canaccord
Avanir Pharmaceuticals (AVNR) F3Q12 Earnings Call August 8, 2012 4:30 PM ET
Good day everyone and welcome to the Avanir fiscal 2012 third quarter conference call. My name is Louisa and I will be your operator for today. At this time all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of this conference. (Operator Instructions)
As a reminder, this conference call is being recorded for replay purposes. I’d now like to turn the call over to Dr. Ian Clements, Head of the Investor Relations. Please proceed, sir.
Thanks, Theresa and good afternoon everybody. I would like to welcome you to our conference call to discuss our financial and operating results for the fiscal 2012 third quarter.
To discuss our results, I am joined by Keith Katkin, our President and Chief Executive Officer, who will provide a strategic overview of our business and fiscal 2012 third quarter performance. Christine Ocampo, Vice President of Finance, who will provide additional details on our financial performance during the quarter. Rohan Palekar, our Chief Commercial Officer; and Dr. Joao Siffert, Senior Vice President, Research and Development, who will provide an R&D update. For the Q&A portion of today's call we will also be joined by Dr. Randall Kaye, our Chief Medical 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, future expense levels, the timing and success of future development of AVP for other indications and the potential approval of NUEDEXTA in new markets.
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, 2011 and periodic reports filed with Securities and Exchange Commission.
From an investor communications perspective, we will be presenting an overview of the company two meetings this month. Next week we will present at the Canaccord Genuity Conference in Boston and the Wedbush Pacific Growth Healthcare Conference in New York. A webcast of these presentations will be accessible through the Investor Relations section of our website.
With that said, I'll now turn the call over to Keith Katkin. Keith?
Thank you, Ian and good afternoon everyone. The Fiscal 2011 third quarter was another strong quarter for Avanir. We continue to see strong growth in NUEDEXTA sales and prescriptions and made substantial progress on our clinical and regulatory initiatives. We are delighted to announce that net NUEDEXTA revenues for the quarter exceeded $10 million representing net revenue growth of over 37% over the previous quarter.
Gross NEUDEXTA sales also grew by 33% over the previous quarter. Five quarters post our launch we continue to set new record high prescriptions and based on our most recent weekly prescription numbers of 2232, our annualized gross run rate is approximately $52 million.
Later on the call, Rohan will be giving an update on our commercial activities and the strong growth we continue to see in NEUDEXTA sales.
Addressing some of the recent corporate highlights, first in June we announced a valuable new addition to our intellectual property portfolio. US patent number 8227484 entitled pharmaceutical compositions comprising Dextromethorphan and Quinidine for the treatment of neurological disorders.
This new patent claims methods for treating pseudobulbar affect or emotional ability using low dose Quinidine formulations of NEUDEXTA. This patent was issued on July 24, 2012 and was recently added to the FDA Orange Book. This additional patent listed in the Orange Book for NEUDEXTA further strengthens our patent in the States and creates another hurdle for ANDA filers to overcome.
Second, the growth we are delivering in NEUDEXTA sales combined with a strong balance sheet firmly position us for commercial success and delivery of a number of exciting catalysts in our development pipeline. The most recent clinical achievement centered around our early June announcement that the FDA has accepted the company’s investigational new drug application for the study of AVP-923 for the treatment of agitation in patients with Alzheimer’s disease. Joao will provide more details on this exciting initiative later on the call and the progress we continue to make exploring the broader potential of this dual sigma-1 agonist and NMDA receptor antagonist. With that introduction I will now ask Rohan to say a few words. Rohan?
Thanks Keith and hello everybody. It's my pleasure to update you this afternoon on the progress we've been making in our commercial activities. The fundamentals of our commercial business remain strong and all our indicators point towards a successful 2012.
On the prescription side as Keith mentioned we saw strong quarter-over-quarter growth as prescriptions increased by approximately 33% to 26,428. Over the same period, new prescriptions grew by approximately 22% to 11,736. I would like to highlight a couple of key factors driving this growth.
First, awareness of NUEDEXTA amongst physicians continues to grow and reached an all-time high in our recently completed market research. This demonstrates that our sales and marketing initiatives are continuing to have significant impact in the marketplace.
Second, the number of physicians prescribing NUEDEXTA each week continues to grow here again reaching an all time high in June. Similarly our reach amongst nursing homes is also increasing and we now cover over a third of the beds in the country.
It is important to point out that this number is based on coverage with the group of initial representatives we hired last year. Another key instruments in the institutional segment buying process is the long-term care pharmacy. This quarter we made good progress adding new pharmacy accounts with a quarter-on-quarter increase of 14% in the number of pharmacies purchasing NUEDEXTA based on IMS tracking.
Even more important, the number of long-term care pharmacies reordering grew by 24% from the previous quarter. Third, our managed care team has been productive with the number of payer initiative to increase the percentage of prescriptions filled at retail pharmacies.
Consequentially claims approval is at an all-time high, up approximately 50 percentage points from a year ago. We remain in active negotiations with a few plants that still have restrictions in NUEDEXTA and anticipate some key wins over the next few months. Additionally, we have rolled out a comprehensive range of patient support programs, so that most patients have access to financial assistance if needed.
As we look at the different segments of our business, I am pleased with the progress the team has made in both the retail and institutional segments. In the retail segment of our business, we grew total prescriptions approximately 18% over the previous quarter as penetration increased within the neurology, psychiatry and primary care communities.
During the same period, total prescriptions in the institutional segment grew approximately 47% over the previous quarter. This institutional growth has been driven by new customers orders, increase in the size of reorders from existing pharmacies and an increase in the average number of capsules per prescription.
This completed quarter represented the second full quarter of our launch of our institutional business and we believe there is further upside here. In order to capitalize on this opportunity, we have decided to increase the long-term care sales force to 55 representatives, allowing us to cover approximately 60% of nursing home beds.
We plan to have these new representatives fully deployed in the quarter ending December 31, and expect to see benefit in the first calendar quarter of 2013. On the retail side, we continue to use physician prescribing trends to refine our targeting strategy to improve efficiency and drive greater sales. With the planned long-term care sales for [expansion], patient initiative and improved physician targeting we remain excited about the future potential of NUEDEXTA. I will now handle with the call to Christine to address our financial results. Christine.
Thanks, Rohan and good afternoon everyone. My comments today will cover financial results for the third quarter of fiscal 2012. Please refer to the financial results included in the press release for the first nine months results. In addition to the financial results summarized in the press released issues earlier this afternoon, you can find additional information in our upcoming Form 10-Q.
All figures discussed today are approximate. Addressing third quarter, we reported total net revenue for the three months ended June 30, 2012 of $10.5 million as compared to $2.5 million for the comparable period in fiscal 2011. For the third quarter, we recorded growth product sales of NUEDEXTA up $12.2 million and net sales of NUEDEXTA were $10.1 million.
During the quarter ended June 30, 2012 our gross to net discount decreased to 17.7% compared to 18.3% in the prior quarter. Going forward, we expect growth to net to increase, as we enter into contract with additional managed care entities and stabilize over time somewhere between 20% and 25% excluding the impact of any future price increases. Regarding inventory levels, third quarter wholesaler inventories were maintained at approximately two weeks. For the third quarter of fiscal 2012, cost of sales was $564,000 and gross profit was $9.5 million. Expressed as a percentage of net product sales, our gross margin was 94.4%.
Research and development expenses were $6.8 million for the quarter ended June 30, 2012 compared with $3.3 million for the same period in the prior year. In the fiscal third quarter of 2012, our R&D spend was primarily attributed to non-clinical post marketing requirements, medical affairs, EMA regulatory expenses and the costs associated with the prime setting.
Additionally, costs associated with the in licensing of deuterated dextromethorphan from Concert Pharmaceuticals were recorded in this expense line. Selling, general and administrative expenses for fiscal 2012 third quarter were $17.9 million compared to $15.2 million for the corresponding period of the prior year. The increase was primarily due to an increase in expenses related to the commercialization activities for NUEDEXTA. Total operating expenses for the fiscal 2012 third quarter were $24.7 million compared with $18.4 million for the comparable quarter in 2011. Total operating expenses of the fiscal 2012, this quarter decreased by 7% over the previous fiscal quarter, demonstrating our ability to manage cost by achieving 30% growth in net sales.
For the three month ended June 30, 2012 and 2011, the company recorded $1.2 million and $1 million respectively of stock based compensation expense.
Cash yields and operations for the quarter ended June 30, 2012 was $14.9 million. Our net loss for the third quarter of fiscal 2012 was $15 million or $0.11 loss per share, compared with a net loss of $16.1 million or $0.13 per share for the same quarter in 2011.
As of June 2012, we had total cash, cash equivalents and restricted investments in marketable securities of $84.1 million.
Now, looking forward for the remainder of the year, we are revising our operating expense guidance and are now anticipating that operating expenses will be in the range of $94 million to $96 million.
R&D expenses will be approximately in the range of $22 million to $23 million, including our medical affairs organization and our development program. SG&A expense will be approximately in the range of $72 million to $73 million. The increase in our operating expenses for fiscal 2012 is due to additional cost incurred as part of the in licensing and acceleration of our deuterated dextromethorphan program, expansion of institutional sales force and increase litigation costs.
Regarding NEUDEXTA revenue, we continue to evaluate the appropriate time to provide guidance. And finally, today you may have seen that we filed the universal [shelf] for 100 million which includes an ATM facility. The new [shell] was filed in anticipation of the exploration of our current [shell] which was filed in September 2009 and expires next month in September 2012.
We believe it is a prudent financial practice to have an effective [shell] and an ATM facility in place as we have had one in place for the last three years. Importantly, we continue to believe that based on our current NEUDEXTA revenue and expense plan, we do not anticipate a need for any significant dilutive financing in the future. With that summary of our financial results I would like to turn the call over to Joao. Joao?
Dr. Joao Siffert
Thanks, Christine and hello everyone. So with the R&D front we also continue to make some progress and remain focused on development of NEUDEXTA the NMDA receptor antagonists and sigma-1 receptor agonist. The first they are doing the quarter we are pleased to announce the acceptance of our IND for the study of (inaudible) the patients with dimension. This is a significant accomplishment by the team as the FDA allows us to move into a Phase II study based on the rational provided in the study protocol and also on the overall safety database of AVP-923 including the post marketing database from NEUDEXTA.
Subsequent to the acceptance of this IND the team has been working diligently to enroll the first patient which we anticipate will take place before the end of his quarter. We are extremely excited to conduct the study in this of tremendous (inaudible). As many of you know, there are an estimated 5 million Americans with Alzheimer's disease, the number that is expected to be as high as 16 million 2050.
Behavioral and psychiatric symptoms develop in as many as 60% of community-dwelling dementia patients and in more than 80% of patients with dementia living in nursing homes.
As the diseases progresses the risk of such complications approaches 100%. Dementia related behavioral symptoms including agitation can be extremely distressing to the individual, the family and their caregivers. They have been associated with more rapid cognitive decline associated with the institutionalization and increased caregiver burden.
With approved treatments specifically agitations and patients with Dementia and the increase safety concerns related to the (inaudible) of antipsychotics in the patient population. This remains indeed an area of great medical need.
Second, we continue to make good progress with the prime study, now underway in the US and aboard. The studies testing the safety and efficacy of three dose levels of AVP-923 for the treatment of Central Neuropathic Pain for patients with Multiple Sclerosis.
We currently have approximately 70 global sites in the US, Europe and Latin America. Our current estimated timeline is that we should announce top line data in the second half of calendar 2013. (inaudible) the newest development program with the deuterium-modified dextromethorphan or d-DM. So we believe that d-DM stands to provide therapeutically affected levels of dextromethorphan with the same pharmacologist dextromethorphan and potentially without the need for an enzyme inhibitor such as Quinidine. As part of our portfolio strategy we intend to explore the utility of d-DM and several neurological and. A Phase I human trial that's been planned later this calendar year with the purpose to better characterize the pharmacokinetic profile of deuterated dextromethorphan. We anticipate being able to share data from the study in early 2013.
Turning to activities on the NUEDEXTA let me start with PRISM registry. This is the largest PBA observational study ever conducted across hundreds of neurologists, psychiatrists and institutional sites in the US. Preliminary estimates based on PRISM results indicate substantial prevalence of PBA across multiple neurologic populations including dementia, stroke and traumatic brain injury.
At the time of the interim data cut in April 2012, a total of 3,647 patients with Alzheimer’s disease, stroke, EBI, MS, Parkinson’s and ALS had been involved in the study. Among these patients 37% had a CNS-LS score above 13 and approximately 10% had CNS-LS score above 21. These numbers which are consistent with the published literature suggested that it may still be a significant under diagnosis of PBA. We intend to present and publish the final prevalence data as well as the impact of PBA on quality of life and use of psychotropic medications in this upcoming year.
Finally, back in October of 2011 we filed the NUEDEXTA MMA for pseudobulbar affect. We received the day 120 questions from the agency in March and are in the process of responding to them. Based on the new timelines, we expect to have CHMP recommendation by the first calendar quarter of 2013 with a European Commission decision to follow approximately three months later.
With that update on clinical research and medical affair activities, I will hand it over back to Keith. Keith?
Thanks Joao. I am very pleased with the continued progress we are making with NUEDEXTA. We have made significant progress on both the commercial and clinical fronts and continue to focus on executing on our business plan. In terms of remainder of this year, our focus will continue to be building NUEDEXTA market and PBA and growing sales, further advancing NUEDEXTA and AVP-923 and deuterated dextromethorphan into new clinical opportunities, advancing the European regulatory process for NUEDEXTA and PBA and finally actively managing our cash position and expenses.
With that summary of our business and financial update, I would now like to open up the call for questions. Operator?
Thank you. (Operator Instructions) And your first question comes from the line of Charles Duncan with JMP Securities. Please proceed.
Charles Duncan - JMP Securities
So my first question is regarding NUEDEXTA guidance; you are still evaluating and when it would be appropriate to give then, I am kind of wondering what you are thinking in terms of what kind of milestone is this, is it revenue milestone, is it certain market penetration milestone, or is it some annual milestone; when you are going to be able to give guidance?
Sure thanks Charles and appreciate the comment. In regards to when we will give revenue guidance, I think it really just depends on if it makes sense to give revenue guidance quite frankly and to this point we haven't really come to the conclusion that makes sense and as we talked to many of the buy side and the sell side, everyone is hard pressed to come up with a compelling reason to first to give to revenue guidance. So it’s not that we evaluate each quarter as to whether value in giving that guidance and to-date we have not been able to identify a good reason to go ahead and do that.
So we will continue to evaluate on a quarter-by-quarter basis, but I should point out that most of our colleagues in the industry who have given out guidance during particularly the launch date of the products typically has not faired very well for them. So I think that’s another important consideration as we decide whether or not to provide guidance. We are focused on growing the business keeping up the gross rate fixed we have got out there and making sure that we continue to set record prescription levels.
Charles Duncan - JMP Securities
Also you talked about there being some upside in part or in the institutional marketing efforts and I appreciate some detailed information on that. But wondering is that upside due to the increased number of reps or penetration and in addition when you increase the number of reps will there be any disruption in the current sales force with regard to their accounts?
Let me turn it over to Rohan answer that question Charles.
A good question Charles, so I am going to break it up into two parts; so the growth is the function of two things, one is increasing the number of reps, allows us to get to a broader of reach of homes, but more importantly is even within the homes it’s getting the depth of penetration. I think we chatted at earlier call when you look at the number of residents add at about 1.4 million, about 1 million of them have underlying neurological conditions which could have PBA.
Now PBA percentage might be just 10% of those. So there's yet significant upside and that's where we think we need to get to the breadth so we cover most of the homes, but also once we get into their home really get the depth within that home, so get from four to five patients to 20 patients within each home.
To answer your second question there is a slight disruption which will take place as we expand, but what we are trying to do is minimize the disruption by cutting the territories in such a manner that they are more discreet. But we will see a little bit especially as we go through the recruiting phase just now and the reps do come on board. However, having said that, the long term benefit we feel offsets this little time period we will have when we see the disruption.
Charles Duncan - JMP Securities
Okay, my last question is regarding the MAA. Thanks for the information on that. You said though that you got the day 120 questions in March, I am not sure if I heard that right and I am kind of wondering what the rate limiting step is to addressing those questions, were there any additional analysis that need to be done and when you think those questions will have been satisfied?
Sure Charles yes, so we've got a 120 day questions in mid-March that is correct and that we will respond in mid-September. As we stated before there is nothing surprising or different than we had heard from the FDA during the US review process. The way the EMA works is you have to pick a particular date when you are going to respond to the questions and given everything that our clinical team is currently working on beyond the EMA filing, when you think about the agitation study that they are working on, when you think about MS pain study as well as some of the other areas of focusing on; it’s quite a substantial amount of work for the team. So we picked the EMA response point which we thought allowed us to create the most thorough and high-quality answers as possible to give us the best possibility of success with EMA.
Your next question comes from the line of [Andrew Thomas] with Summer Street Research. Please proceed.
I had just one quick question. What do you think of the recent prescription trends; can you provide some more color there?
Sure, I think we like what we're seeing in the recent prescriptions trends to the last three weeks at all time highs from a prescription level. If you look at the June numbers, the June growth over May was a little bit softer than we would have like to see it around 2%. But we expect that given the lot of internal activities that we have going on, some of which Rohan alluded to in the previous questions, and as we look forward, we think that certainly the summer is going to continue to have a seasonal impact on the business, but as we get into September and October, I expect the business will return to its previous growth rates.
Your next question comes from the line of Ritu Baral with Canaccord. Please proceed.
Hi guys thanks for taking the question. This is [Brittany] in for Ritu. One quick question on the new patent, how will that affect Paragraph 4 filing?
Sure. In terms of the impact of the new Paragraph 4 filing, essentially it’s procedural at this point in time. So, what has to happen is similar to what happened with the original filing is at the end of filers, we’ll have to file against the newly issued patent and then we will have to add the new patent to the current and the litigation that’s going on.
So, really it's procedural in nature at this point in time, but I think what's important is looking at the new patents and how it affects are overall patent estate and as I commented in the prepared remarks, it really further improves our overall intellectual property estate for NUEDEXTA.
And then have you guys given any color on the Alzheimer's trial design?
We’ve given some color. I will say, it will be approximately a 200 patient study that will be two arms comparing NUEDEXTA versus placebo and that we plan on enrolling the first patient into that study by the end of this calendar quarter, so by the end of September.
Okay and then no new color there?
No, nothing additional. Our team is working to get the first patient enrolled and once we get that patient enrolled and get our sites activated here in the US, then we will be up and running in terms of getting closer to the data milestone.
The next question comes from the line of Thomas (inaudible). Please proceed.
Regarding the sales force ramp up of five reps for (inaudible) I think in the – that sense because that is kind of the low hanging fruit for NUEDEXTA. Can you remind me how many sales reps you guys have been total across all segments and what percentage of it is institutional so far?
So we currently have 71 representatives on the retail side and 42 representatives on the long-term care. So we had started of a pilot with long term care last October with 32 representatives, second calendar quarter our third fiscal quarter we increased that 32 to 42 and now we are going to take it up to 55. So it will be a total of 126 across the two segments.
Regarding the SG&A, $72 million to $73 million full-year guidance, does that include stock-based compensation by any chance.
No that expense guidance does not include FAS 123, that's just operating expenses excluding share based comp.
My other question is I'm seeing the discount and allowance is you've guide to a range of 20% to 25%, according to my calculations that now is about 18%, can you give me some reasons for the increase in the near future.
Sure, as we are guiding in terms of the gross adjustment, really guiding towards where we believe it will be over the next six to 12 months and what's really driving our belief that we could see that increase in growth and then it's primarily around our new Medicare Part D contracts. As Rohan had mentioned in his portion we are making a good progress with many of the Medicare Part D payers.
And as we continue to make progress and are ultimately successful coming under contract with them, then we expect that we will see our growth continue to increase to levels of about 20% to 25%.
Your next question comes from the line of (inaudible) with Wedbush Securities. Please go ahead.
Just a quick question here on long-term care setting scripts versus the retail setting, I know you know, trucking the scripts here weekly. It appears that the numbers aren’t lining up just as well as we had thought. I am wondering what are your comments are there if you are seeing difference in trends and maybe the split that you're seeing in percentage terms? Thanks.
Could you give a little more color in terms of the scripts not lining up? so just want to make sure?
Sure, the trends are somewhat in same directions. You know, generally there is lower growth in the retail setting it appears but just wondering also about split between the retail and institutional settings if you can comment on that.
I mean that’s perhaps [direct] also from maybe refills, are you seeing stronger refills in institutional settings than you are, retail settings perhaps? Thanks.
I can certainly answer that I can let Rohan any additional color. So overall, in LTC, you would expect that you will see a better refill rate obviously. These patients are in institutions and their beds are typically managed by people within the institution. So certainly we expect to see higher refills within that setting. In regards to the split of the business, I think the split is consistent with what we would expect right now over the long term care business represents over 50% of our prescription and we think with the further expansion to a total of 55 representatives focused on long-term care, we will continue to see the institutional business as a percent of our business increased.
That said, I don’t want to overlook the roughly 20% growth that are we seeing within the retail side of the business and we do believe that retail does continue to present a significant opportunity and we will continue to focus portion of our resources on retail as we continue to grow NEUDEXTA prescriptions. But let me turn over to Rohan for any additional color.
I think that captures, the one additional point I would make is while we reported them as two different segments there is a fair bit of overlap and spill over benefit we get. As our long-term care segment continues to grow because a lot of these physicians whether it be medical directors or the consulting who influence those, they are also trying to have retail practice, so that’s one thing we should always consider and that’s why we have efforts against both these segments because of that spill over benefit we get.
Your next question comes from the line of Ritu Baral with Canaccord. Please proceed.
Ritu Baral - Canaccord
Can you comment on the dropout rate that you are seeing in your MS pain study and just the overall level of tolerability?
It's actually quite low surprising low actually, for pain study. So it’s doing well and the overall tolerability is excellent. So I will say this of course would always a caveat that within the Phase II we got to be parsimonies and don’t intend to make a major claim, but it has been quite good and in part with what we’ve seen in development before that.
Ritu Baral - Canaccord
And how has the PRISM registry enrollment being going; you mentioned the poster in the release including some of the findings. If you could take us through I guess some of the high points of those in and how do you think that can be important and I guess modifying your marketing message going forward or incorporating it into?
Sure, I’ve got Randall on the line. So I’ll let Randall answer that.
Dr. Randall Kaye
Hi Ritu, It’s Randall. As you know, the PRISM registry is probably the largest observational study that’s ever been conducted in pseudobulbar affect. Enrollments continues to be great, in fact, we’re already getting as some preliminary estimates of PBA that looks like prevalence to upwards of one out of three patients with this core underlying neurologic conditions such as traumatic brain injury, and stroke and Alzheimer’s disease.
So what we plan to do is we will work towards capturing the data finalizing over the next couple of months and try to keep that information out for publication and through conferences. And once the data set is finalized I am we’ll have an (inaudible) sit down and talk about how we’re going to incorporate that into a medical marketing message. But it’s pretty clear that there is a significant amount of pseudobulbar affect that is out there and I suspect that a number of physicians might be substantially under diagnosed in PBA.
Ritu Baral - Canaccord
And have you given an updated breakout of Tier 2 versus Tier 3 coverage and how that shifted in the last quarter?
Hi Ritu, this is Rohan. So we have not provided specifics on that. What I would say is we've had a couple of key wins, getting us some major programs which will in Tier 3 move to Tier 2. To be honest, one of our big focus is really to make sure we lift the restrictions and get to unrestricted status and that's been a key driver also we are looking at to remove the PAs where applicable.
At this time, we show no further questions in the queue. I would like to turn the call back over to Dr. Ian Clements for any closing remarks.
Thank you, Louisa. Thanks everybody for dialing in today. In closing, I would like to thank you for your continued interest in Avanir. We look forward to providing updates on the progress that we continue to make at upcoming conferences and indeed on future calls. If you have any further questions or you would like to discuss any portion of the results, please feel free to call me on 949-389-6737. Thank you.
Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect and have a great day.
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