Brenna Mullen – IR
Keith Katkin – President and CEO
Christine Ocampo – VP, Finance
Randall Kaye – SVP, Clinical Research & Medical Affairs, and Chief Medical Officer
Phil Tenna [ph]
Ross Gordon [ph]
Jim McDermott [ph]
Carol Warder [ph]
AVANIR Pharmaceuticals, Inc. (AVNR) F3Q09 (Qtr End 06/30/09) Earnings Call Transcript July 29, 2009 11:00 AM ET
Good morning. My name is Andrea and I'll be your conference operator today. At this time, I will like to welcome everyone to AVANIR Pharmaceuticals Fiscal 2009 Third Quarter Conference Call. All lines have been placed on mute to prevent any background noise.
After the speakers' remarks, there will be a question and answer session. (Operator instructions) I would now like to turn the call over to Ms. Mullen, you may begin.
Thank you and good morning everyone. Joining me on today's conference call is Keith Katkin, President and Chief Executive Officer, Dr. Randall Kaye, Chief Medical Officer and Christine Ocampo, Vice President of Finance.
I will begin the call by addressing our forward-looking statements. Following this, I'll turn the call over to Keith Katkin.
As a reminder, the statements made on this call represent our judgment as of today, July 29, 2009. Our remarks and responses to questions during this conference call may constitute forward-looking statements, including plans, expectations and financial projection, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from the expected results expressed in our forward-looking statements.
These forward-looking statements include among others, statements about our expectations for the continued development at Zenvia and the likelihood of success concerning FDA approval, as well as statements regarding anticipated expenditure levels, future cash balances and clinical development timelines.
We encourage you to take the time to review our recent fillings with the Securities and Exchange Commission, which present these matters in more detail as well as related risk factors. AVANIR disclaims any intent to update any forward-looking statements made during this call.
Now, I will turn over the call to Keith Katkin.
Thank you, Brenna. Good morning everyone. Thank you for joining us on our fiscal 2009 third quarter earnings call. I'll start today's call by providing a brief business update before turning it over to Christina Ocampo, who will review our financial results followed by Dr. Randall Kaye, who will provide a brief summary of our Zenvia clinical development programs.
The third fiscal quarter was a very exciting period for AVANIR as we started to wind up the clinical development of Zenvia in pseudobulbar affect or PBA and take the initial steps to prepare complete response to the FDA approvable letter.
In July, we announced that the final patient had completed the double-blind phase of the confirmatory Phase III STAR trial and we were pleased that 87% of the patients completed the 12-week blinded phase of the study. This completion rate compares favorably with our experience in previous trials testing a higher dose formulation of Zenvia.
In addition, we announced that we had fully enrolled in the open label extension of the STAR trial. In all, 90% of eligible patients choose to enroll in the open label study, which will give us increased safety data to enhance our regulatory package. This high rollover rate is also favorable compared to our previous experience.
Looking forward, we continued to expect top line data from the blinded phase in August and data from the open label safety phase by the end of this year. We plan to file our complete response to the approvable letter in the first half of 20-10, and expect an approval decision from the FDA in the second half of next year. These are important milestones for AVANIR and pivotal step towards making Zenvia available to the estimated 2 million people in the United States that suffer from PBA.
In regard to the Zenvia development program and diabetic peripheral neuropathic pain, our strategy remains seeking an alignment with the FDA on the clinical requirements for the neuropathic pain indication, while directing our capital towards the PBA program which is the closest to market opportunity.
From a corporate perspective, in early June, AVANIR regained compliance with NASDAQ continued listing requirements. We therefore remain listed on the NASDAQ global market exchange under the ticker symbol AVNR. At the end of June, we were pleased to announce that AVANIR was added to the Russell 3000 Index, the Russell 2000 Index, and the Russell Global Index.
In addition to the Russell indices, it is emblematic of the increasing interest in AVANIR from various stakeholders as we approach top line data. On the financial front, we continue to closely manage cash expenditures in order to maximize our capital run rate. We ended the quarter with approximately $26.6 million in cash remaining that our balance sheet and expect a cash burn for the fiscal year ending September 30th in the lower end of the $22 million to $24 million range.
As a result, we anticipate having adequate cash to fund company operations through the expected FDA approval decision on Zenvia in the second half of calendar year 2010. This is an exciting time for everyone at AVANIR. We are within a month of unblinding top line data from the confirmatory phase III STAR trial. We are already taking initial steps to plan the complete response to the FDA approval letter, and we are planning to reinitiate activities in support of commercial readiness. All of these actions are reflected over a commitment to bring Zenvia to market as quickly and safely as possible.
With that, I'd like to turn the call over to Christine Ocampo, who will review our financial results.
Thanks, Keith, and good morning everyone. My comments today will cover our financial results for the third quarter and the first 9 months of fiscal 2009 as well as our expected cash burn for the fiscal year.
In addition to the financial results summarized in the press release issued earlier this morning, you can find additional information in our 2008 annual report on Form 10-K and our most recent Form 10-Q.
I will begin with a discussion of our results for the third quarter. Total net revenues were $591,000 for the third quarter of fiscal 2009 as compared to $2.6 million in the same period of the prior year. The decrease in revenue is primarily attributed to the occurrence as to [ph] non-recurring revenue sources in 2008. These revenue sources consist of $1.5 million milestone payment received from Healthcare Brands International and grant revenue from the government funded Anthrax Antibody Program, which we licensed to Emergent BioSolutions in 2008.
Third quarter fiscal 2009 revenues consisted of the recognition of deferred revenue of $591,000. Total operating expenses for the third quarter of fiscal 2009 were $5.6 million compared to $5.5 million in the same period of the prior year.
Third quarter fiscal 2009 operating expenses consisted of research and development expenses of $3.4 million compared to $3.1 million in the same quarter in the prior year and general and administrative expenses of $2.2 million compared to $2.4 million in the same quarter in the prior year.
Research and development expenses in the third quarter of 2009 consisted of costs attributed to the confirmatory Phase III STAR trial, as well as other supportive studies for the full response to the approvable letter. The decrease in general and administrative expenses is primarily attributed to our streamlined organization and focus on cost containment.
The net loss from continuing operations for the third quarter of fiscal 2009 was $5 million or $0.06 per share compared to a net loss of $957,000 or $0.1 per share for the same period a year ago.
Cash used in operations for the third quarter was $4.4 million.
And now moving on to our results for the first nine months of 2009, total net revenues were $3.2 million for the first nine months of fiscal 2009 as compared to $5.8 million in the same period of the prior year. The decrease in revenue is primarily attributed to the occurrence of June non-recurring revenue sources in 2008 as I discussed before.
Revenues consisted of the recognition of deferred revenue of $1.5 million, royalty revenue generated from our license agreement with GlaxoSmithKline for sales of Abreva in the amount of $950,000 and royalty revenue generated from our license agreement with Azur Pharma in the amount of $395,000.
Total operating expenses for the first nine months of fiscal 2009 were $18.4 million compared to $18 million in the same period of the prior year.
Operating expenses consisted of research and development expenses of $11.7 million compared to $10.1 million in the same period in the prior year, and general and administrative expenses of $6.7 million compared to $7.9 million in the same period in the prior year.
The increase in research and development expenses is attributed to cost for the confirmatory Phase III STAR trial as well as other supportive studies for the full response to the approvable letter.
The decrease in general and administrative expenses is primarily attributed to our streamlined organization and focus on cost containment.
The net loss from continuing operations for the first nine months of fiscal 2009 was $15 million or $0.19 per share compared to a net loss of $10.7 million or $0.20 per share for the same period a year ago.
We ended the third quarter with total cash of $26.6 million and cash used in operations for the first nine months of fiscal 2009 of $15.6 million.
Based on our performance thus far in fiscal 2009 and our ability to closely manage our expenses and contain costs, we anticipate that our total cash burn in fiscal 2009 will be in the lower end of the $22 million to $24 million range.
We expect that our current cash on hand will be adequate to fund continuing operations and the clinical development of Zenvia for PBA through the anticipated FDA approval decision date, which is expected in the second half of calendar 2010.
And now, I'll turn the call over to Dr. Randall Kaye who will provide an update on the progress of our Zenvia clinical program.
Thanks, Christine, and good morning everyone. As Keith described, we will be unblinding data on August. So this is obviously a very exacting time for AVANIR as well as our clinical team. Therefore today, I wanted to take this opportunity to review the STAR trial design. The STAR trial is a confirmatory phase 3 trial of Zenvia in patients with pseudo-bulbar affect resulting from an underlying neurological disorder. The STAR trial is being conducted under a special protocol assessment from the US Food and Drug Administration. This randomized multi-center international trial compares active treatment with the Zenvia 30-10 mg or Zenvia 20-10 mg to placebo during a 12-week double blinded phase, which is followed by a 12 week open label safety extension phase. The STAR trial had an initial target enrollment of 270 patients, 90 with multiple sclerosis, and 180 with amyotrophic lateral sclerosis or ALS. These are patients who exhibit signs and symptoms of PBA and this was conducted at approximately 60 sites in the US as well as Latin America.
At the conclusion of enrollment, a total of 326 patients were enrolled, 197 with underlying ALS and 129 with underlying MS. The primary efficacy analysis was based on changes in PBA episode rates recorded in patient diaries. Episode counts will include laughing and crying and will be reported and analyzed as a rate expressed as episodes per day. The primary outcome is the additional reduction in episode rates experienced with Zenvia 30-10 compared to placebo over the course of the 12-week trial.
In addition, secondary end points for this clinical trial will include Center for Neurologic Study-Lability Scale or the CNS-LS score, the Neuropsychiatric Inventory Questionnaire, the SF-36 Health Survey, the Beck Depression Inventory, and Pain Rating Scale score in MS patients only. Safety and tolerability of Zenvia will be determined by reporting and assessment of adverse events, physical exam, vital signs, electrocardiogram, respiratory function test, and clinical assessment of laboratory values. As previously discussed, we've exceeded our target enrollment.
These incremental patients will allow us to further enhance the safety database for the complete response to the approvable letter, and will increase the overall statistical power of the STAR trial.
In summary, we continue to make considerable progress with our Zenvia clinical programs with top line data expected next month, and open label safety data expected later this year. We remain committed to making Zenvia available to patients as quickly and as safely as possible.
Thanks for your attention. I'd like to turn the call back to Keith now.
Thank you, Randall. We are very excited to be so close to achieving such a significant milestone for the company, and we will continue to work to create shareholder value for – by advancing this important therapy for a patient population that currently has no approved treatment options.
With that I'd now like to open the call to questions.
As we're waiting for our first question, many investors have asked us about our plans for data dissemination from the STAR trial. Obviously, as we mentioned today we are very excited to announce the top line data in August, and we anticipate that the full data set including all primary and secondary endpoints will be presented at an upcoming scientific conference later this year. Any questions, operator?
You have a question from the line of Phil Tenna [ph].
Thanks for taking the question. Congrats on the progress. Just on the – couple of questions understanding that you got ALS and MS patients in the phase III and in the open label. Is there any commentary that can be given or has been given at least in the blinded part as to what percentage of the 282 patients are ALS or MS and also in the open label extension if there is – the proportions of ALS and MS patients had elected to go on?
Sure. So, as you may recall Bill the original study design, which was under a special protocol assessment with the FDA called for 270 patients and that was comprised of 180 patients with ALS and 90 patients with MS. So that was part of the original protocol agreement with the FDA and as you also may be aware, we did wind up over enrolling the study by about 21% and in total we ended up with, I believe, 197 patients with ALS and with 129 patients with MS. So we really did a nice job exceeding the original specified FDA targets in both the ALS population and the MS population.
Right, so then out of the 282 that completed, you have the breakout of how many were MS and how many were with ALS?
We have ensured data specifically in regards to the numbers, and actually I'm not even sure the numbers myself of the top of my head, but the rollover rates, we're happy with the overall rollover rate, which is 90% for all patient population. So with such a high rollover rate, obviously there wasn't lot of patients that fell out of the study between the end of the double line period and the start of the open label. So we are very happy with the size of the database level and the open label from both the ALS and the MS perspective.
And I guess, you know, the high rollover rate into the open label extension, one interpretation would be that obviously the patients feel that there is something good that's going on. Can you just talk a little bit about what is involved in the open label over and above the provision of drug for the patients? Is there some other form of care that is perhaps making patients want to participate in that?
Sure, I'll turn that over to Randall to answer that question.
Hi Bill, generally as a clinical trial when you see high rollover rate and it gives us a lot of confidence in the way the trial is overall designed that there is a very ensconced and committed investigator group, and they are able to work closely with their patients to encourage them to rollover from the double-blind phase. Obviously, patients don't know nor does the investigator know whether they are on 30-10, 20-10 or placebo.
What they are all given the promise of is that they can have 12 weeks of open label therapy, Zenvia 30-10 b.i.d. and they will continue the therapy as I mentioned over the course of 12 weeks. The assessments that are done, patients come in a little less frequently, basically one less visit. It is predominantly focused on the assessment of safety. However, we had had that at one important efficacy assessment. We will be looking at CNS-LS score at the beginning and end of the open label phase.
Okay, all right. That's very helpful. Thanks very much.
Okay, thanks, Bill.
Your next question comes from the line of Ross Gordon [ph].
Good morning, Ross.
Could you give us a rough idea of what the market is in patients and dollars, both in the US and out of the US for PBA?
Sure, and I should caveat that by saying we avoided giving specific revenue forecasts, but have done what we can to help people build their own revenue models. So I could talk you through some of our assumptions related to the patient, the size of the patient population as well as some of our pricing assumptions and then let people determine what they think they own penetration rates would be out there.
So in terms of the US market opportunity, as I believe people are aware, we did spend a fair bit of time doing detailed research to understand the US patient population for PBA, and that involved a very large questionnaire that we partnered with a polling company to conduct, and we surveyed over 2500 patients that suffered from the underlying neurologic conditions that PBA is associated with.
When we concluded that study, and about 2500 patients participated in that study, what we found is that about 10% of the population across all underlying neurologic damage or injury suffered from moderate to severe PBA. So with a universe of about 20 million patients that suffer from the trigger conditions for PBA, if you take 10% of that you get to about 2 million people in the US that suffer from moderate to severe PBA, and our data shows that about 90% of these patients have actually brought up these conditions with their physician.
So these episodes of PBA that the patients are having are significant enough for them to discuss it with their physicians. So we believe the addressable population is approximately 2 million patients and we designed our sales force and will design our sales force to call on a majority, the physicians that see a majority of those patients.
In terms of the pricing assumption, we are doing a lot of thinking around pricing right now. Originally back in 2006 we had set the parameters of pricing somewhere between branded SSRIs, which were about $3 a day to some of the newer pain medications, which at that time were between $6 and $7 dollars a day. So those were the daily prices that we are looking at back then. I can tell you that given the current market conditions as well as some of the upcoming product launches from other companies like the Acorda Therapeutics, for example of fampridine, who have been very vocal about taking an annualized price target of between $5000 and $10,000 a year.
We are going to be watching those that launch very closely and see what kind of adoption are in those pricing rates. But I think conservatively people should plan on pricing somewhere between about $1500 a year to $2000 a year and then beyond that there is definitely opportunity for upside looking at that product launches. So you can see that even with a small market penetration, the revenue opportunity for Zenvia becomes very significant very quickly.
What about out of the US?
Outside of the US, quite frankly we haven’t characterized the ex-US opportunity as well. The research that we have done suggests that there is same prevalence rate of PBA associated with the underlying trigger conditions. So we would believe that in terms of a percentage level that roughly the same percent of patients would have PBA and some of our preliminary pricing work outside the US would suggest that you can't garner quite the same price that you can get inside of the US, which is obviously pretty typical all across the world.
So we would expect a lower price and obviously we also would expect to partner the ex-US opportunity with someone that has far more expertise in the European market as well as dealing with pricing within Europe that would allow us to maximize that opportunity as well.
The other question I have is, are you currently discussing with potential partners both for the US and out of the US?
We have stated in the past that interest has increased very significantly. Our partnership inquest has increased very significantly for Zenvia. Obviously, if you consider and look across the CNS space right now and you take a look at the number of unpartnered CNS assets that companies really own the entire rights to, there is may be one other one that I can think of. So interest has been high. We are talking about all possibilities with partners, everything from just neuropathic pain partnership to ex-US to global partnerships, and our internal plan remains to be able to commercialize Zenvia for PBA ourselves.
We believe that we demonstrated the ability to do that a number of years ago with our successful relaunch of FazaClo, the atypical antipsychotic that we marketed for a year where we doubled the sales, but that said certainly we will entertain discussions with partners because if we can find someone that would be willing to fund the other areas of Zenvia that we are very excited about like neuropathic pain, like dementia related, secondary to Alzheimer's and the like. But those are obviously programs which could add significant value to the Zenvia asset, and if we can increase the market significantly so long as our pie of the total marketed figure that we think we could achieve by ourselves, then those are certainly discussions we are interested in having.
About how much would that cost to develop DNP?
We haven't provided any specific guidance in terms of the cost of the (inaudible) program. I think a lot of it still depends on the outcome of our discussion with the FDA in terms of what the requirements will be for the program. So stay tuned for more information on that as we get a little more clarity on what that program will look like.
Okay, thank you.
(Operator instructions) Your next question comes from the line of Jim McDermott [ph].
Hi. One of the questions that I always sort of wondered about is, the MS patients that are enrolling are often people who also have pain problems, and have you seen any anecdotal evidence that in fact may be that will be an additional incentive for using Zenvia?
I think it would be premature to speculate on providing additional usage or that patients have been motivated to use Zenvia because of its impact on MS-related pain, but I can share with you the data that we have to date, which I think is very provocative. You may or may not be aware that in the first study that we did in MS patients and that was at the original 30-30 dose formulation, 30 mg of dextromethorphan combined with 30 mg of quinidine. We did have a secondary endpoint in that study that looked at MS related pain, and when we unblinded that study we did see that there was a statistically significant reduction in pain in that secondary endpoint.
And that obviously led to us in the current STAR trial as Randall mentioned earlier, we also included a secondary endpoint for MS pain in the STAR trial. So we are very interested in looking at those results. I think to set expectations appropriately, if you consider the fact that there are 129 patients with MS enrolled in the study, so you have about 43 per treatment arm. I think it would be difficult to demonstrate a statistically significant improvement in pain with that few patients, but I think that it serves really as a – we consider to be a very good phase II like study in regards to MS pain, and we'll be looking at that data in a number of different ways to explore clinical utility of Zenvia in MS pain.
Okay, thank you. One other thing you keep looking at penetration is that MS patients seem to have a pretty good network, particularly in the United States.
You mean in terms of…
The indication, yes, here…
I think they are very active if you look at the MS Society and MS Foundation they have huge followings. We have been working in tandem with them, with the MS advocacy groups for as long as we have been working on the program. So we are very excited to really be able to engage that community fully with an approved product in PBA, and we are excited at the receptivity we have been given by the advocacy groups, because they recognize that many of their patients suffer from PBA and that there are no approved treatments.
Okay, thank you.
Your next question comes from the line of Carol Warder [ph].
Good morning, Carol.
Good morning. Could you just review the power of the STAR trial and what is a clinically meaningful result?
Sure, I'll turn that over to Randall.
This is a 90% power, actually a little over 90% power to effect [ph] 36% treatment effect overall. This is a power analysis that was done predominantly in order to figure out overall what was the number of patients that would be required to establish a P value with significance at the 0.05 level or lower. The clinical significance question that you asked overall, with this we would anticipate that if you would compare the 30-10 current formulation to the 30-30. Overall, what we saw in 30-30, we saw a 46% treatment effect overall and with the new formulation anticipating about 25% less efficacy, we would expect a 36% treatment effect overall.
Great, thank you.
(Operator instructions) You have a question from the line of Phil Tenna.
Thanks for the follow up. Just on – obviously Keith, there has been a lot of back and forth with the company and the agency over the last few years. I am just trying to gauge, you know, if the discussions with the agency have gone on. What your sense of the FDA's belief of this being an unmet medical need and obviously it seems like, or hopefully it seems like you're dialing down the risk profile considerably with lower quinidine with the anticipation or contemplation about a panel prior to approval.
Great questions, Phil. I'll give you my perspective on that, and then I'll turn it over to Randall to provide his perspective. First, I guess in regards to the agency interest in regards to the PBA, we've had a number of really positive signs over the last two years that we have been working on this. I think first and foremost, if you go back to the original filing of the NDA back in 2006 or late 2005, we did receive a priority review from the FDA, which means that there is an unmet medical need or no available treatment options for an important disorder. So we were pleased that as early as the original filing of the NDA, the FDA really acknowledged this would be an important therapy for these patients. I think subsequent to that we have had a lot of dialogue with the agency, and I would characterize it as very favorable.
The agency really partnered with us on this program. They sat side-by-side and collaboratively worked through what this protocol would look like, and we had a number of in-person and over the phone meetings, and I would say that we hear a lot of negative stories about (inaudible) from other companies within the sector, and our experience quite frankly has been the exact opposite. We found them highly responsive. They turned the SPA according to the original timeline, and again as we were working through some of the questions and issues in the SPA process, they were really just very helpful and very collaborative. So we feel really good about where we are at with the SPA and the interactions that we have had to date, and we are looking forward to unblinding the data and sharing with them, and getting the complete response to the approvable letter filed. I'll let Randall add whatever he'd like to add.
I will just add maybe a little bit more Phil from a clinical perspective. Clearly there is a high unmet medical need. That is no currently approved medication available for patients suffering from pseudo-bulbar affect. In talking with investigators both in the US as well as Latin America, in Latin America the physicians there basically say they don't screen for it very often, they don't talk about it very often because they have no treatment option available for these patients.
In the US, physicians often will go to off-label therapies for which none have sufficient and adequate efficacy in safety data basis. So there clearly is a strong clinical need for the first product available for patients with this disorder. You had asked a question about a panel. Panels often are introduced into the regulatory approval process when there is a specific question that needs to be answered often.
It is to help with the discussion around the balance between benefit and risk. Our approach at this stage before we see data, before we start to talk with the agency about this is that we do not anticipate a panel; however, we will plan as if we will have one and we will put our tremendous amount of resources in place to make sure that we anticipate the kind of questions that the FDA would ask before they ask them, and to that area we have recently hired a senior director of regulatory affairs, who has really dramatically improved our ability to have clear, concise, expeditious discussions with the agency.
Okay, great. Thanks very much.
There are no audio questions at this time, sir.
Great. I'd like to thank everybody for joining our fiscal third quarter conference call, and that we look forward to speaking with everyone in August with results, with the top line results of the STAR trial. Thanks very much.
Thank you for your participation. This concludes today's conference. You may now disconnect.
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