Sarepta Therapeutics Inc (SRPT) 2010 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the third-quarter 2010 AVI BioPharma earnings conference call. My name is Derrick and I will be your operator for today. At this time, all participants are in listen-only mode. At the end of the conference, we will be facilitating 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 conference over to Mr. David Walsey, Senior Director of Investor Relations and Corporate Communications. Please proceed.

Thank you, Derrick. And thank you for joining today's call. Earlier today, we released our financial results for the third quarter of 2010. The press release is available on our website at www.avibio.com and the 10-Q as filed with the SEC.

Joining me on today's call are Dave Boyle, interim President and CEO, and Dr. Steve Shrewsbury, our Chief Medical Officer.

First, I need to inform you that during this call, we will be making a number of statements that are forward-looking. These forward-looking statements include statements about our expectations regarding future expenses; funding from government and other sources; the development of AVI's product candidates, including preclinical development, filing of IND applications, completion of Phase 1 human safety clinical trials, child, clinical development and FDA approval; the ability to refine and scale our manufacturing processes; the efficacy of our PMO chemistries and other RNA-based technology; our ability to partner with others with respect to the development of our product candidates; and the timing of future announcements regarding our business and product candidates.

These forward-looking statements involve risks and uncertainties, many of which are beyond AVI's control. Any of such risks could materially and adversely affect our business, results of operations, and the trading price of our common stock. For a detailed description of risks and uncertainties related to our business, you are encouraged to review the official corporate documents filed with the Securities and Exchange Commission.

With that said, let me turn the call over to Dave Boyle, AVI's interim President and CEO, and Chief Financial Officer.

Thank you, David, and good afternoon, everyone, and thank you for joining us on AVI's 2010 third-quarter earnings call.

At AVI today, we are intent on asserting our leadership position in the research and development of RNA-based therapeutics utilizing our unique proprietary phosphorodiamidate morpholino oligomer, or PMO-based platform technology. Over the last several months, we have refined our business strategy to focus our efforts on addressing rare diseases and infectious diseases, and we have put into place the operational plans to support that strategy.

By aggressively leveraging the versatility and unique capabilities of our proprietary technology platforms, we are rapidly advancing our development programs and fueling the emergence of an important pipeline of clinical stage products. Our lead program in Duchenne Muscular Dystrophy, or DMD, is scheduled to progress into a Phase 2 clinical study later this year. In 2011, we expect that the DMD program will be joined in the clinic by our influenza, Ebola, and Marburg therapeutic programs. In addition, we are advancing a range of promising research-stage programs toward development.

Our influenza, Ebola, and Marburg programs being developed in collaboration with the TMT program of the US Department of Defense, are supported by contract awards potentially totaling over $300 million. As these fully-funded antiviral programs move forward, we expect that this work will result in significant benefits to AVI, including increased revenues, developments of additional manufacturing capabilities, and additional clinical data on our PMOplus platform technology.

These multiple development program successes demonstrate the power and breadth of the potential of our PMO-based platform technology. Our intrinsically charged neutral PMO-based chemistry is a key to many advantages inherent in our platform technology. While earlier generation RNA therapeutic-based chemistries are naturally negatively charged, the charged neutral state of our PMO-based next-generation chemistries allows us to enhance and modulate the drug-like properties, cell penetration, potency and tissue targeting of our therapeutic candidates.

We have been particularly pleased by the success we've had with our third-generation PMOplus chemistry, which appears to be well-suited to a broad range of therapeutic applications. We are also very encouraged by the emerging data we have obtained from our newest advanced chemistry, which we refer to as PMO-X. This group of chemistries represents a novel, fourth-generation construct.

It is intended to realize even greater potency from the foundation of the parent PMO by introducing specific chemical groups to enhance tissue targeting, cell penetration, and in vivo potency. PMO-X takes advantage of the highly stable and malleable blank slate of the core PMO backbone, and selectively installs new site change, a terminal modifications to dial in the specific drug-like characteristics, which enhance a therapeutic candidate's overall profile.

The stable and malleable nature of the PMO also provides us the ability to continue to explore new modifications and innovations that will allow us to evolve our PMO-based chemistry even further, and potentially provide more advances in the future.

During the remainder of today's call, I would like to begin with a short review of our third-quarter and recent highlights. I'll then ask Steve Shrewsbury, our Chief Medical Officer, to review the status of our Duchenne Muscular Dystrophy Program and other development stage programs.

After Steve's review, I'll provide a summary of our financial results and guidance released earlier today. I will then provide a review of upcoming milestones before opening the call for your questions.

AVI's continuing operation and performance had resulted in several important successes over the last several months, including -- we have successfully advanced our lead clinical program for Duchenne Muscular Dystrophy and have recently announced final results from our Phase 1b/2 trial demonstrating a broadly favorable therapeutic profile with promising safety, biological, and exploratory clinical performance assessments. These data support rapid advancement of the program into a randomized, double-blind, placebo-controlled Phase 2 trial. Shortly, Steve will provide more information on this program.

Also, AVI received an reward from the US government for the advanced development of our lead Ebola and Marburg virus therapeutics worth up to $291 million. Our flu -- influenza product candidate, AVI 7100, which has demonstrated a reduction of viral titer in a ferret model of up to 3.9 Logs greater than Tamiflu, has gained awards of up to $26 million for its continuing development. And we have progressed our earlier-stage R&D programs towards preclinical proof of concept, including our antibacterial program, which may represent a new class of antibiotics.

A US patent has issued that provides key claims covering the use of PMOs as antibacterial agents. The patent covers the use of peptide conjugate plus phosphorodiamidate morpholino oligomers, or PPMOs; another third-generation oligomer class to target the acyl carrier protein, a gene considered essential for bacterial growth in both gram positive and gram negative bacteria.

And lastly, we have increased our proactive outreach to potential strategic partners, which we expect will lead to new alliance opportunities.

We also have continued to support our business with a strong presence and data presentations at multiple scientific conferences. These conferences include infectious disease-related events, such as ICAAC and IBSA; [DMV]-related events such as the recent International Congress on Neuromuscular Disease and World Muscle Society meetings; and RNA therapeutic technology events such as OTS. You can see presentations from all of these conferences on our website.

AVI's visibility in the financial community continues to increase, with presentations at several conferences in the last few months and also upcoming presentations. We are especially pleased to have the recently initiated research coverage from ThinkEquity that has now added to our continued coverage from research analysts at Rodman & Renshaw and Maxim Group.

Now I would like to turn the call over to Steve to provide a development update on our programs. Steve?

Thank you, Dave. In the last several months, we have made considerable advances across several important programs. As our lead program, perhaps the advances in our Duchenne Muscular Dystrophy Program are the most notable.

In October, we announced data from the completed Phase 1b/2 clinical trial of AVI-4658, our lead PMO-based therapeutic candidate being developed as a systemically-administered treatment for a substantial subgroup of patients with Duchenne Muscular Dystrophy.

The data demonstrates the broadly favorable therapeutic profile with promising safety, biological, and exploratory clinical performance assessments that supports rapid advancement of the program into the next phase of clinical development -- a randomized, double-blind, placebo-controlled Phase 2 trial in the US, which we plan to begin this year. A review of the data from all patients who completed the trial establishes support for the following conclusions.

AVI-4658 was well-tolerated in all patients. Adverse events were mostly mild or moderate in intensity, not dose-related, and none were considered probably related to study drug. There were also no drug-related serious adverse events or severe adverse events.

Substantial novel dystrophin expression in up to 55% of muscle fibers, which although variable among patients, tended to be greatest in the highest two dose cohorts. All patients receiving 10 or 20 milligrams per kilogram of AVI-4658 demonstrated increases in dystrophin-positive fibers compared to biopsies obtained before starting AVI-4658 treatment. Dystrophin expression was correctly localized in muscle cells just underneath the sarcolemma, and was accompanied by restoration of the dystrophin-associated glycoprotein complex, a protein complex necessary for the proper function of muscle cells.

Statistically significant reductions in key inflammatory markers, including CD3, CD4, and CD8 key lymphocyte counts potentially suggest an alteration in the underlying degenerative disease process. Importantly, there was no immune response to newly-made dystrophin observed. There was general stability in exploratory markers of patient clinical performance, including cardiac, pulmonary, and muscle function assessments.

Data highlighting results from the Phase 1b/2 trial were presented at multiple scientific venues this year, including the International Congress on Neuromuscular Diseases in Naples, Italy in July; and more at the World Muscle Society meeting in Kumamoto, Japan in October. These presentations were well-received and I believe there is considerable excitement and increased support for our DMD program based on our promising data to date.

Based on these promising results and on our preclinical package, we plan on initiating the Phase 2 trial this year at Nationwide Children's Hospital in Columbus, Ohio to evaluate higher doses of AVI-4658. The design for the trial was discussed with an expert panel of physicians and scientists assembled by AVI to review/study 28 data and to discuss clinical plans in DMD moving forward.

Following the input from these experts, the planned study will be a randomized, double-blind, placebo-controlled Phase 2 trial evaluating higher weekly doses of AVI-4658 of 50 milligrams per kilogram and 100 milligrams per kilogram. After completion of 12 weeks of dosing, patients will have a repeated muscle biopsy and will be followed for an additional 14 weeks. This trial will assess the safety, tolerability and pharmacokinetics of AVI-4658, as well as biological activity of the compound as determined by levels of dystrophin restoration in patients. The study will also assess exploratory parameters of clinical performance.

The study protocol was submitted to the FDA under our open IND, which we announced in July of this year, and we are in the process of seeking IRB approval from Nationwide Children's Hospital. We are also continuing to advance AVI-5038, our lead preclinical PPMO Duchenne Muscular Dystrophy drug candidate, intended to skip Exxon 50 in the gene coding for dystrophin.

As previously reported, we have noted toxicology findings in the primates' kidney as part of our series of GLP studies. Based on those findings, we are conducting additional preclinical work to help clarify the therapeutic index of AVI-5038, including strategies intended to mitigate possible effects in the kidney. Results from these ongoing efforts will help guide decision-making concerning development plans for this candidate. We will provide updated information on the status of this candidate in 2011.

Our influenza program evaluating AVI-7100 as our lead candidate has also been continuing to advance. AVI-7100 uses our PMOplus chemistry and it targets a region of the flu virus that we believe is well-conserved across multiple flu strains, both seasonal and pandemic. Results announced in August from two preclinical studies evaluating AVI-7100 against a fully-virulent strain of pandemic H1N1 virus in a ferret model, demonstrated potent, statistically significant reductions in the average viral titer in the upper respiratory region versus saline and also versus Tamiflu controls.

In the analysis of these two studies, AVI-7100 results have been statistically significant reductions of up to 3.9 Log in the combined daily average viral titer through peak viral layered, Phase 1 to 3, versus saline control and Tamiflu controls. Data from the initial ferret and some earlier mouse studies represented at ICAAC and IDSA over the last couple of months. These presentations are available on our website.

Further preclinical study of AVI-7100 is ongoing against multiple flu strains, Tamiflu-resistant H1N1, avian flu, H5N1, and seasonal flu, H3N2. We anticipate obtaining results from these studies over the next few months.

We are also in the process of completing the preclinical package, which we believe will support an IND for AVI-7100. We plan to submit this IND to the FDA in the next few weeks, and we are planning to initiate a Phase 1 trial program in the first quarter of 2011.

The lead PMOplus candidates for Ebola and Marburg programs, AVI-6002 and AVI-6003, respectively, continue to progress. Both programs are also scheduled to enter Phase 1 trials in the first quarter of 2011 under already-open INDs. These two Phase 1 programs, plus the Phase 1 influenza program, will all be evaluating the initial safety, tolerability, and pharmacokinetics of our novel PMOplus therapies. These will be the first evaluations in humans of any PMOplus therapies, and given the favorable profile we've seen in the preclinical studies, we are very excited to further characterize the profile of our PMOplus candidates.

Also with respect to our lead therapeutic candidates against Ebola and Marburg, Nature and Medicine recently published new preclinical data demonstrating that AVI-6002 and AVI-6003 provide post-exposure efficacy in non-human primates. Treatment of Ebola virus-infected primates with AVI-6002 led to 60% survival, and the treatment of Marburg-infected primates with AVI-6003 conferred 100% survival compared to control groups, where both viruses were universally lethal. In addition to survival, both AVI-6002 and AVI-6003 demonstrated improvements in levels of viremia, harmful inflammatory indicators, and measurements of virus-induced liver damage.

Our dengue program investigating AVI-6006, our lead candidate, has also advanced. Over the last few months, we've presented preclinical data at both ICAAC and IDSA, further supporting the utility of our PMOplus chemistry. The data from preclinical studies evaluating AVI-6006 in dengue virus-infected mouse and ferret models have demonstrated dose-dependent reductions in viral titer and a broad therapeutic index.

Before turning the call back to Dave, you may recall in December 2006, we entered into a two-year reset contract with the Defense Threat Reduction Agency, or DTRA, of the Department of Defense to fund development of our RNA-based therapeutic candidates for Ebola, Marburg and Junin hemorrhagic viruses. Earlier this month, we agreed with DTRA that the key activities under this contract had been completed and this contract will be deemed concluded. We expect to complete all activities under the contract this year.

That completes our update on our development stage programs, so I'll now hand the call back to Dave Boyle.

Thanks, Steve. Now let me turn to our financial results and guidance.

For the third quarter of 2010, AVI reported an operating loss of $3.8 million compared with an operating loss of $2.9 million in the third quarter of 2009. The increase in the operating loss is a result of a $1.6 million increase in R&D expenses and a $1.6 million increase in G&A costs, offset in part by a $2.3 million increase in government research contract revenues.

Research and development expenses were $9.1 million in the third quarter of 2010 compared to $7.5 million in the third quarter of 2009, an increase of $1.6 million. The increase was due primarily to increases in research costs for the H1N1 program and higher compensation employee costs for additional research and development staff.

General and administrative expenses for the third quarter were $3.4 million compared to $1.8 million in the third quarter of 2009, an increase of $1.6 million. The increase was attributable to higher compensation costs, legal expenses, a reduction in the fair value of property held for sale, and facilities costs related to AVI's new Bothell, Washington facility.

Revenue for the third quarter of 2010 increased to $8.7 million from $6.4 million in the third quarter of 2009 as a result of a net increase in revenues and the new H1N1 and Ebola and Marburg government research contracts. In the first nine months of 2010, the operating loss was $19.2 million, compared with an operating loss of $11.5 million in the first nine months of last year. The $7.7 million increase in the operating loss was primarily the result of a $4.8 million increase in the G&A costs and a $4.3 million increase in research and development costs, offset in part by a $1.4 million increase in government research contract revenues.

R&D expenses were $22.1 million in the first nine months of 2010 compared to $17.8 million last year. The increase was due primarily to $2 million in research costs for the H1N1 and Junin projects; $1.4 million in costs for active investigational therapeutic components; and $900,000 in increased compensation and employee costs for the addition of new staff.

G&A expenses in the first nine months of 2010 were $11 million compared to $6.2 million in the first nine months of 2009, an increase of $4.8 million. The increase was primarily the result of a $2.6 million one-time charge related to the April 2010 departure of AVI's former Chief Executive Officer. The increase was also attributable to higher compensation costs, legal expenses, a reduction of the fair value of the property held for sale, and facilities costs related to AVI's new Bothell, Washington facility.

Revenue for the first nine months of 2010 increased to $13.9 million from $12.4 million in the first nine months of last year as a result of a net increase in the revenue from government research contracts. The net loss for the third quarter of 2010 was $7.3 million or $0.07 per share, compared to a net loss for the third quarter of 2009 of $8.1 million or $0.08 per share. The $8 million -- excuse me, $800,000 decrease is primarily due to the increase in the operating loss, offset by a change in the valuation of certain warrants described below.

The net loss for the first nine months of 2010 was $24.5 million or $0.22 per share, compared to a net loss for the first nine months of last year of $28.7 million or $0.33 per share. The $4.2 million decrease was primarily due to the increase in the operating loss, offset by the valuation of certain warrants described below.

In connection with AVI's 2009 and prior equity financings, the Company issued warrants that are classified as non-cash liabilities. The amount of the warrant liability is primarily affected by changes in AVI's stock price between each financial reporting period, and causes the warrant liability to fluctuate as the market price of AVI stock fluctuates.

In the third quarter of 2010, the warrant valuation increased by $3.6 million relative to the second-quarter of 2010. In the first nine months of 2010, the warrant valuation increased by $5.5 million relative to the valuation at December 31, 2009.

AVI had cash and cash equivalents of $36 million as of September 30, 2010, a decrease of $12.3 million from December 31, 2009. This decrease was due primarily to the cash used in operations during the first nine months of 2010, and cash used for property and equipment and patent-related costs of approximately $1.5 million, offset by cash inflows from the exercise of stock options and warrants of $2.5 million. This results in a net burn through three-quarters of $14.8 million.

For the full year 2010, we confirm our previous guidance for expenditures for operations net of government funding and other collaborative efforts to be approximately $21 million to $25 million. We believe AVI will continue to receive funding from government and other sources to pursue the development of product candidates, and that assumes certain revenues from these awards in providing this guidance. If AVI does not continue to receive the funding from its current contracts, this guidance may change.

The team at AVI is very committed to the continued efficient operation of our business, to meet our financial guidance, and the execution of our strategy to meet our corporate milestones. We will remain focused on advancing DMD and our other development stage programs, influenza, Ebola, and Marburg, while aggressively advancing our R&D efforts in rare and infectious diseases to create a pipeline of proprietary programs that can be fully retained or leveraged to create value via strategic partnerships.

By building on our versatile RNA-based platform technologies, next-generation chemistries, and diverse in-house technical expertise, we believe there is significant potential for AVI to advance programs which create novel therapeutics for patients who have no or limited treatment options, and to create value for our shareholders by appropriately advancing these opportunities independently and with partners.

I look forward to sharing our plans and future developments with you as we advance our programs. Updates for you to look forward to include the initiation of the US AVI-4658 clinical trial for patients with DMD later this year, with initial data expected in the second half of 2011; continuing disclosure of the data from our preclinical studies of AVI-7100 against multiple influenza strains as those data become available; a potential IND filing for AVI-7100 later this year, and the initiation of the clinical studies in early 2011; updates related to our work and to the announced Ebola and Marburg contracts, including initiation of clinical studies in early 2011; disclosure of research-stage programs in rare and infectious diseases as they mature towards full development; and lastly, the potential for partnership announcements.

We believe that the execution of our business strategy and the progress in our development programs is leading to a growing appreciation within our industry and the scientific community of our proprietary, RNA-based therapeutics programs. This appreciation and interest is leading to AVI's greater visibility in the industry and active dialogues with potential pharma partners and drug development collaborators.

As we move through the fourth quarter of 2010 and into 2011, we expect our ongoing business development efforts, program development efforts, and strategic focus will yield both expanded partnership and program opportunities. As AVI moves ahead, we will be sharing our progress with you in a clear, consistent, and timely manner.

Thank you very much for joining me on the call today. We will now ask our Operator, Derrick, to take your questions.

(Operator Instructions). Yale Jen, Maxim Group.

Good afternoon and thanks for taking my questions. Just actually just one question [of the] detailed information you provided, which is that before the US DMD study starting this year -- end of this year -- or later this year, would we anticipate any interim data to be presented at different times? And just generally, how the trial design will be structured in that way, if that's the case.

The actual design of the study and the exact dates, Yale, are still under discussion with both the regulatory authorities and the [ILB]. So probably a little premature to determine how we will proceed there.

So it's not necessarily known at this moment whether the trial design will include any interim data analysis or be only look at the data that the study is completed?

As we mentioned in the call, actually, we think the first data will be available from that trial publicly in the second half of 2011.

Okay, great. Thanks a lot. I appreciate it and congrats on [your] clinical developments there.

Okay, thanks for the question, Yale.

Yigal Nochomovitz, Rodman & Renshaw.

Good afternoon and thanks for taking the questions. I have a question regarding the Phase 2 data from the UK study. As we saw, there was clinical stability in the cardiopulmonary and the ambulatory function. I just wanted to get a sense of how this would compare to a similar population of DMD boys that were untreated?

I know it was a single arm study, but maybe based on historical information, you could give us a sense as to whether you would expect a decline over a similar period of time over this study or would you also see stability? And how does this correlate with the age of the boy?

Right. The Study 28 from the UK, the inclusion criteria were age 5 to 15 and ambulant at baseline. The maximum age in the study was a boy at the age of 13. Usually between somewhere around age 10 to 12, many patients with Duchenne Muscular Dystrophy become non-ambulant and end up in their wheelchair.

So the fact that we had quite a few boys aged between 10 and 13 who seemed to remain stable over the not only 12 weeks of treatment, but for the full 26-week observation period, may be a good sign. But you're right; until we have actually had the opportunity to do a comparative study, it's difficult to say.

In terms of natural history data, there isn't much that's currently being published, although I am aware that several groups are actually collecting this information and will be publishing in due course with some quite large datasets. It will be very interesting to have a look at that data when it's published and see if there is anything we can determine from it.

You may be familiar with some of the data from some of the other companies, like PTC, for instance, which does show fairly dramatic deteriorations, particularly in older boys, over a six-month observation period. So that's really why I feel that the stability we've seen may indeed be quite an optimistic sign.

Thank you. And on that point, regarding the rapid decline as the boys get older, in terms of the upcoming Phase 1 -- Phase 2 study in the United States, how are you going to assure that the trial will be appropriately balanced, so that the AVI patients receiving the drug aren't necessarily the ones that are older and potentially could progress more? What have we done there to balance the arms?

Well, because this is a subset of an already orphan disease indication, it's very difficult to be completely balanced between the arms. But the investigators who we're working with are obviously aware of the need to try and keep the arms as equally balanced as possible. And we'll be doing our best to ensure that. But it will be a small study and the primary objective of the next study is going to be safety. And then we'll be looking at dystrophin expression. So, we'll do the best that we can with the patients that are available.

Okay. Thank you. And David, turning to the AVI-5038, you mentioned that there will be a decision potentially in 2011 regarding the path forward for that program. Is that going to be a go/no-go decision? Or is there some intermediate outcome, meaning there could be a continued evaluation of the drug?

Well, at this point, as we've mentioned, we've seen kidney toxicity, and again, I want to be sure to differentiate that the Exxon 50 skipping drug is a PPMO, which is a very different chemistry. It's a peptide conjugated PMO versus the AVI-4658 program, which is a basic PMO. The basic PMO-4658, as you've seen, has an extremely benign safety profile -- very, very good -- whereas the [arginine of] its peptide actually has some challenges for the kidney.

What we're doing with the 5038 program, the PPMO-based program, is to take a look at some mitigation strategies around the kidney toxicity. We've seen some very promising animal data with respect to potency, but we have run into the toxicity issue. We believe that we can mitigate that, then there could potentially be a path forward.

And I always hesitate to speculate on development -- key development decisions until we have data, but I think that the work we're doing will help us to define if there is a development path forward or not, and what that may be. So that's where we are in that program.

Okay. And you also mentioned in the prepared remarks that you've increased your outreach to potential partners. I'm wondering if you could elaborate briefly there in terms of which programs are being discussed with partners, and would you at all consider a partnership for one or more of your programs, a corporate goal in the upcoming 2011?

Certainly, we've indicated that part of our strategy is to actually leverage the platform via important strategic relationships. And we are very actively seeking to do that in a number of areas.

I want to be clear that it's also part of our strategy to retain a number of products for our proprietary pipeline. We do believe there is great potential and breadth to what we can do with our platform technologies in a number of areas on which we focus. And we have discussions in several of those areas that are actually ongoing right now.

The good news is that there are a lot of different things where we have some early-stage data and can be subject to either building to our pipeline, as we've talked about with some of our early-stage programs that we're focused on, or potentially assets that could be of interest to strategic partners. So I don't want to limit the area of discussions, but there are actually a number of different areas that we are currently in discussions with various strategic partners.

Thanks. And one final question on the new and interesting antimicrobial program, could you give us a sense there as to how far away you are from nominating a lead and potentially filing an IND?

That's not something that we forecast at this point. I always hesitate, particularly with earlier-stage research programs, to give specific guidance as to development milestones especially.

What we do expect is with the ongoing early-stage work, that we are looking to mature those product candidates towards full development programs. As that comes about, we will, of course, begin to communicate what those programs are, and then give you a better idea of some of the timing of the development milestones after that happens.

Okay. And is the target potentially broader than just the Burkholderia organisms that you've mentioned, that it was published earlier in the year?

I'm not going to comment on targets at this particular time. We will give you more specific information once we mature some of those programs into development and begin to talk about them.

Okay. Thank you very much and good luck with the continued progress.

Okay. Thanks very much, Yigal.

At this time, I'm showing no further questions in queue. I would like to turn the call back to Mr. Dave Boyle for any closing remarks.

Again, I'd like to thank you all for joining us on today's call. We are very busy and very excited about what's going on here at AVI, as we move forward our business on all fronts. Thanks again very much for your time today.

Ladies and gentlemen, that concludes today's conference. Thank you for your participation. You may now disconnect. Have a great day.