Alnylam Pharmaceuticals Inc (ALNY) 2009 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the Alnylam Pharmaceuticals Conference Call to discuss the First Quarter 2009 financial results. (Operator Instructions) I would now like to turn the call over to Alnylam.

Good afternoon. I'm Cynthia Clayton, Director of Investor Relations and Corporate Communications. With me today from Alnylam are John Maraganore, our Chief Executive Officer, Barry Greene, our President and Chief Operating Officer, Akshay Vaishnaw, Senior Vice President of Clinical Research, Patty Allen, our Vice President of Finance and Treasurer is also with us, but is suffering from laryngitis. [Mike Mason], our Director of Finance, will be handling Patty's section today. Patty will, however, be available for Q&A.

During today's call, John will go over the highlights of the quarter. Akshay will provide an R&D summary. Mike will review our financials and guidance. Barry will summarize our business highlights and our progress against goals, and we will then open the call for your questions.

Before we begin, I would like to remind you that this call will contain remarks concerning Alnylam's future expectations, plans and prospects, which constitute forward-looking statements for the purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements, as a result of various important factors including those discussed in our most recent annual report on file with the SEC.

In addition, any forward-looking statements represent our views only as of the date of this recording and should not be relied upon as representing our views as of any subsequent dates. We specifically disclaim any obligation to update any such statements. I will now turn the call over to John.

Thanks, Cynthia, and welcome and thanks for everyone, for joining us today on our First Quarter 2009 Call. This past quarter has been extremely productive, as we continue to remain resolutely focused on the key value drivers of our business. Scientific leadership, product pipeline, intellectual property, and business development.

To sum it up, Alnylam is in a stronger position than ever, and we are very much on track to execute on our mission of building a top-tier biopharmaceutical company founded on RNAi. Moreover, our continued progress and scientific leadership has made it clearer than ever, and not just to us, that RNAi therapeutics are advancing rapidly as a whole new class of innovative medicines.

In my introductory comments, I'd like to highlight several key achievements that we've achieved to date in 2009. First, our clinical pipeline is continuing to mature with enrollment now complete in our Phase II RSV trial, and the trial of Phase I dosing with our first systemic RNAi therapeutic, ALN-VSP for liver cancer.

In addition, we are on track to advance a third program to the clinic by the end of this year. For a six-year-old company to advance three organically-derived drug candidates to the clinic based on a cutting-edge new technology is actually a remarkable achievement. A major reason for this progress is the success we've had in achieving delivery of RNAi therapeutics, and while there will always be more to do here, the progress has been substantial as evidenced by our scientific leadership in major conferences, and publications even just this past quarter in peer-reviewed scientific journals.

Second, our existing alliances are going extremely well, and we were excited to announce yesterday that Novartis has again exercised their option to purchase additional shares as they did last year. We were also extremely pleased with the strength of our major platform alliances with Roche and Takeda, and the new partnership we formed with Cubist this past quarter, or this quarter, around our RSV program.

In addition, just last week we extended our long lasting alliance with Isis to advance a promising new technology with single stranded RNAi, or SSRNAi. Also this quarter, we further capitalized our microRNA therapeutics effort led by Regulus. MicroRNA therapeutics continue to represent an entirely new frontier of pharmaceutical research, and we're very excited about where that effort is heading.

Now, given the breadth of our technology and the robust scientific progress we have demonstrated to date, I'm pleased to report that our ongoing discussions with other potential pharmaceutical partners continue to progress quite well, and we are on track to achieve our 2009 goal of two or more partnerships in 2009 which of course excludes our Cubist deal and excludes our recently announced new partnership with Isis.

Third, our intellectual property position remains strong, with over 600 issued or granted patents worldwide, of which nine were awarded this quarter. We have had some setbacks in our Kreutzer-Limmer estate as part of the European patent process, but we continue to believe in the inventive subject matter in these patents and we look forward to getting these patents back on track through the appeal process.

What's critical here is not one patent alone, but the entire estate. And, our estate remains unmatched and the wind is firmly on our back as evidenced by the Tuschl I patent award in Europe and the continued extension of worldwide patent awards in our Tuschl II estate as evidenced by the recent news in China. And, there's a lot more coming.

To be clear, we believe that our IP will continue to be required for the development and commercialization of all RNAi therapeutics, and we're not alone in that belief. As Mike, stepping in for Patty, will soon report to you today, we also continue to achieve solid financial performance. In fact, we have one of the top 10 net cash positions across the entire US biotechnology industry. This is a remarkable position to be in during this challenging economic period. It means that we are here to stay in a big way, and are focused on executing on our business plan to build a great company that's leading one of the most important innovations for new medicines to have appeared in decades.

And finally, I'd like to highlight a key promotion that we announced in January. Namely, we promoted Dr. Akshay Vaishnaw to the role of Senior Vice President of Clinical Research. We're very proud to have Akshay as a strong member of our management team, and those of you that have met him understand how fortunate we are to have such an excellent leader of our pipeline efforts.

With that introduction, I'll now turn the call over to Akshay for a review of our clinical activities, our pipeline, and our scientific progress in a little bit more detail. Akshay?

Thanks, John. Over the past quarter, we've made important advancements with our pipeline programs. First, we were thrilled to advance ALN-VSP for liver cancer into the clinic. Our first clinical program with a systemically-delivered RNAi therapeutic, and also our first oncology program.

The Phase I Trial conducted in the US is a multi-center, open-label, dose escalation study designed to involve approximately 55 patients with advanced liver cancer, including hepatocellular carcinoma and other solid tumors with liver involvement that have failed to respond to or have progressed after standard treatments.

The primary objective is to evaluate the safety, tolerability and pharmacokinetics of intravenous ALN-VSP, including demonstration of the maximum tolerated dose. As our first systemically-delivered RNAi therapeutic, we are very excited about the potential for this program for Alnylam, as well as for the field.

For ALN-RSV01, we recently completed enrollment in a Phase II double-blind, randomized clinical trial to assess the safety and tolerability of inhaled ALN-RSV01 versus placebo in adult lung transplant patients naturally infected with RSV. The study's still blinded and we expect to announce data in the second half of this year.

Just to reiterate, the primary objective of this Phase II study is safety and tolerability, and we do not expect any statistically significant antiviral data as the study wasn't powerfully subjective. Indeed, any antiviral data will be completely exploratory in nature.

The ALN-RSV program is partnered with Kyowa Hakko in Asia, and Cubist in the rest of the world excluding Asia. At the completion of our Phase II study analysis, we look forward to meeting with our partners to chart the best path forward for our ALN-RSV program including both ALN-RSV01 and second generation compounds in both adult and pediatric patient populations.

Turning now to future INDs, we remain on track to expand our clinical pipeline this year with candidates including ALN-PCS for the treatment of hypercholesterolemia, ALN-HTT for the treatment of Huntington's Disease, or ALN-TTR for the treatment of transthyretin amyloidosis. So, by the end of 2009 we'll have entered three RNAi therapeutic programs into clinical development, putting us well on track to meet our RNAi 2010 goal of four or more RNAi therapeutic programs in clinical development by the end of 2010.

As John mentioned, we continue to pioneer the field with our scientific leadership, resulting in four new publications and further data presentations at the AACR and Keystone meetings in this quarter alone. These specific milestones are described in further detail in our press release, and we believe that we're on track to achieve our goal of 15 peer review publications in 2009.

In summary, we're very pleased with our scientific and clinical progress so far, and we're excited about advancing our pipeline even further this year. I'd like to now turn the call over to Mike, to review our financials. Mike?

Thanks, Akshay, and good afternoon, everyone. Our business remains extremely solid from a financial perspective, allowing us to continue to execute on our overall business plan including the advancement of our science, pipeline, intellectual property, and business partnerships. There are details of our financial results in our press release, so I will use the time on this call to highlight certain key results.

Most importantly, we ended the first quarter of 2009 with $504.7 million in cash. As John mentioned, this strong cash position represents one of the top 10 net cash positions across the entire US biotechnology industry, and provides us with significant financial flexibility as we have no need to raise new capital in the equity markets for the foreseeable future.

Our strategy of conservative cash management continues to safeguard our cash position and we continue to have no write-offs related to our cash and fixed income portfolio to date.

Our GAAP revenues were $25.1 million for the first quarter of 2009. As you know, the amortization of up-front payments from the strategic alliances we have formed with Roche and Takeda accounts for a significant portion of our quarterly GAAP revenues.

From our Roche alliance, we are recognizing approximately $14 million in GAAP revenue each quarter over a 5-year period. With our Takeda alliance, we are amortizing the up front payments and milestones totaling $150 million over a seven-year period, which equates to over $5 million per quarter in GAAP revenues.

For our recent Cubist alliance, we are amortizing a $20 million up front payment over seven years which equals over $700,000 per quarter. Finally, please recall that the $15 million in up-front payments from our second quarter 2008 alliance with Kyowa Hakko Kirin continues to be deferred for GAAP revenue purposes until we can determine our last deliverable to Kyowa.

R&D expenses were $25.3 million in the first quarter of 2009 compared to $20.3 million in the first quarter of 2008. G&A expenses were $7.7 million for the past quarter compared to $5.9 million in the prior period. We reported a GAAP net loss of $7.9 million, or $0.19 per share on both a basic and diluted basis.

In addition, yesterday we announced that Novartis elected to exercise their option to purchase additional shares of Alnylam in accordance with our 2005 agreement. Novartis purchased approximately 66,000 newly-issued shares of our common stock at $17.50 per share, based on a contractual calculation of a 20-day trading average ending March 30, 2009, and resulting in company proceeds of about $1.2 million.

This is the maximum amount of primary shares that Novartis can purchase under our agreement at this time, whereby annually they have the right to settle up and maintain their current ownership level of approximately 13.4% of our common stock.

We will record the proceeds from this transaction in the second quarter. We certainly view this election by Novartis to purchase their maximum amount of Alnylam shares as a very strong vote of confidence in our collaboration and our technology.

In summary, we are in a strong financial position with over $0.5 billion in cash and zero debt. To reiterate our 2009 financial guidance provided earlier this year, we expect to end the year with over $435 million in cash, and with a non-GAAP cash net operating loss of approximately $35 million to $45 million.

The SSRNAi alliance with Isis that we announced last week will not affect our cash guidance for the year. Additionally, as we state in our 2009 financial guidance in January, we expect to incur approximately $20 million to $30 million of other cash payments, including our recent Q1 $10 million investment in Regulus, full-year 2009 cash tax payments of approximately $6 million for which the majority of tax payments were made in Q1, capital expenditures, and other potential strategic investments including the SSRNAi deal with Isis.

We continue to expect our 2009 spend profile will represent a prudent and modest increase as compared to 2008. I will now turn the call over to Barry to discuss our business highlights and our progress against goals. Barry?

Thanks, Mike, and hello everyone. In addition to the pipeline and scientific progress Akshay mentioned, we had a great quarter in terms of strengthening our business relationships and our intellectual property positions. I'd like to spend a moment reviewing this progress.

We are very pleased to have successful partnerships with some of the leading innovative pharmaceutical and biotech companies such as Roche, Novartis, Biogen Idec, Takeda, Medtronic, Cubist, Kyowa Hakko, Isis, and others. As we've discussed, the need for innovation in our industry has never been more clear, and we continue to have important discussions with the most senior leaders in our industry.

During the quarter, in fact, we established a global partnership with Cubist for further advancement of our ALN-RSV program. This partnership is a 50/50 co-development and profit share arrangement in North America, and a milestone and royalty bearing license arrangement in the rest of the world outside of Asia, where ALN-RSV is partnered with Kyowa. It is important to point out that on a combined basis, Alnylam's partnerships with Kyowa and Cubist include $35 million in up front payments and greater than $160 million in potential development and sales milestone payments.

These are extremely competitive set of deal terms, especially where we keep 50% of the US market. As we announced just last week, we also expanded our relationship with Isis and our efforts on the delivery of RNAi therapeutics through a new alliance focused on the development of single stranded RNAi. As part of the collaboration, Isis has co-exclusively licensed its single stranded RNAi technology to Alnylam in exchange for up front payments, research and development milestone payments, and royalties. This new arrangement is a testament to the positive collaborative relationship we have with Isis, where our two companies are establishing the leading position in RNA therapeutics.

We view single stranded RNAi technology as early yet promising, and clearly our focus remains on double-stranded SRNAs where we've had major success in our efforts, as has been described.

Further, Alnylam Isis continued their investment in Regulus Therapeutics, strengthening the company's balance sheet with a $20 million Series A preferred equity financing.

Regulus is focused on the discovery, development and commercialization of microRNA therapeutics, an entirely new frontier of pharmaceutical research. Alnylam and Isis were the sole and equal investors in the financing, and we maintained our approximately 50% position. Indeed, we found no need to add new investors to Regulus at this time due to our continued excitement about this effort and the very clear value we can return to Alnylam shareholders by maintaining a maximal ownership position.

Now, let me move on to intellectual property. Alnylam's IP estate includes issued, allowed or granted fundamental patents in many of the world's major pharmaceutical markets that claim the broad structural and functional properties of RNAi therapeutic products. These accomplishments are outlined in our press release.

So far in 2009, we have had 9 new patents issued or granted in countries around the world, putting us well on track to meet or very likely exceed our goal of 15 or more patent grants in 2009. Most importantly, we are pleased with the grant of the Tuschl I patent in Europe, and the Tuschl II patent in China, as well as the first grant of the Kay & McCaffrey Patent. It's important to look at our fundamental patents together, and appreciate the aggregate benefits they provide as a whole to our business. All told, and to reiterate what John said earlier, we remain very confident in our unparalleled intellectual property position and believe that it is needed for the development and commercialization of all RNAi therapeutics.

In summary, to review our 2009 goals, this year we intend to have three programs in the clinic, sign two or more partnerships, and end the year with greater than $435 million in cash, and further strengthen our scientific leadership and IP position. There's clearly a dynamic set of news flow that we expect in the months to come. In the meanwhile, we've gotten off to a great start in 2009. So, we're well positioned for success this year with an advancing pipeline, leading science, very clear financial strength, active business development efforts, and an extremely talented team.

With that, I'd now like to turn the call back to the operator, and get your questions. Kamisha?

Thank you. (Operator Instructions) And, your first question comes from the line of Stephen Willey from Thomas Weisel Partners. Please proceed.

Hi, good afternoon, thanks for taking my questions.

No problem. Hope you're doing well.

I'm doing well, thank you very much. A quick question on RSV. I know Cubist had mentioned on their call that they are actually, I think, looking at a dose escalation study that's under way right now, in healthy volunteers. Can you maybe just give us a little bit of background on kind of what the objectives are there? Is it just primarily safety, or are you looking for some more PK type stuff, or --?

Yes, let me have Akshay answer that question. We first described that study by the way at our last call, which was the year-end call. But Akshay, do you want to describe the study?

Yes. That, that's a very interesting study and it really flows from increasing insights from our animal model, where we are able to show that splitting doses in the RSV mouse model, where we've shown a lot of positive data with ALN-RSV01, gives equally if not better efficacy. And, we wanted to translate that into the human setting by exploring safety and PK of a dose given either in totality or in aggregate at one level, or splitting it into a BID or TID measurement, and really that's the goal of that study. Safety and PK, of split doses. And as we learn more about that, that gives us a better opportunity to exercise that kind of pharmacology in naturally-infected patient setting.

Then maybe just a little bit more background on some of the next generation compounds that are being worked on in the clinic for RSV?

Sure. Akshay, you want to handle it?

Yes. We've been very lucky. It's kind of an intrinsic property, I guess, of each of our programs that we have many, many options to go back to because for any given target, we'll have a large panel of backups that are waiting. And some of the attributes we'll look at, will be potency, bioavailability, there may be aspects of safety, and as we move the program forwards obviously all of these would be considered if we go to a backup and decide to go to one of those molecules in the large panel that we have.

Yes, and I would just add to that, Stephen, that obviously the RSV program is our first clinical program, and it's been a remarkably important experience in terms of developing the entire class of therapeutics, and one of the things that we have the benefit of doing is obviously as we learn from the advancement to that molecule, we can learn about attributes that we might want to optimize in second generation molecules. The hope here and the expectation is that it also provides a differentiation strategy for advancing products in both the pediatric and the adult population, and clearly understand from our perspective that there are attractive market opportunities for both the pediatric and the adult populations. So, obviously having a different molecule that can be truly differentiated is part of an overall strategy that we've been engaged here for quite some time.

Okay. And then the second half data release on the trial, would we just expect to see top line data come out of a press release? Is there an infectious disease conference in the back half of the year that we should kind of have our eyes open towards?

Well, we'll likely release the data when we're able to, when we have the data un-blinded and analyzed in its form. And, that's likely how you will first hear of it, Stephen. And then, obviously, there are a number of meetings in the back half of the year that we would expect to be able to present the data at, either in an oral presentation or in a poster-type presentation. And, that's our typical practice for disclosing data.

Okay. Maybe just one more question if I may? I know Tekmira announced today that the FDA, I think, accepted their IND for their ApoB.

Exactly.

And can you maybe just walk us through I think, your thoughts on the PCSK target versus the ApoB in that indication?

Sure. I mean, I think that first of all it's absolutely fantastic news that Tekmira got the clearance to go ahead with their program, and obviously there will be a lot that both companies can benefit by the advancement, because they use a related delivery formulation for the advancement of systemic RNAi therapeutics. There's a lot of joint learning from all that. And obviously the FDA's review of a very high quality package that we have also had the privilege of seeing is I think a strong testament for the quality of the work they've done.

But, related to targets, in ApoB and PCSK 9, one could have a group of very smart people around a table and as often happens in science and medicine, have a range of different views. Our view is that PCSK 9 is clearly a extremely well-validated genetic target in the context of the treatment of hypercholesterolemia, and we think that the data that have been generated over the last two to three years, that have clearly demonstrated the role of PCSK 9 in the regulation of LDL receptor levels, and the mechanism of accelerating plasma LDL clearance levels by silencing PCSK 9, is in our view the most compelling mechanism for the treatment of hypercholesterolemia and it's why we're betting on that opportunity.

We certainly could have pursued ApoB, if we wanted to. We have chosen not to pursue ApoB as a clinical program and to focus on PCSK 9, and it's plain and simply based on just the very, very clear cut human genetic data corroborated by lots of other data that argue that PCSK 9 is in fact the preferred target in our view. In our view. And other people may have different views and there's just a difference of views and difference of opinions, and obviously we'll ultimately see which approach is best. And I don't think it's an either-or in the future, either.

Great. Thanks for the color, and thanks for taking my questions.

Good.

Your next question comes from the line of Pamela Bassett from Cantor Fitzgerald. Please proceed.

Thank you. Hi, everybody.

Hey, Pamela.

Hi. Can you talk a little bit about kind of what the decision criteria might be, around advancing the one of the three pre-clinical programs, and -- during the --?

Yes, absolutely. I mean, they're both -- all three of them are very active programs, right now, that are in sort of pre-development development stages, if you will. And it's data-driven. It's also, we're literally at the cusp of making the critical allocation decisions to pull one of them ahead of the others. Probably at the next conference call we'll be able to tell you explicitly which one is top dog for the year. But there -- all three are actually quite advanced, and are making good progress. But it's ultimately data-driven, Pamela, and it's driven by not only the data around the pre-clinical studies where we presented much of these data to you, but it's also driven a lot by the clinical strategies. So, we looked long and hard, and this is one of the reasons we're blessed to have Akshay here on our team. We look long and hard at the clinical path forward for all three programs, to really reflect on which one should be our highest priority. It's basically portfolio management, something that companies need to do well. But all three of them will ultimately be in the clinic by our thinking, because all three of them are important therapeutic opportunities addressing some very serious unmet medical needs.

And does that strategic thinking also extend as far as partnering activity, as these move forward?

That's an integral part of all of that. You know, in terms of how we think about partnering, and again, on our product side, our partnering strategy is to partner ex-US and minimally retain 50% of the value of these products in the US market. And our goal is to ultimately commercialize these products at least on a 50/50 basis, with partners in the US, and obviously have strong partners for the rest of the world.

So, getting things into Phase II, you're not necessarily having to wait or wanting to wait. Might we see earlier stage partnering around some of these pre-clinical programs, or even VSP?

I think that minimally, our thinking has always been to advance these programs to an IND stage, because that adds significant value for relatively incremental additional costs, and certainly incremental additional risks potentially. And so, minimally that's been a strategy for us. From that point forward whether we choose to wait or partner sooner is completely up to the type of market based deal, economics, and the strength of the partner very importantly, that we can find.

I can tell you for example that in some of those cases, and let me remind you that Medtronic is already 50/50 partnered in the -- Huntington's is already 50/50 partnered in the US with Medtronic, so that one's already spoken for.

Right.

In that regard. And we're developing that product as a drug device combination, so there's simply no better partner in the world than Medtronic, bar none. To say the least. But in the case of TTR or PCSK 9, there's already interest in both those programs, but again we would choose to wait to the IND stage.

Okay. And for ALN-VSP, and I'm sorry if you already addressed this, should we be looking for data from the Phase I towards the end of the year, or is it going to be next year?

Well, the Phase I is an open label study, and it's a study that is enrolling the beginning stages of its enrollment. It's enrolling well. Multiple patients have been dosed. And we have not yet decided when we would make data available from that study, and so perhaps at the next call, Pamela, we'd be able to provide some more color on that.

We don't want to have, and should not have for many reasons, inappropriate communication of data that is every other patient if you will, to take one extreme. So we want to make sure that we have good data sets, so that we can appropriately communicate the things that we're seeing as we advance that study.

But bear in mind that the initial dosing right now is at the lowest dose. These are dose escalation studies, and data at this stage may or may not be relevant in the context of where the drug's activity's going, as we get to the higher doses.

And remind me, John, how many patients are enrolled?

Approximately 55. Oh, you mean currently? Yeah, I just said multiple. Multiple patients so far.

Okay. But the -- it'll be up to 55?

That's correct, Pamela.

And the last question.

Sure.

I think I heard that Tekmira is using a related delivery technology, delivery system? To -- what is being used for ALN-VSP, is that correct?

Yeah, that's correct. It's not -- it's not identical. But it is very closely related.

So, is it a second -- is there a reason for that difference, that is related to what they're trying to do versus what you're using VSP for, or is this another delivery system that you have access to?

It's really a very simple iteration. As you know, the liposomal nanoparticle has -- is comprised of different lipid components, and it's truly just a adding a little bit of salt into the recipe, is a simple analogy to think of. Okay? And it reflects the fact that they had done some tweaks that they were able to lock down in their development process, that weren't locked down at that point in time when we'd launched our ALN-VSP program. But these are really very small changes that are not expected to have any meaningful benefit or change.

And of course, you have access to --?

And we have access to all of that for you know, our PCSK 9 program, our TTR program, or whichever program we want to take advantage of. The technology related to delivery is always evolving, and so you have to take forward the delivery technology that is appropriate for the clinical application at the time in which you launch your development program. So, there can be changes. One can expect changes from one iteration of our LNPs to the next, but they are part of a related family.

Okay, great. Thanks very much, John.

Great.

(Operator Instructions) And your next question comes from the line of Ted Tenthoff from Piper Jaffray. Please proceed.

Great, thanks.

Hi, Ted.

Hey, how are you, John?

Great.

Two quick housekeeping questions. What was the Novartis revenue contribution in the quarter, and how will you recognize the Isis license fee this quarter?

Okay. Mike, do you want to do this, or Patty, if you can speak up?

I can, I can answer.

Better have Mike do it.

It doesn't sound good, but for the quarter Novartis GAAP revenues were $2.7 million, Ted.

Great, thanks.

And then the Isis $10 million we're still discussing the accounting with our auditors, but we believe we're going to be exempting it in Q2.

And was it $10 million or was it $11 million?

I'm sorry, $11 million, it's $11 million.

And then John, kind of --

Aren't you glad that Patty let Mike do the call?

From kind of a higher, [30,000-foot view], what really is the difference between SSRNAi and [anti sent]?

Oh, that's easy, Ted. One uses an RNSH mechanism for targeting the cleavage of a given mRNA, and the other uses Ago2 and the RISC complex of the RNAi pathway. So they have completely different enzyme machineries and also different, likely different localizations within the cell as to where they occur.

But you know, keep in mind, SSRNAi is still very early. It's an interesting technology, we're excited to be working with Isis on it. It's real early and it doesn't change, it still has a long way to go before it's going to compete with double-stranded approaches for sure. But we're the leaders in RNAi, and we need to be involved in all aspects of RNAi, and single stranded technology is part of that for engaging the RISC complex, and so we need to be involved with that and we are involved with that with our excellent friends in Carlsbad.

All right, thank you very much.

Great, thanks Ted.

At this time, there are no questions in queue. I will now turn it back over to John for closing remarks.

Thank you, and thanks everybody for joining us today. We are -- we couldn't be more excited about what we have done this past period, and we certainly look forward to updating you on what will be an exciting and very dynamic year, so stay tuned. Bye bye, now.

Thank you for your participation in today's conference. This concludes your presentation. You may now disconnect, and have a wonderful day.