施貴寶 (BMY) 2008 Q4 法說會逐字稿

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  • Operator

  • Greetings, and welcome to the ZymoGenetics Fourth Quarter and Year End 2008 Financial Results Conference Call. (Operator instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Susan Specht, Director of Corporate Communications. Thank you. You may begin.

  • Susan Specht - Dir. Corp. Communications

  • Good afternoon, everyone. Welcome to ZymoGenetics Fourth Quarter and Year End 2008 Conference Call. Before we begin, I need to remind you that we will be making forward-looking statements as part of our prepared remarks and in answering your questions. These statements are subject to many risks and uncertainties that could cause actual outcomes to be much different than we predict. Please look at our SEC filings including the Form 10-K for more information. And now, I'll turn the call over to our Doug Williams, our CEO.

  • Doug Williams - CEO

  • Good afternoon, everyone, and thank you for joining us on the call. We'll be reviewing our fourth quarter and full year 2008 financial performance, and providing guidance for 2009. But before I turn it over to Jim Johnson our CFO to discuss the numbers, I'd like to highlight major areas of progress since the last quarterly call.

  • Perhaps the most significant news was the announcement of our collaboration with Bristol-Myers Squibb for the development and commercialization of Interferon lambda. We believe that Bristol is the ideal partner for this molecule and that partnering at this stage of development assures the smoothest and fastest path to registration. This transaction will provide us with significant near-term cash and downstream economic participation in the success of Interferon lambda.

  • We expect that we will receive $200 million in cash through a combination of license fees and milestones during 2009. Furthermore, we will share the profits and retain a co-promotion right in the US. We will also receive double-digit royalties on sales outside the US. This is of course dependent on our continued participation in funding a portion of the development costs in the US and EU.

  • Turning now to IL-21, we've recently completed a transaction that we believe substantially increases the value of this molecule to ZymoGenetics. We acquired ex-North American rights to IL-21 for all indications from Novo Nordisk. This transaction was structured in a way to avoid any upfront cash consideration to Novo, but with provisions for sharing a portion of the license fees above certain threshold levels and royalties on ex-North American sales. We believe that having the worldwide rights to this program will provide an attractive licensing opportunity.

  • Our Phase II studies with IL-21 and renal cell carcinoma and melanoma are proceeding and will provide final data in both indications this year. We believe that the data shows that we have an active agent in both indications with an acceptable tolerability for outpatient dosing.

  • In addition to progress with Interferon lambda and IL-21, we've made progress with our RECOTHROM business. Jim will give you the specific financials, but we feel encouraged by the growth we've seen in sales during the fourth quarter. We believe the new pricing strategy implemented in October, along with the efforts of our sales and marketing team are responsible for this increased sales activity.

  • In an effort to strengthen our RECOTHROM team, we brought Stephen Zaruby into the Company as president. Stephen has extensive sales and marketing experience in the hospital setting and has the mandate to make RECOTHROM a success as well as managing any line extension, product acquisition, or co-promotion strategies to make our commercial operations more efficient and profitable.

  • With respect to additional data on the safety and efficacy of RECOTHROM, we presented the results of our Phase IIIb study at ASH in December. This study further expanded our safety experience with the product and demonstrated that RECOTHROM did not produce an immune response in patients with pre-existing anti-bovine thrombin antibodies. Remember that the black box warning for bovine thrombin states that patients who have anti-bovine thrombin antibodies should not be re-exposed to bovine thrombin. RECOTHROM offers a treatment alternative for these patients to avoid this re-exposure risk.

  • The results further document that in certain surgical settings, a substantial percentage of patients continue to have a detectable, pre-existing, anti-bovine thrombin antibody titer.

  • Before I turn it over to Jim, let me signal a shift in how we'll be speaking about RECOTHROM from now on. In prior quarters, early in the launch, we had given updates on softer, sometimes confusing metrics, such as P&G committee meeting numbers and formulary decision outcomes. We've now been in the market for a year and we're shifting away from those metrics to providing net sales guidance, which is the metric that matters. Jim?

  • Jim Johnson - CFO

  • Thank you, Doug. There were a number of positives reflected in our fourth quarter financial results. The continued growth in RECOTHROM sales is starting to have a meaningful impact on revenues. We've also had a substantial amount of license and collaboration revenue in the quarter. And we're seeing greater impact from our efforts throughout 2008 to reduce R&D expense. As a result, our net loss for the quarter declined to $9.2 million, or $0.13 per share, compared to $38.6 million, or $0.56 per share in the fourth quarter of 2007.

  • Revenues for the quarter totaled $36 million. The settlement of our litigation with Bristol-Myers Squibb by licensing them our Ig fusion patent brought in $21 million of this total. The full license fee was recognized as revenue in the fourth quarter because we have no ongoing or future obligations under the agreement. In addition, we recognized $9.5 million of deferred revenue under our collaborations with Bayer and Merck Serono.

  • RECOTHROM net sales for the quarter were $4.7 million and this is 165% greater than net sales in the third quarter. We saw increased demand each month during the quarter. It's important to point out though that there was an increase in the levels of wholesalers stocking during the quarter. We've estimated the increase at approximately $800,000, which could end up affecting first quarter 2009 revenues by one to two weeks of sales.

  • Cost of product sales for the quarter was $4.7 million, which included a $3.8 million reserve for inventory projected to become obsolete. We now have a better visibility into our rate of market penetration. And although we're planning to extent the shelf life of our finished product to 36 months, we won't have the stability data until late 2009.

  • We recorded the obsolescence reserve in recognition of these factors and with this reserve, we believe the issue is now behind us.

  • R&D expense for the quarter reflects our ongoing efforts to reduce operating costs. Fourth quarter 2008 expense dropped substantially, in fact nearly in half, from the fourth quarter of 2007. And there were three primary factors responsible for this.

  • This continuation of our Atacicept development costs resulting from the restructuring of our Merck Serono collaboration. Lower internal cost resulting from head count reductions made in the first quarter of 2008. And expensing of RECOTHROM inventory costs in the fourth quarter of 2007, prior to FDA approval.

  • SG&A expense was up about 8% in the quarter to $14.6 million, and nearly all of this increase was attributable to sales and marketing costs.

  • Our operating expenses for the quarter included $5.3 million of non-cash stock compensation expense, but of this $3.3 million was included in R&D and $2 million in SG&A.

  • I'm going to shift subjects now and look ahead to 2009 and our financial expectations for the year. Before I do that however, I want to remind you that these estimates reflect our current thinking based on today's circumstances. We expect further improvement in the numbers because we plan to complete additional collaboration or licensing transactions, which we expect to bring in more cash. And we expect to take further steps to reduce our operating costs.

  • So, for 2009 RECOTHROM sales we expect to see a continued upward trend and we believe that net sales for the year will fall within the range of $25 million to $35 million.

  • Other revenues should be in the range of $95 million to $105 million. The largest component of this amount is revenue from our Interferon lambda collaboration with Bristol-Myers Squibb, which is expected to close later this quarter.

  • Similarly to our collaboration with Bayer for RECOTHROM, we will record the Bristol-Myers Squibb license and collaboration revenue using the percentage of completion method.

  • Revenue will be recognized proportionally based on the costs we incur each period. And we expect to receive $200 million of cash in 2009 under the collaboration, however the amount we record as revenue must be reduced by any amounts payable back to Bristol-Myers Squibb for their program related costs. Remember that we're responsible for paying the first $100 million of the program costs.

  • Over the coming three years, we expect to recognize total revenue under the collaboration of approximately $150 million and of this, we expect that approximately $50 million to $60 million will be earned in 2009. And the first quarter revenue amount will be quite a bit less than in quarters two through four due to timing of the transaction.

  • Moving to costs and expenses, we expect 2009 costs of product sales to be in the range of 20% to 22% of net sales. R&D expense for the year is expected to fall within the range of $115 million to $125 million, which includes a substantial ramp up in PEG-Interferon lambda development costs that's offset by savings from the conversion of the Atacicept collaboration.

  • SG&A expense should be in the range of $60 million to $65 million and there will be very little growth here other than the commission payable to buyer on RECOTHROM net sales in the US.

  • Overall, we expect our net loss for the year to be in the range of $55 million to $75 million or from $0.80 per share to $1.09 per share.

  • Our cash situation is strong. We ended 2008 with about $90 million of cash and investments and we expect to end 2009 with somewhere in the range of $120 million to $140 million. But this doesn't reflect additional cash that we expect to bring in from new transactions and further reductions in operating expenses that we expect to achieve.

  • And additionally, we still have $75 million available to us under our Deerfield line of credit that can be drawn anytime between now and January 2010.

  • Overall, the financial trends for the Company are improving. And we have the financial resources we need to carry out our business plan in 2009 and beyond.

  • Back to you, Doug.

  • Doug Williams - CEO

  • Thank you, Jim. I'll turn your attention now to what you can expect as far as milestones for the Company in 2009. On the RECOTHROM front, we're focused on building on the sales momentum we saw in Q4 of 2008 to meet or exceed our 2009 sales guidance. Interferon lambda should begin Phase II clinical testing in the second half of 2009. We're currently finalizing our development plans with Bristol-Myers Squibb and we have a poster presentation to update you on our Phase Ib study at the EASL meeting in Copenhagen in late April. We'll present data on the combination of Interferon lambda plus ribavirin in this session.

  • We plan to present final data from the renal cell study in combination with Nexavar at ASCO. We'll also complete accrual and have final data in melanoma with IL-21 as a single agent by year-end. These data will support partnering activities with this molecule for further development and commercialization.

  • We're also actively pursuing additional partnering transactions to facilitate more rapid movement of our preclinical assets into development and to bring additional cash into the Company. This is part of the strategy we've articulated to reduce the Company's cash consumption.

  • So, in summary we have three major strategic objectives for the year. The first is to make RECOTHROM the success in the marketplace we think it can be. Our second priority is to aggressively develop Interferon lambda with our partner Bristol-Myers Squibb, initiating key Phase II clinical trials. And finally, we remain committed to reducing our cash burn in 2009 through additional cost cutting and partnering activities.

  • At this time, we'll be ready to take your questions.

  • Operator

  • Thank you. Ladies and gentlemen, we will now be conducting a question and answer session. (Operator instructions) Our first question is from Edward Tenthoff with Piper Jaffray. Please go ahead with your question.

  • Edward Tenthoff - Analyst

  • Great, thank you very much and congratulations on a much improved year-end. I know there's been a lot of work and a lot of tough decisions, so congrats on all the hard work and progress.

  • If I may, just starting with the RECOTHROM sales for the quarter, the stocking issue and sort of the pricing update. You've given the guidance of $25 million to $35 million. Can you give us a little bit more color on that? Are you finding that you are converting bovine? Is it coming at the expense of other human thrombin? Give us a little bit more color on that fourth quarter success and sort of how the pricing is staking up currently.

  • Doug Williams - CEO

  • Hi, Ted. This is Doug. Thanks for the compliment at the beginning of your question. We do think that the quarter was certainly a good one for us and moving us in the right direction.

  • I think as far as the fourth quarter for RECOTHROM, certainly the pricing change that we took in October I think was a key reason for accounts to convert. We've been seeing I think more activity in the marketplace in the fourth quarter in terms of sales activity. That has begun to translate into dollars and I think we're beginning to get a handle now on the run rate sort of based on that fourth quarter. And that's what has sort of led us to project forward and give our guidance for 2009 with some sense of confidence.

  • As far as the stocking issue is concerned, I think again we've sort of looked at the run rate and made an estimate based on what we had seen as the levels of wholesaler stock that were sort of consistent with previous levels of sales. And made an estimate that approximately $800,000 of the fourth quarter reflected stocking sort of in anticipation of the beginning of the year. So, we've sort of based that off of comparing the sales curve with the previous stocking curve then and really coming up with that gap and estimating that that's attributable to about $800,000 of that number.

  • Edward Tenthoff - Analyst

  • Right. And just from the competitive side, can you say is the gains coming to the expense of bovine? Are you still seeing OMRIX J&J or has that transaction caused some disturbance there? Just give us a little bit of color on the market.

  • Doug Williams - CEO

  • I think in terms of the topical hemostat market, we've got information now on 2008 and how that market has played out. The IMS information would tell us that primarily what seems to be happening in the marketplace is a displacement of bovine thrombin. I think that the majority of that change is attributable to us taking market share away from Thrombin-JMI. I think the level of activity for EVITHROM is still somewhat difficult to ascertain, although certainly the numbers would lead you to believe that they haven't been making significant inroads in terms of that particular product.

  • Now again, I think we've always said that we're not certain of the reporting around EVITHROM as far as those numbers are concerned, but certainly the information that we have would suggest that in terms of capturing market share from Thrombin-JMI that we're sort of leading the way versus the other plasma based thrombins that are out there.

  • And we don't see any real discernable difference in terms of J&J's acquisition of OMRIX. We didn't really expect that there would be given that J&J has always been responsible for the marketing and sales of the product all along.

  • Edward Tenthoff - Analyst

  • Right, that's very helpful. I appreciate it.

  • Operator

  • The next question is from Marshall Urist with Morgan Stanley. Please state your question.

  • Marshall Urist - Analyst

  • Yeah, hey guys. Good afternoon. So, I just wonder if we can go back and talk a little bit more about the RECOTHROM guidance. I mean I know you don't want to talk about the formulary placements and everything, but can you give us a sense of the extent to which the pace there is improving and are you seeing any change in the -- in complete conversion versus sharing formularies?

  • And then on the guidance for next year, when you got to that number, it's still a pretty healthy improvement off the run rate from the quarter if you back out the inventory charges. I was wondering what are you guys assuming in there in terms of how much of that is sort of follow through from accounts where you're already in and then how much are you counting on the new accounts and formulary replacements to get you that number?

  • Doug Williams - CEO

  • I mean without giving you too much color around how we triangulated in on that range, I mean suffice to say that we feel as though we have a much better handle on what's happening in the market right now than we did certainly earlier last year. We've looked at our current run rate and made a few assumptions about some of the accounts that we know have converted but aren't yet reflected in the sales. So, I think that we've taken sort of a data oriented approach to generating that range that we provided and we feel pretty comfortable right now with that range based on what we see today.

  • So, I think we feel as though there are some accounts that obviously haven't begun their ordering process. And I think overall what we're seeing in the market in terms of general activity trends, we're getting more P&T committee meetings. We're still successful at those P&T committee meetings. And again, we're trying to move away from spending too much time on those softer metrics, which many of the people whose names I see are on the call have expressed some dismay of not really knowing how to utilize that information effectively given all of the different variables that play into the time it takes for an account to convert. The time it takes for a converted account to switch to actual steady state ordering patterns. It's been a complicated metric for people to understand. So, I think we feel pretty comfortable with the numbers we've put out there based on the fourth quarter run rate and what we see moving forward into the market.

  • Marshall Urist - Analyst

  • Okay, got you. And then I just wanted to ask you another question about the -- how you guys are thinking about the cost structure in R&D. And obviously some of the work that you're going to be doing there is going to be masked by the first $100 million from the Interferon lambda deal. So, I just wonder if you could give us a sense of how your thinking about that through the year and how we might be able to think about where the R&D base could be once kind of emerging from $100 million number.

  • Jim Johnson - CFO

  • Yeah. Hi, Marshall. This is Jim. It's kind of difficult because we're still working with a very preliminary development plan. But generally speaking, I can tell you that in the guidance that we've provided, we've assumed that in 2009 we would be incurring the first $40 million to $50 million of the $100 million that we're committed to cover under the deal. So, essentially figure roughly half of that $100 million in 2009 and the other half in 2010. And then we'll be converting to the -- to 20% proportion that we're committed to on a longer-term basis.

  • Marshall Urist - Analyst

  • Okay, got you. And then last question. Is the -- is just -- if you guys could talk about if there's anything -- how things are going on the other partnering transactions and timelines for that throughout the year. Do you guys have a goal there? Or is it just any time over the year?

  • Jim Johnson - CFO

  • Well, as you know it's difficult to predict the specific timing. I will tell you that we are actively having partnering discussions right now. And we would hope to be able to conclude those fairly shortly. But I can't give you a specific timeline given the uncertain nature of those types of transactions.

  • Marshall Urist - Analyst

  • Okay, great. Thanks, guys. I appreciate it.

  • Operator

  • You next question is from Han Li with Stanford Group. Please go ahead with your question.

  • Han Li - Analyst

  • Oh, yes. Good afternoon. Questions on RECOTHROM. (Inaudible) file [you can mark] the application last August. Any update on the European regulatory discussion and timeline of approval? And also, can you give us some color on that European thrombin market? We know that J&J also filed for their human thrombin product in Europe too.

  • Doug Williams - CEO

  • The -- as it relates to buyers filing in Europe, there's no real update at this point to provide you with other than our assumptions haven't changed. We're still operating under the joint assumptions that the existing package of data that we provided will be acceptable to garner registration in that territory.

  • Again, as you know the communication issues around contact with the EU authorities is something that we have to sort of follow the lead of our partner on. And until they're ready to disclose any additional information we sort of follow their lead in this regard. But at this point, there's no change in the assumptions. We're still operating under the assumption that the existing package will be acceptable to garner approval in the EU territory and beyond.

  • And as far as the thrombin market, again I think this is a situation where there is no standalone thrombin in the EU market today. Bayer believes that that provides a very significant opportunity to basically launch a product and build a new market where there isn't one. The current options for physicians in the EU territory are either cheap surgical sponges, which really don't have much in the way of hemostatic properties. Or expensive fiber and sealants, which by definition are expensive and physicians sort of keep those in reserve.

  • I think the price point for a standalone thrombin product in that market could be quite attractive and therefore it represents a good market opportunity for Bayer. That's the way they have seen it obviously since they struck the deal with us. And again, we're optimistic that we'll receive approval on schedule.

  • Han Li - Analyst

  • Okay. When you say on schedule of approval timeline, are you just -- should we -- the earliest we expect it should be sometimes this summer in Europe?

  • Doug Williams - CEO

  • It's usually about 12 to 14 months I think is the average time in the EU.

  • Han Li - Analyst

  • So, if you filed August -- last August, should be sometime August, September early?

  • Doug Williams - CEO

  • Again, I think that's an estimate. I'm not sure that the EU follows quite as rigorous a calendar in that way. So, I would assume second half of 2009 sometime.

  • Han Li - Analyst

  • Uh-huh. Quickly, roughly ballpark, the European and other territories in terms of market size. Can we think it's equal size or bigger than the current US market?

  • Doug Williams - CEO

  • I think the way we've been thinking about the ex-US market is that in the aggregate it's probably a comparable size to the US market.

  • Han Li - Analyst

  • Okay. And quickly, a couple of housekeeping items. On the RECOTHROM -- the US sales, you recorded US sales that pay a royalty to Bayer, which is commercial partner. So, what -- that will go into the expense line going to SG&A (inaudible)?

  • Doug Williams - CEO

  • Yeah, that's correct.

  • Han Li - Analyst

  • And you disclosed this up to 20% royalty rate?

  • Doug Williams - CEO

  • That's the high-end of the range is 20%, but it starts in the mid-teens.

  • Han Li - Analyst

  • I see. I notice all the Bristol-Myers -- Interferon lambda deal. You say the revenue is recognized as a percent -- percentage of completion. What -- but over what period? Is it seven or 17 years? Or longer or --?

  • Doug Williams - CEO

  • Well, it's yeah. It's a good question. It might have not been clear in my comments. But generally speaking it's based on our commitments to incur costs. And because we -- in that agreement we have an option to convert it from an active agreement to a passive agreement, much like we did with Atacicept. At any point in time, we're not stuck to that very long period of time for revenue recognition. So, we look at what our current intentions are as far as active participation. And we came up with an approximately three-year commitment period.

  • Han Li - Analyst

  • I see.

  • Doug Williams - CEO

  • So, basically the net amount of revenue that we plan to recognize is about $150 million over three years.

  • Han Li - Analyst

  • Okay. And on the -- lastly on the $100 million clinical cost -- of development cost you have the first $100 million. I heard you mention that you have to reimburse Bristol (inaudible) from the top line revenue?

  • Doug Williams - CEO

  • Basically the way it works is that on a cash basis, we'll bring in $200 million in 2009. Whatever part of that ends up going back to Bristol just closed to our balance sheet and never goes onto our P&L. And so, basically it's netted out.

  • Han Li - Analyst

  • Got it. Right. Thank you very much.

  • Operator

  • The next question is from David Miller with Biotech Stock Research. Please go ahead with your question.

  • David Miller - Analyst

  • Great. Thanks for taking my question. King Pharmaceuticals has a new Phase IV clinical trial that they're working on. It's a four ARM trial of about 600 patients whose intent is to try to get at the -- or at least from their intent as stated, intended to try to get the effect -- at the effect of possible exposure to Thrombin-JMI on APTT. Can you give us some thought about how you're thinking about this trial in terms of competitive positioning? And what you have in your plans or in your existing data that you can use out in the field on this issue?

  • Doug Williams - CEO

  • Sure, we're certainly aware of the study. It's been ongoing for a while. I think if you look at the study design, it's our belief that it will not be able to clarify or negate the risks associated with immunogenicity simply because of the way they've chosen to design the study. It will, in our estimation, not enable them to remove the black box warning based on the way in which the study has been designed.

  • So, we continue to monitor the situation. We're obviously exploring various options to react to whatever their chosen course of action is in the marketplace with that data. But suffice to say that we believe and certainly there's documented evidence to show in the literature that the issue with immunogenicity and coagulopathy is not a problem that has gone away. It continues to be an issue and likely will continue to be one.

  • David Miller - Analyst

  • Have you had any inquiries from cooperative groups or other large centers who want to run a study to kind of do a straight up comparison between the two drugs to solve this issue once and for all?

  • Doug Williams - CEO

  • No, we have not.

  • David Miller - Analyst

  • Okay. And then the last question is can you give us any kind of guidance or just general kind of guidelines on when you might be including RECOTHROM in other products? Basing them in sponges or other kinds of means to kind of extend the use of the product in the surgical suite?

  • Doug Williams - CEO

  • I can't give you specific guidance on that now other than to say that we have pre-clinical activities ongoing for a flowable version. And that the timeline associated with when that would be approved is largely based on the need to have discussions with regulatory agencies about what path that might take. So, if we were to move forward, that would be the first formulation just based on the level of activity that we've already completed pre-clinically.

  • There are other ideas and Stephen Zaruby and his team will be exploring those and others as possible line extension strategies in the future. But for now, I can't give you a specific timeline given the lack of certainty around the regulatory path.

  • David Miller - Analyst

  • Okay. And then I guess I have one other question on the guidance for cash use. Does that assume that any kind of end licensing of products for the RECOTHROM sale force?

  • Doug Williams - CEO

  • Yeah, the answer is no on that. It did not assume any end licensing activities.

  • David Miller - Analyst

  • Okay. Great. Thank you very much.

  • Operator

  • The next question is from Edward Tenthoff with Piper Jaffray. Please go ahead with your question.

  • Edward Tenthoff - Analyst

  • Great. Thank you very much. Two quick housekeeping points on my end too. Firstly, the amortization period for the Bristol upfront. How long is that going to be?

  • Jim Johnson - CFO

  • It's basically going to be recognized over three years.

  • Edward Tenthoff - Analyst

  • Over -- okay. So, over three years. So, it amorts over three years and then we'll get that revenue in as you recognize it. As you've described.

  • Jim Johnson - CFO

  • Yeah, it's on the level of costs that we incur over that period. So, it's not necessarily going to be even from quarter to quarter. It'll basically wax and wane with the costs under the -- that we're basically managing in the Phase II program.

  • Edward Tenthoff - Analyst

  • Yeah, from the revenue side. Can you give us a precise stock based comp between R&D and SG&A?

  • Jim Johnson - CFO

  • I can, to stall for just a moment.

  • Edward Tenthoff - Analyst

  • Sure. Then I'll ask one other one while you're looking that up. With the $21 million that you recognized coming in from the Bristol settlement, does that impact cash in the quarter?

  • Jim Johnson - CFO

  • Are you talking about the Ig-fusion settlement?

  • Edward Tenthoff - Analyst

  • Yeah, Ig-fusion settlement. Yeah. Will that (inaudible) cash?

  • Jim Johnson - CFO

  • That $21 million was received in November.

  • Edward Tenthoff - Analyst

  • Okay, November.

  • Jim Johnson - CFO

  • Okay, so I have the stock based comp numbers for the full year 2008.

  • Edward Tenthoff - Analyst

  • Great.

  • Jim Johnson - CFO

  • $13.572 million in R&D. And $7.7 million exactly -- $7.7 million even in SG&A.

  • Edward Tenthoff - Analyst

  • Great. I appreciate you going into that. So, one more for Doug, not to monopolize the time too, too much. But how did you get such a sweet deal on Interferon lambda based on 18 patients? Characterize those negotiations. And I mean again, hats off because you've really turned this thing around here on the balance sheet side. But give us a little bit more insight into what really drew Bristol. Were there other parties involved? Just give us a little bit more color on how you pulled that off.

  • Doug Williams - CEO

  • I'll give you a little bit of color Ted. I think certainly there were multiple parties that expressed an interest in this particular asset. I think as you recognize well, the HCV space is one that is very competitive right now as far as bidding for interesting looking compounds.

  • I think from Bristol's perspective, they wanted to have an Interferon offering to complement their own internal programs with small molecule direct antivirals. And I think that they stepped up to the plate and really the negotiations were very active at the end. They really came together I think very quickly in the sort of post AASLD period where people really got a sense of the fact that this compound really did have quite a bit of activity in terms of direct antiviral activity. But also looks like it had the target product profile in terms of better tolerability.

  • I think if you look at our single agent data, you could make the case that it actually looks better than anything that's been reported with an Interferon alpha offering. We've been fairly conservative in just how far we want to go in terms of describing that data, but suffice to say that the numbers are the numbers and it's very clear that this is an active agent. It's very clear that it, at least thus far, meets our target product profile. And I think the reason we got, as you characterized it, such a sweet deal is because it's far and away the most differentiated of the Interferon offerings out there.

  • So, it was -- I think we were fortunate to be able to sort of capture the interest in the HCV marketplace with an agent that's got a profile that is arguably one that anybody interested in an Interferon offering would really want to have.

  • Edward Tenthoff - Analyst

  • Great. Very helpful.

  • Operator

  • (Operator instructions) The next question is from Lucy Lu with Citigroup.

  • Kinam Hong - Analyst

  • Yeah, hi. This is [Kinam] Hong standing in for Lucy. Congratulations, by the way, on the quarter. I have a question, just following the last question about (inaudible). The drug selling in the HCV status (inaudible) has been pretty competitive also. It's more a dynamic process with the addition of [PIs] to the mix. I was wondering if you could please comment and give a little more parity on the developmental path for the lambda program in the context of this standard, which may include a PI.

  • Doug Williams - CEO

  • Yeah, I think at this point I can't give you a whole lot of clarity about the development plan. I think that it is under active discussion. There are multiple scenarios that we're exploring because as you rightly point out, it's a very dynamic market. We are building in assumptions around expectations for the approval of at least the first of the direct antivirals and what impact that would have on the timelines associated with our program. But I think until we get a little more clarity from regulatory agencies about an acceptable path forward, we'll essentially defer giving specific guidance about exactly what the clinical plan is going to look like.

  • But suffice to say that we plan to be very aggressive in our thinking. Very aggressive in terms of our design issues and what we present to the FDA because we, like everyone else, see that speed and speed to the market is an essential element of success for this program.

  • Kinam Hong - Analyst

  • Okay, thank you very much.

  • Operator

  • I'm showing no further questions in queue. I'd like to turn the call back over to management for closing remarks.

  • Susan Specht - Dir. Corp. Communications

  • That ends our call. If you have questions, please contact Corporate Communications. Thank you.

  • Operator

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