Earnings Labs

Pacira BioSciences, Inc. (PCRX)

Q3 2018 Earnings Call· Thu, Nov 1, 2018

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the Third Quarter 2018 Pacira Pharmaceuticals Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Susan Mesco, Head of Investor Relations. Ma'am, you may begin.

Susan Mesco - Pacira Pharmaceuticals, Inc.

Management

Thank you, Heather and good morning everyone. Welcome to today's conference call to discuss our third quarter financial results. Joining me on today's call are Dave Stack, Chairman and Chief Executive Officer; Dr. Richard Scranton, our Chief Medical Officer; and Charlie Reinhart, our Chief Financial Officer. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations. Such statements represent our judgment as of today and may involve risks and uncertainties. Please refer to our filings with the SEC which are available from the SEC or our website for information concerning the risk factors that could affect the company. With that, I will now turn the call over to Dave Stack.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Thank you, Susan. Good morning, everyone and thanks for joining. We are pleased to share with you our outstanding third quarter financial results. Once again, these results underscore the demand for an opioid-sparing solution like EXPAREL and our team's success in decreasing the number of patients who are exposed to the risk of the operating room, as a gateway to opioid misuse and abuse. As we embark upon the final two months of 2018, we are extremely pleased with the mounting level of interest and demand. I'll start off with a few key highlights from the quarter. EXPAREL grew by 23% over the third quarter of 2017 and also grew sequentially over the second quarter despite two fewer selling days. In terms of average daily sales, EXPAREL sales were 6% higher than the second quarter levels. Drilling down, we are seeing continued interest on the use of EXPAREL as a brachial plexus nerve block for upper extremity procedures. Specifically, many anesthesiologists are viewing EXPAREL as a game changer, and the positive results that they are achieving with brachial plexus blocks are driving use in newer regional anesthesia techniques, such as transverse abdominis, pectoralis and fascial iliaca plane blocks. We continue to hear EXPAREL's success stories from physicians who are using an opioid minimization strategy, as a catalyst to shift both large and small procedures to the ambulatory setting. This is triggering very encouraging growth trends for both the 10 mL and 20 mL vials. Much of the nerve block's success is attributable to our highly successful collaboration with J&J. Their commitment, passion and critical mass are delivering significant results. Together, we are integrating EXPAREL across multiple joint marketing programs, including a new initiative that will promote EXPAREL and TYLENOL as a platform for opioid-free post-surgical pain relief. On the patient…

Richard E. Scranton - Pacira Pharmaceuticals, Inc.

Management

Thanks, Dave and good morning to all joining today's call. Since we last spoke, we have continued to make great progress, executing on our clinical and regulatory strategies. EXPAREL has been used in more than 4.5 million patients since approval. Given its excellent safety profile, we are focused on broadening the use of EXPAREL within key procedures. In parallel, we're pursuing new indications where non-opioid solutions are greatly needed and where we believe our DepoFoam technology would be the most physiologically appropriate drug delivery technology, given its safe profile and flexibility. Pediatrics is an area in urgent need of opioid-free alternatives and I'll start here. Last month, as Dave noted, the team attended the ASA meeting and the inbound interest at our booth around pediatrics was extraordinarily high. At the ASA meeting, investigators from Cleveland Clinic presented data from a retrospective cohort analysis, which described the safety profile of EXPAREL in the pediatric population. A total of 924 surgical cases were included in the analysis. 356 pediatric patients received EXPAREL and these patients were matched to 568 patients who had received bupivacaine. The primary outcome, which was two or more postoperative complications possibly related to local anesthetics did not occur in any patient. The authors concluded that local infiltration with EXPAREL was found to be safe in these pediatric surgical patients. Pediatric patients have few options other than opioids to manage severe postsurgical pain. So the high level of interest among anesthesiologists is not surprising, with clinicians very eager for pediatric patients to be included in the EXPAREL label. To that end, we are preparing to launch an expended PK and safety study in children aged 6 to 17 undergoing cardiovascular or spine surgeries. These painful procedures are ideal for EXPAREL, which will provide analgesia via a long-lasting field block…

Charles A. Reinhart III - Pacira Pharmaceuticals, Inc.

Management

Thank you, Rich and good morning everyone. Before I review our third quarter financial results, I'd like to remind you that we will be discussing non-GAAP financial measures this morning. A description of these metrics, along with our reconciliation to GAAP can be found in this morning's press release. The third quarter of 2018 was another strong quarter for EXPAREL and our company. Net EXPAREL sales were $82.2 million, representing a 23% increase over the third quarter of 2017. With multiple EXPAREL growth drivers now bearing fruit, we are very pleased to once again be in the position to raise our full-year EXPAREL sales guidance to $325 million to $330 million from our prior range of $320 million to $325 million. Our non-GAAP gross margin for the third quarter of 2018 was 79% versus 75% for the third quarter of last year. Our third quarter 2018 gross margin was favorably impacted by increased facility utilization which lowered our cost per vial. Non-GAAP research and development expenses increased to $13.8 million for the third quarter of 2018 versus $11 million for the third quarter of last year. The increase in R&D was largely driven by the scale up of our manufacturing capacity in Swindon. We are now in the final stages of the regulatory process for the first stage of our capacity expansion and expect to begin commercial production within the next few months. Our non-GAAP selling, general, and administrative expenses increased to $38.4 million in the third quarter of 2018 compared to $34.3 million for the third quarter of last year, primarily due to our expanded public affairs campaign focused on improving access to non-opioid options like EXPAREL; increased sales and promotional activities, including our new team of outpatient account managers who are engaging with ambulatory centers as well as…

Operator

Operator

Thank you. Your first question comes from Randall Stanicky with RBC. Your line is open.

Randall S. Stanicky - RBC Capital Markets LLC

Analyst

Great, thanks guys. Dave or Charlie, maybe just to start-off, I have a couple of questions. But – in the past you've talked about monthly growth trends and those trends have been accelerating in recent months. Can you perhaps give us some color in terms of how September, and I don't know if you have October, looked? Just to get a sense, are we still seeing those monthly trends track in the upper teens? Is that acceleration still continuing?

Charles A. Reinhart III - Pacira Pharmaceuticals, Inc.

Management

So I would say, we reported obviously revenue growth of 23%. That was reasonably consistent throughout the period frankly.

Randall S. Stanicky - RBC Capital Markets LLC

Analyst

Okay. So when we look at the fourth quarter guidance, I think it's implying, if my math is correct, bolted to 19%. We should be thinking about that as a conservative bar. I mean, you've raised guidance – you've beaten and raised guidance for the last two quarters in a row. There's no growth slowdown in your guys' confidence in that growth and that acceleration or at least that level of growth continuing remains high given all of the things you have going on, is that fair?

Charles A. Reinhart III - Pacira Pharmaceuticals, Inc.

Management

So, Randall, we remain very excited about what we're seeing in our business and are very optimistic. I think the comment about it being conservative is probably an accurate statement. The only other thing to consider is that our sales trajectory changed last year in the fourth quarter. So just to remind you, we had roughly 7% growth for Q1 through Q3 and it increased to 10% for the fourth quarter. So the denominator in fourth quarter growth percent is a little stronger than it has been in the other quarters. That's all.

Randall S. Stanicky - RBC Capital Markets LLC

Analyst

Got it. And then on the J&J side, I know, Dave you talked about this relationship continuing to expand and it sounds like with TYLENOL, you've continued to integrate yourself into the J&J relationships, so new initiatives there. What's the next step there? I mean, are there additional opportunities to further closing that relationship going forward? And if so what would those be?

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

The answer is – well, thanks for the question first, Randall. Yes, I mean, now we're being driven by the marketplace more than any strategic intent that's developed in somebody's office. And the interest in the passionate J&J around opioid-sparing is really driving many of the decisions that we've got. So as we look forward, we're working with customers and working with different groups within J&J, who have regular discussions with their customers about the need for opioid-sparing solutions. The best example would be the bariatrics pilot in that regard where the opportunity to not have patients with nausea and vomiting and all of the other issues that you have with an opioid are palpable in the marketplace and pretty easy for folks to understand. So I think where we've entered a new phase in a relationship is where we're able to marry where they're going and where we're going. We referenced DYNACORD during the call. There's a number of other development initiatives and strategic developments at Johnson & Johnson that marry very well with the customer bases that we're talking to, who are the primary focus of our opioid-sparing efforts. And DYNACORD is one, there's a number of others. And as Rich mentioned, both with the spine and with the hip fracture, a lot of what's being done between the two organizations is being driven by their input on which customers they have and which clinical development and the device development programs they have, that would benefit a lot from an opioid-sparing solution. So I would tell you that some of the movement here actually was never anticipated when we put this together and I think it speaks to the personal relationships we have with the J&J folks as well as the opportunity around the product.

Randall S. Stanicky - RBC Capital Markets LLC

Analyst

That's great. Dave, thanks.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Thanks, Randall.

Operator

Operator

Thank you. Your next question comes from David Amsellem with Piper Jaffray. Your line is open. David A. Amsellem - Piper Jaffray & Co.: Hey, thanks. Just had a few. So, I wanted to look forward to 2019 and get your sense on the extent to which commercial insurers are going to follow the lead of CMS regarding the unbundling. I know you had the announcement regarding the Aetna pilot program. But can you talk to that, and talk qualitatively about how impactful in a positive way that could be? So that's number one. And then number two, as you think about – as we think about continued growth of the product, do you have a better sense of how of the extent to which the unbundling could benefit brachial plexus and shoulder? Maybe the better way of asking it is how much of those procedures are done in ambulatory surgical centers? And if that's a big part of the mix, should we think about the unbundling as being particularly impactful to brachial plexus? Thanks.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Thanks, David. One of the real strategic opportunities for us frankly as it relates to the CMS approval is that it will standardize the reimbursement. Let me take it in the opposite direction, David, and if I describe the problem that's being solved, it'll be easier to understand why this is a solution. So many of the big payers would tell you that they believe that they pay for EXPAREL today. The problem is that because we don't have a J code and the SOP for how the providers are billing the payers is to use the general use of the J code for their road map and how they get paid. The absence of a road map for EXPAREL has been a real issue for us and has led to individual payers coming up with their own set of numbers and their own reimbursement protocols, some by mills, some by a milliliter, some by a milligram, some by bundling EXPAREL into a procedure code et cetera. So we believe that this is really important to us in terms of making it relatively easy for the local providers to standardize their ability to bill for EXPAREL across the continuum way more than Medicare. So in terms of a qualitative impact of that change, there are procedures where it is commonplace to have them done in an ambulatory surgery center already and a brachial plexus block would actually be a marquee if that was our working hypothesis. But I think it's also important to know that in many of these scenarios, the profit margins are quite thin. And so, we think that having the ability to bill for EXPAREL even in an environment where it is currently the standard of care is going to really accelerate the opportunity to move from…

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Thanks, David.

Operator

Operator

Thank you. Your next question comes from David Steinberg with Jefferies. Your line is open.

David Michael Steinberg - Jefferies LLC

Analyst · Jefferies. Your line is open.

Thanks very much and good morning. Couple of questions. You touched upfront on some of the changes with Aetna and AAMOS and how things were going in the oral surgery market. I know it's an area that gets sort of back-burnered, because it's a smaller area and the mL vials are smaller and less profitable. Could you talk about what sort of momentum you're seeing in the oral surgery market? Do you have the right critical mass in place in terms of sales force? And I know you mentioned that the 10 mL vial size increased 115% this quarter. Was part of that in the oral surgery setting? And can you even break out any sales you have in that setting? And the second question is, I know that Symphony Health for a long time kind of correlated with EXPAREL and then it stopped. And then more recently, there's been a very tight correlation. But this quarter, Symphony Health way underestimated the actual sales number. I was wondering what your view of the most recent Symphony data and whether that will better correlate over time? Thanks.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Thanks, David. I'll answer your first question. I think what you're seeing from Aetna and other commercial payers is probably the best predictor of the future for us. There is great strategic interest in those – in the commercial payers paying for EXPAREL to avoid that first exposure of opioids being for these folks that are having third molar extraction, and so I think it's an important strategic tool for them. And so I think we have every reason to believe that when you marry that with a D code, that we will see oral surgery increase and prominence as a way to provide an opioid-sparing solution to patients. We do see continued momentum in oral surgery and on a per patient basis, it's actually quite important to us. As you point out, it is a 10 mL vial. It is 5 mL for each tooth. But we see – we can't define exactly how the product is being used, because most of these procedures are done in an ambulatory environment. But we can see the momentum, because there are a number of orders on a daily basis that are going specifically to oral surgery practices, and especially, the national oral surgery groups who order on a regular basis. And so, part of the reason we put the 24 folks out there was specifically to allow folks that have a retail focus and plastic surgery and oral surgery are the basis of that beyond the ambulatory care setting. So, yes, I think I would be – and I know you've been on this for a while now, David, when we have our discussions. I didn't fully appreciate the value of oral surgery to EXPAREL and the marketplaces proved me wrong and it is quite an important growth driver. Symphony data, I just don't know what to tell you. I have no idea how they do what they do. It's very difficult to sit here and try to analyze their data on a month-to-month and quarter-to-quarter basis and try to figure out what the gaps might be. So I'm just going to have to admit the feed on that one.

David Michael Steinberg - Jefferies LLC

Analyst · Jefferies. Your line is open.

Fair enough. Next question. So, in July, CMS proposed upgrading EXPAREL reimbursement in the ASC setting. And they put a very detailed document outlining the rationale for changing certain rules governing CMS's packaging policy for certain drugs to be consistent with the goals of the present commission and combating drug addiction in the opioid crisis. And doing so, in the document, the agency found that total units of EXPAREL use in ASC setting declined sharply from a peak of around 330,000 units a year in calendar 2014 to about 74,000 units per year in calendar year 2017. So that's a 258,000 total annual decline in that setting over those three-year period, which represent a potential lost sales of around $80 million if you use the current $315 List/WAC price. So I was assuming and thinking about the potential upside once this is instituted, would you say that if you run the number, is it around $80 million or even if you assume a 50% gross to net, that would be about $40 million in incremental annual EXPAREL contribution. Is that a reasonable way of thinking about it?

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

I think over time it's not unreasonable, David, but I think we are part of the reason for the pilots frankly and part of the reasons that we've got these ambulatory sales force out there now is many of these procedures are contracted between the ASC and the payer. And because many of the providers didn't realize that the payers had EXPAREL as a covered benefit, they have not been – those rates have not been negotiated. So the J code gives us a very straight-line opportunity to have those discussions, but in many cases, they have to be had in the future. So I think if you look out in time, well, I would have to ask you – I don't think that that $80 million number is appropriate for 2019. I think this will be a more gradual uptake in the marketplace than that. I think if you look out further than that, I would tell you that we would think that that number is quite conservative. And the reason that I say that is, in our discussions with payers, they see their ability to move patients to the outpatient marketplace based on patient demand as well as physician demand to be quite a lot more than looking at the current market as a static market and then trying to figure out how much impact the J code would have. So we won't get to $80 million next year, but I think that that's quite conservative going forward after that date. Does that answer your question David?

David Michael Steinberg - Jefferies LLC

Analyst · Jefferies. Your line is open.

Yes, it does. Very helpful. Thank you, David.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Right. And Randall has helped me think through there's a couple of different ways as well. And there are papers out there that are written by economists that suggest that if we take all the noise out of the marketplace, things like biopsies in places where you would never use a long-acting product for acute pain, something like 30% of the surgeries are done in an ambulatory environment today, which means 70% are done in an inpatient environment. And the projections over the next eight to 10 years is that that's going to flip. If that's even close to being true, then you can understand why we would be investing heavily in ambulatory care, and why I would suggest that your $80 million number might be very conservative.

David Michael Steinberg - Jefferies LLC

Analyst · Jefferies. Your line is open.

Great. Thanks.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Okay. Thanks.

Operator

Operator

Thank you. Your next question comes from Dana Flanders with Goldman Sachs. Your line is open. Dana Flanders - Goldman Sachs & Co. LLC: Hi. Thanks for the questions. My first is maybe you could just give us an update on the ease of access to EXPAREL just within the hospital channel? Is that changing at all? Can you maybe just give us a flavor of your latest discussion across key stakeholders, just given what we're seeing in the outpatient setting? And then my second one, Charlie, just the strength you're seeing across gross margins, why would you expect that to dip in the Q4 or next year? Is that Swindon coming online? Or should we expect gross margins to continue to strengthen over time? Thanks.

Charles A. Reinhart III - Pacira Pharmaceuticals, Inc.

Management

So, let me take the gross margin question, Dana first. And I think we had a really strong quarter. There are all kinds of factors that go into how total gross margin comes out, and we had a quarter where a lot of those were good. We had volume, we had good yield, et cetera. We're guiding to 74% to 75% for the year, which is where we're more comfortable at this point. As far as margins going forward, we said a number of times that as we expand our manufacturing capacities, that ultimately we expect to be in the mid-$85 million range, and that's still a couple of years out, and we'll provide more guidance on 2019 specifics in early 2019 when we provide guidance for the year.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

And I'll take the first piece, Dana. So yes, we do see improving access. On the impatient side, it's quite interesting. So we priced EXPAREL 10 mL at $170, very specifically to provide an easy leverage point for the anesthesiology community to do brachial plexus blocks. As you know well, there's been some controversy in the anesthesia marketplace about the efficacy of EXPAREL. And so, what we've created it was an opportunity for anesthesiologist to use this product. They see the profound efficacy. I mean, we're getting 4, 4.5 days for $170. And then it's the conversation changes completely to who said this stuff doesn't work? And so, once you have given the anesthesiologist choose a really important and knowledgeable customer for us, the opportunity to use the drug and that kind of a way, then we see a move pretty rapidly to play through field blocks, the fascial iliaca, the PECs, the TAPs that we've referenced several times during this discussion. And those are largely 20 mL procedures, and you see that the anesthesiologists then joins the group of people who are demanding the use of EXPAREL in the hospital environment. So we see – we've had some very interesting discussions, some just in the last 24 hours with big ambulatory groups who want to start using EXPAREL very aggressively to drive there the momentum of their business around the fact that that will be reimbursed, and you see the halo of that, that people that have had success with EXPAREL in the ambulatory environment, especially people who are very vocal on P&T committees and have a lot of say about how pain is managed in the hospital market, to demand EXPAREL, and we are getting new formulary in-hospital wins everyday. Dana Flanders - Goldman Sachs & Co. LLC: Great. Thank you.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Thanks, Dana.

Operator

Operator

Thank you. Your next question comes from Serge Belanger with Needham & Company. Your line is open. Serge Belanger - Needham & Co. LLC: Hi. Good morning. A couple of questions for me. First, on the unbundling that we're expecting for January. How confident are you in getting the J code in that time? And the unbundling seems set for the ambulatory surgery centers. Have you heard of any movements for the hospital outpatient segment at this point?

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Good question, Serge. We're as confident as you could be. I mean, the comment period is not whether or not they're going to do it, it's to determine if there are some additional qualifiers that need to be put on use. And so we fully expect to receive a J code sometime in the next few days. We don't have a good sense of what that payment will be and how they will fix ASP plus 6%, but we're sure enough that we're going to get a code, that we're hiring people and putting them out in the field. So I think that sort of shows we're speaking with our mouth, right? So in the marketplace, the other, the OPPD, we started those discussions with the CMS. And we expect that those discussions will continue. There is I mean, we've had very productive and very patient-directed discussions with the FDA, as well with CMS and HHS about the need to the follow through on the ASC J code with an OPPD code. We'll continue to work on that the same way we did with CMS on the J code. I can't tell you that I can handicap that, but I think that there's a strong strategic rationale for us to improve patient care by making outpatient use available for EXPAREL as well. Serge Belanger - Needham & Co. LLC: Okay. Second question is about the (00:46:05), the pilot program by Aetna that was announced earlier this week, what are they evaluating in this pilot program and do you expect it could expand naturally in sometime in 2019?

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Yeah. The Aetna pilot, I mean, it's basically letting their ambulating centers know, well, so it's a bridge basically to the J code. So what it does is it lets these centers know that Aetna is paying for EXPAREL now and that people can start to use EXPAREL now in advance of the J code and Aetna is going to pay for it. So it is a true pilot, right? We're working with the providers to determine which procedures they think are best, how much educational activity is required in order to make that happen? We've been out this week and with a number of places talking to them about, do you want ERAS protocols? What kind of activity is it going to require for us to support the rapid movement of this product? And so, it's a very real pilot in terms of getting ready for a national launch. So this isn't intended to be a national program, it's not intended in any way to restrict the use of the product, right? Their idea and our idea are both that we'll learn enough so that this can move very quickly on a national basis. And I should add that, Aetna has been a great partner and there are strong personal relationships that support that partnership as well. But we also have a number of discussions ongoing with other ambulatory providers, and we expect that we will have pilot programs with those folks going mimicking the Aetna experience here. Serge Belanger - Needham & Co. LLC: Thanks for taking the questions.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Thanks.

Operator

Operator

Thank you. Your next question comes from Ami Fadia with Leerink. Your line is open.

Ami Fadia - Leerink Partners LLC

Analyst · Leerink. Your line is open.

Good morning. Thanks for the question. And apologize if this was discussed previously. What's the likelihood of CMS expanding the unbundling for EXPAREL to the hospital outpatient setting? And if that decision doesn't come now, do you think there's still a possibility of that happening in the future? And then related to that, what's the current mix of the ASC settings in the U.S.? I heard a comment about 30%, is that your stance on that? And what was that mix when EXPAREL had a separate J code a couple of years ago, and kind of the script data that was referenced in the CMS document talked about those scripts. And did those scripts include hospital outpatient as well also? Thank you.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

So first we didn't have a J, we had a C code. (00:49:04)

Ami Fadia - Leerink Partners LLC

Analyst · Leerink. Your line is open.

Yeah, sorry. C code.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

No, that's okay. No, I'm not trying to – it is slightly different and just to point that out. So we've talked to CMS about the analysis that was done and about when we had the C code, it was new and it came during a launch phase. And so folks that didn't have access to non-opioid treatment therapies or any long-acting local anesthetics, it's hard to really make full value of the technology during a launch phase when you're talking to folks about how to use the drug and generally it wouldn't run right to an outpatient environment. So we've had I think a cordial discussion on the fact that a five-year average is probably not a great way to look at this, that if you looked at it in the context of the first three years when we had a C code and you got to a certain point, you would understand that the last year is very different than the first year. And then when you take that away, you have a very different scenario. So if you looked at it over the last two years when there was no payment relative to the last year that there was a payment, you would see that – you would come to a very different conclusion than if you took a five-year moving average which is the way that CMS approached it. So I think whether they're going to – I think our expectation is that we are going to get a J code for the ambulatory setting. We have had collaborative discussions and I think CMS is very interested in trying to meet the goals of the Opioid Commission. And they are also very much interested in patient care. And I think they have been – they have clearly been moved by all of the letters and all of the testimonies that were sent in during the comment period. And so we expect that we will continue to have discussions around outpatient use. Honestly, again, as I said after the last set of discussion, how that's going to end up, I don't know. We'll give it the same effort that we gave CMS, as it related to the ambulatory setting and we were successful there. So that gives us some confidence but nothing more than that.

Ami Fadia - Leerink Partners LLC

Analyst · Leerink. Your line is open.

Got it, thank you.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Thank you.

Operator

Operator

Thank you. Your next question comes from Gary Nachman with BMO. Your line is open.

Gary Nachman - BMO Capital Markets

Analyst · BMO. Your line is open.

Hi good morning. Dave, talk a little bit more about the new field managers who are working with the ACSs. How many are there? And how have they been laying the groundwork for when you get the J code? Just give us a better sense of expectations on that uptake next year.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Yes, thanks Gary. I mean, you've known us for a long time, Gary. So we cut the market and in order to get at 60-plus percent of the market, you need something in the mid-30s. But the ambulatory care market is very much concentrated. So you have states where you have huge opportunity in ambulatory care, and you have states and in some cases whole regions where you have almost none. And so, what we decided to do was to take the place where these folks would have the opportunity to have a very strong input by putting them in places where there was a very strong focus on ambulatory care that already existed. And so, I mean, I would just tell you – I don't want to – I always have to be careful here, because so much of what we say on these calls shows up being the strategic plan for some of the people that think they're our competitors. So I'll be a little bit careful here. But I would tell you, there's 24 people and nine of them are in one state. And so, it speaks to the concentrated effort here. And so, what they're doing is there's another internal team that you would expect, that is in charge of launching this product. And it includes reimbursement specialists and folks that have done this before for many small teams. So they're working at the top level with the IDMs and with the ambulatory care groups and all of that. And then the reps are at the local level, sharing the information that are coming from the IDMs and saying, okay, they think that they pay for it. They want to pay for it. You don't think they pay for it. What's missing, right? What's in that gap? And how much of that can we cover in the next 60 days, so that we can be ready to go on January 1? And the biggest single thing is that we don't want to tell people that something is possible and then have them bill for it and have all those bills rejected. That's what we're trying to avoid. It's not a negative strategy, but I think you get it, right? So that's a lot of it is, given these folks some time out there to get to know these customers, we're having web access with these folks. We're having web access with the Aetna folks and some of the other big commercial payers. And so, they are all slightly different in terms of how they got to where they are with EXPAREL. And so, we're learning how to address these folks individually as customers as well as a group of people who will have a reimbursement opportunity on January 1. I don't know if that's helpful or not, Gary, but that's what comes to...

Gary Nachman - BMO Capital Markets

Analyst · BMO. Your line is open.

Yeah. No, that color is very helpful. And then just a couple more. With nerve block in place, have the overall number of accounts ordering EXPAREL been increasing it? Or is it now about further penetrating existing accounts in the hospital setting?

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

No. I'm happy to tell you that the number of accounts is growing both actually. But the number of accounts on almost a daily basis is growing, on a weekly basis for sure.

Gary Nachman - BMO Capital Markets

Analyst · BMO. Your line is open.

Okay.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

It's interesting Gary, because you sit here, you almost hope that when you have days that you don't have big orders, because it's really in our benefit to have, I'd much rather see several hundred people order two boxes, than have one person order 100 boxes, right?

Gary Nachman - BMO Capital Markets

Analyst · BMO. Your line is open.

Right. I know you used to give us a number of accounts and then it seemed like it sort of flat-lined a little bit, but given some of these recent initiatives, it would seem like that could have accelerated in terms of penetrating some new accounts.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

No doubt about it. And there's also a lot of excitement with the D codes. And that goes back to David Steinberg, and how many times he told me that we should be moving more in dental. The dental – we've been at the dental meetings and the interest in dental providers commercial dental providers and putting EXPAREL in as part of their program is really interesting to us. And those are mostly new customers when you see them on a daily basis.

Gary Nachman - BMO Capital Markets

Analyst · BMO. Your line is open.

Okay. And then just last one for Charlie. How do expect spending levels to trend into next year? How much more might investments go up from 2018? It seems like you're getting a good return on that investment, but just directionally, how should we think about that? Thanks.

Charles A. Reinhart III - Pacira Pharmaceuticals, Inc.

Management

Gary, I don't really think we've made specific comments about 2019, except in generality to say that we don't think it'll be significantly different than where we are. I don't think there's going to be any major changes. And we will give you more specifics when we provide 2019 guidance.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Yeah. I think Gary, even beyond that, right, it's all about leverage now for us, and execution. With J&J and all of the resources that they bring to bear here, I mean – the lot of the costs associated with Swindon and the new manufacturing facilities has already been covered. So we have a lot of opportunity to manufacture. I think we're putting some people into the 2019 plan, but very selectively around certain customer uses. And we're at a point now where we almost put somebody else there for a book of business, it's already been covered, but for somebody in the marketplace that doesn't have the time to cover it adequately rather than prospecting. So I think for us this is all about leverage now and we see a very distinct disparity between the ability to grow revenue versus the requirement to grow expenses.

Gary Nachman - BMO Capital Markets

Analyst · BMO. Your line is open.

Okay. Great. Thanks.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Thanks, Gary.

Operator

Operator

Thank you. Your next question comes from Boris Peaker with Cowen. Your line is open. Boris Peaker - Cowen & Co. LLC: Great. Thanks for taking my question. I was just curious to know what you're seeing with regards to the bupivacaine shortage in the market? And how is that impacting you now or may impact EXPAREL in the future?

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Yeah, thanks for the question, Boris. Very difficult to tell, to be honest with you. I mean, what we see specifically is when we see directives from pharmacy not to use the available caines in general by the way, its not just bupivacaine, to fill up elastomeric pumps. Right, so they telling folks, don't use 12 mg, 1600 mg to fill up a pump when we can use it selectively and treat a dozen patients with that same amount of bupivacaine. But at the same time, I would tell you that we can go into hospital that is, that tells us that they are short and they are looking for alternatives and we put programs in place. We can go into a sister hospital, and in many cases, it's across the street and wonder if they want to do the same thing in response to the bupivacaine shortage and they look at us like we just dropped out of a spaceship. So I can't tell you that if we can get a full grasp on exactly what the issue is and whether it's – it doesn't seem to be administered across the country in the same way. I'll tell you what we are fairly comfortable with is that when clinicians go to a EXPAREL ERAS protocol because of the bupivacaine shortage, we don't see them going back to the bupivacaine once bupivacaine becomes available again. So we think that it is spotty, but it is important and another leverage point for us. Boris Peaker - Cowen & Co. LLC: Got it. And so your manufacturing of EXPAREL, would you make your own bupivacaine or do you source that from external sources? And if you're sourcing it, is there any potential concern about disruption?

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

No. There's dozens of places where you can buy API bupivacaine. That is not the issue here at all. The issue is related to the regulatory process and the ability of the folks who are making parenteral products to be able to make that – right now there would settle to make it breakeven. They're losing money on every vile. And so it's – but this is not an API issue, this is a manufacturing into parenteral problem. Boris Peaker - Cowen & Co. LLC: Great. Thank you very much for taking my questions.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Okay. Thanks, Boris.

Operator

Operator

Thank you. And I'm showing no further questions at this time. I'd like to turn the call back over to Dave Stack, Chairman and CEO for closing remarks.

David M. Stack - Pacira Pharmaceuticals, Inc.

Management

Thank you, Heather. Thank you for your questions in time this morning. We look forward to providing additional updates in the future. Next up for us is that Jefferies Conference in London, followed by the Piper Conference in New York. We look forward to seeing you there.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. And you all may disconnect. Everyone have a wonderful day.