Nov 5, 2018
Executives
Jeryl Hilleman - CFO Lisa Earnhardt - President & CEO
Analysts
Robbie Marcus - J.P. Morgan Bob Hopkins - Bank of America Merrill Lynch Richard Newitter - Leerink Partners Matthew O'Brien - Piper Jaffray Chris Pasquale - Guggenheim Brian Weinstein - William Blair Ravi Misra - Berenberg Capital Markets Suraj Kalia - Northland Securities Kyle Rose - Canaccord
Operator
Good morning, and welcome to the Intersect ENT Third Quarter 2018 Earnings Conference Call. All participants will be in a listen-only mode.
[Operator Instructions]. After today's presentation, there will be an opportunity to ask questions.
Please note this event is being recorded. I now would like to turn the conference over to Jeryl Hilleman, Chief Financial Officer.
Please go ahead.
Jeryl Hilleman
Thank you, Keith, and thank you all for participating on today's call. Joining me today is Lisa Earnhardt, President and CEO.
Before we begin, I'd like to remind you that we will make forward-looking statements within the meaning of Federal Securities Laws. Actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, our outlook for financial performance, sales force growth, clinical studies, approval of new products and indications and procurement of reimbursement codes and coverage, which are based upon our current estimates and assumptions as well as other risks detailed from time-to-time in the reports we file with the SEC.
We disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein. I'll now turn the call over to Lisa Earnhardt.
Lisa?
Lisa Earnhardt
Good morning. I'm pleased to report a solid Q3 including positive results and strong execution on the initiatives that we outlined on our last call.
We've made significant progress on improving SINUVA product access and growing our field reimbursement and sales teams. The feedback from physicians and patients on their SINUVA experience continued to be enthusiastic and gratifying and we are proud of the strides we are making on access.
Before we dive into our Q3 results, I'd like to first address the status of the SINUVA J-Code. This past Friday, CMS issued their half final rule which listed many new J-Codes, but did not include one for SINUVA.
The final decision will be reflected in CMS's 2019 HCPCS file which is yet to be posted. However, based on the lack of a specific code listed in the HOPPS rule, we do not expect to receive a product specific J-Code in this round.
To interpret what this means, we refer back to the preliminary decision issued by the CMS in May. In this communication, CMS listed up to individual payors to determine the appropriate code for submission including a miscellaneous code.
Today commercial payors have accepted use of the unassigned J-Code for prior authorization and payments and payors that have described coding in their policies have recommended use of the unassigned J-Code. All in all, while use of an unassigned J-Code adds some inefficiency to both the prior authorization and claims processes, it is served effectively for both.
We therefore expect to continue our plans to ramp SINUVA meaningfully next year. This view is supported by the significant progress we have made with payors and with the favorable experience today in both the rate of prior authorization and payments.
SINUVA has recently received positive coverage physicians by Aetna and HCFC, the largest of the Blues behind [indiscernible] and has also been added a formulary by both Anthem and by OptumRX. Overall SINUVA is now covered by five out of the six largest commercial payors representing 90% of covered lives among this large group or 140 million lives.
We are now also starting to gain experience and realize positive net coverage from regional payors as well. Finally, we do plan to submit a new code application for a J-Code to CMS for the 2019 cycle.
There is precedent for success with second applications and we feel the picture will be clear without the soon to be sunset CPT codes on the register. In short, we foresee a clear path forward for SINUVA in 2019 with or without a product specific J-Code.
Now let's switch gears to our targeted SINUVA launch. The clinical feedback, as many of you know, from your firsthand conversations has been very positive.
The results are consistent with the strong outcomes in our clinical trials. Each and every patient story reminds us of the meaningful impact this technology has on patient's quality of life.
During the quarter, we enrolled about a 1,000 patients for prior authorization via our reimbursement hub. As you may recall, we had targeted 50% to 75% approval of completed prior authorizations for our early quarters of launch.
I'm pleased to report that we were at the top of that range in Q3 at approximately 75% and we expect to see that level continue to climb with experience and with expanded payor coverage. On the treatment side, 400 physicians have now treated 700 patients with SINUVA with 350 of those in Q3.
This represents solid growth in line with our expectations for our targeted launch doubling the number of both physicians and patients from the first four months of launch. We are also pleased with the progress we have made on improving product access.
We increased staffing at reimbursement hub to reliably process prior authorization in line with our performance metrics, including the time for a payor review; we are now consistently processing submissions in under a month. We expect this timeline to continue to shorten as physician offices and payors gain familiarity with SINUVA.
As we gain greater visibility into payor requirements, we are now better positioned to educate physicians at how to navigate both specialty pharmacy in buy-and-bill access. A number of physician offices doing buy-and-bill rose to 80 by the end of Q3 a 100% increase gained in August and September.
We expect more and physicians will be willing to include buy-and-bill access in their practices we gain payment experience. To support this, we are collecting data on payment history and while still early we observed that the vast majority of commercial claims are being paid with the remaining few in the appeals process pending additional information.
Importantly, assuming physicians fill appropriately per their contract, the payment rates are consistent with what we would expect from a physician administered drug. That is the cost of the implant is covered along with an appropriate workout.
In addition to improving product access and payor coverage, we expanded our field reimbursement and sales teams which will help with both SINUVA and PROPEL. Turning to PROPEL, our Q3 year-over-year growth was similar to Q2 consistent with our stated expectations.
Contour continues to be a strong element in our mix at 29% of PROPEL family sales and we continue to add about 50 new PROPEL family accounts a quarter. As discussed previously, we are expanding our sales teams to enable more with time with current physician users, including attending cases to encourage broader usage of PROPEL.
We communicated in our last call that we would be adding approximately 20 sales consultants and contract reps by year-end. We were pleased that we brought the majority of those reps onboard during Q3 raising our total field force to 132 field reps, an increase of 13% from the end of Q2, and 20% from the start of the year.
Our focus in Q4 is to train and integrate these new team members to support 2019 growth. We believe, we will continue to improve the growth of both PROPEL and SINUVA and are therefore maintaining our 2018 guidance of $106 million to $109 million.
We expect SINUVA to contribute about 4% of fourth quarter revenue as we continue to work with physicians to establish a strong base of buy-and-bill. We are also continuing our outlook for sustained growth of approximately 20% as we expressed on our last call.
Let me now turn the call over to Jeri to take you through our financial results and outlook and I will conclude the call with a discussion of our product pipeline.
Jeryl Hilleman
Thank you, Lisa. Our third quarter SINUVA revenue was just over $800,000, an increase of 59% over Q2.
Our list price remains 12.75 and our net price after adjusting for channel fees and government mandated discounts continues to be about $1,000 a unit. As Lisa noted, our outlook for the year remains constant.
Moving to gross margin, our Q3 margin of 79% is in line with our continuing guidance of approximately 80% for the year. We continue to expect gross margins to rise as we ramp volume against overhead and increased efficiencies with our new product.
Our operating expenses for the quarter were $27.6 million or $78.8 million year-to-date. We are growing headcount this year by about 30% to over 400 employees and headcount comprises about three-fourths of our operating expenses.
This takeout growth is primarily in sales manufacturing and reimbursements. Based on timing of hires and other factors, we are now able to fine tune our outlook for expenses to approximately $110 million to $111 million from our previous view of $113 million to $115 million.
We believe this growth has been impactful toward addressing our challenges and we feel that we have a very strong and complete team in place as we look to 2019. I'll now turn the call back to you, Lisa.
Lisa Earnhardt
Thank you, Jeri. Innovation is core to Intersect ENT.
We remain committed to delivering solutions across the continuum of care for chronic sinusitis sufferers. To that end, we will soon be initiating the ASCEND trial a clinical study of a new platform product a Drug-Coated Balloon.
This product leverages our core competencies and proprietary technologies in both polymer science and drug delivery and enables us to address what we believe is an under-served opportunity. While current balloons are effective in opening the peripheral sinuses at the time of dilation, they do not address the underlying inflammatory process.
As a result, our market research indicates that physicians prescribe steroids in over 80% of balloon procedures to manage inflammations stemming from both the disease and the procedure itself. We believe that our product, if successful, would change this treatment paradigm through local delivery of medicine fury at the time of dilation improving sinus patency rates and reducing the need for adjunct steroid interventions.
Further as evidenced by the successful adoption of PROPEL, physicians have welcomed the combination of drug delivery with surgical interventions. We will commence a clinical study soon to assess safety and efficacy of our Drug-Coated Balloon.
The ASCEND study will be 70 patient randomized blinded trial that will set sinus patency at multiple time points. We will discuss more specifics of the trial design once the study commences in early 2019.
We anticipate completion of the study and results by the end of 2019. Depending on study outcomes in our ongoing interactions with the FDA, this study may be sufficient for regulatory submission.
If successful, ASCEND would be submitted to the FDA under the PMA pathway with an overall outlook for potential approval in two to three years. Finally, we believe that the ASCEND Drug-Coated Balloon is highly complementary to our current offerings.
We envision the majority of use in the office where less severe cases are typically treated versus in surgery where propellant fans may be used in both the ethmoid and peripheral sinuses. SINUVA is used in the ethmoid sinus so we see no treatment overlap.
There is little use of the PROPEL family of products in the office, so we view this pipeline product as accretive to our current product portfolio. Further because this device focuses on sinus procedures and fits under well established reimbursement, it would be a straightforward addition to our sales tag and most importantly will provide physicians an additional option for treatment of their sinus sufferers.
In closing, I'd like to reiterate that we've executed on the key objectives we laid out on our last call. We have improved product access for SINUVA including streamlining the prior authorization process coupled with making huge strides on the national care front.
We are brick by brick establishing the foundation for buy-and-bill. And finally, we have significantly expanded our sales and reimbursement teams which will help support our growth in 2019.
The team has been executing at a high level fueled by our collective belief in the potential for localized drug delivery to become the standard of care for sinus sufferers. We are fortunate to hear patients stories each and every day that keep us focused on delivering on the potential for both SINUVA and PROPEL.
And finally, we are pleased to advance the ASCEND Drug-Coated Balloon as we work to offer solutions across the continuum of care for the treatment of chronic sinusitis. We remain greatly appreciative of your attention and interest and now Jeri and I will remain on the line to address your questions.
Keith, would you please open up the lines.
Operator
Yes, certainly, thank you. We will now begin the question-and-answer session.
[Operator Instructions]. And the first question comes from Robbie Marcus from J.P.
Morgan.
Robbie Marcus
Great, thanks for taking my question. You have given us a lot to process on the call, almost all of its good from my sense.
Maybe Lisa and Jeri you can start with talking about your recent improvement in reimbursement and give us a sense how that affects both your sales rep productivities to the base business and going forward, how much time is going to be need to spend there because it seems like now with 75% of claims getting out probably higher end of that exiting the quarter, more reps are being hired, more docs are getting experienced, it sounds like it's getting a lot more positive. So help us understand how we think about that heading into 2019?
Lisa Earnhardt
Yes. We're definitely Robbie about the current snapshot as it relates to coverage, certainly encouraged that the majority of national payors have -- are at this point covering SINUVA, so that certainly bodes well for us as we head into 2019.
That combines with the growth of both our sales and reimbursement teams to provide further conviction around our ability to continue to drive growth in next year and beyond. I don't know if there's any specific question from a -- I know you had mentioned productivity and I think it's probably premature for us to comment on that but we do believe those in particular those two initiatives as well as the overall streamlining of product access will help enable our sales team to focus on what they do best which is discussing the clinical benefits or technology and let some of the more administrative parts of getting product access, happened in more streamlined fashion.
Robbie Marcus
Yes, maybe -- maybe just to get a little more specific, if I think about last year's productivity versus this year's productivity the reps in the base PROPEL business, a lot of the time was spent dealing with SINUVA reimbursement, it seems like that's improving a whole lot. So you want the Street to think about going into 2019 that productivity could start to improve as reimbursement becomes less of a headwind or should we assume that they still have to spend a significant amount of time dealing with reimbursement now that it's still a miscellaneous code most likely?
Jeryl Hilleman
Yes, Robbie you're right. We have definitely expanded our sales team, we've also expanded the field reimbursement team and the goal is that the sales team spends less time having to track down product access questions that could over time and should over time improve productivity.
Our most pointed focus though is really, as Lisa mentioned, continuing to grow the business in a range of 20% and that would really include higher level of growth for PROPEL than what we've seen since the launch of SINUVA. So we're really very much focused for going into next year driving top-line growth which over time will of course improve productivity.
Robbie Marcus
Okay, great. And then just lastly on the product pipeline, have you run any trials yet to date with the Drug-Coated Balloon that you see confidence that you could just submit with one trial here and I'll leave it at that?
Appreciate the question.
Lisa Earnhardt
Yes, Robbie, we run a small clinical code in particular around the pharmacokinetics of the Drug-Coated Balloon itself. I think what gives us very confidence is just our vast experience in delivering drug to the sinuses.
So the work that we've done with all of our PROPEL and SINUVA products in combination with a lot of the work we've done invention animal testing gives us confidence as we head into the ASCEND trial.
Jeryl Hilleman
Yes. And just to clarify, we're not sure this will and won't be the pivotal that's really going to depend on results if there is a potential for this to be a pivotal.
But when Lisa talked about the timelines we said two to three years to allow flexibility there.
Operator
Thank you. And the next question comes from Bob Hopkins with Bank of America Merrill Lynch.
Bob Hopkins
Good morning. Just for the first question, I was just wondering if you could go back to the product specific J-Code commentary that you made and maybe help us understand just from your perspective what are the reasons why it's sort of played out the way it did?
Lisa Earnhardt
Yes, Bob, I think that we sort of reflect back on the May decision or the preliminary decision that CMS put forth that referenced the Category 3 CPT code for the placement of a steroid releasing implants and they asserted at that time that those codes were most appropriate and therefore separate SINUVA J-Code was not necessary. As you well know and as CMS knows at this point those codes will be sunset at the end of this year.
And so we really, we don't have this additional feedback from CMS but that's our understanding would be that they just let their preliminary decision lie and that we would then reapply as of January of 2019 and that point those codes would no longer be -- would no longer be effective.
Jeryl Hilleman
Yes, just to clarify we don't have any further insights from CMS at this point on that which is publically available.
Bob Hopkins
And then in terms of the challenges that presents to you as you look to next year, maybe you could just talk about that either in terms of the challenges or lack thereof. Like this has really changed anything and then in that context, I just also while we're on the topic of next year appreciate you guys mentioning the 20% again but should we assume that means that you're comfortable with the base business growing 10% and then SINUVA revenues somewhere in the sort of $11 million to $13 million range?
Is that's what implied by that 20% are you comfortable the base business can still grow double-digits next year? Thank you.
Lisa Earnhardt
Yes, Jeryl would handle the second part of that question then I'll refer back to the first.
Jeryl Hilleman
We got just overall, we haven't really parsed the detail and so only 20% will certainly do that when we give specific guidance. But we have said that we'd expect PROPEL to grow low-double-digits at a preliminary view and we do expect to see continuing growth in that franchise.
Lisa Earnhardt
Yes, but then you asked earlier on about the J-Code and what headwinds might this present. And we think about reimbursement and coverage for a product we think of it as coding coverage and payments.
Coding is just one piece of it. I think we've always been very consistent that the most important part is coverage i.e.
will payors pay for the products and at what rates? And we feel like at this point based on our experience in particular in the last month or four to six weeks where we've had a number of national payors either publish a positive policy and/or put us in formulary, we believe we're in good stead there.
That said there are some inefficiencies that we've described at nauseam previously with needing to use an unassigned J-Code. It's becoming easier for us as we flex those muscles.
And it's something we believe we can get through just with brute force and we will advance our resources as needed to make sure we're doing all that we can to support physician practices in their submissions and ultimately their claims, but we think we've always surmised all along that it's coverage that really is the most important element of driving success for SINUVA.
Operator
Thank you. And the third question comes from Richard Newitter with Leerink Partners.
Richard Newitter
Hi, thanks for taking the questions. I wanted to start just with the Anthem and AETNA, the changes in coverage policy decisions.
I know that Anthem was kind of a little bit different than AETNA; one is specifically a medical policy positive coverage. I think Anthem was just adding it's a drug formulary.
Can you just describe one, what you've seen happen specifically with those types of insurers prior authorization, submissions and how the process has changed respectively within those two types of insurance carrier submissions?
Lisa Earnhardt
Go ahead, Jeryl.
Jeryl Hilleman
Lisa and I [indiscernible] you asked. We are so excited.
Rich, you're right the medical benefit is one where there's a little bit more hands on processing and they look to the medical needs of the specific patient and their pharmacy. So a little bit more straightforward based more on product and we have been tracking down both.
It's going to be as we get more and more coverage, we'll get a better sense of how those products is selling to more commonly process we have had success with both. And we can't speak specifically to AETNA or Anthem or OptumRX until we gain more experience with that coverage but being on formulary certainly does provide additional, great potential for the product coverage.
Richard Newitter
Let me maybe just follow-up on that, so can you give us a sense just as an example Anthem being on formulary does that specifically help with the specialty pharmacy submission process, maybe decrease the reliance as much on buy-and-bill with those patients or is this something that helps more with buy-and-bill and same question for AETNA?
Jeryl Hilleman
Yes, it's a good question. I think it's important that we gain experience with those peers putting patients through before we comment on that and something we thought be in a better position to speak to next call.
Richard Newitter
Okay. Just if it’s some recent leadership changes in the last couple of weeks there.
I just love to hear if there are any -- any that you specifically like to call out that you think are going to that seem to be potentially given increase confidence either on the SINUVA launch or the base business acceleration prospect we love to hear kind of any new people that are at the firm, that will be helpful I think. Thanks.
Lisa Earnhardt
Yes, happy to Rich and I think, most importantly as you may remember from our May earnings call we shared that Rich Kaufman who has been our longtime Chief Operating Officer and one of our first employees would be retiring early 2019. So we didn't begin a search for his replacement.
And as you might imagine it's big shoes to fill. The great news is that a lot has changed since Rich joined the company years ago.
And so as we look forward we're really able to identify and recruit some hands that can really take us to the next level from a operational excellence standpoint. And we're thrilled to welcome Christine Kowalski to our organization.
Her area of focus will be in operations, supply chain, manufacturing, quality, information technology. So really making the trains run on time.
And so she's done similar roles at emerging growth companies as well as had Executive positions at both J&J and then Guidant/Boston Scientific. So that one in particular is an exciting move for us as we think about taking on our next chapter of growth.
Rich is still with us and is focused on driving innovation which is core to Rich's passions and certainly core to us at Intersect ENT. So we're thrilled to have him still on board in driving the innovation portion of our organization in particular with the ASCEND product trials getting up and running.
He will be with us until the first quarter.
Richard Newitter
Okay, thanks. And one last one just on the Drug-Coated balloon initiative.
Is there any reimbursement consideration I know balloons are well covered and paid for. But I'm just curious if there would be any other reimbursement type considerations, additional types of codes that would be required to have a Drug-Coated balloon and specifically the drug on top of the balloon part.
Thanks.
Lisa Earnhardt
Yes, we believe the existing codes and reimbursements is sufficient and will cover our Drug-Coated Balloon offerings once we -- if and once we get to market.
Operator
Thank you. And the next question comes from Matthew O'Brien with Piper Jaffray.
Matthew O'Brien
Good morning. Thanks so much for taking the questions.
Just with respect to the treatment landscape for recurrent polyps obviously SINUVA has got a place there but you've got Optinose in the space you've got a new pharmaceutical product that supposed to be out at the end of next year which has shown pretty good data so far. So can you just talk about the landscape for SINUVA?
With those competitive products in the market, where it fits and how durable it will be as those products hit the market?
Lisa Earnhardt
That's a good umbrella question, Matt, and I think I'll start with the fact that we see SINUVA as a very unique mode of therapy within there that has a very strong residence with paid residents with patients who are looking for immediate opening and a very safe local drug delivery profile and also certain cost profile. So if you compare that with the benefits, SINUVA delivers to patients with other therapies that certainly you will find a home in the continuum of care, intranasal steroids sprays have been used for a long time.
Intranasal nasonex was actually the control arm of SINUVA. And while -- and so SINUVA really can be used alongside of intranasal steroids sprays I won't speak specifically to Optinose but I'm just speaking to the category of intranasal steroids sprays we see as complimentary to the use of SINUVA.
With regard to monoclonal antibodies as a category, there's a very different mode of action, working systemically against specific molecules involved in the inflammatory cascade blocking those molecules. It's a very high commitment for patients to do sometimes by weekly injections, either themselves or going to doctor's offices is a very different cost profile.
So between the systemic the compliance and the cost, it's a different treatment modality and will probably find a place among certain patients but again we see SINUVA as having a unique broad market opportunity and continue to work to the same addressable market as we always have.
Matthew O'Brien
Okay, that's fair. And then as far as Drug-Coated Balloon opportunity, can you talk and I may have missed this as far as the drug that's going to be on there, the polymer that you're going to be using and then just the general market size because you're going to be going into a category right there actually is some competition versus what you're doing today, how you’re going to try to position that product versus the other blues that are in the marketplace and from a cost perspective et cetera?
Lisa Earnhardt
Yes, I'll start with the question and ask Jeri to comment a little bit on the market size and how we view that. From a technology standpoint the drug we will be using is the same anti-inflammatory we've used on our PROPEL and SINUVA products which is medicine fury.
At this point we're declining to talk about specifics around the Drug-Coating is deliberate, we view that is a proprietary piece of the technology at this point. So where we do believe it's a unique, very much a unique offering to be able to have a two and one device that could be used for these patients in particular in the office setting.
Jeryl Hilleman
Yes, as you think about market size we would long put forth that we believe is about 800,000 patients with early stage of disease that would not had sinus surgeries that could be treated. As a sub segment of that with growing potential is the balloon market which we estimate to be around 200,000 procedures today with some office being the largest growing segment of that.
And we think that with the Drug-Coated Balloon there is certainly the potential to offer very different treatment and a very different profile for balloons usage than what is currently available today with the drug being available to treat local inflammation associated with the disease and the procedure.
Operator
Thank you. And the next question comes from Chris Pasquale with Guggenheim.
Chris Pasquale
Thanks. Lisa and Jeri, how far along are you in the process of building out the evidence to support payment under the buy-and-bill model, it sounds like you're relatively pleased with the early success, what do you think you're ultimately going to need there to make that case to physicians kind of across the country and across different payor groups?
Is that something that requires 500 cases or 1,000 cases can you help us there?
Lisa Earnhardt
Yes, Chris, it’s a good question we are early on in collecting payment because as you might imagine there's a natural delay that comes with the treatments and that is usually a couple of months before the physician receives payment. We are pleased with the fact that the vast majority of claims that we've had an opportunity to see has been paid, there's just literally a handful that have gone needed to go through the appeals process.
We have about 50 or so EOB or Explanation of Benefits that we have that we're starting to be able to use with physicians in particular reimbursement team as we talk to them about buy-and-bill and what they might be able to expect. So still it’s early, what that number is in terms of the ideal number obviously this is a situation where more truly is more.
And as you think we're getting to the part we have sort of a representative bail us in terms of the types of payors as well as across the country and those are the things that are probably most important is making sure we have that evidence that can be used and believed by physicians across the country.
Jeryl Hilleman
Also as we continue to get coverage, it just creates a very different environment when physicians can look to a lot of positive policy. So when you put the policy growth coupled with the emergent pictural payment, we think that that will help doctors make that decision to go ahead and buy the product.
Chris Pasquale
Thanks. And then I wanted to revisit the question around ASCEND, your portfolio up until now has been built around extended release products, how confident are you that one-time drug delivery at the time of the procedure will actually be sufficient to meaningfully impact the prognosis for these balloon patients and can you share anything from a pharmacokinetic study about how long drug sticks around in the tissue at therapeutic levels?
Lisa Earnhardt
Yes, we believe there will be a therapeutic benefit during that post-operative feeling or period or the post dilation period based on in particular preclinical research. It's important to note that while the drug is delivered at one time i.e.
during dilation, there is sort of release over a period of time and at this point I'm not going to talk about how we're able to do that, but we believe based on our preclinical experience and early clinical experience and bench testing that we'll be able to deliver therapeutic levels of medicine fury.
Chris Pasquale
Can you share what you’re randomizing against, is it commercially available balloons or is it something else?
Lisa Earnhardt
Yes. It's a non-Drug-Coated Balloon.
Operator
Thank you. And the next question comes from Brian Weinstein with William Blair.
Brian Weinstein
Hi, guys. Thanks for taking my questions.
I just wanted to ask about the 20% guidance for next year. You said that on the last call and you said it today but then I just want to see, I think Jeri you said in that 20% range, I don't want to get too cute on this but I just want to clarify kind of is the guidance for next year 20% or is it kind of in the 20% range?
Jeryl Hilleman
Yes, we think it's consistent to say approximately 20% which I would feel is synonymous with in the 20% range and the intent is to give more precise guidance as we complete the fourth quarter and get into the conference at the beginning of the year. So it's not changing anything it’s just we always said approximately 20% really with the intent to paint a ZIP code or fixture for what we expect the growth without giving pinpoint guidance prematurely.
Brian Weinstein
Okay, great. And then, I don't know if it's too early to talk about this or not, but can you just talk about any additional investments that you think you may need next year.
It sounds like, the new investments that you've made have started to bear some fruit but can you talk about what you think you might need to add for next year?
Lisa Earnhardt
Yes. We're working through our plans but our focus will continue to be on making sure, we have the right field support both on reimbursement sales and that we continue to do everything we can to build up the reimbursement picture.
But I think we put a lot of headcount in place this year and will probably deleveraging our headcount as we go into next year but continue to add support for SINUVA and then of course clinical trial spending for the ASCEND program which is in line with our rate of historic R&D spending.
Operator
Thank you. And the next question comes from Ravi Misra with Berenberg Capital Markets.
Ravi Misra
Hi, great. Thanks.
Good morning thanks for taking the question. Just one on the buy-and-bill.
Can you just remind us how long it's taking doctors to get paid when actually do to perform the procedure after the authorization has come? And then secondly for the ASCEND trial you give kind of the market size there but what gives you confidence that this technology is different that you have IP protection around it that the competition won't be able to do a similar type of design there?
Thanks.
Lisa Earnhardt
Yes, what's your first question, Ravi, thank you for both questions. The first one was with regards to the time it takes from the time that the physician gets the prior authorization to actual payment.
It's important to note that the one thing in prior authorization then they're treating that patient and that could happen the next day or could usually happen a couple weeks later. And then once they treat their patients to the time to actually get payment it's usually about six to eight weeks.
It does vary based on the patients plan and their payor as well as the completeness of the materials that the physicians' offices submit but that's pretty typical, so that's why there has been a delay in actually getting the proof because as you know the majority we had a ramp with SINUVA and we didn't get to any sort of meaningful clinical case volumes until the summer timeframe. And the second question was with regards to the ASCEND program.
You know it's hard for us to comment on what other companies are doing in this space. We believe and we have been and continue to be the leader in localized drug delivery and that's really where this product is, is unique it was something that was built from the ground up here.
And so we believe we're in a strong position both from a differentiation standpoint as well as an intellectual property standpoint.
Operator
Okay. Thank you.
And the next question comes from Suraj Kalia of Northland Securities.
Suraj Kalia
Good morning Lisa. Good morning Jeri.
Can you hear me all right?
Lisa Earnhardt
Yes.
Suraj Kalia
So two quick questions. Lisa, I know you haven't given many details on ASCEND with respect -- what should we focus as you guys get more details should the balloon-designed inflation pressures all time to exiting for MF.
What's the -- I'm trying to understand what's the differentiating factor here? And the second thing, Lisa, is by math you'll have little over 2,800 accounts on PROPEL, please correct me if I'm wrong.
Can you give us an idea of how many of these are doing these procedures independently and can help us [indiscernible] 10% of growth rate -- of growth rate for PROPEL? Any color would be great.
Ladies, thank you for taking my questions.
Lisa Earnhardt
Yes, so the first question I was having a little hard time hearing you Suraj. But the first question with regards to ASCEND is really is proprietary drug formulation that allows us to believe we're going to be in a unique position in this marketplace.
We likely won't share a lot of the details around there but certainly we'll look share more specifics around the progress -- on the product itself the dose et cetera in the future as our clinical trials proceed then we move towards commercialization. I'm not sure I caught that second question, Jeri did you?
Jeryl Hilleman
No. I'm afraid I didn't.
Lisa Earnhardt
Okay.
Jeryl Hilleman
Suraj, would you mind repeating the second?
Suraj Kalia
Sure. Lisa what I was trying to understand this PROPEL the math indicates growth rate; let's say in the 10% low-double-digits, how many sites doing these pieces independently of the 2,800 or so that you have.
I'm just trying to independent because [ph] is there a fundamental change or is it just resources being diverted to SINUVA any color would be great.
Lisa Earnhardt
Yes, there really was no fundamental change. Our perspective for PROPEL this year outside of the SINUVA launch which as you know has been, I hate to use the word distraction because it's a labor of love and there's a lot of enthusiasm with SINUVA but it certainly has taken some of our sales teams time in the last quarter or two and we would expect the same thing in the fourth quarter but we do believe the additional resources we've brought on board in the third quarter and what they're up to speed in train booked are having a more a immediate impact in particular as it relates to the PROPEL franchise.
Jeryl Hilleman
Yes, the other thing to note though is that we are comparing our growth now to how we grew immediately after the contour launch and I think that that has some effect just on the rate of growth we’re experiencing at present because if you know contour really took off very quickly and very strongly. We're continuing to drive growth with all the products and I think as we would characterize it thus far is aligned with the additional sales resources we're putting through the product alignment and product access for SINUVA and all of these current factors we're in.
Operator
Thank you. [Operator Instructions].
And the next question comes from Kyle Rose with Canaccord.
Kyle Rose
Great, thank you very much for putting me in. Can you hear me all right?
Lisa Earnhardt
Yes, hi Kyle.
Kyle Rose
So I wanted to -- a lot has been asked. But I just wanted to talk about the sales force expansion a little bit, and maybe just kind of help us understand the type of reps you’ve been bringing on for the sales consultants and then historically as you’ve added the sales consultants to existing territories, what the productivity has trended like I was trying to get an understanding of how we should think about the contribution and over what time period they become more productive?
Jeryl Hilleman
Yes, Kyle this is Jeri. I will take that question initially.
And if you think about sales consultants they really fill a role of working more closely with doctors as they evaluate patients and think about how they evaluate patient's stent procedures. So it’s much more of a PROPEL focused growth and it's one that we historically use to be a strong complement to the territory manager who really owns all the products and who is really responsible for achievements within the territory.
So we're focused on bringing on-field sales consultants and it's a role that we’ve had great success with in leveraging up to now, we think it’s just very well received we have for how we see growing PROPEL in the future. And then I’m sorry what's the second part of your question?
Kyle Rose
Just historically productivity levels, when you’ve add those consultants into those territories?
Jeryl Hilleman
Well, I think anything -- anyone who is new in the role is going to take some time to get up to see as we completed training of these sales consultants at the end of the third quarter and I think as we get into the fourth quarter, they’ll be gaining experience and we would expect to see good productivity from them probably as we get into next year with some benefits this quarter.
Kyle Rose
Great. And then just one quick question on SINUVA.
I think you mentioned and you’ve had 400 physicians used thus far, can you just give us a range or a little more color as to frame the physician interest, I mean are there another 400 who are waiting for more clarity on buy-and-bill or specific better coverage in there geographies, just how do we think about that 400 in relation to the momentum and kind of the trajectory entering 2019?
Lisa Earnhardt
Yes, Kyle. We definitely are focused on those 400 physicians that was our goal of ours and in the third quarter and we’ll continue in the fourth quarter as we really establish the pathway to a more full commercial launch in 2019.
We do think that targeted approach has served us well. We are aware of many more physicians who are interested in using the product and we look forward to serving their needs, I think one of the biggest hurdles at this point and Kyle you called it out is just as we gain more experience with buy-and-bill, as there are more positive peer coverage decisions that will help us have more confidence on going more broadly to the -- we have I don't know around 2,500 ENTs today who have on the role for PROPEL in the practice.
We certainly want to walk before we run and we believe that is the right course of action as we move forward with this SINUVA launch in the near-term.
Operator
Thank you. This concludes our question-and-answer session.
I would like to turn the conference back to Lisa Earnhardt for any closing remarks.
Lisa Earnhardt
Great. Thanks so much Keith and thank you all for joining us this morning.
We certainly appreciate your interest and support. Have a great day.
Operator
Thank you. The conference has now concluded.
Thank you for attending today's presentation. You may now disconnect your lines.