Supernus Pharmaceuticals Inc (SUPN) Q4 2019 Earnings Call Transcript

Supernus Pharmaceuticals Inc (SUPN) Q4 2019 Earnings Call Transcript

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Supernus Pharmaceuticals Inc (NASDAQ:SUPN)
Q4 2019 Earnings Call
Feb 26, 2020, 9:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen, and welcome to the Supernus Pharmaceuticals Fourth Quarter and Full Year 2019 Financial Results Conference Call. [Operator Instructions]

I would now like to turn the conference over to Peter Vozzo of Westwicke, Investor Relations representative for Supernus Pharmaceuticals. You may begin.

Peter VozzoManaging Director

Thank you, Jonathan.

Good morning, everyone, and thank you for joining us today for Supernus Pharmaceuticals’ fourth quarter and full year 2019 financial results conference call.

Yesterday, after the close of the market, the Company issued a press release announcing these results. On the call with me today are Supernus’ Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Greg, Patrick. Today’s call is being made available via the Investor Relations section of the Company’s website at ir.supernus.com. Following remarks by management, we will open the call to questions.

During the course of this call, management may make certain forward-looking statements regarding future events and the Company’s future performance. These forward-looking statements reflect Supernus’ current perspective on existing trends and information and can be identified by such words as expect, plan, will, may, anticipate, believe, should, intend and other words of similar meaning. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section on the Company’s 2018 Annual Report on Form 10-K. Actual results may differ materially from those projected in these forward-looking statements.

For the benefit of those of you who may be listening to the replay, this call is being held and recorded on February 26, 2020, at approximately 9:00 AM Eastern Time. Since then, the Company may have made additional announcements related to the topics discussed. Please reference the Company’s most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward-looking statements except as required by applicable securities laws.

I will now turn the call over to Jack.

Jack A. KhattarPresident and Chief Executive Officer, Director

Thank you, Peter.

Good morning, everyone, and thanks for taking the time to join us as we discuss our 2019 fourth quarter and full year results.

In our press release yesterday, we announced the results of the P302 study, which was the second Phase III study of SPN-810 for the treatment of impulsive aggression in ADHD patients 6 through 11 years old. The study was similar in design to the first P301 Phase III study. It was a randomized, double-blind, placebo-controlled, multicenter parallel group clinical trial in patients diagnosed with ADHD. The study missed the primary endpoint, showing that patients receiving the 36 milligram dose had a reduction of 51% in the average weekly frequency of impulsive aggression episodes compared to 54% in the placebo arm. These results differ from the first Phase III trial where the drug effect was much higher at 59% reduction in the frequency of episodes and the placebo effect was much lower at 47% reduction. As in the P301 trial, the drug was safe and well tolerated. Given the results of the P302 trial and the results we announced last year from the P301 trial, all development activities related to SPN-810 in impulsive aggression have been put on hold.

Regarding SPN-812, the FDA accepted for review our NDA with a PDUFA target action date of November 8, 2020. We remain focused on preparing for the potential commercial launch of SPN-812 by year-end. In addition, we expect to complete enrollment in the ongoing Phase III program with SPN-812 in adult patients by the end of 2020. This is an important trial that will potentially help us expand the use of SPN-812 if approved by the FDA in the adult market.

Our launch plans and preparation for the introduction of SPN-812 are well under way. We have initiated several programs that focus on disease awareness and education and that have broad reach to parents and patients. We have also made progress in our discussions with the managed care plans regarding the importance of SPN-812 in the current treatment paradigm for ADHD. In addition, we have completed important work on the novel mechanism of action of SPN-812, highlighting its activity as a serotonin and norepinephrine modulating agent and scientifically proving that it is much different from existing therapies in the marketplace. We plan on presenting and publishing this scientific work throughout the year at various conferencing, starting with a poster and presentation next week at the ASENT 2020 neurotherapeutics meeting in Bethesda, Maryland.

For SPN-604 for the treatment of bipolar disorder, we expect enrollment in the ongoing pivotal Phase III monotherapy trial for the treatment of bipolar disorder to continue through 2021.

Moving on to the existing neurology business. Total prescriptions for Trokendi XR and Oxtellar XR for the full year 2019, as reported by IMS, reached 836,399 prescriptions, representing a 6.4% increase over 2018.

For Trokendi XR, Supernus managed to grow prescriptions to 672,485 for the full year 2019, representing a 5.3% increase compared to 2018, despite the intensified competition by CGRPs and the slight decline in the topiramate market. However, due to the inventory build in 2018 and continued pressure from managed care, net product sales for Trokendi XR in 2019 were down by 6.4% as compared to 2018.

For Oxtellar XR, prescriptions for the full year 2019 were 163,914, representing an increase of 11.1% over 2018. This compares favorably to the 3% prescription growth in the oxcarbazepine market and is due to the launch of the monotherapy indication for Oxtellar XR in 2019. As with Trokendi XR, but to a lesser degree, net sales of Oxtellar XR and the comparisons over 2019 [Phonetic] were impacted by the inventory build and managed care pressure, yielding a net increase of 4.3% in net sales in 2019 compared to 2018.

As we mentioned on our last quarterly earnings call, any positive impact of volume growth and price increases in 2020 are likely to be offset by continued pressure from gross to net sales reductions. For 2020, we expect a continuation of competitive pressure in the migraine market due to the introduction of additional CGRP treatments and headwinds from managed care.

Finally, our activity in corporate development continues in 2020 as we look for neurology and psychiatry assets that represent a strategic fit with our current portfolio.

I’ll now turn the call over to Greg who will provide more details on our fourth quarter and full year financial performance.

Gregory S. PatrickChief Financial Officer

Thank you, Jack, and good morning, everyone.

As I review our fourth quarter and full year 2019 financial results, please refer to yesterday’s press release. Total revenue for full year 2019 was $393 million compared to $409 million in 2018. Total revenue for full year 2019 was comprised of net product sales of $383 million and royalty revenue of $9 million as compared to net product sales of $400 million, royalty revenue of $8 million and licensing revenue of $0.75 million in 2018.

As we previously disclosed, wholesalers, distributors and pharmacies increased their inventory levels of the Company’s products in the fourth quarter of 2018. We estimate that this caused net product sales in both the fourth quarter and full year of 2018 to be approximately $10 million higher than would have been otherwise had inventory levels remained consistent quarter to quarter. This inventory build in the fourth quarter of 2018 was effectively reversed in the first quarter of 2019. As a result, net product sales were approximately $10 million lower in both the first quarter and for the full year 2019 than would have been otherwise. These fluctuations in net product sales primarily affected Trokendi XR.

Net product sales for full year 2019 were $383 million compared to $400 million for full year 2018. Net product sales for Trokendi XR for the full year 2019 were $295 million compared to $315 million for full year 2018. Net product sales for Oxtellar XR for full year 2019 were $88 million compared to $85 million for full year 2018.

Turning to the fourth quarter. Total revenue was $100 million compared to $116 million in the fourth quarter of 2018. Total revenue for fourth quarter 2019 included net product sales of $98 million and royalty revenue of $3 million as compared to net product sales of $114 million and royalty revenue of $2 million in the prior year period. Net product sales for the fourth quarter of 2019 were $98 million compared to $114 million in the fourth quarter of 2018. The year-over-year decrease is primarily due to the $10 million inventory build in the fourth quarter of 2018 which I just described. As with the full year results, these fluctuations in net product sales primarily affected Trokendi XR. Net product sales for Trokendi XR for the fourth quarter 2019 were $75 million compared to $88 million in 2018. Net product sales for Oxtellar XR for the fourth quarter of 2019 were $23 million compared to $25 million in the prior year period.

Turning now to expenses.

Research and development expenses were $69 million for full year 2019 and $20 million for fourth quarter 2019, lower than $89 million and $30 million in the respective prior year periods. The decrease over both periods is primarily attributable to the one-time upfront expense of approximately $14 million for the acquisition of Biscayne Neurotherapeutics, Inc. in the fourth quarter of 2018. In addition, the decrease for full year 2019 was also due to the completion of four Phase III clinical trials for SPN-812, partially offset by the cost to manufacture SPN-812 to support our NDA filing.

SG&A expenses for full year 2019 were $158 million, essentially unchanged from $160 million in 2018. SG&A expenses in the fourth quarter of 2019 were $36 million, down from $42 million in the same quarter last year. The decrease in SG&A expense in the fourth quarter of 2019 is primarily attributable to the development and production of promotion materials and marketing programs associated with the launch of the monotherapy indication for Oxtellar XR in the fourth quarter of 2018. In addition, employee-related expenses were lower.

Operating expenses for full year 2019 were $149 million compared to $144 million in 2018. The increase in operating earnings is primarily due to lower R&D and SG&A expenses in 2019.

Operating earnings for the full year 2019 were negatively impacted by the inventory drawdown in the first quarter of 2019, as I mentioned earlier. This resulted in full year 2018 operating earnings being $10 million higher and full year 2019 operating earnings being $10 million lower than would have been otherwise. Operating earnings in the fourth quarter of 2019 were $41 million compared to $40 million in the fourth quarter of 2018. The quarterly comparison was negatively impacted by the aforementioned increase in channel inventory holdings in the fourth quarter of 2018. The increase in channel inventory holdings in 2018 caused the fourth quarter 2018 operating earnings to be higher by approximately $10 million than would have been otherwise.

Net earnings were $113 million for full year 2019 or $2.10 per diluted share compared to $111 million or $2.05 per diluted share for full year 2018. Net earnings in the fourth quarter of 2019 were $33 million or $0.62 per diluted share, an increase of 29% on a diluted share amount as compared to $26 million or $0.48 per diluted share in the same period last year.

As of December 31, 2019, the Company had $939 million in cash, cash equivalents, marketable securities and long-term marketable securities, an increase of $164 million as compared to $775 million as of December 31, 2018.

Turning now to financial guidance for full year 2020. The Company is providing the following. Net product sales to range from $360 million to $390 million and operating income to range from $70 million to $100 million. Regarding SG&A expenses, other than the impact of the addition of the sales force personnel in anticipation of the 2020 launch of SPN-812, SG&A expenses are expected to be consistent quarter-to-quarter in 2020. Higher expenses year-over-year reflect primarily the pre-launch activities for SPN-812.

I will now turn the call back to the operator for questions. Thank you.

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from the line of Ken Cacciatore from Cowen and Company. Your question, please.

Kenneth CacciatoreCowen and Company — Analyst

Hey, good morning, guys. As we now think forward to the 812 introduction, maybe, Jack, you could just give us a sense of the pricing of the current branded ADHD products and maybe talk about their coverage and why would that be materially different than what you can accomplish with 812. And then second question on business development. Are you still thinking about CNS and movement disorders? Or would you be thinking about maybe venturing into different therapeutic classes? Thank you.

Jack A. KhattarPresident and Chief Executive Officer, Director

Yeah, sure. Regarding the current market and the current pricing as far as brands are concerned, and this covers stimulants, nonstimulants, the whole market actually in ADHD, it ranges somewhere between $350 to $550 or $600 for a 30 day prescription on a branded basis. And as far as contracting and so forth and our discussions with managed care, it’s really becoming very important to highlight to them, as I mentioned in my prepared remarks, the fact that SPN-812 is such a novel compound. And we’ve been able to actually to prove that scientifically through some very interesting work as far as the activity of the product, the receptor activity and what it’s really modulating and what neurotransmitters it’s impacting, and relating that actually to the clinical data that we have which supports all the data we’ve been able to generate on the activity side and the mechanism of action.

So we’re very excited about all this new data that, as I mentioned, we’re going to first review publicly next week and hopefully with more posters and presentations later through the year. And that has become very important to differentiate SPN-812 from every other product that currently is on the marketplace, including the nonstimulants that everybody else continues to say you are very similar to them and we are not. And actually that’s where SPN-812 differentiates itself, starting with the mechanism, all the way to showing very different clinical data that we’ve talked about numerous times in our Phase III program across all four Phase III programs, even the Phase II programs where the data is so consistent and predictable in helping patients and improving their symptoms in the ADHD market.

So we’re very excited about the acceptance of that data, the way it came out, the strength of that data, and also very excited about all the discussions we’ve had so far with the managed care plans as they start understanding and seeing that this is truly a novel mechanism, a novel product that this market has not seen for the last decade or even more. So it’s really a very important therapy that they’re looking to add and they’re seeing it as something that could really benefit a lot of patients in a much differentiated way.

Regarding business development, we continue to be very intensely involved with many opportunities that we’re looking at. And that does cover the whole CNS domain, neurology and psychiatry. We continue to emphasize later stage commercial assets if we can find them and or assets that are in late stage development. In addition to that, we are looking at some of the earlier stuff as well because we are very conscious of the fact that we really need to reload the pipeline.

So, as I’ve said in the past, we’ve been very active and continue to be very active, and we hope to do something this year. Obviously, our goal is to utilize the significant cash balance that we have on our balance sheet. Certainly, we’ve raised the money and we continue to generate very strong cash flows, and our intention is to use those proceeds and that cash position to bring in new external growth opportunities through acquisitions or licensing and we’re very, very active in that space.

Operator

Does that answer your question?

Kenneth CacciatoreCowen and Company — Analyst

Yes, it does. Thank you.

Operator

Thank you. Our next question comes from the line of David Steinberg from Jefferies. Your question, please.

David SteinbergJefferies — Analyst

Thanks. I just wanted to follow up Ken’s question on business development. Now that your other ADHD asset is no longer going to be marketed, your pathway is pretty clear. You have one new asset to launch before Trokendi, the IP expires, and with the settlement, the generics come in. So I’m just wondering, with just one asset to launch going forward, is there a greater urgency to do an on-market product versus a development stage asset?

And then secondly, Jack, I think you said, it sounds like there is a very good chance you’re going to actually in-license or buy something this year. I know in the past one of the reasons you have not acquired anything, as you said, 90% of the transactions, the value goes to the seller, not to the buyer, i.e., valuations are too high. So dovetailing your comment, does that mean you’re seeing more attractive valuations in the marketplace? Thanks.

Jack A. KhattarPresident and Chief Executive Officer, Director

Yeah. Regarding whether we have a higher level of urgency now or not, I mean, I’ll tell you, and I know many people have heard me say that. I mean, the urgency level was always there because everybody who understands this business, pharmaceutical business, we all know at anytime a project may die for one reason or another. So we never really bank on the fact that 812 will make it all the way or 810 will make it all the way. So we’ve been really lucky, actually, through our existence to have such a low, low attrition rate in our R&D programs since even our inception.

As I mentioned, our employees — a few months ago when we first got the first data on 810 — actually, this is the first ever Phase III data — efficacy safety data that didn’t work for us over the past 20-some years. So actually, yeah, I mean, we always bank on the fact that it’s never a straight line. You never can guarantee that any of your products in the pipeline will work, and therefore you always work with an urgency level, given the situation we have with Trokendi XR to make sure that we have a transition that is as smooth as possible as far as the revenue and the potential reduction in the revenue when the generics come in.

Is that urgency level any higher? Not really. It continues to be very high level anyway. Yes, we are focused on commercial products, if we can get them. As far as the valuations, they continue to be challenging out there. But we think we should be able to get something done, and we hope that we will be able. Can I promise finding? No, unfortunately we can’t. We can promise that we’re putting the effort and we’re working pretty hard to make it happen. Thus, although we can’t really control clearly as far as the certainty around the date as to when something like this happens is very difficult to predict, but we’re certainly very much involved in a lot of different things. We’ve been looking at and we hope to get something done.

Operator

Thank you. Our next question comes from the line of Annabel Samimy from Stifel. Your question, please.

Annabel SamimyStifel, Nicolaus & Company — Analyst

Hi guys. Thanks for taking my question. I just wanted to go back to the comments you made about how you’ve started conversations with managed care. I know what you are pitching to them in terms of SPN-812’s differentiation in activity. But maybe you can talk about what kind of feedback you’ve been getting back from them in the initial conversations.

And then secondly, I was hoping for a little bit of clarity on the EBITDA guidance. It is fairly significantly down. So I imagine that that SG&A is going up as of the SPN-812 launch. You said that SG&A will be consistent through the year. But consistent from where? At the new stepped up level? Or from fourth quarter and then it steps up toward the end of the year with the sales? Thank you.

Jack A. KhattarPresident and Chief Executive Officer, Director

Yeah. Regarding the first portion of the question, which is on managed care and the feedback we have been getting, the more we have discussions with them and the more data we share with them, we started our initial discussions with them, clearly on the Phase III data as we started getting the data, explaining it to them, putting it in perspective with the current therapies out in the marketplace. And the initial discussions, I’ll tell you, they were saying, well, the market is already satisfied, so how is 812 different.

And as we took the time to explain to them and walk them through the data and showing to them the real clear points of differences, we’re having very different discussions recently with them and specifically, as we show them also the mechanism of action and the data behind 812 and how truly different it is from everything they’ve seen. They do also acknowledge that, yes, in the last 10 years or 15 years or whatever, all these products [Phonetic] were different formulations of the same drugs, and they have that attitude of course that please don’t come to me with another reformulation of amphetamine or methylphenidate or whatever the case might be.

So they like the fact that this is a new treatment, completely new treatment, even different than Strattera or any other nonstimulants. They like the fact that it really presents to patients a true novel treatment option. And they acknowledge the fact also that this is a category where you only have four molecules that are really options to patients versus when you look at other conditions where you have potentially 10 products or 15 different antidepressants or schizophrenic and/or product in different CNS conditions. So they’re really starting to realize the value of 812 and the benefit it can — we’ve been very encouraged with these discussions.

I’ll let Greg take over on the second part of the question.

Gregory S. PatrickChief Financial Officer

Thank you, Jack, and thanks for the question, Annabel. As we commented in our last call, we did note — and I think Jack has continually noted that the Company’s prepared a major effort behind the launch of SPN-812 later this year. The precursor to that is a very much stepped up level of marketing activities — pre-marketing activities as regards to the launch and a preparation for that launch.

So, the way to I guess I think about our operating income guidance would be to, first of all, start with R&D expenses and think about them more or less consistent with where we’ve been over the past couple of years. Particularly, if you pull out the Biscayne acquisition in 2018, there is an ongoing run rate there in the kind of $70 million to $80 million range. So let’s use that as a basis for comparison. And that would suggest, as we have mentioned in last call and I’ll reiterate in this call, SG&A expenses north of $200 million is a pretty reasonable expectation for this year. And the math would suggest that. And that is in contrast of $160 million in 2018.

You asked about the — the question about consistent. That’s right, consistent quarter to quarter. So looking at the base of being in the range of $200 million or perhaps a little bit north of that, thinking about that being relatively flat over the course of the year because that reflects the pre-marketing activities and the like, as I just mentioned. And one exception to that would be the addition of the sales force. Largely, that’s going to be a fourth quarter activity. And we’ve mentioned the number of reps which the Company would anticipate adding, which is north of 100. So I think that that math will help you to annualize those expenses. Hope that helps.

Annabel SamimyStifel, Nicolaus & Company — Analyst

That’s perfect. Thank you.

Gregory S. PatrickChief Financial Officer

Welcome.

Operator

Thank you. Our next question comes from the line of Patrick Trucchio from Berenberg Capital. Your question, please.

Patrick TrucchioJoh. Berenberg, Gossler & Co. — Analyst

Thanks. Good morning. I have a follow-up on the commercial launch on SPN-812. Can you talk about the timing for the launch for 812 being later in the fourth quarter relative to the start of the 2020 school year? That would be well under way at that time. And should we therefore think of an uptick as being more modest in the first couple of quarters, two or three quarters of the launch before picking up at the start of the school year in 2021? And then secondly, can you also discuss your level of engagement with KOLs on SPN-812? What the view of KOLs is on this compound? And finally, when would you anticipate commercial launch expenses to start to build given the late 2020 launch?

Jack A. KhattarPresident and Chief Executive Officer, Director

Okay. Yeah, Patrick, I’ll start with — as far as the timing of the launch, as we said, the PDUFA is November 8. So basically, we will — and we’ve been working pretty hard. The moment we get the approval, our, obviously, plan is to launch as quickly as we can. So, depending how ready we can be with the label and expecting what the label is before November 8 and how quickly we can get the product done and into the warehouse, you can estimate it’s a few weeks from then basically. So our intent is to launch it as soon as possible. Every day will count. Even if it is December 31 or whatever it is, we’re going to launch it whenever quickly we can do that.

As far as the comment, launching it during that time of the year versus the back to school, is it ideal to launch an ADHD product around the back-to-school season? Absolutely. And we’ve said that even way back a couple of years ago that we would love to be able to do with that. But we are where we are at this point. And our obviously plans are to optimize the launch and maximize the potential of 812 regardless when we launch it. And if it is a year-end, then be it, and we’ll make the best out of that.

Now, having said all that, that doesn’t mean there will be no demand in December or January or whatever, because if you really think about it from a patient perspective and the parents, there is a lot of kids during the school year who are seeing problems surfacing. So not all the problems of ADHD symptoms and issues surface only at the beginning of the school year. Actually, many of those problems do surface later in the year as some of these p kinderen of kinderen krijgen rapportkaarten voor echt worstelen in de klas, begin later met opschortingsbrieven. Deze problemen komen niet aan de orde vanaf de eerste dag.

We zullen dus duidelijk de vraag hebben. Zal de opname langzamer zijn? Hoogstwaarschijnlijk ja, het zal langzamer zijn dan het zou zijn gelanceerd rond het schooljaar en het raam in de zomer of september-oktober tijdsbestek. Dus ja, de opname, we verwachten dat het een beetje langzamer is, maar op de lange termijn verandert het potentieel van het product helemaal niet, of je het nu in januari, december of in de zomer daarvoor lanceert school.

Wat de KOL’s betreft, ik bedoel, ik moet het je echt vertellen. Ik bedoel, KOL’s – het is duidelijk dat we de eerste mensen zijn die de gegevens van SPN-812 zien, niet eens zien, maar ook ervaren dat sommigen van hen, hoewel ze natuurlijk verblind waren, in onze fase III-onderzoeken , en ze wisten niet of de kinderen placebo of het medicijn kregen. Maar de resultaten die ze van deze patiënten uit de eerste hand zagen, zoals ze ons vertellen, waren echt opmerkelijk, dat ze vonden dat het medicijn zou moeten werken, succesvol moeten zijn, enzovoort. En terwijl we de feitelijke gegevens met hen deelden, bevestigde het gewoon alles wat ze uit de eerste fase in het Fase III-onderzoek hebben gezien dat we hebben gedaan.

En het is heel opwindend voor hen om te weten dat ze mogelijk een optie kunnen hebben daar als een niet-stimulerende, niet-gereguleerde stof die al in week één kon werken en met een effect dat ze uit de eerste hand zagen in de studies die de hele studie duurden en die ook in zowel onoplettendheid als hyperactiviteit konden werken, net zoals de gegevens zijn verbeterd en geven ze tegelijkertijd – en dit is belangrijk voor artsen – hen een breed therapeutisch venster en dosisbereik waarmee ze kunnen werken, 100 mg tot 400 mg zonder opoffering van enige tolerantie of veiligheid en de zekerheid hebben dat dit product zeer goed wordt getolereerd gezien het profiel waarover we al verschillende keren hebben gesproken en de zeer lage stopzettingspercentages achter dit product.

Dus ze zijn erg enthousiast over het hebben van die opti Aan. Velen van hen zien zelfs geen nadeel voor het proberen. Het is net wat moeten ze verliezen? Het is een niet-gereguleerde stof, zo gemakkelijk te gebruiken. Bovendien hebben we voor veel kinderen misschien niet eens titratie nodig. De 100 milligram werkte buitengewoon goed in onze klinische studies. Dus het is zo gemakkelijk te gebruiken. Je zult vrij snel weten of het voor deze kinderen gaat werken of niet. En in het ergste geval kunt u altijd een stimulerend middel toevoegen als u dat wilt. Dus het is echt heel, heel positief ontvangen door de KOL’s en ze kunnen niet wachten tot we het product op de markt hebben.

Dus dat is echt de samenvatting van waar we ons nu bevinden op 812 en hoe opgewonden. Ik bedoel, ons niveau van opwinding blijft maar stijgen en stijgen naarmate we hopelijk dichter bij de lanceringsdatum komen.

Patrick Trucchio Joh. Berenberg, Gossler & Co. – Analist

En precies wanneer verwacht u dat de commerciële lanceringskosten dit jaar beginnen te bouwen?

Gregory S Patrick Chief Financial Officer

Ja. Patrick, zoals ik al eerder op de vraag van Annabel heb gezegd, zijn de lanceringskosten aan het bouwen, eigenlijk zijn ze in 2019 aan het bouwen. En aangezien er een step-up is – een zeer significante step-up tussen 2019 en 2020 in termen van VAA-kosten , ze zijn ingebed in het volledige jaar van 2020. Dus we hebben uitgegeven in afwachting van de lancering, en die uitgaven zullen dit jaar echt toenemen.

Dus het antwoord op uw vraag is, nu. De andere component van de lanceringskosten is die welke verband houdt met het verkoopteam. En zoals ik al zei, in antwoord op de vraag van Annabel, zal dat grotendeels een uitgave van het vierde kwartaal zijn. We gaan dat aanpassen zodat die herhalingen worden toegevoegd net vóór de verwachte datum van goedkeuring. Dus vanuit kostenoogpunt denk je dat je zou verwachten dat die uitgave in wezen een vierde kwartaal is.

Jack A. Khattar President en Chief Executive Officer , Directeur

Dus de enige back-load-kosten zijn de verkoopkosten, maar de marketing- en lanceringskosten zijn redelijk verdeeld over alle kwartalen. Dat is een soort punt dat we mensen echt willen laten begrijpen. Het is dus niet zo dat alle lanceringskosten in de tweede helft van dit jaar worden belast. Het wordt redelijk verdeeld over de kwartalen, met uitzondering van de kosten van het verkoopteam zelf.

Patrick Trucchio Joh. Berenberg, Gossler & Co. – Analist

Dat is nuttig. Hartelijk dank.

Jack A. Khattar President en Chief Executive Officer, Director

Natuurlijk. Welkom.

Operator

[Operator Instructies] Onze volgende vraag komt uit de lijn van David Amsellem van Piper Sandler. Uw vraag alstublieft.

Zachary Sachar Piper Sandler – Analist

Hallo allemaal. Dit is Zach voor David. Bedankt voor het beantwoorden van mijn vraag. Slechts een paar snelle van mij op SPN-812. We hopen dit te doen – het spijt me als u dit al hebt gezegd, maar we hoopten een idee te krijgen van wat u in eerste instantie denkt in termen van contractering van betalers en specifiek wat uw mening is over het potentieel voor de patiënten misschien door een step-through van een generieke versie van Strattera of Intuniv te gaan om toegang te krijgen tot 812. En ten tweede, ik denk dat u hier al op heeft gewezen, maar waar u aan denkt op het gebied van prijzen [ Uncipherable] het product? Bedankt.

Jack A. Khattar President en Chief Executive Officer, Director

Ja, zeker. Zoals ik al eerder zei, is het op dit punt een voortdurende discussie voor zover het de betalers betreft. Het is dus niet alsof we een definitief standpunt innemen dat ze op de een of andere manier hebben ingenomen. Dus die zullen doorgaan tot de lancering. En ons doel is duidelijk om vanaf de eerste dag zoveel mogelijk dekking te hebben. Maar alle discussies tot nu toe – en terwijl we steeds meer discussies blijven voeren en de gegevens waarnaar ik verwees met betrekking tot het mechanisme en de nieuwheid van het product met hen delen, denk ik dat ze echt beginnen te begrijpen dat dit is niet zoals een generieke Strattera of een generieke Intuniv. En daarom is het de moeite waard om het als een heel ander product te beschouwen dan deze producten.

Dat gezegd hebbende, betekent dit niet dat ze je met een open arm zullen verwelkomen en het je gemakkelijk maken. Ik wil dus niet dat mensen mijn opmerkingen verkeerd begrijpen. Het zal natuurlijk een uitdaging zijn, maar we zullen er doorheen werken en we hebben veel gegevens om ons te helpen SPN-812 van deze producten te scheiden.

Over prijzen maken we geen specifieke opmerkingen over wat onze prijsstrategie zal zijn of wat de prijs zal zijn. Maar eerder werd een vraag gesteld over het assortiment merkproducten op de markt. En ik noemde ergens in de $ 350 tot $ 550 het assortiment merkproducten dat momenteel op de markt is, en dat omvat niet-stimulerende middelen tot stimulerende middelen.

Zachary Sachar – – Piper Sandler – Analist

Oké. Bedankt.

Jack A. Khattar President en Chief Executive Officer, Director

Natuurlijk.

Operator

Bedankt. Hiermee is de vraag-en-antwoordsessie van het programma van vandaag afgerond. Ik wil het programma graag teruggeven aan Jack Khattar voor verdere opmerkingen.

Jack A. Khattar President en Chief Executive Officer, Director em >

Bedankt. We zijn gericht op het verkrijgen van goedkeuring voor SPN-812 en, indien goedgekeurd, de lancering van wat de eerste nieuwe behandeling zou zijn die in meer dan tien jaar op de ADHD-markt zou worden geïntroduceerd. Hoewel de resultaten van ons SPN-810-programma teleurstellend zijn, blijven we investeren in onze R & D-pijplijn en zijn we van plan later dit jaar een R & D-update te verstrekken. We zullen ook externe groeimogelijkheden blijven nastreven door bedrijfsontwikkeling. Bedankt voor het meedoen vanmorgen. We kijken ernaar uit u het hele jaar door te updaten.

Operator

[Opmerkingen van operator sluiten]

Duur: 40 minuten

Deelnemers bellen:

Peter Vozzo Managing Director

Jack A. Khattar – President en Chief Executive Officer, Director

Gregory S. Patrick Chief Financieel medewerker

Kenneth Cacciatore Cowen and Company – Analist

David Steinberg – Jefferies – Analist

Annabel Samimy Stifel, Nicolaus & Company – Analist

Patrick Trucchio Joh. Berenberg, Gossler & Co. – Analist

Zachary Sachar Piper Sandler – Analyst

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