Q4 2020 Supernus Pharmaceuticals Inc Earnings Call
Good afternoon, and welcome to soup, I noticed pharmaceuticals fourth quarter and full year 'twenty 'twenty financial results Conference call.
Operator: Good afternoon, and welcome to Supernus Pharmaceuticals' fourth quarter and full year 2020 financial results conference call. At this time, all participants are in a listen only mode.
And this time all participants are in a listen only mode. Neither we will conduct a question and answer session and instructions will follow at that time.
Operator: Later, we will conduct a question and answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Vozzo of Westwick, the Investor Relations Representative for Supernus Pharmaceuticals. You may begin. Thank you, Alex.
As a reminder, this conference call is being recorded.
I don't know like to turn the conference over to Peter Bozzo off last week, and Investor Relations Representative Force Super and as Pharmaceuticals, you may begin.
Thank you Alex good afternoon, everyone and thank you for joining us today from <unk> Pharmaceuticals fourth quarter and full year 2020 financial results conference call today. After the close of the market. The company issued a press release announcing these results on the call with me today are Super and US as Chief Executive Officer, Jackatar, and Jim Kelly Chief Financial Officer.
Peter Vozzo: Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' fourth quarter and full year 2020 financial results conference call. Today, 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 Jim Kelly, Chief Financial Officer. Today's call is being made available via the Investor Relations section of the company's website at
Today's call is being made available via the Investor Relations section of the company's website at IR Dot supernal dotcom and <unk>.
Peter Vozzo: Following remarks from 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. However, any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filing. Actual results may differ materially from those projected in these forward-looking statements.
Following my remarks management, we will open the call to questions. During the course of this call management may make make certain forward looking statements regarding future events and the company's future performance. These forward looking statements reflects the Pernis is current and perspective on existing trends and information and he such forward looking statements are not guarantees of future performance and involve risks.
And uncertainties, including those noted and the risk factors section of the company's latest SEC filings.
Actual results may differ materially from those projected and these forward looking statements from.
Peter Vozzo: For the benefit of those of you who may be listening to the replay, this call was held and recorded on February 25th, 2021 at 4.30 p.m. Eastern Time. Since then, the company may have made additional announcements related to the topics discussed. Please refer to the company's most recent press releases and current filings with the SEC. Supernus undertakes no obligation to update these forward-looking statements, except as required by applicable securities laws. I will now turn the call over to Jack.
And the benefit of those of you who may be listening to the replay. This call is being held and recorded on February 25th 2021, four at 430 P M 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.
Pernice declines declines any obligation to update these forward looking statements, except as required by applicable securities laws and I'll now turn the call over to Jack.
Jack A. Khattar: Thank you, Peter. Good afternoon, everyone.
Thank you Peter good afternoon, everyone and thanks for taking the time to join US as we discuss our 'twenty and 'twenty fourth quarter and full year results.
Jack A. Khattar: And thanks for taking the time to join us as we discuss our 2020 fourth quarter and full year results. Despite its numerous unprecedented challenges and uncertainties, the year 2020 ended up being a monumental year for Supernus with significant accomplishments. The company surpassed the half-a-billion-dollar sales level behind the continued growth of Chukendi XR and Oxteler XR and the recently acquired CNS products. We reported record revenues of $520 million and record operating earnings of $174 million for the year 2020. More importantly, during the year, we achieved significant strategic objectives that should position us well for the future.
Despite its numerous unprecedented challenges and uncertainties the year 'twenty and 'twenty ended up being a monumental year for supporting us with significant accomplishments.
Company has surpassed the half a billion dollar sales level behind the continued growth of Trokendi, XR and ox Selinexor and the recently acquired CNS products, we reported for the year Twenty-twenty record revenues of $520 million and record operating earnings of 174 million.
More importantly, during the year and we achieved significant strategic objectives and that should position us well into the future.
Jack A. Khattar: By executing two key strategic transactions, we diversified our revenue and profit base, strengthened our pipeline, and enhanced our long-term growth with two key programs, SP&A 20 and SP&A 30, and also expanded our commercial capabilities in CNS. The company is well positioned to launch SPNA-12, if approved by the FDA, as the next novel ADHD treatment for pediatric patients. As we indicated in our press releases earlier this month, we resubmitted the SPNA-12 NDA for pediatric patients and subsequently received from the FDA a new PDUFA action date in early April 2021.
By executing two key strategic transactions, we diversified our revenue and profit space strengthened our pipeline and enhance our long term growth with two key programs SPN 820, and SPN 830, and also expanded our commercial capabilities and CNS.
The company is well positioned to launch SPN 812, if approved by the F. D. A as the next novel ADHD treatment for pediatric patients as.
As we indicated in our press releases earlier this month, we resubmitted the SPN 812 N D E and pediatric patients and subsequently received from the F D. A and new Purdue for action date in early April 'twenty and 'twenty one.
We are now preparing for a potential launch and the second quarter of this year with more than 175 sales representatives and leveraging our internal expertise and ADHD and CNS.
Jack A. Khattar: We are now preparing for a potential launch in the second quarter of this year with more than 175 sales representatives leveraging our internal expertise in ADHD and CNS. Finally, in December 2020, we will announce positive results from a phase 3 study for SPNA12 in adults with ADHD. We plan to submit a supplemental NDA to the FDA for SPNA-12 for the treatment of ADHD in adult patients in the second half of 2021, assuming approval for pediatric patients.
Finally, and December 'twenty, 'twenty, we announced positive results from a phase III study for SPN 812, and adults with ADHD.
And we plan to submit a supplemental NDA to the FDA for SPN 812 for the treatment of ADHD in adult patients and the second half of 'twenty 'twenty, one assuming approval for pediatric patients.
Jack A. Khattar: The adult indication is important to help expand the use of SPNA-12 in the adult segment, which represents approximately half of the total ADHD market in the U.S. Turning now to the Apomorphine Infusion Pump NDA, or SPN 830, we are scheduled to meet with the FDA in March 2021 in a Type A meeting to discuss the contents of the refusal to file letter we received in November 2020. In the letter, the FDA requested certain documents and reports be submitted in support of the application.
The adult indication is important to help expand the use of SPN eight and 12 in the adult segment, which represents approximately half of the total ADHD market and the U S.
Turning now to the April morphine infusion pump NDA or SPN 830, we are scheduled to meet with the F. D. A and March 'twenty 'twenty, one and a type a meeting to discuss the contents of the refusal to file letter we received in November 'twenty and 'twenty.
And the letter the FDA requested certain documents and reports to be submitted and support of the application. We believe additional testing of the device will be necessary to support the SPN 830 NDA resubmission.
Jack A. Khattar: We believe additional testing of the device will be necessary to support the SPN 830 NDA resubmission. We plan to resubmit the NDA after completing our discussions with the FDA and all the required activities for filing. Regarding SPNA20, our first-in-class orally active mTORC1 activator, development activities are ongoing, including a multiple ascending-dose study in healthy volunteers.
We plan to resubmit the NDA after completing our discussions with the FDA and all of the required activities for filing.
Regarding SPN a 'twenty our first in class orally active M talk on activator development activities are ongoing including and multiple ascending dose study in healthy volunteers. The program remains on track to enter phase II clinical testing and treatment resistant depression by the end of 2021.
Jack A. Khattar: The program remains on track to enter Phase II clinical testing in treatment-resistant depression by the end of 2021. Moving on to the commercial products, we are pleased with the overall performance of our products in 2020, despite the adverse impact of the pandemic on Salesforce access to physicians, patient visits, and new patient initiation. Candy XR delivered healthy growth of 8% in net sales over 2019, reaching an all-time high of $320 million in sales. Similarly, Oxtalerx had a great year, reaching $99 million in net sales, representing a 12% growth compared to last year.
Moving on to the commercial products. We are pleased with the overall performance of our products in 'twenty and 'twenty. Despite the adverse impact of the pandemic on sales force access to physicians patient visits and new patient initiations true.
Okay, and the XR delivered and Twenty-twenty healthy growth of eight per cent and net sales over 20, and 19, reaching an all time high of $320 million and and sales. Similarly, ox fell and XR had a great year, reaching $99 million and net sales, representing a 12% growth compared to last year.
On a prescription basis as reported by IMS and as compared to 20, and 19 Oxtail XR showed growth of three three per cent and twenty-twenty, while growing by 8.2 per cent and extended units as represented by the number of tablets for Trokendi XR, while IMS prescriptions declined.
Jack A. Khattar: On a prescription basis, as reported by IMS and as compared to 2019, Oxfeller XR showed growth of 3.3% in 2020, while growing by 8.2% in extended units, as represented by the number of tablets. For Trocandi XR, while IMS prescriptions declined by 11.7% in 2020, the extended units declined by 5.1% compared to 2019. This trend in extended units for both products is due to the fact that the average size of a monthly prescription for Trockandy XR and Oxteller XR has been trending upwards since the start of the pandemic, and such a larger size of the monthly prescription was sustained through the fourth quarter.
Line by 11, 7% in 'twenty and 'twenty the extended units declined by $5 one per cent compared to 20 and 19.
This trend and extended units for both products is due to the fact that the average size of a monthly prescriptions for Trokendi XR and ox Selinexor has been trending upwards since the start of the pandemic and such larger size of monthly prescription was sustained through the fourth quarter.
For a book in net sales recorded by supporting Us and 'twenty 'twenty four and a partial year since the acquisition were $74 million with 31 million and the fourth quarter.
Jack A. Khattar: For Apokin, net sales recorded by Supernus in 2020 for a partial year since the acquisition were $74 million, with $31 million in the fourth quarter. Overall, the product fared well in 2020; however, the resurgence of COVID in the fourth quarter and resulting increased closure of physician offices, together with some increased competition in the segment, pressured the brand performance compared to the third quarter. For Zydeco, in the year 2020, IMS prescriptions declined by 1% versus last year, while extended units grew by 3.8%.
Overall, the product fared well in 'twenty and 'twenty, however, the resurgence of Covid and the fourth quarter, and the resulting increase closure or physician offices.
There was some increased competition and this segment pressured the banana performance compared to the third quarter.
For us at <unk>, and the year of 'twenty and 'twenty IMS prescriptions declined by 1% versus last year, while extended units grew by three eight per cent.
Jack A. Khattar: Finally, myoblock continues to be the most affected by the pandemic where physician visits are instrumental for patient initiation and therapy maintenance. Regarding corporate development, we continue to be active in looking for strategic opportunities to further strengthen our future growth and leadership position in CNS. With that, I will now turn the call over to Jim.
And finally Myobloc continues to be the most affected by the pandemic what physician visits are instrumental for patient initiation and therapy maintenance.
And regarding corporate development, we continue to be active and looking for strategic opportunities to further strengthen our future growth and leadership position in CNS and with that I will now turn the call over to Jim.
Jim Kelly: All right. Thank you, Jack. Good afternoon, everyone.
Alright, Thank you Jack.
Hi, good afternoon, everyone.
Jim Kelly: As I review our fourth quarter and full year results, please refer to today's release. Total revenue for the full year 2020 was $520.4 million, an increase of 32% over $392.8 million in 2019. The total revenue was comprised of net product sales of Tricandi XR and Extellar XR, $418.3 million; $91 million from Apikin, Zadago, and Myoblock, which were acquired late in the second quarter of 2020; and royalty revenue of $11 million. For the fourth quarter of 2020, total revenue was $143.6 million, an increase of 43% over $100.4 million in the same period of 2019. Total revenue was comprised of net product sales from Trucandi XR and Extellar XR of $101.2 million. $39.5 million from Apikin, Zadago, and Myoblock, and royalty revenue of $2.8 million. Now, to expenses.
And as I review, our fourth quarter and full year results. Please refer to today's release.
Total revenue for the full year, 'twenty, and 'twenty was 524 million and increase of 32% over $392 8.002 million 19.
The total revenue was comprised of net product sales of Trokendi, XR and ex teller XR $418 3 million.
91 million from a Perkins Dargo and Myobloc, which were acquired late in the second quarter of 'twenty, and 'twenty and royalty revenue of $11 million.
For the fourth quarter of 'twenty and 'twenty total revenue was $143 6 million and increase of 43% over 100.4 million and the same period for 2019.
Total revenue was comprised of net product sales from Trokendi, XR and Extel, our XR of one on $1.2 million.
$39 5 million from eight Mckinsey Dogger and Myobloc and.
And royalty revenue of $2 8 million.
Turning now to expenses SG&A expenses for the full year 2020 were 200.7 million compared to $153 2 million in 2019.
Jim Kelly: SG&A expenses for the full year 2020 were $200.7 million, compared to $153.2 million in 2019. SG&A expenses for the fourth quarter of 2020 were $56.5 million, compared to $34.5 million in the prior year period. This increase for both periods was primarily due to the expense-associated commercialization efforts for Apikin, Zydeco, and Myoblock and our ongoing preparations for the expected launch of SPNA-12. Amortization expense for intangible assets was 15.7 million for the full year 2020 and 5.9 million for the fourth quarter of 2020 compared to 5.2 million and 1.3 million respectively in the same periods of the prior year.
SG&A expenses for the fourth quarter of 'twenty, and 'twenty were $56 5 million compared to $34 5 million and the prior year period.
This increase for both periods was primarily due to the expense associated commercialization efforts for a preqin sadako and Myobloc and our ongoing preparations for the expected launch of SPN eight and 12.
Amortization expense for intangible assets was $15 7 million for the full year, 'twenty and 'twenty and $5 9 million for the fourth quarter of 2020, compared to $5 2 million and $1 3 million respectively and.
And the same periods of the prior year.
Jim Kelly: A new expense category is contingent consideration expense, which reflects the incremental period amount for contingent purchase price consideration we expect to pay related to the U.S. World Med acquisition, in addition to what we've already recognized as a liability.
And your expense category is contingent consideration expense, which reflects the incremental period amount for contingent contingent purchase price consideration, we expect to pay related to the U S World Med acquisition.
In addition to what we've already recognized as a liability.
Of the 230 million and potential milestone payments associated with this transaction, we have recognized a 76.7 million liability as of year end 2020.
Jim Kelly: Of the $230 million in potential milestone payments associated with this transaction, we have recognized a $76.7 million liability as of year-end 2020. Research and development expenses were $76.0 million for the full year 2020 compared to $69.1 million for the full year 2019. This increase was primarily due to the $10 million milestone payment related to the Navitour Development and Option Agreement, an offset by a decline in our late-stage clinical program spending. R&D expenses for the fourth quarter of 2020 were $17.9 million. This was lower than $19.8 million in the same period of 2019 due to a continuation of this decline in late stage spending.
Research and development expenses were 76.0 million and for the full year, 'twenty and 'twenty compared to $69 1 million for the full year 2019.
This increase was primarily due to the 10 million milestone payment to the nerve it related to the NAV of tour development and option agreement and offset by a decline and our late stage clinical program spend.
R&D expenses for the fourth quarter of 'twenty, and 'twenty were $17 9 million.
This was lower than the $19 8 million and the same period of 2019 due to a continuation of this decline and late stage spending trend.
Jim Kelly: For the full year 2020, operating earnings were $173.7 million compared to $148.6 million in 2019. Operating earnings for the fourth quarter of 2020 were 43 million compared to 40.8 million in the same period of the previous year. Net earnings of 127 million for the full year 2020, or $2.36 per diluted share, compared to $113.1 million for $2.10 per diluted share for the full year 2019. Net earnings in the fourth quarter of 2020 were $30.8 million or $0.57 per diluted share compared to $33.1 million or $0.62 per diluted share in the same period the previous year.
For the full year 2020 operating earnings were $173 7 million compared to $148 6.002 million 19.
Operating earnings for the fourth quarter of 2020 for $43 million compared to $40 8 million and the same period the previous year.
Net earnings of $127 million for the full year, 'twenty, and 'twenty or $2 and 36 per diluted share.
Compared to $113 1 million per $2.10 per diluted share for the full year 2019.
Net earnings and the fourth quarter of 2020, or $30 8 million or 57 cents per diluted share compared to $33 1 million per 62 cents per diluted share and the same period.
Previous year.
Jim Kelly: As of December 31, 2020, the company had $772.9 million in cash, cash equivalents, and marketable securities, compared to $938.8 million as of December 31, 2019. In 2020, the company made cash payments of approximately $300 million related to the acquisition of the CNS portfolio of US World Med and $25 million to Navator upon executing the development and option agreement related to SPNA 20. Now turning to financial guidance for the full year 2021, we expect total revenues to range from 550 to 580 million, comprised of net product sales and royalty revenue, and including
As of December 31, 2020, the company had $772 9 million and cash cash equivalents and marketable securities compared to $938 8 million as of December 31, 2019.
During 'twenty and 'twenty the company made cash payments of approximately $300 million related to the acquisition and the CNS portfolio on U S World Meds.
And 25 million to never tour on executing the development and option agreement related to SPN 820.
Now turning to financial guidance for the full year 2021.
We expect total revenues to range from $550 million to $580 million comprised of net product sales and royalty revenue and including and preliminary 10 million of net product sales estimate.
Operator: [inaudible]
Jim Kelly: a preliminary 10 million net product sales estimate for SPN 812 based on the expected launch later in Q2 2021 if approved by the FDA. For the full year 2021, we expect combined R&D and SG&A expenses in the range of $380 million to $410 million and operating earnings between $65 million and $90 million. In addition, we expect full year 2021 amortization of intangible assets of approximately 24 million.
And for SPN, eight and 12 based on the expected launch later in Q2 2021, if approved by the FDA.
For the full year 2021, we expect combined R&D and SG&A expenses and the range of 380 million to $410 million and operating earnings between $65 million and $90 million.
In addition, we expect full year 2021 amortization of intangible assets of approximately $24 million.
And when viewing our operating earnings guidance and the context of 'twenty and 'twenty performance. It is clear that 2021 is an important investment and here for the company and as we prepare for the expected launch of SPN 812 for pediatric patients with ADHD and the second quarter of 2021.
Operator: When viewing our operating earnings guidance in the context of 2020 performance, it is clear that 2021 is an important investment year for the company as we prepare for the expected launch of SPM V12 for pediatric patients with ADHD in the second quarter of 2021. With that, I'll turn the call back to the operator. As a reminder, to ask a question, you will need to press star 1 on your telephone; again, that is star 1 on your telephone keypad. To withdraw your question, press the pound key.
With that I'll turn the call back to the operator.
And.
As a reminder to ask a question you will need to press star one on your its value.
Your phone and again that is star one on your telephone keypad to withdraw your question first about <unk>.
Operator: We request that you limit your questions to two at a time, and then feel free to re-enter the queue if you have further questions. Please stand by while we compile the Q&A roster. Your first question comes from the line of David Steinberg of Jeffries. Your line is now open. Okay, thanks very much. I have a couple questions on 8.12.
And request that you limit your questions to two at a time and then feel free to reenter the queue. If you have further questions.
Please standby, while we compile the Q&A roster.
Your first question comes from the line of David Steinberg of Jefferies. Your line is now open.
Okay. Thanks, very much I have a couple of questions on a 12 first congrats on the.
David Steinberg: First, congrats on the earlier designation by FDA so you can launch in Q2. I assume then you'll have lots of time before you hit back to school season, which is obviously when a lot of the switching goes on. So to that end,
Earlier.
Nation by F D a C and launch in Q2.
I assume then you'll have lots of time before you hit back to school season, which is obviously when a lot of the switching goes on and so to that and.
David Steinberg: You know, in your payer discussions, which I assume must be pretty red-hot right now, what's your current thinking in terms of, are they going to manage this area heavily? Obviously, the only major branded drug on the market is Vyvanse, which is still $2 billion, but everything else is generic. I'm just curious how heavily you think they're going to manage the category. What are you thinking about pricing right now? I know you don't have a label, but you probably have some idea what the label looks like.
You know and your payer discussions, which ive seen and must be pretty red Hot right now.
And what's what what's your current thinking in terms of a.
Are they going to manage this area heavily obviously the only major branded drug on the market as Vyvanse, which is still $2 billion, but everything else is generic just curious how heavily do you think they're going to manage the category and secondly.
What are you thinking about pricing right now I know you don't have a label, but you probably have some idea of what the label looks like and thirdly.
David Steinberg: And thirdly, given that so much prescribing goes on in the back-to-school season and you're gonna have it on the market for over two quarters, I was curious about your $10 million in sales guidance. I would have thought, with over six months of marketing, that the number might be higher than that. And so the question is, are you being conservative, or is it part of your strategy to get as many patients as you can on it, and that means heavy co-pay assistance and other initiatives where the early price per script will be fairly low? Thanks.
Given that.
So much prescribing goes on and the back to school season, you and Youre going to have it on the market for over two quarters and I was curious about your $10 million and sales guidance.
I would've thought with with over over six months of marketing that number might be higher than that and so the question is are you being conservative or is part of your strategy to get as many patients as you can on it and that means heavy co pay assistance and other initiatives.
And where the where the early price per script will be fairly low.
And David.
Jack A. Khattar: Hey, David. I think I have got most of the questions. I'll try to answer each one of them.
I think I got most of the questions I'll try to hit each one of them.
As far as discussions with the payers.
Jack A. Khattar: As far as you know, discussions with the payers. Of course, I mean, now they're at a much higher level of intensity because we have a much clearer view as to when potentially the launch is. I mean, so far, the discussions have been very encouraging. That's really all I can say.
Of course, I mean, now it's at a much higher intensity and level of intensity, because we have a much clear sight as to when potentially the launch is.
I mean, so far the discussions have been very encouraging that's really all I can say I can't be too specific clearly with the strategy and where we might end up because nothing is finalized anyway. So it would be and estimate on my part regardless.
Jack A. Khattar: I can't be too specific with the strategy and where we might end up because nothing is finalized anyway. So it will be an estimate on my part, regardless. But we are excited about the discussions so far and the fact that, you know, people understand that this is a completely new therapy. It's a novel treatment, it's a non-controlled substance, and in more than a decade, we haven't seen anything really meaningful that has been launched in this whole market. And the options for patients are fairly limited.
But we are excited about the discussion and so forth and the fact that people understand that this is a completely new therapy and that's.
And novel treatments, and uncontrolled substance and and more than a decade, we haven't seen anything really meaningful that hasnt been launched and this whole.
Our market and the options for the patients are fairly limited you're on.
Jack A. Khattar: You only have two stimulants, basically, and two non-stimulants that are heavily used in this market. So bringing a fifth compound molecule with the clinical profile that we have has been really exciting to see the reaction, not only from payers but also, and I mentioned that earlier several times, from KOLs and the excitement they have about having something else they can really use than just another formulation of amphetamine or methylphenidate. So the level of intensity, as you said, obviously, is much higher as far as our discussions are concerned, and we are encouraged so far. But at the end of the day, clearly, nothing is done until it's all signed and sealed.
And they have two stimulants, basically and two non stimulant and so a lot of heavy to use and this market so bringing a fifth compound.
Molecule with the clinical profile that we have has been really exciting to see the reaction not only payers, but also I mentioned that earlier on several times the kols.
And the excitement they have about having something else. They can really use them and just another formulation of amphetamine and methylphenidate.
So the level of <unk> and <unk>.
Density as you said, obviously as much higher as far as our discussions and we are encouraged so far at the end of the day clearly and nothing is done until it's all signed and sealed so we don't have any of those final so to speak but things are moving pretty fast.
Jack A. Khattar: So we don't have any of those finals, so to speak, but things are moving pretty fast. Will the category be more organized than it was before? Typically, in general, when you have a category with new products launching, which we saw in the migraine category when all the new branded CGRPs came in, the market all of a sudden became in the spotlight, and payers started paying more attention to it. So naturally, that always attracts attention when you have new products being launched in any market, and I would expect this to apply here as well. As far as our pricing, you know, we don't disclose prices or discuss pricing strategies. So for now, I'll just leave it that way.
Will the category B, a and you know more to manage than it was before.
Typically in general on the one you have a category with new product, so launching which we saw that and the migraine category right now and all the new branded C. G. Rps came in the market the market all of a sudden.
Became and the spotlight and payers started paying more attention to it so naturally and that always brings attention. When you have new products being launched and any market and I would expect this top line probably here as well.
And so how does all of the pricing.
We don't disclose pricing on discuss pricing strategy. So for now I'll just leave it that way everybody will know what the pricing is at the same time, when we launched the product.
Jack A. Khattar: Everybody will know what the pricing is at the same time when we launch the product. And regarding the final question on the, I mean, 10 million estimate, clearly, we try to put a lot of thought into this, as you might imagine, the specific date and the exact date of launch. Yes, we have a better idea now than we did at the beginning of the year when we got the CRL and so forth. But clearly, that is why, you know. It is an estimate. Could it be higher?
And regarding the final question on the I mean 10 million estimate clearly we try to put a lot of thought and this as you might imagine the specific date exact date of launch yes, we have a better idea now than we had at the beginning of the year when we got to see our Ela and so forth.
But clearly.
That is why you know it is and estimate could it be higher yes, it's going to happen that we could do much better than that.
Jack A. Khattar: Yes, it could happen that we could do much better than that. We did mention many times before that we would be clearly investing heavily in this product. To us, this is a huge product opportunity for us. It is a huge market opportunity, in general. We will be launching it commensurate with the opportunity itself, so our investment level will be heavy. Clearly, you know, as you will see, as you notice in the guidance, obviously, we are spending, and we will be spending a lot of money on this product.
We did mention many times before that clearly we will be investing heavily and this product to us. This is a huge product opportunity for us it's a huge market opportunity in general.
We will be launching get commensurate with the opportunity itself. So our investment level will be heavy.
Clearly you know as you will see as you notice and the guidance and obviously, we are spending and we will be spending a lot of money behind this product.
Jack A. Khattar: We do, of course, have the opportunity here to sample the product as well, given that it is an uncontrolled substance, whereas stimulants, of course, you cannot sample those products. So, we certainly will. [inaudible] If you give people the chance to try this product, they will very quickly appreciate the clinical and medical profile of this product, given what we've seen so far, obviously, from all the Phase III clinical data.
We do have of course, the opportunity here to sample the product as well given that it is and uncontrolled substance.
Whereas stimulants of course, you cannot sample those product so we certainly will.
Deploy a lot of different programs a lot of different spending around the product to make sure not only rebuilt the demand, but also we have the access and we give patients the chance to try the product and we are strong believers that if.
If you give people the chance to try this product they will very quickly appreciate the clinical and medical profile of this product and given what we've seen so far obviously from all the phase III clinical data.
Operator: Okay, thanks. Your next question comes from the line of David Amsellem from Piper Sandler. Your line is now open.
Okay. Thanks.
Your next question comes from the line of David <unk>.
And then of Piper Sandler Your line is now open.
Thanks.
David A. Amsellem: So just a couple of things. First, on SPN 830, and I apologize if I missed the commentary earlier and the call I joined late, but can you just elaborate on, you know, the SOMA specific things that need to be hashed out with the device? And I guess where I'm sort of going with this is, you know, is there any, you know, human factor work that you have to do or, you know, anything along those lines that would be a gating item for your resubmission? Just help us understand some of the specifics. And then secondly, you know, I'll sort of ask.
Just a couple so first on SPN 830 and I.
Apologize if I missed the commentary early and the call and joined late but can you just elaborate on the.
The the sone and the specific things that need to be hashed out.
With the device and and I guess, where I'm sort of going with this is.
Is there any human factor work that you have to do or you know.
Any anything along those lines that would be a gating item to your resubmission and just help US understand you know some of the the specifics.
And then and then secondly, sort.
And sort of as you know the the business development M&A question.
David A. Amsellem: the business development M&A question. You know, you were obviously acquisitive last year.
And obviously we're acquisitive.
Last year.
You are building a psychiatry focused sales force and I guess with that and mine is that your top priority to bring in and asset where you can leverage that additional commercial infrastructure that you're going to be building or are you looking at other things maybe help us understand your thinking there. Thanks.
Jack A. Khattar: You are building a psychiatry-focused sales force. So I guess with that in mind, is that your top priority to bring in an asset where you can leverage that additional commercial infrastructure that you're going to be building? Or are you looking at other things? Maybe help us understand your thinking there. Thanks.
Jack A. Khattar: Starting with the pump regarding the refusal to file, as we mentioned at the beginning when we got it and we got a little bit more clarity about what is really specifically in the list that is in the RTF, it's a list of a lot of different things, documents, reports, data to be presented in different format, the more details on certain things and the file includes in it or less details in other areas, but it also requires some additional testing that I mentioned in my prepared remark and what I'm referring to is not a human factor study, it's more of testing of the device itself, it's really environmental, there's a battery of environmental tests that typically you have with these type of products, drug device combinations and we are really seeking a lot of the clarity around all of this in the March meeting. So I wish I can be more clear or specific on it, we actually ourselves need a little bit deeper clarity from the FDA and that's why the March meeting will be extremely important for us to see out of the different tests that may be required or not required and if they are required, are they required to be right from the beginning in the resubmission or are there ones that we can do before the resubmission but others that can stay later on can be followed on so there's a lot of questions around different pieces that we really need good clarity before we try to give people any idea or estimate as to when we could potentially resubmit.
Yeah sure I'm, starting with the with the pump regarding the refusal to file.
You know as we mentioned at.
At the beginning when we got it and we got there a little bit more clarity about what is really specifically and the list that is and the RT F.
It's a list of a lot of different things documents reports data to be presented and different format. The more details on certain things and the file.
Includes and it or less details on other areas.
But it also requires some additional testing that I mentioned and our my prepared remark and and what I'm, referring to is not a human factor study. It's more of testing of the device itself, it's really environmental and there was a battery of environmental tests that typically you have with these type of products.
Drug device combinations, and we are really seeing a lot of clarity around all of this and the March meeting. So I wish I can be more clear or specific on it we actually our selves need a little bit deeper clarity from the FDA and that's why the March meeting will be extremely important for us to see.
Out of the different tests that may be required or not required and if they are required on our required to be right from the beginning and the resubmission or are there other ones that we can do before the AR and AR for the Resubmission, but others that can stay later on can be followed on so there was a lot of questions around different pieces.
And that we really need a good clarity before we try to give people any idea or estimate as to when we could potentially resubmit.
Jack A. Khattar: We're really working pretty hard and very quickly in parallel; we're not waiting for the March meeting; we're already working on a lot of the other items that we do have clarity on, getting those pieces ready for the resubmission. But at the end of the day, the March meeting will be very crucial for us in moving forward. And then regarding the second question on BD and M&A, it's actually, I mean, it's certainly a good point.
And we're really working pretty hard and very quickly and in parallel and you know we're not waiting for the March meeting, where we'd already waiting and working on a lot of the other items that we do have clarity on you know getting those pieces already for the resubmission, but at the end of the day. The March meeting will be very crucial for us and moving forward.
And then on regarding the second question on the BD and the M&A.
And it's actually I mean, it's certainly a good point of course, we ought to building the Psychiatry Foundation, it's another leg of growth and the company and we will be and we're very committed to psychiatry with SPN eight wells. So naturally a finding on other product that could leverage our infrastructure will be a good fit for SPN 812.
Jack A. Khattar: Of course, we are building the psychiatric foundation. It's another leg of growth in the company, and we will be, and we're very committed to psychiatry with SPNA-12. So naturally, finding another product that could leverage our infrastructure will be a good fit for SPNA-12. But we're also very, very conscious of the fact that we want to give SPNA-12 our full attention at least in the first full year of launch. So the sales force will be very, very committed to SPNA-12 and pushing it as hard as we can.
But we'd also and <unk>.
And he very conscious about the fact that we want to give SPN 812 full attention at least and the first full year of launch and so.
On the sales force will be very very committed to what SPN 812, and pushing it as hard as we can.
Jack A. Khattar: And therefore, you know, we don't necessarily have a top priority that says we have to get another psychiatric product for the sales force. If it does come in, as we all know in BD and M&A, you could have your wish list, but in the end, it's a factor and a function of availability and a willing seller. We will figure out how to, you know, resource the new opportunity, whether it is in psychiatry or neurology.
And therefore, you know we don't have necessarily a top priority that says we have to get on other psychiatry product for the sales force. If it does come in as we all know and BD and M&A. You know you could have your wish list within the and it's a fact that on a function of availability and a willing seller.
We will figure it out how to you know.
Resource no the new opportunity, whether it is and psychiatry or neurology, but we continue to be very active on both ends.
Jack A. Khattar: But we continue to be very active on both ends, you know, with both areas because, at the end of the day, you can be very, very choosy here. A lot of it is really a function of the availability of good, high-quality assets at a reasonable price.
And with both areas and because at the end of the day you can be very very choosy here. It's a lot of it is really a function of availability of good high quality assets at a reasonable price.
Operator: Again, if you would like to ask a question, please press star 1 on your telephone. Again, that is star 1 on your telephone keypad. Your next question comes from the line of Annabel Samimy of Stifel. Your line is now open.
Again, if you would like to ask a question. Please press star one on your telephone and again that is style one on your telephone keypad.
Your next question comes from the line of Annabel <unk> of Stifel. Your line is now open.
Operator: Hi, everyone. Thanks for taking our questions. This is Nick Ahn for Annabel.
Hi, everyone and thanks for taking my question and this is Nick on for Annabel.
Nick Ahn: I just wanted to go back to, I guess, the adult data that came out last year. We haven't really had a chance to talk about it with you guys, but we definitely thought that that data was pretty impressive, especially compared to Stratera in adults. I guess we're wondering what your thoughts are around this data and whether you thought it was particularly good or if that changes your thoughts on the potential of that market or your strategy going forward.
And I just wanted to go back actually to I guess, the adult data that came out last year.
Haven't really had a chance to talk about it with you guys, but we definitely thought.
And that data was pretty impressive, especially even compared to terra in adults.
I guess, we were wondering what your thoughts around the theater is and whether you thought it was particularly good.
And if that changes your thoughts on the potential and that market or your strategy going forward.
Nick Ahn: And then you mentioned some competitive headwinds for Apikin that you saw in the fourth quarter. We were wondering if you could elaborate on those competitive dynamics and how you see that franchise going forward without the pump in the near term. Thank you.
And then you mentioned some competitive headwinds for epic and that you saw on the fourth quarter we.
We were wondering if you could elaborate on the.
Competitive dynamics, and how you see that franchise going forward.
Without the pump and the near term thank you.
Sure.
Jack A. Khattar: Sure. So on the first question with the adult data, I mean, we were equally impressed with the data on the product and very excited about the results in Phase III. Obviously, it's very unfair for me because it's not a head-to-head trial with either moxetine or stratera, but we really like what we saw, the profile that emerged from the product, not only on the clinical side from an efficacy perspective but also on the safety and the tolerability, discontinuation rates, and so forth.
So on the first question with the adult data.
We are we were equally.
Equally impressed with the data on on the product and very excited about and the results and the phase III.
Obviously, it's a very unfair for me because it's not a head to head trial with eight Amoxapine all threat era.
But we really like what we saw we are the profile that emerged from the product and.
Not only on the clinical side from an efficacy perspective, but also the safety and the tolerability discontinuation rates and so forth.
Jack A. Khattar: So we're really excited about it and also excited about the fact it's also consistent with what we saw in the pediatric adolescents. So, I mean, the product, remarkably, has shown tremendous consistency in its efficacy, safety, and tolerability across now three different patient populations. Not only that, but it shows consistency with a very large window as far as dosing and the flexibility in doses from 100 mg all the way up to 600 mg that we studied in adults.
So we're really excited about it and also excited about the fact, it's also consistent with what we saw in the pediatric adolescent and so I mean the product remarkably.
And it has shown and now so many phase III trials.
Tremendous consistency and its efficacy and safety and Tolerability across now three different patient populations and now.
Not only that it shows the consistency with a very large window as far as dosing and the flexibility and those as you know from 100 milligram all the way up to 600 milligrams that we studied and adult so that gives physicians also have tremendous flexibility.
Jack A. Khattar: So that gives physicians tremendous flexibility from a dosing perspective while not sacrificing really much as far as tolerability and safety are concerned. Speed of action, I mean, across all the different points, the consistency is truly remarkable across all the points that we studied in the phase III study. So we're extremely excited, we're very pleased with the consistency and how clean the data is, and hopefully, we'll get the pediatric approval very, very soon, and then we're already, in parallel, working very diligently in preparing the SNDA for the adult so that once we get the approval, we can quickly activate and become very active towards filing the SNDA for the adult.
From a dosing perspective, while not sacrificing really much as far as Tolerability and safety.
Speed of action I mean across all the different points of the consistency is truly remarkable across all the points that we studied and the phase III study. So we're extremely excited we're very pleased with the consistency and the whole clean the data is and and hopefully we'll get the pediatric approval.
Very very soon and then we'd already and parallel working.
And actually very diligently and preparing the S. N D. A for the adult so that once we get the approval we can quickly.
Activate and become very active towards filing the S. N D. A.
It is an important segment as I mentioned and the.
Jack A. Khattar: It is an important segment, as I mentioned in the marketplace, and we see a big place for 812 in that segment. Regarding Apokin and the competitive dynamics, many of you asked me last time about, and many of you know about Kenmobi, for example, which is the only other apomorphine product. So that's really what I was referring to.
The marketplace and we see a big place for a 12 and that segment.
Regarding a book and on the competitive dynamics and many of you asked me last time about and many of you know about can mobi for example, which is the only other April morphine products. So that's really what I was referring to.
Jack A. Khattar: It's a new product that came onto the market, it was launched in September, and naturally, you're going to have people attracted to the product. It's a sublingual tablet; they're going to try it and see whether it's the right product for them or not. I will continue to say we believe the two products have very different profiles and will end up really appealing to very different patient profiles. Apokin's clinical profile is on its label, obviously, and you can look at the label for Kenmobi.
And new product that came and the market was launched in September and naturally you're going to have people you know and.
Track that to the product, it's a sublingual tablet, they're going to try it and see whether it's the right product for them or not I will continue to say, we believe you know the two products have very different profiles and will end up really appealing to a very different patient profiles.
You know a book ends a clinical profile has on its label, obviously and you can look at the label of Ken moving I mean again. These are not head to head trial. So I will caution everybody when they compare the two but the drug is the same drug and the efficacy is very obviously, a very different and so so short term.
Jack A. Khattar: Again, these are not head-to-head trials, so I will caution everybody when they compare the two, but the drug is the same drug, and the efficacy is very obviously, very different. So, short term, you might get some headwinds because of that, naturally, but also we do welcome, of course, extra attention to the molecule. I mean the apomorphine molecule. Apokin has been the only product that is an apomorphine-based. Apomorphine is a very good drug when it's used appropriately in the right setting for the right patient, and therefore, extra attention to the molecule actually could benefit all of us.
Might get some headwinds because of that naturally but also we do welcome of course extra attention to the molecule I mean, the April morphine molecule.
On a book and for many many years has been the only product.
And that is in April morphine based April morphine as a drug as a very good drug and it's used appropriately and the right setting for the right patient and.
And therefore extra attention to the molecule actually could benefit and all of US. There are so many patients out there that experience off episodes and I'm not even a close as far as our patient population that we are trading. So there is tremendous area of growth.
Jack A. Khattar: There are so many patients out there that experience episodes, and they're not even close to the patient population that we are treating. So there is tremendous area of growth for everybody and a big, large amount of business here to be had by different players in the market. The other issues that we witnessed in the fourth quarter were really the typical COVID issues because of the resurgence, and that's what I tried to refer to.
And for everybody and a big large you know our size of business here to be had by different players and and the market.
And the other issues that we you know we we witnessed in the fourth quarter is really the typical COVID-19 issues because of the resurgence and that's what I tried to refer to patient initiations also felt some pressure there because of the resurgence in COVID-19 because again with a book and you have to have a nurse intervention training of the.
Jack A. Khattar: Patient initiations also felt some pressure there because of the resurgence in COVID. Because again, with Apokin, you have to have nurse intervention, training of the patient to get them going with the injection and how they use the product so they learn how to use it appropriately, and so forth.
Patient to get them going with the injection and how they use the product so they learn how to use it appropriately and so forth. So all these factors resulted in and the decline from the third quarter to the fourth quarter.
Jack A. Khattar: Very helpful. Thank you. Do you have any further questions at this time? You may continue.
Very helpful. Thank you.
Sure.
You don't have any further questions at this time you may continue presenters.
Thank you.
Jack A. Khattar: Thank you. We're very pleased with the conclusion of the year 2020 with record results for Supernus. It's been a year with great uncertainty and significant new challenges across so many facets of our business. Yet, our employees persevered and delivered growth on Procandixor and Oxtalrixor, advanced our pipeline, and executed on transformative transactions that position us for success in the years to come. We're looking forward to 2021 to be a year of continued uncertainties with COVID, but with much hope for a much more normal environment than last year.
We were very pleased with the conclusion of the year of 'twenty and 'twenty with our record results for supporting Us and.
A year with great uncertainty and significant new challenges across so many facets of our business yet our employees persevered and delivered growth on Trokendi XR and I'll spell it XR advanced our pipeline and executed on strength formative China's actions that position us for success and the year still come.
We're looking forward in 'twenty and 'twenty, one to be a year of continued uncertainties with COVID-19. However, with much hope for a much more normal environment than last year, we will be launching SPN 812, if approved by the FDA for ADHD treatment and pediatric patients and continuing to advance.
Jack A. Khattar: We will be launching SPN 812 if approved by the FDA for ADHD treatment in pediatric patients and continuing to advance SPN 830 along its regulatory path towards potential approval as well. We believe these two late-stage assets represent two important growth drivers for the company, and we are focused and committed to driving them toward commercialization and market success. Thank you very much for your time today, and we look forward to updating you on our progress throughout the year.
SPN 830, along its regulatory path towards potential approval as well.
We believe these two late stage assets represent two important growth drivers for the company and we are focused and committed to driving them towards commercialization and market success.
Thank you very much for your time today, and we look forward to updating you on our progress throughout the year.
Yeah.
Ladies and gentlemen.
Operator: Ladies and gentlemen, that concludes today's conference call. Thank you for participating. You may now all disconnect.
That concludes today's conference call. Thank you for participating you may now disconnect.
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