Q3 2020 Supernus Pharmaceuticals Inc Earnings Call

<unk> results conference call at this time, all participants are in a listen only mode later.

Operator: Conference call. At this time, all participants are in a listen-only mode.

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, Jimmy.

Later, we will conduct a question and answer session and instructions will follow at that time.

As a reminder, the call, but it's always being recorded.

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

Thank you Jamie good morning, everyone and thank you for joining us today for Supernus Pharmaceuticals third quarter 2020 financial results Conference call yesterday. After the close of the market. The company issued a press release announcing these results.

Peter Vozzo: Good morning, everyone, and thank you for joining us today for Supernus Pharmaceuticals' third quarter 2020 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, Chief Financial Officer, Greg Patrick, who, as previously announced, is retiring, and our newly appointed Chief Financial Officer, Jim Kelly.

On the call to me today are Supernus, Chief Executive Officer, Jack Qatar, Chief Financial Officer, Greg Patrick who has previously announced is retiring and our newly appointed Chief Financial Officer, Jim Kelly Today's call is being made available via the Investor Relations section of the company's website at IR Dot Supernus Dotcom following remarks by management, we will open the.

Peter Vozzo: Today's call is being made available via the Investor Relations section of the company's website at www.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. Such forward-looking statements reflect Supernus' current perspective on existing trends and information, and such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factor section of the company's 2019 Annual Report on Form 10-K. Actual results may differ materially from those projected in these forward-looking statements For the benefit of those who may be listening to the replay, this call will be held and recorded on November 4, 2020, at approximately 9 a.m. Eastern Standard Time.

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 such forward looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the risk factor section of the company's 2019.

Ana report on form 10-K.

Actual results may differ materially from those projected in these forward looking statements for the benefit of those who maybe listening to the replay. This call is being held and recorded on November 4th 2020 at approximately 90 M. Eastern time. Since then the company may have made additional announcements related to the topics discussed.

Jack A. Khattar: 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 does not assume any obligation to update these forward-looking statements except as required by applicable securities laws. Thank you, Peter. Good morning, everyone.

Please reference the company's most recent press releases and current filings with the FCC Supernus declines any obligation to update these forward looking statements, except as required by applicable securities laws I will now turn the call over the Jack.

Thank you Peter good morning, everyone and thanks for taking the time to join US as we discuss our 2023rd quarter results.

Jack A. Khattar: And thanks for taking the time to join us as we discuss our 2020 third quarter results. Supernus has made significant progress this year despite the continued challenges caused by the COVID pandemic. During the first nine months of 2020, Supernus delivered strong product sales performance, diversified its revenue base, and enhanced its long-term growth prospects. In addition, the company executed on two corporate transactions and advanced its late stage pipeline.

Supernus has made significant progress this year. Despite the continued challenges caused by the cold had been damaged during the first nine months of 2020 supporting US delivered strong product sales performance diversifying its revenue base and enhance its long term growth prospects. In addition, the company executed on Twoq.

Corporate transactions and advance its late stage pipeline.

Jack A. Khattar: The integration of the Parkinson's disease products has been progressing well, and we continue to expect all integration activities to be significantly completed by year end. Regarding our late-stage pipeline, starting with the apomorphine infusion pump, or SPN-830, we submitted the NDA in September of this year, and if approved by the FDA, we plan to launch the product in the fourth quarter of 2021. Turning to SPNA 12, with a PDUFA target action date of November 8, 2020 for the NDA, we remain engaged with the FDA regarding their ongoing review, including label negotiations. Our preparation and readiness for the commercial launch of SPNA-12 are on track for the January 2021 launch, and our team has implemented various virtual and digital platforms to allow us to effectively reach our physician audience in the restrictive COVID environment.

Integration of the Parkinson's disease products has been progressing well and we continue to expect all integration activities to be significantly completed by year end.

Regarding our late stage pipeline and starting with the April morphine infusion pump or ESP in 830, we submitted the N.D.A. in September of this year and if approved by the F.D.A., We plan to launch the product in the fourth quarter of 2021.

Turning to Sps 12, with a PDUFA target action date of November 820, 24, the N.D.A., we remain engaged with the FDA regarding their ongoing review, including label negotiations, our preparation and readiness for the commercial launch of SPX 12 are on track for a job.

January 2021 launch and our team has implemented the various virtual and digital platforms to allow us to effectively reach our physician audience in the restrictive cobot environment.

Jack A. Khattar: We plan to launch SPNA-12 with more than 175 sales representatives, leveraging our internal expertise by transferring sales reps and sales management from our current neurology sales force. We will then backfill the current neurology sales force as needed, with the goal of having approximately a total of 335 representatives promoting all our commercial products in 2021. We've completed enrollment in the SPNA-12 Phase III trial in adult patients and expect top-line data in the first quarter of 2021. This is an important trial to help us expand the use of SPNA-12, if approved by the FDA, in the adult market segment, which represents approximately half of the total ADHD market in the U.S.

We plan to launch a span AIDS world with more than 175 sales representatives, leveraging our internal expertise by transferring sales reps and sales management from our current neurology sales force. We will then backfill the current neurology sales force as needed with the goal of having approximately a total.

335, representatives promoting all our commercial products in 2021.

We've completed the enrollment and they have spent a 12 phase three trial in adult patients and expect topline data in the first quarter of 2021. This is an important trial to help us expand the use of SP on a 12, if approved by the FDA and the adult market segment, which represents approximately half.

The total 80 to the market in the U.S.

Finally regarding a span a 20 hour first in class orally active M talk one activator preclinical and development activities are ongoing with the goal of initiating a phase two clinical program and treatment resistant depression by the end of 2021.

Jack A. Khattar: Finally, regarding SPNA20, our first-in-class orally active mTORC1 activator, preclinical and development activities are ongoing with the goal of initiating a Phase II clinical program in treatment-resistant depression by the end of 2021. Moving on to the commercial products, we're pleased with the overall performance of our products despite the adverse impact of the pandemic on Salesforce access to physicians, patient visits, and new patient initiation. Overall, looking at the first nine months of the year in total, prescriptions, as reported by IMS for oxalatexor, showed strong resilience with 5% growth, and extended units, as represented by the number of tablets, showed 10% growth compared to the same period last year. For TUCAN DXR, while IMS prescriptions for the first nine months of 2020 declined by 10%, the extended units declined by approximately 3% compared to last year.

Moving onto the commercial products, we were pleased with the overall performance of our products. Despite the adverse impact of depend damage on salesforce access to physicians patients visits and new patient initiations.

Overall looking at the first nine months of the year and total prescriptions as reported by IMS for Oxtellar XR showed strong resiliency with 5% growth and the extended units as represented by the number of tablets showed a 10% growth compared to the same period last year.

For Trokendi XR, well IMS prescriptions for the first nine months period of 2020 declined by 10% the extended units declined by approximately 3% compared to last year. This.

This trend and extended units is due to the fact that the average size of a monthly prescriptions for Trokendi XR and Oxtellar XR has been trending upward since the start of depend dynamic and such larger size of monthly prescription was sustained through the third quarter.

Taken together with annual price increase this resulted in a higher average wholesale acquisition cost per prescription for both products.

Jack A. Khattar: This trend in extended units is due to the fact that the average size of a monthly prescription for trochandiaxor and oxtalaxor has been trending upwards since the start of the pandemic, and such a larger size of the monthly prescription was sustained through the third quarter. Taken together with the annual price increase, this resulted in a higher average wholesale acquisition cost per prescription for both products.

And when you couple that with the favorability in the gross to net deductions that we have seen in the second and third quarters. All this resulted in gross and net sales of Trokendi, XR and Oxtellar XR or 11% in the first nine months of 2020 compared to last year.

Similarly, we are pleased with the overall performance of the Parkinson's portfolio with April Guineans Hidalgo performing well despite the impact of the pandemic Meyer block on the other hand has been and continues to be the most affected by the pandemic what physician visits are instrumental in patient initiation and therapy maintenance.

Jack A. Khattar: And when you couple that with the favorableability and the gross-to-net deductions that we have seen in the second and third quarters, all this resulted in growth in net sales of Trocandex R and Oxtalex R of 11% in the first nine months of 2020 compared to last year. Similarly, we're pleased with the overall performance of the Parkinson's portfolio, with Apokin and Zydago performing well despite the Myoblock, on the other hand, has been and continues to be the most affected by the pandemic where physician visits are instrumental in patient initiation and therapy maintenance.

In summary product sales performance and 2020 has been better than we originally expected in this uncertain environment. Therefore, we are increasing our expectations for full year product sales and operating earnings.

Finally, we continue to be active in looking for strategic opportunities to further strengthen our future growth and leadership position in CNS.

Before I hand, the call over to Greg to provide more details on our third quarter financial performance I would like to welcome Jim Kelly to supporting US as our new Chief Financial Officer, Jim Some background experience and track record of accomplishments, including nearly 10 years of public company CFO experience in our industry.

Jack A. Khattar: In summary, product sales performance in 2020 has been better than we originally expected in this uncertain environment. Therefore, we are increasing our expectations for full-year product sales and operating earnings. Finally, we continue to be active in looking for strategic opportunities to further strengthen our future growth and leadership position in CNS. Before I hand the call over to Greg to provide more details on our third quarter financial performance, I would like to welcome Jim Kelly to Supernus as our new Chief Financial Officer. Jim's background, experience, and track record of accomplishments, including nearly 10 years of public company CFO experience in our industry, make him well-prepared and suited for the role.

Makes him well prepared and suited for the oral I know he looks forward to getting to know you and to updating you on our progress moving forward.

And of course, I would like to thank Greg for his many years of dedicated leadership financial discipline and numerous contributions to supporting us as well as his commitment a smooth transition Greg has built a strong team and established the company on a solid financial foundation with that I'll now turn the call over to him.

Thank you Jack and good morning, everyone as.

As I review.

View, our third quarter results. Please refer to yesterday's press release.

Total revenue for the third quarter 2020 was $155.1 million, an increase of 52% over $102.1 million in the same quarter last year.

Total revenue was comprised of net product sales of Trokendi, XR and Oxtellar XR of $111.2 million $40.9 million from the Parkinson's disease products and royalty revenue of $3 million.

Greg Patrick: I know he looks forward to getting to know you and to updating you on our progress moving forward. And, of course, I would like to thank Greg for his many years of dedicated leadership, financial discipline, and numerous contributions to Supernus as well as his commitment to a smooth transition. Greg has built a strong team and established the company on a solid financial foundation. With that in mind, I'll now turn the call over to him. Thank you, Jack. And good morning, everyone.

In the third quarter of 2020 net product sales of Oxtellar, XR and Trokendi XR increased 11% compared to the same period and 29 chain due to an 8% price increase taken in January for both products and volume expansion for Oxtellar XR.

Turning next to expenses research and development expenses were $16.8 million for the third quarter of 2020, essentially unchanged from $16.9 million in the same quarter last year.

Greg Patrick: As I review our third quarter results, please refer to yesterday's press release. Total revenue for the third quarter of 2020 was $155.1 million, an increase of 52% over $102.1 million in the same quarter last year. Total revenue was comprised of net product sales of Trochendy XR and Ocstella XR of $111.2 million, $40.9 million from the Parkinson's disease products, and royalty revenue of $3 million. In the third quarter of 2020, net product sales of Xtellar XR and Trokendi XR increased 11% compared to the same period in 2019 due to an 8% price increase taken in January for both products Turning next to expenses, research and development expenses were $16.8 million for the third quarter of 2020, essentially unchanged from $16.9 million in the same quarter last year. SG&A expenses for the third quarter of 2020 were $54.7 million compared to $39.3 million in the prior year period.

SGN <unk> expenses for the third quarter of 2020 were $54.7 million compared to $39.3 million in the prior year period.

This increased $15.4 million was primarily due to the expenses associated with the Parkinson's disease products.

And the second quarter of this year.

In addition, our ongoing preparations for the launch of SPS 812 contributed to the year over year expense increase.

As a result of the U.S. World Meds acquisition that the second quarter. This year amortization expense for intangible assets in the third quarter of 2020 was $6.1 million compared to $1.3 million in the same quarter last year.

Operating earnings for the third quarter of 2020 or $56.1 million compared to $39.7 million in the same period last year.

Net earnings were $40 million for the third quarter of 2020 or 74 cents per diluted share.

Compared to $28.9 million or 54 cents per diluted share in the third quarter last year.

As of September Thirtyth 2020, the company had $740 million in cash cash equivalents marketable securities and long term marketable securities compared to $939 million as of December 31st 29 chain.

During the first nine months of 2020, the company generated $108 million of cash from operations.

Greg Patrick: This increase, $15.4 million, was primarily due to the expenses associated with the Parkinson's disease products acquired in the second quarter of this year. In addition, our ongoing preparations for the launch of SPN A-12 contributed to the year-over-year expense increase. As a result of U.S. World Med's acquisition in the second quarter this year, amortization expense for intangible assets in the third quarter of 2020 was $6.1 million compared to $1.3 million in the same quarter last year.

Offsetting this cash inflow the company made upfront cash payments of approximately $300 million for the acquired Parkinson's disease products inclusive of acquisition related expenses, plus $25 million ton avatar upon executing the development an option agreement for Sps and a 20.

Before turning the call to Jim I would like to express my appreciation to you our investors as well as to my colleagues, it's upon us and our board of directors for the opportunity to serve the company over the past nine years. Thank you.

Alright.

Thank you, Greg and congratulations on an amazing career, and especially incredibly impactful last.

Greg Patrick: Operating earnings for the third quarter of 2020 were 56.1 million dollars, compared to 39.7 million dollars in the same period last year. Net earnings were $40 million for the third quarter of 2020, or $0.74 per diluted share, compared to $28.9 million, or $0.54 per diluted share, in the third quarter of last year. As of September 30, 2020, the company had $740 million in cash, cash equivalents, marketable securities, and long-term marketable securities, compared to $939 million as of December 31, 2019.

Supernus I know.

Yes.

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So now turning to financial guidance.

We are raising.

2020 financial guidance for net product sales and operating earnings while lowering full year guidance for SGN AE and expenses.

This updated guidance reflects the acquisition of Parkinson's disease products as of June nine 2020.

For the full year 2020, we expect net product sales to range from 500 million to 530 million compared to the previously expected range of 460 million.

Jim Kelly: During the first nine months of 2020, the company generated 108 million dollars of cash from operations. Offsetting this cash inflow, the company made upfront cash payments of approximately $300 million for the acquired Parkinson's disease products, inclusive of acquisition-related expenses, plus $25 million to Navitor upon executing the development and option agreement for SPN 820. Before turning the call to Jim, I would like to express my appreciation to you, our investors, as well as to my colleagues at Supernus and our board of directors, for the opportunity to serve the company over the past nine years. Thank you. Hey, thank you, Greg. And congratulations on an amazing career and an especially impactful last night.

Yeah.

R&D expenses are expected to be approximately 75 million for the full year compared to the previous expectation of 85 million.

SGN expenses are expected to range from approximately 215 million to 225.

Compared to the previously expected range.

240 million to 160 million.

SGN a expenses are anticipated to be higher in the fourth quarter of 2020, I at least 15 million as compared to the third quarter due to increased marketing spend to prepare for the market. The market launch of asking any 12 and to build out the sales force as Jack bench.

On the call.

Turning to amortization of intangible assets, we expect to incur approximately 16 million for the full year compared to the previous estimate.

Yes.

Jim Kelly: I know the team will greatly miss your contribution and leadership. So now turning to the financials, we are raising our full year 2020 financial guidance for net product sales and operating earnings while lowering full year guidance for SG&A. Recall this updated guidance reflects the acquisition of the Parkinson's disease products as of June 9, 2020. We expect net product sales to range from $500 million to 530 million compared to the previously expected range of $460 million to $500 million. R&D expenses are expected to be approximately $75 million for the full year compared to the previously expected expectation of $85. SG&A expenses are expected to range from approximately $215 million to $225 million, compared to the previously expected range.

We anticipate full year 20 operating earnings.

Now range from 145 million.

Thanks.

Inclusive.

Intangible assets.

So with that said, we'll now turn the call over to the operator to take your questions.

[noise]. Thank you as a reminder to ask the question you all need to press Star then one on your Touchtone telephone you would draw your question from the queue. Please press the pound key we request that you limit your questions to two at a time and then feel free to reenter the queue. If you have further questions.

One moment, while we compile the culinary roster.

Our first question comes from Ken Cacciatore with Cowen and company. Your line is now open.

Thanks, So much first Greg what an amazing run.

Congratulations and all the best in your retirement, it's been really great working with you. My question is on.

How we should think about eight wells next year, Jack as we introduced that product we've been seeing kind of elongated timeframe to get managed care onboard for a lot of these launches and I know that the back to school season is just going to be in the fall you're launching in January can you just talk about the pacing we got to work on managed care first before we go out push.

Operator: $240 million to $160 million. SG&A expenses are anticipated to be higher in the fourth quarter of 2020 by at least 15 million compared to the third quarter due to increased marketing prepare for the market, the market for the launch of SPNA 12 and to build out the sales force as Jack turns to amortization of intangible assets. We expect to incur approximately $16 million for the full year compared to the previous. We anticipate full year 2020 operating earnings to now range from $145 million to $160 million So with that said, we'll now turn the call over to the operator to take your questions. Thank you. As a reminder, to ask a question, you will need to press star then one on your touch-tone telephone. To withdraw your question from the queue, please press the pound key.

The launch so how we should be just thinking of that ramp.

And then second question is around its kind of balancing as we get a little bit late in the Trokendi is exclusivity balancing how we.

Look to maximize that product from a profitability standpoint versus investments and now a 12 and April morphine pump hopefully if that's approved just kind of how we should be thinking about how the PML will look as we rebalanced be so launches versus the end of the exclusivity for Trokendi. Thank you.

Yeah, Hi, good morning, Ken regarding a 12 first as far as the launch and the elongated period that you mentioned as far as managed care coverage and so forth that we've seen with recent launches in our industry.

We've been working with the managed care and the key.

Accounts and payers and so forth for about a year and a half now in force those discussions accelerated as we got the phase three data and we started sharing all that with them.

Ken Cacciatore: 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. One moment while we compile the Q&A roster. Our first question comes from Ken Cacciatore with Calendin Company. Your line is now open. Thanks so much. First, Greg, what an amazing run.

So we've been working pretty hard to have access and coverage as soon as possible try to minimize that elongated so to speak period of lack of coverage or delayed coverage.

So we are really working hard to do that across the board to make sure the product can get off a good start right from the beginning.

Ken Cacciatore: Congratulations and all the best in your retirement. It's been really great working with you. My question is how we should think about 8-12 next year, Jack.

We are also obviously, we'll be ready for the school season that you refer to so in the first six months, we would expect that our coverage will continue to improve so if we launch assuming we launch as we said in January we expect the coverage continue to improve so that as we get to the school season.

Jack A. Khattar: As we introduced that product, we've been seeing kind of an elongated timeframe to get managed care on board for a lot of launches, and I know the back-to-school season is going to be in the fall, but you're launching in January. Can you talk about the pacing? You know, are we going to work on managed care first before we go out and push the launch? So how should we be thinking about that ramp? And then the second question is around kind of balancing as we get a little bit late in Trocandy's exclusivity, balancing how we look to maximize that product from a profitability standpoint versus investments in now A12 and apomorphine pump, hopefully if that's approved, just kind of how we should be thinking about how the P&L will look as we balance these launches versus Yeah, hi, good morning, Ken.

We should be fully ready to have full access to the product overall.

Regarding the Trokendi XR to question you know, how do we balance exclusivity profitability allocation of resources and so forth of course.

You know, we still have a two solid years hopefully for Trokendi XR and we still believe that has a great potential for the product. So we are again.

Continue to support the product it still has a tremendous potential out there. Despite the CG ought to be isn't the penetration by competition.

This year's spend dynamic obviously had hurt the brands are obviously more than it did before oxtellar XR, because it's very difficult to separate to your brand from generics. When you don't have the chance to have face to face interaction.

Jack A. Khattar: Regarding A12 first, as far as the launch and the elongated period that you mentioned, as far as managed care coverage and so forth that we've seen with recent launches in our industry, we've been working with managed care and the key accounts and payers and so forth for about a year and a half now. And, of course, those discussions accelerated as we got the phase three data, and we started sharing all that with them. So we've been working pretty hard to have access and coverage as soon as possible, trying to minimize that elongated, so to speak, period of lack of coverage or delayed coverage. So we are really working hard to do that across the board to make sure the product can get off to a good start right from the beginning. We will also obviously be ready for the school season that you referred to.

With the physicians and the sampling issues and so forth with patient. So we will balance all that is for the next year of course, our priorities are to the future drivers of growth in this company and Trokendi XR is not if you try to driver for our company. So naturally you will see us doing a lot of resource allocation.

Behind the most promising assets in the company and the portfolio specifically.

Specifically SP on a 12.

Followed by the pump hopefully if we end up launching that asset, which we believe is a great asset for us.

By the end of next year. So theoretically in 12 months, we're looking at two product launches AD supported us for two products are the hold great promise for the future.

Clearly, we will invest appropriately behind both of them are while at the same time continue to advance a 20, which is a very exciting asset that we hope in the future as time goes on we'll be able to share more and more of that exciting data.

Jack A. Khattar: So in the first six months, we would expect that our coverage will continue to improve. So if we launch, as we said, in January, we expect the coverage to continue to improve so that as we get to the school season, we should be fully ready to have full access to the product overall. Regarding the Trocandy XR question, you know, how do we balance exclusivity, profitability, allocation of resources, and so forth?

Thank you.

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

Thanks, very much couple of questions first on the Trokendi XR.

Order was there any stocking did you change any changes and co pay assistance and.

Jack A. Khattar: Of course, you know, we still have two solid years, hopefully for Trocandy XR, and we still believe there is great potential for the product. So we are, again, continuing to support the product. It still has tremendous potential out there despite the CGRPs and the penetration by competition. This year's pandemic obviously hurt the brand, obviously more than it did for Oxtaler XR, because it's very difficult to separate your brand from genetics when you don't have the chance to have face-to-face interaction with physicians and the sampling issues and so forth with patients. So we will balance all that for next year.

Can you give us the update on gross to nets versus the prior two quarters and then as far as Etwelve, because you're getting pretty close to potential approval and launch Jack any updates you could share with us in some of the payer research you've done.

And then just two more technical question I know you're going to launch in January but in your guidance will there be any sales as well.

In the December from from stocking. Thanks.

Yes sure. The first question on a bookend the X or we really didn't see any anything regarding stocking.

As far as the gross to net order for Copays or gross to net in general what we have seen that in the third quarter is what you typically see in every normal year, which is a slight improvement in gross to net from one quarter to the other after the first quarter, which we all know is normally the ugliest, where the gross to net and then thing.

Jack A. Khattar: Of course, our priorities are the future drivers of growth in this company, and Trocandy XR is not a future driver for our company. So naturally, you will see us doing a lot of resource allocation behind the most promising assets in the company and the portfolio, specifically SPNA-12, followed by the pump, hopefully, if we end up launching that asset, which we believe is a great asset for us, by the end of next year. So theoretically, in 12 months, we're looking at two product launches at Supernus for two products that hold great promise for the future. And clearly, we will invest appropriately behind both of them, while at the same time, continuing to advance 820, which is a very exciting asset that we hope in the future, as time goes on, we'll be able to share more and more of that exciting data. Thank you. Our next question comes from David Steinberg with Jefferies. Your line is now open.

Things improve over the year.

So during the year and specifically in the third quarter and that's exactly what we saw that continue the regular improvement now you might recall last quarter, we had a one time adjustment to the gross to net which we did emphasize last quarter that was a one time thing that we didn't expect that to repeat so it did not to repeat as a favorite.

Mobile adjustment and the gross to net for the third quarter. So any improvement in the third quarter was your typical improvement versus the first quarter of the EBITDA as the time goes on.

As far as a 12 payer research and so forth as I mentioned earlier in my comments I mean, we're really striving and working very very hard to have as much access as possible in coverage.

As early as possible clearly.

And the research and all the conversations we've had with the payers continue to point to the same profile that we have talked about that 812 is differentiated as a new chemical entity is the first to be introduced hopefully if approved by the F.D.A. in more than a decade.

David Steinberg: Thanks very much. A couple of questions. First, on Trican-DXR. For the quarter, was there any stocking?

I mean, we haven't seen anything new in this category in this disease.

Jack A. Khattar: Any changes to co-pay assistance? Can you give us the update on gross to net versus the prior two quarters? And then as far as 8-12 goes, you're getting pretty close to a potential approval launch. Jack, any updates you can share with us on some of the payer research you've done? And then just a more technical question, I know you're going to launch in January, but according to your guidance... Will there be any sales of 812 in December from stockings? Yeah, sure. The first question on Procandix, we really didn't see anything regarding stocking. As far as gross net or co-pays or gross net in general, what we've seen there in the third quarter is what you typically see in every normal year, which is a slight improvement in gross net from one quarter to the next after the first quarter, which we all know is normally the ugliest with gross net, and then things improve over the year.

State anything introduced us.

Since advance an intuitive as different molecules and different mechanism of action 812, as a very unique mechanism of action is a very differentiated product as far as efficacy tolerability as far as onset of action it.

It's it's a broad spectrum type of product, meaning it's shown in its phase three that it works equally well in hyperactivity and attention.

So when you look at the totality of the profile again based on our phase three data clearly we don't have a label yet so it's not proper for me to make a few comments, we don't have a pool, we don't have a label, but I'm talking regarding our data and the data we've seen in our phase three program and sharing this data with kao else with the payer.

Yes, really have shown us nothing but excitement as they see this product they look at it versus what they've seen in the less than that and you know 10 years or 11 years or so and the re formulations of amphetamines or order methylphenidate. So we continue to be extremely excited about the product and its differentiation in the marketplace and we.

Jack A. Khattar: So during the year and specifically in the third quarter, that's exactly what we saw, you know, the continued regular improvement. Now, you might recall last quarter, we had a one-time adjustment to the gross net, which we did emphasize last quarter. That was a one-time thing that we didn't expect it to repeat. So it did not repeat as a favorable adjustment and gross net for the third quarter.

I think it should become an end up being a a major treatment option for patients out there.

Do we expect any you know specifically any sales in December I mean, we might ship something in December but if there is anything it wont be anything meaningful so our guidance for this year doesn't really reflect much of an 812 or sales.

Jack A. Khattar: So any improvement in the third quarter was your typical improvement versus the first quarter of the year as time goes on. As far as A12 payer research and so forth, as I mentioned earlier in my comments, I mean, we are really striving and working very, very hard to have as much access as possible and coverage as early as possible, clearly. And the research and all the conversations we've had with the payers continue to point to the same profile that we have talked about, that A12 is differentiated, it's a new chemical entity, it's the first to be introduced, hopefully, if approved by the FDA, in more than a decade. I mean, we haven't seen anything new in this category, in this disease state, anything introduced since Vivans and Intunev A12 has a very unique mechanism of action, and it is a very differentiated product as far as efficacy, tolerability, and onset of action are concerned.

Thanks.

Thank you. Our next question comes from Annabel Samimy with Stifel.

One moment.

Your line is now.

Hi, Thanks for taking my questions and.

Greg Congratulations on your retirement, we're all a little bit tell us.

So.

Few questions here no.

Now that you've had April kind for a quarter can you give us some more specifics around compliance and refill rates what you can do there.

Have you identified any other areas of growth to optimize sales side can you penetrate the population further what are the barriers to uptake is there anything surprising about any of the world that products and on 812, you know I'm sure you're very late in the game here with labeling discussions are there any.

Points in the label that we should be thinking about in terms of what you're really looking for and what might resonate with submissions and prescribers in general thanks.

Yes regarding the April can well firstly, the total portfolio on the Parkinson's side no. There there are no major surprises since we took the products over.

Jack A. Khattar: It's a broad-spectrum type of product, meaning it's shown in its phase three that it works equally well in hyperactivity and in attention. So when you look at the totality of the profile, again, based on our phase three data, clearly we don't have a label yet, so it's not proper for me to make any comments. We don't have approval, we don't have a label, but I'm talking about our data and the data we've seen in our phase three program. And sharing this data with KOLs, with payers, really has shown us nothing but excitement as they see this product, they look at it, versus what they've seen in the last 10 years or 11 years or so in reformulated amphetamines or methylphenidate So we continue to be extremely excited about the product and its differentiation in the marketplace, and we think it should become and end up being a major treatment option for patients out there. Do we specifically expect any sales in December?

You know the the one negative that has been is the myobloc, which we talked about a couple of times, which we also knew about obviously through our due diligence and given that the pandemic at that time was at its highest bad moments so to speak when we did the transaction. So we were very well aware of the potential impact on MYOB.

Given the the brand and what it takes as far as initiation of patients and the necessity for patients to actually visit their doctors and get that injection. So so overall, we're very pleased with the performance of the products given the circumstances Abe.

A book end continue to perform well. So we are very pleased with its performance and the continued compliance with the patients.

Yes, there are some challenges in general within the Parkinson area, because again, given the cold weather environment patient initiation new patient visits you have to believe it you know it has been adversely impacted however, despite that we're very pleased with how the brand has been performing and the stability of the brand or even.

Jack A. Khattar: We might ship something in December, but if there is anything, it won't be anything meaningful. So our guidance for this year doesn't really reflect much of an 8-12 sales. Thank you. Your next question comes from Annabel Samimy with Stiefel. Your line is now open.

Showing some actually some growth not just stability so we.

We're very excited about a book and we have been working very close with the team on the commercial side or on the Salesforce side as well and we think we have identified few areas, where we potentially could optimize you know the way we are promoting the product I don't want to be too specific about we think there are some opportunities there.

Annabel Eva Samimy: I am. Hi, thanks for taking my questions. And Greg, congratulations on your retirement. We're all a little bit jealous.

Annabel Eva Samimy: So just a few questions here. Now that you've had AbleKind for a quarter, can you give us some more specifics around compliance and refill rates, what you can do there? And have you identified any other areas of growth to optimize sales? Like, can you penetrate the population further?

I can't really be specific about it I don't want to make any promises until we see the impact of any optimization that we've done so far.

But overall again, we're very pleased with what we acquired we're very pleased with how the products are performing and the team is really doing a tremendous job on all of these products.

Jack A. Khattar: What are the barriers to uptake? Is there anything surprising about any of the WorldMed products? And on 8-12, I'm sure you're very late in the game here with labeling discussions. Are there any points in the label that we should be thinking about in terms of what you're really looking for and what might resonate with physicians and prescribers in general? Yeah, regarding the APOC and, well, first, the total portfolio on the Parkinson's side, no, there are no, you know, major surprises since we took the products over. You know, the one negative that has been is the myoblock, which we talked about a couple times, which we also knew about, obviously, through our due diligence, and given that the pandemic at that time was at its highest bad moments, so to speak, when we did the transaction, so we were very well aware of the potential impact on myoblock, given the brand and what it takes as far as initiation of patients and the necessity for patients to actually visit their doctors and get that injection.

The next part of the question on a 12 and the label I really cannot make any comments on the label given that we are in the midst of discussions with the FDA.

If you just follow up on on it are you running that for growth are you running that free cash.

We're on every product weekend for growth and clearly I mean, we acquired the products not to just.

Most of the products. They book in has a huge potential and we're working extremely hard to rejuvenate the brand and get it at a higher level and more importantly, especially for because of the pump that is coming next year. So we really our plan is to grow the franchise the April Kim product.

The fan the injection as well as the pump together as an April morphine franchise will be one of the leading franchises in Parkinson's that is our plan, which basically includes of course, having a successful launch on the pump, but also maintain and potentially even grow the April can pan injection.

Great. Thank you.

Thank you. Our next question comes from David Amsellem at Piper Sandler Your line is now open.

Jack A. Khattar: So, overall, we're very pleased with the performance of the products, given the circumstances. APOC can continue to perform well, so we are very pleased with its performance and the continued compliance with the patients. Yes, there are some challenges in general within the Parkinson's area because, again, given the COVID environment, patient initiation, and new patient visits, you have to believe, you know, it has been adversely impacted.

Hey, Thanks, just just a couple on my end.

Yes.

On April Ken and I apologize if I if I Miss this miss this commentary, but what's your sense of.

The long term impact of the sublingual form of April morphine, and what that could have on on the franchise do you think that that's something that could come into the franchise or do you think that overall usage on the April morphine as a modality is low enough where you know.

Jack A. Khattar: However, despite that, we're very pleased with how the brand has been performing and the stability of the brand, even showing some, actually, some growth, not just stability. So, we're very excited about APOC. We have been working very closely with the team on the commercial side, on the Salesforce side as well, and we think we've identified a few areas where we potentially could optimize the way we are promoting the product. I don't want to be too specific, but we think there are some opportunities there. I can't really be specific about it, and I don't want to make any promises until we see the impact of any optimization that we've done so far. But, overall, again, we're very pleased with what we acquired. We're very pleased with how the products are performing, and the team is really doing a tremendous job on all of these products. The next part of the question on 812 and the label: I really cannot make any comments on the label given that we are in the midst of discussions with the FDA.

Multiple formulations in coexist that's number one and then secondly on the pump what are your thoughts on the Abbvie.

Subcu continuous infusion of 11 Dope, a pro drug got 951 and.

The potential for.

Competition, there and the extent to which your product your pump product that there's.

Can coexist.

Love to get your thoughts on.

The competitive dynamics and market dynamics there. Thanks.

Yes, sure so starting with the April can and just April morphine in general and your question about can mobi.

And it's really important to points first of all we there are no head to head clinical trial. So this is not a fair kind of comparison all I can talk about of course is our data our phase three and the data behind a booking and what you really see in our label what do you really see a the data that April can has been supported with.

It is truly amazing product with reliable.

Efficacy efficacy and that has not only reliable it's also fast and its fairly robust and what I'm, specifically, referring to I mean, you can see that the product starts working as earliest 10 minutes actually and about 94%.

Jack A. Khattar: If you just follow up on ApeCon, are you running that for growth, or are you running that for cash? We run every product we can for growth, and clearly, I mean, we acquired the products not to just milk the products. Apokin has a huge potential, and we're working extremely hard to rejuvenate the brand and get it at a higher level, and more importantly, especially because of the pump that is coming next year. So really, our plan is to grow the franchise, the Apokin product, the pen, the injection, as well as the pump together as an apomorphine franchise to be one of the leading franchises in Parkinson's. That is our plan, which basically includes, of course, having a successful launch of the pump, but also maintaining and potentially even growing the Apokin pen injection. Great, thank you.

Within 20 minutes, I mean that patients get the relief within 20 minutes that is really very very strong efficacy. In addition to that 95% of the off episodes are resolved I mean. This is this is really robust efficacy. It is also you know something that obviously you know.

We know these patients I mean, they have sometimes very difficult days and.

Maintaining functionality you know even getting dressed so getting out of bed. I mean this is extremely important when you have data that strong.

Also the reliability of the efficacy, meaning from the time you take the first dose.

If I remember the number it's somewhere around 97% of patients you know benefits from the first dose and that actually less even through the last of those they take it during that day with about another 90 or 95% a lot of 90% numbers here, but it really speaks to the robustness.

Jack A. Khattar: Thank you. Our next question comes from David Amsellem with Piper Sandler. Your line is now open.

And the efficacy of this product.

David A. Amsellem: Hey, thanks. Just, just a couple on my end. First, on Apikin, and I apologize if I missed this, missed this commentary, but what's your sense of the long-term impact of the sublingual form of apomorphine and what that could have on the franchise? Do you think that that's something that could cut into the franchise, or do you think that overall usage of apomorphine as a modality is low enough where multiple formulations can coexist? That's number one.

So we feel very strongly about a buck and the position a pick in the will occupy in this category because of the strong efficacy behind its profile April morphine is a very good drug obviously, but the delivery of April can in an injection pen is very very different and that is something we'll tablet.

Thats really all I can see you guys can read the label on can maulvi and the data.

Hi, and that product. So we think we may end up with a very different patient profile.

For both products. So there is clearly room for both products to be in the marketplace and we welcome the extra attention to April morphine as a drug in general as you has referred to because I think.

David A. Amsellem: And then secondly, on the pump, what are your thoughts on the AbbVie SubQ continuous infusion of the levofopa prodrug on 951 and the potential for competition there and the extent to which your product, your pump product, and theirs can coexist? I would love to get your thoughts on, you know, the competitive dynamics and market dynamics there. Thanks. Yeah, sure. Starting with Apokin and just apomorphine in general and, you know, your question about Kinmobi.

More and more physicians will realize and will understand that April morphine as a drug as a major place in therapy in this category, which will lay the or help us against your next question, which was the Abbvie product, which is actually levodopa based product not than April morphine based products. So.

A little bit harder to even talk more about the abbvie given that we don't have obviously a label to talk about to see what the profile is and so forth, but in general we're very excited about the molecule itself April morphine.

Jack A. Khattar: And it's really important to point, first of all, that there are no head-to-head clinical trials, so this is not a fair kind of comparison. All I can talk about, of course, is our data, our phase three data, and the data behind Apokin. And what you really see on our label, what you really see, the data that Apokin has been supported by is a truly amazing product with reliable efficacy, efficacy that is not only reliable, but it's also, you know, fast, and it's fairly robust. And what I'm specifically referring to, I mean, you can see that the product starts working as early as ten minutes, actually, and about within 20 minutes. I mean, patients get relief within 20 minutes. That is really very, very strong efficacy. In addition to that, 95% of the off episodes are resolved. I mean, this is really robust efficacy. It is also, you know, something that obviously, you know, we know these patients. I mean, they sometimes have very difficult days in maintaining functionality, you know, even getting dressed or getting out of bed.

And specifically the way it was delivered in April can and the profile of a book and the efficacy that comes with that product.

Okay. That's helpful. If I may just sneak in a follow up on on on 812.

Could we see any delay in the approval time and given you have some additional readouts coming around the corner with the updated want to wait and also have you had.

Your manufacturing inspections.

Yeah as far as the data that is coming up but thats in the adult.

At the end D.A. just as a reminder was only for pediatrics. So it's a different patient population.

So at this point, we haven't heard anything or haven't had any signal from the F.D.A. that they might delay it because we have a read out on the adult study so.

That's all we can say at this point and.

As far as the inspections manufacturing again, we also haven't heard from the FDA or haven't seen any signals that leads us to believe that it will be any delay because of inspections or anything like that.

Jack A. Khattar: I mean, this is extremely important when you have data that strong. Also, the reliability of efficacy, meaning from the time you take the first dose. If I remember correctly, it's somewhere around 97% of patients benefit from the first dose, and that actually lasts through the last dose they take during that day with about another 90 or 95%, a lot of 90% numbers here, but it really speaks to the robustness and the efficacy of this product. So we feel very strongly about Apekin and the position it will occupy in this category because of the strong efficacy behind its profile. Apomorphine is a very good drug, obviously, but the delivery of Apekin in an injection pen is very, very different than a sublingual tablet.

As I mentioned earlier I think last earnings call. It even before you know we have some very good.

Cmos here that we are working with on the product from the ISI, thus far as well as the final dosage form and the finished product. So we feel very good about our partners in that area from a supply perspective. However, again, we don't know under the 100% sure.

All I can say is we haven't seen any signals that lead us to believe that that will be an area that could be a problem but.

We were coming very close to the PDUFA date. So we'll see you very soon I guess.

Okay. Thanks Jack.

Sure.

Thank you and as a reminder to ask the question you will need to press Star then one on your Touchstone telephone to withdraw your question from the queue. Please press the pound key our.

Our next question comes from David Steinberg with Jefferies. Your line is now open.

Jack A. Khattar: That's really all I can see. You guys can read the label on Kenmobi and the data behind that product. So we think we may end up with a very different patient profile for both products. So there is clearly room for both products to be in the marketplace, and we welcome the extra attention to apomorphine as a drug in general, as you have referred to, because I think more and more physicians will realize and will understand that apomorphine as a drug has a major place in therapy in this category, which will later help us against your next question, which is the Advy product, which is actually a Livodopa-based product, not an apomorphine-based product.

Thanks, I just had two follow up questions.

The first one is.

Do you to.

Process behind lowering operating expenses sort of this late in the year and.

And then secondly, it looks like you generate save $100 million cash flow through retail you can.

We have around three quarters 1 billion.

Cash.

Even after paying pain.

It's so.

So you could make a reasonably sizable acquisition what do you what's your current thinking into <unk>.

Near term in terms of market assets.

You know.

Looking for accretion versus sort of earlier stage products at this point and a great all the best in retirement. Thanks.

Jack A. Khattar: So it's a little bit hard to even talk more about Advy, given that we don't have, obviously, a label to talk about to see what their profile is and so forth. But in general, we're very excited about the molecule itself, apomorphine, and specifically the way it is delivered in Apekin and the profile of Apekin and the efficacy that comes with that product. Okay, that's helpful. If I may just sneak in a follow-up on 8-12. Could we see any delay in the approval time, given you have some additional readouts coming around the corner? Would the FDA want to wait? And also, have you had your manufacturing inspection?

It's David.

Yes, I'll take a crack at the operating expenses for the remainder of the year that a lot of factors that play into that and.

First of all I'm sure everybody appreciates, the fact that with a cold with environment, it's been very difficult to manage in general an operation and never mind try to predict what happens next quarter or even the amount of promotion activity you may be able to do or may not be able to do because of the end.

Vitamin.

Or certain trends that you might see in prescriptions that you may have to do more and operating expenses and now you may find out that you actually don't need that given that the extended units have done better.

Jack A. Khattar: Yeah, as far as the data that is coming up, that's in the adult population. The NDA, just as a reminder, was only for pediatrics, so it's a different patient population. So at this point, we haven't heard anything or haven't had any signal from the FDA that they might delay it because we have a readout from the adult study. So that's all we can say at this point. As far as the inspections and manufacturing, again, we also haven't heard from the FDA or haven't seen any signals that lead us to believe there will be any delay because of inspections or anything like that. As I mentioned earlier, I think the last earnings call or even before, you know, we have some very good. CMOs here that we are working with on the product from the API side as far as as well as the final dosage form and the finished product, so we feel very good about our partners in that area from a supplier perspective. However, again, we don't know for sure, but all I can say is we haven't seen any signals that lead us to believe that that will be an area that could be a problem but, We're coming very close to Transcribed by https://otter.ai. Thank you, and as a reminder, to ask a question, you will need to press star then 1 on your touchtone telephone. To withdraw your question from the queue, please press the pound key. Our next question comes from David Steinberg with Jeffreys. Your line is now open.

So there was a lot of factors that get into the operating expenses clearly that has impacted and let us to finally believed that we could lower it for the rest of the year. Similarly on R&D you.

We've had obviously to put one trial.

On a hold the adult trial than we have to restart the recruitment is really hard to predict you know how quickly the expenses will pick up or don't pick up.

So and not just the adult trial, we have so much going in R&D. So it's not just one trial. Obviously there was a multiplicity of different trials different activities that have been impacted also by cobot, causing some delays and switching or shifting of certain activities potentially for next year or so and so forth. So that also.

In fact that operating expenses a.

We had some estimates on the integration and so for the U.S. World might acquisition on than Avatar program. So all these estimates ended up being favorable which led in totality.

The the lowering of the operating expenses for this year, Yes, David Let me just build on Jack's comments just for a second.

The adjustment of our EPS DNA expenses for the year is really it continues to recognize the secular.

Acceleration and SDN expenses, but.

Between the second quarter third quarter, and then the third into the fourth what the adjustment really just does it acknowledges exactly what Jack just said the expenses came in later in the third quarter were still projecting a significant increase.

Between the third and the fourth and just if you push the math, you'll see that the run rate in the fourth quarter is right in line, perhaps a little bit down.

From what we projected and what we discussed last quarter. So there really isn't any change in thinking change in philosophy or change in strategy. It just a matter of putting the favorability in the third quarter and then tie trading the guidance for the year that's it.

David Steinberg: Thanks. I just had two follow-up questions. The first one is, what led you to the thought process behind lowering operating expenses sort of this late in the year? And then secondly, you know, it looks like you generate, say, $100 million in your in-cash flow if you were to take... have around three quarters of a billion. So you could make a reasonably sizable acquisition. What's your current thinking in the near term in terms of on-market assets? you know, and looking for accretion versus sort of earlier stage products at this point. And Greg, all the best to you in your retirement. Thanks.

And regarding this the second question you know the cash position and as far as M&A activity or business development activities as I mentioned in my prepared remarks, we continue to be very active.

So we haven't slowed down and looking at potential opportunities here, whether it's and licensing whether it's acquisitions, whether it's a product deal or a company deal. So we continue to have the same focus the same drive the same intensity as far as utilizing our cash where they can get to use for future growth So and we're looking at.

David Steinberg: Thanks, David. Yeah, I'll take a crack at the operating expenses for, you know, the remainder of the year. There are a lot of factors that play into that.

Assets that could be can marshal assets or later stage and of course, we talked about that also a few times regarding our pipeline hopefully as a 12 moves on.

Jack A. Khattar: And first of all, I'm sure everybody appreciates the fact that, in a COVID environment, it's been very difficult to manage an operation in general and, never mind, try to predict what happens next quarter or even the amount of promotion activity you may be able to do or may not be able to do because of the environment or certain trends that you might see in prescriptions that you may have to spend more on operating expenses. And now you may find out that you actually don't need it given that the extended units have done better. So there are a lot of factors that get into the operating expenses, and clearly that has impacted and led us to finally believe that we could lower them for the rest of the year, similarly on R&D. We've had, obviously, to put one trial on hold, the adult trial; then we had to restart the recruitment. It's very hard to predict how quickly the expenses will pick up or don't pick up.

As the pump moves on and they get to the marketplace hopefully in the next 12 months or so both of them are clearly we'll have to reload the pipeline and were working pretty hard to get assets. In addition to a 20 in a 2007, which are the two key assets at this point in the pipeline. So we are hard at work looking at.

Other opportunities and it.

It is with agnostic it could be in urology, it could be psychiatry, and we'd also open to other specialty areas. If they do come across our desk and they are fairly opportunistic areas that we could look at.

Thank you and I'm showing no further questions in the queue at this time.

I'd like to turn the call back and jackets are for any closing remarks.

Thank you the year 2020 is shaping up to be one of the most successful years since our inception.

We are looking at achieving a cornerstone milestone of 500 million or more in net sales and starting to establish another chapter of growth with a major presence into psychiatry space.

Jack A. Khattar: And not just the adult trial; we have so much going on in R&D, so it's not just one trial. Obviously, there's a multiplicity of different trials, different activities that have been impacted also by COVID, causing some delays and switching or shifting of certain activities potentially to next year and so forth. So that also impacted operating expenses. We had some estimates also on the integration and so forth with the U.S. World Med Acquisition of the Navitor program. So all these estimates ended up being favorable, which led, in totality, to the lowering of the operating expenses for this year. Yeah, David, let me just build on Jack's comments for a second. The adjustment of our SD&A expenses for the year is really, it continues to recognize the secular acceleration in SD&A expenses between the second quarter, the third quarter, and then the third into the fourth. What the adjustment really just does is it acknowledges exactly what Jack just said. The expenses came in later in the third quarter.

Our employees continue to execute well across many areas of our business. They have delivered solid operating results. During the first three quarters of the year with a strong 29% growth in revenues and 21% growth in operating earnings compared to last year.

Soon we will be entering 2021 in a strong position to launch a span a 12 in January and to potentially get approval and launch SP any 30 by the end of the year. These two late stage assets represent two important growth drivers for the company and we are very focused on driving them towards commercialization.

And market success. Thank you for joining us. This morning, we look forward to finishing strong in 2020 and to setting the stage for an exciting 2021.

Ladies and gentlemen, thank you for your participation on today's conference. This does.

Concludes your program you may now disconnect.

Greg Patrick: We're still projecting a significant increase between the third and the fourth. And just if you push the math, you'll see that the run rate in the fourth quarter is right in line, perhaps a little bit down from what we projected and what we discussed last quarter. So there really isn't any change in thinking, change in philosophy, or change in strategy. It's just a matter of putting the favorability in the third quarter and then titrating the guidance for the year. That's it.

[music].

Jack A. Khattar: And regarding the second question, you know, the cash position as far as M&A activity or business development activities are concerned, as I mentioned in my prepared remarks, we continue to be very active, so we haven't slowed down in looking at potential opportunities here, whether it's licensing, whether it's acquisitions, whether it's a product deal or a company deal. So we continue to have the same focus, the same drive, the same intensity as far as utilizing our cash and putting it to use for future growth. And we're looking at assets that could be commercialized at a later stage. And, of course, we talked about that also a few times regarding our pipeline. Hopefully, as 8.12 moves on, as the pump moves on, and they get to the marketplace, hopefully, in the next 12 months or so, both of them, clearly, we'll have to reload the pipeline, and we're working pretty hard to get other assets in addition to 8.20 and 8.17, which are the two key assets at this point in the pipeline. So we are hard at work looking at other opportunities, and it is, we're agnostics. It could be neurology, it could be psychiatry, and we're also open to other specialty areas if they do come across our desk and they are fairly opportunistic areas that we could look into. Thank you, and I'm showing no further questions in the queue at this time.

Jack A. Khattar: I'd like to turn the call back to Jack Khattar for any closing remarks. Thank you. The year 2020 is shaping up to be one of the most successful years since our inception. We're looking at achieving a cornerstone milestone of $500 million or more in net sales and starting to establish another chapter of growth with a major presence in the psychiatric space. Our employees continue to perform well across many areas of our business. They have delivered solid operating results during the first three quarters of the year, with a strong 29% growth in revenues and 21% growth in operating earnings compared to last year. Soon, we will be entering 2021 in a strong position to launch SPNA 12 in January and, potentially, to get approval and launch SPNA 30 by the end of the year.

Jack A. Khattar: These two late-stage assets represent two important growth drivers for the company, and we are very focused on driving them toward commercialization and market success. Thank you for joining us this morning. We look forward to finishing strong in 2020 and to setting the stage for an exciting 2021. Ladies and gentlemen, thank you for your participation in today's conference. This does conclude your program. You may now disconnect.