Q4 2021 Supernus Pharmaceuticals Inc Earnings Call
Operator: At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the call over to Peter Vozzo of Westwick Investor Relations, a representative of Supernus Pharmaceuticals. You may begin.
At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.
Reminder, this conference call is being recorded.
I would now like to turn the call over to Peter <unk> of last week Investor Relations Representative for Superior Pharmaceuticals, you may begin.
Thank you Mei good afternoon, everyone and thank you for joining us today for <unk> pharmaceuticals, preliminary fourth quarter and full year 2021 financial results Conference call.
Peter Vozzo: Thank you, May. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' preliminary fourth quarter and full year 2021 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 Chief Financial Officer, Tim Dec. Today's call is being made available via the Investor Relations section of the company's website at ir.supernus.com.
Today after the close of the market the company issued a press release announcing these results on the call with me today are Sip furnaces, Chief Executive Officer, Jackatar, Chief Financial Officer, Tim deck. Today's call is being made available via the Investor Relations section of the company's website at IR Dot So pernis dot com following remarks by management, we will open the call.
Peter Vozzo: Following remarks by management, we will open the call to questions. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Supernus' current perspective on existing trends and information. However, any 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 latest SEC filings. For the benefit of those of you who may be listening to the replay, this call was held and recorded on February 28, 2022.
The questions. During the course of this call management may make certain forward looking statements regarding future events and the Companys future performance. These forward looking statements reflects apprentices current perspective on existing trends and information any such forward looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the <unk>.
Peter Vozzo: 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 afternoon, everyone.
<unk> Factors' section of the company's latest SEC filings actual results may differ materially from those projected in these forward looking statements for the benefit of those of you who may be listening to the replay. This call is being held and recorded on February 28 2022.
Since then the company may have made additional announcements related to the topics discussed. Please reference the Companys. Most recent press releases and current filings with the SEC subpoenas declines any obligation to update these forward looking statements, except as required by applicable securities laws I'll now turn the call over to Jack.
Thank you Peter good afternoon, everyone and thanks for taking the time to join US as we discuss our preliminary 2021 and fourth quarter and full year results.
Jack Khattar: And thanks for taking the time to join us as we discuss our preliminary 2021 fourth quarter and full year results. I would like to first make a few comments about the year 2021 as a whole and then get into more details about specific corporate accomplishments. 2021 was another outstanding year for Supernus during which we continued to execute on our long-term growth strategy and to work towards minimizing the impact of the 2023 Trocandex R transition. In 2021, we launched Kelbree, the first novel non-stimulant ADHD treatment to be launched in over a decade.
I would like to first make a few comments about the year 2021 as a whole and then get into more details about specific corporate accomplishments.
Jack Khattar: We also closed on the acquisition of Adamis, adding Gokovri as another key growth asset. And we resubmitted the NDA for SPN 830, the apomorphine infusion device, which represents our third future growth driver. In addition, we closed the year with record revenues for Supernus of approximately $580 million, up 11% compared to 2020. Finally, we advanced to Phase 2, the clinical development of SPN 820, our novel product candidate for treatment-resistant depression, and nominated SPN 443 and SPN 446, two internally discovered novel CNS drug candidates for development in CNS indications.
'twenty one was another outstanding year for supporting Us during which we continued to execute on our long term growth strategy and to work towards minimizing the impact of the 20th twenty-three Trokendi XR transition.
During 2021 we launched calibrate the first novel non stimulant ADHD treatment to be launched in over a decade.
We also closed on the acquisition of Adamos, adding recovery as another key growth asset and we resubmitted the NDA for SPN 830, the April morphine infusion device, which represents our third future growth driver.
In addition, we closed the year with record revenues for supporting us of approximately $580 million up 11% compared to 2020.
Finally, we advanced to face to the clinical development of SPN eight 'twenty, our novel product candidates for treatment resistant depression and nominated SPN Ford Ford Free and SPN afford 462 internally discovered novel CNS drug candidates for development and C. N S.
Vacations.
Moving onto specific corporate accomplishments and starting with the Atmos acquisition, we made significant progress with the integration of the business with our Parkinsons sales force that is now fully trained in the field promoting go covering.
Jack Khattar: Moving on to specific corporate accomplishments, and starting with the Adamus acquisition, we made significant progress with the integration of the business with our Parkinson's sales force that is now fully trained in the field promoting Gokabre. Gokhari recorded a total of 3,330 prescriptions in the month of January, the product's first full month under Supernus in 2022, representing a 30% increase compared to the month of January in 2021. The Adamus transaction contributed approximately $10 million in revenues in the fourth quarter, and we are on track regarding our goal of $60-80 million in synergies over the first 12 months of owning the business. As mentioned earlier, we resubmitted the NDA for the SPN 830 infusion device for the continuous treatment of motor fluctuations and Parkinson's disease in the fourth quarter.
<unk> recorded a total of 3330 prescriptions in the month of January the products first full month under support us in 2022 representing a 30% increase compared to the month of January in 2020 one.
The damage transaction contributed approximately $10 million in revenues in the fourth quarter and we are on track regarding our goal of $60 million to $80 million in synergies over the first 12 months of owning the business.
As mentioned earlier, we resubmitted the NDA for SPN 830 infusion device for the continuous treatment of motor fluctuations in Parkinson's disease, and the fourth quarter and since then we have received FDA acceptance of the submission with the Purdue date in early October 2022 .
Jack Khattar: Since then, we have received FDA acceptance of the submission with a PDUFA date in early October 2022. The company is preparing for the potential commercial launch of SPN 830 in the first quarter of 2023, assuming timely approval by the FDA. Regarding Kelbree, the launch is progressing well, continuing its growth trajectory with total IQVIA prescriptions in the fourth quarter reaching 34,328, an increase of 122 percent compared to total prescriptions of 15,453 in the third quarter of 2021. In January 2022, the most recent month available, total prescriptions reached 14,177.
The company is preparing for the potential commercial launch of SPN 830 in the first quarter of 'twenty twenty-three, assuming timely approval by the F D. A.
Regarding calibrate the launch is progressing well continuing its growth trajectory with total IQ via prescriptions.
Fourth quarter, reaching 34328, an increase of 122% compared with total prescriptions of 15453 in the third quarter of 2021 .
In January 2022 the most recent month available total prescriptions reached 14177.
Moreover, in the first quarter of 2022 total prescriptions are showing a quarter to date during the first seven weeks sequential growth rate of 42% versus the corresponding same seven week period in the fourth quarter of 2021 .
Jack Khattar: Moreover, in the first quarter of 2022, total prescriptions are showing a quarter to date sequential growth rate of 42% versus the corresponding same seven-week period in the fourth quarter of 2021. In addition, Calvary continues to expand its base of prescribers with over 5,600 prescribers in the fourth quarter of 2021, up from 3,470 prescribers in the third quarter of 2021. And finally, preparations for the potential launch in the adult market are well underway, assuming timely approval by the FDA of the supplemental NDA for the adult indication.
In addition category continues to expand its base of prescribers with over 5006 hundred prescribers in the fourth quarter of 2021 up from 3470 prescribers in the third quarter of 2021 .
And finally preparations for the potential launch in the adult market are well underway, assuming timely approval by the FDA of the supplemental NDA for the adult indication.
Jack Khattar: Supernus will continue its heavy investment in Calgary's launch activities in 2022 as it enters the adult segment of the ADHD market, which represents about 50 to 60 percent of the total market. On the managed care side, we have made good progress in managed care coverage with continued improvement in gross to net deduction. For SPNA 20, our first-in-class orally active mTORC1 activator, we initiated a phase 2 multicenter randomized double-blind placebo-controlled parallel design study in adults with treatment-resistant depression.
<unk> will continue its heavy investment in calories launch activities in 2022 as it enters the adult segment of the ADHD market, which represents about 50% to 60% of the total market.
On the managed care side, we have made good progress when managed care coverage with continued improvement in gross to net deductions.
For SPN eight 'twenty, our first in class orally active M talk one activate or we initiated a phase two multi center randomized double blind placebo controlled parallel design study in adults with treatment resistant depression.
The phase two study will examine the efficacy and safety of SPN 820 over the course of five weeks of treatment and approximately 400 patients.
Jack Khattar: The Phase II study will examine the efficacy and safety of SPNA20 over a course of five weeks of treatment in approximately 400 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery Asperg Depression Rating Scale total score, which is a standard depression rating scale. We continue to expect to start a Phase II program with SPN 817 in the second half of 2022 for the treatment of focal seizures in adults. If you recall, SVN817 represents a novel mechanism of action for an anticonvulsant and utilizes the synthetic form of fuprazine A, which is a potent acetylcholinesterase inhibitor with pharmacological activities in CNS conditions such as epilepsy
The primary outcome measure is the change from baseline to end of treatment period on the Montgomery Asbury Depression rating scale total score, which is a standard depression rating scale.
We continue to expect to start the phase II program with SPN 817 in the second half of 2022 for the treatment of focal seizures in adults few recall SPN 817 represents a novel mechanism of action for an anti come balsam and utilizes synthetic form few parisien a which.
As a potent as with local and esterase inhibitor with pharmacological activities in CNS conditions, such as epilepsy.
Moving onto the commercial products Oxter, Alex our finished another year with strong performance, reaching net sales of $111 million up 12% compared to 'twenty 'twenty also trokendi XR continues to hold up well. Despite the increased competition in the migraine prevention market, finishing.
Jack Khattar: Moving on to the commercial products, Oxfeller XR finished another year with strong performance, reaching net sales of $111 million, up 12% compared to 2020. Also, Trocandi XR continues to hold up well despite the increased competition in the migraine prevention market, finishing the year with approximately $305 million in net sales. For full year 2021, the two products combined delivered net product sales of $416 million, essentially flat compared to $418 million in 2020.
The year with approximately $305 million in net sales.
For the full year 2021 that two products combined delivered net product sales of $416 million essentially flat compared to 418 million and 2020.
A book and closed out the year with sales close to $100 million given the competitive headwinds faced during the year.
Jack Khattar: Apokin closed out the year with sales close to $100 million, given the competitive headwinds it faced during the year. Recently, the company became aware of an approval of a generic for the Apokin injection cartridge. The timing of availability of such a product is still largely unknown, and the generic cartridge will still need to be paired with the apokin pen to administer the apomorphine injection. Finally, we will continue to be active in corporate development, 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 Tim. Thank you, Jack. Good afternoon, everyone.
Recently, the company became aware of an approval of a generic to the April can injection cartridge. The timing of availability of such a product is still largely unknown and the generic cartridge will still need to be paired with the APAC intend to administer the April morphine injection.
Finally, we will continue to be active in corporate development 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 Tim.
Thank you Jack good afternoon, everyone.
Timothy Dec: As I review our preliminary fourth quarter and full year 2020 results, please refer to today's press release. As noted in that press release, the company currently anticipates it will require additional time to finalize the financial statements for the year ended December 31st, 2021 due to the following reasons. As discussed in November 2021, the company was the target of a ransomware attack. While the attack had no significant impact on the business or caused any long-term disruption to the company's operations, it did impact the long-term viability of our accounting.
As I review, our preliminary fourth quarter and full year 2021 results. Please refer to today's press release.
As noted in that press release the company currently anticipates it will acquire will require additional time to finalize the financial statements for the year ended December 31st 2021 due to the following reasons.
Timothy Dec: The attack required us to restore securely backed up data into its legacy ERP system, manually process certain functions which were previously automated in its legacy ERP system, and simultaneously accelerate its planned transition to upgrade to a more modern ERP. Also, in November 2021, the company completed its acquisition of Adamas Pharmaceuticals. The integration of ADAMAS is well underway and is expected to be complete by the end of Q2 of this year. As a result of having to restore our legacy ERP system, running a parallel ERP implementation, and integrating ADAMAS operations, the company will be unable to file the 10-K title.
As discussed in November 2021 the company was a target of a ransomware attack, while the attack had no significant impact on the business or cause any long term disruption to the company's operations. It did impact our long term viability of our accounting system.
The attack required us to restore securely backed up data into its legacy ERP system <unk>.
Annually process certain functions, which are previously automated and its legacy ERP system and simultaneously accelerate its planned transition to upgrade to a more modern ERP system.
Also in November 2021, the company completed its acquisition of the Diamond Pharmaceuticals. The integration of the damage is well underway and is expected to be complete by the end of Q2 of this year.
As a result of having to restore our legacy ERP system running a parallel ERP implementation and the integration of a dam must operations. The company will be unable to file the 10-K timely we'll be filing a 10 b twenty-five tomorrow after market close.
Timothy Dec: We will be filing a 10B25 tomorrow aftermarket. The challenges over the past several months have been significant, and I am very proud of the progress that has been made. Realistically, a new ERP implementation can generally take between 9 and 15 months, depending on its complexity.
The challenges over the past several months have been significant I'm very proud of the progress that has been made realistically a new ERP implementation can generally take between nine and 15 months depending on its complexity.
Timothy Dec: The implementation of our new ERP system is expected to take six to eight months and should be completed during Q2 of this year. Therefore, we hope to be able to file our 10K on or before the end of the two-week race period ending March 16. Before I go over the numbers for the fourth quarter and full year 2021, I want to remind everybody that the financial information is preliminary and, therefore, subject to change.
The implementation of our new ERP says system is expected to take six to eight months and should be completed during Q2 of this year.
Therefore, we hope to be able to file our 10-K on or before the end of the two week race period ending March 16th.
Before I go over the numbers for the fourth quarter and full year 2021, I want to remind everybody that the financial impact information is preliminary and therefore subject to change.
Preliminary total revenue for the fourth quarter of 2021 will be approximately $159 1 million, an 11% increase compared to $143 6 million in the same quarter last year.
Timothy Dec: Polymeriary Total Revenue for the 4th quarter of 2021 will be approximately 159.1 million, a 11% increase compared to 143.6 million and the same quarter lashes. Total revenue in the current period was comprised of net product sales of $155 million, and Royalty Revenue of $4.1 million.
Total revenue in the current period was comprised of net product sales of $155 million and royalty revenue of $4 1 million.
The increase was primarily due to net product sales of go covering.
From the acquisition of the damage and November 'twenty, 'twenty, one and the launch of caliber and the second quarter of 2022.
Timothy Dec: The increase was primarily due to net product sales of GoCovery from the acquisition of Adamus in November 2021 and the launch of Kelbree in the second quarter of 2022. For the fourth quarter of 2021, combined research and development and SG&A expenses are expected to range between $105 million and $110 million, as compared to $74.4 million for the same period in 2020. The increase in expenses is primarily due to activities to support the launch of CalBRI and transition costs associated with the ADAMAS acquisition.
For the fourth quarter of 2021 combined research and development and SG&A expenses are expected to range between $105 million and $110 million as compared to $74 4 million for the same period in 2020 the.
The increase in expenses is primarily due to activities support the launch of calibrate and transition cost associated with the <unk> acquisition.
Amortization of intangible assets for the fourth quarter of 2021 are expected to range between 11 million and $12 million compared to $5 6 million for the same period in 2020.
Timothy Dec: Ammorization of Intangible Assets for the fourth quarter of 2021 is expected to range between 11 million and 12 million, compared to 5.6 million for the same period in 2020, with the increases primarily due to the acquired intangible assets of an oven. Operating earnings for the fourth quarter of 2021 are expected to range between $20 million and $25 million, as compared to $40 million for the same period in 2020. The decrease in operating earnings is primarily attributable to higher expenses to support the launch of CalBRE and transition and other costs associated with the Adamas acquisition. For the full year 2021, total revenue was $579.8 million, an 11% increase over $520.4 million in 2020. Total revenue was comprised of net product sales of $567.5 million and royalty revenue of $12.3 million.
The increase is primarily due to the acquired intangible assets of autonomous.
Operating earnings for the fourth quarter of 2021 are expected to range between $20 million and $25 million as compared to $40 million for the same period in 2020.
The decrease in operating earnings is primarily attributable to higher expenses to support the launch of Calvin and transition and other costs associated with the <unk> acquisition.
For the full year 2021, total revenue was $579 8 million, an 11% increase over $520 4 million in 'twenty 'twenty.
Timothy Dec: The increase was primarily due to the acquisition of the CNS portfolio of U.S. World Meds in June of 2020, growth in net product sales of Oxtellar XR, the launch of Kelbree in the second quarter of 2021, and net product sales of ProCovri from the acquisition of Adamis in November of 2021. For the full year 2021, combined R&D and SGA expenses are expected to range between $377 million and $382 million, as compared to $276.6 million for the full year 2020.
Timothy Dec: Again, the increase in expenses is primarily due to activities to support the launch of Calgary, as well as the timing of both the Adonis and U.S. World Med acquisitions. Amortization of intangible assets for the full year 2021 is expected to range between $29 million and $30 million, compared to $15.7 million for the full year 2020.
Total revenue was comprised of net product sales of $567 5 million and royalty revenue up $12 3 million.
Timothy Dec: The increase is primarily due to the timing of the U.S. World MEDS and ADAMAS acquisitions. Operating earnings for the full year 2021 are expected to range between $100 million and $105 million as compared to $173.7 million for the full year 2021. The decrease in operating earnings is primarily due to increased expenses to support the launch of CalBRI and the timing of the U.S. World Med acquisition. As of December 31, 2021, the company had approximately $458.8 million in cash, cash equivalents, and marketable securities, compared to $772.9 million as of December 31, 2021.
The increase was primarily due to the acquisition of the CNS portfolio of U S World Meds in June of 2020.
Growth in net product sales of <unk> stellar XR the launch of Calgary in the second quarter of 2021, and net product sales of go cover from the acquisition of the Dallas in November of 2021 .
For the full year 2021 combined R&D and SG&A expenses are expected to range between $377 million and $382 million as compared to $276.6 million for full year 2020 again the increase in expenses is primarily due to activities support the launch of calibrating.
As well as timing of both the Adonis and U S World Med acquisitions.
Amortization of intangible assets for the full year 2021 are expected to range between $29 million and $30 million compared to $15 7 million for the full year 2020.
The increase is primarily due to the timing of the U S World Meds and Abdominous acquisition.
Operating earnings for the full year 2021 are expected to range between 100 million at $105 million as compared to $173 7 million for the full year 2020.
The decrease in operating earnings is primarily due to increased in expenses to support the launch of Calgary and the timing of the U S World Med acquisition.
As of December 31, 2021, the company had approximately $458 8 million in cash cash equivalents and marketable securities compared to $772 9 million as of December 31, 2020.
The decrease is due to the acquisition of Thomas offset by cash flow from operations.
Timothy Dec: The decrease is due to the acquisition of Adonis, offset by cash flow from operations. As discussed on our last call, and given the magnitude of the growing number of acquisition-related items, starting in 2022, we'll be adding non-gap financial measures to our quarterly earnings release, as we believe they provide greater transparency and can assist in understanding and assessing as well as reflect how we manage the business internally and set operational goals.
Yeah.
As discussed on our last call and giving the magnitude of the growing number of acquisition related items, starting in 2022, we'll be adding non-GAAP financial measures to our quarterly earnings releases as we believe they provide greater transparency and can assist in understanding and assessing so pernicious business.
As well as reflect how we manage the business internally and set operational goals.
These non-GAAP adjustments will be amortization of intangible assets.
Timothy Dec: These non-GAAP adjustments will be amortization of intangible assets, share-based compensation changes, and contingent consideration, and depreciation. Now turning to our GAAP financial guidance for the full year 2022, we expect total revenue to range from $640 million to $680 million, comprised of net product sales and royalty revenue. For the full year 2022, we expect combined R&D and SG expenses to range from $460 million to $490 million.
Share based compensation changes in contingent consideration.
And depreciation.
Now turning to our GAAP financial guidance for the full year 2022.
We expect total revenue to range from 640 million to $680 million comprised of net product sales and royalty revenue for.
For the full year 2022, we expect combined R&D and SG&A expenses to range from $460 million to $490 million.
Overall, we expect full year 2022 GAAP operating earnings to range from 20 million to $40 million.
Timothy Dec: Overall, we expect full-year 2022 GAAP operating earnings to range from $20 million to $40 million. We expect an effective tax rate of 25-28%. And finally, turning to our non-GAAP financial guidance for full year 2020, we expect our non-GAAP operating earnings to range from $130 million to $165 million.
We expect an effective tax rate of 25% to 28%.
And finally, turning to our non-GAAP financial guidance for full year 2022.
We expect our non-GAAP operating earnings to range from $130 million to $165 million.
It is important to note as Jack mentioned earlier, we will continue to invest heavily in the caliber and launch activities in 2022 as we enter the adult segment of the ADHD market.
Timothy Dec: It is important to note, as Jack mentioned earlier, we will continue to invest heavily in the CalBRI launch activities in 2022 as we enter the adult segment of the ADHD market. Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP. With that, I will turn the call over to the operator for Q&A. As a reminder, to ask a question, you will need to press Star 1 on your telephone. To withdraw your question, press the pound key.
Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP .
With that I will turn the call over to the operator for Q&A.
As a reminder to ask a question you will need to press star one on your telephone to lead all your question press the pound key please standby well compile the Q&A roster.
Operator: Please stand by while we compile the Q&A roster. Your first question comes from the line of David Steinberg of Jefferies. Your line is open. Thanks, and good afternoon.
Your first question comes from the line of David Steinberg of Jefferies. Your line is open.
Thanks, and good afternoon, I have a couple of questions.
David Steinberg: I have a couple questions. First, Jack, you gave us a total revenue guide number, but can you break it down for us a little more specifically, guidance for Apokine, Kelbree, and Gocoveri? And I ask that in particular because you mentioned Apikine just had a generic. You've obviously had competition in the last year from Ken Moby, but what is your guidance, particularly for Apikine, given the generic? I know that previously you talked about a mid-20s quarterly run rate.
First Jackie you gave a total revenue guide number but.
Can you break it down for us a little more specifically.
<unk> for April kind of calibrate and discovery and asset.
And particularly because.
You mentioned April kind of just had a generic you've obviously had competition in the last year from Kim Obi, but.
What is in your guidance.
Particularly for April kind of given the generic I know that previously you talked about a mid twenty's quarterly run rate.
And then secondly.
David Steinberg: And then secondly, on the adult pending approval, what's the average dose of Kelbree so far? I know that if it's below 200 milligrams, the WAC is $300. And if it's above 200 milligrams, it's 600 WAC.
On the adult penta.
Pending approval, what's the what's the average.
Most of.
Of calories, so far I know that if it's below 200 milligrams. The WAC is $300 and if it's above 200 milligrams at 600 whack.
And related to that would be you know once it gets approved in adults with effectively the revenue per script be double the adult versus pediatric given the weight based dosing. Thanks.
Yeah sure.
Jack Khattar: And related to that would be, you know, once it gets approved, an adult would effectively have double the revenue per script be double the adult versus the pediatric given the weight-based dosing. Thanks. Yeah, sure. First, on the revenue side, I mean, some of the key dynamics around the portfolio and the different products. I will just.., note some of the most important points, you know, to talk about. Clearly, The grotto is going to be coming from Calbury, mainly Go Curvery. Oxalatexor to a very minor degree, so to speak.
First on the revenue side I mean, some of the key dynamics around the portfolio and the different products I will just.
Note some of the most important points you know if they were to talk about clearly.
The growth is going to be coming from calibrating, our mainly go coverage.
Oxter lettic sort of very minor degree so to speak I mean, the oxide looks at it grew last year by about 12% I don't know if it will grow by exactly the same amount, but it's still you know are holding very nicely.
Jack Khattar: I mean, Oxalatexor grew last year by about 12%. I don't know if it will grow by exactly the same amount, but it's still, you know, holding very nicely. The brands that will face pressure are going to be, you know, Turkendix or A-Pokken, as you mentioned in the question. And Turkendix R has obviously been a major surprise for us. We've been, you know, kudos and credit to all our employees and managing the business and maintaining it in a much healthier situation as we, you know, much healthier than we ever all expected, and it's really holding up extremely So the question will always remain in 2020: will it continue to hold up as well?
The brands that will face pressure are going to be you know trokendi XR a bookend as you mentioned in the question.
And Trokendi XR has obviously has been a major surprise for us, we've been and kudos and credit to all our employees and managing the business and maintaining it in a much healthier situation. As we are you know a much healthier than we ever all expected and it's really a holding up extremely well. So the question will always remain in.
And 2022 will it continue to hold up as well is going to decline a little bit but to what extent and how far it will decline so between APAC and on Trokendi XR that is where do you see most of the pressure from a competitive point of view.
As far as the generic to APEC and its impact on the brand I mean, it's really still so early for us at this point to make a deep assessment and very detailed assessment as to what the impact on the brand will be this is a very recent news that just came you know came in within the last 48 hours 24 hours.
I noted in my remarks, the cartridge will require the use of our pen. So it's not going to be a similar situation as if this were an oral tablets or capsules that is quickly substitutable. So the impact for this year may be limited again, it all depends on the timing of and the availability.
Of that product to start with and then secondly, depending on all of the logistics and the tactics surrounding and availability of a generic product.
I will remind everyone that we have a very strong support network around the products starting with the nurse educators the importance of the intervention of the nurse and initiating new patients on April morphine.
As well as very significant hub services surrounding that patient to help them to get on therapy and stay on therapy.
So we always felt you know these are important services that are important to the patients and they value These services and being on the product and getting that help you know through these hum and clinical educators.
Jack Khattar: So, I hope that gives you at least a framework as to where the pressure points are, you know, within the products in the portfolio. In Calgary, as I mentioned, since we're talking about revenue, we will be investing heavily behind the product, and we will continue to invest heavily. I mean, we just launched pediatrics, so we're not even done with the launch in pediatrics, and clearly, we're very excited about also launching in the adult segment, which is about half the market or a little bit more than half of the market. Very exciting times for us with Calvary.
So I hope that gives you at least a framework as to where the pressure points are you know within the products in the portfolio.
<unk> and caliber as I mentioned since we're talking about the revenue I mean, we will be investing heavily behind the product and we will continue to invest heavily.
We just launched pediatric so we'd not like even done with the launch in pediatrics and clearly we are very excited about also launching in the adult segment, which is about half the market a little bit more than half of the market. So.
Jack Khattar: We're going to go all in on the product. We think this is a huge, huge product for Supernus, and we're going to invest appropriately behind the product. And then in relation to that, regarding the average dose from the adult perspective, you know, we think it will probably be somewhere between around the 500 milligram daily dose, 500 to 600, more probably on the 500. Initially, it always starts lower as physicians start using the product, getting more comfortable with it, and then they titrate a little bit up.
Very exciting times for us with caliber you were going to go all in on the product. We think this is a huge huge product for supporting us and we're going to invest appropriately behind the product.
And then in relation to that regarding the average does from the adult perspective.
We think it will be probably somewhere between around the 500 milligram daily those 500 to 600 more probably on the 500 initially it starts with always start slower as physicians start using the product getting more comfortable with it and then they titrate that a little bit the app. So it certainly will be much higher than it.
Jack Khattar: So it certainly will be much higher than it is currently with the pediatric and adolescent population, which we project to be more in the 300 to 400 range. The adult population will probably be more in the 500 to 600 in the long term. Thanks. But just to follow up, Jack, you did give overall revenue guidance, and the generic was approved Friday. And you had said previously that you should expect Apokine to be in the mid-20s on a quarterly run rate.
It is currently with the pediatric and adolescent.
Which we project to be more on the in the 302, Florida hundred range adult will be probably more on the 500 to 600 in the long term.
Thanks, but just to follow up Jackie.
Jack you did give overall revenue guidance and the generic was approved Friday.
And you had said previously that you should expect April kind to be in the mid twenties on a quarterly run rate. So in your overall guidance is that still the case that.
Jack Khattar: So in your overall guidance, is that still the case that, you know, Apikine will be averaging about $25 million a quarter? Can you give us that? And then, just a final question, how much sampling are you doing on Calvary and how much understated would the actual scripts be? If you stop, if you stop, fan.
April kind will be averaging about $25 million a quarter can you give us some view there and then just final question.
How much sampling that you're doing and calibrate how much understated would the actual scripts be if you stopped.
If you stop sampling.
Yeah.
Jack Khattar: Yeah, on Apokin, I mean, we are factoring in potentially some impact on genetics. But again, it's so, so difficult for us to quantify it for folks at this point. So back to your number, you know, which we had said the 25, you know, per quarter. Well, obviously, with the news, we would plan on maybe being it, you know, much lower than that than the 25. And so again, I know you're looking for a number or more real framework from a quantitative perspective, but it's really hard for us to give you specifics, and we try to shy away from giving guidance per product, so to speak.
APAC in I mean, we are factoring potentially some impact on generics what again is so so difficult for us to quantify it for folks at this point so back to your number which we have said 25 you know.
Fourth quarter, well, obviously with the news you know we would plan on maybe being at a much lower than that.
And then the 25.
And so so again I know you're looking for a number over to more of a real framework from a quantitative perspective, but it's really hard for us to give a specific and we try to shy away from giving guidance per product so to speak.
Jack Khattar: Maybe by next quarter, we'll have more visibility on the status of the generic, and we can be a little bit more specific; we'll be more than happy to do that. As far as the samples for Calgary, we will continue with a very similar level of activity, and we'll do the same with the adult. So that continues to be, and as far as, you know, is there a gross-up factor or a discount factor that you can apply to the prescriptions because of the sampling?
Maybe by next quarter, we'll have more visibility on the status of the genetic and we can be a little bit more specific it will be more than happy to do that.
As far as the samples for the category, we will continue with a very similar level of activity and we will do the same with the adult so that continues to be and as far as you know is that a gross up factor or a discount factor that you can apply until they prescriptions because of the sampling.
Jack Khattar: You know, we've talked about historically something in the 15 to 20% range, maybe, potentially as the conversion that we would hope to be getting from the samples that otherwise would be real prescriptions. Okay, thanks, Jack. Sure. Your next question comes from the line of David Amsellem from Piper Sandler. Your line is open.
We've talked about historically something in the 15% to 20% maybe.
Hum.
Potentially as the conversion that we would hope to be getting from the samples that otherwise would be a real prescriptions.
Okay. Thanks Jack.
Sure.
Your next question comes from the line of David <unk> of Piper Sandler Your line is open.
Thank so half a few and I wanted to switch gears and ask you some questions on <unk> coverage.
David Amsellem: Thanks. So, I have a few, and I wanted to switch gears and ask you some questions on GoCovery as a starting point. So, you know, Adamas provided a number of metrics regarding volumes and new starts. Is that something that you're going to do in some way going forward? And can you talk to me about what volumes were like in 4Q, where new starts are trending. So that's number one on GoCovery. And then number two, and I know you haven't provided product-specific sales guidance, but in thinking about GoCovery, what's your take on how new starts are going to trend as 2022 progresses? I know that there were some pandemic-related headwinds cited by Adonis.
As a starting point so.
You know <unk> provided a number.
Of metrics regarding volumes and new starts does that something that you're going to do in some way.
Going forward and can you talk to.
What volumes were like in <unk>, where new starts are trending.
So that's number one I'll go cover and then number two and I know you haven't provided.
Product specific sales guidance, but in thinking about the recovery what's your take on.
How.
New starts are going to trend as 2022 progresses.
Know that there was some pandemic related headwinds cited by Thomas can you talk to.
David Amsellem: Can you talk about how the pandemic or the easing of the pandemic might provide something of a lift for the product? And just your overall impressions in terms of where GoCovery is going to trend in 2022? Thanks.
Now the pandemic.
Or the easing of the pandemic might provide something of a lift for the product and just your overall impressions in terms of where those are.
We're go Cauvery is going to trend in 2022.
Yeah.
Jack Khattar: Yeah, I mean, regarding the brand overall, one of the metrics I mentioned was obviously the prescriptions in January versus the previous year, same period last, you know, 2020, which was about 30% growth in January of 2022 versus January 2021 from a prescription basis. We'll be happy, you know, to dig deeper and give you guys more, you know, various metrics if you find some of these are really helpful. But we think, I mean, the brand will continue on its growth trajectory as we experienced in the last year, perhaps with some enhancement as we take more control of the product and have more effect on the way it is being promoted and positioned and so forth as time goes on. Now, clearly, you have a lot of other factors.
Yeah, I mean regarding the the brand overall.
One of the metrics I mentioned, where obviously the prescriptions in January versus the previous year. The same period last you know 2020, which was about 30% growth in January of 2022 versus January 2021 .
From a prescription basis.
We'll be happy to dig deeper in and give you guys more.
Various metrics if if if you find some of these are really helpful.
But we think I mean, the brand will continue on its growth trajectory as you know we've experienced in last year, perhaps with some enhancement as we take more control of the product and have more effect on the way it is being promoted and positions and so forth as time goes on.
Now clearly you have a lot of other factors one of them. You you know you mentioned as the pandemic and we hope that it is easing off.
Jack Khattar: One of them you mentioned is the pandemic, and we hope that it is easing off completely, not just on GoCovery, but on all our products or even Calgary, as far as access to physicians and so forth. So we hope that actually does go away as time goes on, on all the products, not just the GoCovery franchise. So certainly, you know, as time goes on, again, back to probably next quarter, we will have a much better feel for all these dynamics.
Off completely not just uncle covered on all our products or even calibrate as far as access to physicians and so forth. So we hope that actually does go away as time goes on on all our products not just the go covered franchise.
Jack Khattar: Also, Q1 will be behind us, so to speak. As we all know, Q1 is always a difficult quarter anyway in our business because of the high deductibles, insurance, and so forth. And therefore, we'll be able to give you guys a little bit better, much more educated numbers around many metrics, not just new patients or volumes or things like this. But also, we will have a better feel for how the pandemic is gone or not gone by then. Okay. Can you talk to Newstarts, or is that something that you're not going to provide for coverage? I mean, we can. I don't have it with me.
Okay.
Okay and.
Can you talk to new starts or is that something that you're not going to provide uncle cover it.
I mean, we we can I don't have it with me I wasn't prepared to talk about it today, but we were happy to you know look at those numbers and provide them.
Jack Khattar: I wasn't prepared to talk about it today, but we're happy to, you know, look at those numbers and give them. Okay, and then just overall, on the guide on the top line guide, I mean, you know, obviously, It's hard to, you know, it's a hard question to ask in terms of where you guided relative to consensus, but it is lower than consensus or where the street is. So I guess with that in mind, you know, is that a function of some conservatism or reality on APICON?
Okay, and then and then just overall, but the guide on the top line Guy that name you know obviously.
It's it's hard to you know it's it's a hard question to ask in terms of you know where you guided relative to to consensus, but it is lower than consensus or where where the street is so I guess with that in mind. You know is is that a function of some conservatism.
Or reality on a beacon is it a function of you know, perhaps you know some some channel destocking on Trokendi be ahead of the generic I'm just trying to get a sense of you know the some of the assumptions underlying that the the 640 to 680.
Jack Khattar: Is it a function of, you know, perhaps, some channel destocking on TROCANDI ahead of the generic? I'm just trying to get a sense of, you know, some of the assumptions underlying that the 640 to 680. Yeah, the main differences are Tocan DXR and Apokin, which are the pressure points that I mentioned versus ConsenSys, for example. So we are probably assuming a little bit, you know, a worse case scenario on both products than what ConsenSys has. So that's where the pressure points are.
Yeah the.
The the main differences are Trokendi X at on a book and which are the pressure points, though I mentioned the universals consensus for example, so we are assuming.
<unk> a little bit you know worst case on both products than what the consensus half. So that's what are the pressure points at it's not about the good old and go cover your order good off on calories. So it's more about the legacy mature products like a broken until Kennedy X R.
Jack Khattar: It's not about growth in GoCovery or growth in Calgary. So it's more about the legacy mature products like Apokin and Tocan DXR. So are we more conservative?
So how do we more conservative yeah, I mean, we might end up being actually proven to be very conservative and that guidance, but at this point not knowing a lot of things that could happen. This year. So we're trying to be on the safe side, especially on these two products. So a lot of the difference between our guidance and they can.
Jack Khattar: Yeah, I mean, we might end up being proven to be very conservative in that guidance. But at this point, we don't know a lot of things that could happen this year. So we're trying to be on the safe side, especially on these two products. So a lot of the difference between our guidance and ConsenSys is really on these two products. Okay, that's helpful.
<unk> says is really on these two products.
Okay. That's helpful and last question if I may just done on on his death and I apologize if I if I missed this but you know with the closing of the donnas and integrating that asset and also you know dancing some internal <unk>.
Jack Khattar: And last question, if I may just on on on biz dev, and I apologize if I if I missed this, but, you know, with the closing of Adonis and integrating that asset, and also, you know, advancing some internal products through the pipeline. How are you thinking about, , , , , , , , , , , , , , , Yeah, I mean, ideally, probably a similar acquisition like U.S. World Med gives you commercial product and gives you a really nice quality late stage pipeline product that of course will be hitting both goals or achieving both goals. We always would favor commercial if we can find it and find it in a reasonable manner and it's a quality asset.
<unk> through the pipeline how are you thinking about acquisitions Uhm. These days in terms of your lean and for are you leaning more into a commercial state or development stage assets or you know maybe ideally you want something like <unk>, where do you get the best of both worlds.
How are you thinking about that.
Yeah, I mean, ideally yeah, probably a some of the acquisition like you as well and that gives you a commercial product and gives you a really nice quality late stage pipeline product that of course will be you know hitting both goals are achieving both goals, we always would favor commercial if we can.
Find it and find it in a reasonable manner and it's a quality assets about schroeder of that we are very focused on really building the pipeline specifically what it comes with in the area of Midstage too late stage, because if you really think about the <unk> and the launch an adult you think about hopefully.
Jack Khattar: But short of that, we are very focused on really building the pipeline specifically where it comes in the area of mid stage to late stage. Because if you really think about Calgary and the launch in adults, you think about, hopefully, the launch of the pump also sooner than later. Then you look at our pipeline; the rest of our pipeline is in phase two or earlier. So ideally, and we are focused right now on trying to find pipeline assets that could be later than phase two or between phase two and phase three or in phase three. Those would be very nice assets that we would look for and would be, in either case, neurology or psychiatry.
The launch of the pump also you know sooner than later then you look at our pipeline the rest of our pipeline his face two or earlier, so ideally and we are focused right now on trying to find pipeline assets that could be later than face to order between phase two and phase three or in phase three.
Those would be you know very nice assets that we would look for and and would be in either case. So neurology all psychiatry sold fairly agnostic as to what you know which area N C. N S. Those assets could be.
Jack Khattar: So we're fairly agnostic as to which area in CNS those assets could be. Thanks, Jack. Again, to ask a question, you will need to press Star 1 on your telephone keypad. Again, that is Star 1 on your telephone keypad. Your next question comes from the line of Jack Padovano of Stifo. Your line is open. Hi, this is Jack calling in for Annabel Samimy.
Okay. Thanks for <unk>.
Yeah.
Again to ask a question you will need to process, Taiwan on your telephone keypad again that is star one on your telephone keypad.
Your next question comes from the line of Jack My.
My designer of Stifel, Yeah lighting something.
Hi, This is Jack calling in for an <unk>. Thanks for taking a question.
Jack Padovano: Thanks for taking our question. Um, we were, um, we had some questions on guidance. What is the assumption baked in for the timing of the normalization of Calgary growth to net?
Uhm, we were you had some questions on guidance.
Uhm what is the assumption based in uhm for the timing on the normalization of the Calgary growth Tonight is that going to be more of a second half event rather than at first have one and if that comes later than expected will that have any impact on me S. P N 830 opportunity.
Jack Padovano: Is that going to be more of a second half event rather than a first half one? And if that comes later than expected, will that have any impact on the SPN 830 opportunity? Yeah, as far as the gross net improvement, I hinted at it a little bit in my remarks, you know, that we are improving the gross net, you know, in Calgary. Actually, it's been moving along much better than we expected and had planned, and hopefully, it will stay that way.
Yeah as far as the grass than at the improvement I did him to a little within my remarks, you know that we are improving the grass than that you know an calibrate.
Actually it's been moving along much better than we expected and had planned and hopefully it will stay that course some of you might remember that in my previous remarks I made the you know you specified the goal that probably by the time, we launched the adult we would like to be.
Jack Padovano: Some of you may remember that in my previous remarks, I specified the goal that, probably, by the time we launch the adult product, we would like to be in somewhere between 50 and 55, which is in line with the typical, you know, portfolio that you normally have on current products. Actually, we're approaching that much quicker. Now, Q1 is always going to be an anomaly and is going to screw up any trend you start with in the fourth quarter. So Q1 will always go up a little bit for the obvious reasons we all know.
And the somewhat 50 to 55, which is in line with typical you know portfolio that you normally have on code on products.
Actually went with we're approaching that much quicker now Q1 is all there's gonna be an anomaly in and I was gonna screw up any trend you start with in the fourth quarter. So the Q1 will always go up a little bit because of the obvious reasons, we all know, but it looks like we should be able to hit that goal that.
Jack Khattar: But it looks like we should be able to hit that, you know, goal that around the adult launch, we should be somewhere in that neighborhood of 50 to 55 in gross net. And I missed the relationship between that and the SPN 830 part of your question. Oh, um, that was just if that happened to come later than expected, would that have any impact on that opportunity, but if it's going to be as expected, then the two opportunities are fairly separate from that perspective. We view both products extremely important, and we will launch as soon as we can on any of them, whether it's the Adult Kelby or it's the SPN 830 pump.
Around the adult launch we should be somewhere in that neighborhood of 50 to 55 and good Austin at.
And I I missed the relationship between that and the S. B N 830 part of your question.
Oh that would that would just if if that happened to come later than expected would that have any impact on that opportunity, but if it's going to become as expected then.
And that should be <unk>.
No I mean, <unk> I mean, the two the two opportunities are fairly separate from that perspective, I mean, we view of both products extremely important and we will launch as soon as we can on any of them whether they get to the adult Calvary audits. The S. B N 830 pump.
Those products you can bet that we'll do everything possible to get them to the market as soon as possible once we can.
Jack Khattar: Those products, you can bet that we'll do everything possible to get them to the market as soon as possible, once we can. Great. Thank you. There are no questions at this time. Please continue. Okay, thank you.
Great. Thank you.
Sure. There are no question at this time please continue.
[noise]. Okay. Thank you we close our 20th 21 is a banner ear force a furnace was significant corporate achievements that will prepare us for the next phase in our history as a growth company.
Jack Khattar: We closed 2021 as a banner year for Supernus with significant corporate achievements that will prepare us for the next phase of our history as a growth company. We look forward to driving growth behind Calvary, GoCovery, and SPNA30, as well as continuing to manage our legacy products and significantly reduce our dependency on Trucan DXR. I would like to thank all our employees for delivering another strong performance in 2021 and positioning us well to have a great year in 2022. Thanks again for joining us today. We look forward to updating you on our progress throughout the year. This concludes today's conference call. Thank you for participating. [Music]
We look forward to driving growth behind Calvary Gocovri and S. B N 830, as well as continuing to manage our legacy products and significantly reduce our dependency on Trokendi X R. I would like to thank all our employees for delivering another strong performance in 2021 and positioning us well to have a <unk>.
Right here in 20 twenty-two thanks again for joining US today, we look forward to updating you on our progress throughout the year.
This concludes today's conference call. Thank you for participating you may not disconnect.
Yeah.
[music].
Jack Khattar: It's going to decline a little bit, but to what extent and how far it will decline? So between A-Pokken and Turkendix R, that's where you see most of the pressure from a competitive point of view as far as the generic to A-Pokken and its impact on the brand. I mean, it's really still too early for us at this point to make a deep assessment and a very detailed assessment as to what the impact on the brand will be, because this is very recent news. I just came in, you know, came in within the last 48 hours or 24 hours. As I noted in my remarks, the cartridge will require the use of our pen.
Jack Khattar: So it's not going to be a similar situation as if this were an oral tablet or capsule that is quickly substitutable. So the impact for this year may be limited. Again, it all depends on the timing and the availability of that product to start with. And then, depending on all the logistics and the tactics surrounding and the availability of a generic product, I will remind everyone that we have a very strong support network around the product, starting with the nurse educators, the importance of the intervention of the nurse and initiating new patients on APO morphine as well as very significant support services surrounding the patient to help them to get on therapy and stay on therapy.
Jack Khattar: So we always felt, you know, these are important services that are important to the patients, and they value these services in being on the product and getting that help, you know, through these hubs and clinical educators.