SUPERNUS PHARMACEUTICALS INC
For the period ended Sep 30, 2024. Filed Nov 4, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 4, 2024
SUPN$26.16-2.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-06.
0001356576-24-000051
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-04.
0001356576-24-000067
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 91 previous paragraphs and 110 current paragraphs.
58 unchanged; 28 reworded; 24 added; 4 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (24)
Current report
•In October 2024, the Company announced and discussed the data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder (MDD). The data were based on 40 enrolled subjects, of which 38 completed the 10-day treatment period. The primary objective of the study was to assess efficacy in MDD, as well as the onset of efficacy. The Phase 2a study demonstrated rapid and substantial decrease in depressive symptoms, and 80% decrease in suicidal ideation. SPN-820 was well-tolerated with few adverse events.
Current report
•In addition, the Company presented new data at the 2024 Psych Congress in October 2024 that demonstrate a rapid Montgomery–Asberg Depression Rating Scale (MADRS) response rate (≥50% reduction) and remission (MADRS ≤10), reaching 50.0% and 35.0% of participants, respectively, at 4 hours, with additional improvement to 84.2% and 63.2% of participants by Day 10.
Current report
•The Company is conducting an open label Phase 2a study in patients with treatment-resistant seizures. In May 2024, the Company announced data from a planned interim analysis from the initial stage of the study (Stage A). The Company has now completed enrollment of Stage A and is reporting topline data from all subjects with focal seizures who received the 3mg and 4mg twice daily doses, completed the maintenance period (n=10), and enrolled in the post-maintenance extension period (n=6).
Current report
•Maintenance period:
Current report
◦56% median seizure reduction from baseline.
Current report
◦70% of subjects had 30% or more seizure reduction.
Current report
◦60% of subjects had 50% or more seizure reduction.
Current report
◦30% of subjects had 75% or more seizure reduction.
Current report
•Post-maintenance extension period:
Current report
◦66% median seizure reduction from baseline.
Current report
◦83% of subjects had 30% or more seizure reduction.
Current report
◦67% of subjects had 50% or more seizure reduction.
Current report
◦50% of subjects had 75% or more seizure reduction.
Current report
•Seizure Freedom:
Current report
◦Maintenance period: 1 out of 10 subjects (10%) who completed a post-baseline seizure diary had at least one four-week seizure free period.
Current report
◦Post-maintenance extension period: 1 out of 6 subjects (17%) had at least one four-week seizure free period.
Current report
•Assessment by EpiTrack®, a validated cognitive screening tool designed for patients with epilepsy, indicated that 75% of 16 subjects was equally split between those who improved and those who had no change in cognitive function.
Current report
•SPN-817 was safe and had acceptable tolerability with 2 subjects discontinuing because of treatment related adverse events out of the 26 subjects who entered the maintenance period. Stage B of the study is on-going and includes the concomitant use of an anti-emetic to reduce cholinergic adverse events observed in the study.
Current report
Royalty, licensing and other revenues were $5.4 million and $4.9 million for the three months ended September 30, 2024 and 2023, respectively. The increase was due to increase in royalty revenues from royalty arrangements with third parties.
Current report
During the three and nine months ended September 30, 2024, the Company recorded $11.5 million and $12.0 million of insurance recoveries for certain legal costs, respectively. Legal costs were recorded under general and administrative expense as incurred. Correspondingly, the insurance recoveries were recorded as a reduction to general and administrative expenses. There were no insurance recoveries recorded in 2023.
Current report
Contingent Consideration Gain
Current report
Income Tax Expense
Current report
Income tax expense was $6.4 million (14.3% effective tax rate) and $13.0 million (18.1% effective tax rate) for the three and nine months ended September 30, 2024, as compared to an income tax expense of $25.9 million (261.6% effective tax rate) and $1.6 million (92.1% effective tax rate) for the three and nine months ended September 30, 2023. The change in both periods was primarily due to higher forecasted earnings before taxes for the three and nine months ended September 30, 2024 as compared to the near break-even forecasted earnings before taxes in 2023.
Current report
The Company's effective income tax rates for the three and nine months ended September 30, 2024 vary from the statutory federal tax rate in United States (U.S. federal tax rate) of 21% primarily due to increased tax benefits related to current and prior years research and development tax credits. The Company's effective income tax rates for the three and nine months ended September 30, 2023 vary from the statutory U.S. federal tax rate primarily due to near break-even forecasted earnings before taxes.
Removed paragraphs (4)
Previous report
•Enrollment is ongoing in the Phase II open-label study in patients with major depressive disorder (MDD). The primary objective of the study is to assess efficacy in MDD, as well as onset of efficacy. Topline results from the study are expected by the end of 2024.
Previous report
•In May 2024, the Company announced data from the planned interim analysis of its exploratory open-label Phase IIa clinical study of SPN-817 for treatment-resistant seizures. The interim analysis was based on 41 enrolled subjects, of which 19 completed the maintenance period. The Company continues to expect topline results for the full study in the second half of 2024.
Previous report
Contingent Consideration Expense (Gain)
Previous report
Income Tax Expense (Benefit)
Reworded paragraphs (28)
Previous wording
In October 2023, we resubmitted the New Drug Application (NDA) for SPN-830 to the FDA. In April 2024, the FDA issued a Complete Response Letter regarding the NDA for SPN-830. For further discussion, see Operational Highlights section below.
Current wording
In April 2024, the FDA issued a Complete Response Letter regarding the NDA for SPN-830. In August 2024, we resubmitted the New Drug Application (NDA) for SPN-830 to the FDA. For further discussion, see Operational Highlights section below.
Previous wording
huperzine A, whose MOA includes potent acetylcholinesterase inhibition, with pharmacological activities in CNS conditions such as epilepsy. The development will initially focus on the drug's anticonvulsant activity, which has been shown in preclinical models to be effective for the treatment of partial seizures and Dravet Syndrome. SPN-817 is in clinical development and has received Orphan Drug designation for several epilepsy indications from the FDA.
Current wording
SPN-817 represents a novel mechanism of action (MOA) for an anticonvulsant. SPN-817 is a novel synthetic form of huperzine A, whose MOA includes potent acetylcholinesterase inhibition, with pharmacological activities in CNS conditions such as epilepsy. The development will initially focus on the drug's anticonvulsant activity, which has been shown in preclinical models to be effective for the treatment of partial seizures and Dravet Syndrome. SPN-817 is in clinical development and has received Orphan Drug designation for several epilepsy indications from the FDA.
Previous wording
•Total IQVIA prescriptions for Qelbree were 184,342 in the second quarter 2024, an increase of 26% compared to the prior year period.
Current wording
•Total IQVIA prescriptions for Qelbree were 194,025 in the third quarter 2024, an increase of 19% compared to the prior year period.
Previous wording
•In August 2024, the Company resubmitted to the FDA the NDA for apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations ("OFF" episodes) in Parkinson’s disease.
Current wording
•In August 2024, the Company resubmitted to the FDA the NDA for apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations ("OFF" episodes) in Parkinson’s disease. On August 16, 2024, the FDA acknowledged the resubmission of the NDA for the apomorphine infusion device (SPN-830). The resubmission is considered filed, with a user fee goal date (PDUFA date) of February 1, 2025.
Previous wording
•Nearly three-quarters of planned patients have been enrolled in the ongoing Phase IIb multi-center randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression. The study is examining efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 268 patients in up to 50 clinical sites. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. Topline data from the Phase IIb trial is expected in the first half of 2025.
Current wording
•The Company expects to complete enrollment in the ongoing Phase 2b multi-center randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression in November 2024. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 236 patients in approximately 50 clinical sites. The primary outcome measure is the change from baseline to end of treatment period on the MADRS Total Score. Topline data from the Phase 2b trial are expected in the first half of 2025.
Previous wording
•A Phase IIb randomized, double-blind, placebo-controlled study in patients with treatment resistant focal seizures is expected to start by the end of 2024.
Current wording
•A Phase 2b randomized, double-blind, placebo-controlled study in patients with treatment resistant focal seizures is expected to start by the end of 2024 studying 3mg and 4mg twice daily doses.
Previous wording
•The Company plans to initiate a Phase I single dose study in healthy adults in 2024 following submission of an Investigational New Drug application. The primary objective of the study is to assess safety and tolerability.
Current wording
•The Company initiated a Phase 1 single dose study in healthy adults in the third quarter of 2024. The primary objective of the study is to assess safety and tolerability.
Previous wording
Comparison of the Three and Six Months ended June 30, 2024 and 2023
Current wording
Comparison of the Three and Nine Months ended September 30, 2024 and 2023
Previous wording
Revenues consist primarily of net product sales of our commercial products in the U.S., supplemented by royalty and licensing revenues from our collaborative licensing arrangements. The following table provides information regarding our revenues during the three and six months ended June 30, 2024 (dollars in thousands):
Current wording
Revenues consist primarily of net product sales of our commercial products in the U.S., supplemented by royalty and licensing revenues from our collaborative licensing arrangements. The following table provides information regarding our revenues during the three and nine months ended September 30, 2024 (dollars in thousands):
Previous wording
Net product sales were $162.5 million and $128.3 million for the three months ended June 30, 2024 and 2023, respectively. The increase was primarily due to increases in net product sales from Qelbree, GOCOVRI and Oxtellar XR partially offset by the decline in net product sales of Trokendi XR due to generic erosion.
Current wording
Net product sales were $170.3 million and $149.0 million for the three months ended September 30, 2024 and 2023, respectively. The increase was primarily due to increases in net product sales from Qelbree and GOCOVRI partially offset by the decline in net product sales of Trokendi XR due to generic erosion.
Previous wording
Net product sales were $301.0 million and $268.9 million for the six months ended June 30, 2024 and 2023, respectively. The increase was primarily due to increases in net product sales from Qelbree, GOCOVRI and Oxtellar XR partially offset by the decline in net product sales of Trokendi XR due to generic erosion.
Current wording
Net product sales were $471.3 million and $417.9 million for the nine months ended September 30, 2024 and 2023, respectively. The increase was primarily due to increases in net product sales from Qelbree and GOCOVRI, partially offset by the decline in net product sales of Trokendi XR due to generic erosion.
Previous wording
The accrued product returns balance increased from $51.3 million as of June 30, 2023 to $58.5 million as of June 30, 2024. This increase was primarily due to higher net product sales and timing of related return activity offset by the $4.1 million adjustment in the estimated provision for product returns related to prior year sales. The majority of this adjustment attributable to Qelbree, reflecting favorable actual returns experience in the second quarter for Qelbree. As a result, the Company changed its estimated provision for product returns based on the most recent experience.
Current wording
The accrued product returns balance increased to $57.4 million as of September 30, 2024 from $54.3 million as of September 30, 2023. This increase was primarily due to higher net product sales and timing of related return activity offset by the $7.3 million adjustment in the estimated provision for product returns related to prior year sales. The majority of this adjustment is attributable to Qelbree, reflecting favorable actual returns experienced in 2024 for Qelbree. As a result, the Company changed its estimated provision for product returns based on the most recent experience.
Previous wording
The accrued product rebates balance increased from $97.5 million as of June 30, 2023 to $116.6 million as of June 30, 2024 due to timing of Medicaid billing from states and higher net product sales.
Current wording
The accrued product rebates balance increased to $111.7 million as of September 30, 2024 from $108.1 million as of September 30, 2023 due to timing of payments associated with government programs.
Previous wording
The provision for product returns decreased from $11.7 million for the six months ended June 30, 2023 to $6.7 million for the six months ended June 30, 2024. The decrease was primarily due to the aforementioned $4.1 million adjustment in the estimated provision for product returns related to prior year sales.
Current wording
The provision for product returns decreased to $8.3 million for the nine months ended September 30, 2024 from $17.4 million for the nine months ended September 30, 2023. The decrease was primarily due to the aforementioned $7.3 million adjustment in the estimated provision for product returns related to prior year sales.
Previous wording
The provision for product rebates decreased from $211.4 million for the six months ended June 30, 2023 to $199.0 million for six months ended June 30, 2024. The decrease was primarily attributable to lower Trokendi XR sales partially offset by higher Qelbree sales.
Current wording
The provision for product rebates decreased to $293.6 million for nine months ended September 30, 2024 from $311.8 million for the nine months ended September 30, 2023. The decrease was primarily attributable to lower Trokendi XR sales, partially offset by higher Qelbree sales and favorability in commercial programs.
Previous wording
Royalty, licensing and other revenues were $5.8 million and $7.2 million for the three months ended June 30, 2024 and 2023, respectively. Royalty, licensing and other revenues were $11.0 million and $20.4 million for the six months ended June 30, 2024 and 2023, respectively. The decrease in both periods was primarily due to lower royalties on generic Trokendi XR due to the increased number of generic entrants.
Current wording
Royalty, licensing and other revenues were $16.4 million and $25.3 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease was primarily due to lower royalties on generic Trokendi XR due to the increased number of generic entrants.
Previous wording
Cost of goods sold was $17.9 million and $21.1 million for the three months ended June 30, 2024 and 2023, respectively. Cost of goods sold was $34.2 million and $44.6 million for the six months ended June 30, 2024 and 2023, respectively. The decrease in both periods was primarily driven by manufacturing efficiencies of Qelbree and decline in net product sales of Trokendi XR due to generic erosion.
Current wording
Cost of goods sold was $17.6 million and $19.6 million for the three months ended September 30, 2024 and 2023, respectively. Cost of goods sold was $51.8 million and $64.2 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease in both periods was primarily driven by manufacturing efficiencies of Qelbree and a decline in net product sales of Trokendi XR due to generic erosion.
Previous wording
R&D expenses were $26.2 million and $24.4 million for the three months ended June 30, 2024 and 2023, respectively. R&D expenses were $51.1 million and $45.6 million for the six months ended June 30, 2024 and 2023, respectively. The increase in both periods was primarily due to increased clinical program costs on SPN-820 and on the open-label study of Qelbree, and increased manufacturing costs of our product candidates.
Current wording
R&D expenses were $29.0 million and $22.7 million for the three months ended September 30, 2024 and 2023, respectively. R&D expenses were $80.1 million and $68.2 million for the nine months ended September 30, 2024 and 2023, respectively. The increase in both periods was primarily due to increased clinical program costs on SPN-817, SPN-820 and on the open-label study of Qelbree, and increased manufacturing costs of our product candidates.
Previous wording
Amortization of intangible assets was $20.1 million and $20.1 million for the three months ended June 30, 2024 and 2023, respectively. Amortization of intangible assets was $40.2 million and $40.1 million for the six months ended June 30, 2024 and 2023, respectively.
Current wording
Amortization of intangible assets was $19.5 million and $21.2 million for the three months ended September 30, 2024 and 2023, respectively. Amortization of intangible assets was $59.7 million and $61.3 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease is primarily due to impairment charges on certain acquired intangible assets in the fourth quarter of 2023 which reduced amortization expense in fiscal year 2024.
Previous wording
Contingent consideration was a gain of $4.4 million and an expense of $0.8 million for the three months ended June 30, 2024 and 2023, respectively. Contingent consideration was a gain of $5.5 million and a gain of $0.9 million for the six months ended June 30, 2024 and 2023, respectively. The change for both periods was primarily driven by the passage of time for the sales-based milestones associated with the Adamas Acquisition and change in the estimated timeline of achievement of the regulatory and development milestones associated with the USWM Acquisition. See Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations-Operational Highlights-Product Pipeline Update-SPN-830 (apomorphine infusion device) for treatment of Parkinson's disease (PD).
Current wording
Contingent consideration was a gain of $1.0 million and a gain of $0.5 million for the three months ended September 30, 2024 and 2023, respectively. Contingent consideration was a gain of $6.5 million and a gain of $1.3 million for the nine months ended September 30, 2024 and 2023, respectively. The change for both periods was primarily driven by the passage of time for the sales-based milestones associated with the Adamas Acquisition and change in the estimated timeline of achievement of the regulatory and development milestones associated with the USWM Acquisition. See Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations-Operational Highlights-Product Pipeline Update-SPN-830 (apomorphine infusion device) for treatment of Parkinson's disease (PD).
Previous wording
Other income (expense) was an income of $3.7 million and $0.5 million for the three months ended June 30, 2024 and 2023, respectively. Other income (expense) was an income of $7.1 million and $4.3 million for the six months ended June 30, 2024 and 2023, respectively. The increase in both periods was due to higher interest income on marketable securities largely driven by an overall higher investment balance in 2024 and no debt outstanding in the 2024. The interest expense recognized in 2023 was related to the 2023 Notes which were paid off in April 2023.
Current wording
Other income (expense) was an income of $4.1 million and $1.8 million for the three months ended September 30, 2024 and 2023, respectively. Other income (expense) was an income of $11.2 million and $6.1 million for the nine months ended September 30, 2024 and 2023, respectively. The increase in both periods was due to higher interest income on marketable securities largely driven by an overall higher investment balance in 2024 and no debt outstanding in 2024. The interest expense recognized in 2023 was related to the 2023 Notes which were paid off in April 2023.
Previous wording
Income tax expense was $6.4 million and $6.5 million for the three and six months ended June 30, 2024, as compared to an income tax benefit of $16.3 million and $24.2 million for the three and six months ended June 30, 2023, respectively. The change in both periods was primarily due to increased pre-tax income for the three and six months ended June 30, 2024 as compared to the same periods in 2023. The effective tax rate was 24.3% and 24.5% for the three and six months ended June 30, 2024, as compared to 95.1% and 298.7% for the three and six months ended June 30, 2023, respectively. The effective tax rate for the three and six months ended June 30, 2024 was lower compared to the same period in 2023 primarily due to an increase in pre-tax income forecasted for the full year 2024 and the near break-even pre-tax losses forecast in 2023 . The annual forecasted earnings represent the Company's best estimate as of June 30, 2024 and 2023, are subject to change and could have a material impact on the effective tax rate in subsequent periods. ASC 740, Income Taxes(ASC 740), requires the Company to estimate the annual effective income tax rate for the full year and apply it to pre-tax income (loss) for each interim period, taking into account year-to-date amounts and projected results for the full year.
Current wording
The annual forecasted earnings represent the Company's best estimate as of September 30, 2024 and 2023, are subject to change and could have a material impact on the effective tax rate in subsequent periods. Accounting Standard Codification 740, Income Taxes(ASC 740), requires the Company to estimate the annual effective income tax rate for the full year and apply it to pre-tax income (loss) for each interim period, taking into account year-to-date amounts and projected results for the full year.
Previous wording
We have financed our operations primarily with cash generated from product sales, supplemented by revenues from royalty and licensing arrangements, as well as proceeds from the sale of equity and debt securities. Continued cash generation is highly dependent on the success of our commercial products, as well as the success of our product candidates if approved by the FDA. While we expect continued profitability in future years, we anticipate there may be significant variability from year to year in the level of our profits particularly due to the following: continued market and payor pressures for our commercial products; the unfavorable impact of the loss of patent exclusivity for Trokendi XR in January 2023; the potential unfavorable impact of the forthcoming loss of exclusivity of Oxtellar XR and XADAGO; funding for research and development of our product candidates; and the additional funding to launch SPN-830, if approved by the FDA.
Current wording
We have financed our operations primarily with cash generated from product sales, supplemented by revenues from royalty and licensing arrangements, as well as proceeds from the sale of equity and debt securities. Continued cash generation is highly dependent on the success of our commercial products, as well as the success of our product candidates if approved by the FDA. While we expect continued profitability in future years, we anticipate there may be significant variability from year to year in the level of our profits particularly due to the following: continued market and payor pressures for our commercial products; the unfavorable impact of the loss of patent exclusivity for Trokendi XR in January 2023; the potential unfavorable impact of the loss of exclusivity of Oxtellar XR and XADAGO; funding for research and development of our product candidates; and the additional funding to launch SPN-830, if approved by the FDA.
Previous wording
The Company believes its balances of cash, cash equivalents, and unrestricted marketable securities, which totaled $347.2 million as of June 30, 2024, along with cash generated from ongoing operations and continued access to debt markets, will be sufficient to satisfy its cash requirements over the next 12 months and beyond.
Current wording
The Company believes its balances of cash, cash equivalents, and unrestricted marketable securities, which totaled $403.2 million as of September 30, 2024, along with cash generated from ongoing operations and continued access to debt markets, will be sufficient to satisfy its cash requirements over the next 12 months and beyond.
Previous wording
Net cash provided by operating activities was $74.0 million and $30.3 million for the six months ended June 30, 2024, and 2023, respectively. The increase in cash flows provided by operating activities is primarily due to changes in working capital which reflects the timing impacts of cash collections on receivables and settlement of payables, and higher net income for the six months ended June 30, 2024 compared to the same period in prior year.
Current wording
Net cash provided by operating activities was $127.5 million and $66.1 million for the nine months ended September 30, 2024, and 2023, respectively. The increase in cash flows provided by operating activities is primarily due to higher net income for the nine months ended September 30, 2024 compared to the same period in prior year, and changes in working capital which reflects the timing impacts of cash collections on receivables and settlement of payables.
Previous wording
Net cash used in investing activities was $100.2 million for the six months ended June 30, 2024 compared to $300.1 million cash provided by investing activities during the same period in 2023. The change was primarily due to higher cash flows from the maturities of marketable securities in 2023. Proceeds from the maturities of marketable securities in 2023 were used to repay the 2023 Notes at maturity date of April 1, 2023.
Current wording
Net cash used in investing activities was $177.2 million for the nine months ended September 30, 2024 compared to $334.7 million cash provided by investing activities during the same period in 2023. The change was primarily due to an increase in cash outflows from purchases of marketable securities, partially offset by higher cash inflows from the maturities of marketable securities.
Previous wording
Net cash provided by financing activities was $3.2 million for the six months ended June 30, 2024 compared to $398.7 million used during the same period in 2023. The change was primarily due to the payment of the total principal amounts and remaining outstanding interest due on the 0.625% Convertible Senior Notes in April 2023.
Current wording
Net cash provided by financing activities was $6.3 million for the nine months ended September 30, 2024 compared to $399.0 million used during the same period in 2023. The change was primarily due to the payment of the total principal amounts and remaining outstanding interest due on the 0.625% Convertible Senior Notes in April 2023.
Previous wording
For a discussion of new accounting pronouncements, see Note 2 in the Notes to the Condensed Consolidated Financial Statements in Part I, Item 1, Unaudited Condensed Consolidated Financial Statements, of this Quarterly Report on Form 10-Q.
Current wording
For a discussion of new accounting pronouncements, see Note 2 Summary of Significant Accounting Policies, in the Notes to the Condensed Consolidated Financial Statements in Part I, Item 1, Unaudited Condensed Consolidated Financial Statements, of this Quarterly Report on Form 10-Q.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
SPN-817 represents a novel mechanism of action (MOA) for an anticonvulsant. SPN-817 is a novel synthetic form of