On November 8, 2023 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the third quarter of 2023, and associated Company developments (Press release, Supernus, NOV 8, 2023, View Source [SID1234637274]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our third-quarter performance underscores the strength of our growth products, with combined Qelbree and GOCOVRI net product sales increasing 52% in the third quarter of 2023 compared to the same period last year," said Jack Khattar, President and CEO of Supernus. "In addition to our strong commercial execution, during our R&D Day in October 2023, we highlighted our pipeline of first-in-class differentiated CNS product candidates that have the potential to bolster future growth."

Qelbree Update

Total IQVIA prescriptions were 163,344 in the third quarter of 2023, an increase of 73% compared to the same period last year and 12% compared to the second quarter of 2023.
Qelbree continues to expand its base of prescribers, with approximately 24,189 prescribers in the third quarter of 2023, up from 21,291 prescribers in the second quarter of 2023.
The Company presented new data at Psych Congress 2023 in September showing improved efficacy in children ages 6 years and older with attention-deficit hyperactivity disorder (ADHD) when Qelbree is administered with stimulants, as well as in adults with ADHD who undergo long-term treatment with Qelbree.
___________________________________________
(1) Adjusted Operating Earnings is a non-GAAP measure and is calculated as Operating Earnings (Loss) (GAAP) plus amortization of intangible assets, share-based compensation, contingent consideration expense (gain) and depreciation. A reconciliation of the full year 2023 financial guidance for Operating Loss (GAAP) to Adjusted Operating Earnings (non-GAAP) is included under the heading "Full Year 2023 Financial Guidance – GAAP to Non-GAAP Adjustments."
(2) Total revenues, excluding Trokendi XR net product sales is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP). A reconciliation of this measure to Total revenues (GAAP) is included under the heading "Reconciliation of GAAP Total revenues to Non-GAAP Total revenues excluding Trokendi XR net product sales."

Product Pipeline Update

The Company hosted a successful Research & Development (R&D) Day in October 2023 highlighting clinical and R&D progress and its emerging pipeline of novel CNS product candidates. During the R&D Day the Company provided a product pipeline update as set forth below:

SPN-830 (apomorphine infusion device) for treatment of PD

In November 2023, the FDA accepted the resubmission of the New Drug Application (NDA) for SPN-830 for continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease (PD). The resubmission is now considered filed, with a user fee goal date (PDUFA date) of April 5, 2024.
SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression

The Phase IIb multi-center randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression is ongoing. The study will examine the 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 2025.
The Company plans to initiate a Phase II open-label study in approximately 40 subjects with major depressive disorder (MDD) before year-end 2023. The primary objective of the study is to assess efficacy in MDD, as well as onset of efficacy.
SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy

An open-label Phase IIa clinical study of SPN-817 for treatment-resistant seizures is ongoing. The study is examining the safety and tolerability of SPN-817 as adjunctive therapy in adult patients with treatment-resistant seizures, as well as assessing efficacy. The Company expects topline results from the Phase IIa study in the first half of 2024.
The Company expects to initiate a Phase IIb randomized, double-blind, placebo-controlled study in approximately 436 patients with treatment-resistant focal seizures in the first half of 2024. The primary endpoint is change from baseline in focal seizure frequency per 28 days. Topline results from the Phase IIb study are expected in 2026.
SPN-443 – Novel stimulant for ADHD/CNS

The Company is planning in 2024 to initiate a Phase I single dose study in approximately 24 healthy adults following submission of an Investigational New Drug (IND) application. The primary objective of the study is to assess safety and tolerability.
Financial Highlights

Total revenues (GAAP and non-GAAP)

For the three months ended September 30, 2023, total revenues and total net product sales (GAAP) were $153.9 million and $149.0 million, respectively, compared to total revenues and total net product sales of $177.4 million and $172.7 million for the same period in 2022. For the nine months ended September 30, 2023, total revenues and total net product sales were $443.2 million and $417.9 million, respectively, compared to total revenues and total net product sales of $499.9 million and $485.6 million for the same period in 2022. The decrease in net product sales in both periods was primarily due to the decline in net product sales of Trokendi XR. This decline in net product sales of Trokendi XR was partially offset by an increase in net product sales of Qelbree, GOCOVRI and APOKYN for the three months ended September 30, 2023, and an increase in net product sales of Qelbree and GOCOVRI for the nine months ended September 30, 2023.

Total revenues excluding Trokendi XR net product sales (non-GAAP) for the three and nine months ended September 30, 2023, increased 24% and 25%, respectively, compared to the same periods in 2022.

The following table provides information regarding total revenues during the three and nine months ended September 30, 2023 and 2022 (unaudited, dollars in millions):

Three Months Ended
September 30, Nine Months Ended
September 30,
2023 2022 Change % 2023 2022 Change %
Total net product sales $ 149.0 $ 172.7 (14 )% $ 417.9 $ 485.6 (14 )%
Royalty revenues(1) 4.9 4.7 4 % 25.3 14.3 77 %
Total revenues (GAAP) $ 153.9 $ 177.4 (13 )% $ 443.2 $ 499.9 (11 )%
Total revenues excluding Trokendi XR net product sales (non-GAAP) $ 133.3 $ 107.8 24 % $ 368.5 $ 295.9 25 %
___________________________________________
(1) Royalty revenues include royalties on generic Trokendi XR, other licensed products and intellectual property.

The following table provides information regarding total net product sales during the three and nine months ended September 30, 2023 and 2022 (unaudited, dollars in millions):

Three Months Ended
September 30, Nine Months Ended
September 30,
2023 2022 Change % 2023 2022 Change %
Net product sales
Qelbree $ 37.1 $ 18.3 103 % $ 93.8 $ 37.7 149 %
GOCOVRI 32.9 27.9 18 % 87.7 75.2 17 %
Oxtellar XR 29.6 30.5 (3 )% 82.4 88.0 (6 )%
Trokendi XR 20.6 69.6 (70 )% 74.7 204.0 (63 )%
APOKYN 21.5 18.3 17 % 56.3 57.2 (2 )%
Other(1) 7.3 8.1 (10 )% 23.0 23.5 (2 )%
Total net product sales $ 149.0 $ 172.7 (14 )% $ 417.9 $ 485.6 (14 )%
___________________________________________
(1) Includes net product sales of MYOBLOC, XADAGO and Osmolex ER.

Operating earnings (loss) (GAAP and non-GAAP)

For the three months ended September 30, 2023, operating earnings (GAAP) was $8.1 million, compared to operating loss (GAAP) of ($1.5) million for the same period in 2022. For the nine months ended September 30, 2023, operating loss (GAAP) was ($4.3) million, compared to operating earnings (GAAP) of $11.8 million for the same period in 2022. The increase in operating earnings (GAAP) in the third quarter of 2023 was due primarily to lower selling and marketing expenses compared to the third quarter of 2022 due to the launch of Qelbree to the adult population and the Qelbree direct-to-consumer campaign, which substantially occurred in the third quarter of 2022. The operating loss (GAAP) in the nine months ended September 30, 2023 was primarily due to a decrease in net product sales of Trokendi XR, partially offset by growth in net product sales of Qelbree and GOCOVRI, and a decrease in operating expenses.

For the three months ended September 30, 2023, adjusted operating earnings (non-GAAP) were $37.3 million, compared to $25.4 million for the same period in 2022. For the nine months ended September 30, 2023, adjusted operating earnings (non-GAAP) were $77.9 million, compared to $91.1 million for the same period in 2022.

Reconciliation of GAAP Operating earnings (loss) to Non-GAAP Operating earnings

An itemized reconciliation between operating earnings (loss) on a GAAP basis and operating earnings on a non-GAAP basis is as follows (unaudited, dollars in millions):

Three Months Ended
September 30, Nine Months Ended
September 30,
2023 2022 2023 2022
Operating earnings (loss) – As Reported (GAAP) $ 8.1 $ (1.5 ) $ (4.3 ) $ 11.8
Adjustments:
Amortization of intangible assets 21.2 20.6 61.3 61.9
Share-based compensation 7.9 5.0 20.3 13.3
Contingent consideration expense (gain) (0.5 ) 0.5 (1.3 ) 1.9
Depreciation 0.6 0.8 1.9 2.2
Operating earnings – As Adjusted (non-GAAP) $ 37.3 $ 25.4 $ 77.9 $ 91.1
Non-GAAP operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation.

Net earnings (loss) (GAAP)

For the three months ended September 30, 2023, net earnings (loss) (GAAP) and diluted earnings (loss) per share (GAAP) were ($16.0) million and ($0.29), respectively, as compared to $1.7 million and $0.03, in the same period in 2022. For the nine months ended September 30, 2023, net earnings (GAAP) and diluted earnings per share (GAAP) were $0.1 million and $0.00, respectively, as compared to $35.2 million and $0.62 in the same period in 2022.

Balance sheet

At September 30, 2023, the Company’s cash, cash equivalents, and current and long-term marketable securities were approximately $225.3 million, compared to $555.2 million as of December 31, 2022. This decrease was primarily due to repayment of the Company’s $402.5 million 0.625% Convertible Senior Notes due 2023 (2023 Notes), partially offset by cash generated from operations.

Full Year 2023 Financial Guidance (GAAP)

The Company is revising its full-year 2023 financial guidance as set forth below (dollars in millions).

Current
(as of November 8, 2023) Previous
(as of August 8, 2023)
Total revenues(1)(2) $590 – $610 $580 – $620
Combined R&D and SG&A expenses $420 – $440 $450 – $480
Operating loss(3) ($15) – ($5) ($30) – ($10)
___________________________________________
(1) Includes net product sales and royalty revenue, and approximately $90 million of Trokendi XR.
(2) Reflects Trokendi XR generic erosion in 2023.
(3) Includes amortization of intangible assets and contingent consideration expense (gain).

Full Year 2023 Financial Guidance – GAAP to Non-GAAP Adjustments

An itemized reconciliation between projected operating loss on a GAAP basis and projected operating earnings on a non-GAAP basis is as follows (dollars in millions):

Current
(as of November 8, 2023) Previous
(as of August 8, 2023)
Operating loss – GAAP ($15) – ($5) ($30) – ($10)
Adjustments:
Amortization of intangible assets $83 $83
Share-based compensation $25 – $29 $20 – $24
Contingent consideration $0 – $1 $0 – $1
Depreciation $2 $2
Operating earnings – non-GAAP $95 – $110 $75 – $100
Non-GAAP Financial Information

This press release contains financial measures that present financial information which do not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP operating earnings adjusts for non-cash share-based compensation expense, depreciation and amortization, and accretion of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. In addition to non-GAAP operating earnings, we also present total revenues excluding net product sales of Trokendi XR which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP). With the loss of exclusivity due to generic entrants, we do not expect net product sales of Trokendi XR to constitute a significant part of our revenue in the future. We believe that the use of non-GAAP financial measures provides useful supplemental information to management, investors, analysts and others regarding the Company’s revenue and results of operations and assist management, investors, analysts, and others in understanding and evaluating our revenue growth and the performance of the business.

There are limitations associated with the use of non-GAAP financial measures and therefore comparability may be limited. These limitations include: non-GAAP financial measures that may not be entirely comparable to similarly titled measures used by other companies; these may not reflect all items of income and expense, as applicable, that affect our operations; there may be potential differences among calculation methodologies; these may differ from the non-GAAP information used by other companies, including peer companies. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2023 financial guidance is also being provided on both a reported and a non-GAAP basis.

Reconciliation of GAAP Total revenues to Non-GAAP Total revenues excluding Trokendi XR net product sales

An itemized reconciliation between total revenues on a GAAP basis and Total revenues excluding Trokendi XR net product sales, a non-GAAP measure, is as follows (unaudited, dollars in millions):

Three Months Ended
September 30, Nine Months Ended
September 30,
2023 2022 Change % 2023 2022 Change %
Total revenues (GAAP)(1) $153.9 $177.4 (13 )% $443.2 $499.9 (11 )%
Less: Trokendi XR net product sales 20.6 69.6 (70 )% 74.7 204.0 (63 )%
Total revenues excluding Trokendi XR net product sales (Non-GAAP) $133.3 $107.8 24 % $368.5 $295.9 25 %
___________________________________________
(1) Includes net product sales and royalty revenue.

Conference Call Details

Supernus will host a conference call and webcast today, November 8, 2023, at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.