Supernus Announces Second Quarter 2023 Financial Results

• Qelbree^® net product sales growth of 179% and 193% in the first three months and first six months of 2023, respectively, compared to the same periods in 2022
  • $31.0 million and $56.8 million of net product sales in the first three months and first six months of 2023, respectively
• GOCOVRI^® net product sales growth of 17% and 16% in the first three months and first six months of 2023, respectively, compared to the same periods in 2022
  • $28.8 million and $54.8 million of net product sales in the fist three months and first six months of 2023, respectively
• Total revenues of $289.3 million in the first six months of 2023; excluding Trokendi XR^® net product sales, total revenues increased by 25% in the first six months of 2023, compared to the same period in 2022
• Operating loss (GAAP) in the first six months of 2023 was ($12.4) million, compared to operating earnings (GAAP) of $13.3 million in the first six months of 2022
• Adjusted operating earnings (non-GAAP) in the first six months of 2023 was $40.5 million, compared to $65.7 million in the first six months of 2022
  

ROCKVILLE, Md., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. ( SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the second quarter of 2023, and associated Company developments.

“Our growth products continue to deliver robust growth with Qelbree and GOCOVRI combined net product sales growing by 67% in the second quarter of 2023 compared to the same period last year,” said Jack Khattar, President and CEO of Supernus. “In addition, despite the seasonally weak summer season in the ADHD market, Qelbree's net product sales grew by 20% in the second quarter of 2023 compared to the first quarter of 2023 showing the resiliency of the brand and its growth potential. We remain well positioned to drive strong revenue growth in 2024 and beyond.”

Qelbree Update

• Total IQVIA prescriptions were 146,344 in the second quarter of 2023, an increase of 133% compared to the same period last year and 9% compared to the first quarter of 2023.
• Increase in prescription size and improvement in gross to net resulting in 10% increase in average net price per prescription to $212 in the second quarter of 2023 compared to the first quarter.
• Qelbree continues to expand its base of prescribers, with approximately 21,291 prescribers in the second quarter of 2023, up from 19,197 prescribers in the first quarter of 2023.
• The salesforce expansion has been completed and the field sales team is fully trained, allowing the Company broader reach and increased capacity as it prepares for the “back-to-school” season for Qelbree.

Product Pipeline Update

R&D Day

• On October 18, 2023, Supernus will host an R&D Day in New York City. The management team plans to provide an overview of the Company’s pipeline, with emphasis on SPN-820/821, SPN-817 and new clinical candidates from the Company’s discovery program. In addition, key thought leaders will share their perspectives on the current treatment paradigms, unmet medical needs, and the Company's clinical development programs. Further details are forthcoming.
  

SPN-830 (apomorphine infusion device) - Continuous treatment of motor fluctuations (“off” episodes) in Parkinson's disease (PD)

• The Company continues to expect to resubmit the New Drug Application for SPN-830 in the fourth quarter of 2023.
  

SPN-820/821 - Novel first-in-class activator of mTORC1 for the treatment of treatment-resistant depression

• The Phase II 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 270 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, a standard depression rating scale.
  

SPN-817 – A novel product candidate for the treatment of epilepsy

• The open-label Phase II clinical study of SPN-817 in patients with treatment-resistant seizures is ongoing. Depending on the rate of enrollment, the Company expects to have data in the first half of 2024.
  

Financial Highlights

Total revenues

For the three months ended June 30, 2023, total revenues and total net product sales were $135.5 million and $128.3 million, respectively, compared to total revenues and total net product sales of $170.1 million and $165.5 million for the same periods in 2022. For the six months ended June 30, 2023, total revenues and total net product sales were $289.3 million and $268.9 million, respectively, compared to total revenues and total net product sales of $322.5 million and $312.9 million for the same periods in 2022. The decrease in net product sales in both periods was primarily due to the decline in net product sales of Trokendi XR, partially offset by an increase in net product sales of both Qelbree and GOCOVRI.

Excluding net product sales of Trokendi XR, total revenues for the three and six months ended June 30, 2023, increased 18% and 25%, respectively, compared to the same periods last year.

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

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⁽¹⁾ Royalty revenues include royalties on generic Trokendi XR, other licensed products and intellectual property.
⁽²⁾ Total revenues, excluding Trokendi XR net product sales is a non-GAAP measure. Refer to "Non-GAAP Financial Information" below for a description of its calculation.

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

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⁽¹⁾ Includes net product sales of MYOBLOC^®, XADAGO^® and Osmolex ER^®.

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

For the three months ended June 30, 2023, operating loss (GAAP) was ($17.6) million, compared to operating earnings (GAAP) of $11.3 million for the same period in 2022. For the six months ended June 30, 2023, operating loss (GAAP) was ($12.4) million, compared to operating earnings (GAAP) of $13.3 million for the same period in 2022. The operating loss (GAAP) in both periods in 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, an increase in royalty revenues and a decrease in operating expenses.

For the three months ended June 30, 2023, adjusted operating earnings (non-GAAP) were $10.0 million, compared to $37.6 million for the same period in 2022. For the six months ended June 30, 2023, adjusted operating earnings (non-GAAP) were $40.5 million, compared to $65.7 million for the same period in 2022.

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

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):

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 June 30, 2023, net earnings (loss) (GAAP) and diluted earnings (loss) per share (GAAP) were ($0.8) million and ($0.02), respectively, as compared to $7.9 million and $0.14, in the same period in 2022. For the six months ended June 30, 2023, net earnings (GAAP) and diluted earnings per share (GAAP) were $16.1 million and $0.29, respectively, as compared to $33.5 million and $0.57 in the same period in 2022.

Balance sheet

At June 30, 2023, the Company's cash, cash equivalents, and current and long-term marketable securities were approximately $189.1 million, compared to $555.2 million as of December 31, 2022. This decrease was primarily due to repayment of the 0.625% Convertible Senior Notes due 2023 (2023 Notes), partially offset by cash generated from operations.

On April 1, 2023, the Company paid the total principal amount of $402.5 million due under its 2023 Notes, in addition to payment of the remaining outstanding interest of $1.3 million. Following the repayment, the 2023 Notes are no longer outstanding. In addition, as of June 30, 2023, the Company has fully repaid the $93 million borrowing against the credit line.

Full Year 2023 Financial Guidance (GAAP)

For the full year 2023, the Company reiterates its prior financial guidance as set forth below (dollars in millions).

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⁽¹⁾ Includes net product sales and royalty revenue.
⁽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):

Supplemental Revenue Reconciliation (unaudited)

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⁽¹⁾ Includes net product sales and royalty revenue.

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 f