Management's Discussion and Analysis of Financial Condition and Results of Operations is intended to help the reader understand the results of operations and the financial condition ofSupernus Pharmaceuticals, Inc. (the Company, we, us, or our). The interim condensed consolidated financial statements included in this report and this Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with our audited consolidated financial statements and notes thereto for the year endedDecember 31, 2021 and the related Management's Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K, filed with theSecurities and Exchange Commission onApril 13, 2022 . In addition to historical information, this Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbors created thereby. These forward-looking statements may include declarations regarding the Company's belief or current expectations of management, such as statements including the words "budgeted," "anticipate," "project," "forecast," "estimate," "expect," "may," "believe," "potential," and similar statements or expressions, which are intended to be among the statements that are forward-looking statements, as such statements reflect the reality of risk and uncertainty that is inherent in our business. Actual results may differ materially from those expressed or implied by such forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which are made as of the date this report was filed with theSecurities and Exchange Commission . Our actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under the "Risk Factors" section of our Annual Report on Form 10-K, our Quarterly Report on Form 10-Q filed with theSecurities and Exchange Commission onAugust 8, 2022 and elsewhere in this report as well as in other reports and documents we file with theSecurities and Exchange Commission from time to time. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of this Quarterly Report on Form 10-Q. Solely for convenience, in this Quarterly Report on Form 10-Q, the trade names are referred to without the TM symbols and the trademark registrations are referred to without the circled R, but such references should not be construed as any indicator that the Company will not assert, to the fullest extent under applicable law, our rights thereto. 32
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Overview
We are a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson's Disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. The Company is developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders.
We have a portfolio of commercial products and product candidates.
Commercial Products
•Trokendi XR® (topiramate) is the first once-daily extended-release topiramate product indicated for the treatment of epilepsy in patients 6 years of age and older inthe United States (U.S.) market. It is also indicated for the prophylaxis of migraine headache in adults and adolescents 12 years and older.
•Oxtellar XR® (oxcarbazepine) is indicated as therapy for the treatment of
partial onset seizures in patients 6 years of age and older. It is also the
first once-daily extended-release oxcarbazepine product indicated for the
treatment of epilepsy in the
•Qelbree® (viloxazine extended-release capsules) is a novel non-stimulant product indicated for the treatment of ADHD in adults and pediatric patients 6 years and older. OnApril 2, 2021 , theU.S. Food and Drug Administration (FDA) approved Qelbree for the treatment of ADHD in pediatric patients 6 to 17 years of age. InMay 2021 , the Company launched Qelbree for pediatric patients in theU.S. OnApril 29, 2022 , the FDA approved Qelbree for treatment of ADHD in adult patients. The Company launched Qelbree for adult patients inMay 2022 . •GOCOVRI® (amantadine) extended-release capsules is the first and only FDA approved medicine indicated for the treatment of dyskinesia in patients with PD receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa with PD experiencing "off" episodes.
•APOKYN® (apomorphine hydrochloride injection) is a product indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced PD.
•XADAGO® (safinamide) is a once-daily product indicated as adjunctive treatment to levodopa/carbidopa in patients with PD experiencing "off" episodes.
•Osmolex ER® (amantadine) extended-release is a once-daily product for the treatment of PD and drug-induced extrapyramidal reactions in adult patients.
•MYOBLOC® (rimabotulinumtoxinB injection) is a product indicated for the treatment of cervical dystonia and chronic sialorrhea in adults. It is the only botulinum toxin type B available on the market.
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Research and Development
We are developing a pipeline of novel CNS product candidates for the treatment of various CNS conditions. The table below summarizes our product candidates in clinical development. Product Candidate Indication Development NDA Continuous treatment of motor Complete Response Letter (CRL) SPN-830 fluctuations ("off" episodes) in PD received from FDA in October patients 2022 SPN-820 Treatment-resistant depression Phase II SPN-817 Treatment-resistant seizures Phase I SPN-443 CNS Preclinical SPN-446 CNS Preclinical
SPN-830 (apomorphine infusion device)
SPN-830 is a late-stage drug/device combination product candidate for the continuous treatment of motor fluctuations ("off" episodes) in PD patients that are not adequately controlled with oral levodopa and one or more adjunct PD medications. If approved, it would be the only continuous infusion of apomorphine available in theU.S. and an important step for PD patients that would have otherwise been candidates for potentially invasive surgical procedures, such as deep brain stimulation. Continuous slow infusion may also limit some of the side effects of a bolus injection of apomorphine. InDecember 2021 , we resubmitted the NDA to the FDA. InFebruary 2022 , we received a notice from the FDA that the resubmission of the NDA for SPN-830 is considered as a Standard Review, thereby was assigned a PDUFA target action date in earlyOctober 2022 . InOctober 2022 , the FDA issued a CRL regarding the NDA for SPN-830. The CRL requires additional information and analysis related to the infusion device and drug product across several areas of the NDA including, but not limited to, labeling, product quality and manufacturing, device performance and risk analysis. In addition, the FDA mentions that approval of the NDA requires inspections that could not be completed in a timely manner due to COVID-19 travel restrictions. The CRL does not request additional efficacy and safety clinical studies. The FDA has made an initial determination that the amendment to the Company's application in response to the CRL will be subject to a Class 2, or six-month, review timeline.
SPN-820 (NV-5138)
SPN-820 is a first-in-class, orally active small molecule that directly activates brain mechanistic target of rapamycin complex 1 (mTORC1), a gatekeeper of cellular metabolism and renewal. SPN-820 binds to and modulates sestrin, which senses amino acid availability in the brain, a potent natural activator of mTORC1. SPN-817 (huperzine A) 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.
Adamas Reorganization
In the first quarter of 2022 and subsequent to the Adamas Acquisition, the Company completed a reorganization of the Adamas legal entities in an effort to obtain operational, legal and other benefits that also resulted in certain state tax efficiencies. The reorganization had no effect on the condensed consolidated financial statements other than certain state tax efficiencies. (See Note 12, Income Tax (Benefit) Expense). 34
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COVID-19 Impact
While the impact of the ongoing COVID-19 pandemic did not have a material adverse effect on our financial position or results of operations for the three months and nine months endedSeptember 30, 2022 , we continue to closely monitor the events and circumstances surrounding the COVID-19 pandemic and its impact on all aspects of our business operations. Since the situation surrounding the COVID-19 pandemic remains fluid and the duration uncertain, the long-term nature and extent of the impacts of the pandemic on our business operations and financial position cannot be reasonably estimated at this time. See "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-K and "Risk Factors" in Part II, Item 1A of our Quarterly Report on Form 10-Q filed with theSecurities and Exchange Commission onAugust 8, 2022 for additional information on risk factors that could impact our business and our results.
Operational Highlights
Qelbree Launch Update
•Total IQVIA prescriptions were 94,328 in the third quarter of 2022, an increase of 50% compared to total prescriptions of 62,938 in the second quarter of 2022. InSeptember 2022 , the most recent month available, total prescriptions reached 34,633. •Qelbree continues to expand its base of prescribers, with approximately 14,265 prescribers in the third quarter of 2022, up from 9,276 prescribers from the second quarter of 2022. Product Pipeline Update
SPN-830 (apomorphine infusion device) - Continuous treatment of motor fluctuations ("off" episodes) in Parkinson's disease (PD)
•InOctober 2022 , the Company announced theU.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the SPN-830 New Drug Application (NDA). The CRL does not request additional efficacy and safety clinical studies but rather requires additional information and analysis related to the infusion device and drug product across several areas of the NDA, including labeling, product quality and manufacturing, device performance and risk analysis. In addition, the FDA mentions that approval of the NDA requires inspections that could not be completed in a timely manner due to COVID-19 travel restrictions. Supernus will continue to work closely with the FDA to address all questions, and when possible, to provide clarity regarding the potential timing of a resubmission of the NDA. The FDA has made an initial determination that the amendment to the Company's application in response to the CRL will be subject to a Class 2, or six-month, review timeline.
SPN-820 - Novel first-in-class activator of mTORC1
•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
•An open-label Phase II clinical study of SPN-817 in patients with treatment-resistant seizures is expected to start in the fourth quarter of 2022.
Critical Accounting Policies and the Use of Estimates
A summary of our significant accounting policies is included in Note 2, Summary of Significant Accounting Policies of our audited consolidated financial statements included in the Annual Report on Form 10-K for the year endedDecember 31, 2021 . There were no significant changes to the disclosures with respect to our critical accounting policies in our Annual Report on Form 10-K for the year endedDecember 31, 2021 . 35
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Results of Operations
Comparison of the Three and Nine Months Ended
Revenues
Revenues consist primarily of net product sales of our commercial products in theU.S. , supplemented by royalty revenues from our collaborative licensing arrangements. The following table provides information regarding our revenues during the three and nine months endedSeptember 30, 2022 and 2021 (dollars in thousands): Three Months Ended September 30, Change Nine Months Ended September 30, Change 2022 2021 Amount Percent 2022 2021 Amount Percent Net product sales Trokendi XR$ 69,599 $ 80,935 $ (11,336) (14)%$ 204,033 $ 231,531 $ (27,498) (12)% Oxtellar XR 30,528 29,728 800 3% 88,007 82,120 5,887 7% GOCOVRI 27,878 - 27,878 ** 75,179 - 75,179 ** Qelbree 18,326 2,370 15,956 ** 37,708 2,685 35,023 ** APOKYN 18,261 24,627 (6,366) (26)% 57,156 73,338 (16,182) (22)% Other(1) 8,132 7,872 260 3% 23,564 22,867 697 3% Total net product sales$ 172,724 $ 145,532 $ 27,192 19%$ 485,647 $ 412,541 $ 73,106 18% Royalty revenues 4,629 2,932 1,697 58% 14,263 8,184 6,079 74% Total revenues$ 177,353 $ 148,464 $ 28,889 19%$ 499,910 $ 420,725 $ 79,185 19%
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(1) Includes net product sales of MYOBLOC, XADAGO and Osmolex ER.
The$27.2 million and 19% increase in net product sales for the three months endedSeptember 30, 2022 , as compared to the same period in 2021, was primarily due to the inclusion of$27.9 million in net product sales of GOCOVRI, subsequent to the completion of the Adamas Acquisition inNovember 2021 , as well as a$16.0 million increase in net product sales of Qelbree, which was launched inMay 2021 . Partially offsetting this increase was a$11.3 million decrease in net product sales of Trokendi XR and a$6.4 million decrease in net product sales of APOKYN primarily attributable to the decline in unit demand due to competitive headwinds. The$73.1 million and 18% increase in net product sales for the nine months endedSeptember 30, 2022 , as compared to the same period in 2021, was primarily due to the inclusion of$75.2 million in net product sales of GOCOVRI, subsequent to the completion of the Adamas Acquisition inNovember 2021 , the increase of$5.9 million in net product sales of Oxtellar, as well as a$35.0 million increase in net product sales of Qelbree, which was launched inMay 2021 for pediatric patients and inMay 2022 for adult patients. Partially offsetting this increase was a$27.5 million decrease in net product sales of Trokendi XR and a$16.2 million decrease in net product sales of APOKYN primarily attributable to the decline in unit demand due to competitive headwinds.
Sales Deductions and Related Accruals
We record accrued product returns and accrued product rebates as current liabilities in Accrued product returns and rebates, on our condensed consolidated balance sheets. We record sales discounts as a reduction against Accounts receivable, net on the condensed consolidated balance sheets. Both amounts are generally affected by changes in gross product sales, changes in the provision for net product sales deductions, and the timing of payments/credits. 36
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The following table provides a summary of activity with respect to sales deductions and related accruals during the periods indicated (dollars in thousands): Accrued Product Returns and Rebates Reduction to Accounts Product Product Receivable for Returns Rebates Sales Discounts Total Balance at December 31, 2021$ 35,127 $ 97,597 $ 13,537$ 146,261
Provision
Provision for current year sales 13,846 321,860 55,693 391,399 Adjustments relating to prior year sales (3,225) 31 (3) (3,197) Total provision$ 10,621 $ 321,891 $ 55,690$ 388,202 Less: Actual payments/credits (6,440) (300,326) (56,447) (363,213) Balance at September 30, 2022$ 39,308 $ 119,162 $ 12,780$ 171,250 Balance at December 31, 2020$ 29,603 $ 96,589 $ 11,404$ 137,596
Provision
Provision for current year sales 9,945 275,352 51,472 336,769 Adjustments relating to prior year sales (1,525) 1,334 19 (172) Total provision$ 8,420 $ 276,686 $ 51,491$ 336,597 Less: Actual payments/credits (4,611) (274,639) (51,677) (330,927) Balance at September 30, 2021$ 33,412 $ 98,636 $ 11,218$ 143,266
Accrued Product Returns and Rebates Balances
The accrued product returns balance increased from$33.4 million as ofSeptember 30, 2021 to$39.3 million as ofSeptember 30, 2022 principally due to the timing of related return activity and an increase in provision for product returns primarily for Qelbree.
The accrued product rebates balance increased from
Provision for Product Returns and Rebates
The provision for product returns increased from$8.4 million for the nine month period endedSeptember 30, 2021 to$10.6 million for the nine month period endedSeptember 30, 2022 . The change was primarily attributable to an increase in volume of products sold with the launch of Qelbree for pediatric patients in the second quarter of 2021 and for adults in second quarter of 2022, partially offset by lower sales of Trokendi XR.
The provision for product rebates increased from
Royalty Revenues
Royalty revenues include a royalty from net product sales of Mydayis, a product ofTakeda Pharmaceuticals Company Ltd. , Namzaric royalties, and noncash royalty revenue pursuant to our agreement withHealthcare Royalty Partners III, L.P. (HC Royalty). HC Royalty receives royalty payments from United Therapeutics Corporation (United Therapeutics) based on net product sales of United Therapeutics' product Orenitram. Royalty revenues were$4.6 million and$2.9 million for the three months endedSeptember 30, 2022 and 2021, respectively. Royalty revenues were$14.3 million and$8.2 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The increase was primarily due to the Namzaric royalties for the three and nine months endedSeptember 30, 2022 . Namzaric royalty rights were acquired in connection with the Adamas Acquisition. 37
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Cost of Goods Sold
Cost of goods sold was$25.9 million and$18.1 million for the three months endedSeptember 30, 2022 and 2021, respectively. The increase was primarily due to higher Qelbree sales, offset by lower royalty expense compared to the same period in the prior year. Cost of goods sold was$64.3 million and$58.1 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The increase was primarily due to higher Qelbree sales, offset by lower royalty expense compared to the same period in the prior year. Royalty expense associated with the acquired commercial products, APOKYN and XADAGO, made up the majority of cost of goods sold. Royalty expense declined$2.4 million for the three months endedSeptember 30, 2022 and$5.7 million for the nine months endedSeptember 30, 2022 primarily due to the decline in APOKYN sales in 2022.
Research and Development Expenses
R&D expenses were$19.6 million and$19.7 million for the three months endedSeptember 30, 2022 and 2021, respectively. R&D expenses were$56.8 million and$69.4 million for the nine months endedSeptember 30, 2022 and 2021. The$12.6 million decrease for the nine months endedSeptember 30, 2022 was primarily due to the write-down of the$15.0 million investment inNavitor LLC which was attributable to a single in-process research and development (IPR&D) asset and recorded in R&D expense in the first quarter of 2021, offset by a$2.0 million increase in costs associated with regulatory activities mainly related to acquired products.
Selling, General and Administrative Expenses
The following table provides information regarding our selling, general and administrative (SG&A) expenses during the periods indicated (dollars in thousands): Three Months Ended September 30, Change Nine Months Ended September 30, Change 2022 2021 Amount Percent 2022 2021 Amount Percent Selling and marketing$ 85,704 $ 50,704 $ 35,000 69%$ 219,798 $ 137,531 $ 82,267 60% General and administrative 26,610 21,328 5,282 25% 83,451 65,493$ 17,958 27% Total$ 112,314 $ 72,032 $ 40,282 56%$ 303,249 $ 203,024 $ 100,225 49% Selling, general and administrative expenses increased by 56% to$112.3 million for the three months endedSeptember 30, 2022 . The increase was primarily due to increased marketing expenditures of approximately$30.5 million primarily for activities to support the launch of Qelbree to the adult population and the Qelbree direct-to-consumer campaign, which substantially occurred in the third quarter of 2022, as well as the acquired commercial products from Adamas Acquisition. In addition, general and administrative expenses increased$3.3 million due to higher professional and consulting costs and increased employee-related costs mainly to support IT and finance operations related to the ransomware incident, financial reporting and Adamas integration in 2022. Selling, general and administrative expenses increased by 49% to$303.2 million for the nine months endedSeptember 30, 2022 . The increase was primarily due to increased marketing expenditures of (i) approximately$46.1 million primarily for activities to support the launch of Qelbree to the adult population and the Qelbree direct-to-consumer campaign, which substantially occurred in the third quarter of 2022, as well as (ii) approximately$8.0 million related to the commercial products acquired from the Adamas Acquisition. In addition, general and administrative expenses increased$10.7 million due to higher professional and consulting costs and increased employee-related costs mainly to support IT and finance operations related to the ransomware incident, financial reporting and Adamas integration in 2022.
Amortization of Intangible Assets
Amortization of intangible assets was$20.6 million and$6.0 million for the three months endedSeptember 30, 2022 and 2021, respectively. Amortization of intangible assets was$61.9 million and$18.0 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The increase was due to amortization of the definite-lived intangible assets acquired in the Adamas Acquisition.
Contingent Consideration Expense (Gain)
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The change in fair value of the contingent consideration liabilities was an
expense of
The change in fair value of the contingent consideration liabilities was an expense of$1.9 million and a gain of$7.7 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The contingent consideration gain was primarily due to a reduction of the sales based contingent consideration liabilities associated with the USWM Acquisition recorded in the second quarter of 2021, offset by an increase in the estimated fair value of regulatory and developmental milestones due to the passage of time and the accretion to the payout amount related to the milestone achieved in the first quarter of 2022.
Other Income (Expense)
Other income (expense) was income of$1.1 million and an expense of$3.6 million for the three months endedSeptember 30, 2022 and 2021, respectively. The increase in other income was principally due to a decrease of$4.2 million in interest expense. The decrease in interest expense was primarily related to the Company's adoption of ASU 2020-06 onJanuary 1, 2022 . As a result of the adoption, the Company no longer records interest expense on the previously recorded discount for the embedded conversion feature on the 2023 Notes. Other income (expense) was income of$13.8 million and an expense of$8.8 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The increase in other income was primarily due to$12.9 million recognized in connection with the gain associated with theNavitor investment and a decrease in interest expense of$12.0 million primarily related to the Company's adoption of ASU 2020-06. Income Tax (Benefit) Expense Income tax benefit was$2.2 million and income tax expense was$7.4 million for the three months endedSeptember 30, 2022 and 2021, respectively. The decrease was mainly due to lower earnings before income taxes. The effective income tax rate was 493.9% and 25.5% for the three months endedSeptember 30, 2022 and 2021, respectively. The change in effective income tax rate was primarily due to larger excess tax benefits of stock-based awards in 2022. Income tax benefit was$9.6 million and income tax expense was$20.1 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The effective income tax rate was (37.6)% and 28.3% for the nine months endedSeptember 30, 2022 and 2021, respectively. The change in income tax (benefit) expense and effective income tax rate was primarily due to tax benefits associated with the Adamas legal entities reorganization in the first quarter of 2022.
Liquidity and Capital Resources
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 commercial launch of Qelbree and the future commercial launch of SPN-830 (apomorphine infusion device), if approved by the FDA; continued market and payor pressures for our commercial products; and the likely unfavorable impact of the upcoming loss of patent exclusivity for Trokendi XR inJanuary 2023 , or sooner under certain conditions. The Company believes its balances of cash, cash equivalents and unrestricted marketable securities, which totaled$523.7 million as ofSeptember 30, 2022 , along with cash generated from ongoing operations and continued access to debt markets, will be sufficient to satisfy its cash requirements over the next 12 months and beyond. We may, from time to time, consider raising additional capital through: new collaborative arrangements; strategic alliances; additional equity and/or debt financings; or financing from other sources, especially in conjunction with opportunistic business development initiatives. We will continue to actively manage our capital structure and to consider all financing opportunities that could strengthen our long-term financial profile. Any such capital raises may or may not be similar to transactions in which we have engaged in the past. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all. 39
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Financial Condition
Cash and cash equivalents, marketable securities, and long-term marketable securities as of the periods presented below, are as follows (dollars in thousands): September 30, December 31, Change 2022 2021 Amount Percent Cash and cash equivalents$ 111,492 $ 203,434 $ (91,942) (45)% Marketable securities 280,297 136,246 144,051 106% Long-term marketable securities 131,937 119,166 12,771 11% Total$ 523,726 $ 458,846 $ 64,880 14%
Total cash and cash equivalents, marketable securities and long-term marketable
securities increased by
As ofSeptember 30, 2022 andDecember 31, 2021 , the outstanding principal on our 0.625% Convertible Senior Notes Due 2023 (2023 Notes) was$402.5 million . No 2023 Notes have been converted as ofSeptember 30, 2022 . We have reclassified the debt from long-term to current liabilities on our Condensed Consolidated Balance Sheet, as the debt matures in less than twelve months as ofSeptember 30, 2022 . There were no changes to the separate convertible note hedge transactions (collectively, the Convertible Note Hedge Transactions) and separate warrant transactions (the Warrant Transactions). Refer to Part I, Item 1, Unaudited Condensed Financial Statements, Note 9, Convertible Senior Notes Due 2023, in the Notes to the Condensed Consolidated Financial Statements, for further discussion of the 2023 Notes and our other indebtedness.
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