☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes☒ No ☐

Indicate by check mark whether the registrant has submitted electronically ~~and posted on its corporate Web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit ~~and post~~ such files). Yes☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

This Quarterly Report on Form 10-Q contains forward‑looking statements relating to future events and our future performance 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. ~~Stockholders~~Readers are cautioned that such statements involve risks and uncertainties, including: We may not be able to successfully market Inbrija, Ampyra, or any other products that we may develop; our ability to attract and retain key management and other personnel, or maintain access to expert advisors; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures and take other actions which are necessary for us to continue as a going concern; risks related to the successful implementation of our business plan, including the accuracy of our key assumptions; risks related to our corporate restructurings, including our ability to outsource certain operations, realize expected cost savings and maintain the workforce needed for continued operations; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of Inbrija to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of Inbrija and Ampyra; third-party payers (including governmental agencies) may not reimburse for the use of Inbrija at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; reliance on collaborators and distributors to commercialize Inbrija and Ampyra outside the U.S.; our ability to satisfy our obligations to distributors and collaboration partners outside the U.S. relating to commercialization and supply of INBRIJA and AMPYRA; competition for Inbrija and Ampyra, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of Ampyra following our loss of patent exclusivity; the ability to realize the benefits anticipated from ~~the Biotie and Civitas transactions,~~acquisitions because, among other reasons, ~~because~~ acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the ability to successfully integrate Biotie’s operations into our operations; we may need to raise additional funds to finance our operations and may not be able to do so on acceptable terms; our ability to successfully market and sell Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S., which will likely be materially adversely affected by the March 2017 court decision in our litigation against filers of Abbreviated New Drug Applications to market generic versions of Ampyra in the U.S.; the risk of unfavorable results from future studies of Inbrija ~~(CVT-301, levodopa~~(levodopa inhalation powder)~~, tozadenant~~ or from ~~our~~ other research and development programs, or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market Inbrija, tozadenant, or any other products under development; third party payers (including governmental agencies) may not reimburse for the use of Ampyra, Inbrija or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the occurrence of adverse safety events with our products; ~~failure to maintain~~the outcome (by judgment or settlement) and costs of legal, administrative, or regulatory ~~approval of~~proceedings, investigations or ~~to successfully market Fampyra outside of the U.S. and our dependence on our collaborator Biogen in connection therewith; competition;~~inspections, including, without limitation, collective, representative or class-action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain ~~third party~~third-party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s beliefs and assumptions. All statements, other than statements of historical facts, included in this report regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed

in the forward-looking statements we make, and investors should not place undue reliance on these statements. In addition to the risks and uncertainties described above, we have included important factors in the cautionary statements included in this report and in our Annual Report on Form 10-K for the year ended December 31, ~~2016,~~2022, particularly in the “Risk Factors” section (as updated by the disclosures in our subsequent quarterly reports, including this report), that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments that we may make. Forward-looking statements in this report are made only as of the date hereof, and we ~~do not assume~~disclaim any intent or obligation to ~~publicly~~ update any forward-looking statements as a result of developments occurring after the date of this ~~report.~~report except as may be required by law.

We and our subsidiaries own several registered trademarks in the U.S. and in other countries. These registered trademarks include, in the U.S., the marks “Acorda Therapeutics,” our stylized Acorda Therapeutics logo, ~~“Biotie Therapies,~~“Inbrija,” “Ampyra,” ~~“Zanaflex,” “Zanaflex Capsules,” “Qutenza”~~ and “ARCUS.” Also, our ~~mark~~marks “Fampyra” ~~is a~~and “Inbrija” are registered ~~mark~~marks in the European Community Trademark Office and we have registrations or pending applications for ~~this mark~~these marks in other jurisdictions. Our trademark portfolio also includes several registered trademarks and pending trademark applications ~~(e.g., “Inbrija”)~~ in the U.S. and worldwide for potential product names or for disease awareness activities. Third party trademarks, trade names, and service marks used in this report are the property of their respective owners.


(In thousands, except per share data)	Three-month period ended September 30, 2017			Three-month period ended September 30, 2016			Nine-month period ended September 30, 2017			Nine-month period ended September 30, 2016			Three-month period ended June 30, 2023			Three-month period ended June 30, 2022			Six-month period ended June 30, 2023			Six-month period ended June 30, 2022
Revenues:
Net product revenues	$	134,357		$	128,508		$	379,705		$	359,350		$	25,965		$	27,484		$	44,684		$	46,059
Royalty revenues		4,444			4,841			13,391			12,831			3,687			3,567			7,215			7,526
License revenue		2,264			2,264			6,793			6,793
License revenues														23			—			34			—
Total net revenues		141,065			135,613			399,889			378,974			29,675			31,051			51,933			53,585
Costs and expenses:
Cost of sales		29,992			27,644			84,840			77,265			3,065			8,800			6,299			14,768
Cost of license revenue		159			159			476			476
Research and development		33,286			54,777			130,963			149,640			1,550			1,525			2,936			3,219
Selling, general and administrative		40,741			54,805			142,100			176,388			21,825			30,067			44,339			57,005
Asset impairment		39,446			—			39,446			—
Amortization of intangible assets														7,691			7,691			15,382			15,382
Change in fair value of derivative liability														—			(7	)		—			(37	)
Changes in fair value of acquired contingent consideration		(400	)		3,700			16,800			11,900			(824	)		(3,110	)		(1,915	)		(6,133	)
Total operating expenses		143,224			141,085			414,625			415,669			33,307			44,966			67,041			84,204
Operating loss		(2,159	)		(5,472	)		(14,736	)		(36,695	)		(3,632	)		(13,915	)		(15,108	)		(30,619	)
Other (expense) income, (net):
Other income (expense), net:
Interest and amortization of debt discount expense		(4,180	)		(4,404	)		(13,783	)		(12,161	)		(7,773	)		(7,474	)		(15,344	)		(15,036	)
Interest income		30			46			103			309			58			20			151			21
Other income														2			1,250			94			1,250
Realized loss on foreign currency transactions		(18	)		(179	)		(458	)		(1,674	)		(1	)		—			(1	)		—
Other income		—			—			—			10,026
Total other expense, (net)		(4,168	)		(4,537	)		(14,138	)		(3,500	)
Total other expense, net														(7,714	)		(6,204	)		(15,100	)		(13,765	)
Loss before taxes		(6,327	)		(10,009	)		(28,874	)		(40,195	)		(11,346	)		(20,119	)		(30,208	)		(44,384	)
(Provision for) benefit from income taxes		(18,868	)		(3,023	)		(23,421	)		7,686
Benefit from (provision for) income taxes														1,965			(26,563	)		4,003			(26,821	)
Net loss	$	(25,195	)	$	(13,032	)	$	(52,295	)	$	(32,509	)	$	(9,381	)	$	(46,682	)	$	(26,205	)	$	(71,205	)
Net loss attributable to non-controlling interest		—			307			—			985
Net loss attributable to Acorda Therapeutics, Inc.	$	(25,195	)	$	(12,725	)	$	(52,295	)	$	(31,524	)
Net loss per share attributable to Acorda Therapeutics, Inc. —basic and diluted	$	(0.55	)	$	(0.28	)	$	(1.14	)	$	(0.70	)
Weighted average common shares outstanding used in computing net loss per share attributable to Acorda Therapeutics, Inc.—basic and diluted		46,002			45,378			45,918			45,178

Net loss per share—basic													$	(7.55	)	$	(54.01	)	$	(21.10	)	$	(97.33	)
Net loss per share—diluted													$	(7.55	)	$	(54.01	)	$	(21.10	)	$	(97.33	)
Weighted average common shares outstanding used in computing net loss per share—basic														1,242			864			1,242			732
Weighted average common shares outstanding used in computing net loss per share—diluted														1,242			864			1,242			732

(3) Revenue

In May 2017, the FASB issued Accounting Standards Update 2017-09, “Compensation – Stock Compensation” (Topic 718): Scope of Modification Accounting (ASU 2017-09). This new standard provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. ASU 2017-09 allows for prospective application and is effective for fiscal years beginning after December 15, 2017, and interim periods therein with early adoption permitted for interim or annual periods. The Company is currently evaluating the impact adoption of this guidance may have on its consolidated financial statements.

~~(3) Acquisitions~~

~~Biotie Therapies Corp.~~

On April 18, 2016, the Company acquired a controlling interest in Biotie Therapies Corp. (“Biotie”) pursuant to a combination agreement entered into in January 2016. We believe that tozadenant, acquired through Biotie, and Inbrija (CVT-301, levodopa inhalation powder), our most advanced program, have the potential to position the Company as a leader in Parkinson’s disease therapy. In accordance with ~~the combination agreement,~~ASC 606, the Company ~~closed a public tender offer for all of Biotie’s capital stock, pursuant to which~~recognizes revenue when the Company acquired approximately 93% of the fully diluted capital stock of Biotie for a cash purchase price of approximately $350 million. On May 4, 2016, the Company acquired an additional approximately 4% of Biotie’s fully diluted capital stock pursuant to a subsequent public offer to Biotie stockholders that did not tender their shares in the initial tender offer. The purchase consideration for the subsequent tender offer was approximately $14.5 million. The acquisition of the additional 4% of Biotie’s fully diluted capital stock resulted in the Company owning approximately 97% of the fully diluted capital stock of Biotie (the “Acquisition”) as of June 30, 2016.

~~On September 30, 2016, the Company acquired the remaining approximately 3% of Biotie’s fully diluted capital stock in exchange for the payment~~customer obtains control of a ~~cash security deposit of approximately $13.5 million, as determined by~~promised good or service, in an amount that reflects the ~~Finnish arbitral tribunal administering redemption proceedings for the shares not tendered~~consideration to ~~the Company. Accordingly, the Company owned 100% of the fully diluted capital stock of Biotie as of September 30, 2016.~~

In the three-month period ended March 31, 2017, the Company received a refund of the cash security deposit of approximately $2.7 million following the final determination and payment of the redemption price for the shares subject to the redemption proceedings.

The Company estimated the fair value of the assets acquired and liabilities assumed as of the date of acquisition based on the information available at that time. The Company recorded its final measurement-period adjustments to the purchase price allocation from the acquisition date through April 18, 2017. During the six-month period ended June 30, 2017, the Company recorded final measurement period adjustments of approximately $6.4 million to its purchase price allocation with a corresponding offset to goodwill. The final measurement period adjustments included a reduction to current liabilities of approximately $3.8 million related to the repurchase of the Biotie convertible capital loans as the Company was able to determine the fair market value of these loans, a reduction to other long-term liabilities of approximately $2.7 million due to the finalization of the valuation of the Biotie non-convertible capital loans and an increase to deferred tax liabilities of approximately $0.2 million due to the finalization of the provisional amounts recorded for deferred tax liabilities.

~~The following table presents the final allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date of April 18, 2016:~~

(In thousands)

Preliminary
Allocation, as
adjusted through
December 31, 2016

Measurement
Period
Adjustments

Final
Allocation as of April 18, 2017

Cash and cash equivalents

$
73,854

$
—

$
73,854

Other current assets

1,878

—

1,878

Other long-term assets

4,962

—

4,962

Intangible assets (indefinite-lived)

260,500

—

260,500

Intangible assets (definite-lived)

65,000

—

65,000

Current liabilities

(18,572
)

3,837

(14,735
)
Deferred taxes

(89,908
)

(156
)

(90,064
)
Other long-term liabilities

(25,690
)

2,740

(22,950
)
Fair value of assets and liabilities acquired

272,024

6,421

278,445

Goodwill

103,876

(6,421
)

97,455

Total purchase price

375,900

—

375,900

Less: Noncontrolling interests

(25,736
)

—

(25,736
)
Purchase consideration on date of acquisition

$
350,164

$
—

$
350,164

The Company accounted for the Acquisition as a business combination using the acquisition method of accounting. Under the acquisition method of accounting, the total purchase price of the acquisition is allocated to the net tangible and identifiable intangible assets acquired and liabilities assumed based on their fair values as of the date of acquisition. The Company incurred approximately $18.6 million in acquisition related expenses to date. For the three-month period ended September 30, 2017, there were no acquisition related expenses incurred. For the nine-month period ended September 30, 2017, the Company incurred approximately $0.6 million in acquisition related expenses, all of which were expensed and included in selling, general and administrative expenses in the consolidated statements of operations. The results of Biotie’s operations have been included in the consolidated statements of operations from the acquisition date of April 18, 2016.

~~The definite-lived intangible asset will be amortized on a straight line basis over the period in~~ which the Company expects to ~~receive economic benefit and will~~ be ~~reviewed~~entitled in exchange for ~~impairment~~the good or service. ASC 606 requires entities to record a contract asset when ~~facts and circumstances indicate that~~a performance obligation has been satisfied or partially satisfied, but the ~~carrying value~~amount of consideration has not yet been received because the receipt of the ~~asset may not be recoverable.~~consideration is conditioned on something other than the passage of time. ASC 606 also requires an entity to present a revenue contract as a contract liability in instances when a customer pays consideration, or an entity has a right to an amount of consideration that is unconditional (e.g., receivable), before the entity transfers a good or service to the customer.

~~The fair value~~As of June 30, 2023, the Company had contract liabilities of $8.2 million, as compared to $6.2 million as of June 30, 2022, which are comprised of the ~~indefinite lived intangible assets were capitalized as of~~upfront payments received under the acquisition date and subsequently accounted for as indefinite-lived intangible assets until disposition of the assets or completion or abandonment of the associated research and development efforts. Accordingly, during the development period these assets will not be amortized into earnings; rather, these assets will be subject to periodic impairment testing. Upon successful completion of the development efforts, the useful lives of the indefinite lived intangible assets will be determined and the assets will be considered definite-lived intangible assets and amortized over their expected useful lives.

Goodwill is calculated as the excess of the purchase price and the noncontrolling interest over the estimated fair value of the assets acquired and liabilities assumed. The goodwill recorded is primarily related to establishing a deferred tax liability for the indefinite lived intangible assets which have no tax basis and, therefore, will not result in a future tax deduction. None of the goodwill is deductible for tax purposes.

~~Goodwill~~

~~Changes in the carrying amount of goodwill were as follows:~~

(In thousands)

Balance at December 31, 2016

$
280,599

Decrease to goodwill for measurement period adjustments

(6,421
)
Foreign currency translation adjustment

11,139

Balance at September 30, 2017

$
285,317

~~(4) Preferred Stock~~

~~Stockholder Rights Plan~~

On August 31, 2017, the Board of Directors of the Company adopted a stockholder rights plan (Rights Plan) to preserve the ability of the Board to protect the interests of stockholders in transactions that may result in an acquisition of control of the Company, including tender offers and open market purchasesterms of the Company’s ~~securities. In general terms,~~supply and distribution

agreements with Hangzhou Chance Pharmaceuticals Co., Ltd. (“Chance”) and Esteve Pharmaceuticals GmbH (“Esteve Germany”) related to the ~~Rights Plan works by significantly diluting the stock ownership~~commercialization of ~~any person or group that acquires 15% or more~~Inbrija in China and Germany, respectively. As of June 30, 2023, approximately $0.5 million of the ~~outstanding common stock of the Company without the approval of the Board (such person, an Acquiring Person).~~

~~Under the Rights Plan, o~~n August 31, 2017, the Board authorized and declared a dividend of one preferred share purchase right (Right) for each outstanding share of common stock, par value $0.001 per share, of the Company. The dividend was payablecontract liability balance is expected to ~~the stockholders of record on September 11, 2017 (Record Date). Each Right, when it becomes exercisable, entitles the registered holder to purchase~~be recognized as revenue from the ~~Company one one-thousandth of a share of Series A Junior Participating Preferred Stock, par value $0.001 per share, of~~remaining performance obligations over the Company at a price of $110 per one one-thousandth of a Preferred Share, subject to adjustment. As of September 30, 2017, there were 1,000,000 preferred shares authorized and no such shares issued and outstanding. In addition, one Right will automatically attach to each Common Share that becomes outstanding between the Record Date and the earliest of the Distribution Date, the redemption of the Rights or the expiration of the Rights. The Distribution Date is the close of business on the tenth day after the first date of public announcement that any person has become an Acquiring Person or such earlier date as a majority of the Board becomes aware of the existence of an Acquiring Person. Until a Right is exercised, the holder thereof, will have no rights as a stockholder of the Company, including, without limitation, the right to vote or to receive dividends. The Rights are not exercisable until the Distribution Date. The Rights will expire at the close of business on August 31, 2018, unless earlier redeemed or exchanged by the Company.

~~(5) Corporate Restructuring~~

~~On April 5, 2017, the Company announced a corporate restructuring to reduce its cost structure and focus its resources on its two late-stage programs, Inbrija and tozadenant.~~

~~The adoption of this restructuring plan followed the previously-announced decision by the United States District Court~~next 12 months for the ~~District of Delaware invalidating certain patents pertaining to Ampyra. Under this ruling, Acorda~~Esteve Germany agreement as goods are shipped. The Company expects to ~~maintain exclusivity to Ampyra through July 2018, depending on~~recognize the ~~outcome of~~remaining balance over the ~~appeal of~~next 9 years. The Company will re-evaluate the ~~Court’s decision.~~transaction price in each reporting period and as certain events are resolved or other changes in circumstances occur.

~~As part of this restructuring,~~The Company did not recognize any revenues during the ~~Company reduced headcount by approximately 20%. The majority of the reduction in personnel was completed in the three-month~~ period ended June 30, ~~2017.~~ 2023 from its distribution agreement with Chance.

The ~~Company estimates that during 2017 it will incur approximately $8.0 million~~following table disaggregates the Company’s revenue by major source. The Company’s Royalty Revenue set forth below relates to Fampyra royalties payable under the Company’s License and Collaboration Agreement with Biogen and the royalties payable from Neurelis Inc. for sales of ~~pre-tax charges for severance and employee separation related costs related to the restructuring.~~

In the three-month period ended September 30, 2017, the Company incurred approximately $0.03 million in pre-tax severance and employee separation related costs associated with the restructuring. In the nine-month period ended September 30, 2017, the Company incurred pre-tax severance and employee separation related expenses of approximately $7.6 million associated with the restructuring. The pre-tax charges incurred include a cash component of approximately $6.7 million

representing employee charges for severance payments and benefits and a non-cash component of approximately $0.9 million representing stock compensation charges. Of the pre-tax severance and employee separation related expenses incurred, $5.6 million was recorded in research and development expenses and $2.0 million was recorded in selling, general and administrative expenses.~~The majority of the restructuring costs are~~Valtoco which is expected to ~~be paid by~~wind down in the ~~end~~third quarter of ~~2017.~~2023.

~~A summary of the restructuring charges for the three- and nine-month periods ended September 30, 2017 is as follows:~~


(In thousands)	Three-month period ended June 30, 2023		Three-month period ended June 30, 2022		Six-month period ended June 30, 2023		Six-month period ended June 30, 2022
Revenues:
Net product revenues:
Ampyra	$	16,913	$	18,178	$	29,519	$	33,082
Inbrija		8,285		7,437		13,872		11,108
Inbrija ex-U.S.		767		1,868		1,293		1,868
Total net product revenues		25,965		27,484		44,684		46,059
Royalty revenues		3,687		3,567		7,215		7,526
License Revenue		23		—		34		—
Total net revenues	$	29,675	$	31,051	$	51,933	$	53,585

(4) Share-Based Compensation

Severance and

Other Employee

(In thousands)

Costs

Other Costs

Total

Q2 Restructuring costs

$
7,515

$
75

$
7,590

Q2 Payments

(6,166
)

(75
)

(6,241
)
Q3 Restructuring costs

29

5

34

Q3 Payments

(458
)

(5
)

(463
)
Restructuring Liability as of September 30, 2017

$
920

$
—

$
920

~~(6) Share-based Compensation~~

During the three‑month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016,~~2022, the Company recognized share-based compensation expense of ~~$6.7~~$0.1 million and ~~$10.0~~$0.5 million, respectively. During the ~~nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016,~~2022, the Company recognized share-based compensation expense of ~~$26.2~~$0.2 million and ~~$27.4~~$1.0 million, respectively. Activity in options and restricted stock during the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 and related balances outstanding as of that date are reflected below. The weighted average fair value per share of options granted to employees for the three-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022 were approximately ~~$9.46~~$10.35 and ~~$11.21,~~$11.55, respectively. The weighted average fair value per share of options granted to employees for the ~~nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022 were approximately ~~$10.68~~$9.86 and ~~$13.65,~~$17.05, respectively.

The following table summarizes share-based compensation expense included within the Company’s consolidated statements of operations:

For the three-month
period ended September 30,

For the nine-month
period ended September 30,

(In millions)

2017

2016

2017

2016

Research and development

$
2.0

$
2.9

$
8.4

$
7.7

Selling, general and administrative

4.7

7.1

17.8

19.7

Total

$
6.7

$
10.0

$
26.2

$
27.4


	For the three-month period ended June 30,				For the six-month period ended June 30,
(In thousands)	2023		2022		2023		2022
Research and development expense	$	4	$	25	$	5	$	52
Selling, general and administrative expense		124		446		195		903
Cost of Sales		—		—		—		1
Total	$	128	$	471	$	200	$	956

A summary of share-based compensation activity for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 is presented below:

Stock Option Activity

Number of
Shares
(In thousands)

Weighted
Average
Exercise
Price

Weighted
Average
Remaining
Contractual
Term

Intrinsic
Value
(In thousands)

Balance at January 1, 2017

9,072

$
31.11

Granted

1,619

20.29

Cancelled

(671
)

31.35

Exercised

(332
)

21.11

Balance at September 30, 2017

9,688

$
29.63

5.9

$
10,026

Vested and expected to vest at
September 30, 2017

9,547

$
29.76

5.8

$
9,327

Vested and exercisable at
September 30, 2017

7,010

$
30.35

4.8

$
4,503


	Number of Shares (In thousands)			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term		Intrinsic Value (In thousands)
Balance at January 1, 2023		52		$	1,571.06		—		—
Granted		61			12.32		—		—
Cancelled		(5	)		2,809.49		—		—
Exercised		—			—		—		—
Balance at June 30, 2023		108		$	617.70		7.9	$	57,580
Vested and expected to vest at June 30, 2023		106		$	623.96		7.9	$	56,855
Vested and exercisable at June 30, 2023		715		$	1,484.71		5.5	$	16,922

~~Restricted Stock and Performance Stock Unit Activity~~

~~(In thousands)~~
~~Restricted Stock and Performance Stock Units~~	~~Number of Shares~~
~~Nonvested at January 1, 2017~~		~~625~~
~~Granted~~		~~542~~
~~Vested~~		~~(51~~	)
~~Forfeited~~		~~(183~~	)
~~Nonvested at September 30, 2017~~		~~933~~

Unrecognized compensation cost for unvested stock options, restricted stock awards, and ~~performance~~restricted stock units as of ~~September~~June 30, ~~2017~~2023 totaled ~~$42.1~~$0.7 million and is expected to be recognized over a weighted average period of approximately ~~2.9~~1.6 years.

~~(7)~~During the six‑month period ended June 30, 2023, the Company did not make any repurchases of shares.

(5) Loss Per Share

The following table sets forth the computation of basic and diluted loss per share for the three- and ~~nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016:~~2022:


(In thousands, except per share data)	Three-month period ended September 30, 2017			Three-month period ended September 30, 2016			Nine-month period ended September 30, 2017			Nine-month period ended September 30, 2016			Three-month period ended June 30, 2023			Three-month period ended June 30, 2022			Six-month period ended June 30, 2023			Six-month period ended June 30, 2022
Basic and diluted
Net loss	$	(25,195	)	$	(12,725	)	$	(52,295	)	$	(31,524	)
Net loss—basic													$	(9,381	)	$	(46,682	)	$	(26,205	)	$	(71,205	)
Net income (loss)—diluted													$	(9,381	)	$	(46,682	)	$	(26,205	)	$	(71,205	)

Weighted average common shares outstanding used in computing net loss per share—basic		46,002			45,378			45,918			45,178			1,242			864			1,242			732
Plus: net effect of dilutive stock options and restricted common shares		—			—			—			—			—			—			—			—
Weighted average common shares outstanding used in computing net loss per share—diluted		46,002			45,378			45,918			45,178			1,242			864			1,242			732
Net loss per share—basic	$	(0.55	)	$	(0.28	)	$	(1.14	)	$	(0.70	)	$	(7.55	)	$	(54.01	)	$	(21.10	)	$	(97.33	)
Net loss per share—diluted	$	(0.55	)	$	(0.28	)	$	(1.14	)	$	(0.70	)	$	(7.55	)	$	(54.01	)	$	(21.10	)	$	(97.33	)

Securities that could potentially be dilutive are excluded from the computation of diluted ~~earnings~~loss per share when a loss from continuing operations exists or when the exercise price exceeds the average closing price of the Company’s common stock during the period, because their inclusion would result in an anti-dilutive effect on per share amounts.

The following amounts were not included in the calculation of net loss per diluted share because their effects were anti-dilutive:


(In thousands)	Three-month period ended September 30, 2017		Three-month period ended September 30, 2016		Nine-month period ended September 30, 2017		Nine-month period ended September 30, 2016		Three-month period ended June 30, 2023		Three-month period ended June 30, 2022		Six-month period ended June 30, 2023		Six-month period ended June 30, 2022
Denominator
Stock options and restricted common shares		9,147		8,278		9,232		7,821		100		59		100		59
Convertible note – Saints Capital		—		10		—		10

Performance share units are excluded from the calculation of net loss per diluted share as the performance criteria has not been met for the three- and six-month periods ended June 30, 2023 and 2022. Additionally, the impact of the ~~convertible debt and the impact of the convertible capital loan assumed from Biotie were~~2024 Notes was determined to be anti-dilutive and excluded from the calculation of net loss per diluted share for the ~~three~~three- and ~~nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016.~~2022.

~~(8)~~(6) Income Taxes

The Company’s effective income tax rate differs from the U.S. statutory rate ~~principally~~primarily due to state taxes, Federal research and development tax credits, jurisdictions with pretax losses for which no tax benefit can be recognized and the effects of share based compensation which are recorded discretelyan increase in the ~~quarters in which they occur.~~valuation allowance and expense recorded on the equity forfeiture.

For the three-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016,~~2022, the Company recorded a ~~$18.9~~benefit of $2.0 million and ~~$3.0~~a provision of ($26.6) million ~~provision~~ for income taxes, respectively. The effective income tax rates for the Company for the three-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022 were ~~-298.2%~~17.3% and ~~-30.2%~~(132.0%), respectively. The ~~variance~~variances in the effective tax rates for the three-month period ended ~~September~~June 30, ~~2017~~2023, as compared to the three-month period ended ~~September~~June 30, ~~2016~~2022, was primarily due ~~primarily~~ to an increase in the existing valuation allowance recorded on ~~jurisdictions with Biotie pretax losses~~the Company’s deferred tax assets for which no tax benefit can be recognized, ~~state taxes,~~ as a result of the ~~tax implications of costs related to the Biotie transaction, the reduction~~deemed ownership that occurred in the ~~research & development~~prior year under IRS Section 382 which required a valuation allowance to be recorded on the Company’s tax ~~credit~~attributes and the ~~absence~~forfeitures of ~~orphan drug development in 2017~~. equity of which no tax deduction is recorded.

For the ~~nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016,~~2022, the Company recorded a ~~$23.4~~benefit of $4.0 million and a provision ~~for and $7.7~~of ($26.8) million ~~benefit from~~for income taxes, respectively. The effective income tax rates for the Company for the ~~nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022 were ~~-81.1%~~13.3% and ~~19.1%~~(60.4%), respectively. The ~~variance~~variances in the effective tax rates for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023, as compared to the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2016~~2022, was primarily due ~~primarily~~ to an increase in the existing valuation allowance recorded on ~~jurisdictions with Biotie pretax losses~~the Company’s deferred tax assets for which no tax benefit can be recognized, as a result of the ~~tax implications of costs related to the Biotie transaction, the reduction~~deemed ownership that occurred in the ~~research & development~~prior year under IRS Section 382 which required a valuation allowance to be recorded on the Company’s tax ~~credit~~attributes and the ~~absence~~forfeitures of ~~orphan drug development in 2017.~~equity of which no tax deduction is recorded.

The Company continues to evaluate the realizability of its deferred tax assets ~~and liabilities~~ on a quarterly basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits, and the regulatory approval of products ~~currently~~ under development. Any changes to the valuation allowance or deferred tax assets and liabilities in the future would impact the ~~Company's~~Company’s income taxes.

The ~~Internal Revenue Service commenced an examination of the Company’s US income tax return for 2015~~Company has ongoing state examinations in ~~the third quarter of 2017.~~Massachusetts which cover multiple years. There have been no proposed adjustments at this stage of the examination. The New Jersey examination was finalized during the first quarter of 2023 for tax years 2015 through 2018 with no adjustments.

The following table presents additional information about liabilities measured at fair value on a recurring basis and for which the Company utilizes Level 3 inputs to determine fair value.

The Company estimates the fair value of its acquired contingent consideration using a probability weighted discounted cash flow valuation approach based on estimated future sales expected from Inbrija~~(CVT-301, levodopa~~ (levodopa inhalation powder), a ~~potential new~~U.S. Food and Drug Administration (“FDA”) approved drug ~~candidate~~ for the treatment of OFF periods ofin Parkinson’s ~~disease and CVT-427, a Phase I candidate. CVT-427 is an inhaled triptan intended for acute treatment of migraine using the ARCUS delivery system.~~disease. Using this approach, expected future cash flows are calculated over the expected life of the agreement ~~are~~and discounted ~~and then exercise scenario probabilities are applied.~~to estimate the current value of the liability at the period end date. Some of the more significant assumptions made in the valuation include (i) the estimated revenue forecast for Inbrija, and ~~CVT-427 revenue forecasts,~~ (ii) ~~probabilities of success, and (iii)~~ discount ~~periods~~period and rate. The ~~probability of achievement of revenue milestones~~milestone payments ranged from ~~26.3%~~$0 million to ~~85% with milestone payment outcomes ranging from $0 to $62~~$15 million for Inbrija. The discount rate used in the ~~aggregate~~valuation was 22% for ~~Inbrija~~the three- and ~~CVT-427.~~six-month periods ended June 30, 2023 and 2022. The valuation is performed ~~quarterly. Gains~~quarterly and ~~losses~~changes in the fair value of the contingent consideration are included in the statement of operations. For the ~~three- and nine-month~~six-month periods ended ~~September~~June 30, ~~2017,~~2023 and 2022, changes in the fair value of the acquired contingent consideration were primarily due to change in projected revenue and the ~~re-calculation~~recalculation of cash flows for the passage of ~~time and updates to certain other estimated assumptions.~~time.

The acquired contingent consideration is classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the various inputs to the valuation approach, including but not limited to, assumptions involving ~~probability adjusted~~ sales estimates for Inbrija ~~and CVT-427~~ and estimated discount rates, the estimated fair value could be significantly higher or lower than the fair value determined.

During 2019, a derivative liability was initially recorded as a result of the issuance of the 2024 Notes (See Note 10 to the Consolidated Financial Statements included in this report for more information on the 2024 Notes). The fair value measurement of the derivative liability is classified as Level 3 under the fair value hierarchy as it has been valued using certain unobservable inputs. These inputs include: (1) share price as of the valuation date, (2) assumed timing of conversion of the 2024 Notes, (3) historical volatility of the share price, and ~~Recorded~~(4) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases or decreases in any of those inputs in isolation could result in a significantly lower or higher fair value measurement. The fair value of the derivative liability was determined using a binomial model that calculates the fair value of the 2024 Notes with the conversion feature as compared to the fair value of the 2024 Notes without the conversion feature, with the difference representing the value of the conversion feature, or the derivative liability. There are several embedded features within the 2024 Notes that did not meet the conditions for equity classification at ~~Fair Value on~~the time of issuance. As a ~~Nonrecurring Basis~~

result, these features were aggregated and recorded as a derivative liability conversion option. The ~~Company’s non-financial assets, such as intangible assets are recorded~~derivative liability conversion feature is measured at fair value ~~if an impairment charge is recognized.~~ on a quarterly basis and changes in the fair value will be recorded in the consolidated statement of operations.

The Company ~~reviewed for impairment,~~received stockholder approval on August 28, 2020 to increase the ~~intangible asset for Selincro based on a downward revision~~number of authorized shares of the Company’s common stock from 13,333,333 shares to ~~the projected royalty revenue the Company expects to receive from its licensee.~~61,666,666 shares. As a result of the ~~review,~~share approval, the Company determined that multiple embedded conversion options met the ~~carrying value~~conditions for equity classification. The Company performed a valuation of these conversion options as of September 17, 2020, which was the ~~intangible asset was greater than~~date the ~~estimated~~Company completed certain securities registration obligations. The resulting fair value of these conversion options was calculated to be $18.3 million which was reclassified to equity and presented in the ~~intangible asset.~~ statement of stockholder’s equity as of September 30, 2020 net of the $4.4 million tax impact. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The Company performed a valuation of the derivative liability related to certain embedded conversion features that are precluded from equity classification. The fair value of ~~the intangible asset for Selincro~~these conversion features was ~~determined using a discounted cash flow valuation approach which is based on application~~calculated to be negligible as of ~~the double digit contracted royalty rate to the estimated projected sales of Selincro by the licensee. The significant assumptions~~June 30, 2023. Key inputs used in the ~~valuation~~calculation of the fair value include ~~the estimated projected sales of Selincro by the licensee, the discount period over which the Company expects to receive royalties~~stock price, volatility, risky (bond) rate, and the discount rate which is derived from the Company’s weighted average cost of capital. The fair value of the intangible asset for Selincro is classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market.

~~The table below presents the non-financial assets that were measured and recorded at fair value on a nonrecurring basis and the total impairment losses recorded~~last observed bond price during the ~~three-month~~six-month period ended ~~September~~June 30, ~~2017.~~ 2023.

(13) Subsequent Events

Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the ~~Credit Agreement~~Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were ~~written off.~~issued, and determined there were no subsequent events that required disclosure or adjustment in these financial statements except for the following disclosure:

~~Convertible Capital Loans~~

Sublease of the Waltham Facility

In ~~the three-month period ended March 31, 2017,~~July 2023, the Company ~~paid~~sublet to a third party approximately ~~$1.7 million (€1.5 million) to repurchase~~13,000 square feet (roughly half) of its lab space at the ~~outstanding principal amount of these loans. In April 2017,~~Waltham, Massachusetts location. The sublease commenced on August 1, 2023, and will last for the Company paid approximately $0.2 million (€0.2 million) to repurchase the outstanding principal amount of the last outstanding loan. There were no convertible capital loans outstanding as of June 30, 2017.

~~(12) Commitments and Contingencies~~

~~A summary~~remainder of the Company’s commitments and contingencies was included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. The Company’s long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business.lease agreement through 2026.

The Company is currently party to various legal proceedings which are principally patent litigation matters. The Company has assessed such legal proceedings and does not believe that it is probable that a liability has been incurred or that the amount of any potential liability or range of losses can be reasonably estimated. As a result, the Company did not record any loss contingencies for any of these matters. Litigation expenses are expensed as incurred.

Item 2. Management’s ~~Discussi~~onDiscussion and Analysis ofof Financial Condition and Results of Operations

The following discussion and analysis of our consolidated financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and related notes included in this Quarterly Report on Form ~~10-Q.~~10-Q and with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the SEC on March 15, 2023. In addition, you should read the “Risk Factors” and the disclaimers regarding forward-looking statements included in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2022 for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Background

We are a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders. We market ~~three FDA-approved therapies, including~~Inbrija (levodopa inhalation powder), which is approved in the U.S. for intermittent treatment of OFF episodes, also known as OFF periods, in people with Parkinson’s disease treated with carbidopa/levodopa. Inbrija is for as needed use and utilizes our ARCUS pulmonary delivery system, a technology platform designed to deliver medication through inhalation that we believe has potential to be used in the development of a variety of inhaled medicines. We also market branded Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S. as treatment to improve walking in patients with multiple sclerosis, or MS.

Our Products

Inbrija/Parkinson’s Disease

Inbrija is the first and only inhaled levodopa, or L-dopa, for intermittent treatment of OFF episodes, also known as OFF periods, in people with Parkinson’s disease treated with carbidopa/levodopa regimen. Approximately one million people in the U.S. and 1.2 million people in Europe are diagnosed with Parkinson’s; it is estimated that approximately 40% of people with Parkinson’s in the U.S. experience OFF periods. The U.S. Food and Drug Administration (“FDA”) approval of Inbrija is for a single dose of 84 mg (administered as two capsules), which may be taken up to five times per day. U.S. net revenue for Inbrija was $8.3 million for the quarter ended June 30, 2023 and $7.4 million for the quarter ended June 30, 2022.

Inbrija is also approved for use in the European Union (“EU”). The European Medicines Agency approved Inbrija dose is 66 mg (administered as two capsules) up to five times per day (per EU convention, this reflects emitted dose and is equivalent to the 84 mg labelled dose in the U.S.). Under the EU approval, Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor. We have entered into agreements to commercialize Inbrija in Spain, Germany, Latin America, and China, and we are in discussions with potential partners for commercialization of Inbrija in other jurisdictions outside of the U.S. Net revenues for ex-U.S. Inbrija sales were $0.8 million for the quarter ended June 30, 2023.

Inbrija utilizes our ARCUS platform for inhaled therapeutics. Because of our limited financial resources, we previously suspended work on ARCUS and other proprietary research and development programs. However, we are discussing potential collaborations with other companies that have expressed interest in formulating their novel molecules for pulmonary delivery using ARCUS, and we have performed feasibility studies for a number of these opportunities.

Ampyra/MS

Ampyra is an extended-release tablet formulation of dalfampridine approved by the FDA as a treatment to improve walking in patients with multiple sclerosis, or ~~MS, as demonstrated by an increase in walking speed. We have a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease and~~ MS. We have two late-stage programs in Parkinson’s disease, including Inbrija (the proposed brand name for CVT-301, levodopa inhalation powder), our most advanced program, as well as our tozadenant program, which we acquired with Biotie Therapies Corp. in 2016. We believe that these programs, which are further described below, have the potential to position Acorda as a leader in Parkinson’s disease therapy.

We currently derive substantially all our revenue from the sale of Ampyra. In March 2017, we announced a decision by the United States District Court for the District of Delaware in litigation with certain generic drug manufacturers u~~pholding our~~ Ampyra Orange Book-listed patent set to expire on July 30, 2018, but invalidating our four other Orange Book-listed patents pertaining to Ampyra that were set to expire between 2025 and 2027. Under this decision, we expect to maintain patent exclusivity with respect to Ampyra at least through July 30, 2018, depending on the outcome of appeal of the District Court’s decision. ~~The other parties to the lawsuit with whom we have not reached settlement have appealed the District Court’s decision upholding the patent that expires in July 2018, and~~ we have appealed the ruling on the four invalidated patents. We expect the appeals process to take approximately 12 to 18 months from the filing of the appeal in May 2017. In August 2017, we filed our opening brief to the United States Court of Appeals for the Federal Circuit. Both the Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) filed amicus briefs in support of our appeal. The defendants have now filed their opposition and opening cross-appeal brief. We expect reply briefs to be filed in November 2017, followed by oral argument to be scheduled by the appellate court. We expect to experience a rapid and significant decline in Ampyra sales beyond July 2018 duebecame subject to competition from generic versions of Ampyra that may be marketed after the expiration of our remaining Ampyra patent, unless the District Court’s decision on the four invalidated patents is overturned on appeal, which could include reversal or remand by the appeals court back to the District Court.

~~In April 2017, following the District Court’s decision, we implemented a corporate restructuring to reduce our cost structure and focus our resources on our two~~starting in late ~~stage Parkinson’s disease programs, Inbrija and tozadenant,~~2018 as ~~well as on maximizing Ampyra value. As part of this restructuring, we reduced headcount by approximately 20%. The majority of the reduction was completed in April 2017. As~~ a result ~~we expect~~of an adverse court ruling that invalidated certain Ampyra Orange Book-listed patents. We have experienced a significant decline in Ampyra sales due to ~~realize annualized cost savings~~competition from ~~the reduction~~several generic versions of ~~personnel~~Ampyra. Additional manufacturers may market generic versions of ~~approximately $21.0 million beginning in the second quarter of 2017.~~

We believe that our Inbrija and tozadenant programs, if approved, will serve as the foundation for Acorda’s future value. In June 2017, we submitted a New Drug Application, or NDA, for Inbrija to the FDA. In August 2017, we announced that we received a Refusal to File (RTF) letter from the FDA regarding the Inbrija NDA. Upon its preliminary review, the FDA determined that the NDA was not sufficiently complete to permit a substantive review. The FDA specified two reasons for the RTF: First, the date when the manufacturing site would be ready for inspection; and second, a question regarding the submission of the drug master production record. The FDA also requested additional information at resubmission, which was not part of the basis for the RTF. Subsequently, in September 2017, we announced that we have engaged in a constructive dialogue with the FDA to determine the most efficient path forward to resubmitting the Inbrija NDA. We believe the issues raised in the RTF are addressable,Ampyra, and we expect our Ampyra sales will continue to resubmit the NDA in the fourth quarter of 2017. Based on current guidelines, we would expect the FDA to notify us within 74 days of the submission date regarding whether the submission has been deemed complete and is accepted for full review. The FDA has not requested or recommended additional clinical efficacy or safety studies. O~~ur other top priorities through early 2018 are to:~~

~~Submit a Marketing Authorization Application, or MAA, for Inbrija in the EU in the first quarter of 2018.~~ ~~We have revised the timing of our submission of the MAA given our team’s focus on the NDA resubmission.~~

~~Continue with preparations for commercialization and launch of Inbrija in the~~decline over time. U.S.

~~Complete the ongoing Phase 3 efficacy clinical trial of tozadenant, with topline results expected in the first quarter of 2018.~~

~~Maximize Ampyra value.~~

Our current strategic priorities also include our ongoing discussions with potential partners regarding Inbrija outside of the U.S., including the EU and certain other countries. We are also pursuing other business development initiatives, including monetization of existing royalty streams for Fampyra and Selincro, further described below, and exploring partnering and out-licensing opportunities for some of our early-stage programs.

As of September 30, 2017, we had cash and cash equivalents of approximately $192.5 million and expect to be cash flow positive for 2017 with a projected year end cash balance in excess of $200 million. We expect a similar year-end 2018 cash balance based on our current internal assumptions for 2018 Ampyra revenue. We have $345 million of convertible senior notes due in 2021 with a conversion price of $42.56.

~~We believe that operating expense reductions from the restructuring will enable us to fund operations through key milestones for our late-stage development programs, including the launch of~~ ~~Inbrija~~ in the U.S., pending resubmission of the NDA and approval from the FDA, and obtaining topline data from the ongoing tozadenant Phase 3 efficacy trial in the first quarter of 2018. Importantly, we have kept our commercial team intact despite the restructuring. Our sales force and commercial organization have proved highly effective in the commercialization of Ampyra and, pending FDA approvals, we expect them to be major assets in commercializing Inbrija and tozadenant.

~~Biotie Acquisition~~

In 2016, we acquired Biotie Therapies Corp. pursuant to a combination agreement with Biotie for a purchase price of approximately $376 million. As a result of the acquisition, we have obtained worldwide rights to tozadenant, an oral adenosine A2a receptor antagonist currently in Phase 3 development as an adjunctive treatment to levodopa in Parkinson's disease patients to reduce OFF time. We believe that this late stage program, together with Inbrija, our other late stage program, have the potential to position Acorda as a leader in Parkinson’s disease therapy. Further expanding our pipeline, we also obtained global rights to SYN120, an oral, 5-HT6/5-HT2A dual receptor antagonist in Phase 2 development with support from the Michael J. Fox Foundation for Parkinson’s-related dementia. Biotie is also developing BTT1023, a product candidate for the orphan disease Primary Sclerosing Cholangitis, or PSC, a chronic and progressive liver disease for which there is no FDA-approved treatment.

Also, Biotie receives double digit royalties from sales of Selincro, a European Medicines Agency (EMA)-approved orally administered therapy for alcohol dependence therapy. Selincro has been introduced across Europe by Biotie's partner, H. Lundbeck A/S, a Danish pharmaceutical company specializing in central nervous system products. Selincro is not approved for use in the U.S. and is not under development for use in the U.S.

~~Ampyra~~

~~General~~

Ampyra was approved by the FDA in January 2010 to improve walking in people with MS. To our knowledge, Ampyra is the first and only drug approved for this indication. Efficacy was shown in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). Ampyra was made commercially available in the United States in March 2010. Net net revenue for Ampyra was ~~$132.6~~$16.9 million for the ~~three months~~quarter ended ~~September~~June 30, ~~2017~~2023 and ~~$128.8~~$18.2 million for the ~~three months~~quarter ended ~~September~~June 30, ~~2016.~~2022.

Since the March 2010 launch of Ampyra, approximately 124,000 people with MS in the U.S. have tried Ampyra. We believe that Ampyra is increasingly considered by many physicians a standard of care to improve walking in people with MS. Seven years after approval, Ampyra continues to grow, reflecting the continued unmet medical need among people with MS for a treatment to improve walking. As of September 30, 2017, approximately 70% of all people with MS who were prescribed Ampyra received a first refill, and approximately 40% of all people with MS who were prescribed Ampyra have been dispensed at least six months of the medicine through refills, consistent with previously reported trends. These refill rates exclude patients who started Ampyra through our 60-day free trial program. Our 60-day free trial program provides eligible patients with two months of Ampyra at no cost. During the first three quarters of 2017, on average, approximately22

80% of new Ampyra patients enrolled in the 60-day free trial. The program is in its sixth year, and data show that 60-day free trial participants have higher compliance and persistency rates over time compared to patients not in the program. Approximately 50% of patients who initiate therapy with the 60-day free trial program convert to paid prescriptions.

Ampyra is marketed in the U.S. through our own specialty sales force and commercial infrastructure. We currently have approximately 90 sales representatives in the field calling on a priority target list of approximately 7,000 physicians. We also have established teams of Medical Science Liaisons, Regional Reimbursement Directors, and Market Access Account Directors who provide information and assistance to payers and physicians on Ampyra; National Trade Account Directors who work with our limited network of specialty pharmacies; and Market Development Managers who work collaboratively with field teams and corporate personnel to assist in the execution of the Company’s strategic initiatives.

Ampyra is distributed in the U.S. exclusively through a limited network of specialty pharmacy providers that deliver the medication to patients by mail; Kaiser Permanente, which distributes Ampyra to patients through a closed network of on-site pharmacies; and ASD Specialty Healthcare, Inc. (an AmerisourceBergen affiliate), which distributes Ampyra to the U.S. Bureau of Prisons, the U.S. Department of Defense, the U.S. Department of Veterans Affairs, or VA, and other federal agencies. The specialty pharmacy providers that deliver Ampyra by mail, and Kaiser Permanente, are contractually obligated to hold no more than an agreed number of days of inventory, ranging from 10 to 30 calendar days, and some have agreed to hold a minimum of 10 business days of inventory.

We have contracted with a third party organization with extensive experience in coordinating patient benefits to run Ampyra Patient Support Services, or APSS, a dedicated resource that coordinates the prescription process among healthcare providers, people with MS, and insurance carriers. Processing of most incoming requests for prescriptions by APSS begins within 24 hours of receipt. Patients will experience a range of times to receive their first shipment based on the processing time for insurance requirements. As with any prescription product, patients who are members of benefit plans that have restrictive prior authorizations may experience delays in receiving their prescription.

Three of the largest national health plans in the U.S. – Aetna, Cigna and United Healthcare – have listed Ampyra on their commercial formulary. Approximately 75% of insured individuals in the U.S. continue to have no or limited prior authorizations, or PA’s, for Ampyra. We define limited PAs as those that require only an MS diagnosis, documentation of no contraindications, and/or simple documentation that the patient has a walking impairment; such documentation may include a Timed 25-Foot Walk (T25W) test. The access figure is calculated based on the number of pharmacy lives reported by health plans.

~~License and Collaboration Agreement with Biogen~~

Ampyra is marketed as Fampyra outside the U.S. by Biogen International GmbH, or Biogen, under a license and collaboration agreement that we entered into in June 2009. Fampyra has been approved in a number of countries across Europe, Asia, and the Americas. Our Fampyra patents have been challenged in Germany and could be similarly challenged in other countries where Fampyra is marketed by Biogen, and these challenges could lead to generic competition for Fampyra. Notwithstanding patent challenges in Germany, a generic drug manufacturer has launched a competing product in Germany, which will likely result in a decline in Fampyra royalties in that country.

Long-Term Supply Arrangements

Catalent

In February 2021, we sold our Chelsea manufacturing operations to Catalent Pharma Solutions (“Catalent”). In connection with the sale, we entered into a long-term, global manufacturing services (supply) agreement (the “2021 MSA”) with Catalent for the manufacture of Inbrija. The 2021 MSA provided that we would purchase Inbrija exclusively from Catalent, and were obligated to make minimum purchase commitments for Inbrija of $18 million annually through the expiration of the agreement on December 31, 2030.

In December 2021, we entered into an amendment of the 2021 MSA that adjusted the structure of the minimum payment terms for the period from July 1, 2021 through June 30, 2022 (the “Adjustment Period”). Under the amendment, the minimum payment obligation for the Adjustment Period was replaced with payments to Catalent for actual product delivered during the Adjustment Period subject to a cap for the Adjustment Period that corresponds to its original minimum purchase obligation for that period (i.e., $17 million), and with certain payments being made in the first half of 2022 instead of during the second half of 2021. As a result of the amendment, payments to Catalent for product delivered during the Adjustment Period were approximately $8.4 million less than the $17 million minimum inventory purchase obligation for that period.

On December 31, 2022, we entered into a termination letter, which was subsequently amended and restated in March 2023, to terminate the 2021 MSA. In connection with the termination of the 2021 MSA, we are obligated to pay a $4 million termination fee to Catalent, payable in April 2024. The parties also entered into a Settlement and Release Agreement with respect to certain batches of Inbrija that were not delivered in 2022 as scheduled, and that were delivered in the first quarter of 2023.

Effective January 1, 2023, we entered into a new manufacturing services agreement with Catalent, which was subsequently amended in March 2023 (as amended in March 2023, the “New MSA”). Under the New MSA, Catalent will continue to manufacture Inbrija through 2030, with reduced minimum annual commitments through 2024 and significantly lower pricing thereafter. The New MSA provides for the scale-up of new spray drying equipment (“PSD-7”), which will provide expanded capacity for the long-term worldwide manufacturing requirements of Inbrija. We will be subject to purchase commitments in 2023 and 2024 of 15 and 24 batches of Inbrija, respectively, at a total cost of $10.5 million and $15.5 million, respectively. Thereafter, in 2025, we will pay Catalent a fixed per capsule fee based on the amount of Inbrija that is delivered for sale in the U.S. and other markets.

It is anticipated that by 2026, the PSD-7 equipment will be fully operational, which will significantly reduce the per capsule fees for all markets. We agreed to a minimum purchase requirement of at least three batches per year on the PSD-7 equipment, and will provide up to $1 million in each of 2023 and 2024 for capital expenditures to assist in the capacity expansion efforts. In addition, we are obligated to pay Catalent $2 million in 2023 in connection with certain activities relating to the operational readiness of the PSD-7.

The New MSA, unless earlier terminated, will continue until December 31, 2030, and will be automatically extended for successive two-year periods unless either party provides the other with at least 18-months’ prior written notice of non-renewal. Either party may terminate the New MSA by written notice under certain circumstances, including material breach (subject to specified cure periods) or insolvency. We may also terminate the New MSA upon certain specified regulatory events and for convenience upon 180 days’ prior written notice.

Patheon

In October 2022, an arbitration panel issued a decision in our dispute with Alkermes Plc (“Alkermes”) and ruled that the existing license and supply agreements with Alkermes were unenforceable. As a result of the panel’s ruling, we are no longer required to pay Alkermes any royalties on net sales for license and supply of Ampyra, and we are free to use alternative sources for supply of Ampyra, which we have already secured for U.S. supply.

We had previously designated Patheon, Inc. (“Patheon”) as a second manufacturing source of Ampyra. In connection with that designation, we entered into a manufacturing agreement with Patheon, and Alkermes assisted us in transferring

manufacturing technology to Patheon. Patheon now supplies us with our Ampyra needs. Under the manufacturing services agreement, we agreed to purchase from Patheon, on a non-exclusive basis, a portion of our requirements for Ampyra in the U.S. We pay Patheon a fixed per bottle fee (60 tablets per bottle) based on the annual quantity of Ampyra bottles that are delivered for sale. As a result of the arbitration ruling in October 2022, we were free to obtain supply of Ampyra from alternative sources and Patheon became our sole manufacturer and packager of Ampyra for sales in the U.S.

The manufacturing services agreement is automatically renewed for successive one-year periods on December 31 of each year, unless either party provides the other party with at least 12-months’ prior written notice of non-renewal. Either party may terminate manufacturing services agreement by written notice under certain circumstances, including material breach (subject to specified cure periods) or insolvency. We may also terminate the manufacturing services agreement upon certain regulatory actions or objections. Patheon may terminate the manufacturing services agreement if we assign the agreement to a third party under certain circumstances.

The manufacturing services agreement contains customary representations, warranties and covenants, including with respect to the ownership of any intellectual property created pursuant to the manufacturing services agreement, as well as provisions relating to ordering, payment and shipping terms, regulatory matters, reporting obligations, indemnity, confidentiality, and other matters.

We rely on a single third-party manufacturer to supply dalfampridine, the active pharmaceutical ingredient, or API, in Ampyra, and also on a single supplier for a critical excipient used in the manufacture of Ampyra. If these companies experience any disruption in their operations, our supply of Ampyra could be delayed or interrupted until the problem is solved or we locate another source of supply or another packager, which may not be available. We may not be able to enter into alternative supply or packaging arrangements on terms that are commercially reasonable, if at all. Any new supplier or packager would also be required to qualify under applicable regulatory requirements. Because of these and other factors, we could experience substantial delays before we are able to obtain qualified replacement products or services from any new supplier or packager.

Financial Management

As of June 30, 2023, we had cash, cash equivalents, and restricted cash of approximately $26.4 million. Restricted cash includes $1.1 million, of which $0.8 million is related to self-funded employee health insurance, and $0.3 million is related to collateralized standby letters of credit. On June 1, 2023, we made a cash interest payment of approximately $6.2 million in satisfaction of the interest payment due on June 1, 2023, which was made out of restricted cash. Following the June 1, 2023 interest payment, we no longer have the option to pay interest on the 2024 Notes in our common stock and we have fully utilized the restricted cash that was set aside for the payment of interest on the 2024 Notes.

Reverse Stock Split

In June 2022, we were notified by The Nasdaq Stock Market (“Nasdaq”) that we were not in compliance with Nasdaq’s listing rule 5450(a)(1), which requires that listed securities maintain a minimum closing bid price of at least $1.00 per share (the “Minimum bid requirement”). On June 2, 2023, we effected a 1-for-20 reverse stock split of the shares of our outstanding common stock and proportionate reduction in the number of authorized shares of our common stock from 61,666,666 to 3,083,333. On June 26, 2023, we announced that we had received notice from the Nasdaq notifying us that, as of June 20, 2023, we had regained compliance with the Minimum bid requirement.

The reverse stock split applied equally to all outstanding shares of the common stock and did not modify the rights or preferences of the common stock. The reverse stock split also resulted in a corresponding adjustment to outstanding equity awards as well as shares reserved for future issuance under our incentive compensation plans. All figures in this report relating to shares of our common stock (such as share amounts, per share amounts, and conversion rates and prices), including in the financial statements and accompanying notes to the financial statements, have been retroactively restated to reflect the 1-for-20 reverse stock split of our common stock.

COVID-19 Pandemic

Our business and financial condition have been impacted by, and are subject to risks resulting from, the COVID-19 global pandemic. The COVID-19 global pandemic has caused significant disruptions in the healthcare industry and delivery of healthcare to patients; for example, the pandemic has made it more difficult for some patients to visit with their physician and obtain pharmaceutical prescriptions. We also believe that the pandemic may have caused certain patients to lessen their

mobility and therefore their need for certain therapeutics. We believe these factors contributed to volatility in new Inbrija prescriptions since the start of the pandemic in 2020 and continued to impact prescriptions in 2022. The ultimate impact of the COVID-19 global pandemic, or any other health epidemic, is highly uncertain and subject to change, and can have a material adverse effect on our business, operating results, and financial condition.

Inbrija and ARCUS

Inbrija is the first and only inhaled levodopa, or L-dopa, for intermittent treatment of OFF episodes, also known as OFF periods, in people with Parkinson’s disease treated with carbidopa/levodopa regimen. The FDA approved Inbrija for a single dose of 84 mg (administered as two capsules), which may be taken up to five times per day. U.S. net revenue for Inbrija was $8.3 million for the quarter ended June 30, 2023 and $7.4 million for the quarter ended June 30, 2022. Inbrija utilizes our ARCUS platform for inhaled therapeutics. ARCUS is a dry-powder pulmonary drug delivery technology that we believe has potential to be used in the development of a variety of inhaled medicines. The ARCUS platform allows systemic delivery of medication through inhalation, by transforming molecules into a light, porous dry powder. This allows delivery of substantially higher doses of medication than can be delivered via conventional dry powder technologies.

Inbrija is also approved for use in the 27 member states of the EU, as well as Iceland, Norway, and Liechtenstein, for a single dose of 66 mg (administered as two capsules) up to five times per day (per EU convention, this reflects emitted dose and is equivalent to the 84 mg labelled dose in the U.S.). Following the UK’s exit from the EU, we were granted a grandfathered Marketing Authorization by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK in January 2021.

We have entered into agreements to commercialize Inbrija in Spain, Germany, Latin America, and China, and we are in discussions with potential partners for commercialization of Inbrija in other jurisdictions outside of the U.S. In 2021, we entered into exclusive distribution and supply agreements with Esteve Pharmaceuticals, S.A. (“Esteve Spain”) and Esteve Pharmaceuticals GmbH (“Esteve Germany”) to commercialize Inbrija in Spain and Germany and we received a €5 million (approximately $5.9 million) upfront payment, and we are entitled to receive sales-based milestones. Under the terms of both the Esteve Spain and Esteve Germany supply agreements, we are entitled to receive a significant double-digit percentage of the Inbrija selling price in exchange for supply of the product. Esteve Germany and Esteve Spain launched Inbrija in Germany in June 2022 and in Spain in February 2023, respectively. Net revenues for ex-U.S. Inbrija sales were $0.8 million for the quarter ended June 30, 2023.

In May 2022, we announced that we entered into exclusive distribution and supply agreements with Pharma Consulting Group, S.A. (known as Biopas Laboratories) to commercialize Inbrija in nine countries within Latin America, including Brazil and Mexico. Under the terms of the Biopas agreements, we are entitled to receive a significant double-digit, tiered percentage of the Inbrija selling price in exchange for supply of the product, and we are entitled to sales-based milestones.We expect Biopas to commence sales of Inbrija in at least one country in 2024.

In May 2023, we entered into a distribution agreement and a commercial supply agreement with Hangzhou Chance Pharmaceuticals Co., Ltd (“Chance”), for the exclusive distribution of Inbrija in China. Chance is obligated to use commercially reasonable efforts to market Inbrija in China. The agreements remain in effect until the earlier of (a) the last commercial sale of Inbrija on a jurisdiction- by- jurisdiction basis, and (b) 12 years from the effective date of the agreements, subject to customary termination for insolvency and certain other termination rights. We received a non-refundable upfront payment of $2.5 million, and a near term milestone payment of up to $6 million, depending on the clinical study requirements to be determined by the Chinese National Medical Products Administration (NMPA). We will also receive $3 million upon regulatory approval of Inbrija in China, up to $132.5 million in sales milestones based on specified sales volumes, and a fixed fee for each carton of Inbrija supplied to Chance.

We believe there are potential opportunities for using ARCUS with central nervous system, or CNS, as well as non-CNS, disorders. Due to several corporate restructurings since 2017 and associated cost-cutting measures, including the corporate restructurings we announced in January and September 2021, we suspended work on ARCUS and other proprietary research and development programs. However, we continue to discuss potential collaborations with other companies that express interest in formulating their novel molecules for pulmonary delivery using ARCUS, and have performed feasibility studies for a number of these opportunities.

Ampyra

Ampyra was approved by the FDA in January 2010 to improve walking in adults with multiple sclerosis. Efficacy was shown in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). Ampyra became subject to competition from generic versions of Ampyra starting in late 2018 as a result of an adverse court ruling that invalidated certain Ampyra Orange Book-listed patents. We have experienced a significant decline in Ampyra sales due to competition from several generic versions of Ampyra. Additional manufacturers may market generic versions of Ampyra, and we expect our Ampyra sales will continue to decline over time. U.S. net revenue for Ampyra was $16.9 million for the quarter ended June 30, 2023 and $18.2 million for the quarter ended June 30, 2022.

Prior to October 2022 our primary source of supply of Ampyra was provided through a manufacturing and license agreement with Alkermes. In connection with a dispute over license and supply royalties, in the fourth quarter of 2022, an arbitration panel awarded to us an aggregate of $18.3 million including prejudgment interest. In addition, the arbitration panel ruled the agreements with Alkermes as unenforceable, and as a result we no longer have to pay Alkermes any royalties on net sales for license and supply of Ampyra, and we are now free to use alternative sources for supply of Ampyra, which we have secured. We expect the cost savings associated with this decision to greatly benefit Ampyra’s value to us.

License and Collaboration Agreement with Biogen

Ampyra is marketed as Fampyra outside the U.S. by Biogen under a license and collaboration agreement that we entered into in June 2009. Fampyra has been approved in a number of countries across Europe, Asia, and the Americas. Biogen initiated a commercial launch of Fampyra in China in 2022. Our Fampyra patents have been challenged in Germany and could be similarly challenged in other countries where Fampyra is marketed by Biogen. Fampyra currently faces generic competition in Germany, notwithstanding that certain of the Germany Fampyra Patents remain in effect, and challenges to the Fampyra patents could lead to additional generic competition with Fampyra in Germany and other countries.

Under our agreement with Biogen, we are entitled to receive double-digit tiered royalties on net sales of Fampyra and we are also entitled to receive additional payments based on achievement of certain regulatory and sales milestones. We received a $25 million milestone payment from Biogen in 2011, which was triggered by Biogen’s receipt of conditional approval from the European Commission for Fampyra. The next expected milestone payment would be $15 million, due when ex-U.S. net sales exceed $100 million over four consecutive quarters.

~~Ampyra Patent Update~~

We have five issued patents listed in the Orange Book for Ampyra, four of which were recently held invalid in litigation in U.S. District Court with certain generic drug manufacturers, as further described below in this report. The first is U.S. Patent No. 5,540,938, the claims of which relate to methods for treating a neurological disease, such as MS, and cover the use of a sustained release dalfampridine formulation, such as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg for improving walking in people with MS. In April 2013, this patent received a five year patent term extension under the patent restoration provisions of the Hatch-Waxman Act. With a five year patent term extension, this patent will expire on July 30, 2018. We have an exclusive license to this patent from Alkermes (originally with Elan, but transferred to Alkermes as part of its acquisition of Elan’s Drug Technologies business). This patent was held valid by the District Court in the litigation,milestones, although ~~in June 2017 the other parties to the lawsuit with whom~~ we ~~have not reached settlements appealed the District Court’s decision upholding this patent.~~

The other four Orange Book-listed patents were held invalid by the District Court in the litigation with generic drug manufacturers. These patents, which had been set to expire in 2025 through 2027, include: U.S. Patent No. 8,007,826, with

claims relating to methods to improve walking in patients with MS by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily; U.S. Patent No. 8,354,437, which includes claims relating to methods to improve walking, increase walking speed, and treat walking disability in patients with MS by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily; U.S. Patent No. 8,440,703, which includes claims directed to methods of improving lower extremity function and walking and increasing walking speed in patients with MS by administering less than 15 mg of sustained release 4-aminopyridine (dalfampridine) twice daily; and U.S. Patent No. 8,663,685 with claims relating to methods to improve walking in patients with MS by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily.

The patent litigation referenced above relates to Paragraph IV Certification Notices received from ten generic drug manufacturers in 2014 and 2015, who submitted Abbreviated New Drug Applications with the FDA seeking marketing approval for generic versions of Ampyra (dalfampridine) Extended Release Tablets, 10mg. The ANDA filers challenged the validity of our Orange Book-listed patents for Ampyra, and they also asserted that generic versions of their products do not infringe certain claims of these patents. In 2015 and 2016, we reached settlement agreements with six of the generic companies. A bench trial against the remaining four generic companies was completed in September 2016. In February 2017, we announced that we had reached a settlement agreement with one of those four generic companies. In March 2017, the U.S. District Court for the District of Delaware rendered a decision upholding our Orange-Book listed patent for Ampyra set to expire in July 2018, but invalidating our four other Orange Book-listed patents. In May 2017, we appealed the ruling on these four patents, and as described above, in June 2017 the other non-settling parties appealed the decision on the patent set to expire in July 2018. We expect the appeals process to take approximately 12 to 18 months from the filing of the appeal in May 2017. In August 2017, we filed our opening brief to the United States Court of Appeals for the Federal Circuit. Both the Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) filed amicus briefs in support of our appeal. The defendants have now filed their opposition and opening cross-appeal brief. We expect reply briefs to be filed in November 2017, followed by oral argument to be scheduled by the appellate court. We expect to experience a rapid and significant decline in Ampyra sales beyond July 2018 due to competition from generic versions of Ampyra that may be marketed after the expiration of our remaining Ampyra patent, unless the District Court’s decision on the four invalidated patents is overturned on appeal, which could include reversal or remand by the appeals court back to the District Court.

In April 2017, we received a Paragraph IV Certification Notice from an additional generic drug manufacturer, Micro Labs Ltd. (“Micro”), advising that it had submitted an ANDA to the FDA seeking marketing approval for a generic version of Ampyra (dalfampridine) Extended Release Tablets, 10mg. Micro has challenged the validity of four of our five Orange Book-listed patents for Ampyra, and did not file against our U.S. Patent No. 5,540,938, and it also asserted that a generic version of its product does not infringe certain claims of these patents. In response to the filing of the ANDA, in May 2017 we filed a lawsuit against Micro in the U.S. District Court for the District of New Jersey, ~~asserting infringement of our U.S. Patent Nos. 8,007,826, 8,354,437, 8,440,703, and 8,663,685.~~

In 2011, the European Patent Office, or EPO, granted EP 1732548, with claims relating to, among other things, use of a sustained release aminopyridine composition, such as dalfampridine (known under the trade name Fampyra in the European Union), to increase walking speed. In March 2012, Synthon B.V. and neuraxpharm Arzneimittel GmBH filed oppositions with the EPO challenging the EP 1732548 patent. We defended the patent, and in December 2013, we announced that the EPO Opposition Division upheld amended claims in this patent covering a sustained release formulation of dalfampridine for increasing walking in patients with MS through twice daily dosing at 10 mg. Both Synthon B.V. and neuraxpharm Arzneimittel GmBH have appealed the decision. In December 2013, Synthon B.V., neuraxpharm Arzneimittel GmBH and Actavis Group PTC EHF filed oppositions with the EPO challenging our EP 2377536 patent, which is a divisional of the EP 1732548 patent. On February 24, 2016, the EPO Opposition Division rendered a decision that revoked the EP 2377536 patent. We believe the claims of this patent are valid and we have appealed the decision. Both European patents, if upheld as valid, are set to expire in 2025, absent any additional exclusivity granted based on regulatory review timelines. Fampyra also has 10 years of market exclusivity in the European Union that is set to expire in 2021.

~~We will vigorously defend our intellectual property rights.~~

~~Legal proceedings relating to our Ampyra patents are described in further detail in Part II, Item 1 of this report.~~

~~Other Marketed Products~~

Zanaflex Capsules and Zanaflex tablets are FDA-approved as short-acting drugs for the management of spasticity, a symptom of many central nervous system disorders, including MS and spinal cord injury. These products contain tizanidine

~~hydrochloride, one of the two leading drugs used to treat spasticity. The net revenue we receive from Zanaflex products has declined substantially due to generic competition.~~

Qutenza is a dermal patch containing 8% prescription strength capsaicin the effects of which can last up to three months and is approved by the FDA for the management of neuropathic pain associated with post-herpetic neuralgia, also known as post-shingles pain. We acquired commercialization rights to Qutenza in July 2013 from NeurogesX, Inc. These rights include the U.S., Canada, Latin America and certain other territories. Grunenthal GmbH (as the assignee of Astellas Pharma Europe Ltd.) has exclusive commercialization rights for Qutenza in the European Economic Area (EEA) including the 28 countries of the European Union, Iceland, Norway, and Liechtenstein as well as Switzerland, certain countries in Eastern Europe, the Middle East and Africa.

~~Research & Development Programs~~

We have a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease and MS. Following the restructuring described above, our focus is on advancing our late stage Parkinson’s disease programs – Inbrija and tozadenant – and we believe that these products, if approved, will serve as the foundation of our future value and have the potential to position us as a leader in Parkinson’s disease therapy.

~~Inbrija (CVT-301, levodopa inhalation powder)/Parkinson’s Disease~~

Inbrija (the proposed brand name for CVT-301, levodopa inhalation powder), is a self-administered, inhaled formulation of levodopa, or L-dopa, for the treatment of OFF periods in Parkinson’s disease. Parkinson’s disease is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons in the brain responsible for producing dopamine. The disease causes a range of symptoms such as impaired ability to move, muscle stiffness and tremor. The standard of care for the treatment of Parkinson’s disease is oral carbidopa/levodopa, but oral medication can be associated with wide variability in the timing and amount of absorption and there are significant challenges in creating a regimen that consistently maintains therapeutic effects as Parkinson’s disease progresses. The re-emergence of symptoms is referred to as an OFF period, and despite optimized regimens with current therapeutic options and strategies, OFF periods remain one of the most challenging aspects of the disease.

Inbrija delivers a precise dose of dry-powder formulation of L-dopa to the lung. Oral medication can be absorbed with slow and variable onset of action, as the medicine is absorbed through the gastrointestinal (digestive) tract before reaching the brain. Inhaled treatments enter the body through the lungs and reach the brain shortly thereafter, bypassing the digestive system. Inbrija is based on our proprietary ARCUS platform, a dry-powder pulmonary drug delivery technology that we believe has potential applications in multiple disease areas. This platform allows delivery of significantly larger doses of medication than are possible with conventional dry powder formulations using a simple, breath-actuated proprietary inhaler. This in turn provides the potential for pulmonary delivery of a much wider variety of pharmaceutical agents.

In 2016, we completed a Phase 3 efficacy and safety clinical trial of Inbrija for the treatment of OFF periods in Parkinson’s disease. In February 2017, we announced efficacy and safety data from this clinical trial, showing a statistically significant improvement in motor function in people with Parkinson’s experiencing OFF periods. The clinical trial had three arms: Inbrija 84 mg and 60 mg doses (equivalent to 50 mg and 35 mg fine particle doses, respectively), and placebo. The trial met its primary outcome measure of improvement in motor function as measured by the Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS III) in people with Parkinson’s experiencing OFF periods. UPDRS III is a validated scale, which measures Parkinson’s disease motor impairment. The primary endpoint was measured at 30 minutes post-treatment for the 84 mg dose at the 12-week visit. UPDRS III change was -9.83 compared to -5.91 for placebo with a p-value of 0.009. The magnitude of Inbrija’s benefit versus baseline was consistent with the data from the prior Phase 2b clinical trial, further described below, and represents a statistically significant, clinically meaningful improvement in motor function. The placebo-adjusted difference was lower in the Phase 3 clinical trial than the Phase 2b clinical trial but still represented a clinically important difference. In June 2017, we announced additional data from the Inbrija Phase 3 efficacy and safety trial at the International Congress of Parkinson’s Disease and Movement Disorders (MDS). The secondary endpoints of achievement of an ON state with maintenance through 60 minutes (statistically significant), Patient Global Impression of Change (PGIC), and reduction in UPDRS III score at 10 minutes were supportive of the primary endpoint result.

~~The safety profile of Inbrija in the Phase 3 trial was consistent with that observed in a prior Phase 2b clinical trial.~~

84 mg, 60 mg and Placebo: Adverse events reported in any study arm at greater than 5% were cough, upper respiratory tract infection, throat irritation, nausea and sputum discoloration. Cough was the most common adverse event, reported by approximately 15% of subjects who received Inbrija. When reported, it was typically mild and reported once per participant during the course of treatment. Three of 227 participants receiving Inbrija discontinued the study due to cough. Reports of serious adverse events were: 3, or 2.7% in the placebo arm, 6, or 5.3% in the 60 mg arm, and 2, or 1.8% in the 84 mg arm. There was one death in the study, a suicide in the 60 mg group, judged by the investigator not to be related to drug.

84 mg: The most commonly reported adverse events in the Inbrija 84 mg group compared to the placebo group were: cough (14.9% vs. 1.8%, reported mostly once/subject), upper respiratory tract infection (6.1% vs. 2.7%), nausea (5.3% vs. 2.7%), sputum discoloration (5.3% vs. 0%) and dyskinesia (3.5% vs. 0.0%). ~~When cough was reported, it was typically characterized as mild. Two of 114 participants receiving CVT-301 84 mg discontinued the study due to cough.~~

In March and June 2017, we announced interim results from two additional ongoing, long-term Phase 3 studies to assess the long-term safety profile of Inbrija in people with Parkinson’s. These results showed no statistical difference in pulmonary function between the group receiving Inbrija and an observational control group. These results are consistent with the previously reported Phase 2b and Phase 3 clinical trials. In March 2017, we also announced results from separate clinical studies that assessed the safety profile of Inbrija in people with asthma, smokers and early morning OFF.

~~In June 2017, we submitted an NDA for Inbrija to the FDA.~~ In August 2017, we announced that we received a Refusal to File (RTF) letter from the FDA regarding the Inbrija NDA. Upon its preliminary review, the FDA determined that the NDA was not sufficiently complete to permit a substantive review. The FDA specified two reasons for the RTF: First, the date when the manufacturing site would be ready for inspection; and second, a question regarding the submission of the drug master production record. The FDA also requested additional information at resubmission, which was not part of the basis for the RTF. Subsequently, in September 2017, we announced that we have engaged in a constructive dialogue with the FDA to determine the most efficient path forward to resubmitting the Inbrija NDA. We believe the issues raised in the RTF are addressable, and plan to resubmit the NDA in the fourth quarter of 2017. Based on current guidelines, we would expect the FDA to notify us within 74 days of the submission date regarding whether the submission has been deemed complete and is accepted for full review. The FDA has not requested or recommended additional clinical efficacy or safety studies. ~~Given our team’s focus on the NDA resubmission,~~ ~~we have revised the timing of our submission of a Marketing Authorization Application, or MAA, to the European Medicines Agency to the first quarter of 2018.~~ ~~The NDA was submitted under section 505(b)(2) of the Food Drug and Cosmetic Act, referencing data from the branded L-dopa product Sinemet~~^®~~. We believe the Phase 3 efficacy and safety clinical trial, combined with data from the two additional Phase 3 studies and supported by existing Phase 2b data, are sufficient for the NDA filing.~~ ~~Our commercial preparations for the launch of Inbrija continue.~~ ~~We are projecting that, if approved, annual peak net revenue of Inbrija in the U.S. alone could exceed $500 million.~~ ~~We are in discussions with potential partners regarding Inbrija outside of the U.S.,~~ ~~including the EU and certain other countries.~~ We do not anticipate ~~the change~~achievement of any of those milestones in the ~~MAA submission timeline to impact our ongoing partnering discussions or expectations for Inbrija outside the U.S.~~foreseeable future.

In June 2015, we presented data from a Phase 2b clinical trial of Inbrija at the 19th International Congress of Parkinson's Disease and Movement Disorders (MDS). The data showed that patients experiencing an OFF period, treated with Inbrija, experienced significantly greater improvements in motor function than patients treated with an inhaled placebo; the difference in improvement was already apparent 10 minutes after dosing and was durable for at least an hour, the longest time point at which patients were measured.

~~Tozadenant/Parkinson’s Disease~~

Through Biotie we acquired worldwide rights to tozadenant, an oral adenosine A2a receptor antagonist currently in Phase 3 development as an adjunctive treatment to levodopa in Parkinson’s disease patients to reduce OFF time. A2a receptor antagonists have the potential to be the first new class of drug approved in the U.S. for improvement of motor symptoms in Parkinson’s disease in over 20 years. We believe that tozadenant would be complementary to our other Phase 3 product for Parkinson's disease, Inbrija, because while tozadenant is being developed as a chronic maintenance therapy for reducing overall OFF time, Inbrija is being developed as an on-demand therapy for improvement of OFF periods when they occur. We believe that tozadenant, if approved by the FDA, represents a potential commercial opportunity in the U.S. greater than that of Inbrija.

Biotie is currently conducting a Phase 3 clinical trial, in which tozadenant is taken along with a person’s other Parkinson’s disease therapies. The trial is being conducted under a special protocol assessment, or SPA, from the FDA and is comparing two of the dose arms of tozadenant, 60 mg and 120 mg, that were selected from the prior Phase 2b clinical trial versus placebo. The trial is assessing improvement of motor function and activities of daily living in people with Parkinson’s while taking tozadenant. The Phase 2b trial showed, among other positive findings, that 120 mg doses of tozadenant resulted in an average increase of 1.1 hours of ON time without troublesome dyskinesias, relative to placebo; this was in patients already receiving multiple other Parkinson’s therapies. We believe that this trial, if successful, together with data from the prior Phase 2b clinical trial, will provide sufficient efficacy data to file an NDA with the FDA. We expect efficacy data from this trial in the first quarter of 2018. In June 2017, we presented new data from clinical and pre-clinical studies of tozadenant at the 2017 International Congress of Parkinson's Disease and Movement Disorders (MDS). A separate open-label, long-term safety study commenced enrollment in April 2017.

~~ARCUS Product Development~~ – ~~CVT-427/Acute Migraine~~

In addition to Inbrija, discussed above, we are exploring opportunities for other proprietary products in which inhaled delivery using our ARCUS drug delivery technology can provide a significant therapeutic benefit to patients. Disorders of the central nervous system, or CNS, in addition to Parkinson’s disease, may be addressed by ARCUS products with the delivery of active agents to the CNS with rapid onset and reduced systemic exposure. For example, we are currently developing CVT-427, an inhaled triptan (zolmitriptan) intended for acute treatment of migraine by using the ARCUS drug delivery technology. Triptans are the class of drug most commonly prescribed for acute treatment of migraine. Oral triptans, which account for the majority of all triptan doses, can be associated with slow onset of action and gastrointestinal challenges. The slow onset of action, usually 30 minutes or longer, can result in poor response rates. Patients cite the need for rapid relief from migraine symptoms as their most desired medication attribute. Additionally, individuals with migraine may suffer from nausea and delayed gastric emptying which further impact the consistency and efficacy of the oral route of administration. Triptans delivered subcutaneously (injection) provide the most rapid onset of action, but are not convenient for patients. Many triptans are also available in nasally delivered formulations. However, based on available data, we believe that nasally delivered triptans generally have an onset of action similar to orally administered triptans.

In December 2015, we initiated and completed a Phase 1 safety/tolerability and pharmacokinetic clinical trial of CVT-427 for acute treatment of migraine. In June 2016, at the 58th Annual Scientific Meeting of the American Headache Society, we presented pharmacokinetic data from the Phase 1 trial which showed increased bioavailability and faster absorption compared to oral and nasal administration of the same active ingredient in healthy adults. In particular, the data showed that CVT-427 had a median Tmax of about 12 minutes for all dose levels compared to 1.5 hours for the oral tablet and 3.0 hours for the nasal spray. There were no serious adverse events, dose-limiting toxicities, evidence of bronchoconstriction or discontinuations due to adverse events reported in this study. The most commonly reported treatment-emergent adverse events were cough, chest discomfort, headache, and feeling hot. Apart from cough, single dose CVT-427 tolerability was generally consistent with the known safety profile of zolmitriptan. In December 2016, we completed a special population study to evaluate safe inhalation of CVT-427 in people with asthma and in smokers. Some subjects showed evidence of acute, reversible bronchoconstriction, post-inhalation, which we believe requires further investigation. We are evaluating next steps for the program and CVT-427 will not advance into a Phase 2 study by the end of 2017, as previously expected.

~~Other Research and Development Programs~~

Following is a description of our other research and development programs. We are evaluating options to partner or out-license some of these programs in light of our current corporate and capital allocation priorities.

~~SYN120:~~ Through Biotie we obtained global rights to SYN120, an oral, 5-HT6/5-HT2A dual receptor antagonist in Phase 2 development with support from the Michael J. Fox Foundation for Parkinson’s-related dementia. We expect to complete an ongoing Phase 2 exploratory study in the second half of 2017 and we expect data from this trial in the first quarter of 2018.

~~BTT1023:~~ Biotie is also developing BTT1023 (timolumab), a product candidate for the orphan disease Primary Sclerosing Cholangitis, or PSC, a chronic and progressive liver disease. There are no approved drug therapies for PSC and liver transplant is the only treatment. Interim data from an ongoing Phase 2 proof-of-concept clinical trial of BTT1023 for PSC are expected in the first quarter of 2018.

~~rHIgM22:~~ We are developing rHIgM22, a remyelinating antibody, as a potential therapeutic for MS. We believe a therapy that could repair myelin sheaths has the potential to restore neurological function to those affected by

demyelinating conditions. A Phase 1 trial using one of two doses of rHIgM22 or placebo in people with MS who are experiencing an acute relapse is currently ongoing. In addition to assessing safety and tolerability during an acute relapse, the study includes exploratory efficacy measures such as a timed walk, magnetization transfer ratio imaging of lesion myelination in the brain and various biomarkers. We expect to complete the trial in the second half of 2017.

~~Cimaglermin alfa:~~ Cimaglermin alfa is a member of the neuregulin growth factor family, and has been shown to promote recovery after neurological injury, as well as enhance heart function in animal models of heart failure. In 2013, we commenced a Phase 1b single-infusion trial in people with heart failure, which is assessing tolerability of three dose levels of cimaglermin, and also includes assessment of drug-drug interactions and several exploratory measures of efficacy. In 2015 we announced that we had stopped enrollment in this trial based on the occurrence of a case of hepatotoxicity (liver injury) manifested by clinical symptoms and an elevation in liver chemistry tests meeting the FDA Drug-Induced Liver Injury Guidance (FDA 2009) stopping rules. We also received a notification of clinical hold from the FDA following submission of this information. The abnormal blood tests resolved within two to three weeks. We subsequently conducted additional analyses and non-clinical studies to further define the nature of the hepatoxicity, and met with the FDA to present these data as part of our request that the program be removed from the clinical hold. The FDA lifted the clinical hold in April 2017.

~~NP-1998:~~ NP-1998 is a Phase 3 ready, 20% prescription strength capsaicin topical solution that we had been assessing for the treatment of neuropathic pain. In 2013, we acquired development and commercialization rights in the United States, Canada, Latin America and certain other territories. We believe NP-1998 has the potential to treat multiple neuropathies, but we have no current plans to invest in further development of NP-1998.

~~Corporate Update~~

On August 31, 2017, our Board of Directors adopted a stockholder rights plan to preserve the ability of the Board to protect the interests of stockholders in transactions that may result in an acquisition of control of the Company, including tender offers and open market purchases of our securities. In general terms, the rights plan works by significantly diluting the stock ownership of any person or group that acquires 15% or more of our outstanding common stock without the approval of the Board. The rights plan also provides, among other things, that when specified events occur, our stockholders will be entitled to purchase from us shares of junior preferred stock. The rights plan will expire on August 31, 2018. The preferred stock purchase rights are triggered ten business days after the date of a public announcement that a person or group acting in concert has acquired, or has obtained the right to acquire, beneficial ownership of 15% or more of our outstanding common stock. The preferred stock purchase rights would cause dilution to a person or group that attempts to acquire us on terms that are not approved by our Board. While we believe our rights plan enables our Board to help ensure that our stockholders are not deprived of the opportunity to realize the full and fair value of their investments, the rights plan may inhibit a change in control by a third party in a transaction not approved by our Board. If a change in control is inhibited or delayed in this manner, it may adversely affect the market price of our common stock.

~~Financial Guidance for 2017~~

~~We are providing the following guidance with respect to our 2017 financial performance:~~

~~We expect 2017 net revenue from the sale of Ampyra to range from $535 million to $545 million.~~

Research and development (R&D) expenses in 2017 are expected to range from $160 million to $170 million, excluding share-based compensation charges and restructuring costs. The majority of R&D expenses for the remainder of 2017 are primarily related to our two late-stage programs. Inbrija (CVT-301, levodopa inhalation powder) program costs include extension study and safety study costs as well as manufacturing expenses. Tozadenant program costs include Phase 3 clinical trial costs as well as chemistry, manufacturing and controls (CMC) related expenses.

Selling, general and administrative (SG&A) expenses in 2017 are expected to range from $160 million to $170 million, reduced from our prior guidance of $170 million to $180 million, excluding share-based compensation charges and restructuring costs. The majority of SG&A expenses for the remainder of 2017 are to support Ampyra and our two late stage Parkinson’s disease programs, and general and administrative costs for the rest of the organization.

~~We expect to be cash flow positive for 2017 with a projected year end cash balance in excess of $200 million.~~

The projected range of R&D and SG&A expenses in 2017 are provided on a non-GAAP basis, as both exclude share-based compensation charges and restructuring costs. Due to the forward looking nature of this information, the amount of compensation charges and benefits needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, we believe the presentation of these non-GAAP financial measures, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our projected operating performance because they exclude non-cash charges that are substantially dependent on changes in the market price of our common stock and non-recurring restructuring costs. We believe these non-GAAP financial measures help indicate underlying trends in our business, and are important in comparing current results with prior period results and understanding expected operating performance. Also, our management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage our business and to evaluate its performance.

Results of Operations

Three-Month Period Ended ~~September~~June 30, ~~2017~~2023 Compared to ~~September~~June 30, ~~2016~~2022

Net Product Revenues

~~Ampyra~~Inbrija

We recognize product sales of Inbrija following receipt of product by companies in our distribution network, which for Inbrija primarily includes specialty pharmacies and distributors. We recognized net revenues from the U.S. sales of Inbrija of $8.3 million and $7.4 million for the three-month periods ended June 30, 2023 and 2022, respectively, an increase of $0.9 million, or 11%. The increase in Inbrija net revenues of $0.9 million was composed of a decrease in volume of $0.2 million, partially offset by net price increase and discount and allowance adjustments of $1.1 million for the three-month period ended June 30, 2023. Additionally, we recognized revenues from our supply agreements with Esteve Germany and Esteve Spain for sales in ex-U.S. of $0.8 million and $1.9 million for the three-month periods ended June 30, 2023 and 2022, respectively.

Ampyra

We recognize product sales of Ampyra following receipt of product by companies in our distribution network, ofwhich for Ampyra primarily includes specialty ~~pharmacy providers, Kaiser Permanente and ASD Specialty Healthcare, Inc.~~pharmacies, which deliver the medication to patients by mail. We recognized net ~~revenue~~revenues from the sale of Ampyra to these customers of ~~$132.6~~$16.9 million and ~~$128.8~~$18.2 million for the three-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016,~~2022, respectively, ~~an increase~~a decrease of ~~$3.8~~$1.3 million, or ~~2.9%~~7%. The decrease in Ampyra net ~~revenue increase~~revenues of $1.3 million was ~~comprised~~composed of a decrease in volume of $1.9 million, partially offset by net price ~~increases, net of~~increase and discount and allowance adjustments of ~~$5.2~~$0.6 million ~~partially offset by decreased net volume of $1.4 million. Effective January 1, 2017~~for the three-month period ended June 30, 2023.

Discounts and ~~July 1, 2017, we increased our list sale price to our customers by 9.5% and 4%, respectively.~~Allowances on Sales

Discounts and allowances ~~which~~for both Inbrija and Ampyra are included as an offset in net ~~revenue consist~~revenues consisting of allowances for customer credits, including estimated chargebacks, rebates, and discounts. Discounts and allowances are recorded following shipment of ~~Ampyra tablets~~our products to our ~~network of specialty pharmacy providers, Kaiser Permanente and ASD Specialty Healthcare, Inc.~~customers. Adjustments are recorded for estimated chargebacks, rebates, and discounts. Discounts and allowances also consist of discounts provided to Medicare beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap ~~(i.e.~~(i.e., the “donut hole”). Payment of coverage gap discounts is required under the Patient Protection and Affordable Care ~~Act, the health care reform legislation enacted in 2010.~~Act. Discounts and allowances may increase as a percentage of sales as we enter into new managed care contracts in the future.

We ~~note~~believe that ~~there was an unexpected contraction~~first and fourth quarter revenues for Inbrija and Ampyra are subject to certain recurring seasonal factors relating to the commencement of a new calendar year. For example, some patients refill their prescriptions earlier ahead of the new year, in the fourth quarter, in anticipation of the year-end reset of health plan deductibles and the Medicare donut hole, or a year-end switch of their insurance plans or pharmacy benefit providers. Also, we believe specialty pharmacies may increase their inventory ~~levels~~in anticipation of the holidays and ~~an increase in~~new year. These factors have had a positive impact on fourth quarter revenues and a negative impact on first quarter revenues. Also, discounts and allowances typically are highest in the ~~three-month period ended September 30, 2017. However,~~first quarter, and lowest in the fourth quarter, and when this ~~has not affected our 2017 Ampyra net revenue guidance as discussed above under Financial Guidance for 2017.~~ occurs, fourth quarter revenues increase, and first quarter revenues decrease, on a relative basis.

~~Other Net Product~~Royalty Revenues

We recognized ~~net~~$3.7 million and $3.6 million in royalty revenues for the three-month periods ended June 30, 2023 and 2022, respectively, an increase of $0.1 million or 3%.

License Revenues

We recognized negligible license revenue ~~from~~and no license revenues for the ~~sale~~three-month periods ended June 30, 2023 and 2022, respectively.

Cost of ~~other products~~Sales

We recorded cost of ~~$1.8~~sales of $3.1 million for the three-month period ended ~~September~~June 30, ~~2017,~~2023 as compared to ~~$(0.3)~~$8.8 million for the three-month period ended ~~September~~June 30, ~~2016, an increase of $2.1 million.~~

~~Discounts and allowances, which are included as an offset in net revenue, consist of allowances for customer credits, including estimated chargebacks, rebates, returns and discounts.~~

~~License Revenue~~

We recognized $2.3 million in license revenue for both the three-month periods ended September 30, 2017 and 2016, related to the $110.0 million received from Biogen in 2009 as part of our collaboration agreement. We currently estimate the recognition period to be approximately 12 years from the date of the Collaboration Agreement.

~~Royalty Revenue~~

~~We recognized $3.1 million and $2.6 million in royalty revenue for the three-month periods ended September 30, 2017 and 2016, respectively, related to ex-U.S. sales of Fampyra by Biogen.~~

~~We recognized $0.5 million and $1.0 million in royalty revenue for the three-month periods ended September 30, 2017 and 2016, respectively, related to the authorized generic sale of Zanaflex Capsules.~~

~~We recognized $0.8 million and $1.1 million in royalty revenue for the three-month period ended September 30, 2017 and 2016, respectively, related to sales of Selincro.~~

~~Cost of Sales~~

~~We recorded cost of sales of $30.0 million for the three-month period ended September 30, 2017 as compared to $27.6 million for the three-month period ended September 30, 2016.~~2022. Cost of sales for the three-month period ended ~~September~~June 30, ~~2017~~2023 consisted primarily of ~~$22.8~~$2.8 million in inventory costs related to recognized revenues ~~$3.0~~and $0.3 million in royalty fees based on net product shipments, $2.4 million for costs related to Selincro, $0.9 million which represents the cost of Zanaflex Capsules authorized generic product sold, and $0.7 million for costs related to the amortization of intangible assets.

other period costs. Cost of sales for the three-month period ended ~~September~~June 30, ~~2016~~2022 consisted primarily of ~~$22.2~~$8.5 million in inventory costs related to recognized revenues, ~~$2.9~~$0.2 million in royalty fees based on net product shipments, and ~~costs~~$0.1 million in other period costs.

Amortization of Intangibles

We recorded amortization of intangible asset related to ~~Selincro~~Inbrija of ~~$2.3 million.~~

~~Cost of License Revenue~~

~~We recorded cost of license revenue of $0.2~~$7.7 million for the three-month periods ended ~~September~~June 30, ~~2017~~2023 and 2016, respectively. Cost of license revenue represents the recognition of a portion of the deferred $7.7 million paid to Alkermes in 2009 in connection with the $110.0 million received from Biogen as a result of our collaboration agreement.2022.

Research and Development

Research and development expenses for the three-month ~~period~~periods ended ~~September~~June 30, ~~2017~~2023 and June 30, 2022 were ~~$33.3~~$1.6 million ~~as compared to $54.8~~and $1.5 million, for the three-month period ended September 30, 2016, a decrease of approximately $21.5 million, or 39.2%. The decrease was due primarily to reductions in spending of $9.5 million for Inbrija (CVT-301, levodopa inhalation powder), $5.1 million for our Ampyra life cycle management program, $4.8 million for salaries and benefits related costs, $2.3 million for our discontinued Plumiaz program, $1.3 million for our other programs and $1.2 million in regulatory spending, partially offset by increased spending for products acquired as a result of the Biotie acquisition of $2.6 million.respectively.

Selling, General and Administrative

Sales and marketing expenses for the three-month period ended ~~September~~June 30, ~~2017~~2023 were ~~$20.8~~$9.6 million compared to ~~$24.8~~$10.7 million for the three-month period ended ~~September~~June 30, ~~2016,~~2022, a decrease of approximately ~~$4.0~~$1.1 million, or ~~16.1%~~11%. The decrease was ~~attributable~~primarily due to a decrease in ~~marketing, trade and sales related~~marketing-related spending of ~~$2.0~~$0.5 million for Inbrija, a decrease in ~~overall~~ salaries and benefits of ~~$1.7~~$0.5 million, and ~~reductions~~a decrease in spending for Ampyra and other selling related expenses of ~~$0.3~~$0.1 million.

General and administrative expenses for the three-month period ended ~~September~~June 30, ~~2017~~2023 were ~~$20.0~~$12.2 million compared to ~~$30.0~~$19.3 million for the three-month period ended ~~September~~June 30, ~~2016,~~2022, a decrease of approximately ~~$10.0~~$7.1 million, or ~~33.3%~~37%. ~~This~~The decrease was primarily due to a decrease in ~~business development, legal, finance~~rent and ~~other related expenses~~facility costs of ~~$6.5~~$2.5 million, ~~and~~a decrease of $2 million in professional fees, a decrease in salaries and benefits ~~related costs~~ of ~~$3.4 million.~~

~~Asset Impairment~~

~~We recognized an asset impairment charge~~$1.3 million, and a decrease of ~~$39.4~~$1.2 million in other departmental spending.

Change in Fair Value of Derivative Liability

A derivative liability was recorded in December 2019 as a result of the issuance of the 2024 Notes. The derivative liability is measured at fair value on a quarterly basis and changes in the fair value are recorded in the consolidated statement of operations. We recorded no income due to the change in the fair value of the derivative liability for the three-month period ended ~~September~~June 30, ~~2017 related to our intangible asset~~2023. Income was negligible for ~~Selincro. We reviewed~~ the ~~intangible asset for impairment due to a downward revision to~~change in the ~~projected royalty revenue we expect to receive. As a result of the review, we determined that the carrying~~fair value of the ~~asset was greater than the estimated fair market value as of September 30, 2017. We did not recognize an asset impairment charge in~~derivative liability for the three-month period ended ~~September~~June 30, ~~2016.~~2022.

Changes in Fair Value of Acquired Contingent Consideration

As a result of the original ~~Civitas~~ spin out of Civitas from Alkermes, part of the consideration to Alkermes was a future royalty to be paid to Alkermes on ~~Civitas products. Acorda~~Inbrija. We acquired this contingent consideration as part of the Civitas acquisition. The fair value of that future royalty is assessed quarterly. We recorded ~~income pertaining~~a gain relating to changes in the ~~fair-value~~fair value of our acquired contingent consideration of ~~$0.4~~$0.8 million for the three-month period ended ~~September~~June 30, ~~2017~~2023 as compared to ~~an expense~~income of ~~$3.7~~$3.1 million for the three-month period ended ~~September~~June 30, ~~2016. Changes~~2022. The changes in the ~~fair-value~~fair value of the acquired contingent

consideration were primarily due to the ~~re-calculation~~change in projected revenue and the recalculation of ~~discounted~~ cash flows for the passage of time, ~~and updates to certain other estimated assumptions.~~as well as an increase in the discount rate.

Other Expense, Net

Other expense, net was ~~$4.2~~$7.7 million and $6.2 million for the three-month ~~period~~periods ended ~~September~~June 30, ~~2017 compared to~~2023 and 2022, respectively. Nearly all other expense, ~~of $4.5 million for~~net was interest on the three-month period ended September 30, 2016, a difference of $0.3 million. The difference is due primarily to a decrease in interest and amortization of debt discount expense of $0.2 million, and a decrease in realized losses on foreign currency exchange of approximately $0.2 million.2024 Notes.

Benefit from/(Provision ~~for~~for) Income Taxes

For the three-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016, the Company~~2022, we recorded a ~~$18.9~~benefit from income taxes of $2 million and ~~$3.0 million~~a provision for income taxes of ($26.6) million, respectively. The effective income tax rates for the ~~Company for the~~ three-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022 were ~~-298.2%~~17.3% and ~~-30.2%~~(132.0)%, respectively.

The variance in the effective tax rates for the three-month period ended ~~September~~June 30, ~~2017~~2023 as compared to the three-month period ended ~~September~~June 30, ~~2016~~2022 was due primarily to an increase during the second quarter of 2022 in the existing valuation allowance recorded ~~for jurisdictions with Biotie pretax losses~~on our deferred tax assets for which no tax benefit can be recognized, as a result of the ~~tax implications of costs related to the Biotie transaction, state taxes, the reduction~~deemed ownership that occurred in the ~~research and development~~prior year under IRS Section 382 which required a valuation allowance to be recorded on the Company’s tax ~~credit~~attributes and the ~~absence~~forfeitures of ~~orphan drug development in 2017~~.equity of which no tax deduction is recorded.

~~The Company continues~~We continue to evaluate the realizability of ~~its~~our deferred tax assets ~~and liabilities~~ on a quarterly basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits, and the regulatory approval of products ~~currently~~ under development. Any changes to the valuation allowance or deferred tax assets and liabilities in the future would impact ~~the Company's~~our income taxes.

~~Nine-Month~~28

We have ongoing state examinations in Massachusetts which cover multiple years. There have been no proposed adjustments at this stage of the examination. The New Jersey examination was finalized during the first quarter of 2023 for tax years 2015 through 2018 with no adjustments.

Six-Month Period Ended ~~September~~June 30, ~~2017~~2023 Compared to ~~September~~June 30, ~~2016~~2022

Net Product Revenues

~~Ampyra~~Inbrija

We recognize product sales of Inbrija following receipt of product by companies in our distribution network, which for Inbrija primarily includes specialty pharmacies and distributors. We recognized net revenues from the U.S. sales of Inbrija of $13.9 million and $11.1 million for the six-month periods ended June 30, 2023 and 2022, respectively, an increase of $2.8 million, or 25%. The increase in Inbrija net revenues of $2.8 million was comprised of an increase in volume of $1.6 million and a net price increase and discount and allowance adjustments of $1.2 million for the six-month period ended June 30, 2023. Consistent with trends in previous years, we anticipated declines in first quarter net sales given patient overstocking in the fourth quarter, insurance resetting at the beginning of each year, and quarterly true-up discounts and allowances as discussed below. Additionally, we recognized revenues from our supply agreements with Esteve Germany and Esteve Spain for sales in ex-U.S. of $1.3 million and $1.9 million for the six-month periods ended June 30, 2023 and 2022, respectively.

Ampyra

We recognize product sales of Ampyra following receipt of product by companies in our distribution network, ofwhich for Ampyra primarily includes specialty ~~pharmacy providers, Kaiser Permanente and ASD Specialty Healthcare, Inc.~~pharmacies, which deliver the medication to patients by mail. We recognized net ~~revenue~~revenues from the sale of Ampyra to these customers of ~~$376.1~~$29.5 million ~~as compared to $360.6~~and $33.1 million for the ~~nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016,~~2022, respectively, ~~an increase~~a decrease of ~~$15.5~~$3.6 million, or ~~4.3%~~11%. The decrease in Ampyra net ~~revenue increase~~revenues of $3.6 million was comprised of a decrease in volume of $5.8 million, partially offset by net price ~~increases, net of~~increase and discount and allowance adjustments of ~~$19.0~~$2.2 million ~~partially offset by~~for the six-month period ended June 30, 2023. Consistent with trends in previous years, we anticipated declines in first quarter net ~~volume reductions~~sales given patient overstocking in the fourth quarter, insurance resetting at the beginning of ~~$3.5 million. Effective January 1, 2017~~each year, and ~~July 1, 2017, we increased our list sale price to our customers by 9.5%~~quarterly true-up discounts and ~~4%, respectively.~~allowances as discussed below.

Discounts and Allowances on Sales

Discounts and allowances ~~which~~for both Inbrija and Ampyra are included as an offset in net ~~revenue consist~~revenues consisting of allowances for customer credits, including estimated chargebacks, rebates, ~~discounts~~ and ~~returns.~~discounts. Discounts and allowances are recorded following shipment of ~~Ampyra tablets~~our products to our ~~network of specialty pharmacy providers, Kaiser and ASD Specialty Healthcare, Inc.~~customers. Adjustments are recorded for estimated chargebacks, rebates, and discounts. Discounts and allowances also consist of discounts provided to Medicare beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap ~~(i.e.~~(i.e., the “donut hole”). Payment of coverage gap discounts is required under the Patient Protection and Affordable Care ~~Act, the health care reform legislation enacted in 2010.~~Act. Discounts and allowances may increase as a percentage of sales as we enter into new managed care contracts in the future.

~~Other Net Product~~We believe that first and fourth quarter revenues for Inbrija and Ampyra are subject to certain recurring seasonal factors relating to the commencement of a new calendar year. For example, some patients refill their prescriptions earlier ahead of the new year, in the fourth quarter, in anticipation of the year-end reset of health plan deductibles and the Medicare donut hole, or a year-end switch of their insurance plans or pharmacy benefit providers. Also, we believe specialty pharmacies may increase their inventory in anticipation of the holidays and new year. These factors have had a positive impact on fourth quarter revenues and a negative impact on first quarter revenues. Also, discounts and allowances typically are highest in the first quarter, and lowest in the fourth quarter, and when this occurs, fourth quarter revenues increase, and first quarter revenues decrease, on a relative basis.

Royalty Revenues

We recognized net revenue from the sale of other products of $3.6 million for the nine-month period ended September 30, 2017, as compared to $(1.2) million for the nine-month period ended September 30, 2016, an increase of $4.8 million.

~~Discounts and allowances, which are included as an offset in net revenue, consist of allowances for customer credits, including estimated chargebacks, rebates, returns and discounts.~~

~~License Revenue~~

We recognized $6.8 million in license revenue for the nine-month periods ended September 30, 2017 and 2016, related to the $110.0 million received from Biogen in 2009 as part of our collaboration agreement. We currently estimate the recognition period to be approximately 12 years from the date of the Collaboration Agreement.

~~Royalty Revenues~~

~~We recognized $8.5~~$7.2 million and ~~$7.8~~$7.5 million in royalty ~~revenue~~revenues for the ~~nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016,~~2022, respectively, ~~related to ex-U.S. sales~~a decrease of ~~Fampyra by Biogen.~~$0.3 million or 4%.

License Revenues

We recognized ~~$2.6 million~~negligible license revenue and ~~$3.1 million in royalty revenue~~no license revenues for the ~~nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016, respectively, related to the authorized generic sale of Zanaflex Capsules.~~2022, respectively.

We recognized $2.3 million and $1.9 million in royalty revenue for the nine-month periods ended September 30, 2017 and the period April 18, 2016, which is the date of the acquisition of Biotie, through September 30, 2016, respectively, related to sales of Selincro.

Cost of Sales

We recorded cost of sales of ~~$84.8~~$6.3 million for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 as compared to ~~$77.3~~$14.8 million for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2016.~~2022. Cost of sales for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 consisted primarily of ~~$66.0~~$5.8 million in inventory costs related to recognized ~~revenues.~~revenues and $0.5 million in other period costs. Cost of sales for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017 also~~2022 consisted primarily of ~~$8.5~~$14.2 million in inventory costs related to recognized revenues, $0.5 million in royalty fees based on net product shipments, ~~costs related to Selincro~~and $0.1 million in other period costs.

Amortization of ~~$6.9 million, the cost of Zanaflex Capsules authorized generic product sold of $1.6 million and $1.6 million for costs related to the~~Intangibles

We recorded amortization of intangible ~~assets.~~

~~Cost of sales for the nine-month period ended September 30, 2016 consisted primarily of $62.6 million in inventory costs~~asset related to ~~recognized revenues. Cost~~Inbrija of sales for the nine-month period ended September 30, 2016 also consisted of $8.2 million in royalty fees based on net product shipments, costs related to Selincro of $4.2 million, the cost of Zanaflex authorized generic product sold of $1.6 million and $0.4 million for costs related to the amortization of intangible assets.

~~Cost of License Revenue~~

~~We recorded cost of license revenue of $0.5~~$15.4 million for the ~~nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and 2016, respectively. Cost of license revenue represents the recognition of a portion of the deferred $7.7 million paid to Alkermes in 2009 in connection with the $110.0 million received from Biogen as a result of our collaboration agreement.2022.

Research and Development

Research and development expenses for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 were ~~$131.0~~$2.9 million as compared to ~~$149.6~~$3.2 million for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2016,~~2022, a decrease of approximately ~~$18.6~~$0.3 million, or ~~12.5%~~9%. The decrease was primarily due ~~primarily~~ to ~~reductions~~restructuring and related decreases in ~~spending of $15.2 million for Inbrija (CVT-301, levodopa inhalation powder)~~several research and CVT-427, $10.6 million for our Ampyra life cycle management program, $8.7 million for our discontinued Plumiaz program, $7.8 million for salaries and benefits related costs and $3.4 million for our other programs, partially offset by increased spending for products acquired as a result of the Biotie acquisition of $19.8 million and restructuring expenses of $5.6 million.development programs.

Selling, General and Administrative

Sales and marketing expenses for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 were ~~$71.8~~$19.1 million compared to ~~$77.3~~$20.8 million for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2016,~~2022, a decrease of approximately ~~$5.5~~$1.7 million, or ~~7.1%~~8%. The decrease was ~~attributable~~ primarily due to a decrease in ~~marketing, trade and sales related~~marketing-related spending of ~~$3.9~~$1.4 million for Inbrija, a decrease in ~~overall~~ salaries and benefits of ~~$1.9~~$0.8 million, partially offset by an increase in spending for Ampyra and other selling related ~~activities~~expenses of ~~$0.3~~$0.7 million.

General and administrative expenses for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 were ~~$70.3~~$25.2 million compared to ~~$99.1~~$36.2 million for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2016,~~2022, a decrease of approximately ~~$28.8~~$11 million, or ~~29.1%~~30%. ~~This~~The decrease was primarily due ~~primarily~~ to ~~reductions~~a decrease in ~~business development, legal, finance~~rent and ~~other related expenses of $21.5 million, decreased Biotie acquisition related~~facility costs of ~~$5.7~~$4.8 million, ~~and reductions~~a decrease in professional fees of $3.1 million, a decrease in salaries and ~~benefit related costs~~benefits of ~~$3.4~~$2.6 million, ~~partially offset by restructuring expenses~~and a decrease of ~~$2.0 million.~~

~~Asset Impairment~~

~~We recognized an asset impairment charge of $39.4~~$0.5 million in the nine-month period ended September 30, 2017 related to our intangible asset for Selincro. We reviewed the intangible asset for impairment due to a downward revision to the projected royalty revenue we expect to receive. Asother departmental spending.

Change in Fair Value of Derivative Liability

A derivative liability was recorded in December 2019 as a result of the ~~review, we determined that~~issuance of the ~~carrying~~2024 Notes. The derivative liability is measured at fair value on a quarterly basis and changes in the fair value are recorded in the consolidated statement of operations. We recorded no income due to the change in the fair value of the ~~asset was greater than~~derivative liability for the ~~estimated fair market value as of September 30, 2017. We did not recognize an asset impairment charge in the nine-month~~six-month period ended ~~September~~June 30, ~~2016.~~2023.

Changes in Fair Value of Acquired Contingent Consideration

As a result of the original ~~Civitas~~ spin out of Civitas from Alkermes, part of the consideration to Alkermes was a future royalty to be paid to Alkermes on ~~Civitas products. Acorda~~Inbrija. We acquired this contingent consideration as part of the Civitas acquisition. The fair value of that future royalty is assessed quarterly. We recorded a ~~$16.8 million expense pertaining~~gain relating to changes in the ~~fair-value~~fair value of our acquired contingent consideration of $1.9 million for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 as compared to ~~an expense~~income of ~~$11.9~~$6.1 million for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2016.~~2022. The changes in the ~~fair-value~~fair value of the acquired contingent consideration were primarily due to the ~~re-calculation~~change in projected revenue and the recalculation of ~~discounted~~ cash flows for the passage of time, ~~and updates to certain other estimated assumptions.~~as well as an increase in the discount rate.

Other Expense, Net

Other expense, net was ~~$14.1~~$15.1 million and $13.8 million for the ~~nine-month period~~six-month periods ended ~~September~~June 30, ~~2017 compared to~~2023 and 2022, respectively. Nearly all other expense, ~~of $3.5 million for the nine-month period ended September 30, 2016, a difference of $10.6 million. The difference~~net was ~~due primarily to the realized gain~~interest on the ~~final settlement~~2024 Notes.

Benefit from/(Provision for) Income Taxes

For the six-month periods ended June 30, 2023 and 2022, we recorded a benefit from income taxes of ~~the FX collar in 2016 of approximately $10.0 million, an increase in interest and amortization of debt discount expense of $1.6~~$4 million and a ~~decrease in interest income of $0.2 million, partially offset by a decrease in realized losses on foreign currency exchange of $1.2 million.~~

~~Provision for/Benefit from Income Taxes~~

~~For the nine-month periods ended September 30, 2017 and 2016, the Company recorded a $23.4 million~~ provision for ~~and $7.7 million benefit from~~ income taxes of ($26.8) million, respectively. The effective income tax rates for the ~~Company for the nine-month~~six-month periods ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022 were ~~-81.1%~~13.3% and ~~19.12%~~(60.4)%, respectively.

The variance in the effective tax rates for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 as compared to the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2016~~2022 was primarily due ~~primarily~~ to an increase in the existing valuation allowance recorded on ~~jurisdictions with Biotie pretax losses~~the Company’s deferred tax assets for which no tax benefit can be recognized, as a result of the ~~tax implications of costs related to the Biotie transaction, state taxes, the reduction~~deemed ownership that occurred in the ~~research & development~~prior year under IRS Section 382 which required a valuation allowance to be recorded on the Company’s tax ~~credit~~attributes and the ~~absence~~forfeitures of ~~orphan drug development in 2017~~.equity of which no tax deduction is recorded.

Liquidity and Capital Resources

Since our inception, we have financed our operations primarily ~~through~~from: private placements and public offerings of our ~~common stock~~capital stock; borrowing money through loans and ~~preferred stock, a convertible~~the issuance of debt ~~offering,~~instruments; payments received under our collaboration and licensing ~~agreements,~~agreements; revenue from sales of Ampyra, Fampyra, and Inbrija, as well as our former products, Zanaflex ~~tablets~~ and ~~Zanaflex Capsules~~Qutenza; royalty monetization and ~~Qutenza,~~a revenue interest financing arrangement; and, to a lesser extent, funding from ~~loans,~~ government ~~and non-government grants and other financing arrangements.~~grants. Also, in February 2021, we obtained additional capital from the sale of our Chelsea manufacturing operations.

~~At September~~On June 30, ~~2017,~~2023, we had ~~$192.5~~$25.3 million of cash and cash equivalents, compared to ~~$158.5~~$37.5 million at December 31, ~~2016. We expect that our existing~~2022. Our June 30, 2023 cash and cash ~~flows from operations will be sufficient~~equivalents balance does not include $1.1 million of restricted cash, of which $0.8 million is related to ~~fund our ongoing operations over~~self-funded employee health insurance, and $0.3 million is related to collateralized standby letters of credit. We incurred a net loss of $26.2 million for the ~~next 12 months from the financial statement filing date.~~six-month period ended June 30, 2023.

In April 2017, following a Federal District Court’s decision which invalidated certain of the Company’s patents relating to Ampyra, we implemented a corporate restructuring to reduce our cost structure and focus our resources on our two late stage Parkinson’s disease programs, Inbrija and tozadenant, as well as on maximizing Ampyra value. As part of this restructuring, we reduced headcount by approximately 20%. The majority of the reduction was completed in April 2017. While we believe that the cost savings from the restructuring and subsequent operating expense reductions will enable us to fund operations through the key milestones for our late-stage development programs, including the commercial launch of Inbrija, pending approval from the FDA, and Phase 3 data for tozadenant, there can be no guarantee that we will have

sufficient funding to do so. We may need to seek additional equity or debt financing or strategic collaborations to complete our product development activities, and could require substantial funding to commercialize any products that we successfully develop. We may not be able to raise additional capital on favorable terms or at all.

Our future capital requirements will depend on a number of factors, ~~including~~ including:

•

the amount of revenue generated from sales of ~~Ampyra, the continued progress of~~ Inbrija and Ampyra;

•

our ~~research and development activities,~~ ability to manage operating expenses;

•

the amount and timing of purchase price, milestone or other payments ~~payable~~that we may owe or have a right to receive under collaboration, license, asset sale, acquisition, or other agreements or transactions; and ~~acquisition agreements,~~ the extent to which the terms and conditions of our 2024 Notes restrict or direct our use of proceeds from such transactions;

•

the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims and other intellectual property ~~rights,~~rights; and

•

capital required or used for future acquisitions, or to in-license new products, programs or compounds, or for research and ~~compounds including the~~ development ~~costs~~ relating to ~~those products~~existing or future acquired or in-licensed programs or compounds. ~~To the extent our capital resources are insufficient~~

Our ability to meet our future operating requirements, repay our liabilities, and meet our other obligations, and continue as a going concern are dependent upon a number of factors, including our ability to generate cash from product sales, reduce planned expenditures, and obtain additional financing. If we ~~will need~~are unable to generate sufficient cash flow from the sale of our products, we may be required to adopt one or more alternatives, subject to the restrictions contained in the indenture governing our 2024 Notes, such as further reducing expenses, selling assets, restructuring debt, or obtaining additional equity capital on terms that may be onerous and which are likely to be highly dilutive. Also, our ability to raise additional capital ~~reduce planned expenditures,~~and repay or ~~incur~~restructure our indebtedness will depend on the capital markets and our financial condition at such time, among other factors. In addition, financing may not be available when needed, at all, on terms acceptable to ~~fund~~us or in accordance with the restrictions described above.

In June 2022, we were notified by the Nasdaq that we were not in compliance with Nasdaq’s listing rule 5450(a)(1), which requires that listed securities maintain the Minimum bid requirement. On June 2, 2023, we effected a 1-for-20 reverse stock split of the shares of our ~~operations. If we require additional financing~~outstanding common stock and proportionate reduction in the ~~future,~~number of authorized shares of our common stock from 61,666,666 to 3,083,333. On June 26, 2023, we ~~cannot assure you~~announced that itwe had received notice from the Nasdaq notifying us that, as of June 20, 2023, we had regained compliance with the Minimum bid requirement.

We believe that our existing cash and cash equivalents will be ~~available~~sufficient to ~~us on favorable terms, or~~cover our cash flow requirements for at ~~all.~~

~~Financing Arrangements~~

~~Saints Capital Notes~~

~~Effective January 2017,~~least the ~~Company paid $0.8 million in full payment~~next twelve months from the issuance date of these ~~notes.~~financial statements. However, our future requirements may change and will depend on numerous factors, some of which may be beyond our control.

Financing Arrangements

Convertible Senior Secured Notes Due 2024

~~In June 2014,~~On December 24, 2019, we completed the ~~Company entered into an underwriting agreement (the Underwriting Agreement) with J.P. Morgan Securities LLC (the Underwriter) relating to the issuance by the Company~~private exchange of ~~$345~~$276.0 million aggregate principal amount of our then outstanding 1.75% Convertible Senior Notes due 2021 (the ~~Notes)~~“2021 Notes”) for the 2024 Notes and cash. We issued approximately $207.0 million aggregate principal amount of the 2024 Notes and paid approximately $55.2 million in ~~an underwritten public offering~~cash to participating holders.

The 2024 Notes were issued pursuant to the Company’s Registration Statement on Form S-3 (the Registration Statement) and a related preliminary and final prospectus supplement, filed with the Securities and Exchange Commission (the Offering). The net proceeds from the offering, after deducting the Underwriter’s discount and the offering expenses paid by the Company, were approximately $337.5 million.

~~The Notes are governed by the terms of~~ an ~~indenture,~~Indenture, dated as of ~~June~~December 23, ~~2014 (the Base Indenture) and~~2019, among us, our wholly owned subsidiary, Civitas Therapeutics, Inc. (along with any domestic subsidiaries acquired or formed after the ~~first supplemental indenture, dated as~~date of ~~June 23, 2014 (the Supplemental Indenture, and together with~~issuance, the ~~Base Indenture, the Indenture)~~“Guarantors”), ~~each between the Company~~ and Wilmington Trust, National Association, as trustee and collateral agent (the ~~Trustee)~~“2024 Indenture”). The 2024 Notes are senior obligations of us and the Guarantors, secured by a first priority security interest in substantially all of the assets of us and the Guarantors, subject to certain exceptions.

The 2024 Notes will ~~be convertible into~~mature on December 1, 2024 unless earlier converted in accordance with their terms. Interest on the 2024 Notes is payable semi-annually in arrears at a rate of 6.00% per annum on each June 1 and December 1. On June 1 2023, we made a cash ~~shares~~payment of approximately $6.2 million in satisfaction of the ~~Company’s common stock or a combination~~interest payment due on June 1, 2023 which was made out of ~~cash and shares of~~restricted cash. We no longer have the ~~Company’s common stock, at~~option to pay interest on the ~~Company’s election, based on an initial conversion rate, subject to adjustment, of 23.4968 shares per $1,000 principal amount of~~2024 Notes ~~(which represents an initial conversion price of approximately $42.56 per share), only~~ in the following circumstances and to the following extent: (1) during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and we have fully utilized the ~~conversion rate~~restricted cash that was set aside for the payment of interest on ~~each such trading day; (2) during~~the 2024 Notes.

Subject to a number of exceptions and qualifications, the 2024 Indenture restricts our ability and certain of our subsidiaries to, among other things, (i) pay dividends or make other payments or distributions on their capital stock, or purchase, redeem, defease or otherwise acquire or retire for value any ~~calendar quarter commencing after the calendar quarter ending~~capital stock, (ii) make certain investments, (iii) incur indebtedness or issue preferred stock, other than certain forms of permitted debt, (iv) create liens on ~~September 30, 2014 (and only during such calendar quarter), if the last reported sale price of the common stock for at least 20 trading days (whether~~their assets, (v) sell their assets, (vi) enter into certain transactions with affiliates or ~~not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than~~(vii) merge, consolidate or ~~equal to 130% of the conversion price on each applicable trading day; (3) if the Company calls any~~sell all or substantially all of our assets. The 2024 Indenture also requires us to make an offer to repurchase the 2024 Notes ~~for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; (4)~~ upon the occurrence of ~~specified~~certain asset sales.

The 2024 Indenture provides that a number of events described in the Indenture; and (5) at any time on or after December 15, 2020 through the second scheduled trading day immediately preceding the maturity date. As of September 30, 2017, the Notes did not meet the criteria to be convertible.

The Company could not redeem the Notes prior to June 20, 2017. The Company may redeem for cash all or part of the Notes, at the Company’s option, on or after June 20, 2017 if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending within five trading days prior to the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

~~The Company~~ will ~~pay 1.75% interest per annum on the principal amount of the Notes, payable semiannually in arrears in cash on June 15 and December 15 of each year.~~

If the Company undergoes a “fundamental change” (as defined in the Indenture), subject to certain conditions, holders may require the Company to repurchase for cash all or part of their Notes in principal amounts of $1,000 or an integral

multiple thereof. The fundamental change repurchase price will be equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. If a make-whole fundamental change, as described in the Indenture, occurs and a holder elects to convert its Notes in connection with such make-whole fundamental change, such holder may be entitled to an increase in the conversion rate as described in the Indenture.

~~The Indenture contains customary terms and covenants and events of default. If~~constitute an event of default, ~~(other than~~including, among other things, (i) a failure to pay interest for 30 days, (ii) failure to pay the 2024 Notes when due at maturity, upon any required repurchase, upon declaration of acceleration or otherwise, (iii) failure to convert the 2024 Notes in accordance with the 2024 Indenture and the failure continues for five business days, (iv) not issuing certain notices required by the 2024 Indenture within a timely manner, (v) failure to comply with the other covenants or agreements in the 2024 Indenture for 60 days following the receipt of a notice of non-compliance, (vi) a default or other failure by us to make required payments under other indebtedness of our or certain subsidiaries having an outstanding principal amount of $30.0 million or more, (vii) failure by us or certain subsidiaries to pay final judgments aggregating in excess of $30.0 million, (viii) certain events of bankruptcy or insolvency and (ix) the commercial launch in the U.S. of a product determined by the FDA to be bioequivalent to Inbrija. In the case of an event of default arising from certain events of bankruptcy or ~~reorganization involving the Company)~~insolvency with respect to us, all outstanding 2024 Notes will become due and payable immediately without further action or notice. If any other event of default occurs and is continuing, the ~~Trustee by notice to the Company,~~trustee or the holders of at least 25% in aggregate principal amount of the then outstanding 2024 Notes ~~by notice to the Company and the Trustee,~~ may declare ~~100% of the principal of and accrued and unpaid interest, if any, on~~ all the ~~Notes~~notes to ~~be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will~~ be due and payable immediately. ~~Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving the Company, 100% of the principal and accrued and unpaid interest, if any, on all of the~~

The outstanding 2024 Notes will become due and payable automatically. Notwithstanding the foregoing, the Indenture provides that, to the extent the Company elects and for up to 270 days, the sole remedy for an event of default relating to certain failures by the Company to comply with certain reporting covenants in the Indenture consists exclusively of the right to receive additional interest on the Notes.

The Notes will be senior unsecured obligations and will rank equally with all of the Company’s existing and future senior debt and senior to any of the Company’s subordinated debt. The Notes will be structurally subordinated to all existing or future indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries and will be effectively subordinated to the Company’s existing or future secured indebtedness to the extent of the value of the collateral. The Indenture does not limit the amount of debt that the Company or its subsidiaries may incur.

In accounting for the issuance of the Notes, the Company separated the Notes into liability and equity components. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The carrying amount of the equity component representing the conversion option was determined by deducting the fair value of the liability component from the par value of the Notes as a whole. The excess of the principal amount of the liability component over its carrying amount, referred to as the debt discount, is amortized to interest expense over the seven-year term of the Notes using the effective interest method. The equity component is not re-measured as long as it continues to meet the conditions for equity classification.

~~Our outstanding note~~ balances as of ~~September~~June 30, ~~2017~~2023 consisted of the following:


(In thousands)	September 30, 2017			June 30, 2023
Liability component:
Principal	$	345,000		$	207,000
Less: debt discount and debt issuance costs, net		(38,589	)		(30,836	)
Net carrying amount	$	306,411		$	176,164
Equity component	$	61,195		$	18,257
Derivative liability-conversion Option				$	—

~~Asset Based Loan~~

On June 1, 2016, the Company and certain of its subsidiaries entered into a Credit Agreement (the “Credit Agreement”) with JPMorgan Chase Bank, N.A., as the sole initial lender and the administrative agent for the lenders. On May 4, 2017, the Company voluntarily terminated the Credit Agreement because it no longer served the Company’s needs. The Company did not incur any early termination penalties in connection with the termination. Prior to its termination, the Credit Agreement provided the Company with a three-year senior secured revolving credit facility in the maximum amount of $60 million. The restrictive covenants, as well as the lenders' security interests in collateral, under the Credit Agreement and the related loan documents terminated in connection with the termination of the facility.

Non-Convertible Capital Loans

~~The Non-Convertible Capital Loans (“Tekes Loans”) which were granted by Tekes, a Finnish Funding Agency~~Our Biotie Therapies Ltd. subsidiary received several non-convertible capital loans from Business Finland for ~~Technology~~research and ~~Innovation, had a~~development of specific drug candidates, with an aggregate adjusted acquisition-date fair value of $20.5 ~~million (€18.2 million) at the date of acquisition.~~million. The ~~Tekes~~ loans have a carrying value of $23.3 million as of September 30, 2017. The Tekes Loans consist of fourteen non-convertible loans that bear interest based on the greater of 3% or the base rate set by Finland’s Ministry of Finance minus one (1) percentage point. The maturity dates for these loans range from eightwere to ~~ten years from the date of issuance, however, according to certain~~

~~terms and conditions of the loans, Biotie may repay the principal and accrued and unpaid interest of the loans~~be repaid only when the consolidated retained earnings of Biotie from the development of specific product candidates is sufficient to fully repay the loans.

~~Convertible Capital Loan~~

~~In the three-month period ended March 31, 2017, the Company extended~~ We filed an ~~offer to each~~application with Business Finland for waiver of the ~~convertible capital loan holders to repurchase~~loans and accrued interest. In July 2022, Business Finland granted the ~~outstanding principal~~waiver request, which became effective in December 2022. We recorded a gain on extinguishment of debt of $27.1 million for the carrying amount of ~~each convertible capital loan. The Company paid approximately $1.7 million (€1.5 million)~~the loans including accrued interest in December 2022.

Cash and ~~$0.2 million (€0.2 million) in March and April 2017, respectively, to repurchase the outstanding principal amount of these loans. There were no outstanding balances on these loans as of September~~Cash Equivalents

At June 30, ~~2017.~~

~~Research and Development Loans~~

The Research and Development Loans (“R&D Loans”) which were granted by Tekes had a fair value of $2.9 million (€2.6 million) at the date of acquisition. The R&D Loans have a carrying value of $2.5 million as of September 30, 2017. The R&D Loans bear interest based on the greater of 1% or the base rate set by Finland’s Ministry of Finance minus three (3) percentage points. The principal on these loans will be paid in five equal annual installments beginning in 2017 through 2021.

~~Investment Activities~~

~~At September 30, 2017,~~2023 cash and cash equivalents were approximately ~~$192.5~~$25.3 million, as compared to ~~$158.5~~$37.5 million at December 31, ~~2016.~~2022. Our cash and cash equivalents consist of highly liquid investments with original maturities of three months or less at date of purchase and consist of ~~time deposits and~~ investments in a Treasury money market ~~funds. At September 30, 2017 and December 31, 2016, we held no short-term investments.~~fund. Also, we maintain cash balances with financial institutions in excess of insured limits. We do not anticipate any losses with respect to such cash balances. Our June 30, 2023 cash and cash equivalents balance does not include $1.1 million of restricted cash, of which $0.8 million is related to self-funded employee health insurance, and $0.3 million is related to collateralized standby letters of credit.

Net Cash ~~Provided by~~Used in Operations

Net cash ~~provided by~~used in operations was ~~$37.1~~$18.6 million for the ~~nine-month~~six-month period ending ~~September~~June 30, ~~2017.~~2023. Cash ~~provided~~used by operations for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 was primarily due to to:

•

a net loss of ~~$52.3~~$26.2 million, a decrease in accounts payable, ~~and~~ accrued expenses and other current liabilities of ~~$31.4~~$9.8 million, a ~~decrease in non-current portion~~deferred tax benefit of ~~deferred license revenue of $6.8~~$4 million, ~~and~~ an increase in other assets of ~~$4.0~~$2.7 million, an increase in inventory of $2 million, change in acquired contingent consideration obligation of $1.9 million; partially offset by ~~an asset impairment charge of $39.4 million, stock compensation expense of $25.3 million,~~

•

depreciation and amortization expenses of ~~$18.2 million, a change in contingent consideration liability of $16.8 million, deferred tax provision of $16.7~~$15.8 million, amortization of debt discount and debt issuance costs of ~~$8.9~~$9.1 million, an increase in other non-current liabilities of $2 million, a decrease in ~~inventory~~prepaid expenses and other current assets of ~~$3.3~~$0.5 million, a decrease in accounts receivable of $0.4 million, and ~~restructuring costs, net~~share-based compensation expenses of ~~cash payments of $1.9~~$0.2 million.

Net Cash Used in Investing

Net cash used in investing activities for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 was ~~$11.4 million, which was due primarily to purchases of property and equipment.~~$0.

Net Cash Provided by Financing

Net cash provided by financing activities for the ~~nine-month~~six-month period ended ~~September~~June 30, ~~2017~~2023 was $7.3 million, which was due to $7.0 million in net proceeds from the issuance of common stock and stock option exercises, and a refund of $2.7 million for the completion of the purchase of the noncontrolling interest in Biotie, partially offset by the repayment of loans payable of $2.4 million.$0.

Contractual Obligations and Commitments

A summary of our minimum contractual obligations related to our material outstanding contractual commitments is included in Note 1012 of our Annual ~~report~~Report on Form 10-K for the year ended December 31, ~~2016.~~2022. Our long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business.

Under certain agreements, we are required to pay royalties or license fees and milestones for the use of technologies and products in our ~~R&D~~research and development activities and in the commercialization of products. The amount and timing of any of the foregoing payments are not known due to the uncertainty surrounding the successful research, development, and commercialization of the products. ~~During~~

Effects of Inflation

Our most liquid assets are cash and cash equivalents. Because of their liquidity, these assets are not directly affected by inflation. Because we intend to retain and continue to use our equipment, furniture and fixtures and leasehold improvements, we believe that the ~~nine-month period ended September 30, 2017, commitments~~incremental inflation related to replacement costs of such items will not materially affect our operations. However, the ~~purchase~~rate of ~~inventory decreased as compared to December 31, 2016. As~~inflation affects our expenses, primarily employee compensation and contract services, which could increase our level of ~~September 30, 2017, we have inventory-related purchase commitments totaling approximately $25.3 million.~~expenses.

Critical Accounting Policies and Estimates

Our critical accounting policies are detailed in our Annual Report on Form 10-K for the year ended December 31, ~~2016. As~~2022. Effective January 1, 2022, we adopted ASU 2021-04, “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of ~~September 30, 2017, with the exception of~~Freestanding Equity-Classified Written Call Options.” Other than the adoption of ASU 2016-09, “Compensation – Stock Compensation” (Topic 718) and ASU 2015-11, “Inventory” (Topic 330): Simplifying the Measurement of Inventory, and ASU 2016-06, “Derivatives and Hedging” (Topic 815): Contingent Put and Call Options in Derivative Contracts,these new accounting guidance, our ~~critical~~significant accounting policies have not changed materially from December 31, ~~2016.~~2022.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our financial instruments consist of cash equivalents, convertible senior notes, non-convertible capital loans, research and development loans and accounts payable. The estimated fair values of all of our financial instruments approximate their carrying values at September 30, 2017, except for the fair valueWe are a smaller reporting company as defined by Rule 12b-2 of the ~~Company’s convertible senior notes which was approximately $317 million as of September 30, 2017.~~Exchange Act and are not required to provide the information otherwise required under this item.

We have cash equivalents at September 30, 2017, which are exposed to the impact of interest rate changes and our interest income fluctuates as our interest rates change. Due to the nature of our investments in money market funds, the carrying value of our cash equivalents approximates their fair value at September 30, 2017. At September 30, 2017, we held $192.5 million in cash and cash equivalents which had an average interest rate of approximately 0.7%.34

We maintain an investment portfolio in accordance with our investment policy. The primary objective of our investment policy is to preserve principal, maintain proper liquidity and to meet operating needs. Although our investments are subject to credit risk, our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure from any single issue, issuer or type of investment. Our investments are also subject to interest rate risk and will decrease in value if market interest rates increase. However, interest rate risk is mitigated due to the conservative nature and relatively short duration of our investments. We do not enter into hedging transactions in the normal course of business. However, as a result of the Biotie acquisition which was completed in euros, the Company was exposed to fluctuations in exchange rates between the U.S. dollar and the euro until the completion of the transaction. To mitigate this risk, the Company entered into foreign currency options to limit its exposure to fluctuations in exchange rates between the U.S. dollar and the euro until the initial transactions were completed.

Item 4. Controls and Procedures

Evaluation of disclosure controls and procedures

As required by Rule 13a-15 under the Securities Exchange Act of 1934 (the ~~Exchange Act)~~“Exchange Act”) we carried out an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the ~~third~~second quarter of ~~2017,~~2023, the period covered by this report. This evaluation was carried out under the supervision and with the participation of our management, including our President and Chief Executive Officer and our Chief ~~Business Operations~~Financial Officer and ~~Principal Accounting Officer.~~Treasurer. Based on that evaluation, these officers have concluded that, as of ~~September~~June 30, ~~2017,~~2023, our disclosure controls and procedures were effective to achieve their stated purpose.

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the ~~SEC’s~~Securities and Exchange Commission’s rules, regulations, and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to management, including our ~~Chief Executive Officer~~principal executive and ~~Chief, Business Operations and Principal Accounting Officer,~~principal financial officers, as appropriate to allow timely decisions regarding disclosure.

Change in internal control over financial reporting

In connection with the evaluation required by Exchange Act Rule 13a-15(d), our management, including our President and Chief Executive Officer and our Chief ~~Business Operations~~Financial Officer and ~~Principal Accounting Officer,~~Treasurer, concluded that there were no changes in our internal control over financial reporting during the quarter ended ~~September~~June 30, ~~2017,~~2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

As a result of the acquisition of Biotie Therapies Corp., we are currently in the process of integrating the applicable internal controls of the Biotie business into our internal control over financial reporting.

Limitations on the effectiveness of controls

Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings

~~Ampyra ANDA Litigation~~

~~Overview.~~ ~~As further described below, our Orange Book-listed patents for Ampyra are the subject of lawsuits~~From time to time, we may be involved in litigation or other legal proceedings relating to ~~Paragraph IV Certification Notices received from ten generic drug manufacturers~~claims arising out of operations in ~~2014~~the normal course of our business, including the matters described below. The outcome of litigation and ~~2015, who submitted Abbreviated New Drug Applications, or ANDAs, with~~other legal proceedings is unpredictable, and regardless of outcome, they can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.

In January 2023, the ~~FDA seeking marketing approval for generic versions of Ampyra (dalfampridine) Extended Release Tablets, 10mg. In 2015 and 2016, we reached settlement agreements with six of~~Company filed a petition in the generic companies, and in February 2017, we announced that we had reached a settlement agreement with one additional generic company. As to the remaining three generic manufacturers, in March 2017, the U.S. District Court for the Southern District of ~~Delaware (the “District~~New York (“District Court”) ~~rendered~~to confirm and modify the arbitral award received in October 2022 relating to a ~~decision from a bench trial~~dispute with Alkermes plc (“Alkermes”). In that arbitration proceeding, the arbitration panel found in the Company’s favor that Alkermes had leveraged its patent to illegally obtain royalties beyond the life of the patent in violation of federal law. The arbitration panel held that Alkermes’ conduct in ~~September 2016.~~continuing to charge royalties after the patent expired was unlawful per se and that the underlying agreements were unenforceable. The panel awarded the Company approximately $18.3 million, including interest, representing license royalties overpaid since July 2020 (“Award”). The Company petitioned the District Court ~~upheld our Orange-Book listed patent for Ampyra set~~ to ~~expire in~~confirm the Award, with modifications to the extent the arbitration panel disregarded federal law by declining to award royalties the Company paid prior to July 2020 and after July 2018, ~~but invalidated~~the date on which the arbitration panel found that the parties’ agreements were unenforceable as a matter of law. The petition sought restitution of the remaining illegal royalties that the arbitration panel found were demanded and collected by Alkermes in violation of the law in the amount of approximately $65 million together with pre- and post-award interest and costs. On February 8, 2023, Alkermes filed a brief opposing the relief requested in the Company’s petition and requested that the Award be confirmed without modification. The Company filed a brief in response on February 22, 2023. On August 4, 2023, the District Court confirmed the Award and denied the Company’s request to modify the Award. The Company is considering next steps, which may include an appeal of the District Court’s decision.

On August 20, 2020, ratiopharm Gmbh filed nullity actions against us in the German Federal Patent Court seeking to invalidate both of our ~~four other Orange Book-listed~~German patents ~~for Ampyra. We have~~that derived from our European patents, EP 1732548 (the ‘548 patent) and EP 2377536 (the ‘536 patent), with claims directed to the use of a sustained dalfampridine composition to increase walking speed in a patient with multiple sclerosis. In November 2021, the German Federal Patent Court issued preliminary opinions indicating that the claimed subject matter of the ‘548 patent lacked inventive step and the claimed subject matter of the ‘536 patent lacked novelty and inventive step. At oral hearings in February 2022 and April 2022, the German Federal Patent Court dismissed ratiopharm’s action against the ‘536 patent and the ‘548 patent, respectively, as inadmissible because of ongoing formality proceedings relating to these patents in the European Patent Office. Ratiopharm has appealed the decision on the ~~four invalidated patents, and~~‘536 patent but not the non-settling generic drug manufacturers have appealed the decision upholding the patent set to expire in July 2018. As further described below, in April 2017 we received a Paragraph IV Certification Notice from an additional generic drug manufacturer, who submitted an ANDA with the FDA seeking marketing approval for a generic version of Ampyra (dalfampridine) Extended Release Tablets, 10mg.

~~First ANDA Filers.~~ In June and July of 2014, we received eight separate Paragraph IV Certification Notices from Accord Healthcare, Inc., Actavis Laboratories FL, Inc. ("Actavis"), Alkem Laboratories Ltd. and its affiliate Ascend Laboratories, LLC ("Alkem"), Apotex Inc., Aurobindo Pharma Ltd. ("Aurobindo"), Mylan Pharmaceuticals, Inc., Roxane Laboratories, Inc., and Teva Pharmaceuticals USA, Inc., advising that each of these companies had submitted an ANDA to the FDA seeking marketing approval for generic versions of Ampyra (dalfampridine) Extended Release Tablets, 10 mg. The ANDA filers challenged the validity of our Orange Book-listed patents for Ampyra, and they also asserted that generic versions of their products do not infringe certain claims of these patents. In response to the filing of these ANDAs, in July 2014, we filed lawsuits against these generic pharmaceutical manufacturing companies and certain affiliates in the U.S. District Court for the District of Delaware asserting infringement of our U.S. Patent Nos. 5,540,938, 8,007,826, 8,354,437, 8,440,703, and 8,663,685. Requested judicial remedies included recovery of litigation costs and injunctive relief, including a request that the effective date of any FDA approval for these generic companies to make, use, offer for sale, sell, market, distribute, or import the proposed generic products be no earlier than the dates on which the Ampyra Orange-Book listed patents expire, or any later expiration of exclusivity to which we are or become entitled. These lawsuits with the ANDA filers were consolidated into a single case. A bench trial was completed in September 2016, and the District Court issued a decision in March 2017. The District Court upheld ~~U.S. Patent No. 5,540,938 (the ‘938 patent), which is set to expire in July 2018.~~ ~~The claims of~~ ~~the ‘938 patent~~ relate to methods for treating a neurological disease, such as MS, and cover the use of a sustained release dalfampridine formulation, such as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg for improving walking in people with MS. The District Court invalidated U.S. Patent Nos. 8,663,685, 8,007,826, 8,440,703, and 8,354,437 which pertain to AMPYRA. In May 2017, we appealed the ruling on these patents. As a result of the District Court’s ruling, no generic version of Ampyra will be marketed in the U.S. at least until July 31, 2018, although in June 2017 the non-settling ANDA filers appealed the District Court’s decision upholding the ‘938 patent. Generic versions of Ampyra may be further delayed if the United States Court of Appeals for the Federal Circuit (the “Appellate Court”) overturns the District Court’s decision on the ~~four invalidated patents, which~~‘548 patent, and could ~~include reversal or remand~~refile the nullity actions. On December 6, 2022, the German Federal Court of Justice held that ratiopharm’s ‘536 nullity action was admissible and remanded the case back to the ~~District~~German Federal Patent Court. IfOn January 11, 2022, Stada Arzneimittel also filed a nullity action against the ~~Appellate Court does not overturn~~‘536 patent. The ratiopharm and Stada Arzneimittel ‘536 nullity actions have been consolidated and an oral hearing has been scheduled for March 2024. On July 27, 2022, Teva GmbH also filed a nullity action against the ~~District Court’s decision by July 30, 2018, multiple ANDA filers may be able to launch generic versions of Ampyra absent injunctive relief.~~ ~~In August 2017, we filed our opening brief to the~~ ~~Appellate Court~~. Both the Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) filed amicus briefs in support of our appeal. The defendants have now filed their opposition and opening cross-appeal brief. We expect reply briefs to be filed in November 2017, followed by oral argument to be scheduled by the Appellate Court.

~~In October and December 2015, we entered into settlement agreements with Actavis and Aurobindo to resolve the~~‘548 patent, ~~litigation that we brought against them~~both in the ~~U.S. District~~same court as the ratiopharm nullity actions. On January 27, 2023, the German Federal Patent Court ~~for~~issued a preliminary opinion in the ~~District of Delaware, described above. As a result~~‘548 Teva nullity action that the claimed subject matter of the ~~settlement agreements, Actavis and Aurobindo will be permitted to market generic versions of Ampyra in~~‘548 patent lacked inventive step. At an oral hearing on July 11, 2023, the ~~U.S. at a specified date in 2027, or potentially earlier under certain circumstances. The District~~German Federal Patent Court entered an order dismissing the case against Actavis without prejudice in October 2015. As a result of the settlement agreement with Aurobindo, and upon the request of the parties, the District Court entered a Consent Order, in which it dismissed our litigation against Aurobindo in December 2015. The parties have submitted the agreements to the Federal Trade Commission and the Department of Justice, as required by federal law. In August 2016, we entered into a settlement agreement with Alkem to resolve the patent litigation that we brought against Alkem in the U.S. District Court for the District of Delaware,

described above. As a result of the settlement agreement, Alkem will be permitted to market a generic version of Ampyra in the U.S. at a specified date in 2027, or potentially earlier under certain circumstances. As a result of the settlement agreement with Alkem, and upon the request of the parties, the District Court entered a Consent Order, in which it dismissed our litigation against Alkem in August of 2016. The parties have submitted the agreement to the Federal Trade Commission and the Department of Justice, as required by Federal law. In August 2016, we entered into a settlement agreement with Accord Healthcare, Inc. and Intas Pharmaceuticals Limited (collectively "Accord") to resolve the patent litigation that we brought against Accord in the U.S. District Court for the District of Delaware, described above. As a result of the settlement agreement, Accord will be permitted to market a generic version of Ampyra in the U.S. at a specified date in 2027, or potentially earlier under certain circumstances. As a result of the settlement agreement with Alkem, and upon the request of the parties, the District Court entered a Consent Order, in which it dismissed our litigation against Accord in August of 2016. The parties have submitted the agreement to the Federal Trade Commission and the Department of Justice, as required by state law. The settlements with Actavis, Aurobindo, Alkem and Accord do not resolve the patent litigation that we brought against the other ANDA filers, as described in this report.

In February 2017, we entered into a settlement agreement with Apotex Inc. and its subsidiary Apotex Corporation (collectively “Apotex”) to resolve the patent litigation that we brought against them in the U.S. District Court for the District of Delaware, described above. As a result of the settlement agreement, Apotex will be permitted to market a generic version of Ampyra in the U.S. at a specified date in 2025, or potentially earlier under certain circumstances. The District Court has entered a Consent Order, in which it has dismissed our litigation against Apotex referred to above. The parties have submitted the agreement to the Federal Trade Commission and the Department of Justice, as required by federal law. The settlement with Apotex does not resolve the patent litigation that we brought against other ANDA filers, as described in this report.

~~Second ANDA Filers.~~ In May 2015, we received a Paragraph IV Certification Notice from Sun Pharmaceutical Industries Limited and Sun Pharmaceuticals Industries Inc. ("Sun") advising that they had submitted an ANDA to the FDA seeking marketing approval for a generic version of Ampyra (dalfampridine) Extended Release Tablets, 10 mg. Sun challenged the validity of four of our five Orange Book-listed patents for Ampyra, and did not file against our U.S. Patent No. 5,540,938, and also asserted that generic versions of its products may not infringe certain claims of these patents. In response to the filing of the ANDA, in May 2015 we filed a lawsuit against Sun in the U.S. District Court for the District of Delaware asserting infringement of our U.S. Patent Nos. 8,007,826, 8,354,437, 8,440,703, and 8,663,685. In October 2015, we entered into a settlement agreement with Sun to resolve this patent litigation. As a result of the settlement agreement, Sun will be permitted to market a generic version of Ampyra in the U.S. at a specified date in 2027, or potentially 181 days after a first ANDA filer has entered the market. As a result of the settlement agreement, and upon request of the parties, the District Court entered a Consent Order, in which it dismissed our litigation against Sun in October 2015. The parties have submitted the agreement to the Federal Trade Commission and the Department of Justice, as required by federal law. The settlement with Sun does not resolve the patent litigation that we brought against the other ANDA filers, described in this report.

In September 2015, we received a Paragraph IV Certification Notice from Par Pharmaceutical, Inc. ("Par") advising that it had submitted an ANDA to the FDA seeking marketing approval for a generic version of Ampyra (dalfampridine) Extended Release Tablets, 10 mg. Par challenged the validity of four of our five Orange Book-listed patents for Ampyra, and did not file against our U.S. Patent No. 5,540,938, and it also asserted that generic versions of its products may not infringe certain claims of these patents. In response to the filing of the ANDA, in September 2015 we filed a lawsuit against Par in the U.S. District Court for the District of Delaware asserting infringement of our U.S. Patent Nos. 8,007,826, 8,354,437, 8,440,703, and 8,663,685. In January 2016, we entered into a settlement agreement with Par to resolve this patent litigation. As a result of the settlement agreement, Par will be permitted to market a generic version of Ampyra in the U.S. at a specified date in 2027, or potentially 181 days after a first ANDA filer has entered the market. As a result of the settlement agreement, and upon the request of the parties, the District Court entered a Consent Order, in which it dismissed our litigation against Par in January 2016. The parties have submitted the agreement to the Federal Trade Commission and the Department of Justice, as required by federal law. The settlement with Par does not resolve the patent litigation that we brought against the other ANDA filers, described in this report.

In April 2017, we received a Paragraph IV Certification Notice from Micro Labs Ltd. (“Micro”) advising that it had submitted an ANDA to the FDA seeking marketing approval for a generic version of Ampyra (dalfampridine) Extended Release Tablets, 10mg. Micro has challenged the validity of four of our five Orange Book-listed patents for Ampyra, and did not file against our U.S. Patent No. 5,540,938, and it also asserted that a generic version of its product does not infringe certain claims of these patents. In response to the filing of the ANDA, in May 2017 we filed a lawsuit against Micro in the U.S. District Court for the District of New Jersey, ~~asserting infringement of our U.S. Patent Nos. 8,007,826, 8,354,437, 8,440,703, and 8,663,685. We filed the lawsuit within 45 days from the date of receipt of Micro’s Paragraph IV Certification~~

Notice, which instituted the 30 month statutory stay of approval period to the Micro ANDA under the Hatch-Waxman Act. Requested judicial remedies include recovery of litigation costs and injunctive relief, including a requestheld that the ~~effective date~~‘548 patent was invalid. We are discussing with Biogen the possibility of ~~any FDA approval for Micro~~an appeal. We are working with Biogen to make, use, offer for sale, sell, market, distribute, or import the proposed generic products be no earlier than the dates on which the Ampyra Orange-book listed patents expire, or any later expiration of exclusivity to which we are or become entitled. Since the Micro ANDA was filed after January 22, 2015, which was the end of the new chemical entity (NCE) exclusivity period for Ampyra, the 30 month statutory stay of approval will start from the receipt of the Paragraph IV Certification Notice. This restricts the FDA from approving the Micro ANDA until October 2019 at the earliest, unless the U.S. District Court for the District of New Jersey or the United States Court of Appeals for the Federal Circuit issues a decision adverse to all of our asserted Orange Book-listed patents prior to that date.

~~We will~~ vigorously defend these actions and enforce our ~~intellectual property~~patent rights.

~~Item 1 of Part II of our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2017, and June 30, 2017, include prior updates to the legal proceedings described above.~~

Item 1A. Risk Factors

In addition to the other information set forth in this report, you should carefully consider the risk factors discussed in Part I, Item 1A. Risk Factors, in our Annual Report on Form 10-K for the year ended December 31, ~~2016,~~2022, as updated in our Quarterly Reports subsequently filed during the current fiscal year, including this report, all of which could materially affect our business, financial condition and/or ~~future~~operating results. There have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2022, other than set forth below. These risks are not the only risks ~~facing~~facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating ~~results. Following~~results in the future.

Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and our failure to comply with data protection laws and regulations could lead to government actions, which could cause our business and reputation to suffer.

Evolving state, federal, and foreign laws, regulations and industry standards regarding privacy and security apply to our collection, use, retention, protection, disclosure, transfer and other processing of personal data. Privacy and data protection laws may be interpreted and applied differently from country to country and state to state in the U.S. and may create inconsistent or conflicting requirements, which can increase the costs incurred by us in complying with such laws, which may be substantial. For example, the European Data Protection Regulation (“GDPR”) imposes a broad array of requirements for processing personal data, including elevated disclosure requirements regarding collection and use of such data, requirements that companies allow individuals to obtain copies or demand deletion of personal data held by those companies, limitations on retention of information, and public disclosure of significant data breaches, among other things. The GDPR provides for substantial penalties for non-compliance. Our efforts to comply with the GDPR and other privacy and data protection laws could impose significant costs and challenges that may increase over time, and we are exposed to substantial penalties or litigation related to violations of these or future data privacy laws and regulations.

Similarly, privacy laws and regulations are also expanding in the U.S. The California Consumer Privacy Act (“CCPA”), which became effective January 1, 2020, substantially expands privacy obligations of many businesses, including requiring new disclosures to California consumers, imposing new rules for collecting or using information about minors and affording consumers the right to know whether their data is sold or disclosed, the ~~restated text~~right to request that a company delete their personal information, the right to opt-out of the sale of personal information and the right to non-discrimination in terms of price or service when a consumer exercises a privacy right. Like the GDPR, the CCPA establishes potentially significant penalties for violation. The CCPA also provides a private right of action along with statutory damages for certain ~~risk factors~~data breaches. The California Privacy Rights Act (“CPRA”), which became operational on July 1, 2023, expands on the CCPA, creating additional consumer rights and protections, including the right to ~~report changes since~~correct personal information, the right to opt out of the use of personal information in automated decision making, the right to opt out of sharing consumer’s personal information for cross-context behavioral advertising, and the right to restrict use of and disclosure of sensitive personal information. Similar restrictions are also included in the privacy laws of other states in the U.S.

We are evaluating our ~~publication~~privacy program as a result of ~~risk factors~~these privacy laws, and it is likely we will incur additional expense and investment of resources in our ~~2016 Annual Report on Form 10-K~~efforts to comply. If we are unable to implement a suitable compliance program relating to these or future privacy laws and ~~our update~~regulations, we may face increased exposure to regulatory actions, including substantial fines and penalties.

Item 5. Other Information

Securities Trading Plans of Directors and Executive Officers

During the ~~risk factors in our Quarterly Report on Form 10-Q for the quarter~~three months ended June 30, ~~2017.~~

~~The approval~~2023, none of ~~Zanaflex Capsules is subject to certain post-approval regulatory requirements that we have not completed, and we may be subject to penalties if we fail to comply with these requirements and~~ our ~~Zanaflex products could be subject to enforcement actions~~directors or ~~withdrawal from the market.~~

We have an outstanding FDA commitment to provide an assessment of the safety and effectiveness of Zanaflex Capsules in pediatric patients. This commitment, which is included in the NDA approval for Zanaflex Capsules, was to be satisfied by February 2007. We provided retrospective pediatric safety data to the FDA in April 2007. However, we were not able to complete the pediatric pharmacokinetic study by the February 2007 deadline due to delays in investigator recruitment and obtaining Institutional Review Board approvals. The study was completed and the final report submitted to the FDA in April 2008. The FDA reviewed our report against new standards set out in the Pediatric Research Equity Act (PREA) and reauthorized by both the 2007 FDA Amendments Act (FDAAA) and the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) and concluded that the report did not satisfy the commitment. The FDA informed us that a series of studies designed to further characterize the pharmacokinetics and demonstrate the efficacy and long-term safety of Zanaflex Capsules in children will be required to fulfill the pediatric commitment for Zanaflex Capsules. In June 2011, the FDA informally advised us that it would be amending the pediatric commitment for Zanaflex Capsules to require a non-clinical juvenile toxicology study, as well as formalize the timelineSection 16 reporting officers adopted or terminated any contract, instruction or written plan for the ~~required pediatric studies. In December 2012, the FDA issued a formal written request~~purchase or sale of our securities that confirmed the information in its informal June 2011 request, and set forth specific deadlines for the required pediatric non-clinical and clinical studies. In January 2013, we submitted a request in writing to the FDA to extend the deadlines for these studies, and in September 2014 we received a “Denial of Deferral Request” letter from the FDA. We responded to this denial letter in October 2014, requesting the FDA to reconsider the denial, which the FDA again denied in March 2015. Subsequently in March 2015, we received a notice of non-compliance with PREA. In May 2016, the FDA denied our request for a full waiver of pediatric studies, and subsequently published a letter of non-compliance and our response to the FDA’s letter of non-compliance under 505B99(d)(1) of the Federal Food, Drug and Cosmetic Act. While our request for full waiver of the pediatric studies was denied, in their May 2016 letter the FDA requested that we use existing data from previously completed studies to employ a modeling and simulation approach to characterize the pharmacokinetics of tizanidine in pediatric subjects to select a dose for future study, and further the letter requested that these modeling and simulations be submitted to the FDA. ~~Based on a July 2017 teleconference with the FDA, we understand that the FDA may consider this information as sufficient~~intended to satisfy the outstanding pediatric post-marketing commitment. We believe we have adequately completed the modelling and simulation analysis and we have submitted this information to the FDA. If the FDA deems this information sufficient to support pediatric dosing recommendations, the outstanding pediatric post-marketing requirement may be considered satisfied. However, we have not received written confirmation from the FDAaffirmative defense conditions of ~~this understanding.~~ ~~Additionally, and separate from the pediatric commitment, the FDA asked~~

~~for, and we have completed, a clinical electrocardiogram study~~Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement” (as defined in adult humans to investigate potential QT prolongation (heart rhythm measure). This post-marketing commitment has been fulfilled. The remaining studies could be more extensive and more costly than our prior studies and might result in new data that are not consistent with the current safety and efficacy profileItem 408(c) of the drug, which might require us to change our product labeling and could harm product sales. We also may be subject to penalties for not meeting our pediatric study commitments, including a court-imposed injunction to conduct studies.Regulation S-K.

Certain provisions of Delaware law, our certificate of incorporation, our bylaws and our shareholder rights plan may delay or prevent an acquisition of us that stockholders may consider favorable or may prevent efforts by our stockholders to change our directors or our management, which could decrease the value of your shares.

Our certificate of incorporation and bylaws contain provisions that could make it more difficult for a third party to acquire us, and may have the effect of preventing or hindering any attempt by our stockholders to replace our current directors or officers. These provisions include:37

Our board of directors has the right to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors.

Our board of directors may issue, without stockholder approval, shares of preferred stock with rights, preferences and privileges determined by the board of directors. The ability to authorize and issue preferred stock with voting or other rights or preferences makes it possible for our board of directors to issue preferred stock with super voting, special approval, dividend or other rights or preferences on a discriminatory basis that could impede the success of any attempt to acquire us.

Our board of directors is divided into three classes, each with staggered three-year terms. As a result, only one class of directors will be elected at each annual meeting of stockholders, and each of the two other classes of directors will continue to serve for the remainder of their respective three-year terms, limiting the ability of stockholders to reconstitute the board of directors.

The vote of the holders of 75% of the outstanding shares of our common stock is required in order to take certain actions, including amendment of our bylaws, removal of directors for cause and certain amendments to our certificate of incorporation.

In addition, we have adopted a shareholder rights plan, which provides, among other things, that when specified events occur, our stockholders will be entitled to purchase from us shares of junior preferred stock. The rights plan will expire on August 31, 2018. The preferred stock purchase rights are triggered ten business days after the date of a public announcement that a person or group acting in concert has acquired, or has obtained the right to acquire, beneficial ownership of 15% or more of our outstanding common stock. The preferred stock purchase rights would cause dilution to a person or group that attempts to acquire the Company on terms that are not approved by our board of directors. While we believe our rights plan enables our board of directors to help ensure that our stockholders are not deprived of the opportunity to realize the full and fair value of their investments, the rights plan may inhibit a change in control of the Company by a third party in a transaction not approved by our board of directors. If a change in control is inhibited or delayed in this manner, it may adversely affect the market price of our common stock.

As a Delaware corporation, we are also subject to certain anti-takeover provisions of Delaware law. Under Delaware law, a corporation may not engage in a business combination with any holder of 15% or more of its capital stock unless the holders has held the stock for three years or, among other things, the board of directors has approved the transaction. Our board of directors could rely on Delaware law to prevent or delay an acquisition of us, which could have the effect of reducing your ability to receive a premium on your common stock.

Item 6. Exhibits


Exhibit No.		Description
3.1		Amended and Restated Certificate of ~~Designations of Series A Junior Participating Preferred Stock~~Incorporation of Acorda Therapeutics, Inc. ~~Incorporated~~, dated June 2, 2023 (incorporated herein by reference to Exhibit 3.1 to the ~~Registrant’s~~Company’s Current Report on Form 8-K filed ~~on September 1, 2017~~June 2, 2023).
~~4.1~~31.1		Rights Agreement, dated as of August 31, 2017, between Acorda Therapeutics, Inc. and Computershare Trust Company, N.A., as Rights Agent, which includes the Form of Certificate of Designations, the Form of Right Certificate, and the Summary of Rights to Purchase Preferred Shares attached thereto as Exhibits A,B, and C respectively. Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on September 1, 2017.
~~10.1~~		~~Amendment C, dated October 11, 2017, by and between North River Everett Ave, LLC and Civitas Therapeutics, Inc.~~
~~31.1~~		Certification by the ~~Chief~~Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of ~~1934.~~1934.
31.2		Certification by the Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
32.1		Certification by the ~~Chief~~Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2		Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS**101.INS		Inline XBRL Instance Document.
101.SCH**101.SCH		Inline XBRL Taxonomy Extension Schema Document.
101.CAL**101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF**101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB**101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE**101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104		Cover Page Interactive Data File, formatted in Inline XBRL (included in Exhibit 101).

SIGNATURES

*Indicates management contract or compensatory plan or arrangement.

**In accordance with Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q shall be deemed to be "furnished" and not "filed."

~~SIGNATURES~~

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	Acorda Therapeutics, Inc.

	By:	/s/ Ron Cohen
Date: ~~November 7, 2017~~August 8, 2023		Ron Cohen, M.D. President, Chief Executive Officer and Director (Principal Executive Officer)

	By:	/s/ ~~David Lawrence~~Michael A. Gesser
Date: ~~November 7, 2017~~August 8, 2023		~~David Lawrence~~Michael A. Gesser Chief ~~Business Operations~~Financial Officer and Treasurer (Principal Financial and Accounting ~~Officer~~Officer)

4039


~~420 Saw Mill~~2 Blue Hill Plaza, 3rd Floor, Pearl River ~~Road, Ardsley,~~ , New York		~~10502~~10965
(Address of principal executive offices)		(Zip Code)


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock $0.001 par value per share	ACOR	Nasdaq Global Select Market


Large accelerated filer	☒☐	Accelerated filer	☐
Non-accelerated filer	☐ ~~(Do not check if a small reporting company)~~☒	~~Small~~Smaller reporting company	☐☒
Emerging growth company	☐

(In thousands, except share data)	September 30, 2017			December 31, 2016
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	192,496		$	158,537
Restricted cash		68			79
Trade accounts receivable, net of allowances of $552 and $964, as of September 30, 2017 and December 31, 2016, respectively		53,825			52,239
Prepaid expenses		9,757			12,907
Finished goods inventory		39,870			43,135
Other current assets		7,399			5,760
Total current assets		303,415			272,657
Property and equipment, net of accumulated depreciation		36,484			34,310
Goodwill		285,317			280,599
Deferred tax asset		4,400			4,400
Intangible assets, net of accumulated amortization		705,141			742,242
Non-current portion of deferred cost of license revenue		1,796			2,272
Other assets		8,505			5,855
Total assets	$	1,345,058		$	1,342,335
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	21,741		$	26,933
Accrued expenses and other current liabilities		78,304			104,890
Current portion of deferred license revenue		9,057			9,057
Current portion of loans payable		636			6,256
Current portion of convertible notes payable		—			765
Total current liabilities		109,738			147,901
Convertible senior notes (due 2021)		306,411			299,395
Acquired contingent consideration		88,900			72,100
Non-current portion of deferred license revenue		25,663			32,456
Non-current portion of loans payable		25,174			24,635
Deferred tax liability		98,537			92,807
Other non-current liabilities		10,645			8,830
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value. Authorized 1,000,000 shares at September 30, 2017 and no shares at December 31, 2016; no shares issued as of September 30, 2017 and December 31, 2016, respectively		—			—
Common stock, $0.001 par value. Authorized 80,000,000 shares at September 30, 2017 and December 31, 2016; issued 46,720,478 and 46,182,738 shares, including those held in treasury, as of September 30, 2017 and December 31, 2016, respectively		47			46
Treasury stock at cost (16,151 shares at September 30, 2017 and 12,420 shares at December 31, 2016)		(389	)		(329	)
Additional paid-in capital		957,543			921,365
Accumulated deficit		(284,148	)		(243,970	)
Accumulated other comprehensive income (loss)		6,937			(12,901	)


					June 30, 2023			December 31, 2022
					(unaudited)
Assets
Current assets:
Cash and cash equivalents					$	25,270		$	37,536
Restricted cash						828			6,884
Trade accounts receivable, net of allowances of $875 and $842, as of June 30, 2023 and December 31, 2022, respectively						13,390			13,866
Prepaid expenses						5,480			4,312
Inventory, net						14,797			12,752
Other current assets						5,149			6,765
Total current assets						64,914			82,115
Property and equipment, net of accumulated depreciation						2,163			2,603
Intangible assets, net of accumulated amortization						289,700			305,087
Right of use asset, net of accumulated amortization						4,765			5,287
Restricted cash						255			255
Other non-current assets						2,899			248
Total assets					$	364,696		$	395,595
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable					$	3,175		$	9,809
Accrued expenses and other current liabilities						21,822			23,680
Current portion of lease liabilities						1,567			1,545
Current portion of acquired contingent consideration						3,274			2,532
Deferred revenue						548			384
Total current liabilities						30,386			37,950
Convertible senior notes						176,164			167,031
Non-current portion of acquired contingent consideration						35,226			38,668
Non-current portion of lease liabilities						3,764			4,341
Deferred tax liability						39,556			44,202
Other non-current liabilities						11,732			9,781
Stockholders’ equity:
Preferred stock, $0.001 par value per share. Authorized 1,000,000 shares at June 30, 2023 and December 31, 2022; no shares issued as of June 30, 2023 and December 31, 2022, respectively						—			—
Common stock, $0.001 par value per share. Authorized 3,083,333 shares at June 30, 2023 and December 31, 2022; issued 1,242,376 shares, including those held in treasury, as of June 30, 2023 and December 31, 2022, respectively						1			24
Treasury stock at cost (278 shares at June 30, 2023 and December 31, 2022)						(638	)		(638	)
Additional paid-in capital						1,030,103			1,029,881
Accumulated deficit						(962,478	)		(936,273	)
Accumulated other comprehensive income						880			628
Total stockholders’ equity		679,990		664,211		67,868			93,622
Total liabilities and stockholders’ equity	$	1,345,058	$	1,342,335	$	364,696		$	395,595


			Page
PART I—FINANCIAL INFORMATION
Item 1.	Financial Statements		1
	Consolidated Balance Sheets as of ~~September~~June 30, ~~2017~~2023 (unaudited) and December 31, ~~2016~~2022		1
	Consolidated Statements of Operations (unaudited) for the ~~Three~~Three- and ~~Nine-month~~Six-month Periods Ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022		32
	Consolidated Statements of Comprehensive ~~Loss~~Income (Loss) (unaudited) for the ~~Three~~Three- and ~~Nine-month~~Six-month Periods Ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022		43
	Consolidated Statements of Changes in Stockholders’ Equity (unaudited) for the Three- and Six-month Periods Ended June 30, 2023 and 2022	4
	Consolidated Statements of Cash Flows (unaudited) for the ~~Nine-month~~Six-month Periods Ended ~~September~~June 30, ~~2017~~2023 and ~~2016~~2022		5
	Notes to Consolidated Financial Statements (unaudited)		76
Item 2.2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		1822
Item 3.	Quantitative and Qualitative Disclosures About Market Risk		34
~~Item 4.~~	~~Controls and Procedures~~		34
Item 4.	Controls and Procedures	35
PART II—OTHER INFORMATION
Item 1.	Legal Proceedings		36
Item 1A.	Risk Factors		3836
Item 6.5.	~~Exhibits~~Other Information	37
Item 6.	40Exhibits	38
Signatures		39


	Common stock
(In thousands)	Number of shares		Par value			Treasury stock			Additional paid-in capital		Accumulated deficit			Accumulated other comprehensive (loss) income		Total stockholders' equity
Balance at December 31, 2022		1,242	$	24		$	(638	)	$	1,029,881	$	(936,273	)	$	628	$	93,622
Compensation expense for issuance of stock options to employees		—		—			—			71		—			—		71
Other comprehensive income, net of tax		—		—			—			—		—			91		91
Net loss		—		—			—			—		(16,824	)		—		(16,824	)
Balance at March 31, 2023		1,242	$	24		$	(638	)	$	1,029,952		(953,097	)	$	719	$	76,960
Compensation expense for issuance of stock options to employees		—		—			—			128		—			—		128
Reverse Stock Split Adjustment		—		(23	)		—			23		—			—		—
Other comprehensive income, net of tax		—		—			—			—		—			161		161
Net loss		—		—			—			—		(9,381	)		—		(9,381	)
Balance at June 30, 2023		1,242	$	1		$	(638	)	$	1,030,103	$	(962,478	)	$	880	$	67,868

(In thousands)	Preliminary Allocation, as adjusted through December 31, 2016			Measurement Period Adjustments			Final Allocation as of April 18, 2017
Cash and cash equivalents	$	73,854		$	—		$	73,854
Other current assets		1,878			—			1,878
Other long-term assets		4,962			—			4,962
Intangible assets (indefinite-lived)		260,500			—			260,500
Intangible assets (definite-lived)		65,000			—			65,000
Current liabilities		(18,572	)		3,837			(14,735	)
Deferred taxes		(89,908	)		(156	)		(90,064	)
Other long-term liabilities		(25,690	)		2,740			(22,950	)
Fair value of assets and liabilities acquired		272,024			6,421			278,445
Goodwill		103,876			(6,421	)		97,455
Total purchase price		375,900			—			375,900
Less: Noncontrolling interests		(25,736	)		—			(25,736	)
Purchase consideration on date of acquisition	$	350,164		$	—		$	350,164

(In thousands)
Balance at December 31, 2016	$	280,599
Decrease to goodwill for measurement period adjustments		(6,421	)
Foreign currency translation adjustment		11,139
Balance at September 30, 2017	$	285,317

	Severance and
	Other Employee
(In thousands)	Costs			Other Costs			Total
Q2 Restructuring costs	$	7,515		$	75		$	7,590
Q2 Payments		(6,166	)		(75	)		(6,241	)
Q3 Restructuring costs		29			5			34
Q3 Payments		(458	)		(5	)		(463	)
Restructuring Liability as of September 30, 2017	$	920		$	—		$	920

	For the three-month period ended September 30,				For the nine-month period ended September 30,
(In millions)	2017		2016		2017		2016
Research and development	$	2.0	$	2.9	$	8.4	$	7.7
Selling, general and administrative		4.7		7.1		17.8		19.7
Total	$	6.7	$	10.0	$	26.2	$	27.4


(In thousands)	Level 1		Level 2		Level 3		Level 1		Level 2		Level 3
September 30, 2017
June 30, 2023
Assets Carried at Fair Value:
Cash equivalents	$	9,144	$	—	$	—
Money market funds							$	—	$	—	$	—
Liabilities Carried at Fair Value:
Acquired contingent consideration		—		—		88,900		—		—		38,500
December 31, 2016
December 31, 2022
Assets Carried at Fair Value:
Cash equivalents	$	18,514	$	—	$	—
Money market funds							$	15,322	$	—	$	—
Liabilities Carried at Fair Value:
Acquired contingent consideration		—		—		72,100		—		—		41,200

(In thousands)	Net Carrying Value as of September 30, 2017		Level 1		Level 2		Level 3		Impairment Loss (Level 3) as of September 30, 2017
September 30, 2017
Assets Carried at Fair Value:
Intangible Asset - Selincro	$	14,695	$	—	$	—	$	14,695	$	39,446


(In thousands)	June 30, 2023		June 30, 2022
Liability related to sale of future royalties - beginning balance	$	—	$	4,460
Deferred transaction costs amortized		—		33
Non-cash royalty revenue payable to HCRP		—		(4,739	)
Non-cash interest expense recognized		—		246
Liability related to sale of future royalties - ending balance	$	—	$	—


(In thousands)	Balance Sheet Classification	June 30, 2023		December 31, 2022
Right-of-use assets	Right of use assets	$	4,765	$	5,287
Current lease liabilities	Current portion of lease liabilities		1,567		1,545
Non-current lease liabilities	Non-current portion of lease liabilities		3,764		4,341


(In thousands)
2023 (excluding the three months ended June 30, 2023)	$	773
2024		1,588
2025		1,633
2026		1,678
2027		357
Later years		182
Total lease payments		6,211
Less: Imputed interest		(880	)
Present value of lease liabilities	$	5,331