Financial Performance - U.S. net revenue for Inbrija was $4.7 million for the quarter ended March 31, 2024, compared to $5.6 million for the same quarter in 2023, representing a decline of approximately 16.1%[99] - U.S. net revenue for Ampyra was $11.5 million for the quarter ended March 31, 2024, down from $12.6 million for the same quarter in 2023, indicating a decrease of about 8.7%[102] - Inbrija net revenues from U.S. sales decreased to $4.7 million for Q1 2024, down 16.1% from $5.6 million in Q1 2023[127] - Ex-U.S. Inbrija sales generated $1.7 million in Q1 2024, compared to $0.5 million in Q1 2023, reflecting significant growth[120] - Ampyra net revenues were $11.5 million for Q1 2024, an 8.7% decline from $12.6 million in Q1 2023[128] - The company recognized $2.4 million in royalty revenues for Q1 2024, a decrease of 31.4% from $3.5 million in Q1 2023[131] - Cost of sales increased to $3.7 million in Q1 2024 from $3.2 million in Q1 2023, driven by higher inventory costs[132] - The company incurred a net loss of $27.4 million for the three-month period ended March 31, 2024[142] - Net cash used in operations was $20.2 million for the three-month period ending March 31, 2024, primarily due to the net loss and changes in working capital[155] Bankruptcy and Financial Condition - The company filed for bankruptcy under Chapter 11 on April 1, 2024, to maximize value for stakeholders and ensure uninterrupted product availability[96] - The company is exploring strategic alternatives, including a potential sale of assets under Section 363 of the Bankruptcy Code[97] - The company is subject to substantial costs associated with the administration of the Chapter 11 Proceedings, which may impact its financial condition[97] - The company filed for bankruptcy under Chapter 11 on April 1, 2024, impacting its operations and financial condition[140] - The company believes its existing cash and cash equivalents are insufficient to cover cash flow requirements, raising substantial doubt about its ability to continue as a going concern[144] - The company has incurred and expects to incur significant professional fees and costs related to the Chapter 11 Proceedings[154] Cash and Assets - As of March 31, 2024, the company had cash, cash equivalents, and restricted cash of approximately $10.3 million[116] - As of March 31, 2024, the company had cash and cash equivalents of $9.4 million, down from $30.0 million at December 31, 2023[142] - The principal balance outstanding under the 2024 Notes was $207.0 million as of March 31, 2024, significantly exceeding the price agreed for the Purchased Assets[144] - The fair value of the conversion features of the 2024 Notes was determined to be $59.4 million upon issuance[151] Operational Changes - The company plans to lower its operating budget and reduce the scale of operations due to the Chapter 11 Proceedings[154] - The company has a minimum purchase commitment of $15.5 million for Inbrija in 2024 under the new manufacturing services agreement with Catalent[108] - The termination of the collaboration agreement with Biogen will allow the company to regain global commercialization rights to Fampyra effective January 1, 2025[104] Expenses - Research and development expenses decreased by approximately $0.4 million, or 28.6%, to $1.0 million in Q1 2024 compared to Q1 2023[134] - General and administrative expenses increased by $7.0 million, or 54.3%, to $19.9 million in Q1 2024, primarily due to higher legal costs[136] Tax and Valuation - The effective income tax rate for Q1 2024 was 0.4%, down from 10.8% in Q1 2023, due to changes in the valuation allowance on deferred tax assets[138] Market and Product Information - Approximately 40% of people with Parkinson's in the U.S. experience OFF periods, with an estimated 1 million diagnosed in the U.S. and 1.2 million in Europe[99] - The ARCUS platform allows for the delivery of higher doses of medication through inhalation, which is utilized in the Inbrija product[117] - The 2024 Notes are convertible into shares at an adjusted conversion price of approximately $420.00 per share, with a maximum of 969,102 shares potentially issuable[147] - The company’s common stock has been delisted from Nasdaq, triggering a make-whole fundamental change for the 2024 Notes[146]

Financial Performance - U.S. net revenue for Inbrija was $33.6 million for the year ended December 31, 2023[27]. - Net revenues for ex-U.S. Inbrija sales were $4.8 million for the year ended December 31, 2023[28]. - U.S. net revenue for Ampyra was $63.9 million for the year ended December 31, 2023[30]. - The company reported a net loss of $252.9 million for the year[200]. - The company had $30.6 million in cash and cash equivalents as of December 31, 2023, and incurred net cash flows used in operating activities of $14.0 million during 2023[202]. Business Strategy and Operations - The company plans to commence voluntary Chapter 11 proceedings to maximize value for stakeholders[21]. - The company has a DIP Credit Agreement for a maximum aggregate amount of $60.0 million to fund operations during Chapter 11 proceedings[26]. - The company plans to regain global commercialization rights to Fampyra effective January 1, 2025, after Biogen terminated the collaboration agreement[32]. - The company plans to assume commercialization responsibilities for Fampyra during 2024 and expects to enter into additional collaborations and distribution arrangements[74]. - The company is in discussions for potential collaborations to utilize its ARCUS platform for inhaled therapeutics[29]. Market and Competition - Approximately 40% of people with Parkinson's in the U.S. experience OFF periods, indicating a significant market for Inbrija[27]. - The company has experienced a significant decline in Ampyra sales due to competition from generic versions[30]. - Inbrija faces competition from therapies like Apokyn and new formulations of carbidopa/levodopa, which may limit OFF periods in Parkinson's disease treatment[100]. - Several companies are developing products that may compete with Ampyra, including novel immune system approaches and cell therapy for MS[104]. - The company is aware of competitors developing intranasally delivered levodopa therapies that may compete with Inbrija[101]. Regulatory and Compliance - The FDA may impose significant restrictions on distribution and use of a marketed product under a Risk Evaluation and Mitigation Strategy (REMS)[120]. - The company is subject to inspections by the FDA and other regulatory authorities, which may result in corrective actions if deficiencies are identified[123]. - The company is subject to various federal and state regulations in the U.S., including compliance with the anti-kickback and fraud provisions of the Social Security Act[159]. - Non-compliance with federal and state medical device regulations could lead to severe penalties, including product recalls and fines[139]. - The marketing authorization for Inbrija is valid for five years and can be renewed, with a renewal application submitted in December 2023[145]. Research and Development - The company has deferred internal investment in ARCUS research programs but is exploring collaborations for pulmonary delivery using ARCUS[43]. - The company does not currently have any active development programs for new potential drug products but is open to future collaborations[105]. - The approval process for drug candidates requires substantial time, effort, and financial resources, with no guarantee of timely approval[108]. - The company has no active drug development programs and has suspended work on all research and development programs due to limited financial resources[200]. Financial Risks and Challenges - The company faces significant risks related to its Intended Chapter 11 Proceedings, including the ability to negotiate a sale of assets and maintain relationships with suppliers and customers[179]. - The company is substantially dependent on increasing sales of Inbrija in the U.S. and commercializing it in other countries, facing competition from other marketed products[180]. - The company may experience employee attrition due to the uncertainties surrounding the Intended Chapter 11 Proceedings, which could adversely affect its business[199]. - Future performance is subject to economic, financial, competitive, and other factors beyond the company's control, impacting its ability to service debt[204]. - The company may not generate sufficient cash flow from operations in the future to support operations and service debt[204].

Core Viewpoint - Acorda Therapeutics will regain global commercialization rights to FAMPYRA following Biogen's decision to terminate their collaboration agreement, effective January 1, 2025, allowing Acorda to enhance its market presence and provide access to the medication for multiple sclerosis patients worldwide [1][2]. Group 1: Company Overview - Acorda Therapeutics develops therapies aimed at restoring function and improving the lives of individuals with neurological disorders, including products like INBRIJA for Parkinson's disease and AMPYRA for multiple sclerosis [5]. Group 2: Product Information - FAMPYRA is a prolonged-release formulation of fampridine, indicated for improving walking in adults with multiple sclerosis who have walking disabilities, with the highest reported adverse reaction being urinary tract infections [3]. - AMPYRA is an extended-release formulation of dalfampridine, which acts as a potassium channel blocker to help improve walking speed in adults with multiple sclerosis [4]. Group 3: Transition Plan - Acorda and Biogen are collaborating on a transition plan for Acorda to take over the commercialization and supply of FAMPYRA for the majority of multiple sclerosis patients outside the U.S., with plans to assume responsibilities in 2024 as marketing authorizations and distribution arrangements are finalized [1].

Financial Data and Key Metrics Changes - INBRIJA U.S. net sales for Q3 2023 were $8.1 million, a 4% increase compared to Q3 2022, with a 15% increase for the first three quarters of 2023 versus the same period in 2022 [3][4] - AMPYRA U.S. net revenue for Q3 2023 was $15.7 million, reflecting a 26% decline year-over-year, but only a 17% decline when comparing the first three quarters of 2023 to the same period in 2022 [10][11] - Net global INBRIJA revenue increased by 6.7% in Q3 2023 compared to Q3 2022 and 12.3% year-to-date [12] Business Line Data and Key Metrics Changes - New prescription request forms for INBRIJA were up 32% over Q3 2022 and 38% for the first three quarters of 2023 compared to the same period in 2022, indicating strong brand growth [4][14] - INBRIJA dispense cartons increased by 4% in Q3 2023 compared to Q3 2022 and by 6.5% for the first three quarters of 2023 [4] - AMPYRA's access remains high, with over 65% of covered lives able to access branded AMPYRA through insurance [11] Market Data and Key Metrics Changes - INBRIJA has surpassed apomorphine as the leading on-demand treatment in Spain, while the launch in Germany has been slower than anticipated, necessitating adjustments in marketing strategies [6][7] - INBRIJA's launch in Latin America is progressing, with expectations for multiple approvals in 2024 [6] Company Strategy and Development Direction - The company is focused on maintaining the AMPYRA brand against generics and has adjusted its operating expense guidance downward, reflecting a commitment to fiscal discipline [15] - The company is exploring collaborations for new inhaled therapies using its ARCUS-inhaled technology, which has shown the ability to create shelf-stable mRNA formulations [15] Management's Comments on Operating Environment and Future Outlook - Management acknowledges challenges in forecasting INBRIJA's performance due to the pandemic but expects improved accuracy as conditions normalize [20][21] - The company is maintaining its financial guidance for 2023, expecting INBRIJA U.S. net revenue between $34 million and $38 million and AMPYRA U.S. net revenue between $65 million and $70 million [12][14] Other Important Information - The company is in open communication with convertible debt holders to collaboratively address upcoming debt obligations [15][24] Q&A Session Summary Question: When can we expect the company to be cash flow positive? - Management will provide projections for the year at the year-end call [17] Question: What measures are being taken to better forecast and improve performance? In what way is management being held accountable? - Management has a strong track record with AMPYRA projections and is improving INBRIJA forecasting as conditions normalize. The board ensures management accountability through performance-based compensation [20][21][22] Question: How is the company planning to address the 2024 notes? - Management has maintained a constructive relationship with convertible bondholders and will engage in discussions to find the best solutions for stakeholders [24]

CONTACT: Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com FOR IMMEDIATE RELEASE Acorda Therapeutics Reports Third Quarter 2023 Financial Results • INBRIJA® (levodopa inhalation powder) Q3 2023 U.S. net revenue of $8.1 million; 4% increase over Q3 2022 • AMPYRA® (dalfampridine) Q3 2023 net revenue of $15.7 million; 26% decrease over Q3 2022 • INBRIJA ex-U.S. revenue of $1.4 million; FAMPYRA royalties of $2.5 million • Biopas Laboratories files for approval of INBRIJA in six Latin American countries PEA ...

Revenue Performance - U.S. net revenue for Inbrija was $8.1 million for Q3 2023, up from $7.8 million in Q3 2022, representing a 3.8% increase[122] - Net revenues for ex-U.S. Inbrija sales were $1.4 million for Q3 2023, compared to $1.0 million in Q3 2022, indicating a 40% increase[123] - U.S. net revenue for Ampyra was $15.7 million for Q3 2023, down from $21.1 million in Q3 2022, reflecting a 25.6% decline[125] - U.S. net revenue for Inbrija increased to $8.1 million for the quarter ended September 30, 2023, representing a 4% increase from $7.8 million in the same quarter of 2022[151] - U.S. net revenue for Ampyra decreased to $15.7 million for the quarter ended September 30, 2023, a decline of 26% from $21.1 million in the same quarter of 2022[152] - Ampyra's net revenues for the nine-month period ended September 30, 2023, were $45.2 million, a decrease of 16% from $54.2 million in the same period of 2022[171] - Inbrija's net revenues for the nine-month period ended September 30, 2023, increased to $22.0 million, a 16% increase from $19.0 million in the same period of 2022[169] Financial Commitments and Agreements - The company has minimum purchase commitments for Inbrija of $18 million annually through December 31, 2030, under a long-term supply agreement with Catalent[128] - Under the new manufacturing services agreement with Catalent, the company will have purchase commitments of 15 batches in 2023 at a total cost of $10.5 million and 24 batches in 2024 at a total cost of $15.5 million[131] - The company received a €5 million (approximately $5.9 million) upfront payment from Esteve Pharmaceuticals for the commercialization of Inbrija in Spain and Germany[142] - The company entered into a distribution agreement with Hangzhou Chance Pharmaceuticals for the exclusive distribution of Inbrija in China, receiving a non-refundable upfront payment of $2.5 million and potential milestone payments totaling up to $141.5 million[144] Regulatory and Market Expansion - The company is in discussions for commercialization of Inbrija in additional jurisdictions outside the U.S., with agreements already in place for Spain, Germany, Latin America, and China[140] - Biopas Laboratories is expected to submit regulatory filings for Inbrija in multiple Latin American countries, with up to five approvals anticipated in 2024[143] Financial Position and Cash Flow - As of September 30, 2023, the company had cash, cash equivalents, and restricted cash of approximately $33.6 million[138] - Cash and cash equivalents decreased to $32.5 million as of September 30, 2023, down from $37.5 million at December 31, 2022[188] - Net cash used in operations for the nine-month period ending September 30, 2023, was $11 million, primarily due to a net loss of $35.1 million and an increase in inventory of $5.2 million[200] - The company reported no net cash provided by financing activities for the nine-month period ending September 30, 2023[203] - The company maintains cash balances with financial institutions in excess of insured limits, with no anticipated losses[199] Expenses and Losses - Research and development expenses decreased by approximately $0.2 million, or 13%, to $1.2 million for the quarter ended September 30, 2023, primarily due to corporate restructuring[160] - General and administrative expenses increased by approximately $0.4 million, or 3%, to $13.5 million for the quarter ended September 30, 2023, primarily due to increased finance-related costs[162] - Selling and marketing expenses decreased by approximately $1.9 million or 6%, amounting to $28.7 million for the nine-month period ended September 30, 2023[179] - General and administrative expenses decreased by approximately $10.7 million or 22%, totaling $38.7 million for the nine-month period ended September 30, 2023[180] - The company incurred a net loss of $35.1 million for the nine-month period ended September 30, 2023[188] Changes in Fair Value and Other Financial Metrics - The company recorded a gain of $5.2 million related to changes in the fair value of acquired contingent consideration for the quarter ended September 30, 2023, compared to a gain of $4.6 million in the same quarter of 2022[165] - A gain of $7.1 million was recorded for changes in the fair value of acquired contingent consideration for the nine-month period ended September 30, 2023, compared to a gain of $10.7 million in 2022[182] Cost of Sales - Total cost of sales significantly decreased to $3.4 million for the quarter ended September 30, 2023, down from $11.0 million in the same quarter of 2022[158] - Cost of sales significantly decreased to $9.7 million for the nine-month period ended September 30, 2023, from $25.8 million in the same period of 2022[175] Accounting and Reporting - The company adopted new accounting guidance effective January 1, 2022, but significant accounting policies have not changed materially since December 31, 2022[206] - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[207] Inflation and Economic Factors - Inflation affects the company's expenses, particularly in employee compensation and contract services, which could increase overall expenses[205]

Financial Data and Key Metrics Changes - U.S. net revenue for INBRIJA in Q2 2023 was $8.3 million, a 12% increase compared to Q2 2022 [4] - Total prescriptions for INBRIJA increased by 11% over Q2 2022, while cartons dispensed to patients rose by 5% [4] - For the first half of 2023, new prescription requests increased by 42% compared to the first half of 2022 [5] - AMPYRA U.S. net revenue for Q2 was $16.9 million, a 7% decline from Q2 2022 [11] - Adjusted operating expense guidance tightened to between $93 million and $98 million, down from $93 million to $103 million [15] Business Line Data and Key Metrics Changes - INBRIJA's U.S. net sales are expected to be between $34 million and $38 million for 2023, revised down from $38 million to $42 million [5][14] - AMPYRA's sales are projected to stabilize at approximately $60 million plus over the next several years [11] Market Data and Key Metrics Changes - INBRIJA's performance outside the U.S. is strong in Spain, while uptake in Germany is slower than initial projections [9] - The company is in discussions for potential INBRIJA approvals in up to five Latin American countries [10] Company Strategy and Development Direction - The company launched a new consumer INBRIJA website and brand campaign called "For the Fighters" to support patients with Parkinson's [7] - The strategy includes maintaining the AMPYRA brand against generic competition and improving fiscal discipline [17] - The company is exploring collaborations for new inhaled therapies using its ARCUS technology [18] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the need to lower INBRIJA guidance but emphasized positive trends in new prescription requests and physician engagement [16] - The company is focused on improving cash flow and maintaining open communication with convertible debt holders [17] Other Important Information - The company received an upfront payment of $2.5 million in Q2 2023 related to regulatory updates in China [10] - The ending cash balance is expected to be between $39 million and $44 million [19] Q&A Session Summary Question: Why does the company expect INBRIJA sales to grow despite reducing guidance? - Management explained that while guidance was lowered, it still represents growth over last year, and new prescriptions are a leading indicator for future revenue growth [22][24] Question: Is the company looking to expand INBRIJA in Canada and other European countries? - Management stated they are in discussions for other territories but did not break out specific countries [26]

Revenue Performance - U.S. net revenue for Inbrija was $8.3 million for the quarter ended June 30, 2023, compared to $7.4 million for the same quarter in 2022, representing a 12.16% increase [126]. - U.S. net revenue for Ampyra was $16.9 million for the quarter ended June 30, 2023, down from $18.2 million for the same quarter in 2022, indicating a decline of 7.13% [129]. - Inbrija net revenues from U.S. sales increased to $8.3 million for the quarter ended June 30, 2023, up 11% from $7.4 million in the same quarter of 2022 [160]. - Net revenues for ex-U.S. Inbrija sales were $0.8 million for the quarter ended June 30, 2023 [160]. - Ampyra net revenues decreased to $16.9 million for the quarter ended June 30, 2023, down 7% from $18.2 million in the same quarter of 2022 [162]. - The company recognized net revenues from U.S. sales of Inbrija of $13.9 million for the six-month period ended June 30, 2023, an increase of 25% from $11.1 million in the same period of 2022 [178]. - Ampyra net revenues for the six-month period ended June 30, 2023, were $29.5 million, a decrease of $3.6 million or 11% compared to $33.1 million in the same period of 2022 [179]. - Royalty revenues decreased to $7.2 million for the six-month period ended June 30, 2023, down $0.3 million or 4% from $7.5 million in 2022 [183]. Expenses and Financial Position - Research and development expenses for the quarter ended June 30, 2023, were $1.6 million, slightly up from $1.5 million in the same quarter of 2022 [168]. - Selling, general and administrative expenses decreased to $21.8 million for the quarter ended June 30, 2023, down from $30 million in the same quarter of 2022, a reduction of approximately 27% [170]. - Research and development expenses were $2.9 million for the six-month period ended June 30, 2023, a decrease of approximately $0.3 million or 9% from $3.2 million in 2022 [186]. - Selling and marketing expenses decreased to $19.1 million for the six-month period ended June 30, 2023, down approximately $1.7 million or 8% from $20.8 million in 2022 [187]. - General and administrative expenses were $25.2 million for the six-month period ended June 30, 2023, a decrease of approximately $11 million or 30% from $36.2 million in 2022 [187]. - The company incurred a net loss of $26.2 million for the six-month period ended June 30, 2023 [195]. - Cash and cash equivalents decreased to $25.3 million as of June 30, 2023, down from $37.5 million at December 31, 2022 [195]. - Net cash used in operations for the six-month period ending June 30, 2023 was $18.6 million, primarily due to a net loss of $26.2 million [207]. - The company maintains cash balances exceeding insured limits, with no anticipated losses from these balances [206]. Agreements and Collaborations - The company has entered into agreements to commercialize Inbrija in Spain, Germany, Latin America, and China, with ex-U.S. net revenues for Inbrija sales at $0.8 million for the quarter ended June 30, 2023 [127]. - The company received a €5 million (approximately $5.9 million) upfront payment from Esteve Pharmaceuticals for the commercialization of Inbrija in Spain and Germany [151]. - A distribution agreement with Hangzhou Chance Pharmaceuticals for Inbrija in China includes a non-refundable upfront payment of $2.5 million and potential milestone payments of up to $132.5 million based on sales volumes [153]. - The company is discussing potential collaborations for the ARCUS platform with other companies interested in formulating novel molecules for pulmonary delivery [128]. Manufacturing and Operational Changes - The new manufacturing services agreement with Catalent includes reduced minimum annual commitments of $10.5 million in 2023 and $15.5 million in 2024 for Inbrija production [135]. - The company is obligated to pay a $4 million termination fee to Catalent, payable in April 2024, following the termination of the previous manufacturing services agreement [134]. - A 1-for-20 reverse stock split was executed on June 2, 2023, reducing the number of authorized shares from 61,666,666 to 3,083,333, which helped regain compliance with Nasdaq's minimum bid requirement [144]. - The ARCUS platform allows for the systemic delivery of medication through inhalation, enabling higher doses than conventional dry powder technologies [149]. Tax and Financial Gains - The effective income tax rate for the quarter ended June 30, 2023, was 17.3%, compared to an effective tax rate of (132.0)% for the same quarter of 2022 [174]. - The company recorded a benefit from income taxes of $4 million for the six-month period ended June 30, 2023, compared to a provision for income taxes of ($26.8) million in 2022 [191]. - The company recorded a gain of $0.8 million related to changes in the fair value of acquired contingent consideration for the quarter ended June 30, 2023, compared to $3.1 million in the same quarter of 2022 [172]. - The fair value of acquired contingent consideration recorded a gain of $1.9 million for the six-month period ended June 30, 2023, compared to income of $6.1 million in 2022 [190]. Debt and Financing - Biotie Therapies Ltd. subsidiary received non-convertible capital loans totaling $20.5 million for R&D, with a gain on extinguishment of debt recorded at $27.1 million in December 2022 [205]. - The company filed for a waiver of loans and accrued interest, which was granted by Business Finland in July 2022 [205]. - The company’s long-term contractual obligations include royalties and license fees, but the timing and amount of payments are uncertain [210]. Inflation Impact - Inflation affects the company's expenses, particularly in employee compensation and contract services [211].

Acorda Therapeutics, Inc. (NASDAQ:ACOR) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants Tierney Saccavino - EVP, Corporate Communications Ron Cohen - Founder, CEO, President & Director Michael Gesser - CFO Conference Call Participants Operator Welcome to Acorda Therapeutics First Quarter 2023 Financial and Business Update. [Operator Instructions]. Please be advised that this call is being recorded at the company's request. I will now introduce your host for today's call, Tierne ...

Financial Performance - U.S. net revenue for Inbrija was $5.6 million for the quarter ended March 31, 2023, compared to $3.7 million for the same quarter in 2022, representing a 51.35% increase[128]. - U.S. net revenue for Ampyra was $12.6 million for the quarter ended March 31, 2023, down from $14.9 million for the same quarter in 2022, indicating a decline of 15.43%[131]. - Net revenues for ex-U.S. Inbrija sales were $0.5 million for the quarter ended March 31, 2023[129]. - The company incurred a net loss of $16.8 million for the three-month period ended March 31, 2023[176]. - Royalty revenues decreased to $3.5 million for the quarter ended March 31, 2023, compared to $4.0 million in the same quarter of 2022, a decrease of 12.5%[164]. - The company recorded a gain of $1.0 million related to changes in the fair value of acquired contingent consideration for the quarter ended March 31, 2023, compared to a gain of $3.0 million in the same quarter of 2022[172]. Cash and Cash Equivalents - The company had cash, cash equivalents, and restricted cash of approximately $37.8 million as of March 31, 2023[145]. - As of March 31, 2023, the company had $30.3 million in cash and cash equivalents, down from $37.5 million at December 31, 2022[176]. - As of March 31, 2023, cash and cash equivalents were approximately $30.3 million, down from $37.5 million at December 31, 2022, and do not include $57.5 million of restricted cash[189]. - The company anticipates that existing cash and cash equivalents will cover cash flow requirements for at least the next twelve months[181]. Expenses - The company recorded a cost of sales of $3.2 million for the quarter ended March 31, 2023, down from $6.0 million in the same quarter of 2022[165]. - Research and development expenses decreased to $1.4 million for the quarter ended March 31, 2023, a reduction of approximately 17.6% from $1.7 million in the same quarter of 2022[166]. - General and administrative expenses decreased to $12.8 million for the quarter ended March 31, 2023, down 23.8% from $16.8 million in the same quarter of 2022[168]. Agreements and Partnerships - The company has entered into agreements to commercialize Inbrija in Spain, Germany, Latin America, and China, with a €5 million (approximately $5.9 million) upfront payment from Esteve Pharmaceuticals[150]. - In May 2023, the company entered into a distribution agreement with Hangzhou Chance Pharmaceuticals for the exclusive distribution of Inbrija in China, receiving a non-refundable upfront payment of $2.5 million and potential milestone payments totaling up to $141.5 million[152]. Manufacturing and Operational Changes - The new manufacturing services agreement with Catalent includes reduced minimum annual commitments of $10.5 million and $15.5 million for 2023 and 2024, respectively[137]. - The company is obligated to pay a $4 million termination fee to Catalent, payable in April 2024, following the termination of the previous manufacturing services agreement[136]. Market and Compliance Issues - The COVID-19 pandemic has caused volatility in new Inbrija prescriptions, impacting the company's business and financial condition[146]. - The company received notice of non-compliance with Nasdaq's listing requirements due to stock price falling below $1.00 for over 30 consecutive trading days, with a deadline to regain compliance by June 20, 2023[180]. - The company has committed to effecting a reverse stock split if compliance with the Minimum Bid Requirement is not achieved by the deadline[180]. Debt and Financial Obligations - The 2024 Convertible Senior Secured Notes have an aggregate principal amount of $207.0 million, with a semi-annual interest rate of 6.00%[182]. - The 2024 Notes will mature on December 1, 2024, unless converted earlier, and interest payments will be made in cash following the June 1, 2023 payment[183]. - The company has restrictions under the 2024 Indenture that limit its ability to pay dividends, incur additional debt, or sell assets[185]. Market Potential - Approximately 40% of people with Parkinson's in the U.S. experience OFF periods, with an estimated one million diagnosed in the U.S. and 1.2 million in Europe[128]. - The ARCUS platform allows for the delivery of substantially higher doses of medication than conventional dry powder technologies, enhancing the potential for inhaled therapeutics[147].