In the latest trading session, Aquestive Therapeutics (AQST) closed at $2.63, marking a -1.13% move from the previous day. This change lagged the S&P 500's 0.56% loss on the day. Elsewhere, the Dow saw a downswing of 0.25%, while the tech-heavy Nasdaq depreciated by 0.59%.The the stock of specialty pharmaceutical company has risen by 34.77% in the past month, leading the Medical sector's gain of 3.8% and the S&P 500's gain of 1.2%.Market participants will be closely following the financial results of Aquest ...

Financial Data and Key Metrics Changes - Total revenues increased from $9.2 million in Q3 2022 to $13 million in Q3 2023, representing a 42% increase [17] - Net loss for Q3 2023 was $2 million or $0.03 loss per share, compared to a net loss of $12.5 million or $0.23 loss per share in Q3 2022 [20] - Non-GAAP adjusted EBITDA loss was $1.3 million in Q3 2023, an improvement from a loss of $7.7 million in Q3 2022 [21] - Cash and cash equivalents were $24.9 million as of September 30, 2023 [22] - Revenue guidance for 2023 was increased to approximately $47 million to $50 million from $44 million to $48 million [23] Business Line Data and Key Metrics Changes - License and royalty revenue increased by 193%, primarily due to Sympazan and Azstarys [18] - Manufacturing and supply revenue rose by 36% from Suboxone and Sympazan [18] - Co-development and research fees increased by 24% [18] Market Data and Key Metrics Changes - There was a 31% increase in prescriptions in the two-to-five-year-old space during Q3 2023 compared to Q3 2022 [11] Company Strategy and Development Direction - The company is focused on the clinical development of Anaphylm, with plans to start a pivotal Phase 3 study in Q4 2023 and provide top-line data in Q1 2024 [8] - The company is also advancing its Libervant application for patients aged two to five, with an FDA target action date in April 2024 [11] - The ADRENAVERSE platform is being developed for a topical product, with initial formulations completed and human testing planned [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the refinancing of debt, which provides flexibility for upcoming clinical and regulatory milestones [6] - The company believes that the demand for oral epinephrine products remains high, especially with delays in nasal spray alternatives [9] - Management remains optimistic about the potential for Anaphylm to transform the company in 2024 [8] Other Important Information - The company has no revenue, EBITDA, or cash covenants in its new debt agreement, which allows for operational flexibility [6] - The company anticipates continued growth in its base business and is focused on capital conservation to extend its cash runway [23] Q&A Session Summary Question: Differences in design between the two PK pivotal trials - Management indicated that the design is based on FDA feedback and marketplace learnings, with the adult pivotal study starting in Q4 2023 and data readout expected in Q1 2024 [27][29] Question: Clarity on pivotal studies against IM injection - Management clarified that the pivotal study is a bracketing approach against established reference products, including autoinjectors [36][37] Question: Gating factors for pivotal PK study - Management stated there are no gating factors for starting the pivotal PK study in Q4, focusing on operational readiness [44] Question: Insights on Libervant exclusivity block - Management noted that while they cannot share specific details, they believe there are avenues to bring Libervant to market ahead of orphan drug exclusivity exploration for competing products [47] Question: Cost of remaining trials and NDA filing readiness - Management indicated that the remaining pharmacokinetic studies are cost-efficient and they expect to file for NDA by the end of 2024 [66] Question: Competitive intelligence on ARS Pharma and Neffy - Management stated they only have public domain information regarding competitors and are prepared for an Adcom if requested by the FDA [68]

Q3 2023 Earnings Supplemental Materials November 6, 2023 Advancing medicines. Solving problems. Improving lives. 1 ...

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited financial statements for Q3 2023 show improved financial position and profitability, with a net income of $0.24 million for the nine months [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2023, total assets increased, total liabilities decreased, and the stockholders' deficit improved Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $24,917 | $27,273 | | Total current assets | $42,457 | $39,888 | | **Total assets** | **$59,448** | **$57,070** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $24,057 | $39,528 | | **Total liabilities** | **$162,375** | **$175,624** | | **Total stockholders' deficit** | **$(102,927)** | **$(118,554)** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q3 2023 revenues increased 13% with a narrowed net loss, and nine-month results swung to a $0.24 million net income Statement of Operations Highlights (in thousands, except per share data) | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | **Revenues** | **$13,002** | **$11,463** | **$37,377** | **$36,998** | | Loss from operations | $(2,377) | $(8,853) | $(11,191) | $(31,353) | | Interest and other income, net | $1,514 | $5 | $16,156 | $34 | | **Net income (loss)** | **$(2,035)** | **$(12,536)** | **$241** | **$(42,058)** | | Basic EPS (in dollars) | $(0.03) | $(0.23) | $0.00 | $(0.90) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations significantly improved for the nine months, with cash and equivalents ending at $24.9 million Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used for operating activities | $(1,438) | $(18,235) | | Net cash used for investing activities | $(979) | $(2,498) | | Net cash provided by financing activities | $61 | $11,358 | | **Net (decrease) in cash** | **$(2,356)** | **$(9,375)** | | **Cash at end of period** | **$24,917** | **$18,649** | [Notes to Financial Statements](index=9&type=section&id=Notes%20to%20Financial%20Statements) Notes detail business, revenue, debt, and legal matters, highlighting the November 2023 debt refinancing and a key customer - The company is a pharmaceutical firm focused on alternative drug delivery systems (**PharmFilm®**) for complex molecules, with a pipeline targeting severe allergic reactions and CNS diseases[23](index=23&type=chunk) - For the nine months ended September 30, 2023, a single customer, **Indivior**, represented approximately **79%** of total revenue[43](index=43&type=chunk) - On November 1, 2023, the company redeemed its **12.5% Notes** and issued **$45 million** of new **13.5% Senior Secured Notes** due 2028. This refinancing was used to repay the old debt, with the balance for general corporate purposes[96](index=96&type=chunk) - A securities class action lawsuit and a related shareholder derivative lawsuit against the company and its officers were voluntarily dismissed with prejudice in April 2023[93](index=93&type=chunk)[95](index=95&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses pipeline progress, Q3 revenue growth, improved nine-month profitability, and the recent debt refinancing [Product Pipeline Update](index=32&type=section&id=Product%20Pipeline%20Update) The company is advancing Anaphylm™ with pivotal studies planned and Libervant™ with an NDA filed for pediatric use - **Anaphylm™** (epinephrine sublingual film) has shown positive clinical results with a median Tmax of **10-15 minutes**. The company plans to start its pivotal PK study in **Q4 2023** after incorporating FDA feedback[102](index=102&type=chunk)[103](index=103&type=chunk) - **Libervant™** (diazepam buccal film) received tentative FDA approval for patients **12+**, but marketing is blocked by a competitor's orphan drug exclusivity until **January 2027**[104](index=104&type=chunk) - An NDA for **Libervant™** for pediatric patients (ages **2-5**) was accepted by the FDA, with a PDUFA goal date of **April 28, 2024**[104](index=104&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) Q3 2023 revenues increased 13%, and nine-month profitability improved due to reduced SG&A and significant other income Revenue Comparison (in thousands) | Revenue Type | Q3 2023 | Q3 2022 | % Change | | :--- | :--- | :--- | :--- | | Manufacture and supply | $11,409 | $8,411 | 36% | | License and royalty | $1,103 | $376 | 193% | | Proprietary product sales, net | $0 | $2,281 | N/A | | **Total revenues** | **$13,002** | **$11,463** | **13%** | - Selling, general and administrative (SG&A) expenses decreased by **41%** in **Q3 2023** and **46%** in the **first nine months of 2023**, primarily due to lower selling costs following the out-licensing of Sympazan in October 2022[131](index=131&type=chunk)[132](index=132&type=chunk) - The significant increase in 'Interest and other income, net' for the nine months of 2023 to **$16.2 million** was driven by a **$6.0 million** payment from an **Indivior** agreement amendment, an **$8.5 million** patent litigation settlement, and the receipt of an Employee Retention Tax Credit (ERTC) refund[133](index=133&type=chunk) [Liquidity and Capital Resources](index=44&type=section&id=Liquidity%20and%20Capital%20Resources) The company had $24.9 million cash, with liquidity supported by an ATM facility and the November 2023 debt refinancing - As of September 30, 2023, the company had **$24.9 million** in cash and cash equivalents[134](index=134&type=chunk) - The company has an 'At-The-Market' (ATM) facility with approximately **$27.8 million** available for future sales of common stock as of September 30, 2023[135](index=135&type=chunk) - In a crucial subsequent event on November 1, 2023, the company refinanced its debt, issuing **$45 million** in new **13.5% Senior Secured Notes** due 2028 to redeem its previous **12.5% notes**. This transaction is expected to reduce principal and interest payments by approximately **$28 million** through **June 2025**[96](index=96&type=chunk)[147](index=147&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a 'smaller reporting company,' the company is not required to provide market risk disclosures - The company is not required to provide disclosures about market risk as it qualifies as a 'smaller reporting company'[141](index=141&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of September 30, 2023, with no material changes to internal controls - Management concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective at a reasonable assurance level[142](index=142&type=chunk) - No changes in internal control over financial reporting occurred during the last fiscal quarter that have materially affected, or are reasonably likely to materially affect, internal controls[143](index=143&type=chunk) [PART II – OTHER INFORMATION](index=46&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 19 for details on legal proceedings, including ongoing patent litigation and unfair competition claims - For details on legal proceedings, the report refers to Note 19 of the Financial Statements[146](index=146&type=chunk) [Item 1A. Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) A key risk is the need for substantial additional capital to fund operations, as future funding is not guaranteed - A key risk is the company's need for substantial additional capital to fund its operations, which may not be available on acceptable terms, if at all[146](index=146&type=chunk) - If adequate funds are not available, the company may be required to delay, scale back, or discontinue R&D programs, or explore other strategic alternatives like asset sales or licensing of core programs[147](index=147&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=47&type=section&id=Other%20Items%20(Items%202,%203,%204,%205,%206)) The company reported no unregistered equity sales, senior security defaults, or mine safety disclosures - The company reported no unregistered sales of equity securities, defaults upon senior securities, or mine safety disclosures for the period[147](index=147&type=chunk)

Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q2 2023 Earnings Conference Call August 8, 2023 8:00 AM ET Company Participants Bennett Watson - Investor Relations, ICR Westwicke Dan Barber - Chief Executive Officer Ernie Toth - Senior Vice President, Chief Financial Officer Steve Wargacki - Senior Vice President, Research and Development Ken Marshall - Senior Vice President, Chief Commercial Officer Carl Kraus - Chief Medical Officer Conference Call Participants Jason Butler - JMP François Brisebois - Oppenheim ...

Product Development - Anaphylm pivotal trial protocol submitted to FDA in early August[7] - Company completed additional pilot PK study (AQ109103) for Anaphylm in Q2 2023[7] - Libervant NDA for the two- to five-year-old age group was submitted in Q2[9] Financial Performance - Q2 2023 revenue was $13.2 million, a 24% year-over-year increase compared to Q2 2022 (adjusted for the out-license of Sympazan)[8] - The company ended Q2 2023 with $22.4 million in cash and cash equivalents[8] - Debt was reduced by $3.4 million in Q2 2023, with a year-to-date reduction of $12.5 million[8] Manufacturing - Manufactured 47.9 million doses in June, a 43% increase from Q1 2023[10] Financial Outlook - The company anticipates total revenues of approximately $44 to $48 million for 2023[19] - The company anticipates Non-GAAP adjusted EBITDA loss of approximately $19 to $22 million for 2023[19]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-38599 Aquestive Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of Incor ...

Financial Data and Key Metrics Changes - The company reduced its outstanding debt from $51.5 million on December 31, 2022, to $42.4 million on March 31, 2023, through principal prepayments and scheduled amortization [22] - Total revenues increased from $10.1 million in Q1 2022 to $11.1 million in Q1 2023, marking a 10% increase [24] - Net income for Q1 2023 was $8.1 million, compared to a net loss of $13.2 million in Q1 2022 [25] - Non-GAAP adjusted EBITDA loss improved to $3.9 million in Q1 2023 from a loss of $8.1 million in Q1 2022 [25] - Cash and cash equivalents were approximately $26.9 million as of March 31, 2023 [25] Business Line Data and Key Metrics Changes - License and royalty revenue saw an 82% increase, co-development and research fees increased by 12%, and manufacture and supply revenue rose by 6% compared to the previous year [24] - The company anticipates additional revenue from licensed products for the remainder of 2023 [27] Market Data and Key Metrics Changes - The company is focused on expanding its collaborations and potential deals in both the US and international markets, particularly in Europe and China [19][58] - The company aims to bring Libervant to market before 2027, with ongoing discussions regarding US market access [16] Company Strategy and Development Direction - The company is focused on building a healthy balance sheet, filing Anaphylm for FDA review, and obtaining US market access for Libervant [10] - The company plans to continue pursuing non-dilutive sources of capital and managing expenses to extend its cash runway [22][23] - The company is preparing for an upcoming FDA advisory committee meeting that will provide insights into the FDA's stance on alternate delivery methods for epinephrine [11][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about advancements in scientific research and development for anaphylaxis treatments [11] - The company is focused on addressing the challenges of patient compliance with carrying rescue medications, noting that over 50% of patients do not carry their prescribed medication [14] - Management highlighted the importance of understanding the FDA's views on pharmacokinetics and pharmacodynamics in relation to their product development [32][54] Other Important Information - The company has successfully settled legal issues, generating $8.5 million in non-dilutive financing [9] - The company has received FDA clearance for the brand name Anaphylm, which is seen as a strategic move to enhance patient engagement [13] Q&A Session Summary Question: Update on Anaphylm and PK bracketing - Management discussed the importance of the upcoming FDA advisory committee meeting and its implications for understanding FDA interactions and pharmacokinetics [31][32] Question: Gap between EpiPen approval and current standards - Management noted that there has never been an efficacy study for epinephrine, and they are interested in how the FDA will evaluate the pharmacokinetic curves [36] Question: Administration instructions for Anaphylm - Management clarified that the administration parameters are straightforward but require thorough understanding to ensure proper usage [44] Question: Timing of protocol submission - Management indicated that they would wait for insights from the advisory committee before confirming timelines for protocol submission [40] Question: Potential of Sympazan under Assertio - Management expressed optimism about the sales trajectory of Sympazan since the collaboration began, noting an increase in prescriptions [62]

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20FINANCIAL%20STATEMENTS%20(Unaudited)) The company reported a significant turnaround to a net income of $8.1 million in Q1 2023 from a net loss in Q1 2022 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $61.3 million while the total stockholders' deficit improved to $(109.2) million as of March 31, 2023 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $26,882 | $27,273 | | Total current assets | $43,706 | $39,888 | | **Total assets** | **$61,285** | **$57,070** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $40,383 | $39,528 | | Loans payable, net (non-current) | $25,196 | $33,448 | | **Total liabilities** | **$170,520** | **$175,624** | | **Total stockholders' deficit** | **$(109,235)** | **$(118,554)** | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) The company achieved a net income of $8.1 million in Q1 2023, a reversal from a $13.2 million loss in Q1 2022 Q1 2023 vs Q1 2022 Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | **Revenues** | **$11,134** | **$12,270** | | Total costs and expenses | $15,739 | $22,008 | | Loss from operations | $(4,605) | $(9,738) | | Interest and other income (expense), net | $14,513 | $(3) | | **Net income (loss)** | **$8,068** | **$(13,220)** | | Basic earnings (loss) per share | $0.15 | $(0.32) | | Diluted earnings (loss) per share | $0.11 | $(0.32) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operations was a positive $8.8 million in Q1 2023, a substantial improvement from a $14.5 million use in Q1 2022 Q1 2023 vs Q1 2022 Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash from operating activities | $8,816 | $(14,482) | | Net cash used for investing activities | $(2) | $(104) | | Net cash (used for) provided by financing activities | $(9,205) | $1,298 | | **Net (decrease) increase in cash** | **$(391)** | **$(13,288)** | | Cash at end of period | $26,882 | $14,736 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail revenue concentration, debt redemption, and the settlement of significant legal proceedings Revenue Breakdown by Type (in thousands) | Revenue Type | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Manufacture and supply revenue | $9,762 | $9,171 | | License and royalty revenue | $919 | $506 | | Co-development and research fees | $453 | $403 | | Proprietary product sales, net | $0 | $2,190 | | **Total revenues** | **$11,134** | **$12,270** | - For Q1 2023, Indivior and Hypera were major customers, representing approximately **77% and 14% of total revenue**, respectively[63](index=63&type=chunk) - In Q1 2023, the company redeemed **$9.1 million** of its 12.5% Senior Secured Notes, reducing the outstanding balance to **$42.4 million**[112](index=112&type=chunk)[257](index=257&type=chunk) - A federal securities class action lawsuit and a related shareholder derivative lawsuit against the company and certain officers/directors were **voluntarily dismissed with prejudice** in April 2023[154](index=154&type=chunk)[155](index=155&type=chunk)[157](index=157&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Revenue decreased 9% due to out-licensing, but net income was positive due to other income and reduced SG&A expenses [Product Pipeline and Commercial Products](index=31&type=section&id=Product%20Pipeline%20and%20Commercial%20Products) The company is advancing its pipeline, including AQST-109 for anaphylaxis and the tentatively approved Libervant™ - AQST-109 (epinephrine sublingual film), with the conditionally approved brand name Anaphylm™, has completed End-of-Phase 2 meetings with the FDA[167](index=167&type=chunk)[173](index=173&type=chunk) - Libervant™ (diazepam buccal film) received tentative FDA approval but cannot get final approval for U.S. marketing until a competitor's **orphan drug exclusivity for Valtoco® expires**, scheduled for January 2027[177](index=177&type=chunk) - The company's main licensed commercial product, Suboxone®, retains approximately **34% of the film market share** for opioid dependence treatment[179](index=179&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) Q1 2023 revenue fell 9% due to eliminated proprietary sales, offset by growth in manufacturing and royalty revenue Revenue Comparison: Q1 2023 vs Q1 2022 (in thousands) | Revenue Category | Q1 2023 | Q1 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Manufacture and supply | $9,762 | $9,171 | $591 | 6% | | License and royalty | $919 | $506 | $413 | 82% | | Co-development and research | $453 | $403 | $50 | 12% | | Proprietary product sales, net | $0 | $2,190 | $(2,190) | (100)% | | **Total revenues** | **$11,134** | **$12,270** | **$(1,136)** | **(9)%** | Expense Comparison: Q1 2023 vs Q1 2022 (in thousands) | Expense Category | Q1 2023 | Q1 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Manufacture and supply | $4,737 | $4,214 | $523 | 12% | | Research and development | $3,547 | $4,773 | $(1,226) | (26)% | | Selling, general and administrative | $7,455 | $13,021 | $(5,566) | (43)% | - Interest and other income, net was **$14.5 million** in Q1 2023, primarily due to a **$6.0 million** agreement amendment and an **$8.5 million** patent litigation settlement[225](index=225&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) The company believes its $26.9 million in cash and access to its ATM facility provide sufficient liquidity for the next year - As of March 31, 2023, the company had **$26.9 million in cash** and cash equivalents[226](index=226&type=chunk)[254](index=254&type=chunk) - The company has an "At-The-Market" (ATM) facility with approximately **$32.4 million available** for future sales of common stock as of March 31, 2023[230](index=230&type=chunk) - The company is limited by the SEC's "baby shelf rules," which restricts the amount of funds it can raise through its Form S-3[233](index=233&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a "smaller reporting company," the company is not required to provide information for this item - The company is not required to provide quantitative and qualitative disclosures about market risk because it qualifies as a **"smaller reporting company"**[247](index=247&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023 - Management concluded that as of March 31, 2023, the company's disclosure controls and procedures were **effective at a reasonable assurance level**[249](index=249&type=chunk) - No changes occurred during the last fiscal quarter that have materially affected, or are reasonably likely to materially affect, the company's **internal control over financial reporting**[250](index=250&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) The company directs readers to Note 19 of the financial statements for detailed information on legal proceedings - For detailed information on legal proceedings, the report directs readers to **Note 19, Contingencies**, in the financial statements[252](index=252&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) The company highlights a significant risk related to its need for substantial additional capital to fund operations - The company emphasizes a significant risk related to its need for **substantial additional capital** to fund operations, which may not be available[253](index=253&type=chunk) - As of March 31, 2023, the company had **$26.9 million in cash** and cash equivalents and an outstanding debt balance of **$42.4 million** on its 12.5% Notes[254](index=254&type=chunk)[257](index=257&type=chunk) - If adequate funds are not available, the company may need to **delay or discontinue R&D programs**, reduce commercialization efforts, or explore strategic alternatives[259](index=259&type=chunk)[260](index=260&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None reported[261](index=261&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share AQST NASDAQ Global Market FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ C ...