The latest trading session saw Aquestive Therapeutics (AQST) ending at $2.63, denoting a -1.5% adjustment from its last day's close. This change lagged the S&P 500's daily gain of 1.07%. Elsewhere, the Dow gained 0.35%, while the tech-heavy Nasdaq added 1.74%.Heading into today, shares of the specialty pharmaceutical company had gained 18.14% over the past month, outpacing the Medical sector's gain of 4.02% and the S&P 500's gain of 2.93% in that time.The investment community will be paying close attention ...

WARREN, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the management team will participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference on February 13th. The Aquestive team will hold a fireside chat on February 13th at 3:20 pm ET and will host investor meetings. A webcast of the f ...

Aquestive Therapeutics (AQST) closed at $2.39 in the latest trading session, marking a +0.84% move from the prior day. The stock's performance was ahead of the S&P 500's daily loss of 0.07%. Elsewhere, the Dow gained 0.16%, while the tech-heavy Nasdaq lost 0.36%.Shares of the specialty pharmaceutical company have appreciated by 18.5% over the course of the past month, outperforming the Medical sector's gain of 1.45% and the S&P 500's gain of 3.05%.The investment community will be closely monitoring the perf ...

The latest trading session saw Aquestive Therapeutics (AQST) ending at $2.50, denoting a -0.4% adjustment from its last day's close. This change lagged the S&P 500's 0.29% gain on the day. On the other hand, the Dow registered a loss of 0.25%, and the technology-centric Nasdaq increased by 0.43%.The the stock of specialty pharmaceutical company has risen by 25.5% in the past month, leading the Medical sector's gain of 2.29% and the S&P 500's gain of 2.08%.The investment community will be closely monitoring ...

Flex Point Security Aquestive Therapeutics (NASDAQ:AQST) is quickly approaching a key topline data readout for the Anaphylm (epinephrine) sublingual film that is slated for Q1 of this year. The company announced in December that they have commenced the first patient dosing in its Phase III pivotal study evaluating Anaphylm’s pharmacokinetics “PK” and pharmacodynamics “PD”. If the data is positive, Anaphylm would be heading towards a possible NDA in 2024 as a groundbreaking oral epinephrine candidate in ...

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 ...