Here are three stocks added to the Zacks Rank #5 (Strong Sell) List today:Aquestive Therapeutics, Inc. (AQST) is a pharmaceutical company. The Zacks Consensus Estimate for its current year earnings has been revised 16.7% downward over the last 60 days.Central Garden & Pet Company (CENTA) is a consumer goods company. The Zacks Consensus Estimate for its current year earnings has been revised 5% downward over the last 60 days.LiveRamp Holdings, Inc. (RAMP) is a technology company.The Zacks Consensus Estimate ...

WARREN, N.J., June 27, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the Aquestive management team will participate in the Leerink Partners Therapeutics Forum: I&I and Metabolism and host investor meetings on July 9, 2024. The forum will include panels exploring key therapeutic themes a ...

WARREN, N.J., June 18, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced its expected addition to the broad-market Russell 3000® and Russell 2000® Indexes at the conclusion of the 2024 Russell U.S. indexes annual reconstitution, effective at the open of U.S. equity markets on Monday, July 1, acc ...

WARREN, N.J., May 09, 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 Citizens JMP Life Sciences Conference on May 13, 2024. The Aquestive management team will hold a fireside chat on May 13 at 11:30 am ET and will host investor meetings. A webcast of the fireside chat will b ...

Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q1 2024 Earnings Conference Call May 8, 2024 8:00 AM ET Company Participants Bennett Watson – ICR Westwicke Investor Relations Dan Barber – Chief Executive Officer and President Ernie Toth – Chief Financial Officer Stephen Wargacki – Chief Science Officer Conference Call Participants David Amsellem – Piper Sandler Francois Brisebois – Oppenheimer Ram Selvaraju – H.C. Wainwright Gary Nachman – Raymond James Thomas Flaten – Lake Street Capital Markets Operator Good m ...

Advancing medicines. Solving problems. Improving lives. 1 First Quarter 2024 Earnings Supplemental Materials May 7, 2024 Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. 2 ® Disclaimer Certain statements in this presentation include "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect," "estimate," "intend," "may," "will," or the negative o ...

Aquestive Therapeutics (AQST) reported $12.05 million in revenue for the quarter ended March 2024, representing a year-over-year increase of 8.3%. EPS of -$0.17 for the same period compares to $0.11 a year ago. The reported revenue represents a surprise of -1.37% over the Zacks Consensus Estimate of $12.22 million. With the consensus EPS estimate being -$0.09, the EPS surprise was -88.89%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectatio ...

Aquestive Therapeutics (AQST) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to earnings of $0.11 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -88.89%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.08 per share when it actually produced a loss of $0.12, delivering a surprise of -50%.Over the last four ...

Product Development and Clinical Trials - The company aims to file the NDA for Anaphylm™ (epinephrine) Sublingual Film with the FDA before the end of 2024, following a pre-NDA meeting expected in the second half of 2024[104]. - Anaphylm has shown clinical results comparable to auto-injectors for the emergency treatment of allergic reactions, with positive topline data from multiple studies reported in 2022 and 2023[103]. - The pivotal clinical study for Anaphylm commenced in Q4 2023, with the FDA providing clarity on the study design and endpoints[103]. - The company is conducting additional studies for Anaphylm, including a temperature/pH study expected to complete in Q2 2024 and a pediatric study planned for the second half of 2024[103]. - AQST-108, a sublingual film composed of the prodrug dipivefrin, is in development and is expected to provide an alternative delivery method for epinephrine[104]. - AQST-108, a sublingual film formulation for systemic epinephrine, has shown rapid absorption in preclinical trials and is being developed for various dermatological conditions[105]. - The FDA granted Fast Track designation for Anaphylm in March 2022, indicating the product's potential to address unmet medical needs[103]. - The company reported no serious adverse events in clinical studies for Anaphylm, indicating a favorable safety profile[103]. Financial Performance - The licensed product portfolio generated $50.6 million in revenue for the year ended December 31, 2023, compared to $47.7 million in 2022, with Q1 2024 revenue at $12.1 million, up from $11.1 million in Q1 2023[107]. - Total revenues for the three months ended March 31, 2024, increased by 8% or $919, reaching $12,053 compared to $11,134 in the same period of 2023[126]. - Manufacture and supply revenue rose by approximately 8% or $756, totaling $10,518, driven by a 24% increase in Suboxone revenue and a 27% increase in Sympazan revenue[128]. - License and royalty revenue increased by 23% or $213, reaching $1,132, primarily due to a 158% increase in royalty revenues from Azstarys and a 28% increase from Sympazan[128]. Expenses and Costs - Research and development expenses surged by 67% or $2,385, totaling $5,932, mainly due to clinical trial costs for the Anaphylm program[129]. - Selling, general and administrative expenses rose by 43% or $3,234, amounting to $10,689, reflecting increased operational costs[129]. - Interest expense increased by 94% or $1,349, totaling $2,784, indicating higher borrowing costs[129]. - Total project expenses for Anaphlym increased 85%, or $1,446, for the three months ended March 31, 2024, compared to the same period in 2023[131]. - Clinical trial expenses for Anaphlym rose 113%, or $1,579, to $2,975 for the three months ended March 31, 2024, primarily due to ongoing clinical trial costs[131]. - Selling, general and administrative expenses increased 43%, or $3,234, for the three months ended March 31, 2024, compared to the same period in the prior year[131]. Cash Flow and Financing - The company had $95,200 in cash and cash equivalents as of March 31, 2024, providing liquidity for operating needs for at least the next twelve months[132]. - For the three months ended March 31, 2024, net cash used for operating activities was $(10,384), a decrease of $19,200 compared to the same period in 2023[135][136]. - The company completed an Underwritten Public Offering of 16,666,667 shares at a price of $4.50 per share, resulting in gross proceeds of $75,000 and net proceeds of $70,500 after underwriting discounts[139]. - Net cash provided by financing activities for the three months ended March 31, 2024, was $81,741, an increase of $90,946 compared to the same period in 2023[135][138]. - The company plans to use net proceeds from recent transactions to advance the development of its product pipeline, including Anaphylm and Libervant[139]. Debt and Financial Risks - The company has a significant level of debt with ongoing interest payments and principal repayments starting in June 2026[140]. - The ability to secure additional equity financing is influenced by operating performance, regulatory approval processes, existing debt levels, and market conditions[141]. - If adequate funds are not available, the company may need to reduce staff, delay or discontinue research and development programs, and significantly cut spending[141]. - The company may face dilution of stockholder rights if additional equity securities are issued, which could adversely affect stockholder interests[141]. Regulatory and Market Position - The company remains a smaller reporting company, allowing it to take advantage of certain disclosure exemptions[111]. - As a smaller reporting company, the company is not required to provide detailed market risk disclosures[143].

[Key Highlights](index=1&type=section&id=Key%20Highlights) Aquestive reported significant progress in Q1 2024, including meeting all endpoints in the Anaphylm™ Phase 3 pivotal study, receiving FDA approval for Libervant™ for patients aged 2-5, and strengthening its financial position with a $77.5 million public offering, extending its cash runway into 2026 - Met all endpoints in the Phase 3 pivotal study for Anaphylm™ (epinephrine) Sublingual Film, comparing it favorably to EpiPen and other injectors[1](index=1&type=chunk) - Received FDA approval and initiated U.S. market access for Libervant™ (diazepam) Buccal Film for patients aged two to five[1](index=1&type=chunk) - Completed a **$77.5 million** underwritten public offering, extending the company's cash runway into 2026[1](index=1&type=chunk) - The company is on track to file a New Drug Application (NDA) for Anaphylm™ with the FDA by the end of 2024[1](index=1&type=chunk) [Pipeline Development](index=1&type=section&id=Pipeline%20Development) The company is advancing its key product candidates. Anaphylm™ is progressing towards an NDA submission by year-end 2024 following positive Phase 3 results and constructive FDA feedback. Libervant™ gained approval for a pediatric sub-population. AQST-108 completed its first human clinical study with positive initial data [Anaphylm™ (epinephrine) Sublingual Film](index=1&type=section&id=Anaphylm%E2%84%A2%20(epinephrine)%20Sublingual%20Film) Aquestive reported positive topline data from its Phase 3 pivotal study for Anaphylm™, meeting all primary and secondary PK endpoints compared to injectors like EpiPen®. The company received favorable FDA feedback on key study aspects and is on track to complete remaining pre-submission studies (temperature/pH, self-administration, allergen exposure) in Q2 and Q3 2024, targeting an NDA filing by the end of 2024 - The Phase 3 study met all predefined primary and secondary pharmacokinetic (PK) endpoints when compared to epinephrine intramuscular (IM) injections and autoinjectors (EpiPen® and Auvi-Q®)[3](index=3&type=chunk) - Following a Type C meeting, the FDA indicated that Aquestive has "adequately addressed" previous concerns regarding product hold time and characterization of emesis (vomiting)[3](index=3&type=chunk) - The company is on track to complete the temperature/pH study in Q2 2024, and the self-administration and allergen exposure studies in Q3 2024[4](index=4&type=chunk) - The goal is to file the New Drug Application (NDA) with the FDA before the end of 2024, with a pre-NDA meeting targeted for the second half of 2024[5](index=5&type=chunk) [Libervant™ (diazepam) Buccal Film](index=2&type=section&id=Libervant%E2%84%A2%20(diazepam)%20Buccal%20Film) Libervant™ received FDA approval in April 2024 for treating seizure clusters in pediatric patients aged two to five and is now commercially available for this group. The NDA for patients twelve and older remains tentatively approved but is blocked by an orphan drug market exclusivity for a competitor's product until January 2027 - Received FDA approval in April 2024 for the acute treatment of seizure clusters in patients with epilepsy aged two to five[6](index=6&type=chunk) - The product is immediately available for non-Medicaid prescriptions for this pediatric population in various dosages (5mg, 7.5mg, 10mg, 12.5mg, and 15mg)[6](index=6&type=chunk) - The NDA for patients aged twelve and older is tentatively approved but faces an orphan drug market exclusivity block from a competitor's nasal spray product until January 2027[7](index=7&type=chunk) [AQST-108 (epinephrine) Topical Gel](index=2&type=section&id=AQST-108%20(epinephrine)%20Topical%20Gel) Aquestive is advancing AQST-108, an epinephrine prodrug topical gel, through its Adrenaverse™ platform. The first human clinical study was successfully completed in Q1 2024, showing positive data. Further clinical studies are planned for the second half of 2024 - Completed the first human clinical study for AQST-108 in the first quarter of 2024[8](index=8&type=chunk) - Initial data from the study, which measured epinephrine levels on the skin and in circulation, was positive. Further clinical studies are expected in the second half of 2024[8](index=8&type=chunk) [Commercial and Corporate Developments](index=2&type=section&id=Commercial%20and%20Corporate%20Developments) The company's manufacturing operations saw a significant increase in production volume compared to the prior year, driven by demand for Suboxone®. Royalty-based products continue to be a key revenue contributor. Aquestive significantly strengthened its balance sheet by closing a $77.5 million public offering [Commercial Collaborations](index=2&type=section&id=Commercial%20Collaborations) Manufacturing volume for licensing and supply collaborations increased significantly year-over-year. The company produced approximately 42 million doses in Q1 2024, up from 33 million in Q1 2023, driven by consistent demand for Indivior's Suboxone® Sublingual Film. Revenue from royalty-based products like Sympazan® and Azstarys® also contributed to Q1 results - Manufactured approximately **42 million doses** in Q1 2024, a **27% increase** from **33 million doses** in Q1 2023[9](index=9&type=chunk) - Continued consistent order demand for manufacturing Indivior's Suboxone® Sublingual Film and supported other global collaborations[9](index=9&type=chunk) - Sales of royalty-based products, including Sympazan® and Azstarys®, continued to contribute to the Company's revenue in Q1 2024[9](index=9&type=chunk) [Public Offering](index=3&type=section&id=Public%20Offering) In March and April 2024, Aquestive completed an underwritten public offering, raising total gross proceeds of approximately $77.5 million. The funds are intended to advance the development and commercialization of Anaphylm™ and Libervant™, as well as for general corporate purposes - Closed an underwritten public offering with total gross proceeds of approximately **$77.5 million** from the sale of common stock at **$4.50 per share**[10](index=10&type=chunk) - Net proceeds will be used to advance the development and commercialization of Anaphylm™ and Libervant™ (for ages 2-5), and for working capital and general corporate purposes[10](index=10&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) For Q1 2024, Aquestive reported an 8% increase in total revenues to $12.1 million. However, the company posted a net loss of $12.8 million, a significant shift from a net income of $8.1 million in Q1 2023, primarily due to a one-time income event in the prior year and increased R&D and SG&A expenses. The company ended the quarter with $95.2 million in cash [First Quarter 2024 Financials](index=3&type=section&id=First%20Quarter%202024%20Financials) Total revenues grew to $12.1 million in Q1 2024 from $11.1 million in Q1 2023. The increase was driven by a 30% rise in manufacture and supply revenue (excluding a one-time 2023 item) and a 23% increase in license and royalty revenue. Operating expenses rose, with R&D expenses increasing to $5.9 million and SG&A expenses to $10.7 million, leading to a net loss of $12.8 million, or $0.17 per share Q1 2024 vs. Q1 2023 Financial Highlights | Metric | Q1 2024 (in millions) | Q1 2023 (in millions) | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $12.1 | $11.1 | +8% | | R&D Expenses | $5.9 | $3.5 | +68% | | SG&A Expenses | $10.7 | $7.5 | +43% | | Net (Loss) Income | ($12.8) | $8.1 | N/A | | (Loss) Earnings Per Share (basic) | ($0.17) | $0.15 | N/A | | Non-GAAP Adj. EBITDA Loss | ($7.2) | ($3.9) | +85% | - The change to a net loss was primarily driven by a one-time **$14.5 million** of other income recognized in Q1 2023, combined with increases in SG&A, R&D, and non-cash interest expenses in Q1 2024[13](index=13&type=chunk) - Cash and cash equivalents were **$95.2 million** as of March 31, 2024[14](index=14&type=chunk) [2024 Outlook](index=3&type=section&id=2024%20Outlook) Aquestive provides its full-year 2024 financial guidance, projecting total revenues between $48 million and $51 million and a Non-GAAP adjusted EBITDA loss between $22 million and $26 million Full-Year 2024 Financial Guidance | Metric | Guidance (in millions) | | :--- | :--- | | Total Revenue | $48 to $51 | | Non-GAAP Adjusted EBITDA Loss | $22 to $26 | [Financial Statements](index=10&type=section&id=Financial%20Statements) The condensed financial statements provide detailed, unaudited figures for the company's financial position as of March 31, 2024, and its performance for the three months then ended. Key tables include the Condensed Balance Sheets, Condensed Statements of Operations, and Reconciliation of GAAP to Non-GAAP measures [Condensed Balance Sheets](index=10&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2024, Aquestive had total assets of $129.5 million and total liabilities of $165.8 million, resulting in a stockholders' deficit of $36.3 million. Cash and cash equivalents significantly increased to $95.2 million from $23.9 million at year-end 2023, primarily due to the recent public offering Balance Sheet Summary | Account | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $95,200 | $23,872 | | Total current assets | $113,379 | $40,966 | | Total assets | $129,523 | $57,418 | | **Liabilities & Stockholders' Deficit** | | | | Total liabilities | $165,824 | $163,905 | | Total stockholders' deficit | ($36,301) | ($106,487) | [Condensed Statements of Operations](index=11&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20(Loss)%20Income) For the three months ended March 31, 2024, the company recorded a net loss of $12.8 million on total revenues of $12.1 million. This contrasts with a net income of $8.1 million on revenues of $11.1 million in the same period of 2023. The loss per share for Q1 2024 was $0.17 Q1 Statement of Operations | Line Item | Q1 2024 (in thousands) | Q1 2023 (in thousands) | | :--- | :--- | :--- | | Revenues | $12,053 | $11,134 | | Total costs and expenses | $21,010 | $15,739 | | Loss from operations | ($8,957) | ($4,605) | | Net (loss) income | ($12,828) | $8,068 | | Basic (Loss) earnings per share | ($0.17) | $0.15 | [Reconciliation of Non-GAAP Adjustments](index=12&type=section&id=Reconciliation%20of%20Non-GAAP%20Adjustments%20-%20Net%20(Loss)%20Income%20to%20Non-GAAP%20Adjusted%20EBITDA) The company provides a reconciliation from GAAP net (loss) income to Non-GAAP adjusted EBITDA. For Q1 2024, the GAAP net loss of $12.8 million was adjusted to a Non-GAAP adjusted EBITDA loss of $7.2 million. This compares to a Non-GAAP adjusted EBITDA loss of $3.9 million in Q1 2023 Non-GAAP Adjusted EBITDA Reconciliation | Line Item | Q1 2024 (in thousands) | Q1 2023 (in thousands) | | :--- | :--- | :--- | | GAAP net (loss) income | ($12,828) | $8,068 | | Total non-GAAP adjustments | $5,658 | ($12,004) | | Non-GAAP adjusted EBITDA | ($7,170) | ($3,936) |