Aquestive(AQST) - 2024 Q3 - Quarterly Results

Executive Summary & Business Update Aquestive Therapeutics reported Q3 2024 financial results and business updates, including regulatory meetings for Anaphylm and AQST-108, Libervant market expansion, and a strong cash position Third Quarter 2024 Highlights Aquestive Therapeutics announced Q3 2024 financial results and business updates, including regulatory meeting schedules for Anaphylm and AQST-108, Libervant market expansion, and approximately $78 million in cash reserves, with cash flow projected through 2026 - Anaphylm™ (epinephrine) sublingual film pre-NDA meeting scheduled for Q4 2024[1] - AQST-108 (epinephrine) topical gel pre-IND meeting scheduled for Q4 2024[1] - Libervant® (diazepam) buccal film for patients aged 2-5 years is commercially available through retail distribution channels[1] - As of the end of Q3 2024, the company held approximately $78 million in cash, reaffirming cash flow sustainability through 2026[1] CEO Commentary CEO Daniel Barber highlighted the company's epinephrine prodrug platform as a cornerstone of its growth strategy, with Anaphylm reaching clinical milestones and Libervant successfully expanding market share - The innovative epinephrine prodrug platform is a cornerstone of the company's growth strategy[2] - Anaphylm's adult supportive study is complete, with preparations underway for a pre-NDA meeting with the FDA[2] - AQST-108 is advancing towards a pre-IND meeting, preparing for a potential alopecia areata Phase 2a study next year[2] - Libervant's market share successfully expanded through the deployment of a specialized sales team and national reimbursement coverage[2] Product Development & Commercialization This section details the development and commercialization strategies for Anaphylm, AQST-108, and Libervant, including clinical results, regulatory pathways, and market opportunities Anaphylm™ (epinephrine) Sublingual Film Anaphylm, the first and only oral epinephrine product candidate for severe allergic reactions, shows stable PK/PD characteristics and rapid symptom relief in recent clinical data, with a pre-NDA meeting planned for Q4 2024 and a target launch in Q1 2026 Clinical Study Results Positive top-line data from the OASIS study demonstrated Anaphylm maintained its PK/PD characteristics and provided rapid symptom relief during allergen-induced oral physiological changes, with further analysis confirming consistent PK/PD regardless of film placement - The OASIS study (Oral Allergy Syndrome Challenge Study) yielded positive top-line data, meeting primary and secondary endpoints, indicating Anaphylm maintained its pharmacokinetic (PK) and pharmacodynamic (PD) characteristics during allergen-induced oral physiological changes[4] - Rapid symptom relief was observed within two minutes of Anaphylm administration, with a median time to complete symptom resolution of twelve minutes[4] - Subsequent analysis of the pivotal study showed Anaphylm's PK and PD characteristics remained consistent regardless of film placement or intraoral movement, with 87.5% of subjects maintaining stable film position during disintegration[5][6] Regulatory Pathway & Timeline The company received positive FDA written feedback on Anaphylm's CMC submission, plans a clinical-focused pre-NDA meeting in Q4 2024, expects to submit the NDA in Q1 2025, and aims for a full Anaphylm launch in Q1 2026, if approved - The company received positive pre-NDA written feedback from the FDA regarding Anaphylm's proposed Chemistry, Manufacturing, and Controls (CMC) submission[7] - A clinical-focused pre-NDA meeting with the FDA is scheduled for Q4 2024[7] - The company maintains its guidance for a full Anaphylm launch in Q1 2026, if FDA approved, based on initiating a study in pediatric patients weighing 30 kg and above in Q4 2024 and submitting the NDA to the FDA in Q1 2025[7] AQST-108 (epinephrine) Topical Gel AQST-108, a topically administered adrenergic agonist prodrug for alopecia areata, plans a pre-IND meeting in Q4 2024 to define its Phase 2a study design, targeting a Q2 2025 launch, with potential for a significant share in the over $1 billion alopecia market due to its local action and lack of systemic side effects Development Strategy & Market Opportunity Aquestive outlined AQST-108's development strategy, including a Q4 2024 pre-IND meeting and a Q2 2025 Phase 2a study launch, positioning it for a significant share in the over $1 billion alopecia market due to its local action and favorable safety profile compared to existing JAK inhibitors - The company has scheduled a pre-IND meeting with the FDA in Q4 2024 to determine the Phase 2a study design for AQST-108 in alopecia areata patients, with plans to initiate the study in Q2 2025[8] - Approximately 6.7 million people in the U.S. are affected by alopecia areata, with an existing JAK inhibitor market opportunity exceeding $1 billion, but these treatments carry "black box warnings" and high costs[9] - AQST-108 showed no serious or local adverse events in its first-in-human Phase 1 clinical study, and as a topical medication, it may lack systemic side effects, positioning it for a significant share in the alopecia areata treatment market[9] Libervant® (diazepam) Buccal Film Libervant, the first and only FDA-approved oral rescue product for seizure clusters in epilepsy patients aged 2-5, has expanded its market reach with a national sales team and broad reimbursement coverage, while its NDA for patients aged 12 and above received tentative approval in August 2022, subject to orphan drug exclusivity until January 2027 Market Expansion & Regulatory Status Libervant received FDA approval in April 2024 for acute treatment of seizure clusters in epilepsy patients aged 2-5, with a 12-person national sales team expanding market access and Medicaid coverage, while its NDA for patients aged 12 and above is tentatively approved but subject to orphan drug exclusivity until January 2027, with plans to submit for 6-12 year olds before exclusivity ends - In April 2024, the FDA approved Libervant for the acute treatment of seizure clusters in epilepsy patients aged 2-5 years[11] - The company expanded Libervant's promotion for patients aged 2-5, establishing a 12-person national sales team, achieving national retail distribution, covering Medicaid patients in all states, and continuously expanding commercial insurance coverage[12] - The Libervant NDA for patients aged 12 and above received FDA tentative approval in August 2022, but its market access is limited by another company's nasal spray product's orphan drug exclusivity until January 2027[13] - The company anticipates submitting an approval application for Libervant for epilepsy patients aged 6-12 years before the orphan drug exclusivity period ends[13] Commercial Collaborations Aquestive continues to manufacture products for its licensing and supply collaborations, producing approximately 44 million doses in Q3 2024, supporting Indivior's Suboxone and other global partners, with royalty-based products like Sympazan and Azstarys contributing to Q3 revenue - In Q3 2024, the company manufactured approximately 44 million doses of product, slightly less than the 46 million doses in Q3 2023[14] - The company continues to support the manufacturing of Indivior's Suboxone sublingual film and other global collaboration products such as Assertio Holdings' Sympazan, Hypera's Ondif, and Zambon's Emylif[14] - Royalty-based products, including Sympazan and Azstarys, continued to contribute to the company's revenue in Q3 2024[14] Financial Results Summary This section summarizes Aquestive Therapeutics' Q3 2024 financial performance, including revenue, expenses, net loss, cash position, and non-GAAP adjusted EBITDA Third Quarter 2024 Financial Performance Aquestive Therapeutics' total revenue grew 4% year-over-year to $13.5 million in Q3 2024, driven by increased licensing and royalty income, despite a decline in manufacturing and supply revenue, while significantly higher R&D and SG&A expenses led to an expanded net loss of $11.5 million Key Financial Data for Q3 2024 (Compared to Q3 2023) | Metric | Q3 2024 (million U.S. dollars) | Q3 2023 (million U.S. dollars) | Year-over-Year Change (%) | | :-------------------------------- | :-------------------- | :-------------------- | :--------- | | Total Revenue | $13.5 | $13.0 | +4% | | Manufacturing and Supply Revenue | $10.7 | $11.4 | -6.1% | | Research and Development Expenses | $5.3 | $3.2 | +65.6% | | Selling, General, and Administrative Expenses | $12.1 | $7.4 | +63.5% | | Net Loss | $(11.5) | $(2.0) | +475% | | Basic and Diluted Loss Per Share | $(0.13) | $(0.03) | +333% | - Total revenue growth was primarily driven by increased licensing and royalty income, attributed to the recognition of deferred revenue following the termination of a licensing and supply agreement[15] - The decrease in manufacturing and supply revenue was primarily due to reduced Suboxone and Sympazan revenue, partially offset by increased Ondif revenue[16] - Increased R&D expenses were primarily due to clinical trial costs and product research expenses for the Anaphylm development program[17] - Increased selling, general, and administrative expenses were partly due to a $1.5 million year-over-year change in manufacturing and supply cost allocation, as well as higher commercial expenditures and regulatory fees related to Libervant approval and Anaphylm commercial readiness[18] Cash Position As of September 30, 2024, Aquestive Therapeutics held $77.9 million in cash and cash equivalents, with the company reaffirming its cash flow sustainability through 2026 - As of September 30, 2024, cash and cash equivalents totaled $77.9 million[20] - The company reaffirmed its cash flow sustainability through 2026[1] Non-GAAP Adjusted EBITDA Non-GAAP adjusted EBITDA loss for Q3 2024 was $6.6 million, a significant increase from the $1.3 million loss in Q3 2023, while excluding adjusted R&D expenses, the loss was $1.6 million compared to a $1.7 million income in the prior year Non-GAAP Adjusted EBITDA (Q3 2024 vs. Q3 2023) | Metric | Q3 2024 (million U.S. dollars) | Q3 2023 (million U.S. dollars) | | :------------------------------------------------ | :-------------------- | :-------------------- | | Non-GAAP Adjusted EBITDA Loss | $(6.6) | $(1.3) | | Non-GAAP Adjusted EBITDA Loss Excluding Non-GAAP Adjusted R&D Expenses | $(1.6) | $1.7 (Income) | Outlook Aquestive Therapeutics reaffirmed its FY 2024 financial guidance, projecting total revenue between $57 million and $60 million and a non-GAAP adjusted EBITDA loss between $20 million and $23 million FY 2024 Financial Guidance | Metric | Guidance Range (million U.S. dollars) | | :-------------------------- | :--------------------- | | Total Revenue | $57 to $60 | | Non-GAAP Adjusted EBITDA Loss | $20 to $23 | Company & Product Information This section provides an overview of Aquestive Therapeutics, detailing its mission and product portfolio, along with specific information on Anaphylm, Libervant, and AQST-108 About Aquestive Therapeutics, Inc. Aquestive is a pharmaceutical company dedicated to improving patient lives through innovative science and delivery technologies, developing orally administered products for complex molecules, and advancing a late-stage proprietary product candidate for severe allergic reactions and an early-stage epinephrine prodrug topical gel for various dermatological conditions - Aquestive is a pharmaceutical company dedicated to bringing meaningful improvements to patients' lives through innovative science and delivery technologies[33] - The company develops orally administered products to deliver complex molecules, offering new alternatives to invasive and inconvenient standard therapies[33] - Aquestive has five commercialized products, sold by the company and its licensees in the U.S. and globally, and is the exclusive manufacturer of these licensed products[33] - The company is advancing a late-stage proprietary product candidate (Anaphylm) for severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel product candidate (AQST-108) for various potential dermatological conditions[33] About Anaphylm™ Anaphylm™ (epinephrine) sublingual film is a polymer-matrix-based epinephrine prodrug product, stamp-sized and less than an ounce, dissolving on contact without water or swallowing, with primary packaging thinner than a credit card, portable, and resistant to weather, and its trade name has received conditional FDA approval - Anaphylm™ (epinephrine) sublingual film is a polymer-matrix-based epinephrine prodrug product, similar in size to a postage stamp, weighing less than an ounce, and begins to dissolve on contact[23] - It can be administered without water or swallowing, with primary packaging thinner and smaller than a typical credit card, pocketable, and resistant to weather elements like rain and sunlight[23] - Anaphylm's trade name has received conditional FDA approval, with final approval contingent upon FDA approval of the product candidate[23] About Libervant® Libervant® (diazepam) buccal film is a buccally administered diazepam formulation for the acute treatment of intermittent, stereotypic, frequent epileptic seizures (i.e., seizure clusters, acute repetitive seizures) in epilepsy patients aged 2-5 years, with FDA approval for U.S. market access in April 2024, and tentative approval for patients aged 12 and above in August 2022, subject to orphan drug exclusivity until January 2027 - Libervant® (diazepam) buccal film is a buccally administered diazepam formulation for the acute treatment of intermittent, stereotypic, frequent epileptic seizures in epilepsy patients aged 2-5 years[24] - The FDA approved Libervant for U.S. market access for epilepsy patients aged 2-5 years in April 2024[24] - Libervant for patients aged 12 and above received FDA tentative approval in August 2022, with its U.S. market access limited by existing orphan drug exclusivity, which is expected to expire in January 2027[24] About AQST-108 AQST-108 (epinephrine) topical gel is a locally administered adrenergic agonist prodrug gel product candidate, which completed its first-in-human study without serious or local adverse events, and is based on Aquestive's Adrenaverse™ platform, featuring over 20 epinephrine prodrug candidates designed to control absorption and conversion rates across various dosage forms and administration sites - AQST-108 (epinephrine) topical gel is a locally administered adrenergic agonist prodrug gel product candidate[25] - The first-in-human study showed no serious or local adverse events with AQST-108[25] - AQST-108 is based on Aquestive's Adrenaverse™ platform, which includes over 20 epinephrine prodrug product candidates designed to control absorption and conversion rates across various potential dosage forms and administration sites[25] Important Safety Information (Libervant®) This section provides important safety information for Libervant® (diazepam) buccal film, including contraindications, risks with opioids/alcohol/CNS depressants, abuse/misuse/addiction, physical dependence and withdrawal, and potential for suicidal thoughts or behavior, with drowsiness and headache as the most common side effects - Libervant should not be administered if a child is allergic to diazepam or any of its ingredients, or has acute narrow-angle glaucoma[26] - Taking benzodiazepines, including Libervant, with opioids, alcohol, or other central nervous system (CNS) depressants, including street drugs, can cause severe drowsiness, breathing problems (respiratory depression), coma, and death[26][27] - Libervant carries risks of abuse, misuse, and addiction, which can lead to overdose and serious side effects, including coma and death; drug addiction can occur even when taken as prescribed[28] - Libervant can cause physical dependence and withdrawal reactions, especially if used daily (Libervant is not for daily use); suddenly stopping it can lead to severe and life-threatening side effects, including status epilepticus, severe mental or nervous system changes, and suicidal thoughts[28] - Libervant may cause drowsiness or dizziness and slow thinking and motor skills; like other anti-epileptic drugs, Libervant may cause suicidal thoughts or behavior in a small number of people (about 1 in 500)[29][30] - The most common side effects of Libervant are drowsiness and headache[32] Legal & Disclosures This section outlines the company's use of non-GAAP financial measures and provides important forward-looking statements regarding product development, regulatory approvals, and financial outlook Non-GAAP Financial Information Disclosure This section explains the company's use of non-GAAP financial measures, such as non-GAAP adjusted EBITDA loss and adjusted expenses, which exclude items like stock-based compensation, interest expense, depreciation, amortization, and income taxes, used by management to analyze financial performance and provide additional operational transparency, but not as substitutes for GAAP measures - This press release and webcast earnings call contain financial measures not in accordance with U.S. Generally Accepted Accounting Principles (GAAP), such as non-GAAP adjusted EBITDA loss, non-GAAP adjusted gross margin, non-GAAP adjusted costs and expenses, and other adjusted expense measures[34] - These non-GAAP measures exclude items such as stock-based compensation expense, interest expense, interest expense related to future revenue sales, interest income, depreciation, amortization, and income taxes[34][35] - Aquestive management uses these measures to analyze its financial performance and aid in management decisions, providing additional transparency into operating performance[36] - The company provides outlook only on a non-GAAP basis because the sum or ultimate outcome of these adjustments (e.g., stock-based compensation expense, income taxes, amortization) for future periods cannot be reasonably determined[37] Forward-Looking Statement This section contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, concerning the development, regulatory approval, commercialization, financial condition, and business strategy of product candidates (Anaphylm, AQST-108, Libervant), which are based on current expectations but subject to risks and uncertainties that could cause actual results to differ materially, including clinical trial delays, regulatory hurdles, market competition, and funding risks, with no obligation for the company to update these statements - Forward-looking statements include, but are not limited to, statements regarding the clinical development, regulatory approval, commercialization, financial condition, and business strategy of product candidates Anaphylm™ (epinephrine) sublingual film, AQST-108 (epinephrine) topical gel, and Libervant® (diazepam) buccal film[38] - These forward-looking statements are based on current expectations and beliefs but are subject to various risks and uncertainties that could cause actual results to differ materially from the statements[39] - Risks and uncertainties include those related to product development efforts, delays in the regulatory approval process, competitive products, orphan drug exclusivity, funding adequacy, manufacturing capabilities, market acceptance, intellectual property, legal proceedings, and macroeconomic conditions[39][40] - The company undertakes no obligation to update forward-looking statements or outlook after the date of this press release, except as required by applicable law[40] Financial Statements This section presents the company's condensed balance sheets, statements of operations, and reconciliations of non-GAAP adjustments to provide a comprehensive view of its financial position and performance Condensed Balance Sheets The condensed balance sheets as of September 30, 2024, and December 31, 2023, show a significant increase in cash and cash equivalents, growth in total assets, a slight decrease in total liabilities, and a substantial improvement in total stockholders' deficit Condensed Balance Sheets (in thousands of U.S. dollars) | Metric | September 30, 2024 | December 31, 2023 | | :------------------------------------ | :----------- | :----------- | | Cash and cash equivalents | $77,893 | $23,872 | | Accounts receivable, net and other | $9,684 | $8,471 | | Inventories | $7,021 | $6,769 | | Prepaid expenses and other current assets | $1,972 | $1,854 | | Total current assets | $96,570 | $40,966 | | Property and equipment, net | $3,848 | $4,179 | | Operating lease right-of-use assets, net | $5,310 | $5,557 | | Intangible assets, net | $— | $1,278 | | Other non-current assets | $4,230 | $5,438 | | Total assets | $109,958 | $57,418 | | Accounts payable | $7,572 | $8,926 | | Accrued expenses | $5,025 | $6,497 | | Operating lease liabilities, current | $482 | $390 | | Deferred revenue, current | $1,048 | $1,551 | | Liabilities related to future revenue sales, current | $1,000 | $922 | | Loans payable, current | $25 | $22 | | Total current liabilities | $15,152 | $18,308 | | Notes payable, net | $31,253 | $27,508 | | Royalty obligation, net | $18,835 | $14,761 | | Liabilities related to future revenue sales, net | $62,730 | $63,568 | | Operating lease liabilities, non-current | $5,109 | $5,399 | | Deferred revenue, non-current | $20,266 | $32,345 | | Other non-current liabilities | $2,033 | $2,016 | | Total liabilities | $155,378 | $163,905 | | Total stockholders’ deficit | $(45,420) | $(106,487) | Condensed Statements of Operations and Comprehensive (Loss) Income The condensed statements of operations and comprehensive (loss) income show total revenue of $13.5 million and total costs and expenses of $21.8 million for Q3 2024, resulting in a net loss of $11.5 million and basic and diluted loss per share of $0.13, representing a significant expansion of loss compared to the prior year Condensed Statements of Operations and Comprehensive (Loss) Income (in thousands of U.S. dollars, except per share data) | Metric | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 | | :------------------------------------ | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Revenue | $13,542 | $13,002 | $45,694 | $37,377 | | Cost of manufacturing and supply | $4,437 | $4,798 | $13,352 | $16,152 | | Research and development expenses | $5,269 | $3,196 | $15,363 | $10,216 | | Selling, general and administrative expenses | $12,126 | $7,385 | $34,171 | $22,200 | | Total costs and expenses | $21,832 | $15,379 | $62,886 | $48,568 | | Operating (loss) income | $(8,290) | $(2,377) | $(17,192) | $(11,191) | | Interest expense | $(2,780) | $(1,256) | $(8,343) | $(4,064) | | Interest expense related to royalty obligation | $(1,359) | $— | $(4,075) | $— | | Interest expense related to future revenue sales | $(59) | $(56) | $(175) | $(163) | | Interest income and other income, net | $979 | $1,514 | $2,703 | $16,156 | | Loss on extinguishment of debt | $— | $— | $— | $(353) | | Net (loss) income before income taxes | $(11,509) | $(2,175) | $(27,082) | $385 | | Income tax (benefit) expense | $— | $(140) | $— | $144 | | Net (loss) income | $(11,509) | $(2,035) | $(27,082) | $241 | | Comprehensive (loss) income | $(11,509) | $(2,035) | $(27,082) | $241 | | Basic (loss) income per share | $(0.13) | $(0.03) | $(0.32) | $— | | Diluted (loss) income per share | $(0.13) | $(0.03) | $(0.32) | $— | Reconciliation of Non-GAAP Adjustments - Net (Loss) Income to Non-GAAP Adjusted EBITDA This reconciliation details the process of adjusting GAAP net (loss) income to non-GAAP adjusted EBITDA, including non-GAAP adjustments such as stock-based compensation, interest expense, depreciation, and amortization, with a non-GAAP adjusted EBITDA loss of $6.554 million for Q3 2024 Reconciliation of Non-GAAP Adjustments - Net (Loss) Income to Non-GAAP Adjusted EBITDA (in thousands of U.S. dollars) | Metric | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 | | :---------------------------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | GAAP Net (loss) income | $(11,509) | $(2,035) | $(27,082) | $241 | | Stock-based compensation expense | $1,577 | $774 | $4,696 | $1,766 | | Interest expense | $2,780 | $1,256 | $8,343 | $4,064 | | Interest expense related to royalty obligation | $1,359 | $— | $4,075 | $— | | Interest expense related to future revenue sales | $59 | $56 | $175 | $163 | | Interest income and other income, net | $(979) | $(1,514) | $(2,703) | $(16,156) | | Loss on extinguishment of debt | $— | $— | $— | $353 | | Income tax (benefit) expense | $— | $(140) | $— | $144 | | Depreciation and amortization | $159 | $264 | $571 | $878 | | Total non-GAAP adjustments | $4,955 | $696 | $15,157 | $(8,788) | | Non-GAAP Adjusted EBITDA | $(6,554) | $(1,339) | $(11,925) | $(8,547) | | Non-GAAP Adjusted R&D expenses | $(4,943) | $(3,069) | $(14,521) | $(9,869) | | Non-GAAP Adjusted EBITDA Excluding Non-GAAP Adjusted R&D Expenses | $(1,611) | $1,730 | $2,596 | $1,322 | Reconciliation of Non-GAAP Adjustments - GAAP Expenses to Non-GAAP Adjusted Expenses This reconciliation provides a detailed comparison of GAAP expenses (including total costs and expenses, manufacturing and supply expenses, R&D expenses, and selling, general, and administrative expenses) to non-GAAP adjusted expenses, listing adjustments such as stock-based compensation and depreciation and amortization, with a Q3 2024 non-GAAP gross margin of 69%, higher than the GAAP gross margin of 67% Reconciliation of Non-GAAP Adjustments - GAAP Expenses to Non-GAAP Adjusted Expenses (in thousands of U.S. dollars, except percentages) | Metric | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 | | :------------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Total costs and expenses | $21,832 | $15,379 | $62,886 | $48,568 | | Non-GAAP adjustments: | | | | | | Stock-based compensation expense | $(1,577) | $(774) | $(4,696) | $(1,766) | | Depreciation and amortization | $(159) | $(264) | $(571) | $(878) | | Non-GAAP Adjusted Costs and Expenses | $20,096 | $14,341 | $57,619 | $45,924 | | Cost of manufacturing and supply | $4,437 | $4,798 | $13,352 | $16,152 | | Gross margin on total revenue | 67% | 63% | 71% | 57% | | Non-GAAP adjustments: | | | | | | Stock-based compensation expense | $(102) | $(59) | $(271) | $(155) | | Depreciation and amortization | $(130) | $(214) | $(482) | $(746) | | Non-GAAP Adjusted Cost of Manufacturing and Supply | $4,205 | $4,525 | $12,599 | $15,251 | | Non-GAAP Adjusted Gross Margin on Total Revenue | 69% | 65% | 72% | 59% | | Research and development expenses | $5,269 | $3,196 | $15,363 | $10,216 | | Non-GAAP adjustments: | | | | | | Stock-based compensation expense | $(310) | $(105) | $(788) | $(277) | | Depreciation and amortization | $(16) | $(22) | $(54) | $(70) | | Non-GAAP Adjusted Research and Development Expenses | $4,943 | $3,069 | $14,521 | $9,869 | | Selling, general and administrative expenses | $12,126 | $7,385 | $34,171 | $22,200 | | Non-GAAP adjustments: | | | | | | Stock-based compensation expense | $(1,165) | $(610) | $(3,637) | $(1,334) | | Depreciation and amortization | $(13) | $(28) | $(35) | $(62) | | Non-GAAP Adjusted Selling, General and Administrative Expenses | $10,948 | $6,747 | $30,499 | $20,804 |