- Reaffirms guidance to resubmit Anaphylm™ (dibutepinephrine) sublingual film NDA in Q3 2026; Type A meeting with FDA expected to occur within 30 days
- On track to submit regulatory applications for Anaphylm in
Canada and the EU in 2026 - Extends revenue sharing agreement with RTW to
June 30, 2027 - Excluding one-time items, meets 2025 guidance for revenue and non-GAAP adjusted EBITDA loss
- Guides to end FY2026 with cash and cash equivalents of $70 million
- Company to host investment community conference call on
March 5, 2026
"We are well-positioned in 2026 to advance Anaphylm, the first and only oral epinephrine rescue medication, towards approval for patients around the world," said
Anaphylm™ (dibutepinephrine) Sublingual Film
Anaphylm is a non-device based epinephrine product candidate being developed for the treatment of Type I allergic reactions, including anaphylaxis. The Company believes Anaphylm has the potential to be the first and only non-invasive, orally delivered epinephrine product, if approved by the
On
The CRL did not identify any chemistry, manufacturing, or controls (CMC) deficiencies, and clinical results submitted as part of the NDA regarding comparability to auto-injectors (such as EpiPen® and Auvi-Q®), such as bracketing, repeat dose, and sustainability, were not questioned. No additional studies beyond the requested human factors validation study and related PK study were identified. The FDA indicated that the human factors and PK studies may be conducted in parallel.
To address the items outlined in the CRL, a new human factors validation study and a PK study are planned. A Type A meeting with the FDA has been requested to discuss the most efficient path forward for resubmission, with the NDA anticipated to be resubmitted in the third quarter of 2026, subject to completion of the required studies and expected FDA response timelines. The Company plans to request an accelerated review upon resubmission, but no expedited review can be guaranteed.
The Company continues to advance its global expansion strategy for Anaphylm, including ongoing regulatory engagement in
Aquestive will continue to prepare for the launch of Anaphylm, a potentially transformative product for the emergency treatment of severe allergic reactions, including anaphylaxis. The initial focus of the Company's launch preparation is to optimize Anaphylm's market access for patients, if approved by the FDA. Aquestive is also increasing awareness of Anaphylm through the continued execution of its medical affairs strategy, including presenting scientific data at medical forums throughout 2026. The Company remains committed to a successful launch of Anaphylm, if approved by the FDA.
AQST-108 (epinephrine) Topical Gel
AQST-108 is a topical epinephrine prodrug gel product candidate being evaluated for alopecia areata (AA) and other potential dermatologic or localized indications. In
An initial first-in-human clinical trial of AQST-108 evaluated topical application and systemic exposure and did not identify any serious or topical adverse events. Building on these results, the Company successfully completed dosing in a second Phase 1 clinical trial in the first quarter of 2026 and the data readout from the study is expected in the second quarter of 2026. The intent of this study is to further characterize the safety, tolerability, and pharmacologic profile of the program and to inform potential future development opportunities, including indication selection.
An estimated 6.7 million people in
The topical formulation of AQST-108 is designed to act locally at the site of application, which may support evaluation in settings where minimizing systemic exposure is desirable. This localized delivery approach provides an opportunity to explore additional value for this product beyond a single indication, while maintaining a disciplined, data-driven development strategy.
Commercial Collaborations
Aquestive continues to manufacture products for the licensing and supply collaborations that it has established. The Company manufactured approximately 47 million doses in the fourth quarter 2025, compared to approximately 43 million doses in the fourth quarter 2024. The Company continues to manufacture Indivior’s Suboxone® Sublingual Film product and the Company's other global collaborations, including Sympazan® (clobazam)
The Company, being a
Sales of royalty-based products, inclusive of Sympazan® (clobazam)
Libervant® (diazepam) Buccal Film remains tentatively approved until
RTW Amendment, Warrant and Share Purchase Agreement
On
Legal Settlement
In
Fourth Quarter 2025 Financials
Total revenues increased to
Manufacture and supply revenue increased to
Research and development (R&D) expenses decreased to
Excluding one-time legal expenses, selling, general and administrative expenses increased to
Excluding one-time legal expenses, Aquestive’s net loss for the fourth quarter 2025 was
Excluding one-time legal expenses, Non-GAAP adjusted EBITDA loss was
Full Year 2025 Financials
Excluding the impact of one-time recognition of deferred revenues during the full year 2024, total revenues decreased by
Manufacture and supply revenue increased to
R&D expenses decreased to
Excluding one-time legal expenses, selling, general and administrative expenses increased to
Excluding one-time legal expenses, Aquestive's net loss for the full year 2025 was
Excluding one-time legal expenses, Aquestive's Non-GAAP adjusted EBITDA loss was
As of
2026 Outlook
Aquestive is providing its full year 2026 financial outlook. The Company expects:
| Guidance | ||
| Total revenue (in millions) | ||
| Non-GAAP adjusted EBITDA loss (in millions) |
Our Non-GAAP adjusted EBITDA loss guidance for 2026 includes costs associated with the resubmission of the NDA for Anaphylm, continued pre-commercial infrastructure spending for Anaphylm, clinical trial for AQST-108, and regulatory applications for Anaphylm in
Tomorrow’s Conference Call and Webcast Reminder
The Company will host a conference call at
In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin.
A live webcast of the call will be available on the "Events and Presentations" page of the Investor section of Aquestive’s website: Fourth Quarter 2025 Earnings Call. The webcast will be archived for 30 days.
About Anaphylm™
Anaphylm™ (epinephrine) sublingual film is a polymer matrix-based epinephrine prodrug product. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The primary packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.
About AQST-108
AQST-108 (epinephrine) topical gel is a topically delivered adrenergic agonist prodrug product candidate. Aquestive completed a first in human study for AQST-108 without any serious or topical adverse events. AQST-108 is based on Aquestive’s Adrenaverse™ platform which contains a library of over twenty epinephrine prodrug product candidates intended to control absorption and conversion rates across a variety of possible dosage forms and delivery sites.
About Libervant®
Libervant® (diazepam) buccal film is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA approval for U.S. market access received in
Important Safety Information
Do not give Libervant to your child between the ages of two and five if your child is allergic to diazepam or any of the ingredients in Libervant or has an eye problem called acute narrow angle glaucoma.
What is the most important information I should know about Libervant?
- Libervant is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:
- shallow or slowed breathing,
- breathing stops (which may lead to the heart stopping),
- excessive sleepiness (sedation).
Do not allow your child to drive a motor vehicle, operate heavy machinery, or ride a bicycle until you know how taking Libervant with opioids affects your child.
- Risk of abuse, misuse, and addiction. Libervant is used in children 2 to 5 years of age. The unapproved use of Libervant has a risk for abuse, misuse, and addiction, which can lead to overdose and serious side effects including coma and death.
- Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in Libervant). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
- Your child can develop an addiction even if your child takes Libervant as prescribed by your child’s healthcare provider.
- Give Libervant exactly as your child’s healthcare provider prescribed.
- Do not share Libervant with other people.
- Keep Libervant in a safe place and away from children.
- Physical dependence and withdrawal reactions. Libervant is intended for use if needed in order to treat higher than usual seizure activity. Benzodiazepines, including Libervant, can cause physical dependence and withdrawal reactions, especially if used daily. Libervant is not intended for daily use.
- Do not suddenly stop giving Libervant to your child without talking to your child’s healthcare provider. Stopping Libervant suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures that will not stop (status epilepticus), sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, homicidal thoughts, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if your child gets any of these symptoms.
- Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning, or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
- Physical dependence is not the same as drug addiction. Your child’s healthcare provider can tell you more about the differences between physical dependence and drug addiction.
- Do not give your child more Libervant than prescribed or give Libervant more often than prescribed.
Libervant can make your child sleepy or dizzy and can slow your child’s thinking and motor skills.
- Do not allow your child to drive a motor vehicle, operate machinery, or ride a bicycle until you know how Libervant affects your child.
- Do not give other drugs that may make your child sleepy or dizzy while taking Libervant without first talking to your child’s healthcare provider. When taken with drugs that cause sleepiness or dizziness, Libervant may make your child’s sleepiness or dizziness much worse.
Like other antiepileptic medicines, Libervant may cause suicidal thoughts or actions in a small number of people, about 1 in 500.
- Call a healthcare provider right away if your child has any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- new or worse depression
- feeling agitated or restless
- trouble sleeping (insomnia)
- acting aggressive, being angry or violent
- other unusual changes in behavior or mood
- attempts to commit suicide
- new or worse anxiety or irritability
- an extreme increase in activity and talking (mania)
- new or worse panic attacks
- acting on dangerous impulses
- Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your child’s healthcare provider as scheduled.
- Call your child’s healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If your child has suicidal thoughts or actions, your child’s healthcare provider may check for other causes.
What are the possible side effects of Libervant?
- The most common side effects of Libervant are sleepiness and headache.
- These are not all the possible side effects of Libervant.
- Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA-1088.
For more information about Libervant, talk to your doctor, and see Product Information: Medication Guide and Instructions For Use.
About Aquestive Therapeutics, Inc.
Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. The worldwide leader in delivering trusted, quality medications on oral film, Aquestive operates as both a developer of its own proprietary products and a
Non-GAAP Financial Information
This press release and our webcast earnings call regarding our quarterly financial results contains financial measures that do not comply with
Specifically, the Company adjusts net loss for certain non-cash expenses, including share-based compensation expenses; depreciation and amortization; and interest expense related to the sale of future revenue, interest income and other income, net and income taxes, with a result of adjusted EBITDA loss.?Similarly, manufacture and supply expense, R&D expense, and selling, general and administrative expense were adjusted for certain non-cash expenses of share-based compensation expense and depreciation and amortization. Adjusted EBITDA loss and these non-GAAP expense categories are used as a supplement to the corresponding GAAP measures to provide additional insight regarding the Company’s ongoing operating performance.?
These measures supplement the Company’s financial results prepared in accordance with GAAP. Aquestive management uses these measures to analyze its financial results, and its future manufacture and supply expenses, gross margins, R&D expense and selling, general and administrative expense and to help make managerial decisions. In management’s opinion, these non-GAAP measures provide added transparency into the operating performance of Aquestive and added insight into the effectiveness of our operating strategies and actions. The Company may provide one or more revenue measures adjusted for certain discrete items, such as fees collected on certain licensed products, in order to provide investors added insight into our revenue stream and breakdown, along with providing our GAAP revenue. Such measures are intended to supplement, not act as substitutes for, comparable GAAP measures and should not be read as a measure of liquidity for Aquestive. Adjusted EBITDA loss and the other non-GAAP measures are also likely calculated in a way that is not comparable to similarly titled measures reported by other companies.
Non-GAAP Outlook
In providing the outlook for non-GAAP adjusted EBITDA and non-GAAP gross margin, we exclude certain items which are otherwise included in determining the comparable GAAP financial measures. In order to inform our outlook measures of non-GAAP adjusted EBITDA and non-GAAP gross margin, a description of the adjustments which have been applicable in determining non-GAAP Adjusted EBITDA and non-GAAP gross margin for these periods are reflected in the tables below. In providing outlook for non-GAAP gross margin, the Company adjusts for non-cash share-based compensation expense and depreciation and amortization. The Company is providing such outlook only on a non-GAAP basis because the Company is unable to predict with reasonable certainty the totality or ultimate outcome or occurrence of these adjustments for the forward-looking period such as share-based compensation expense, income tax, amortization, and certain other adjusted items, which can be dependent on future events that may not be reliably predicted. Based on past reported results, where one or more of these items have been applicable, such excluded items could be material, individually or in the aggregate, to reported results.
Forward-Looking Statement
Certain statements in this press release 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 of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (dibutepinephrine) sublingual film through clinical development and approval by the FDA, including our ability to address the concerns raised by the FDA in the CRL dated
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for Anaphylm and AQST-108; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates Anaphylm, Libervant and AQST-108, or failure to receive FDA approval at all of any or all of these product candidates; risk of FDA inspections of manufacturing and clinical study sites for any of our product candidates, including Anaphylm, Libervant and AQST-108; risk of government shutdowns or actions to reduce government workforces on the ability of the FDA to act on the approval of our product candidates, including Anaphylm, Libervant and AQST-108; risk of the Company’s ability to generate sufficient clinical and other human factor data, including with respect to our submission of pharmacokinetic and pharmacodynamic (PK/PD) comparability data for FDA approval of Anaphylm; risks associated with our ability to address the FDA’s comments on and identified deficiencies in our NDA, including the concerns raised by the FDA in the CRL for Anaphylm and whether the FDA may request further information from us (including additional clinical studies), disagree with our findings or otherwise undertake a lengthy review of the resubmission of our NDA, and challenges regarding the following commercial launch of Anaphylm, if approved by the FDA; risks associated with the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm, Libervant and AQST-108, if these product candidates are approved by the FDA; risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product candidates, including Anaphylm, Libervant and AQST-108; risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements to support our growth strategy, and other cash needs, at the times and in the amounts needed, including to commence principal payments on our 13.5% Senior Secured Notes in 2026, and to fund future clinical development and commercial activities for our product candidates, including Anaphylm, Libervant and AQST-108, should these product candidates be approved by the FDA; risk of the impact of our obligations under the Company's Purchase Agreement and the Royalty Rights Agreement with third parties, each of which agreements requires the Company to make payments to each counterparty thereof, respectively, of a portion of our revenues, on our ability to contribute to the funding of our operations and the payment of principal and interest on our debt; the risk of our obligations under such Purchase Agreement and Royalty Rights Agreement impacting our ability to refinance our 13.5% Senior Secured Notes; risk that our manufacturing capabilities will be sufficient to support demand of our product candidates in the
PharmFilm®, Libervant®, Sympazan® and the Aquestive logo are registered trademarks of
Investor inquiries:
brian.korb@asterpartners.com
Balance Sheets (In thousands, except share and per share amounts) (Unaudited) | |||||||
| 2025 | 2024 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 121,169 | $ | 71,546 | |||
| Trade and other receivables, net | 17,763 | 7,344 | |||||
| Inventories, net | 6,169 | 6,044 | |||||
| Prepaid expenses and other current assets | 4,168 | 3,286 | |||||
| Total current assets | 149,269 | 88,220 | |||||
| Property and equipment, net | 3,893 | 3,799 | |||||
| Right-of-use assets, net | 4,621 | 5,182 | |||||
| Other non-current assets | 2,642 | 4,223 | |||||
| Total assets | $ | 160,425 | $ | 101,424 | |||
| Liabilities and stockholders’ deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 29,862 | $ | 10,287 | |||
| Accrued expenses | 5,029 | 5,907 | |||||
| Lease liabilities, current | 631 | 510 | |||||
| Deferred revenue, current | 1,092 | 1,048 | |||||
| Liability related to the sale of future revenue, current | 1,000 | 1,000 | |||||
| Royalty obligations, current | — | 87 | |||||
| Loans payable, current | 9,994 | 26 | |||||
| Total current liabilities | 47,608 | 18,865 | |||||
| Loans payable, net | 27,519 | 32,500 | |||||
| Royalty obligations, net | 25,941 | 20,129 | |||||
| Liability related to the sale of future revenue, net | 62,023 | 62,718 | |||||
| Lease liabilities | 4,337 | 4,968 | |||||
| Deferred revenue, net of current portion | 19,390 | 20,005 | |||||
| Other non-current liabilities | 7,269 | 2,395 | |||||
| Total liabilities | 194,087 | 161,580 | |||||
| Contingencies | |||||||
| Stockholders’ deficit: | |||||||
| Common stock, | 122 | 91 | |||||
| Additional paid-in capital | 413,214 | 302,967 | |||||
| Accumulated deficit | (446,998 | ) | (363,214 | ) | |||
| Total stockholders’ deficit | (33,662 | ) | (60,156 | ) | |||
| Total liabilities and stockholders’ deficit | $ | 160,425 | $ | 101,424 | |||
Statements of Operations and Comprehensive Loss (In thousands, except share and per share data amounts) (Unaudited) | |||||||||||||||
| Three Months Ended | Year Ended | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenues | $ | 13,015 | $ | 11,867 | $ | 44,545 | $ | 57,561 | |||||||
| Costs and expenses: | |||||||||||||||
| Manufacture and supply | 5,836 | 4,520 | 18,555 | 17,872 | |||||||||||
| Research and development | 3,196 | 4,917 | 17,192 | 20,280 | |||||||||||
| Selling, general and administrative | 32,822 | 16,009 | 79,849 | 50,180 | |||||||||||
| Total costs and expenses | 41,854 | 25,446 | 115,596 | 88,332 | |||||||||||
| Loss from operations | (28,839 | ) | (13,579 | ) | (71,051 | ) | (30,771 | ) | |||||||
| Other income (expenses): | |||||||||||||||
| Interest expense | (2,778 | ) | (2,779 | ) | (11,120 | ) | (11,122 | ) | |||||||
| Interest expense related to royalty obligations | (1,433 | ) | (1,384 | ) | (5,737 | ) | (5,459 | ) | |||||||
| Interest expense related to the sale of future revenue | (62 | ) | (61 | ) | (243 | ) | (236 | ) | |||||||
| Interest income and other income, net | 1,252 | 734 | 4,367 | 3,437 | |||||||||||
| Net loss before income taxes | (31,860 | ) | (17,069 | ) | (83,784 | ) | (44,151 | ) | |||||||
| Income taxes benefit | — | 14 | — | 14 | |||||||||||
| Net loss | $ | (31,860 | ) | $ | (17,055 | ) | $ | (83,784 | ) | $ | (44,137 | ) | |||
| Comprehensive loss | $ | (31,860 | ) | $ | (17,055 | ) | $ | (83,784 | ) | $ | (44,137 | ) | |||
| Loss per share attributable to common stockholders: | |||||||||||||||
| Basic and diluted (in dollars per share) | $ | (0.26 | ) | $ | (0.19 | ) | $ | (0.78 | ) | $ | (0.51 | ) | |||
| Weighted average common shares outstanding: | |||||||||||||||
| Basic and diluted (in shares) | 121,966,911 | 91,199,407 | 106,926,528 | 86,726,211 | |||||||||||
Reconciliation of Non-GAAP Adjustments - Net Loss to Adjusted EBITDA (In Thousands) (Unaudited) | |||||||||||||||
| Three Months Ended | Year Ended | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| GAAP net loss | $ | (31,860 | ) | $ | (17,055 | ) | $ | (83,784 | ) | $ | (44,137 | ) | |||
| Share-based compensation expense | 1,376 | 2,403 | 7,624 | 7,099 | |||||||||||
| Interest expense | 2,778 | 2,779 | 11,120 | 11,122 | |||||||||||
| Interest expense related to the sale of future revenue | 62 | 61 | 243 | 236 | |||||||||||
| Interest expense related to royalty obligations | 1,433 | 1,384 | 5,737 | 5,459 | |||||||||||
| Interest income and other income, net | (1,252 | ) | (734 | ) | (4,367 | ) | (3,437 | ) | |||||||
| Income taxes benefit | — | (14 | ) | — | (14 | ) | |||||||||
| Depreciation and amortization | 129 | 147 | 548 | 718 | |||||||||||
| Total non-GAAP adjustments | $ | 4,526 | $ | 6,026 | $ | 20,905 | $ | 21,183 | |||||||
| Adjusted EBITDA | $ | (27,334 | ) | $ | (11,029 | ) | $ | (62,879 | ) | $ | (22,954 | ) | |||
| Excluding one-time legal expenses | $ | (13,200 | ) | $ | — | $ | (13,200 | ) | $ | — | |||||
| Adjusted EBITDA excluding one-time legal expenses | $ | (14,134 | ) | $ | (11,029 | ) | $ | (49,679 | ) | $ | (22,954 | ) | |||
| Excluding adjusted R&D expenses | $ | (3,355 | ) | $ | (4,474 | ) | $ | (15,256 | ) | $ | (18,995 | ) | |||
| Adjusted EBITDA excluding adjusted R&D expenses and one-time legal expenses | $ | (10,779 | ) | $ | (6,555 | ) | $ | (34,423 | ) | $ | (3,959 | ) | |||
Reconciliation of Non-GAAP Adjustments - Total Costs and Expenses to Adjusted Costs and Expenses (In Thousands) (Unaudited) | |||||||||||||||
| Three Months Ended | Year Ended | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Total costs and expenses | $ | 41,854 | $ | 25,446 | $ | 115,596 | $ | 88,332 | |||||||
| Non-GAAP adjustments: | |||||||||||||||
| Share-based compensation expense | (1,376 | ) | (2,403 | ) | (7,624 | ) | (7,099 | ) | |||||||
| Depreciation and amortization | (129 | ) | (147 | ) | (548 | ) | (718 | ) | |||||||
| Adjusted costs and expenses | $ | 40,349 | $ | 22,896 | $ | 107,424 | $ | 80,515 | |||||||
| Manufacture and supply expense | $ | 5,836 | $ | 4,520 | $ | 18,555 | $ | 17,872 | |||||||
| Gross Margin on total revenue | 55 | % | 62 | % | 58 | % | 69 | % | |||||||
| Non-GAAP adjustments: | |||||||||||||||
| Share-based compensation expense | (123 | ) | (103 | ) | (481 | ) | (374 | ) | |||||||
| Depreciation and amortization | (103 | ) | (124 | ) | (442 | ) | (606 | ) | |||||||
| Non-GAAP adjusted manufacture and supply expense | $ | 5,610 | $ | 4,293 | $ | 17,632 | $ | 16,892 | |||||||
| Non-GAAP Gross Margin on total revenue | 57 | % | 64 | % | 60 | % | 71 | % | |||||||
| Research and development expense | $ | 3,196 | $ | 4,917 | $ | 17,192 | $ | 20,280 | |||||||
| Non-GAAP adjustments: | |||||||||||||||
| Share-based compensation expense | 173 | (427 | ) | (1,875 | ) | (1,215 | ) | ||||||||
| Depreciation and amortization | (14 | ) | (16 | ) | (61 | ) | (70 | ) | |||||||
| Non-GAAP adjusted research and development expense | $ | 3,355 | $ | 4,474 | $ | 15,256 | $ | 18,995 | |||||||
| Selling, general and administrative expenses | $ | 32,822 | $ | 16,009 | $ | 79,849 | $ | 50,180 | |||||||
| Non-GAAP adjustments: | |||||||||||||||
| Share-based compensation expense | (1,426 | ) | (1,873 | ) | (5,268 | ) | (5,510 | ) | |||||||
| Depreciation and amortization | (12 | ) | (7 | ) | (45 | ) | (42 | ) | |||||||
| Non-GAAP adjusted selling, general and administrative expenses | $ | 31,384 | $ | 14,129 | $ | 74,536 | $ | 44,628 | |||||||
