Nov 2, 2026 earnings call — Commercial growth and pipeline progress
Total revenue reached $260 million in the quarter, representing 52% year-over-year growth.
Revenue $0.3B (est $0.2B) · EPS $-0.25 (est $-0.63)
Key quotes
"Overall, AUVELITY growth is being driven by both increased prescribing frequency among existing writers and continued acceleration in new writer activation."
"Our NDA for AXS-12 for the treatment of cataplexy in narcolepsy is currently under review by the FDA. With a PDUFA target action date of May 1, 2027."
"We continue to expect that our current cash balance will be sufficient to fund anticipated operations through cash flow positivity."
Analyst Q&A 22
samples to paid prescriptions
Q (Truist): Analyst asked how early patient cohorts move from samples to paid packs and maintenance prescriptions, and whether this matches internal expectations.
A: They are sampling at a similar rate to the MDD launch and demand for ADA samples is strong. They do not have precise data on whether samples are dispensed to patients, but are seeing positive NBRx growth among sampled HCPs and expect that trend to continue.
"So we are sampling at a similar rate to what was observed during the MDD launch." — Ari Maizel
how AUVELITY launch differs from Rexulti
Q (Wolfe): Analyst asked for key differences in market dynamics and marketing strategy versus Rexulti.
A: They declined to comment on other companies' products and said AUVELITY is a different product with a different mechanism, so launch dynamics differ. The market still needs significant education, especially about agitation symptoms and earlier diagnosis, and they are focused on educating about AUVELITY's clinical profile.
"As it relates to the market, there is still significant education required in this marketplace." — Ari Maizel
Q4 and 2027 revenue expectations
Q (Ashwani Verma · UBS): Analyst asked whether Q4 and 2027 consensus numbers should be revised given the launch and recent results.
A: They reported Q3 revenue of $207.6 million and do not give specific guidance for Q4 or 2027. They saw robust sequential NBRx growth (26% Q2 vs Q1 and 21% Q3 vs Q2) and expect continued AUVELITY growth as NBRx convert to TRx.
"So yes, so Q3, we came in at $207.6 million and we do not give specific guidance on for Q4 or for 2027." — Nick Pizzie (CFO)
patient copays and conversion
Q (Leonid Timashev · RBC): Analyst asked how patients are handling copays and whether patients convert from free samples to paid prescriptions.
A: They have worked to ensure Medicare access and coverage; dispensing rates for prescribed patients are good, suggesting coverage and manageable affordability for many. They acknowledged affordability is not universal and they provide education and resources for patients with challenges, but overall are pleased with fills once prescriptions are written.
"What we have seen is good dispensing rates for patients that are prescribed the product would suggest that not only are they getting coverage, but the affordability has been manageable for them." — Ari Maizel
gross-to-net (GTN) changes
Q (Marc Goodman · Leerink Partners): Analyst asked what drove GTN in Q3 and how to expect GTN in Q4 and 2027.
A: GTN improved to the mid- to high 40s in Q3 versus around 50% in Q2. They expect a slight increase in GTN in Q4 due to accruals for scripts adjudicated in Q1 and inventory accruals, and they expect 2027 GTN to look similar to 2026 levels (low 50s in Q1, approx 50% Q2, mid-high 40s Q3, slight tick up in Q4).
"So the GTN for the quarter, improved to the mid- to high 40s in Q3." — Nick Pizzie (CFO)
reducing placebo risk in schizophrenia trials
Q (Jason Gerberry · BofA): Analyst asked how they will design Phase III for AXS-20 to mitigate rising placebo response in schizophrenia trials.
A: Placebo response is considered carefully in study design; they have experience managing high placebo rates in indications like MDD and ADHD. They use multiple small, sometimes proprietary protocol changes they have developed over years and will apply those measures in psychiatry studies.
"So placebo response is something that we think about quite a lot as we design all of our studies." — Herriot Tabuteau (CEO)
long-term care (LTC) opportunity
Q (David Amsellem · Piper Sandler): Analyst asked about the LTC channel opportunity for ADA through 2027 and dialogues with institutions.
A: LTC is performing well with growth similar to patients 65 and older and AUVELITY's clinical profile has been positively received; LTC facilities see a clear value proposition. LTC sales involve multiple stakeholders and a longer sales cycle than community settings, but they are pleased with early progress and view LTC as an important future source of business.
"LTC as a channel is performing well thus far with growth rates that are similar to what we reported for patients 65 and older." — Ari Maizel
impact of salesforce expansion on under-65 TRx
Q (Sean Laaman · Morgan Stanley): Analyst asked how much under-65 TRx growth is due to underlying demand versus salesforce expansion and when productivity should mature.
A: They have seen significant growth from approval and the salesforce expansion and expect continued gains as the salesforce becomes more productive. Before expansion, monthly TRx for patients 65 and younger were approximately 67 thousand and as of September 2026 were approximately 88.2 thousand, about 32% growth, indicating early positive impact from the expansion.
"When you think about, where we were before the sales force expansion for patients 65 and younger, monthly TRx were approximately 67 thousand." — Ari Maizel
Tourette's program status
Q (Malcolm Hoffman · BMO): Analyst asked why Tourette's was removed from the pipeline slide: formal decision or prioritization?
A: They said there is no change to their interest in Tourette's; it is still of interest but positioned further back in the pipeline as they highlighted later-stage programs. No formal change to plans was indicated.
"We are--you know, that is just further back in the pipeline." — Herriot Tabuteau (CEO)
when NBRx will match TRx for 65+
Q (Andrew · Jefferies): Analyst asked whether the NBRx inflection will catch up to TRx in days, weeks, or months/quarters.
A: NBRx for 65 and older grew 211% year-over-year and TRx for that group grew 78% since approval; they expect the upward trajectory to continue. Their continued focus on new patient initiations will support ongoing and persistent demand growth.
"We expect the upward trajectory to continue and our focus on new patient initiations will also continue, which will support ongoing and persistent demand growth." — Ari Maizel
prior treatments and adoption barriers
Q (Joseph Thome · TD Cowen): Analyst asked where new AUVELITY patients come from (naive or prior treatments) and reasons physicians delay use.
A: Prior treatment experience spans a broad spectrum from generic antidepressants and antipsychotics to branded antipsychotics, and both treatment-naive and experienced patients have been prioritized by early prescribers. Barriers are mainly clinician comfort with the clinical profile and finding the first patient to try it; education and awareness are important.
"When we look at prior treatment experience, it really does cover a broad spectrum of prior treatments." — Ari Maizel
AXS-12 review status and market view
Q (Yatin Suneja · Guggenheim): Analyst asked for an update on the narcolepsy review and thoughts on market/competitive dynamics.
A: The review is progressing as expected with just under six months to go and a PDUFA date of May 1; FDA does not plan an AdCom. They are pleased with AXS-12's clinical profile and believe more treatment options are beneficial given heterogeneity and inconsistent responses in the narcolepsy market.
"So with respect to the review, and the review is progressing as expected." — Mark L. Jacobson (COO)
system bottlenecks for ADA launch
Q (Benjamin Burnett · Wells Fargo): Analyst asked whether bottlenecks like distribution or EMR updates could slow ADA adoption and ramp.
A: They reported strong NBRx and TRx growth and see no major bottlenecks. Early EMR and e-prescribing systems needed updates for dosing and administration, but nothing is preventing prescribing at this time.
"But there is nothing standing in the way of prescribing at this point in time." — Ari Maizel
prescription abandonment and Advantage plans
Q (Brian Skorney · Baird): Analyst asked about prescription abandonment, Medicare patients' out-of-pocket caps, formulary management in Advantage plans, and potential disruptions.
A: Abandonment in Medicare is generally higher than commercial but nothing out of the ordinary versus MDD; they have seen no disruption from Advantage plan shutdowns. They secured access with no prior authorization requirements and feedback is that patients are getting access and filling prescriptions at a very high rate.
"The feedback we have received is that patients are getting access and filling prescriptions at a very high rate." — Ari Maizel
desired profile for binge-eating study
Q (Ami Fadia · Needham and Company): Analyst asked what efficacy and safety profile would be competitive for solriamfetol in binge eating disorder.
A: They want to see separation from placebo for the two tested doses and a safety profile consistent with solriamfetol's established safety. They emphasized solriamfetol is efficacious and well tolerated in current indications and a well-tolerated efficacious alternative would be welcomed versus the currently highly scheduled option.
"So what we are looking to see, first of all, is a separation from placebo." — Herriot Tabuteau (CEO)
October scripts and Q4 seasonality
Q (David · Deutsche Bank): Analyst asked how third-party vendor script trends through October compare to expectations and whether seasonality affects Q4.
A: Q4 is shaping up in line with their expectations with continued growth in both indications, though two months remain in the quarter. The team is focused on driving NBRx growth and primary care penetration, they do not guide by quarter, but feel good about overall trends.
"Q4 is shaping up based on our expectations, continued growth in both indications." — Ari Maizel
capture rates of data providers
Q (Greg · Mizuho): Analyst asked about capture-rate differences between Symphony and IQVIA and what they observed this quarter.
A: Capture rates fluctuated, potentially due to adding new pharmacies with the ADA launch; IQVIA appeared most impacted and decreased to around 90%. They were also told a pharmacy chain stopped reporting to one provider, which may affect TRx and NBRx numbers, but they have no further detail from the third-party providers.
"Specifically, IQVIA seems to be impacted the most that decreased to somewhere around 90%." — Nick Pizzie (CFO)
AXS-20 advantages and BD appetite
Q (Matthew Hershenhorn · Oppenheimer): Analyst asked about real-world advantages of AXS-20 versus other novel agents and appetite for more BD deals.
A: They highlighted a favorable safety profile for the PDE10A inhibitor and noted lack of metabolic side effects seen in studies, which could be a meaningful advance if efficacy is strong. They have completed recent BD transactions that make financial sense, can be integrated into the pipeline, and do not change their AUVELITY growth investment strategy.
"So that is just a highlight of the favorable safety profile of this product candidate." — Herriot Tabuteau (CEO)
ENGAGE enrollment and timing
Q (Myles Minter · William Blair): Analyst asked whether enrollment exceeded the target and about potential dose response between 150 and 300 mg.
A: Enrollment is basically completed and they are on track to report top-line results in the first half of the first quarter; a few patients in screening may still percolate but enrollment is done. They did not provide dose-response details in this answer.
"Enrollment is basically completed and we are on track to report top line results in the first half of the first quarter." — Herriot Tabuteau (CEO)
AXS-20 as first-line or add-on
Q (Madison Wynne El-Saadi · B. Riley): Analyst asked if AXS-20 could be used on top of D2 antagonists or muscarinic drugs without movement-disorder risk, or as first-line therapy.
A: They are developing AXS-20 as a first-line therapy; prior studies were conducted with AXS-20 as monotherapy and they plan to replicate that approach in Phase III.
"So we are developing it as a first line therapy." — Herriot Tabuteau (CEO)
SYMBRAVO access and AXS-14 timing
Q (Raghuram Selvaraju · H. C. Wainwright): Analyst asked how covered lives for SYMBRAVO will evolve and when AXS-14 Phase III top-line data and potential NDA filing might occur.
A: They are actively engaged with government and commercial payers and encouraged by ongoing dialogue, but cannot predict timing for new access contracts. For AXS-14, timeline is hard to predict because it is a randomized withdrawal study; once the study concludes, they could be ready to file an NDA shortly after reporting top-line results, typically roughly 6 months or possibly less.
"So onto, the second part of your question regarding AXS-14, the timeline for reporting data is a little hard to predict because this is a randomized withdrawal study." — Herriot Tabuteau (CEO)
AXS-12 commercial and payer talks
Q (Samantha · Cantor Fitzgerald): Analyst asked about the commercial opportunity for AXS-12 in narcolepsy, payer discussions, pricing thoughts, and commercialization planning.
A: They are pleased with AXS-12's profile and believe it will be well received given inconsistent responses to existing meds; payers have responded positively in discussions and recognize cataplexy as debilitating. They do not comment on pricing pre-launch but feel good about payer dialogue and look forward to potential approval.
"Our engagement with payers thus far has been very positive." — Ari Maizel