Axsome Therapeutics - Q1 2023
May 8, 2023
Transcript
Operator (participant)
Hello, welcome to the Axsome Therapeutics First Quarter 2023 Financial Results Conference Call and Webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question-and-answer session will follow the formal presentation. You may ask a question at any time by typing it into the ask a question feature on your screen. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Mark Jacobson. Please go ahead, Mark.
Mark Jacobson (COO)
Thank you, operator. Good morning, and thank you all for joining us on today's conference call. This morning, we issued our earnings press release providing a corporate update and details of the company's financial results for the first quarter of 2023. The release crossed the wire a short time ago and is available on our website at axsome.com. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety, and intended utilization of our investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development plans, our commercial plans regarding SUNOSI, AUVELITY, and our pipeline products, revenue projections, and possible intended use of cash and investments.
These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date. The company disclaims any obligation to update such statements. Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer, Nick Pizzie, Chief Financial Officer, and Lori Englebert, Executive Vice President of Commercial and Business Development. Herriot will provide an overview of the company and progress made in the first quarter of 2023, as well as upcoming milestones.
Following Herriot, Nick will review our financial results, and then Lori will provide a commercial update. We will then open the line for questions. Questions will be taken in the order they are received. With that, I will turn the call over to Herriot.
Herriot Tabuteau (CEO)
Thank you, Mark. Good morning, everyone, and thank you for joining Axsome Therapeutics first quarter 2023 financial results and business update conference call. We saw strong performance in all areas of our business in the first quarter, which included advancing the commercialization of AUVELITY and SUNOSI, progressing our late-stage product pipeline, out-licensing ex-US rights for SUNOSI and strengthening our financial position. Total net product sales in the quarter were $28.8 million, driven by strong performance for AUVELITY and solid performance for SUNOSI. Based on the current prescription trends, we are pleased that our two marketed products are now helping a growing number of patients living with depression and with excessive daytime sleepiness. Later in the call, we will provide further details on our commercial performance for AUVELITY and SUNOSI.
The first quarter was an important milestone for Axsome as it was the first full quarter of sales for AUVELITY. We have also had control of the U.S. rights to SUNOSI for about one year. Earlier in the quarter, we announced the out-licensing of our ex-U.S. marketing rights for SUNOSI in Europe, the Middle East, and North Africa to Pharmanovia. Pharmanovia shares our excitement and commitment to maximize the potential of SUNOSI for patients worldwide. We continue to see significant potential for SUNOSI, both in the current indications as well as in potential new indications. With regards to new indications, we remain on track to initiate phase 3 trial of Solriamfetol, the active molecule in SUNOSI in ADHD in adults in the second quarter.
In addition to Solriamfetol for ADHD, the rest of our leading CNS pipeline includes AXS-07 for migraine, AXS-12 for narcolepsy, AXS-14 for fibromyalgia, and AXS-05 for Alzheimer's disease agitation and for smoking cessation. AXS-07, our developmental candidate for the acute treatment of migraine, manufacturing activities are moving forward to enable the resubmission of this NDA, which is slated for the second half of this year. AXS-12, our product candidate for the treatment of narcolepsy, we continue to expect top-line results from the pivotal phase 3 SYMPHONY trial in the first half of this year. AXS-14, our product candidate for the treatment of fibromyalgia, manufacturing and other activities related to preparations for the planned submission of an NDA are continuing, and we expect to be in a position to submit the NDA for this product candidate in the second half of this year.
With regards to AXS-05 for the treatment of Alzheimer's disease agitation, enrollment in the phase 3 ADVANCE-2 trial is progressing, and we anticipate completing this trial in the first half of 2024. In addition, we plan to initiate a phase 2/3 trial of AXS-05 in smoking cessation in the fourth quarter of 2023. In sum, we expect the next 12 to 18 months to be eventful as we drive the commercialization of AUVELITY and SUNOSI. As we advance our research and development pipeline, I will now turn the call over to Nick, who will provide details of our financial performance.
Nick Pizzie (CFO)
Thank you,Herriot, and good morning. Today, I will discuss our first quarter results and provide some financial guidance. Total revenue in the first quarter of 2023 was $94.6 million, consisting of net sales of our two commercialized products, AUVELITY and SUNOSI. The revenue from the SUNOSI Europe and MENA out licensing agreement signed with Pharmanovia and royalty revenue from SUNOSI sales recorded by Pharmanovia. AUVELITY net sales in the first quarter were $15.7 million. There were no net sales in the comparable period. SUNOSI revenue for the quarter was $13.2 million. U.S. SUNOSI sales were $11.2 million. International SUNOSI revenue was $2 million, including approximately $300,000 in royalty revenue from SUNOSI sales in the out licensed markets.
As a reminder, there was a change in the distribution model during the quarter, which negatively impacted SUNOSI net sales by an estimated $3.3 million. There were no net revenues in the comparable period for SUNOSI. Cost of revenue was $7.6 million in the first quarter compared to none in the prior year. In addition to the manufacturing cost for Auvelity and SUNOSI, cost of revenue includes a one-time charge of $5 million in licensing sharing fees from the upfront payment received in the Q1. Therefore, cost of revenue excluding this one-time charge was approximately $2.6 million. Research and development expenses were $17.8 million for the first quarter versus $12.6 million for the comparable period in 2022.
The increase was primarily related to higher personnel costs associated with supporting the ongoing clinical trials, post-marketing commitments for SUNOSI and AUVELITY, and non-cash stock compensation expense. Selling, general and administrative expenses were $74.2 million for the first quarter versus $25.7 million for the comparable period in 2022. The increase was primarily related to commercial activities for AUVELITY and SUNOSI and higher non-cash stock compensation expense due to the build-out of both commercial teams. Net loss for the first quarter was $11.2 million or $0.26 per share, compared to a net loss of $39.6 million or $1.03 per share for the comparable period in 2022.
The decrease in net loss for the first quarter versus the comparable period was primarily due to product sales from AUVELITY and SUNOSI, offset by higher selling, general and administrative expenses related to these commercial activities and license revenue received from Pharmanovia. We ended the quarter with $246.5 million in cash and cash equivalents compared to $200.8 million as of year-end. During the first quarter, we did not utilize our ATM facility. In January 2023, we amended our loan agreement with Hercules Capital to increase the size of the facility to $350 million to reduce the interest rate and to extend the maturity and interest-only periods while accessing a $55 million tranche.
We believe that our current cash balance, along with the remaining committed capital from the $350 million term loan facility with Hercules Capital, is sufficient to fund anticipated operations into cash flow positivity based on our current operating plan. I will now turn the call over to Lori, who will provide a commercial update.
Lori Englebert (EVP of Commercial and Business Development)
Thank you, Nick, and good morning, everyone. We are off to a great start for 2023. Q1 marked another exciting quarter for Axsome with continued commercial growth for both AUVELITY and SUNOSI. We are pleased with the early metrics on AUVELITY, which all point to a strong launch with significant long-term potential and with how the relaunch efforts on SUNOSI are progressing. I will share key metrics from our commercial efforts for both brands, starting with AUVELITY followed by SUNOSI. The end of Q1 represents the first full quarter of sales for AUVELITY and only five full months post-launch. We are still early in the launch, but remain highly encouraged by the consistent feedback from patients and HCPs. Approximately 31,000 prescriptions were reported in Q1 for AUVELITY, representing a growth of 298% in Q1 versus Q4.
We saw prescription growth accelerate through increased depth with our early HCP adopters as well as increased breadth of new prescribers. At the end of Q1, AUVELITY's prescriber base grew to over 6,000 unique HCP writers versus 2,200 unique HCPs at the end of Q4. HCPs wrote prescriptions for over 15,000 new patients in Q1, bringing the total number of unique patients on AUVELITY to over 21,000 at the end of Q1 versus 6,000 at the end of Q4. Our highly experienced field force continues to drive adoption by educating HCPs on the product profile of AUVELITY. Through high-impact engagements such as detailing and peer-to-peer speaker programs, our field force has now reached over 22,000 HCPs since launch. With regard to payer coverage for AUVELITY across all channels is currently approximately 65% of all covered lives.
In the commercial channel, which is expected to be the primary channel for AUVELITY, coverage is now at approximately 40% of covered lives, and we look forward to additional formulary decisions in the coming months. In the Medicaid and Medicare channels, approximately 100% of lives are now covered. Overall, payer coverage for AUVELITY is proceeding as expected during the standard 6 to 9 month post-launch period, and we expect additional formulary decisions in the coming months. We remain pleased and extremely encouraged by the initial launch progress and are steadfast in our commitment to our launch focus of driving HCP adoption, empowering patients and enabling quality access. Major depressive disorder, or MDD, is highly prevalent and a major public health concern with a mental health crisis that the U.S. is currently facing.
21 million U.S. adults were diagnosed in 2020. There is a reported significant increase in prevalence as a result of the pandemic. AUVELITY is an important new therapeutic option for patients living with this chronic and devastating condition. We are proud of our efforts to make AUVELITY available to patients living with MDD and their physicians. Turning to SUNOSI. In the first quarter, total prescriptions for SUNOSI in the U.S. grew 13% year-over-year and 4% quarter-over-quarter. SUNOSI generated this growth despite a flat overall market and typical Q1 challenges. Payer coverage for SUNOSI remains broad, with 96% of commercial lives and 83% of total lives covered. The growth potential for SUNOSI in the current approved indications remains substantial.
As a reminder, SUNOSI is the first and only DNRI for excessive daytime sleepiness in obstructive sleep apnea and narcolepsy, and the first and only wake promoting agent proven to improve wakefulness through 9 hours. SUNOSI is the only branded therapy available for patients who suffer from EDS and OSA. We expect our increased and enhanced promotional and disease education efforts to drive continued growth for the product in 2023. We recently launched our new All Day campaign for SUNOSI. The new campaign includes updated creative content, additional HCP and patient support tools, and new educational resources. Launching this new campaign is an important next step in the relaunch of SUNOSI. I look forward to updating you on our commercial efforts and results related to the SUNOSI relaunch in the coming quarters.
Our two commercial products, AUVELITY and SUNOSI, address serious, highly prevalent conditions and bring meaningful innovation to millions of potential patients. I will now turn the call back to Mark to lead the Q&A discussion.
Mark Jacobson (COO)
Thank you, Lori. Operator, may we please have our first question?
Operator (participant)
Thank you. If you'd like to be placed into question queue, please press star one at this time. One moment please while we pull for questions. Our first question is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live.
Charles Duncan (Managing Director and Senior Research Analyst of Biotechnology Industry.)
Hey, good morning, Herriot and team. Congratulations on a great quarter for AUVELITY. Nice to see out of the gates. Had a couple of questions. One commercial, one development or pipeline. Regarding the commercial question on AUVELITY, I'm wondering if Lori can provide any more granular feedback on what she has heard from prescribers hearing from patients in terms of those patients been on other drugs in the past, and how this differentiated mechanism is helping them feel and the potential for persistence. Thanks.
Lori Englebert (EVP of Commercial and Business Development)
Hey, Charles. Good morning, and thanks for the question. You know, I think the best way to answer that is to, one, take a look at script trends, and how many patients we actually added in Q1. You know, we added over 15,000 patients in Q1. Physicians are clearly seeing a benefit of the product. We're also seeing a really healthy refill rate right now. I think that's really gonna speak to the persistence and compliance. It's still a little bit too early, you know, into Q1 with only 5 months into launch. Still a little bit too early to see true trends on persistence and compliance, but the refill rate is really healthy.
Charles Duncan (Managing Director and Senior Research Analyst of Biotechnology Industry.)
Can we assume that now, almost halfway through the Q2, you feel pretty good about tone of business?
Lori Englebert (EVP of Commercial and Business Development)
Absolutely. Our, you know, as I mentioned in the prepared remarks, we are really heavily investing in, you know, the optimization of the product in terms of all the, you know, omni-channel approach we're taking from a marketing standpoint, strategic media, congresses, speaker programs. Our field force, you know, with high impact engagements. I qualify high impact engagements with, you know, either detailing the physician and/or, you know, speaker programs. You know, they've reached over 22,000 HCPs, and that's a lot of HCPs with, you know. We're really happy.
Charles Duncan (Managing Director and Senior Research Analyst of Biotechnology Industry.)
Moving to the pipeline. I struggle to ask just one question, but I will ask just one question for Herriot, because you've got a lot of things going on. I guess on AXS-05 let's talk about that. You mentioned ADVANCE-2 enrollment is proceeding well. I'm wondering if you, on a blinded basis, feel good about the phenotype of the patient that you're enrolling and if you can provide us any color. Then if you've learned anything from the recent rig result, the AdCom in terms of Alzheimer's agitation, how does that, you know, impact change or not your strategy with regard to AXS-05 and Alzheimer's agitation?
Herriot Tabuteau (CEO)
Thanks, Charles, for the questions. With regards to the types of patients that we are enrolling in ADVANCE-2, I think we feel comfortable that we are enrolling a very similar type of patient as we enrolled in ADVANCE-1. The protocols are very similar. The entry criteria are very similar. I think the team is executing on enrolling the study and making sure that we have the right patients and that we have a quality trial again. With regards to any learnings from the recent panel, there are a few observations.
One is, it became clear, or it's been clear to us, but now I think, it's been made, you know, publicly clear that the FDA as well as experts, really feel that this is a high unmet medical need. What the panel highlighted was the seriousness of the condition and the quandary, frankly, that physicians find themselves in with no drugs that are approved. The only drugs that are used off-label broadly, are antipsychotics, which are problematic. It's gratifying to, you know, to be able to share that, you know, more broadly, that awareness.
The other learning from the panel is that the way that we are going about developing the product is consistent with how the FDA views that it should be developed in terms of endpoints. Again, this is not anything which is new to us because we've always worked very closely with the FDA for this breakthrough therapy designated product candidate. It's nice to see those points discussed in a public forum.
Charles Duncan (Managing Director and Senior Research Analyst of Biotechnology Industry.)
Very good. It's consistent with our past diligence. Appreciate the added color and good luck with that. With all the stuff going on on the pipeline. I'll hop back in the queue.
Operator (participant)
Thank you. Next question is coming from Jason Gerberry from Bank of America. Your line is now live.
Speaker 15
Hi, good morning. This is Dina on for Jason. Congrats on the progress this quarter, and thank you for taking our question. Just a couple on AUVELITY here. How much did AUVELITY Q1 benefit from inventory stocking? Do you have a firmer handle on the full year growth to net pricing dynamics, or is that still more of a second half of the year event when you get to more normalized rates? Thank you very much.
Nick Pizzie (CFO)
Hey, Dina, it's Nick. Thanks for the question. The performance for AUVELITY was not impacted by changes in inventory level. As we've stated previously, normal inventory levels are at around 2 weeks. During the quarter, there was actually a modest decrease in days on hand of AUVELITY to the distributors. Overall, it was not impactful at all to the net sales. In contrast for SUNOSI, as we mentioned, there was an impact of $3.3 million due to the change of title. Reported sales would've been $3.3 million additional had there been no change on that. I think your second question related to, you know, how do we think about GTN for the remainder of the year.
We're still not currently in a position to give specific guidance around GTN as it's gonna be volatile in the short term. Obviously, there's coverage, mix. Sorry, there's mix in channel throughout the year, that we're gonna have on distribution. Coverage is going to be dynamic and coming online as we've seen it. It's gonna continue to come online throughout the year. Also the utilization of the co-pay card. While we are pleased with the GTN this quarter, we don't expect it to improve in the near term.
Speaker 15
Great. Thank you so much, and congrats again on the progress this quarter.
Operator (participant)
Thank you. Next question is coming from Marc Goodman from SVB Securities. Your line is now live.
Marc Goodman (Senior Research Analyst)
Yeah. Could you give us a sense of commercial coverage, how you're planning that? I know that it's been kind of a slow process at the beginning on purpose. I was wondering, you know, is this gonna speed up as the year progresses? You know, how much of an impact did, you know, volumes get helped by the one contract that you've talked about already? Second question is just the SG&A run rate in the quarter. Just give us a sense of is that the run rate going forward? Should we expect that to kinda ramp from there, or did that include some upfront, you know, costs for the year? Thanks.
Lori Englebert (EVP of Commercial and Business Development)
Yeah. Hey, Marc. Good morning. I'll address the first question and then pass it over to Nick. you know, as we've stated before, we have expected, you know, Axsome to start coming online around six to nine months post-launch. given, you know, we are barely atsix6 months, when we're at 65% of lives covered, we're feeling pretty good about, you know, where we're at with lives covered. we do expect that to continue to evolve over the course of the next few months to the rest of the year. I wanna talk about, you know, just volumes in terms of the contracts that we have in place. We don't necessarily look at it that way.
I'll give you some numbers to think through, and that is 90% of patients who've been prescribed AUVELITY are first line, have failed first line of therapy. 60% of patients are second and third line. This is exactly where we would expect patients to be right now. One, because there is an urgent and unmet need out in the marketplace, but two, as they work through formulary access. We are seeing, you know, a healthy amount of patients using the product later line, obviously with nice success and the continued improvement in terms of moving the line of therapy up. Part of that is helped by the fact that we have a robust patient support services program in place.
The patient support services program is really in place to make sure that, you know, patients that want to get on therapy are able to get on therapy.
Herriot Tabuteau (CEO)
Cool. Marc, I'll take the second part of your question on the SG&A. In actually Q1, we did have some one-time charges as related to the Pharmanovia license. While we're not offering specific guidance for the rest of the year, I would point you to taking a look at what we spent in Q4 as well as Q1 as a ballpark of where we would expect to be, you know, in future quarters for 2023.
Operator (participant)
Thank you. Next question is coming from David Amsellem, from Piper Sandler. Your line is now live.
David Amsellem (Managing Director and Senior Research Analyst)
Thanks. A couple from me. On AUVELITY, can you just talk to qualitatively the kinds of patients who are getting the drug and, you know, in terms of, you know, how many prior treatments, you know, you're seeing prior exposure to SSRIs, SNRIs, bupropion, et cetera. That's number one. Secondly, on reboxetine, I'm trying to tease out how you're thinking about the product in the context of the current treatment landscape, and particularly given that there's some mechanistic overlap with SUNOSI. As you think about narcolepsy, you know, where do you see reboxetine, you know, fitting in commercially? Of course, assuming that there's clinical success. Thank you.
Lori Englebert (EVP of Commercial and Business Development)
Hey, David. I'll take the first one and then pass it over to Herriot. As I just mentioned, to Marc, right now we're seeing, you know, 90% of patients have failed one therapy, but that's not unusual, or exactly as we'd expected. 60%-65% have been on second or third line, therapies prior. We are seeing later line use, which is exactly as we would expect coming out of the gate. Again, you know, this is consistent with, you know, the unmet need in that patient population. We are seeing obviously success, you know, as, you know, objective evidence shows from refill rates, as well as what we're hearing from the field.
As we, you know, access opens up and physicians get clinical experience, we do anticipate that AUVELITY will move up on your line usage.
David Amsellem (Managing Director and Senior Research Analyst)
Great. With regards to AXS-12 or reboxetine, you mentioned, you know, mechanistic overlap with SUNOSI, and how would we think about the two products? Reboxetine is being developed for narcolepsy, primarily for cataplexy. What we saw in the phase two trial was that there was a robust effect on cataplexy, and also an effect on excessive daytime sleepiness. As a reminder, SUNOSI has robust effects on excessive daytime sleepiness, but is not approved to treat cataplexy. The two products would be complementary.
We, you know, we like the profile that we saw in the phase two trial for AXS-12, and we're looking forward to just seeing, you know, what the results of the phase three trial are, and that's gonna inform us in terms of the full profile of the product.
That's helpful. If I may seek a follow-up. Do you think reboxetine on cataplexy has to be markedly better than, you know, what we typically see for off-label uses of dual reuptake inhibitors like venlafaxine and duloxetine? 'Cause I know there is some off-label use. How do you think about that?
Herriot Tabuteau (CEO)
It's that's a hard question to answer because there have been no controlled trials with any of those agents. A lot of it is anecdotal. What we can speak to is the profile of our product. We think that the profile is very attractive. A drug which is which has an effect on both cataplexy as well as excessive daytime sleepiness, which is dosed during the day, which does not have a lot of the scheduling or a lot of, you know, frankly, the serious side effect concerns of the agents that are currently marketed.
David Amsellem (Managing Director and Senior Research Analyst)
Yeah. That's helpful.
Operator (participant)
Thank you. Next question is coming from Joon Lee from Truist Securities. Your line is now live.
Joon Lee (Managing Director and Senior Biotech Analyst)
Hey, thanks for taking our questions and for the updates. Sorry if I misheard, but I think I heard Lori just say that 90% of the patients have failed at least one therapy before getting on AUVELITY. Does that mean that there are 10% who get on, who get AUVELITY as first-line therapy? I just wanna make sure I heard that correctly. I have a follow-up.
Lori Englebert (EVP of Commercial and Business Development)
Hey, Joon. Thanks for the question. There's always going to be some early line usage. Could be either data reporting or it could just be patients who are paying out of pocket, potentially. It could also be, you know, medical necessity, riding through, you know, getting through to that line. This is just reported data that we're seeing. We're seeing, you know, 90% have failed one prior therapy, which is exactly what we would expect.
Joon Lee (Managing Director and Senior Biotech Analyst)
Well, has that share of first line use gone up over time?
Lori Englebert (EVP of Commercial and Business Development)
No, it's actually gone down.
Joon Lee (Managing Director and Senior Biotech Analyst)
Okay. Got it. At high level, AUVELITY gross net for first quarter looks like around 50%. Is that in the ballpark? If so, could we expect further improvement in that gross net, or do you think you're already at the more or less steady-state gross net? Thank you.
Herriot Tabuteau (CEO)
Hey, Joon. Yeah, I think what I actually said is the GTN is in the high upper fifties is where it was for Q1. We wouldn't expect that to materially change or improve in the next future quarters.
Joon Lee (Managing Director and Senior Biotech Analyst)
Thank you.
Herriot Tabuteau (CEO)
Mm-hmm.
Operator (participant)
Thank you. Next question today is coming from Vikram Purohit from Morgan Stanley. Your line is now live.
Vikram Purohit (Equity Analyst)
Hi, good morning. Thanks for taking our questions. First, just a quick clarification question for ADA. Could you just remind us exactly which datasets you plan to include in the eventual filing for ADA, assuming your dataset with ADVANCE-2 matures positively? Secondly, for AXS-12 in narcolepsy, for the SYMPHONY data readout you expect in the coming months, could you remind us what the study's power to demonstrate and what you would consider a kind of strong, clinically meaningful outcome here? Thanks.
Herriot Tabuteau (CEO)
Thanks for the questions. With regards to Alzheimer's Disease Agitation in the filing, so the in the sNDA filing, we would include the results from all the studies that we conducted. As a reminder, we've completed the Advance one trial, which is a pivotal trial, the Advance two trial. Those data will also be included, so that mirrors the Advance one trial. Also, data from the Accord trial will be included, as well as data from the open label safety extension trial. The long term open label safety extension trial. It'll be a pretty full package, and we look forward to reading out the Advance two trial and if that's positive, then filing the sNDA.
With regards to AXS-12 in terms of the powering of the study. The study is 90% powered to detect a change on the cataplexy endpoint. That's the primary endpoint. We've not disclosed what that delta is that we are expecting. What we can point you to are the results from the CONCERT trial, the phase 2 trial. You know, it was based upon those results that we powered our study.
Operator (participant)
Thank you. Next question is coming from Yatin Suneja from Guggenheim Partners. Your line is now live.
Yatin Suneja (Senior Managing Director and Biotechnology Analyst)
Thank you. A couple questions for me. I don't know if you articulated what the exact gross-to-net was or what the approximate gross-to-net was for Q1. That's one. Any thoughts on providing guidance for sales for AUVELITY when you might do that? If you can articulate for us the cadence of patients, you know, whether it's a weekly cadence or a monthly cadence, where it is, how do you expect that to change over time?
Herriot Tabuteau (CEO)
Hey, Yatin. Again, gross to net for AUVELITY in the quarter was in the high upper 50s. This was an improvement from the 60s in Q4, and it was due to a higher proportion of refills of scripts versus new scripts. Again, we're very pleased obviously with the GTN this quarter, but we don't anticipate it to improve in the near term. As it relates to the sales guidance, we're in a very, very early stages of the launch of AUVELITY, along with acquiring SUNOSI just up to a year now. As such, we find it just real premature to provide any such guidance, as there's multiple variables that can affect this number. I think, Lori, you wanna answer the last question?
Lori Englebert (EVP of Commercial and Business Development)
Yeah. Yeah. I'm not 100% sure, the, you know, what you meant by the question. You know, the scripts are written on a monthly basis. Patients are, you know, we are tracking monthly prescriptions.
Operator (participant)
Thank you. Next question is coming from Joseph Thome from TD Cowen. Your line is now live.
Joseph Thome (Managing Director and Senior Biotechnology Equity Research Analyst)
Hi there. Good morning. Congrats on the quarter. Thank you for taking my questions. Maybe the first one on AXS-12. I know you said the focus was largely gonna be on the cataplexy endpoint, but do you anticipate releasing sleepiness scores as well when you report the full data? Then just as you think about the filing package, you know, if these data are positive here, can you comment on the safety database and sort of CMC metrics? Are you ready to file a submission if the data are positive or kind of where do you fall on that? Thank you.
Herriot Tabuteau (CEO)
Sure thing. Thanks for the question. When we report top-line results, historically, we've reported a number of different endpoints. We don't expect the SYMPHONY readout to be any different. We'll try and provide as much information as we can, given the constraints of reporting top-line results from large datasets. With regards to the filing package. In terms of the safety database, we still need to finalize, you know, with the FDA what would be included in the safety database. Preliminarily, we have a lot of safety data.
We're collecting safety data not only from the studies that we have conducted, but also, as a reminder, you know, we in-license a very large patient safety database for reboxetine through our Pfizer agreement. On the CMC front, you know, things are progressing well there. We do manufacture, we do synthesize the API or ourselves. Right now that's been going smoothly and everything's been going smoothly on the CMC side. With regards to, you know, when we would actually be able to file an NDA, a gating factor will be the completion of the long-term safety study. Assuming that, you know, we do have success with the SYMPHONY trial, we would expect being able to file an NDA likely in 2024.
Joseph Thome (Managing Director and Senior Biotechnology Equity Research Analyst)
Great. That's very helpful. Thank you. Then maybe, Lori, definitely helpful on the prescriber base and sort of unique writers. Can you go into a little bit more detail in terms of how physicians are prescribing this? Are they trying it first in one patient and then if that goes well, you know, they go in other patients. Once you get a writer, do they write a lot of prescriptions? Kinda how is it getting these physicians on board and how will that change kinda for the duration of the year, do you think? Thank you.
Lori Englebert (EVP of Commercial and Business Development)
Yeah. Yeah, that's a great question. Consistent with expectations of launch, you have your early adopters that come out of the gate prescribing. Those, you know, if they have clinical success, those have, you know, they have tremendous depth. We are seeing exactly that. The writers that have written, they have really, you know, incredible market share in terms of their use of AUVELITY. They're, they're seeing, you know, positive clinical experience.
You know, as you move further along in the launch and you're trying to increase your breadth, you start seeing, you know, writers that are on an adoption curve that, you know, may need a little bit more time and market understanding, peer influence, or they may need, you know, clinical experience from, you know, one patient before they write more. We're starting to get into that, and our breadth is starting to grow. You know, as I mentioned, in Q1, we added 3,800 new unique HCP writers. You know, we definitely expect that to continue to grow, just as a normal adoption curve would progress.
Joseph Thome (Managing Director and Senior Biotechnology Equity Research Analyst)
Perfect. Thank you very much.
Operator (participant)
Thank you. Next question today is coming from Graig Suvannavejh from Mizuho Securities. Your line is now live.
Graig Suvannavejh (Managing Director and Senior Biopharmaceuticals and Biotechnology Analyst)
Okay. Thanks so much. Congrats on the quarter. I had a couple of questions. Just wanted to get a sense of maybe philosophically speaking, where you are in terms of your commercial infrastructure, whether given the opportunity, you're content to keep its size the way it is right now. Do you feel that perhaps you can be opportunistic and further drive even perhaps better uptake of AUVELITY in particular? Secondly, just wanted to get a sense of just going back to the gross to net and maybe just for clarification on my end, just can you tell us how exactly you go about calculating your gross net? I just wanna make sure that I'm thinking about it the same way you're thinking about it. Thank you.
Lori Englebert (EVP of Commercial and Business Development)
Sure. Nick wants to go first.
Herriot Tabuteau (CEO)
Cool.
Nick Pizzie (CFO)
Hi, Graig. GTN, I mean, it's basically the way everybody else would essentially calculate gross to net. It's based on demand in the quarter and, you know, the utilization of co-pay card, any type of rebates, any additional adjustments as well. That all goes into GTN. We would also accrue for anything that was sold in the quarter that's sitting in the channel that has not been distributed to the pharmacies at that point. That would also be considered part of the GTN adjustment for the period. Lori, you wanna answer the second one?
Lori Englebert (EVP of Commercial and Business Development)
Okay. It... You know, I'm not sure if you're meaning the AUVELITY field force or the SUNOSI field force, but I'll try and answer both 'cause the answer is pretty applicable across both. Just to give you some perspective on the AUVELITY side, there are about 50,000 HCPs who prescribe, you know, really the lion's share of branded therapies. We are calling on 25,000-26,000 HCPs of those 50. Those 25,000 that we're calling on, you know, they write almost 70% of the branded therapies. Our DCC platform, you know, was intentionally structured so that we could, you know, maintain a share of voice, you know, either through reach or with our omni-channel marketing of sales forces, you know, in some cases, 2 times the size of what we have.
Remember, our DCC platform was really set up so that we could optimize productivity through effective and efficient engagements. Right now we are seeing that with our HCP targets. As we're able to reach as many targets as again, sales forces that are somewhat upwards of 2 times the size that we have right now. You know, as we are continuing to invest in both AUVELITY and SUNOSI through omni-channel marketing, strategic media, congress spending, speaker programs, as I've mentioned before, we will obviously continue to make sure that we're maximizing the opportunity for both products.
Herriot Tabuteau (CEO)
Yeah. Then what I would just add to what Lori said is that right now the our marketing efforts and the yield from that is going exactly as we had expected, exactly as we had planned. you know, we've said before that our field force sizing and targeting was based upon all of the data and information that we've looked at through our DCC platform. you know, we feel that we are more than adequately resourced right now. We're very happy with the way that the launch is going. obviously anything can change and we are an organization that can be flexible, but for now, we're adequately resourced.
Operator (participant)
Thank you. Next question is coming from Myles Minter from William Blair. Your line is now live.
Myles Minter (Biotech Equity Research Analyst)
Thanks for taking the questions. Congrats on the quarter. Can you just comment on the proportion of those 31,000 scripts for AUVELITY that are being reimbursed or seeking reimbursement through the commercial versus government channels? Does that differ materially from the broader branded antidepressant market, which I think is 2/3 commercial, 1/3 government?
Lori Englebert (EVP of Commercial and Business Development)
Yeah. Hey, Myles. We are seeing almost exactly what we see in the broader antidepressant category. The broader antidepressant category is about 60% to 65% commercial, and the remaining, the government channel, and that is spot on. We may be skewing a little bit heavier to commercial. I think we're around 70% right now. But it's exactly as expected.
Myles Minter (Biotech Equity Research Analyst)
Okay, cool. Then the second one is just on the SYMPHONY trial. You mentioned that power and assumptions are based on, like, during CONCERT. Does that mean that the baseline cataplexy rates over the week are gonna be similar between those two trials when they read out?
Herriot Tabuteau (CEO)
The entry criteria are similar. You know, whether or not, whether or not the actual numbers are the same, that remains to be seen, but the entry criteria are similar. There's a lot of variability with regards to cataplexy in patients. You know, part of the reason for that is, that cataplexy, although it is a symptom that everybody has, it is triggered. There'll be variability from amongst individual patients based on their social situations.
Myles Minter (Biotech Equity Research Analyst)
Okay, beautiful. Thanks for the question.
Operator (participant)
Thank you. We have time for 2 more questions. Our next question is coming from Matt Kaplan from Ladenburg Thalmann. Your line is now live.
Matt Kaplan (Managing Director and Head of Healthcare Research)
Hi. Yeah. Good morning, and congrats on the results of the quarter. Just wanted to zero in a little bit on Sunosi sucralfate in the ADHD indication and your plans for the Phase 3 Program. Can you talk about a little about the indication and the need there, and then your phase 3 program, the initial study, would that be potentially sufficient for filing as possible?
Herriot Tabuteau (CEO)
Thanks, Matt, for the question. ADHD is a very large market. There are roughly 12 million patients in the U.S. who have ADHD. Right now, they're treated either with stimulants, which have, you know, issues with regards to diversion, and because they're highly controlled. These are drugs that are very effective, that have a very large effect size, but then there are the downsides from a safety perspective. Then there are the non-stimulant medications. The non-stimulant medications, what they suffer from are lower effect sizes. There is a very large need still for effective drugs that are both effective and also that have a very good safety profile.
We like SUNOSI based on the comparison, let's say, in other indications, so in excessive daytime sleepiness, for example, where the clinical trial results show that it appears to be a superior agent to other drugs, so to other wake-promoting agents, for example. We also very much like the results from the SHARP study, which recently read out, where we looked specifically at cognition in patients with OSA. It's not directly analogous, but, you know, we like the clinical profile of the drug in other indications. We like the mechanism of action of the drug. You know, we recently announced that it hits TAAR1, which in preclinical models have been shown to be pro-cognitive.
There's a lot there that we hope to test in the upcoming trial, which we expect to start this quarter. With regards to, you know, what would be needed in order to file. To file an NDA or an sNDA for drug in ADHD, you also do need to demonstrate efficacy in a pediatric population. The study that we're about to launch, that is a study in adults, and we will be also looking to initiate a study in pediatric patients to enable a filing.
Matt Kaplan (Managing Director and Head of Healthcare Research)
Okay. That's very helpful. A quick question for Lori. In terms of, you know, some near-term NDA filings, can you talk about the launch prep you have underway for AXS-07 and potentially, AXS-14 as well, given the timing of those NDAs and filings?
Lori Englebert (EVP of Commercial and Business Development)
Yeah. Thanks for the question. AXS-07, if you remember, we got almost up to the finish line. You know, launch prep was pretty heavily done there. In terms of, you know, marketing materials and preparation for the market and understanding, that's all just, you know, we'll need to do a refresh. Based on, you know, timing for both 7 and 14 will be when we decide, you know, size, structure, thoughts on sales force sizing. Once we have a little bit more understanding on exact timing and dates, then we'll share what that looks like.
Matt Kaplan (Managing Director and Head of Healthcare Research)
Thanks for taking the questions.
Operator (participant)
Thank you. Our final question is coming from Ram Selvaraju from H.C. Wainwright. Your line is now live.
Speaker 16
Hi, this is Bubal dialing in for Ram Selvaraju. Thanks for taking our questions. Couple from us. Firstly, I'd like to get your thoughts on Intra-Cellular Therapies, lumateperone, which produced positive top-line data as monotherapy in patients with MDD and bipolar depression. Were there any takeaways with respect to future clinical directions for AXS-05 on this recently reported data?
Herriot Tabuteau (CEO)
Thanks for the question. With regards to the lumateperone and the data in mood disorders, it's not surprising that an antipsychotic would work in depression. I think it's well known that atypical antipsychotics are used as adjunctive treatment. Any time any company generates data in depression or in bipolar depression, which is positive, we think that that's a great thing because the need is so large and the patient population is so large. There's such a large amount of heterogeneity in terms of response from patients. Yeah. That's great. Let's have more of that.
Speaker 16
All right. Thanks.
Operator (participant)
Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to management for any further or closing comments.
Herriot Tabuteau (CEO)
Well, thank you again for joining us on the call today. We saw strong performance in all areas of our business in the first quarter. We are executing on the commercialization of AUVELITY and SUNOSI, and we are advancing our late-stage pipeline to key milestones in multiple indications. Our marketed and development portfolio positions us to have potentially at least five marketed products by 2025, targeting brain disorders that affect tens of millions of people. Also these are conditions where there's still a great unmet medical need. We look forward to updating you on our progress during the rest of the year. Have a great rest of your day. Thank you.
Operator (participant)
Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.