Axsome Therapeutics Inc

NASDAQ:AXSM

Earnings Call Transcript 2023-Q1

[Operator]

Hello and welcome to the Axsome Therapeutics First Quarter 2023 Financial Results Conference Call and Webcast. [Operator Instructions] 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, Investor Relations]

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 in 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, and 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.

And with that, I will turn the call over to Herriot.

[Herriot Tabuteau, Chief Executive Officer]

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-U.S. 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 1 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 a 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. OAXS-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. With 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. With AXS-14, our product candidate for the treatment of fibromyalgia manufacturing and other activities related to preparation 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 and 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, Chief Financial Officer]

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-license 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 first quarter. 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 cost 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 of 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 in 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]

Thank you, Nick and good morning everyone. We are off to a great start for 2023 and 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 5 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 riders 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 experiential sales force continues to drive adoption by educating HCPs on the product profile of Auvelity, through high-impact engagements, such as detailing peer-to-peer speaker programs, our sales force has reached over 22,000 HCPs since launch.

With regard to payer coverage, coverage for Auvelity across all channels is currently approximately 65% of all covered buys. 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 months 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 in a major public health concern with a mental health crisis that the U.S. is currently facing. 41 million U.S. adults were diagnosed in 2020 and 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 and 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, remain substantial. As a reminder, Sunosi is the first and only DNRI for excessive daytime sleepiness and obstructive sleep apnea and narcolepsy and the first and only wake-promoting agent proven to improve weightfulness through 9 hours.

Sunosi is the only branded therapy available for patients who suffer from EDS and OSA and 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 and I look forward to updating you on our commercial efforts and results related to the Sunosi relaunch in the coming quarters. Our key 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, Investor Relations]

Thank you, Lori. Operator, may we please have our first question?

[Operator]

Thank you. [Operator Instructions] Our first question is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live.

[Charles Duncan, Cantor Fitzgerald]

Yes, good morning Herriot and team. Congratulations on – yes, a great quarter for Auvelity, nice to see out of the gates. I had a couple of questions, one, commercial, one development or pipeline. Regarding the commercial question, on Auvelity, I am wondering if Lori can provide any more granular feedback on what she has heard from prescribers hearing from patients in terms of those patients have been on other drugs in the past and how this differentiated mechanism is helping them feel and the potential for persistence? Thanks.

[Lori Englebert]

Hey, Charles. Good morning and thanks for the questions. So 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. We added over 15,000 patients in Q1 and so physicians are clearly seeing a benefit of the product, but we are also seeing a really healthy refill rate right now. And I think that’s really going to speak to the persistence and compliance. It’s still a little bit too early into Q1 with only 5 months into launch, still a little bit too early to see true trends on persistency and compliance, but the refill rate is really, really healthy.

[Charles Duncan, Cantor Fitzgerald]

And I guess I can assume – can we assume that now almost halfway through the second quarter, you feel pretty good about tone of business?

[Lori Englebert]

Absolutely. As I mentioned in the prepared remarks, we are really heavily investing in the optimization of the product in terms of all the omnichannel approach we are taking from a marketing standpoint, strategic media, congresses, speaker programs, our sales force with high impact engagements and I qualify high-impact engagements with either detailing the physician and/or speaker programs, they have reached over 22,000 HCPs and that’s a lot of HCPs with – and we are really happy.

[Charles Duncan, Cantor Fitzgerald]

And moving to the pipeline, I struggled to ask just one question, but I will ask just one question for Herriot, because you have got a lot of things going on. I guess on 05, let’s talk about that. You mentioned ADVANCE 2 enrollment is proceeding well, I am wondering if you, on a blinded basis, feel good about the phenotype of the patient that you are enrolling and if you can provide us any color? And then if you have learned anything from the recent AdCom in terms of Alzheimer’s agitation, how does that impact change or not your strategy with regard to 05 in Alzheimer’s agitation?

[Herriot Tabuteau, Chief Executive Officer]

Thanks Charles for the questions. With regards to the types of patients that we are enrolling in ADVANCE 2, I think we are – we feel comfortable that we are enrolling a very similar type of patient as we enrolled in ADVANCE 1. The protocols are very similar to 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 few observations. One is it became clear or it’s been clear to us, but now I think it’s been made publicly clear that the FDA as well as experts really feel that this is a high unmet medical need. So what panel highlighted was the seriousness of the condition and the quandary, frankly, that physicians find themselves in with no drugs that are approved and the only drugs that are used off-label broadly or anti-psychotics, which are problematic. So it’s gratifying to be able to share that and do 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. And again, this is not anything that which is new to us, because we have always worked very closely with the FDA for this breakthrough therapy designated product candidate, but it’s nice to see those points discussed in a public forum.

[Charles Duncan, Cantor Fitzgerald]

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 will hop back in the queue.

[Operator]

Thank you. Next question is coming from Jason Gerberry from Bank of America. Your line is now live.

[Unidentified Analyst]

Hi, good morning. This is Dena 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 1Q benefit from inventory stocking and 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 a more normalized rate? Thank you very much.

[Nick Pizzie, Chief Financial Officer]

Hey, Dena, it’s Nick. Thanks for the question. The performance for Auvelity was not impacted by changes in the inventory level. As we have stated previously, normal inventory levels are at around 2 weeks. And during the quarter, there was actually a modest decrease in days on hand of Auvelity on the – to the distributors. So 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 have been $3.3 million additional had there been no change on that.

And I think your second question related to how do we think about GTN for the remainder of the year? We are still not currently in a position to give specific guidance around GTN as it’s going to be volatile in the short-term. Obviously, there is coverage mix that’s going to be – sorry, there is mix in channel throughout the year that we are going to have distribution. Coverage is going to be dynamic and coming online as we have seen it. It’s going to continue to come online throughout the year. And then also the utilization of the co-pay card, so while we are pleased with the GTN this quarter, we don’t expect it to improve in the near-term.

[Unidentified Analyst]

Great. Thank you so much and congrats again on the progress this quarter.

[Operator]

Thank you. Your next question is coming from Marc Goodman from SVB Securities. Your line is now live.

[Marc Goodman, SVB Securities]

Yes. Could you give us a sense of commercial coverage, how you are planning that? I know that it’s been kind of a slow process at the beginning on purpose. I was wondering is this going to speed up as the year progresses and how much of an impact did volumes get helped by the one contract that you have talked about already? And then 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 kind of ramp from there or did that include some upfront costs for the year? Thanks.

[Lori Englebert]

Yes. Hey, Mark. Good morning. I’ll address the first question and pass it over to Nick. So as we said before, we have expected access to start coming online around 6 to 9 months post-launch and given we are fairly at 6 months when we are at 65% of life cover. We are feeling pretty good about where we are at with life cover and we do expect that to continue to evolve over the course of the next few months to the rest of the year. I want to talk about just volumes in terms of the contracts that we had in place. We don’t necessarily look at it that way. I will give you some numbers to think through. And that is 90% of patients who have been prescribed Auvelity are first line – have failed first line therapy, 60% of patients are second and third line. And 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. And so we are seeing 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 and the patient support services program is really in place to make sure that patients that want chemotherapy are able to go there.

[Nick Pizzie, Chief Financial Officer]

Mark, I will take the second part of your question on the SG&A. And actually, Q1, we did have some one-time charges as related to the Pharmanovia license. While we are 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 in the future quarters for 2023.

[Operator]

Thank you. Your next question is coming from David Amsellem from Piper Sandler. Your line is now live.

[David Amsellem, Piper Sandler]

Thanks. So a couple for me. On Auvelity, can you just talk to qualitatively the kinds of patients who are getting the drug in terms of how many prior treatments you are seeing prior exposure to SSRIs, SNRIs, buproprion etcetera? That’s number one. And then secondly, on reboxetine, I am trying to tease out how you’re thinking about the product in the context of the current treatment landscape and particularly given that there is some mechanistic overlap with Sunosi. As you think about narcolepsy, where do you see reboxetine fitting in commercially, of course, assuming that there is clinical success? Thank you.

[Lori Englebert]

Hey, David, I’ll take the first one and then pass it over to Herriot. So as I just mentioned to Mark, right now, we’re seeing 90% of patients have failed one therapy, but that’s not unusual or exactly as we had expected. 60% to 65% have been on second and third line therapies prior. And so we are seeing later line use, which is exactly as we would expect coming out of the gate. Again, this is consistent with the unmet need in that patient population. We are seeing obviously success as objective evidence shows from refill rates as well as what we’re hearing from the field. And as we – as it opens up and physicians get clinical experience, we do anticipate stability will move up our near line usage.

[Herriot Tabuteau, Chief Executive Officer]

Great. And with regards to AXS-12 or reboxetine, you mentioned mechanistic overlap with Sunosi and how would we think about the two products? So reboxetine is being developed for narcolepsy primarily for cataplexy. So what we saw in the Phase 2 trial was that there was a robust effect on cataplexy and also in effect on excessive daytime sleepiness. As a reminder, Sunosi has robust effects on excessive daytime sleepiness, but is not approved to treat cataplexy, so the two products that would be complementary? Now we like the profile that we saw in the Phase 2 trial for AXS-12. And we’re looking forward to seeing what the results of the Phase 3 trial are, and that’s going to inform us in terms of the full profile of the product.

[Unidentified Analyst]

That’s helpful. If I may sneak in a follow-up, do you think reboxetine on cataplexy has to be markedly better than what we typically see for off-label uses of dual uptake inhibitors like venlafaxine and duloxetine. I know there is some off-label use how do you think about that?

[Herriot Tabuteau, Chief Executive Officer]

It’s – that’s a hard question to answer because there have been no controlled trials with any of those agents. So a lot of it is anecdotal. And what we can speak to is the profile of our product. And we think that, that the profile is very attractive. So a drug, which is – which has an effect on both cataplexy as well as excessively daytime weakness, which is dosed during the day, which does not have a lot of the scheduling or a lot of, frankly, the serious side effect concerns of the agents that are currently marketed.

[Unidentified Analyst]

Yes. That’s helpful.

[Operator]

Thank you. Next question is coming from Joon Lee from Truist Securities. Your line is now live.

[Joon Lee, Truist Securities]

Hey, thanks for taking our question 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 Auvelity as first-line therapy just want to make sure I heard that correctly? And I have a follow-up.

[Lori Englebert]

Joon, thanks for the question. There is always going to be some early line uses, it could be either data reporting or it could just be patients who are paying out of pocket potentially, it could also be medical necessity writing through – getting through to that line. This is just reported data that we’re seeing, and we’re seeing 90% are – have failed one prior therapy, which is exactly what we would expect at this point.

[Joon Lee, Truist Securities]

Has that share of first-line use gone up over time?

[Lori Englebert]

No, it’s actually gone down.

[Joon Lee, Truist Securities]

Okay, got it. And at high level, Auvelity gross net for first quarter looks like around 50%. Is that in the ballpark? And if so, could we expect further improvement in that gross net? Or are we – do you think you’re already at the more or less the steady state? Thank you.

[Nick Pizzie, Chief Financial Officer]

Hey, Joon. Yes. I think what I actually said is the GTN is in the high upper 50s is where it was for Q1, and we wouldn’t expect that to materially change or improve in the next future quarters.

[Joon Lee, Truist Securities]

Thank you.

[Operator]

Thank you. Next question today is coming from Vikram Purohit from Morgan Stanley. Your line is now live.

[Vikram Purohit, Morgan Stanley]

Hi, good morning, thanks for taking our questions. So first, just a quick clarification question for ADA. Could you just remind us exactly which data sets you plan to include in the eventual filing for ADA, assuming your data set with advanced two matures positively? And then secondly, for AXS-12 in narcolepsy for the SYMPHONY data readout you expect and in the coming months. Could you remind us what the study is powered to demonstrate and what you would consider a kind of strong clinically meaningful outcome here? Thanks.

[Herriot Tabuteau, Chief Executive Officer]

Thanks for the questions. With regards to disease agitation, in the filings in the S&D filing, we would include the results from all the studies that we conducted. As a reminder, we’ve completed the ADVANCE-1 trial, which is a pivotal trial, the ADVANCE-2 trial, those data will also be included. So that mirrors the ADVANCE-1 trial. Also, data from 4 trial will be included as well as data from the open-label safety extension trial. So the long-term open-label safety extension trial. So it will be a pretty full package, and we look forward to reading out the ADVANCE-2 trial and if that’s positive in filing the sNDA. And with regards to AXS-12 in terms of the powering of the study. So the study is 90% powered to detect a change in on the cataplexy end point. So that’s the primary endpoint. So we’ve not disclosed what that delta is that we are expecting, but what we can point you to the results from the CONCERT trial, the Phase 2 trial and it was based upon those results that we powered our study.

[Operator]

Thank you. Next question is coming from Yatin Suneja from Guggenheim Partners. Your line is now live.

[Yatin Suneja, Guggenheim Partners]

Thank you. A couple of 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. So that’s one. Any thoughts on providing guidance for sales for Auvelity when you might do that? And then if you can articulate for us the cadence of patients, whether it’s a weekly cadence or monthly cadence, where it is, how do you expect that to change over time?

[Nick Pizzie, Chief Financial Officer]

Yatin, again, gross to net for ability in the quarter was in the high upper 50s. This was an improvement from the 60s in Q4 that 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. And then as it relates to sales guidance, we’re in a very early stages of the launch of Auvelity along with acquiring Sunosi, just up to a year now. And as such, we find it just really premature to provide any such guidance as there is multiple variables that can affect this number. I think, Lori, you want to answer the last question?

[Lori Englebert]

Yes, yes. Not 100% sure. What you meant by the question, but the scripts are written on a monthly basis. And so patients are – we are tracking monthly prescriptions.

[Operator]

Thank you. Next question is coming from Joseph Thome from TD Cowen. Your line is now open.

[Joseph Thome, TD Cowen]

Hi, there. Good morning. Congrats on the quarter. And thank you for taking my questions. Maybe the first one on AXS-12. I know you said the focus was largely going to be in a cataplexy endpoint, but do you anticipate releasing sleepiness scores as well when you report the full data? And then just as you think about the filing package, 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 follow that? Thank you.

[Herriot Tabuteau, Chief Executive Officer]

Sure. Thanks for the question. So when we report top line results historically. We’ve reported a number of different endpoints. So we don’t expect the SYMPHONY readout to be any different. So we will try and provide as much information as we can given the constraints of reporting top line results from large data sets. And with regards to the filing package, in terms of the safety database, we still need to finalize with the FDA, what would be included in the safety database. But preliminarily, we have a lot of safety data. So we’re conducting – we are collecting safety data not only from the studies that we have conducted, but also as a reminder, we did in-license a very large patient safety database for reboxetine through our Pfizer agreement. And on the CMC front, things are progressing well there. So we do manufacture, we do synthesize that the EPI ourselves. So right now, that’s been going smoothly and everything is going smoothly on the CMC side. And then with regards to when we would actually be able to file an NDA, a gating factor will be the completion of the long-term safety study. So assuming that we do have success with the SYMPHONY trial, we would expect being able to file an NDA likely 2024.

[Joseph Thome, TD Cowen]

Great. That’s very helpful. Thank you. And 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, they go in other patients? Once you get a writer, do they write a lot of prescriptions? Kind of how is it getting these physicians onboard? And how will that take kind of for the duration of the year do you think? And thank you.

[Lori Englebert]

Yes. Yes, it’s a great question. So consistent with expectations of launch, you have your early adopters that come out of the gate prescribing. And those – if they have clinical success, that’s how they have tremendous depth we are seeing exactly that. The writers that have really incredible market share in terms of their use of Auvelity, so they are seeing positive clinical experience. And then as you move further along with the launch and you’re trying to increase your breadth, then you start seeing riders that are on an adoption curve that may need a little bit more time and market understanding peer influence or they may need clinical experience from one patient before they write more. So we’re starting to get into that and our breadth is starting to grow, as I mentioned. In Q1, we added 3,800 new unique HCP riders. And so we definitely expect that to continue to grow just as a normal adoption curve would progress.

[Joseph Thome, TD Cowen]

Perfect. Thank you very much.

[Operator]

Thank you. Next question today is coming from Graig Suvannavejh from Mizuho Securities. Your line is now live.

[Graig Suvannavejh, Mizuho Securities]

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 and whether given the opportunity, you’re content to keep it sized the way it is right now? Or do you feel that perhaps you can be opportunistic and further drive even perhaps better uptake of Auvelity in particular? And then 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 growth and I just want to make sure that I’m thinking about it the same way you’re thinking about it? Thank you.

[Nick Pizzie, Chief Financial Officer]

Hi, Graig, so 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 the utilization of co-pay card and any type of rebates, any additional adjustments as well. That all goes into GTN. We would also approve 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. So that would also be considered part of the GTN adjustment for the period. Lori, do you want to answer the second one?

[Lori Englebert]

So not sure if you are meaning the Auvelity sales force or so Sunosi sales force, but I will try and answer both because the answer is pretty applicable across both. So just to give you some perspective on the Auvelity side, there are about 50,000 HCPs who prescribe really the lion’s share of branded therapies. We are calling on 25,000, 26,000 HCPs of those 50,000, but those 25,000 that we’re calling on, they write almost 70% of the branded therapies. Our DCC platform was intentionally structured so that we could maintain a share of voice either through reach or with our omni-channel marketing of sales forces in some cases, 2x the size of what we have. Remember, our DCC platform was really set up so that we can optimize productivity through effective and efficient engagements. And right now, we are seeing that with our HCP targets. As we’re able to reach as many targets again, sales force that are somewhat upwards of 2x the size that we have right now. So 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, Chief Executive Officer]

Yes. And 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. We 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. And so 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 in an organization that can be flexible. But for now, we’re at a core resource.

[Operator]

Thank you. Next question is coming from Myles Minter from William Blair. Your line is now live.

[Myles Minter, William Blair]

Thanks for taking the questions. Congrats on the quarter. Can you just comment on the proportion of those 31,000 scripts for valid that are being reimbursed or seeking reimbursement the commercial versus government channels and does that differ materially from the broader branded antidepressant market, which I think is two-thirds commercial, one-third government?

[Lori Englebert]

Yes. Myles, we are seeing exactly – almost exactly what we see in the broader antidepressant category. So the broader antidepressant category is about 60% to 65% commercial and the remaining the government channel, and that is spot on. We may be feeling a little bit heavier to commercial. I think we’re around 70% right now, but it’s exactly as expected.

[Myles Minter, William Blair]

Okay. Cool. And then the second one is just on the SYMPHONY trial. You mentioned powering assumptions or so like or in concert, does that mean that the baseline cataplexy rates over the week are going to be similar between those two trials when they read out?

[Herriot Tabuteau, Chief Executive Officer]

So the entry criteria are similar and whether or not the actual numbers or the same that remains to be seen, but the entry criteria are similar. There is a lot of variability with regards to cataplexy in patients. And part of the reason for that is that cataplexy, although it is a symptom that everybody has, it is triggered. So there’ll be variability from – amongst individual patients based on their social situations.

[Myles Minter, William Blair]

A beautiful thanks for the questions.

[Operator]

Thank you. We have time for two more questions. Our next question is coming from Matt Kaplan from Ladenburg Thalmann. Your line is now live.

[Matt Kaplan, Ladenburg Thalmann]

Hi, good morning and congrats on the results of the quarter. Just wanted to zero in a little bit on Sunosi supplemental in the ADHD indication and any plans for the Phase 3 program, can you talk about – a little bit about the indication and the need there and then your Phase 3 initial study, would that be potentially sufficient for filing as possible?

[Herriot Tabuteau, Chief Executive Officer]

But thanks, Matt, for the question. So ADHD is a very large market. There are roughly 12 million patients in the U.S. who have ADHD. And right now, they were treated either with stimulants, which are – which have issues with regards to diversion and because they are highly controlled. These are drugs that are very effective, that have a very large effect size, but then there are the downside from a safety perspective. And then they are the announced the non-stimulant medications what they suffer from or lower effect sizes. So 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 chronic trial results show that it appears to be superior agent to other drugs, so the other-promoting agents, for example and 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. So it’s not directly analogous, but we like the clinical profile of the drug in other indications. We like the mechanism of action of the drug. Also, we recently announced that it hits [indiscernible] which in preclinical models have been shown to be pro-cognitive. So there is a lot there that we hope to test in the upcoming trial, which we expect to start this quarter. And then with regards to what would be needed in order to file, so to file an NDA or an drug in ADHD, you also do need to demonstrate efficacy in a pediatric population. So the study that we’re about to launch, that is a study in adults and we will be also looking to initiate a study of pediatric patients to enable a filing.

[Matt Kaplan, Ladenburg Thalmann]

Okay. That’s very helpful. And then a quick question for Lori. In terms of some near-term NDA filings, can you talk about the launch prep you have underway for AXS-07 and potentially 14 as well given the timing of those NDAs and filings?

[Lori Englebert]

Yes. Thanks for the question. So 07, if you remember, we got all of this up to the finish line. So launch prep was pretty heavily done there. So in terms of marketing materials and the preparation for the market and understanding, that’s all just – we need to do a refresh. Based on timing for both 7 and 14 will be when we decide structure thoughts on sales force sizing. So once we have a little bit more understanding on the exact timing and dates, then we will share what that looks like.

[Matt Kaplan, Ladenburg Thalmann]

Thanks for taking the questions.

[Operator]

Thank you. Our final question is coming from Raghuram Selvaraju from H.C. Wainwright.

[Boobalan Pachaiyappan, H.C. Wainwright]

Hi, this is Boobalan dialing in for Ram Selvaraju. And thanks for taking our questions. So firstly, I’d like to give your thoughts on intracellular therapeutics, lumateperone, which produced positive top line data as monotherapy in patients with MDD and bipolar depression. Whether any takeaways with respect to future clinical directions for AXO-05 on this recently reported data?

[Herriot Tabuteau, Chief Executive Officer]

Thanks for the questions. With regards to lumateperone and the data in mood disorders, it’s not surprising that an antipsychotic would work in depression. So I think it’s well known that atypical antipsychotics are used as adjunctive treatment. So – and any time, any company generates data in depression or in bipolar depression, which is positive. We think that that’s a great thing because there is the need, if this is so large and the patient population is still large. And there is such a large amount of heterogeneity in terms of response from patients. So yes, that’s great and let’s have more of that.

[Boobalan Pachaiyappan, H.C. Wainwright]

Okay, thanks.

[Operator]

Thank you. We 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, Chief Executive Officer]

Well, thank you again for joining us on the call today, and 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. And also, these are conditions where there is still a great unmet medical need. So 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]

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.