Sage Therapeutics Q1 2025 Earnings Report

Sage Therapeutics EPS Results

• Actual EPS: -$1.01
• Consensus EPS: -$0.99
• Beat/Miss: Missed by -$0.02
• One Year Ago EPS: -$1.80

Sage Therapeutics Revenue Results

• Actual Revenue: $14.06 million
• Expected Revenue: $14.12 million
• Beat/Miss: Missed by -$61.00 thousand
• YoY Revenue Growth: +78.00%

Sage Therapeutics Announcement Details

• Quarter: Q1 2025
• Date: 4/29/2025
• Time: Before Market Opens
• Conference Call Date: Tuesday, April 29, 2025
• Conference Call Time: 4:30PM ET

Sage Therapeutics (NASDAQ:SAGE), a biopharmaceutical company, develops and commercializes brain health medicines. Its product candidates include ZULRESSO, a CIV injection for the treatment of postpartum depression (PPD) in adults; and ZURZUVAE, a neuroactive steroid, a positive allosteric modulator of GABAA receptors, targeting both synaptic and extrasynaptic GABAA receptors, for the treatment of postpartum depression. Its product pipeline also comprises SAGE-324, a compound that is in Phase II clinical trial to treat essential tremors, as well as has completed Phase I clinical trial for epilepsy and Parkinson's diseases; and SAGE-718, an oxysterol-based positive allosteric modulator of the NMDA receptor, which is in Phase II clinical trial for the treatment of depression, Huntington's disease, Parkinson's diseases, Alzheimer's disease, attention deficit hyperactivity disorder, schizophrenia, and neuropathic pain. The company has a strategic collaboration with Shionogi & Co., Ltd. for the development and commercialization of zuranolone in Japan, Taiwan, and South Korea; and a collaboration and license agreement with Biogen MA Inc. to jointly develop and commercialize SAGE-217 and SAGE-324 products. The company was formerly known as Sterogen Biopharma, Inc. and changed its name to Sage Therapeutics, Inc. in September 2011. Sage Therapeutics, Inc. was incorporated in 2010 and is headquartered in Cambridge, Massachusetts.

Sage Therapeutics Q1 2025 Earnings Call Transcript

Presentation

[Operator]

Good afternoon. Welcome to Sage Therapeutics First Quarter twenty twenty five Financial Results Conference Call. Currently, all participants are in a listen only mode. This call is being webcast live on the Investors and Media section of Sage's website at sagerx.com. This call is the property of Sage Therapeutics and recording, reproduction or transmission of this call without the expressed written consent of Sage Therapeutics is strictly prohibited.

[Operator]

Please note that this call is being recorded. I would now like to introduce Ashley Kaplowitz, Vice President of Investor Relations and Capital Markets at Sage.

[Ashley Kaplowitz, Vice President, Investor Relations & Capital Markets at Sage Therapeutics]

Good afternoon, and thank you for joining Sage Therapeutics first quarter twenty twenty five financial results conference call. Before we begin, I encourage everyone to go to the Investors and Media section of our website at sagerx.com, where you can find the press release and slides related to today's call. I would like to point out that we will be making forward looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please review the risk factors discussed in today's press release and in our SEC filings for additional details.

[Ashley Kaplowitz, Vice President, Investor Relations & Capital Markets at Sage Therapeutics]

We will begin the call with prepared remarks by Barry Green, our Chief Executive Officer, who will provide an overview of our progress during the first quarter twenty twenty five. Our Chief Operating Officer, Chris Bonacci, will provide an update on the ongoing commercialization of XERZUVEY and key financial results from the first quarter twenty twenty five. Our Chief Scientific Officer and Interim Head of R and D, Mike Quirk, will then provide a brief update on our pipeline. With that, I'll now turn the call over to Barry.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, Ashley. And thank you everyone for joining us this afternoon. We had a strong start to 2025 as we advanced our commercialization efforts for XERZUVEY, the first and only oral treatment approved for adults with postpartum depression or PPD. And we also are strategically progressing our refocused pipeline. Now before I get into detail, I wanted to briefly address an important initiative.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

The Sage Board of Directors continues to advance its strategic alternatives process. As we previously noted, Sage is conducting a comprehensive process to evaluate a broad range of opportunities for the company to maximize value for shareholders. The review process remains ongoing. We've not set a timetable for the review process and do not intend to disclose further developments until we determine that disclosure is appropriate or necessary. Now turning back to XERZUVY, we continue to be energized by the profound impact we're having on women with TPD and are driving our efforts forward to bring XERZUVY to more women suffering from this urgent medical condition.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

In the first quarter of twenty twenty five, XERZUVY was shipped to greater than 3,000 women with PPD. That represents a twenty two percent increase from the fourth quarter of twenty twenty four. We generated $13,800,000 in collaboration revenue for XERZUVY in the first quarter, which represents 50% of the net revenue recorded by Biogen, a 21% increase from the fourth quarter of twenty twenty four. Importantly, we are starting to see signs of a system wide paradigm shift in the way healthcare providers specifically OBGYNs are increasingly screening, diagnosing, and treating PPD. In fact, as of today, I'm pleased to share that we've reached a significant milestone in advancing patient care.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Since launch, we've shipped XERZUVY to greater than 10,000 women with PPD. We remain focused on our goal of establishing Zurzube as a standard of care for women with PPD. And with our continued progress, we believe we're making advancements toward that goal. In addition to executing on our launch, we also continue to make progress on our pipeline. Last year, we recalibrated our R and D approach and we significantly reduced our cost structure, aligning our resources around the areas that we believe have the greatest potential for value creation.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

As a result of this work, we prioritized our clinical pipeline in neuropsychiatry and neurodevelopmental disorders where we see strong scientific rationale and believe a significant unmet need exists. Specifically, we're excited about the potential opportunities for both SAGE-three nineteen and our NMDA receptor NAM platform, which we believe could add significant value for shareholders and patients if our development efforts are successful. We also continue to evaluate next steps for SAGE-three twenty four. Mike will provide additional details on these programs. As we previously shared, Mike was appointed interim head of R and D and is leading the team forward.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

I'm confident in the continuity and execution of our clinical priorities under his leadership. With the commercial momentum of XERZUVY and PPD, our focused R and D approach and cash runway expected to support operations to mid-twenty twenty seven, we believe we are well positioned toward our goal of creating value for our shareholders. I'll now turn the call over to Chris to discuss XERZUVY and our financial performance for the quarter. Chris?

[Chris Benecchi, COO at Sage Therapeutics]

Thanks, Barry. I'll begin with an update on our XERZUVEY commercialization progress, ongoing initiatives to maximize reach to women with PPD, and conclude with our financials for the first quarter of twenty twenty five. As Barry noted, we are off to a strong start this year as demand for XERZUVEY in the treatment of women with PPD continue to grow. In the first quarter of twenty twenty five, we shipped greater than 3,000 prescriptions representing a 22% increase from the fourth quarter of twenty twenty four. We continue to see greater than seventy percent of women prescribed XERZUVY receive it as their first new treatment for PPD, which we believe shows the potential for XERZUVY to become the standard of care for this urgent medical condition.

[Chris Benecchi, COO at Sage Therapeutics]

In terms of prescriber trends, in the first quarter, almost eighty percent of prescriptions came from OBGYNs who are at the forefront of peripartum care, the most critical time to screen, diagnose and treat PPD. In addition to OBGYNs, we saw the balance of prescriptions come from a mix of psychiatrists and PCPs. As we've expanded our promotional efforts, including through the recent sales force expansions, we believe that utilization of XERZUVEY will continue to increase among these physician types. Further, we continue to see strong overall prescribing trends with ongoing broader adoption of XERZUVEY. Total XERZUVY writers increased by greater than 20% in Q1.

[Chris Benecchi, COO at Sage Therapeutics]

And we continued to observe that once an HCP rights, there is strong repeat prescribing. Importantly, we are seeing that once an OBGYN has prescribed ZERZUVEY, there is a significant increase in the number of women with PPD they treat based on prescriptions for all medications. At the beginning of the year, we announced a robust investment plan intended to help accelerate the launch of ZERZUVEY, which included a joint sales force expansion to broaden our reach of healthcare providers who treat PPD, investments in media opportunities to further communicate the XERZUVY brand value proposition and amplify the message that PPD is an urgent medical condition, and increased visibility via social media to support PPD awareness and educational efforts. In the first quarter, we made significant progress in these areas. Our recent sales force expansion is now complete with our initial expansion in the fourth quarter of twenty twenty four, followed by additions in the first quarter.

[Chris Benecchi, COO at Sage Therapeutics]

Following our launch of consumer social media at the end of twenty twenty four, we saw greater than 65,000,000 video views across meta and TikTok. And at the April, we launched our first HCP social media campaign, which deepens our engagement with HCPs and advances efforts to build awareness of XERZUVY in PPD. We are pleased with the progress made to date and anticipate that our investments this year will help support our goal of significant top line revenue growth in 2025. We look forward to sharing additional updates in the coming quarters. Now, turning to our financial results for the first quarter of twenty twenty five.

[Chris Benecchi, COO at Sage Therapeutics]

As a reminder, our full financial results for this period are detailed in our press release issued this afternoon with further details in our 10 Q. We reported collaboration revenue from the sale of XERZUVEY of $13,800,000 in the first quarter, a 21% increase compared to the fourth quarter of twenty twenty four. As a reminder, our reported collaboration revenue is 50% of the net revenue Biogen reports for XERZUVEY. R and D expenses were $22,800,000 and SG and A expenses were $57,600,000 in the first quarter of twenty twenty five. Sage underwent a reorganization late last year designed to right size the company to support the ongoing launch of XERZUVEY and our focused pipeline development efforts.

[Chris Benecchi, COO at Sage Therapeutics]

R and D expenses were significantly reduced as a result of the restructuring. You'll see that reflected in the decrease of our R and D expenses by 68% in Q1 twenty twenty five, as compared to the same period in 2024. Further, last quarter, we said we expected the first full quarter of savings from the reorganization to be realized in Q1 twenty twenty five. An example of those cost savings is the nearly 40% decrease in R and D expenses in Q1 twenty twenty five as compared to Q4 twenty twenty four. As we noted previously, while we expect XERZUVEY joint commercialization investment to increase in 2025, we anticipate overall operating expenses will substantially decrease in 2025 relative to 2024.

[Chris Benecchi, COO at Sage Therapeutics]

We continue to be very diligent with our investments aimed at creating shareholder value. Our net loss for the first quarter of twenty twenty five was $62,200,000 as compared to our net loss for the fourth quarter of twenty twenty four, which was 95,800,000.0 illustrating Sage's continued efforts to streamline business operations. Based upon our current operating plan, we anticipate that our existing cash, cash equivalents and marketable securities of $424,000,000 as of 03/31/2025, together with anticipated funding from ongoing collaborations and estimated revenues, and excluding any potential milestone payments we may receive under our collaboration agreements will support our operations to mid-twenty twenty seven. With that, I'll turn the call over to Mike to provide an update on our pipeline. Mike?

[Mike Quirk, Chief Scientific Officer & interim Head of R&D at Sage Therapeutics]

Thanks, Chris. As Barry noted earlier, we remained focused on developing medicines for neuropsychiatry and neurodevelopmental disorders, where we see a strong scientific rationale and believe an unmet need exists. I'll begin with SAGE-three nineteen, our wholly owned extrasynaptic preferring GABA A receptor positive allosteric modulator, or PAM, which was designed to have novel pharmacology and a differentiated profile from other GABA A receptor PAMs in our portfolio. Our goal with SAGE-three nineteen is to demonstrate meaningful clinical effect and a product profile that is differentiated by a broader therapeutic index given the preferential modulation of extrasynaptic GABA A receptors. SAGE-three nineteen is currently being investigated as a potential treatment for behavioral symptoms associated with certain neurodevelopmental disorders, which could include autism spectrum disorder, Tourette's, and other rare neurological disorders, all of which are known to have high burdens on patients, families, and the healthcare system.

[Mike Quirk, Chief Scientific Officer & interim Head of R&D at Sage Therapeutics]

We expect to share data from the Phase I multiple ascending dose, or MAD study, by late twenty twenty five, and anticipate that the upcoming results from this study could enable potential studies in a patient population in early twenty twenty six. Further, we have two orally administered NMDA receptor negative allosteric modulators, or NAMS, in preclinical development, SAGE-eight seventeen and SAGE-thirty nine. Our intention with these drug candidates is to develop a drug with similar or better efficacy than NMDA receptor blockers like ketamine, but with a potentially improved safety and tolerability profile. SAGE-eight seventeen and SAGE-thirty nine have distinct preclinical profiles, with SAGE-eight seventeen inhibiting a broad array of NMDA receptor subtypes and showing stronger inhibition, whereas SAGE thirty nine exhibits subtype specificity and has more limited inhibition. We are also exploring SAGE three twenty four, our wholly owned GABA A receptor PAM, for various potential indications, including seizures and developmental and epileptic encephalopathies or DEEs.

[Mike Quirk, Chief Scientific Officer & interim Head of R&D at Sage Therapeutics]

We expect to provide an update on next steps, if any, in mid-twenty twenty five. To be clear, we are not spending developmental dollars on SAGE-three twenty four, but rather we are evaluating SAGE-three twenty four as part of an overall portfolio decision. We remain excited about opportunities to bring forward developmental candidates from our deep reservoir of proprietary compounds that target the GABA and NMDA receptor systems. While many of these activities are ongoing in the background, we look forward to sharing updates on our progress with you in due course. With that, I will turn it over to Ashley to help facilitate the Q and A portion of today's conference call.

[Mike Quirk, Chief Scientific Officer & interim Head of R&D at Sage Therapeutics]

Ashley?

[Ashley Kaplowitz, Vice President, Investor Relations & Capital Markets at Sage Therapeutics]

Thanks, Mike. As a reminder, we will not be answering questions related to the strategic alternatives process and ask that questions be focused on our first quarter twenty twenty five results. Please limit yourself to one question. If you have an additional question, feel free to return to the queue. Now I'll turn the call over to the operator to handle Q and A.

[Ashley Kaplowitz, Vice President, Investor Relations & Capital Markets at Sage Therapeutics]

Operator?

[Operator]

Thank you. Again, please press star one to ask a question. We will pause for just a moment to allow everyone an opportunity to signal for questions. We will take our first question from Anupam Rama with JPMorgan.

[Malcolm Kuno, Analyst at JP Morgan]

Hi, thanks for taking the question. This is actually Malcolm Kuno on for Anupam. What kind of early pull through are you seeing from your Salesforce initiatives?

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Hey, Malcolm. Yes, I'll start and I'll ask Chris to comment.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

As you saw, we had a really strong first quarter of the year with over 20% growth both in demand and revenue. As a reminder, both companies expanded the sales force in the first quarter. That is complete. And what we believe is that we'll continue to see quarter on quarter revenue growth throughout the remainder of the year.

[Chris Benecchi, COO at Sage Therapeutics]

Yeah, what I would add is when we made the decision strategically to expand the sales organization first in the fourth quarter of last year and again beginning this year. What we wanted to do is we wanted to broaden our reach and increase the frequency associated with the contacts that we were having with healthcare professionals. And the implications of that have been that OBGYNs have really seen a significant portion of our activity. And in fact, with 80% of prescriptions coming from OBGYNs, we really are doing a lot of work to make sure that there is an activated prescriber base on the frontline of peripartum care who are engaged and prepared to not only prescribe XERZUVEY, but to in effect broaden the screening process and the diagnosis of PPD, is really exciting. It's always important to have that kind of foundation.

[Chris Benecchi, COO at Sage Therapeutics]

So we've really focused in the sales force on OBGYNs and really capitalizing on that as an opportunity as we go forward.

[Malcolm Kuno, Analyst at JP Morgan]

Great, thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, Maha.

[Operator]

We will take our next question from Salveen Richter with Goldman Sachs.

[Shrunatra Mishra, Associate at Goldman Sachs]

Hi. This is Shrinathar on for Salveen. Could you provide some additional color on the pipeline and your upcoming catalysts? And particularly, what is driving Sage's confidence in the GABA and NMDA pathways given the setbacks on the pipeline that we saw last year?

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Yes, thanks for the question. I'll start and then I'll ask Mike to comment. As we talked about earlier in the year, we recalibrated our R and D approach and really focused our pipeline. We believe that we are now pursuing drugs with the pharmacology appropriate for indication pursuing that's SAGE-three nineteen. We're also focused with our NMD and NAMS on very validated targets.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

So we feel very good about the drugs that we have, the pharmacology that we have, and the indications that go after. We believe that if successful, we'll create major shareholder value as well of course patient impact. Mike, you want to talk a little bit more about that?

[Mike Quirk, Chief Scientific Officer & interim Head of R&D at Sage Therapeutics]

Yeah, Barry, if I could just add on to a little bit of that. I mean, think there are two elements of our RE CALIBRATE approach. One is the areas of disease biology that we're focused on, and really prioritizing neuropsychiatry and neurodevelopment disorders, we think there is

[Mike Quirk, Chief Scientific Officer & interim Head of R&D at Sage Therapeutics]

a very

[Mike Quirk, Chief Scientific Officer & interim Head of R&D at Sage Therapeutics]

strong biological rationale for both SAGE-three 19 or exosynaptic preferring GABA A positive allosteric modulator, as well as for NMDA receptor NAM platform. And second, by also looking at those indications where we think that there are feasible regulatory pathways. And across both of these programs, three nineteen and the NMDA NAM platform, as Barry mentioned, one of the key elements that we're looking at is making sure that we leverage clinical insights and clinical validations as much as possible. So for example, with the NMDA receptor NAMS, we know that negative modulation or inhibition of NMDA receptors is a very valid target in areas of neuropsychiatry and neurodevelopment disorders with molecules such as ketamine memantine. The key difference is with our NAMS, we believe that we'll be able to provide a similar better therapeutic efficacy as open channel blockers, but with an improved tolerability profile.

[Mike Quirk, Chief Scientific Officer & interim Head of R&D at Sage Therapeutics]

So again, really leaning into the clinical insights that we can derive across our programs. And similarly, with three nineteen being a differentiated extrasynaptic preferring PAM, we're able to leverage a lot of our own learnings, as well as learnings from others, in being able to have a lot of the efficacy signals that we've seen in various indications, but also potentially have an improved tolerability profile by specifically modulating the extrasynaptic components of the GABA system.

[Shrunatra Mishra, Associate at Goldman Sachs]

Thanks, Mike.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, Renata.

[Operator]

Thank you. We will take our next question from Vikram Purahit with Morgan Stanley.

[Morgan Gryga, Biotech Equity Research Associate at Morgan Stanley]

Hi, this is Morgan on for Vikram. Thanks for taking our question. On Zirzuve, for those prescribers and patients deciding not to use Zirzuve as their first line treatment, What do you believe are the key factors as to why and which efforts do you have underway that you think are likely to be key to addressing these reasons? Then second question, could you speak about the concentrations of the sales force in particular regions? I know in the last update you had said in the regions where the sales force had been expanded, you had seen, I believe it was a 33% uplift.

[Morgan Gryga, Biotech Equity Research Associate at Morgan Stanley]

Could you provide any color or details there on updates and how that's panning out? Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Yeah, Morgan, thanks for the questions. So let me answer the second one first. As we said, both companies are now complete, have completed their expansion in the first quarter. With that expansion complete, we believe that we're going to see a quarter to quarter growth in the foreseeable future. So that's really all we can comment about on the sales force.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

As Chris said earlier, our reach is greater to more OBGYNs, and in this quarter we saw a significant number of new writers, and we continue to bring new writers on every quarter. And as you heard from Chris earlier, those new writers become repeat writers as new writers come on. So that's a trend we're seeing. In terms of ZERZUVY, more than seventy percent of women prescribed ZERZUVY are receiving it as their first new treatment for PPD. So about a year into launch, that's quite a remarkable number.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

We really don't see obstacles to XERJUVY becoming the frontline use.

[Morgan Gryga, Biotech Equity Research Associate at Morgan Stanley]

Okay, thank you.

[Operator]

Thank you. We will take our next question from Baral with TD Cowen.

[Athena Chin, Biotechnology Equity Research Analyst at TD Cowen]

Hi, guys. This is Athena on for Ritu Baral. Thanks for taking the question. During the last earnings calls, you guys noted that inventory levels for XOXYVEN were kind of fluid. So how should we look at these levels now?

[Athena Chin, Biotechnology Equity Research Analyst at TD Cowen]

And when can we expect them to stabilize? Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, Athena. I'll ask Chris to talk about the inventory.

[Chris Benecchi, COO at Sage Therapeutics]

Yeah, so what I can say is that inventory varies from quarter to quarter as wholesalers apply their various purchasing habits associated with inventory. So it's tough to peg inventory as it fluctuates up and down. What's most important is to really look at demand here and demand is measured by shipments from specialty pharmacies directly to women with PPD, which is why we're so encouraged by the more than 3,000 shipments that went through in the first quarter of twenty twenty five as reflective of the uptake of the interest in ZERZUVEY and the uptake of the medication early in the launch. So again, I direct you to focusing on the demand rather than the inventory fluctuations over a period.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Great. Thanks, Chris.

[Chris Benecchi, COO at Sage Therapeutics]

Thanks, Athena.

[Athena Chin, Biotechnology Equity Research Analyst at TD Cowen]

Thank you.

[Operator]

Thank you. We will take our next question from Paul Matteis with Stifel.

[Julian Pino, Senior Associate - Biotechnology Equity Research at Stifel Financial Corp]

Hey, this is Julian on for Paul. Thanks so much for taking my question. I know first quarter tends to be a little bit difficult to understand, read through on the rest of the year. But I guess in thinking about what you guys are seeing in demand so far for 2Q, I guess, you expecting sort of a reacceleration in growth? And I guess, were you surprised by the somewhat flat quarter over quarter shipments you saw from 4Q?

[Julian Pino, Senior Associate - Biotechnology Equity Research at Stifel Financial Corp]

Thanks.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Yes, Julien, thanks for the question. Well, we actually didn't see a flat quarter to quarter. We saw an over 20% growth from the fourth quarter to the first quarter in both demand and revenue. So we're excited by that. And I can't really comment on how the second quarter has started, other to say what we said before, which is, and we said this in January, we see quarter to quarter growth throughout each quarter of this year and pretty confident in that statement.

[Operator]

Thank you. We'll take our next question from Ami Sadia with Needham.

[Ami Fadia, Senior Analyst at Needham & Company]

Hi. Good afternoon. Thanks for taking my question. Just a quick follow-up to the previous question. As we think about the expansion in the commercial efforts by both yourself and Biogen, how should we think about kind of the acceleration in growth in these sort of shipments as the quarters progress?

[Ami Fadia, Senior Analyst at Needham & Company]

Maybe if you could sort of help us sort of get some sort of a sizing of by how much you've expanded the efforts and what type of impact do you expect from that? That would be helpful. And then a quick follow-up on the inventory question. Can you just quantify if there was any inventory changes in the quarter that might have impacted the end market revenue? Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks for the question. I'll talk about the first part and ask Chris if there's anything to comment on inventory. So look, as we said, the sales force expansions were complete in first quarter. We are excited and encouraged to see over 20% growth in the first quarter in both revenues and demand. And I can't quantify it and we're not giving forward looking forecasts, but we can say that we see quarter on quarter growth.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

And as we've accounted previously, we're getting new riders every quarter and that is a strategic focus. And as you've heard Chris say many times, those new riders become repeat writers. So you think about that dynamic as well as system wide dynamic, continuing to grow PPD. Again, we believe that Xerxuve is the key to unlock the blockbuster potential in PPD and we believe we're on a trajectory to make that happen. Chris, any inventory comments?

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Yeah, think in terms

[Chris Benecchi, COO at Sage Therapeutics]

of inventory, think I said it and I'll repeat the statement. I think there's fluctuation in terms of buying patterns associated with the wholesalers here. And as you see a therapy like XERZUVY that continues to grow quarter over quarter, your wholesalers are trying to project what inventory is going to look like. And when you add expansion into the mix, they're also trying to figure out how to really project forward what the inventory should look like. So there's going to be fluctuations in terms of inventory as they try to project forward what the uptake of XERZUVEY is going to look like as we go forward.

[Chris Benecchi, COO at Sage Therapeutics]

So I wouldn't point you to any one thing in the specific first quarter around inventory other than to go back and say the truest predictor of the success of the product is looking at the demand trend that we're on. And as Barry noted, 22% quarter over quarter more than 3,000 women with PPD receive ZERZUVAC.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Yes. Thanks, Chris. Thanks, Ami.

[Ami Fadia, Senior Analyst at Needham & Company]

Thank you.

[Operator]

Thank you. We will take our next question from Brian Abrahams with RBC Capital Markets.

[Brian Abrahams, MD & Global Sector Head - Health Care Research at RBC Capital Markets]

Thanks so much for taking my question. What do you guys sense is the overall awareness of XERZUVEY both amongst OBGYNs and amongst the expecting a new mother community? And I guess I'm also curious what kind of metrics you can use to assess both that awareness as well as the degree to which screening for PPD may be increasing? Thanks.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Yeah, thanks for it. Let me ask Chris to start and I can move back with some additional color.

[Chris Benecchi, COO at Sage Therapeutics]

Yeah, so it's a great question, Brian. What I would say is, we do tracking studies on a routine basis quarter over quarter. So we look at what physician awareness is of XERZUVEY and what we've said is that there is approximately a ninety percent aided awareness for XERZUVEY, which given where we are at the launch is remarkably high. So when you go out and you look at the physicians that are out there that are treating with PPD, when you have the conversation with them around the medication, ninety percent with aided awareness knows XERZUVIA and understand what it's being used for. So, again, I think that that's really remarkable at this stage.

[Chris Benecchi, COO at Sage Therapeutics]

We're going to continue to do everything that we've talked about around personal promotion through the sales force, as well as non personal promotion to broaden reach, increase our frequency, not only with OBGYNs, but also with psychiatrists and PCPs who see women with PPD to further expand that. Again, capitalizing on the understanding of the product and to broaden the impact that it has when a physician wants to choose XERZUVY for a woman with PPD. I would also say that we've seen a real uptick in terms of screening and diagnosis amongst those who've actually chosen to prescribe XERZUVY. So think about it like this, Once a physician has the experience with XERZUVEY, he or she begins to change her prescribing practices, not only because of the interest in the medication, but an increased or renewed interest in screening and diagnosis. So there's not just an opportunity here in effect for XERZUVE to be used, but it's to increase the overall size of the population that's viable for a medication like XERZUVE.

[Chris Benecchi, COO at Sage Therapeutics]

Thanks, Chris. Thanks, Brian.

[Brian Abrahams, MD & Global Sector Head - Health Care Research at RBC Capital Markets]

Thanks, Chris. Thanks, Barry.

[Operator]

And we'll take our next question from David Amsellem with Piper Sandler.

[David Amsellem, Sr. Research Analyst at Piper Sandler Companies]

Thanks. So wanted to ask you about your partner and specifically, has anything changed regarding their commitment to the product? And I guess to the extent that things are status quo strategically, looking at Xurzuve as primarily a women's health product and where the rest of Biogen's business is, do you get the sense that their commitment to the product might wane just given the strategic fit or lack of strategic fit? Just wanted to get your thoughts there. Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Yeah, thanks David, and welcome to the team. So what I

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

can say is there's no change to

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

the way we're working with our Biogen counterparts, and I'd say they, like us, are very excited by the impact, the profound impact we're having on PPD and the paradigm shift we're seeing in the market. So, I mean, you'd have to ask them, but what we're seeing so far is highly encouraging in terms of a build to market opportunity.

[David Amsellem, Sr. Research Analyst at Piper Sandler Companies]

Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, David.

[Operator]

Thank you. We will take our next question from Douglas Tsao with H. C. Wainwright.

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

Hi, good afternoon. Can you hear me?

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Yep, Doug, we can hear you.

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

So I think that you mentioned that once the prescriber writes a script reserve available, you just see greater activity for PPD in that office. Are they and I think you might have said, I'm sorry if I misheard, but they might be writing other products as well. So I'm just curious sort of how you're seeing that mix and ultimately what it takes to assist them to sort of immediately go for a disease with Yeah,

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Doug, thanks. I'll take that. So just to clarify what we've said is once a healthcare provider, in our case mainly OBGYNs, writes Xerxuve, we're seeing a significant number of new PPD or PPD they're seeing in their practice. So you see a huge practice growth in terms of the women they're treating with PPD. We also said that more than seventy percent of the women prescribed XERZUVEY are receiving it as their first new treatment for PPD.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

So that trend is a very strong trend. I said this earlier, there aren't really obstacles getting in the way of frontline use. You might have a mom already on an antidepressant where XERZUVEY is added, so that wouldn't be part of the seventy percent, but we're not seeing reluctance to use XERZUVEY first.

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

And that's really helpful. And then I guess I'm just curious if you see any, and obviously you did grow quarter on quarter. I'm just curious if we saw any seasonal impact, obviously, across the industry, we talked typically being resets and so forth. And so I'm just curious with as we think about the future quarters looking to sort of some catch up in terms of the growth.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

So, again, we completed the sales force expansion in the first quarter. There's some disruption when you do that. We still had strong quarter to quarter growth, And it's too early to know whether there's any kind of seasonality associated with Xuzuve and PPD. We don't have the classic first quarter Medicare issues that some drugs have. This is commercial Medicaid, so we wouldn't see that.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, Doug.

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

Okay, great. Thank you very much.

[Operator]

Thank you. We'll take our next question from Ayer with Mizuho.

[Uy Ear, Vice President at Mizuho Financial Group]

Hey, guys. Yeah. Thanks for taking our question. Just curious, could you speak a bit about gross to net, whether you've seen it improve from the fourth quarter? Or does it in this quarter, did it experience a typical gross to net depression that other products in the space experience?

[Uy Ear, Vice President at Mizuho Financial Group]

Thanks.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Chris, you want take that?

[Chris Benecchi, COO at Sage Therapeutics]

Yeah. We haven't communicated exactly what the gross to net is in terms of the percentage. What we've said though is that when you think about the gross to net for XERZUVEY, which is the first oral therapy approved for the treatment of women with PPD, that it doesn't require the same type of gross to net that you might see with other antidepressants used more broadly in this category because I think payers recognize the novel or the uniqueness of this medication, which is really important. So, we haven't communicated the number.

[Chris Benecchi, COO at Sage Therapeutics]

It's not that substantial gross to net that we've talked about. And I think, Barry, as you said it, given that there isn't fluctuations associated with Medicare and things like that, that you wouldn't expect to see the ups and downs associated with gross to net in a category like this with a medication like XERUBE.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, Chris. Thanks for the question.

[Operator]

Thank you. We will take our next question from Joel Beatty with Baird.

[Joel Beatty, Senior Research Analyst at Baird]

Thanks. In the survey we published earlier this month, we received comments from quite a few docs that said they liked the profile of ZERZUVEY and wanted to prescribe it more, but then they said that getting payer coverage is often challenging and that this had been a barrier to their use. I'm so curious, how does that fit with what you're hearing from OB GYNs regarding challenging payer coverage?

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Yeah, Joel, I think we hear a lot about these surveys and I would challenge you to find out those you're surveying, whether they're actually using the drug or not or whether they're making assumptions. We see a lot of surveys come back with historical biases, which are not true. You've heard us, we've got over 95% coverage, so the coverage is very, very strong. Now sometimes we hear about a challenge with a prior auth or specialty pharma, but the majority of moms are getting, a vast majority of moms are getting XERZUVY in less than a week from prescription and many, many receive XERZUVY in two to three days. So we are not hearing issues with coverage at all.

[Chris Benecchi, COO at Sage Therapeutics]

I would add Barry, seventy percent of women prescribed ZERZUVIA receiving it as their first new treatment for PPD, which again is another proof point for the kind of coverage that we have and the ability of a woman with PPD to get it and to get it without onerous prior authorizations and step edits.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

This launch profile is very different than classic branded launches. Unfortunately what we see is we see many healthcare providers answering questions with a historical bias rather than a current day fact base.

[Joel Beatty, Senior Research Analyst at Baird]

Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, Joel.

[Operator]

Thank you. We will take our next question from Laura Chico with Wedbush Securities.

[Laura Chico, Managing Director, Equity Research at Wedbush Securities]

Hi, good afternoon. Thanks very much for fitting me in here. I guess, one question I just wanted to clarify. I know there were about 3,000 shipments in the quarter that occurred. Have you quantified the number of HCPs you have that are actively prescribing?

[Laura Chico, Managing Director, Equity Research at Wedbush Securities]

And I'm just trying to understand what would be a reasonable or aspirational goal in terms of the number of prescribers? Thanks.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Yeah, thanks Laura for the question. Let me ask Chris to comment.

[Chris Benecchi, COO at Sage Therapeutics]

Yeah, so Laura, we've looked at

[Chris Benecchi, COO at Sage Therapeutics]

the number, we have a sense for the size of population here in terms of OBGYNs and psychiatrists and PCPs, but we haven't communicated the number at this time. What we've talked about is the number of shipments that go out. We've talked about the percentage of prescriptions coming from OBGYNs and other physicians. So not from us yet on the exact number of physicians.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Exactly.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

What I

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

would add, Laura, and it's an astute question, again, we continue to see new writers coming on every quarter, we don't see that stopping. Once we bring new writers on, they become repeat writers. Obviously the new writers from last quarter repeat writers. And more and more offices come on where they're using Zurzu Way more than 70% frontline and continuing to repeat. So the reason we're confident in our quarter to quarter growth is that the dynamics are in place to continue to make that happen.

[Laura Chico, Managing Director, Equity Research at Wedbush Securities]

Okay, that's helpful, Barry. Maybe I'll just talk of related, but I don't

[Laura Chico, Managing Director, Equity Research at Wedbush Securities]

know if you'll be able

[Laura Chico, Managing Director, Equity Research at Wedbush Securities]

to answer this. In terms of the average script per provider, how are you would you be able to quantify kind of the changes you're seeing there? I think your qualitative commentary suggests it's increasing, but wondering if you can add any metrics there. Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

I quantify it, we're really not providing that. We are saying that once someone writes, we see a significant number of new patients they're treating in the practice. And again, if XERZUV A is used more than seventy percent frontline, we're getting most of that use. There are dynamics where someone might be an antidepressant or previous antidepressant, but that seventy percent continues to grow. Once we raise awareness as an office, they don't look back, they want to treat postpartum depression.

[Laura Chico, Managing Director, Equity Research at Wedbush Securities]

Thanks very much.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, Laura. Appreciate it.

[Operator]

Thank you. Your next question comes from Mark Goodman with Leerink Partners.

[Basma Radwan, Vice President at Leerink Partners]

Hi, good afternoon. This is Basma on for Mark. Can you please tell us what is the current penetration in the OBGYN and what is your target? And we also have a second question on the pipeline. Regarding the three nineteen and the GEEs, are you basing the decision to advance the development in the GEEs based on the safety profile?

[Basma Radwan, Vice President at Leerink Partners]

And if so, what is the threshold of fundamental rates to make a go or no go decision for the development? That's it for us. Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

So let me start with the second one. I think if you're talking about DEs, we're talking about SAGE-three twenty four, and there's a number of factors we're looking into. About whether doses that are suitable for chronic administration will work in the DE population. It's also about what the regulatory pathway looks like and our portfolio. So once we have clarity around dose, regulatory pathway, portfolio, we'll guide mid this year the path forward, if any, with 03/24.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

I'm not sure we can say much more about your first question, so I think we've already talked about that.

[Basma Radwan, Vice President at Leerink Partners]

Got it, thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

You.

[Operator]

Thank you. Your next question comes from Sumant Kulkarni with Canaccord.

[Sumant Kulkarni, Managing Director at Canaccord Genuity Inc]

Good afternoon. Thanks for taking my question. It's nice to see the growth on XERZUE, but what specifically needs to happen to get a more meaningful inflection on the product so we could see sales far outstrip the SG and A dollars that are spent currently? And how would you put that in context relative to your current cash runway or versus the timelines on any meaningful pipeline catalyst that might help extend that runway?

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Sumant, thanks for the multifactorial question there. So, look, we're excited by the fact that we had greater than 20% growth in the first quarter from fourth quarter in both demand and revenue. As we've said, we continue to see quarter to quarter growth now that the expanded forces in there and we've got an aligned commercialization plan. We don't see that growth slowing. We've also said that Xerxuve as a brand will be cash flow positive exiting 2026.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

We're pretty confident in that. As we see opportunities to expand or spend more to continue to grow XERZUVY, we'll take advantage of those opportunities. In terms of product pipeline progression, overall profile of the company, we've guided that we've got cash runway into 2027 and what goes on further will depend upon data and our decisions to move other drugs forward.

[Sumant Kulkarni, Managing Director at Canaccord Genuity Inc]

Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, Suman.

[Operator]

Thank you. Your next question comes from June Lee with Truist Securities.

[Asim Rana, Equity Analyst at Truist Securities]

Good afternoon. This is Austin Ronald on for June. Congrats on the quarter and thanks for taking the questions. Just a question on 03/24. I mean, what remaining work are you looking to do on 03/24 to develop for DEE?

[Asim Rana, Equity Analyst at Truist Securities]

And then in terms of XERZUV, what's the persistence of prescribers? Do you see any prescribers that start the drug and stop prescribing? Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Let me take the second one, guess, in terms of as we've said, once a healthcare provider writes Xuzuve, they become a repeat writer. We're seeing that consistently. Can't really comment on those that have written and stopped, but we're not really seeing that dynamic in the marketplace. It's quite the opposite. In terms of three twenty four, as we said earlier on the call, we're looking at dose appropriate for chronic administration of DEs, regulatory pathway and our overall portfolio.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

And once we have clarity on all of those, which we'll have mid year, we'll provide some guidance on path forward if any. Just another point is we're not spending developmental dollars on stage three twenty four, it's really people working on answering the questions that I've outlined.

[Asim Rana, Equity Analyst at Truist Securities]

Thank you.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thank you.

[Operator]

Thank you. This will conclude the Q and A portion of today's call. With that, I will turn it back over to Mr. Green for closing remarks.

[Barry Greene, CEO & Member of the Board of Directors at Sage Therapeutics]

Thanks, Rachel, and thanks again to everyone for joining us this afternoon to review our results from the first quarter of twenty twenty five. As we look ahead to the ongoing commercialization of XERZUVEY and advancements in our focused pipeline, I'm confident that we're making important progress on our mission to deliver life changing brain health medicines so every person can thrive. Thanks again everyone and have a great evening. Bye.

[Operator]

This does conclude today's call. Thank you for your participation. You may now disconnect.

Participants

Executives

• Ashley Kaplowitz, Vice President, Investor Relations & Capital Markets
• Barry Greene, CEO & Member of the Board of Directors
• Chris Benecchi, COO
• Mike Quirk, Chief Scientific Officer & interim Head of R&D

Analysts

• Malcolm Kuno, Analyst at JP Morgan
• Shrunatra Mishra, Associate at Goldman Sachs
• Morgan Gryga, Biotech Equity Research Associate at Morgan Stanley
• Athena Chin, Biotechnology Equity Research Analyst at TD Cowen
• Julian Pino, Senior Associate - Biotechnology Equity Research at Stifel Financial Corp
• Ami Fadia, Senior Analyst at Needham & Company
• Brian Abrahams, MD & Global Sector Head - Health Care Research at RBC Capital Markets
• David Amsellem, Sr. Research Analyst at Piper Sandler Companies
• Douglas Tsao, Managing Director at H.C. Wainwright & Co.
• Uy Ear, Vice President at Mizuho Financial Group
• Joel Beatty, Senior Research Analyst at Baird
• Laura Chico, Managing Director, Equity Research at Wedbush Securities
• Basma Radwan, Vice President at Leerink Partners
• Sumant Kulkarni, Managing Director at Canaccord Genuity Inc
• Asim Rana, Equity Analyst at Truist Securities