Sage Therapeutics Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
April 25, 2024

There are 17 speakers on the call.

Operator

Good morning, and welcome to Sage Therapeutics First Quarter 2024 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 atsagerx.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. Please note that this call is being recorded.

Operator

I would now like to introduce Ashley Kaplowitz, Vice President of Investor Relations and Capital Markets at Sage.

Speaker 1

Good morning and thank you for joining Sage Therapeutics' 1st quarter 2024 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.

Speaker 1

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 Q1 of 2024. Our Chief Business Officer, Chris Panekhi, will provide an update on the ongoing commercialization of ZERZUBI. We will also be joined by Laura Gault, our Chief Medical Officer, who will review development activities across our programs. We will then be joined by Kimi Iguchi, our Chief Financial Officer, who will review our financial results from the Q1 of 2024. Mike Quirk, our Chief Scientific Officer, will be available for questions during the Q and A portion of the call.

Speaker 1

With that, I'll now turn the call over to Barry.

Speaker 2

Thanks, Ashley, and thank you, everyone, for joining us this morning. As we progress through 2024, we are singularly focused on addressing unmet needs in brain health. And while the science is extremely challenging, we remain motivated toward a common goal, improving human health. As you may have seen, last week we announced negative results from our precedent study in the dals and mDAR program and participants with mild cognitive impairment related to Parkinson's disease. We're deeply disappointed for patients and their families as we know mild cognitive impairment and Parkinson's disease can have a devastating impact on an individual's life.

Speaker 2

We continue to believe that these results are not necessarily predictive of the results in our ongoing studies. It's important to remember that our cognitive impairment is common across Huntington's disease and Alzheimer's disease. The underlying pathophysiology and symptomatology of these diseases are very distinct. We look forward to data across the 1,000 MDR program expected throughout 2024 as well as top line data from our Kinetic-two study in essential tremor expected mid-twenty 24. I'd now like to focus on a very encouraging area of opportunity for Sage and for women with PPD.

Speaker 2

As you'll soon hear from Chris, the launch of ZERZUVA is off to a strong start as is reflected by our 1st full quarter performance. I'm inspired by the positive anecdotes and success stories we're starting to hear from women with DPD who have been treated since launch. The impact of XERZUVE on these moms and their families is profound and it's energizing all of us. We continue to believe ZERZUVE is the key to unlocking the blockbuster potential of PPD, enabling us to help many women suffering from this devastating disease. While early, we're beginning to see signs of practice patterns changing, particularly among OB GYNs.

Speaker 2

With approved oral treatment specifically for PPD, we believe healthcare prescribers have started to shift from suspect and refer to screen, diagnose and treat. I'll highlight a few of the encouraging signals we're seeing in the 1st Q4 of launch. Demand in PPD has been strong and continues to grow. Interest among healthcare prescribers with whom we've engaged or who have learned about XERZUVE has been high, evidenced by XERZUVE being prescribed for women with PPD across a wide range of healthcare prescribers. We're also highly encouraged by the progress we made with commercial and government payers.

Speaker 2

Payers are beginning to develop policies and for the majority of plans to date, we're not seeing onerous prior auths or step edits to PPD. Our teams in the field remain busy, engaging with critical stakeholders, educating prescribers and contributing to the recognition of PPD as an urgent medical condition. We believe the PPD opportunity is significant and have thought broadly about the initiatives needed to achieve commercialization success with ZERZUVE. Our strategy is to launch with a focused approach and scale as we see success. As the early signs of launch have been encouraging, we've been increasing our marketing and non personal promotion resources.

Speaker 2

If the positive trends continue, we believe additional scaling this year makes sense. Our goals are clear, establish XERZUVE as the first line therapy and standard of care for women with PPD and advance our brain health pipeline. Our work is more important than ever and the countless lives we have potential to positively impact continues to serve as our North Star. With that, I'll turn the call over to Chris to provide additional context on the ongoing commercialization of XERZUVE. Chris?

Speaker 3

Thanks, Barry. The XERZUVE launch is off to a strong start and exceeding expectations. We've made important progress during the 1st full quarter of commercial availability, and I'm excited to share our recent launch accomplishments and ongoing initiatives. As we've engaged with healthcare professionals, patient advocacy organizations, payers and policymakers, our mission is clear. There is desperate need and critical gaps in care for women with PPD.

Speaker 3

Sage is committed to working with all stakeholders with the goal of rapid affordable access to ZERZUVE for women with PPD as there often can be incredibly heartbreaking and unintended consequences for the mother, her baby, her family and future generations when PPD is not adequately treated. It is critical to diagnose, treat and provide care and support for all women with PPD. We're beginning to see the initial signs of hope and progress in the 1st few months following the launch of ZERZUVEY. As Barry noted, we are starting to see signs of practice patterns changing, particularly among the OBGYN community. In a short period of time, we believe we are already beginning to see PPD move from a disease where some HCPs would suspect PPD and then refer the patient for evaluation and treatment to a disease that HCPs are confident to diagnose and treat.

Speaker 3

I'm proud to be a part of this important movement and grateful for the countless SAGIANS working to accelerate our impact in collaboration with our partner Biogen. As we said previously, our goal is to establish AZUVE as the first line therapy and standard of care for women with PPD. We believe we are already making meaningful progress. Before I dive into the specifics of early launch performance, it's an important reminder to note that IQVIA data does not reflect all shipments of XERZUVE. The key takeaway is that right now there is variability in the data and it may not provide a complete picture of XERZUMA demand in PPD.

Speaker 3

Even in the future, we see potential for variability in the data. With that said, I'm now excited to share more detail on the encouraging progress seen during our 1st full quarter of launch. XERZUVE generated $12,400,000 in total revenue, of which Sage recognized $6,200,000 in collaboration revenue during the Q1 of 2024. In the Q1, there were more than 1200 prescriptions written. The growth in prescriptions this quarter was strong and reflective of the interest and enthusiasm we're seeing for XERZUVE in the treatment of women with PPD.

Speaker 3

While we believe the number of prescriptions is an important early indicator in the coming quarters as the launch matures, we plan to focus primarily on shipments and collaboration revenue. We were pleased to see prescribing across a wide breadth of HCPs who treat PPD, with the largest percentage of prescriptions coming from OBGYNs. OBGYNs are on the frontline of care for women with PPD and are often the first opportunity for an HCP to recognize symptoms, diagnose and treat. As we know, the patient journey can vary greatly for women suffering from this disease. We also continue to expect growth in prescriptions from psychiatrists and PCPs who are also actively diagnosing and treating women with PPD.

Speaker 3

Further, we are encouraged that the breadth of adoption of ZERZUVE in the treatment of PPD continues to grow, with the number of new ZERZUVE prescribers increasing each month during the Q1. We are also beginning to see signs of depth with repeat prescribing. A growing number of HCPs have already written multiple prescriptions for XERZUVA. Based on early claims data, we see that many XERZUVE patients appear to be receiving XERZUVE as first line therapy for PPD. As of the end of the Q1, more than 700 prescriptions were shipped and delivered to patients.

Speaker 3

Our goal is to get XERZUVE to women with PPD who are ZERZUVA to women with PPD who are prescribed the medication as quickly as possible and we continue to make improvements intended to help optimize the experience for HCPs and patients. This includes educating HCPs on the specialty pharmacy system as well as operational improvements designed to expedite prescription processing. We expect the process will get better and quicker through these efforts and as formulary coverage decisions are made. Working towards broad and equitable access for women with PPD continues to be a key priority and we know access is critical for a successful launch. Conversations continue to advance in an accelerated pace across national, regional and government payers.

Speaker 3

Notably, 2 of 3 national PBMs have published We're encouraged by similar trends with national and regional We're encouraged by similar trends with national and regional insurers. Today, we have over 65% of commercial lives covered for ZERZUVA and PPD, with the majority having no step therapy or complex prior authorization, and we expect this number to increase over the coming months as we continue engaging with payers who have not yet published policies. With respect to Medicaid, we are pleased to see almost half of the states, including several of the largest states, have completed reviews much more quickly than is typically seen for product launch. While Medicaid policies continue to develop, most states that have made a decision to date are covering ZERZUVAY for women with PPD, in line with our expectation of no step therapy and no complex prior authorizations. Where Medicaid policies are in place, we are seeing most women with PPD access their Zuvi at a nominal cost or 0 co pay.

Speaker 3

We expect the majority of Medicaid coverage decisions in PPD by the end of the year. We believe the strong payer progress we and Biogen have seen to date is the result of our active and long standing engagement with payers, our knowledge of the PPD market and the strong value proposition for ZERZUVE in the treatment of women with PPD. It is also critical that we continue to work to enable access to XERZUVE for all women with PPD who are prescribed treatment, regardless of financial means and coverage for our patient support and financial assistance programs for those who are eligible. While we did see use of these programs, the majority of shipments were covered by commercial and government payers in the Q1, even as coverage policies were being developed. We anticipate that if formulary coverage decisions continue to be favorable and as the SP processes further optimize, the need for the functionally uninsured program will decrease over time.

Speaker 3

Lastly, I'm excited to share some color on our ongoing marketing efforts. Based on our experience, we believe this is a highly promotionally sensitive market, which benefits from the surround sound of omnichannel effort. We continue to see enthusiasm from HCPs to learn more about XERZUVE and have expanded commercialization efforts across stakeholders with the goal that XERZUVE is top of mind as first choice treatment for women with PPD. For example, we have executed ACP peer to peer live and virtual branded educational platforms, attracting wide attendance across multiple specialties to treat women with PPD. We also launched our fully operational zerzuve.comhealthcareprofessional website at the end of February in conjunction with several media drivers encompassing paid search, programmatic displays, banner ads and HCP targeted email.

Speaker 3

Recently, we launched the zirzuve.com full consumer website where women with PPD can find branded education, support resources and opt in to receive proactive XERZUVA communications. We're highly encouraged by what we're seeing so far and the launch has reaffirmed our belief that XERZUVE is an important treatment option to address the urgent and profound unmet need for women living with PPD. We want to build on the momentum we have seen in the Q1 of launch to reach even more of the women with PPD who need ZERZUVAX. We know we have more work to do to get there. We know that women living with the disease cannot afford to wait and now with XERZUVE available as a treatment option, they should not have to.

Speaker 3

I look forward to sharing additional details in the coming quarters. With that, I'll turn it over to Laura for a more detailed discussion of our recent pipeline progress. Laura?

Speaker 4

Thanks, Chris, and good morning, everyone. As a clinician, I've seen firsthand the challenges that women with PPD and their families face. And so it is gratifying to see the impact we are already making for these women. I'm excited to be part of such a significant moment in maternal health as we continue to execute on the launches to Zuubay and PPD. I'll now turn to 1,000 mDOR, our wholly owned 1st in class NMDA receptor positive allosteric modulator or PAM as a potential oral therapy for certain cognitive disorders associated with neurodegenerative disease.

Speaker 4

Last week, we reported top line data from the PRECEDENCE study, a double blind placebo controlled Phase 2 study in people with mild cognitive impairment or MCI in Parkinson's disease. After 6 weeks of treatment, patients who received dasalemdor did not demonstrate a statistically significant difference from baseline compared to placebo on the primary endpoint, the WAIS-four coding test score at day 42. Based on the data, we do not plan any further development of DelZ and Endor in Parkinson's disease. As we said on our call last week, it is important to remember that these results are not necessarily predictive of the results we may see in our ongoing Huntington's disease and Alzheimer's disease studies, given the very distinct underlying pathophysiology and symptomatology of these diseases. While we're disappointed by the results of the PRECENET study, we continue to believe in the potential of dasimdor and the other indications we are studying and look forward to the various data readouts anticipated later this year.

Speaker 4

Specifically, in mid-twenty 24, we expect to report top line data from the Surveyor study, a Phase 2 study designed to generate evidence linking cognitive performance to real world functioning in people living with HD. In late 2024, we expect to report top line data from the LIGHT WAVE study, a double blind placebo controlled Phase 2 study of 1,000 mDOR in people with MCI and mild dementia due to Alzheimer's disease. We also expect to report top line data in late 2024 from the DIMENSION study, a double blind placebo controlled Phase 2 study designed to evaluate the efficacy of galzinemdor and cognitive impairment in HD over a 3 month treatment period. As we've described previously, we want to underscore that the primary objective of the Surveyor study is to understand the magnitude of the cognitive impairment in HD relative to healthy individuals. A key secondary objective is to advance our understanding of the effects of 1,000 mTOR on cognition and function in participants with HD.

Speaker 4

It's important to emphasize that the surveyor study is not designed nor powered to show statistically significant differences between DOZANM door and placebo. These data are meant to complement the DIMENSION study by generating evidence to better define clinically meaningful change and the relationship between changes in cognition and function. We look forward to sharing these results with you as they become available. I'll now turn to SAGE-three twenty four, an investigational positive allosteric modulator of GABA A receptors with potential in the treatment of essential tremor or ET. We are developing SAGE-three twenty four in collaboration with Biogen.

Speaker 4

There has been a lack of innovation in treatments for ET with no new approved treatments in more than 50 years. Essential tremor can have a significant impact on an individual's ability to perform everyday tasks. Developing new treatment options that could help an individual maintain his or her quality of life, daily functioning and independence is critical. Following the encouraging data from our completed kinetics study, which demonstrated statistically significant reduction from baseline in upper limb tremor amplitude, we look forward to seeing the data from the Kinetic-two study. This study is a 3 month study designed to identify a dose with a safety and tolerability profile that is suitable for chronic dosing and further development of SAGE-three twenty four as a potential treatment for ET.

Speaker 4

We look forward to sharing these data expected in mid-twenty 24. Lastly, I'd like to reiterate our excitement around our earlier stage pipeline, including SAGE-three nineteen, our extra synaptic preferring GABAA receptor PAM and SAGE-four twenty one, our NMDA receptor PAM. We look forward to sharing more about these programs as they progress. With that, I'll turn the call over for a review of our financials. Kimi?

Speaker 5

Thanks, Laura. Our financial results for the Q1 of 2024 are detailed in our press release issued this morning. Before diving into the financials, I want to share my excitement around the launch of XERZUVA and the opportunity to help so many women suffering with PPD. We and Biogen are mobilized with the goal of capitalizing on early success and jointly supporting the launch of XERZUVE in the United States. Commercialization of XERZUVE remains a key priority for us as we work to expand access in the treatment of women with peak PD and build momentum.

Speaker 5

We also plan to continue to make disciplined pipeline investments backed by data to support our goal of near, mid- and long term value creation. I'll now turn to the financials. Today, we announced collaboration revenue in Q1 from sales of Nezueve of 6,200,000 dollars Our reported collaboration revenue is 50% of the net revenues Biogen reports for XERZUVE. As a reminder, net revenues are recorded by Biogen when ZERZUVE is shipped to the wholesalers and are not calculated based on the number of shipments to patients or prescriptions written for XERZUVA. Net revenues for the Q1 can be attributed to a combination of wholesalers purchasing ZERZUVE to fill orders as well as building inventory in anticipation of increasing demand for DSUVIA in the treatment of women with PPD.

Speaker 5

We're not guiding today on gross to net other than to say given the fact that DIRZUVA is a novel medication and the only oral treatment specifically approved for women with PPD, we do not anticipate the type of discounting we see for other branded CNS agents. Turning to operating expenses. R and D expenses were $71,700,000 in the Q1 of 2024. SG and A expenses were $52,600,000 in the Q1 2024. The decrease in both R and D and SG and A expenses compared to the Q1 of last year was primarily related to decreased headcount, overhead and technology as well as decreased spend on the early stage pipeline, zuranolone clinical trials and manufacturing, primarily as a result of the Q3 2023 restructuring.

Speaker 5

As we previously stated, we expect operating expenses to decrease in 2024 relative to 2023. Our net loss for the Q1 of 2024 was $108,500,000 and we ended the Q1 of 2024 with cash, cash equivalents and marketable securities of approximately $717,000,000 We are reaffirming that based on our current operating plan, we anticipate cash, cash equivalents and marketable securities, anticipated funding from ongoing collaborations and estimated revenues will support operations into 2026. As we said on our last earnings call, we do not anticipate receipt of any additional milestone payments from collaborations in the remainder of 2024. Before I turn the call over for Q and A, I want to reiterate that we remain dedicated to progressing our mission of better brain health for patients. Further, we believe there are a strong financial foundation as we continue to progress through our catalyst rich year for Sage.

Speaker 5

We look forward to providing updates on our progress in the coming quarters. I'll now turn it over to Ashley to handle Q and A with

Speaker 1

the operator. Ashley? Thanks, Kimi. I'll ask that you limit yourself to one question. If you have an additional question, feel free to return to the queue.

Operator

And our first question is coming from Yasmeen Rami with Piper Sandler. Your line is open.

Speaker 4

Hi, guys. Good morning. This is Lauren on for Yas. Just a quick one for us. For the Kinetic 2 study, have you guys guided any powering assumptions?

Speaker 4

And with that, have you detailed an efficacy and safety signal that would warrant moving forward into Phase 3? And then just coinciding with that, have you started to engage with the FDA and KOLs in regard to a Phase 3 for this program? Thank you.

Speaker 2

Yes, Lauren. Thanks for the question about SAGE-three twenty four. Our gabapam meant for chronic administration that's partnered with Biogen in movement disorders initially starting with the essential tremor. Laura, you want to take the question?

Speaker 4

Yes, sure. So with regard to the study design, we have provided study design details on clintrials.gov and it's also in the investor deck that's on our website. We don't provide additional information beyond what's available there. For Phase 3, of course, in any development program as you come close to finishing Phase 2, you start to think about Phase 3 planning. We are certainly doing that in conjunction with Biogen.

Speaker 4

And as part of that, we are engaging experts.

Speaker 2

Yes. And the key to Kinetic 2 is a follow-up from the Kinetic study where we saw at 28 days a statistically significant improvement in tremor amplitude as well as activities of daily living. Kinetic 2 is now we want to see that at 3 months and the real key is to make sure that we have a benefit risk dose to move forward for chronic administration. So that's really what we're looking for at Kinetic 2.

Speaker 4

Perfect. Thank you. I'll hop back in the queue.

Speaker 2

Thanks, Lauren.

Operator

Our next question is coming from Anupam Rama with JPMorgan. Your line is open.

Speaker 6

Hey, guys. Thanks so much for taking the question.

Speaker 3

One of the key questions we've gotten sort of post Biogen and your guys' report this morning is any more color on the inventory build in the quarter versus the orders filled for ZERZUVA and how we should think about this moving forward? Thanks so much.

Speaker 2

Yes, Anupam, thanks for the question and we share your enthusiasm off to the strong start. I'll turn it over to Chris to talk about Kimi to talk about that and then I'll provide some color.

Speaker 3

Kimi? Yes.

Speaker 5

Well, thanks Barry. ZERZUVIA generated $12,400,000 in total revenue, of which Sage recognized $6,200,000 in collaboration revenue during Q1, which we talked about during our opening remarks. The net revenues for the Q1 can be attributed to a combination of wholesalers purchasing inventory to fill orders as well as building inventory. And that's, of course, in anticipation of increasing demand for XERZUVE in the treatment of women with PPD. As the launch progresses and we have a better understanding of the demand and inventory levels, we'll be able to share more at that point.

Speaker 2

Yes. And I just add some color there, Anupam. It's an important question. I know it's gotten a lot of attention. I will comment that the wholesalers are very smart.

Speaker 2

They don't want products sitting on the shelf and aging. So we really believe what we're seeing is demand driven.

Speaker 6

Thanks so much for taking our question and congrats on the strong launch.

Speaker 2

Thanks Anupam.

Operator

Our next question is coming from Salveen Richter with Goldman Sachs. Your line is open.

Speaker 7

Hi, this is Srinathra on for Salveen. Thank you for taking my question and congratulations on the quarter. Could you speak to the process through which OBGYNs are diagnosing PPD? And at what point are these visits happening? Is it proactive on the part of the doctor or the patient?

Speaker 7

And also any general feedback you've received from doctors on the efficacy and safety profile?

Speaker 2

Yes, sure. I'll start and then I'll see if Laura or Chris want to add any color after I answered. So what's really important and what you've highlighted here is that healthcare providers in general are recognizing that PPD is a medical condition with urgency to treat and it's not a moral failing. And that theme is critically important. The other practice pattern that we highlighted and this is really important is that OBGYNs who are the frontline of seeing moms with potential for PPD are moving from the practice pattern of suspecting depression and referring to either primary care of psychiatry to screening, diagnosing and treating.

Speaker 2

And that paradigm shift is continuing when we see it accelerating. So that's really, really important. In terms of what's happening out in the real world, we've got a lot of anecdotes and lots of anecdotes don't add up to data per se, but just give us a flavor. We're hearing from the field is that XERZUVA is performing in the real world as it performed in our clinical trials. And that is a very broad benefit risk profile, rapid onset as early as 2 or 3 days and that women appreciate this is a 14 day course of treatment or completing that treatment.

Speaker 8

Yes. What I would add and I included in my opening remarks is that in the first quarter of 2024, we saw that OBGYNs accounted for the largest percentage of prescriptions. As Barry noted, that's important because what that begins to signal is that treatment practice for women with PPD is beginning to change as you have OBGYNs on the frontline of care for so many of these women. I'd be remiss though if I didn't mention that we expect growth in prescriptions from psychiatrists and PCPs as well as OBGYNs moving forward as they continue to actively diagnose and treat women with PPD, representing more broadly the adoption for ZERZUFA and really the need to change the way that we think about and treat PPD moving forward. So encouraged by all of those physicians really leaning in.

Speaker 4

Yes. And Chris, I would add that when you think about diagnosing PPD, there actually are a lot of tailwinds. And those tailwinds come from professional organizations like ACOG and the American Academy of Pediatrics that have both issued guidance practice guidelines that suggest that patients should be screened throughout their well child care visits. So in most health care settings at this point, this routine screening is happening, which enhances the ability to detect women with PPD earlier in their disease evolution?

Speaker 2

Yes. Thanks, Renata. It's a great question. And as you're hearing, we're pretty excited about the paradigm shift that we're accelerating with ZERZUVE.

Speaker 7

Thank you for the color.

Operator

Our next question is coming from Ritu Baral with TD Cowen. Your line is open.

Speaker 1

Good morning, guys. Thanks for taking the question. I wanted to ask about the difference between the 1200 prescriptions written and the 700 shipped and delivered. How should we think about the delta there? Are those prescriptions that may result in free drug?

Speaker 1

Are those prescriptions that are right now sort of in that time to fill period? And can you comment on percentage free drug and that time to fill period? Thanks.

Speaker 2

Yes, Ritu. Thanks for the question. Let me start with Chris, if Kimi has anything to add on free goods and I'll loop back at the end.

Speaker 8

Yes. So as we noted, ZERZUVA's launch is off to a strong start and exceeding expectations. And we're encouraged by the breadth of adoption of ZERZUVA and the treatment of PPD and see it continue to grow with new prescribers each and every month. And not just new prescribers, but a number of repeat prescriptions coming from many of those same providers as we move forward. As you note, Ritu, with respect to written versus shipped prescriptions, you always expect, particularly at a launch, there to be a delta between written and shipped prescriptions.

Speaker 8

Although over time, what you would anticipate is that would actually catch up as the number of shipped prescriptions catches up with the number of written prescriptions. We continue to see a trend of growing prescriptions each month in Q1 with the 700 prescriptions that were actually shipped and delivered to patients and we'll see that number catch up to the prescriptions that were actually written. Our goal really is to ensure that ZERZUVE gets to all women who are prescribed the medication as quickly as possible And we continue to make improvements to in effect the system that we have in place to optimize the physician patient experience to make sure that the SP model is working as efficiently and effectively as possible. And as coverage policies come online where there aren't onerous prior authorizations and step edits, the medication flows from prescription to shipment quicker and quicker with each successive day. So really excited about the work that we're doing behind the scenes to make that happen because moms deserve to have this medication.

Speaker 8

Women with PPD deserve to have this medication as rapidly as possible.

Speaker 2

Okay, great. Thanks. Thanks, Ritu.

Operator

Our next question is coming from Laura Chico with Wedbush Securities. Your line is open.

Speaker 9

Hey, good morning guys. Thanks very much for taking the question. I guess one thing you mentioned in the prepared remarks centered on potentially scaling up the sales force at a given point. But trying to better understand what type of metrics would you need to see to warrant kind of scaling up? And then kind of related to that, how far from symptom onset are women typically receiving their Zuvi prescription?

Speaker 9

I realize that might change over time, but just curious how at what point from diagnosis are they getting the prescription? Thanks.

Speaker 2

Yes, Laura. Thanks for the couple of questions there. I'll start and then see if Chris wants to add a close. Let me start with the second point. So we don't have solid data on the exact timing from onset of symptoms treatment.

Speaker 2

The great sign we're seeing, however, is the number of scripts coming from OBGYN. You can imagine the patient journey here. If a woman who has previously suffered depression, therefore is at risk, suffers PD, you might expect that the diagnosis and prescription comes from her treating primary care prescribe or primary care office or psychiatry. The fact that we're seeing the OBGYNs prescribed and that about half of the women treated this early claims data, so take it with a greater thought, but about half the women treated were naive, meaning they had not been on anti infras last year, suggest to us that the PPD is being picked up fairly early on in the treatment in the landscape here. So that's a great sign.

Speaker 2

Back to your first question, as we talked about, we really do believe that ZERZUVE is the key to unlock the blockbuster potential of PPD helping as many moms we can. As you know very well, Laura, we started with focused approach and we're already scaling. As we highlighted, we've increased our personal, non personal promotion as well as some of the other efforts around specialty pharma and others, which Chris talked about. So we're excited. As we see continued prescribing patterns, we invite you and we'll talk about field force and other aspects of expansion.

Speaker 2

You'll hear about that in the quarters to come.

Speaker 1

Thanks very much.

Speaker 2

Thank you.

Operator

Our next question is coming from Paul Matteis with Stifel. Your line is open.

Speaker 10

Hey, thanks so much. I was wondering if you could expound upon what this midyear Huntington's readout is going to look like. Like what are the key couple of analyses that you're going to be doing? And more specifically, I was wondering if you could sort of talk about your current thinking on endpoints and specifically the HD cap, which I think you're using as a primary in dimension, but more recently another company in the space had trouble getting the FDA on board with that measure? Thank you.

Speaker 2

Yes, Paul, thanks for that. I guess the 3 or 4 questions in one. Let me turn it over to Laura to tackle the 1,000,000 indoor questions you're asking.

Speaker 4

Sure. Thanks for the question, Paul. So the surveyor study is the study that we expect to read out next in mid-twenty 24. And that study is designed with a particular purpose in mind. It is designed to provide data to put context around the HD cap to help us understand what clinically meaningful change looks like.

Speaker 4

And so with regard to how we designed the study, there's really 2 parts. The first part is comparing baseline HD CAV scores for healthy participants versus patients with Huntington's disease. And that looking at that delta is going to help us understand what the magnitude of the impairment is in this population and also help to anchor the meaningfulness of any improvements that we see in the study. The second part of the study takes those patients with Huntington's disease and randomizes them 1 to 1, 2,000 mTOR or placebo. Now this is a very small group of people.

Speaker 4

40 patients were randomized, so you're talking about 20 subjects in and they're treated for 1 month. And so what we're looking at here is looking at trends in the data. We're trying to understand how the magnitude of the change in cognition and how that pulls through to changes on the global measures and the functional measures. And again, these data are really important to help put the results of the HDCabin context. Operator, we can go to the next question.

Operator

Our next question is coming from Jay Olson with Oppenheimer. Your line is open.

Speaker 11

Hey, congrats on the ZERZUVE launch progress. Since PCPs are relatively less familiar with scheduled drugs for mood disorders compared to psychiatrists and maybe OBGYNs. Can you talk about the strategy for increasing XERZUVA awareness and prescribing among PCPs? And then any color you could provide on your strategy for DTC? Thank you.

Speaker 2

I'll start and then I'll kick it over to Chris. And thanks, Jay. We're also incredibly excited by the trends we're seeing with the launch of ZERZUVI. So as you highlighted, while majority of scripts are coming from OBGYN, we are seeing prescriptions from Sykes and primary care. And that pattern may shift over time, although we're very excited that OBGYNs who are in the frontline of picking up depression in moms here are the key prescribers and we think that trend will continue.

Speaker 2

Now I talked about the patient journey. So what we are likely seeing if there has been a prior history of depression and the moms diagnosed with depression in the pregnancy or postpartum, and they're under the care of a psychiatrist or primary care physician, we're likely seeing scripts coming from that. If they're newly diagnosed, that's where the OBGYNs are coming in. Actually, primary care are very familiar with prescribing antidepressants. In fact, the majority of SSRIs, SSRIs come from primary care versus especially just the volume.

Speaker 2

So they're familiar with it. They've got licenses. They're very familiar with scheduling the scheduled drugs as needed. Chris, do you want to add any more?

Speaker 3

Yes. I think the color that

Speaker 8

I would add to PCPs here, Barry, is the group of PCPs that we're calling on with the sales force right now. It's a core group of PCPs, frankly, who behave more like psychiatrist. They may be in a community where there is not a psychiatrist and therefore they become the de facto clinician that treat many of these patients. So that's those are the PCPs that are being called on from a sales force perspective. Obviously, as I had mentioned in my prepared remarks, we're continuing to increase digital means in order to reach broaden our reach and to increase our frequency across all physician types.

Speaker 8

And digital has been particularly effective in actually going forward and doing that and dialing up the investment in that over the course of the year is going to have that impact in terms of reaching PCPs as we go forward because we know oftentimes they're the ones who become the first line of care after a woman has seen her pediatrician or other types of clinicians seeing women outside of OBGYN and psychiatry. So we'll continue to invest in that. I think your question around DTC is also an important one and certainly one I'm sure is on the mind of many people on the call here today. We've talked about being focused with our investment and scaling with success. But obviously, the first step in this is making sure that we have a very well educated and prepared clinician audience, so that when patients come in and ask for the medication by name that they're ready to effectively prescribe the medication with an understanding of the efficacy and the safety profile.

Speaker 8

Obviously, the first step is educating clinicians. We use both personal and non personal to do that. And when the time is right to expand DTC so that patients can go in and have that informed discussion, we'll actually invest in that. What I would be remiss though, if I didn't mention was the helping tailwind that we have with respect to online and social media activity in and around XERZUVE. This is a popular topic of conversation.

Speaker 8

In many senses, that's going to proceed and has preceded the DTC effort that we know will come in the future. And when the time is right, we'll invest in DTC and move it forward.

Speaker 11

Thank you. Super helpful. Congrats again.

Speaker 2

Thanks, Jay.

Operator

Our next question is coming from Ami Fadia with Needham. Your line is open.

Speaker 12

Hi, good morning. Thanks for taking my question and congrats on the progress on Tuzovay. Sorry about that. Could you talk a little bit more about the use of Zului in first line versus second line? And in what situations do patients get get this away as a second line treatment?

Speaker 12

And are they getting it in combination with any existing SSRI, SNRI treatments? And just to follow-up from an earlier topic, could you sort of go over in what way the SERVIR data will inform the DIMENSION study? Thanks.

Speaker 2

Yes. Let me start with your ZERZUMA question and I can ask Laura to talk about the dasimembourg questions. So as we stated, ZERZUVA is the 1st and only oral medication specifically approved for postpartum depression. Our goal is for ZERZUVA to be used frontline. And what we're seeing from a payer perspective is in fact support of that.

Speaker 2

As Chris highlighted, we're seeing a very strong payer coverage. I call some kind of payer tailwinds with no steps for majority of cut plans and very limited prior offs. So that's a very important thing. We're seeing women step up to be treated. We're seeing healthcare prescribers prescribing OBGYNs leading that chart.

Speaker 2

So all signals are that ZERZUVE is becoming a frontline first choice for the treatment of postpartum depression. I highlighted this earlier, but when we look at early claims data, almost half of the claims data suggest that those being prescribed to ZERUVE already in the Q1, which is pretty remarkable, have not had an antidepressant for the previous year. So we are seeing the trend towards ZERUVI to be used frontline and really no obstacles to make that happen. Laurie, you want to talk about the dalsinimdor?

Speaker 4

Sure. So your impressions related to how surveyor will inform the DIMENSION study. And I think there are really 2 main ways that we would see this happening. The first is, we will get some data that will help us understand the performance of the different scales that we've included in the studies, because the scales included in DIMENSION and Surveyor are largely overlapping. The second is, as I mentioned earlier, we'll be looking to really better identify clinically meaningful change in patients with Huntington's disease on the HDCAB and other endpoints.

Speaker 4

And so that will help inform the data interpretation from DIMENSION. Of course, when we get the surveyor data, we're going to learn as much as we can from it. But we don't have plans at this time to change the DIMENSION study design. Would you change any thoughts on the margin for DIMENSION? As I mentioned, we'll learn as much as we can from the data, but we don't have plans right now to change the study.

Operator

Thank you. Our next question is coming from Brian Abrahams with RBC Capital Markets. Your line is open.

Speaker 13

Hey, good morning guys. Thanks for taking my question and congrats on the early progress of the launch. I'm curious what where are you seeing in these early days as the are you seeing in these early days as the biggest reasons why a diagnosed PPD patient might not receive a written prescription for a course of ZERZUVE? Is it a matter of awareness or coverage? Are there certain types of practices or regions where these are they're more later adopters, tend to be later adopters versus early adopters?

Speaker 13

I'm curious what you're seeing on the ground there. Thanks.

Speaker 2

Yes, Brian. Thanks for the question and I appreciate the congrats to renew. Chris, you want to take that?

Speaker 8

Yes. So let me start with the payer piece here, because I think it's important to highlight this. I think with respect to where we stand today, we're in a very privileged position with this medication and its launch in and around payer coverage. As I noted in my prepared remarks, we're encouraged by the progress that we've made with commercial and government payers. We know that as payers are beginning to develop policies, the majority that we've seen today don't come with onerous prior authorizations in step edits.

Speaker 8

And importantly, that enables a clinician when he or she wants to prescribe the medication to choose their Zuvi first line. And we have 65% of all commercialized covered. That's 180,000,000 lives that are already under coverage with the majority of those being or most of those being plans that don't have onerous prior authorizations and step at it. So from a commercial perspective, we're in good shape. Also with Medicaid, we see that with respect to the Medicaid coverage that we've had that over the Q1 of the year, almost half of the Medicaid states, including several of the largest state have already reviews.

Speaker 8

And again, those don't come with onerous prior authorizations and step edits, effectively meaning that patients can get access to this medication, both equitably and affordably as we go forward. So what I would say to sort of round out my response is that ultimately if a physician hasn't prescribed XERZUVA yet, it's a matter of getting to that clinician with the education that's needed to ultimately to understand the efficacy and safety profile of the medication. Between what we're doing from a personal promotion perspective and now with increased and ongoing investment in non personal efforts in addition to what we're seeing from what's being communicated socially and online, we believe that we're going to be able to enact that change to help a clinician who may not have heard the message hear it and begin to prescribe XERZUVE.

Speaker 2

Yes, Brian, just to round that out, I'd say that just like in drug development, the biology of the launch is working, meaning patients are advocating, healthcare prescribers, particularly OBGYNs are prescribing and payers are paying as Chris highlighted. The rest of it is classic engineering of a launch. We need to get reach and frequency to educate. And as you very well know, changing healthcare provider practice behavior is the key to success and that's what we're in the midst of doing.

Speaker 13

Thanks, Barry. Thanks, Chris.

Speaker 2

Thanks, Brian.

Operator

Our next question is coming from George Farmer with Scotiabank. Your line is open.

Speaker 14

Hi, good morning. Congratulations on all the progress. I was wondering if you could comment on expanded geographies for Zuzuve and how that might be progressing and what other steps might be necessary? I think Biogen mentioned maybe another trial would be required. I was wondering if you could potentially comment on that.

Speaker 2

So George, you talked about when you say geographies, you're talking about ex U. S?

Speaker 3

Yes.

Speaker 2

Yes. So remind you that the relationship that we have, partnership with Biogen is we're fifty-fifty Coco in United States. You've heard over and over that's going incredibly well. And outside Japan, Korea and Taiwan where we have another partner, Biogen is responsible for the rest of the world. So it's really a Biogen question to answer.

Speaker 14

Okay. Thanks.

Speaker 2

Thanks, George.

Operator

Our next question is coming from Sumit Kulkarni with Canaccord. Your line is open.

Speaker 3

Good morning. Nice to see

Speaker 15

the progress on Zazove and thanks for taking my question, which is on dasenamdar. So other than some factors you mentioned before that might make read throughs to upcoming trial readouts challenging, is there anything specific that makes cognitive impairment in Huntington's and Alzheimer's different versus Parkinson's? I'm asking because there are most likely some nuances involved in specific areas of neuronal loss in these disease states and to see if there's a potential mechanistic basis for DASIN to target specific parts of the brain in different ways?

Speaker 2

Yes, Sumant. Well, thanks for the congratulations, Zuva, and great question on dalsinibre and a very important one. Let me ask Mike to start with sort of the biologic appreciation that started Huntington's in 24% cholesterol, maybe Laura can talk about why we think the results we see are not necessarily predictive of future results. Mike? Yes.

Speaker 11

Thanks, Barry. So, what I would say is that there are decades of research that have really implicated NMDA receptor hypofunction in a range of disorders associated with cognitive impairment. And further, there's increasing evidence specifically in of NMDA receptor loss or expression changes in disorders such as Huntington's disease, Parkinson's disease and Alzheimer's disease. That being said, while cognitive impairment is a common feature across these diseases, the underlying pathophysiology and the relative contribution of NMDA receptor dysfunction is likely to be distinct across these groups. And we really have different hypothesis that we're testing across the 3 studies that we're running.

Speaker 11

And so for this reason, we've always seen the studies in HD, Parkinson's disease and Alzheimer's disease as distinct and independent tests of the NMDA receptor hypofunction where we're really looking at different pathophysiological consequences there. So as Barry mentioned, in the context of Clington's disease, which is our lead indication, we're really focusing on the loss of the endogenous modulator 24S hydroxycholesterol as the rationale for why a molecule such as 1,000,000 Ender should work in treating these cognitive impairments. So that's sort of the scientific rationale across these disease. I'll let Laura comment a little bit more about this distinct symptomology and as we think about the disorders.

Speaker 4

Right. So these disorders obviously are all characterized by cognitive impairment, but they have accompanying symptoms that are quite different across. As we talked last week about Parkinson's disease, that's a disorder where you see the onset of cognitive impairment after motor symptoms appear in most cases. In Huntington's disease, the reverse is true. The onset of symptoms can be 10 or 15 years even before the onset of the motor symptoms.

Speaker 4

And so it's a very different progression. You're looking at a younger population. You're also looking at a much more homogeneous population based on the underlying etiology. And then you move over to Alzheimer's disease, a very different population again. In terms of the underlying pathophysiology, we have the amyloid plaques and the neurofibrillary tangles, which are driving the downstream pathology and NMDA receptor hyperfunction.

Speaker 4

But that is a very distinct driver compared to Huntington's and Parkinson's. So for all these reasons, as Mike said, these are really distinct disorders with differences in the symptomatology, differences in the study design, and we expect that each of these is an independent test of the hypothesis.

Speaker 2

Thanks. Thanks, Sumant.

Operator

Our next question is coming from Yatin Sanjay with Guggenheim. Your line is open.

Speaker 15

Thank you for taking my question and congrats on the nice launch. Question on 324 with regard to the kinetics 2 study. Could you maybe help us understand the difference between the endpoint between kinetics and kinetics 2, what you would like to show? And then how should we think about pivotal endpoint because I think there are other companies that are using ADL as an endpoint from for pivotal development. So, anything you can talk from the regulatory perspective on the endpoint side would be great.

Speaker 15

Thank you.

Speaker 2

Yes, Aitin and thank you for congratulatory note on the launch. Laura, you want to take the stage 3 24 question?

Speaker 4

Sure. So with regard to the original kinetics study and the kinetics 2 study that's currently ongoing, we actually use the same primary endpoint, which is the upper limb extremity score from the TETRIS performance scale. We use that measure because it's a sensitive measure to detect change. We are aware as you are that there has been regulatory feedback about using the ADL scale associated with the TETRIS. We are collecting all of that data in the ongoing KineticQ study and we will be poised with a lot of data to have discussions with regulators at the end of Phase 2 about which instrument would be the best for a Phase 3 endpoint.

Operator

Our next question is coming from Douglas Ho with H. C. Wainwright. Your line is open.

Speaker 13

Hi, good morning. Thanks for taking the questions and congrats on the progress. Just curious, what percentage of the overall sort of sales detail so far have been made by you versus Biogen? And I'm just curious in terms of how when you contemplate sort of scaling up the launch, how do you coordinate that and sort of determine or sort of the needed resources?

Speaker 2

Let me start and then Chris can follow-up. So I was actually with our field team a couple of weeks ago and I can tell you that whether you're Sage or Biogen, they're working incredibly well together as a well functioning machine. And the team is very well integrated or helping each other literally every day to do what's right, which is help moms get diagnosed and treated with XERZUVICA as quickly as possible. So it's a very well coordinated effort. Chris, you want to talk we've talked about this before.

Speaker 2

You want to just mention the kind of scaling aspect?

Speaker 8

Yes. I think in terms of the activity at a field level, it's fifty-fifty between the two organizations. We really work well and collaboratively around how we executed a field level with respect to reach and frequency. I think in terms of scaling, those are conversations that are ongoing. The teams talk about the future of this product on a daily basis.

Speaker 8

And it's everything from the strategy that we employ all the way through to the tactics and specifically how we're going to execute. And again, I think as Barry noted, that's an ongoing interaction between the 2 organizations that are committed to fundamentally changing the way PPD is thought about and treated for women that are suffering with the condition.

Speaker 13

Okay, great. Thank you.

Speaker 2

Thanks, guys.

Operator

Our next question is coming from Vikram Prahit with Morgan Stanley. Your line is open.

Speaker 16

Hi, thanks for taking my question. This is Morgan on for Vikram. So on reimbursement for XERZUVE, I know you had mentioned not guiding to gross to net just yet, but where would you expect steady state gross to net to potentially settle out? And how long do

Operator

you think it would take to reach this steady state? Thank you.

Speaker 2

Thanks for the question, Morgan. Kim, you want to take that?

Speaker 5

Yes. As we mentioned and as you just mentioned, we are not guiding to gross to debt today. But again, we've been talking about the fact that we don't anticipate this kind of discounting that you're seeing for recent branded antidepressants. And so and another thing is if you think about the key components of what we expect in our gross to net, they're the typical components. They're the rebates and discounts we'll see, the patient assistance programs, including financial assistance.

Speaker 5

So all the similar kinds of things you'll see, but we just don't anticipate the same type of discounting you see for the other recent antidepressants.

Operator

Thank you. And that 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.

Speaker 2

Thanks, Shelly. Thanks again to everyone for joining us this morning to review our results from the Q1 of 2024. Just to close it out, the full quarter of ZERZUVA launch has been completed and we remain highly encouraged with the progress and we're excited to help the many moms suffering with PPD. Of course, we were disappointed with the outcome of the precedent study, but as you heard from Mike and Laura, we remain on track to read out important data across our pipeline throughout the remainder of the year. We do not believe the precedent is necessarily predictive of future studies as you heard on the call.

Speaker 2

We're also well positioned financially to take us through key milestones and we remain focused on our mission to develop and launch life changing brain health medicine so every person can thrive. Thanks again everyone and have a great day. Bye.

Operator

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

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Key Takeaways

  • ZERZUVE’s launch is off to a strong start, generating $12.4 million in wholesale revenue (Sage’s share $6.2 million), with over 1,200 prescriptions written and 700 shipments delivered in Q1.
  • Payor engagement has been robust, with >65 % of commercial lives and nearly half of Medicaid states covering ZERZUVE for PPD, most without onerous prior authorizations or step edits.
  • The PRECEDENCE study in mild cognitive impairment related to Parkinson’s disease was negative, but Sage expects mid-2024 readouts from SURVEYOR (Huntington’s), Kinetic-2 (essential tremor), and late-2024 data from LIGHTWAVE (Alzheimer’s) and DIMENSION (Huntington’s).
  • Financially, Sage reported a Q1 net loss of $108.5 million and ended the quarter with $717 million in cash, cash equivalents and marketable securities, providing a runway into 2026 without further 2024 milestone payments.
  • Q1 R&D expenses of $71.7 million and SG&A of $52.6 million declined year-over-year following Q3 2023 restructuring, as Sage balances disciplined pipeline investment with plans to scale the PPD launch.
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Earnings Conference Call
Sage Therapeutics Q1 2024
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