Sage Therapeutics Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 11, 2025

There are 16 speakers on the call.

Operator

Good

Speaker 1

afternoon. Welcome to Sage Therapeutics Fourth Quarter and Full Year twenty twenty four 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 express written consent of Sage Therapeutics is strictly prohibited.

Speaker 1

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.

Speaker 2

Good afternoon and thank you for joining Sage Therapeutics' fourth quarter and full year twenty twenty four 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.

Speaker 3

I would like to point

Speaker 2

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. 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 fourth quarter and full year 2024. Our Chief Operating Officer, Chris Panekke, will provide an update on the ongoing commercialization of XERZUVAY and key financial results.

Speaker 2

Our Chief Medical Officer, Laura Gault, will then provide a brief update on our pipeline. In addition, Mike Quirk, our Chief Scientific Officer will be available for questions during the Q and A portion of the call. With that, I'll now turn the call over to Barry.

Speaker 4

Thanks, Ashley, and thank you everyone for joining us this afternoon. 2024 was an important year for Sage, underscored by the early commercial success of XERZUVE, the first and only oral treatment approved for adults with postpartum depression or PPD. We enter 2025 with a plan to build on XERZUVE's commercial momentum, a recalibrated R and D approach and a commitment to financial discipline as we focus on enhancing growth for our shareholders. As we outlined at the JPMorgan Conference in January, we're focused on executing against these three core priorities in 2025, which are intended to deliver short, medium and long term value creation for shareholders and serve unmet needs of patients and families. Our foremost priority is to continue efforts to establish SERGEUVA as a standard of care for PPD.

Speaker 4

The first year of launch exceeded expectations and we plan to invest in 2025 to fuel top line revenue growth. In 2024, we were pleased to see more than 6,600 shipments of XERZUVE to women with PPD, which we believe reflects the growing demand for a fast acting treatment for PPD and physician adoption across HCPs who treat PPD. There are two important dynamics we're starting to see as the launch progresses. A promotionally responsive market and a system wide paradigm shift. Specifically, we're seeing signs of XERZUVE changing practice patterns among OB GYNs and elevating a national dialogue around maternal mental health.

Speaker 4

These dynamics have the potential to accelerate growth and further drive urgency among HCPs in treating PPD. We believe these early successes validate our commercial strategy and provide greater evidence that XERZUVE is the key to unlocking blockbuster potential in PPD. Importantly, that means helping many women suffering from this urgent medical condition. In addition to building on the commercial momentum of XERZUVE, we're prioritizing our pipeline to focus on neuropsych and neurodevelopmental disorders. We believe our recalibrated R and D approach can create value over the long term.

Speaker 4

Laura will provide additional details on SAGE-three zero nine and SAGE-three twenty four as well as our NMDA receptor NAM platform. Lastly,

Speaker 5

we're committed to maintaining the strength of our financial position.

Speaker 4

With the commercial momentum of ZERZUVA PPD, our R and D approach and expected cash runway to mid-twenty twenty seven, we believe we are well positioned to focus on our goal of creating value for our shareholders. Now before I turn the call over to Chris, I want to briefly acknowledge Biogen's unsolicited non binding proposal to acquire Sage as well as

Speaker 5

our Board's decision to initiate a strategic alternatives process.

Speaker 4

As we stated in our press release last month, the Sage Board concluded that the proposal significantly undervalued Sage and is not in the best interest of shareholders.

Speaker 5

The Board also decided to initiate a strategic review

Speaker 4

to evaluate a broad range of opportunities to maximize value for shareholders. As a reminder, we've not set a timetable for the review process nor is there any assurance that the review process will result in any transaction or other strategic outcome. With this in mind, we will not be talking about this further on this call. I do appreciate your understanding. Now with that, we'll move forward and I'll now turn the call over to Chris.

Speaker 4

Chris?

Speaker 6

Thanks, Barry. As mentioned, we've made tremendous progress in the first full year of XERZUVAID's launch in PPD, and I'm excited to discuss our recent achievements and ongoing initiatives. Afterwards, I'll review our results for the fourth quarter and full year 2024. Starting with the launch of XERZUVAY, we are pleased to see consistent demand growth quarter over quarter with nearly 2,500 prescriptions shipped to women with PPD in Q4. This represents a 21% increase from the third quarter of twenty twenty four, even with far fewer days in the field engaging with customers due to the holiday season.

Speaker 6

Across the full year of 2024, more than 6,600 prescriptions of XERZUVE were shipped to women with PPD. We believe that we have continued to see strong demand growth in patient shipments because HCPs are becoming confident in the value proposition of XERZUVE and what it potentially delivers. In the fourth quarter, XERZUVE was prescribed across a breadth of HCPs who treat PPD, including OBGYNs, psychiatrists and PCPs. Almost 80% of those prescriptions came from OBGYNs who are the foundational focus of our launch strategy since they see women throughout their peripartum journey, the most critical time to screen, diagnose and treat. While OBGYNs are at the forefront, we believe that over time we will continue to see utilization of XERZUVE increase among all HCPs who treat women with this condition.

Speaker 6

More than seventy percent of XERZUVE patients are receiving XERZUVE as their first new treatment for PPD. Further, we saw strong trends among prescribers in 2024 with about sixty percent of targeted HCPs writing repeat prescriptions after prescribing XERZUVE. We also see that once an OBGYN has prescribed XERZUVE, there is a significant increase in the number of women with PPD they treat based on prescriptions for all medications. Our messages are resonating. XERZUVAY has a greater than 90% aided brand awareness among OBGYNs and psychiatrists.

Speaker 6

Before I turn to our plans for 2025, I'll provide an update on coverage. As of today, greater than ninety five percent of commercial and Medicaid lives are covered or have a path to coverage, with the majority having no step edits or complex prior authorizations. This remarkable level of coverage one year into launch reflects payer recognition of the value proposition of XERZUVE, which enables broad and equitable access for all women with PPD. To support the continued scaling of XERZUVE, we plan to move forward with a robust investment plan, which includes a joint sales force expansion to cover a wider reach of healthcare providers, investment in media opportunities intended to further amplify the message that PPD is an urgent medical condition and greater visibility via social media designed to increase awareness and educational efforts. We are also planning to expand XERZUVE DTC, including the potential for targeted branded TV media later this year.

Speaker 6

Today's technology allows us to meet women with PPD in their most trusted channels, empowering them to speak to their physician about their PPD symptoms and appropriate treatment options. In terms of personal promotion, we are already seeing an early impact from the sales force expansion. In the territories where we expanded our sales force in the fourth quarter, we saw a 33% growth rate in patient shipments. We believe these efforts are important as we are seeing PPD to be a promotionally responsive market with significant growth potential. We have made remarkable progress in 2024 and are continuing to think big about the commercialization of XERZUVEY as a treatment for women with PPD.

Speaker 6

We look forward to sharing additional updates in the coming quarters. Now turning to our financial results for the fourth quarter and full year of 2024. As a reminder, our full financial results for these periods are detailed in our press release issued this afternoon. We reported collaboration revenue from the sales of XERZUVE of $11,400,000 in the fourth quarter, a 4% increase compared to the third quarter of twenty twenty four and $36,100,000 for the full year. As a reminder, our reported collaboration revenue is 50% of the net revenues Biogen reports for XERSUVY.

Speaker 6

It is important to note that while revenue may fluctuate based on inventory dynamics, we continue to see strong quarter over quarter demand growth in patient shipments and expect this growth to continue. R and D expenses were $37,000,000 and SG and A expenses were $54,000,000 in the fourth quarter of twenty twenty four. Additionally, there were one time restructuring expenses of $22,500,000 in the fourth quarter of twenty twenty four. While XERZUVE joint commercialization investment will increase in 2025, we anticipate overall operating expenses will substantially decrease in 2025 relative to 2024. This reflects reductions in R and D and G and A from our pipeline prioritization and the cost savings from the October 2024 reorganization.

Speaker 6

The first full quarter of savings are expected to be realized in Q1 of twenty twenty five. Our net loss for the fourth quarter of twenty twenty four was $95,800,000 Based upon our current operating plan, we anticipate that our existing cash, cash equivalents and marketable securities of $5.00 $4,000,000 as of 12/31/2024, 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. Now with that, I'll turn the call over to Laura. Laura?

Speaker 7

Thanks, Chris. As Barry mentioned earlier, we remain focused on developing medicines for neuropsychiatry and neurodevelopmental disorders, where there is a strong scientific rationale and opportunities to address meaningful unmet needs. I'll begin with SAGE-three nineteen, our wholly owned extrasynaptic preferring GABA A receptor positive allosteric modulator or PAM, which is designed to have novel pharmacology and a differentiated profile from other GABA PAMs in our portfolio. SAGE-three nineteen is currently being investigated as a potential treatment for behavioral symptoms associated with certain neurodevelopmental disorders, including autism spectrum disorder, Tourette's syndrome and other rare neurological disorders. These disorders place a high burden on patients, families and the healthcare system.

Speaker 7

We are currently conducting a Phase one multiple ascending dose or MAD study to help us better understand the safety, tolerability and target engagement of SAGE-three nineteen across a range of doses. We expect to share data from the Phase one 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 provide a drug with similar or better efficacy than NMDA receptor blockers like ketamine, but with a potentially improved safety and tolerability profile. In addition, we continue to explore potential partnerships and out licensing opportunities for some clinical and preclinical stage compounds.

Speaker 7

Lastly, as we have previously noted, we are also exploring SAGE-three twenty four for potential indications, including seizures and developmental and epileptic encephalopathies or DEEs. We expect to provide an update on next steps, if any, in mid-twenty twenty five. To be clear, we are not spending to further develop SAGE-three twenty four now, but rather we are evaluating SAGE-three twenty four as part of an overall portfolio decision. With that, I will turn it over to Ashley to help facilitate the Q and A portion of today's conference call.

Speaker 2

Thanks, Laura. As a reminder, we will not be answering questions related to our Board's decision to reject Biogen's unsolicited acquisition proposal or to initiate a review of strategic alternatives and ask that questions be focused on our Q4 and full year 2024 results. Please limit yourself to one question. If you have additional questions, feel free to return to the queue. Now, I'll turn the call over to the operator to handle Q and A.

Speaker 2

Operator?

Speaker 1

We'll take our first question from Ritu Baral with TD Cowen.

Speaker 3

Hi guys. Thanks for taking the question. Barry, I wanted to ask about Biogen buy in to the expansion of the marketing opportunity or the marketing effort. You mentioned that the sales force expansion is underway. It's in certain geographies.

Speaker 3

Can you elaborate on that specifically? Has Biogen matched the personnel expansion that Sage has implemented or sort of the number and depth of the programs that Sage has put into place?

Speaker 4

Thanks for the question, Ritu. Appreciate it. So based upon the performance we saw in 2024, and as Chris mentioned on the call, the success we saw in our sales force expansion, we entered 2025 with an aligned integrated commercialization plan. That includes not just the increase of sales force to a new level, but also appropriate investment behind all the other aspects of our commercialization effort, namely medical affairs, disease state awareness, DTC, including continued progress on the coverage side, which is outstanding, but we want to continue to make better. So we're highly aligned and excited for a very successful 2025, helping as many moms as we can this year.

Speaker 3

Could we get a little more color on what the expanded efforts are?

Speaker 4

Let me ask Chris, if you can provide some color.

Speaker 6

Yes. So beyond the point about sales force expansion, social media and a social media influencer campaign through TikTok and Instagram, as well as Facebook are an important part of the social media effort designed to reach not only those that are living with PPD, but also HCPs who are treating many of these women with PPD. As Barry noted, connected TV and DTC is an important part of how we think about another way to reach those that are living with PPD that are out in the community, as well as peer to peer education, digital efforts more broadly. And I would round that out by saying that we have seen an interesting dynamic that we talked about in our prepared remarks, where this is not only about the work that we do to make sure that physicians and women with BPD are aware of XERZUVE, disease state awareness also plays an important role here in the importance of screening and diagnosis in all of this. So again, that's a key component to our initiatives in 2025 as we think about reaching as many women with PPD as possible.

Speaker 3

Great. Thanks.

Speaker 1

We'll move to our next question from Salveen Richter with Goldman Sachs.

Operator

Hi. Thank you for taking my question. This is Shunathra on for Salveen. Could you please elaborate on the inventory dynamics for the quarter, noting the slight disconnect between the prescription growth and the sales growth? And also could you speak to the proportion of free drugs being provided in 4Q?

Speaker 4

Yes, Srinath. So we're we as I just talked about, really happy with what we're seeing across the board in terms of 2024 performance. And that is we're seeing OB GYN step up to own the disease, ACOG guidelines being in line. We're seeing a promotional responsive market and we're seeing accelerants in terms of system wide change. Media continues to cover, XERZUVE and PPD at an extraordinary high level.

Speaker 4

So all the dynamics that set up XERZUVA entering blockbuster potential are there. We also were happy that we saw an over 20% growth in demand quarter on quarter. And I'll ask Chris to talk about sort of the inventory dynamic. But just to be clear, by demand, demand is when a specialty pharma after script is entered ships that prescription to moms. That's a true measure of future revenue because that's a leading indicator.

Speaker 4

But Chris, you want to talk about kind of inventory demand in the supply chain?

Speaker 6

Revenue is measured when product moves from our alliance partner into the channel at the wholesaler level. Now when it comes to inventory management, there's inventory that sits at the specialty pharmacies and inventory that sits at the wholesalers. And what we saw over the fourth quarter is that based on channel dynamics, inventory can fluctuate through both what we've seen at specialty pharmacies as well as wholesalers. So it's Barry noted. When it comes to truly measuring performance, really looking at demand quarter over quarter is the most important metric that we can look at as we go forward.

Speaker 6

Now with respect to the question about free drug, we said that broad and equitable access is paramount for this launch and we've really worked to ensure that broad and equitable access. Free drug plays a role. Free drug helps those that are not insured or underinsured have access to XERZUVE, moms with PPD who need this. And what we saw over the course of the fourth quarter is a reduction in the percentage of free drug from what we saw in Q3. And we would anticipate that based on additional coverage that we would see with respect to commercial and Medicaid plans that that percentage would decrease over time.

Speaker 6

Again, very encouraging when it comes back to ensuring that all women with BPD have access to very important

Speaker 8

medication. Thanks for the question.

Speaker 1

We'll take our next question from Anupam Rada with JPMorgan.

Speaker 9

Hey guys, thanks so much for taking the question.

Speaker 6

Just thinking a little bit more acutely about the first quarter, given historical sort of quarterly seasonality in 1Q in the industry due to payer dynamics, How are you thinking about this relative to how we should be thinking about XERSUVA potential headwinds in the first quarter? Thanks so much.

Speaker 4

Yes, Anupam, thanks for the question. I'll start and see if Chris wants to add color. So we anticipate continued quarter on quarter growth, including the first quarter. And keep in mind that our reimbursement is commercial and Medicaid reimbursement. So we don't see a classic kind of Medicare donut hole first quarter issue.

Speaker 4

We should see continued growth on all dimensions in the first quarter. Chris, anything to add?

Speaker 6

What I would add is that we know that this is a promotionally responsive market from what we saw over the course of the first full year and what we saw when we increased the sales force during the fourth quarter of twenty twenty four. There were fewer selling days during

Speaker 4

the month

Speaker 6

of December and it's part of November as well due to the holiday season. We don't anticipate that kind of disruption based on holidays during the first quarter. So we're excited about what we have in front of us with respect to our ability to continue the successors of XUVAY in Q1.

Speaker 9

Thanks so much for taking the question guys.

Speaker 4

Thanks Anupam.

Speaker 1

We'll take our next question from Vikram Purit with Morgan Stanley.

Speaker 10

Hi, thanks for taking our question. I wanted to dig a little bit deeper on the sales force expansion and also this is Morgan on the phone for Vikram. So for this recent sales force expansion, how significant of a sales bump are you anticipating over time and how quickly does the addition of reps to the field result in incrementally higher revenues? And then additionally, how many reps were added through the last round of expansion and how large is the field force currently sitting? Thank you.

Speaker 4

Yes, Morgan, thanks for stepping in for Vikram. So I can give you some color on what you're asking, but we're not giving guidance or specifics. So as Chris noted, we increased our sales force in the fourth quarter. So we had them in place for the entire fourth quarter. And in those territories we expanded, we saw 33% increase.

Speaker 4

So we can't give go forward guidance, but that's what we saw in the fourth quarter. We're very confident that the combined sales force extension will continue to be an accelerant to our launch and we'll see quarter to quarter demand and revenue growth going forward.

Speaker 1

We'll move to our next question from David Amsellem with Piper Sandler.

Speaker 7

Hi, yes. This is Alex on for David. I have one question for you. On the back of the corporate restructure last quarter and the extended cash runway, do you think you're at all constrained in terms of how much commercial support you can put behind ZERZUVE, particularly relative to the support that Biogen provides for the asset? Thank you.

Speaker 4

Yes, Alex, I don't think we're constrained at all. And as we've talked about from the beginning of XERZUVE launch, we thought really big about the opportunity with PPD. Again, we believe that XERZUVE has blockbuster potential. Epidemiologically, there's about zero point five million women a year that have symptoms of PPD, less than half of those are diagnosed and even less are treated. So the opportunity here is significant.

Speaker 4

We're thinking big about the opportunity. We continue to focus and scale with success. We've scaled with success based upon twenty twenty four volts into twenty twenty five. And we can continue to do so where we believe that a dollar spent will result in immediate improvement in demand and revenue. So we don't feel we're constrained at all.

Speaker 1

Our next question comes from Paul Matteis with Stifel.

Speaker 11

Hey, thanks for taking my question. On the pipeline, Barry, can you just talk a little bit more about how you selected these indications? And I guess taking a step back, neurodevelopmental disorders is an extremely challenging area for drug development. I mean, you probably pick one of the hardest. DEs, those are the toughest to treat, epilepsies.

Speaker 11

Why are these the best uses for capital for Sage going forward over other alternatives? Thanks.

Speaker 4

Paul, I'll start and I'll ask Lorette to jump in. So as we've talked about, we took a hard look at really the last decade of development of Sage and decided to focus on neurodevelopment neuropsych with molecules that have pharmacologic properties that expresses the learnings we have. And I'll let Laura talk about those a little bit more. So we think we've got the right molecules going forward and the right kind of match to pharmacology of these diseases. But Laura, you want to talk more about that?

Speaker 7

Sure. As we thought about the pharmacology of the molecules in our pipeline, we realized that they would be a good fit for disorders like neurodevelopmental disorders or NDDs and for the DEEs. For the DEEs in particular, we have a lot of preclinical data looking at gabapams in animal models of seizure disorder. And we've seen efficacy across a number of gabapams including SAGE-three twenty four. We also know that another gabapam, gonaxalone has demonstrated efficacy in one of the DEs.

Speaker 7

So there's a strong evidence base there that suggests that we could be successful moving SAGE-three twenty four for an indication like that. With regard to the neurodevelopmental disorders, one of the reasons that drug development in the space has been so challenging is that people are trying to treat the core symptoms of the disorder like autism, they're trying to treat the communication difficulties. The approach that we're taking is different. We're really looking to address the behavioral symptoms associated with these disorders. And we believe based on the biology of gabapams and how they work that we are likely to have improvements in anxiety and sleep, in sensory hypersensitivity and in irritability.

Speaker 7

And so we believe strongly that moving SAGE-three 19 forward for an NDD such as autism is warranted based on the data that we have.

Speaker 4

Yes. I'd add that and we'll share more in the quarters to come, but we're also taking a capital allocation approach where we can get answers relatively quickly versus the way that Sage developed for the last decade. And Paul, you and I talked about this in January. The NMDA NAMs are incredibly well validated target relative to the PAMs. We took a big swing and didn't see the results we wanted.

Speaker 11

Right. And Barry, when do you think you could get POC for each of these?

Speaker 4

We'll share more in the future. So for SAGE-three nineteen, we'll have results from a multiple sending dose later this year. We said late this year. What that will tell us is do we have an efficacy profile that looks good, but differentiated from the balanced PAMs? And more importantly or as importantly, do we see a product therapeutic index?

Speaker 4

In other words, less CNS depressed CNS effects. So we'll have that at the end of the year.

Speaker 11

Okay. Thank you. Thanks, Paul.

Speaker 1

We'll take our next question from Tazeena Mott with Bank of America. Hi, thanks for taking my question. Sorry if you already addressed it in your prepared remarks, but can you just talk a little bit about the dynamics of inventory? What have they been and how should we be thinking about incorporating that into

Speaker 12

our estimates for 2025?

Speaker 1

Thanks. I think estimates for 2025? Thanks.

Speaker 4

Yes, Tazeen, we did, but let me start and I'll hand it over to Chris. So we believe the most important metric to look at is shipments. That's a true measure of demand. That is when XERZUVE exits the specialty pharma and gets into the hands of moms specifically directly to their home. And the fact that we saw over 20% growth quarter to quarter with far less days educating healthcare providers in the field is a very strong sign.

Speaker 4

The revenue is more of a function of inventory management. Chris, do you want to highlight through where that supply chain? Yes. I mean,

Speaker 6

inventory is managed as Barry noted at the specialty pharmacy level and at the wholesaler level. And I think what we see is that at both of those points, you have organizations trying to manage inventory based on what's happened in the past and their expectation for the future. And there's variability in how they think about assessing channel dynamics in order to make those decisions. So as you noted, there's fluctuations in how they see inventory and it's most important instead of looking at inventory and the implications that it has on revenue to really focus in on demand, which is the truest way of assessing the demand for this product, the interest in this product on behalf of physicians and the women that they're trying to treat.

Speaker 4

Right. And we said this before, but just for clarity, revenue is a shipment to the wholesaler and that's when revenue is recorded. It's then pulled through specialty farm and then again shipped to mom's house. So that whole supply chain, the inventory dynamic fluctuates there.

Speaker 1

We'll take our next question from Ami Fadia with Needham.

Operator

Hi, good evening. Thanks for taking my question. Just with regards to the additional investments that you highlighted, whether it's through DTC and some of the other sort of media and educational efforts, can you try and quantify by how much you're increasing that? And with regards to the sales force expansion, is that additional expansion anticipated later this year? And at this point in terms of investments from Sage and Biogen, is it sort of about equal or if you could sort of share any details on Biogen's role in that, that will be helpful?

Operator

Thank you.

Speaker 4

Thanks, Ami. I'll start and I'll ask Chris to comment. And again, we can give more color than detailed specifics because we're not giving guidance. What I said is based on the success of 2024, we've entered 2025 with an aligned commercialization plan, which is a fiftyfifty COCO plan. So for every dollar spent, we're each spending $0.5 We're both expanding sales force and we're both expanding efforts across all the other dimensions that I highlighted.

Speaker 4

Chris, any other color to add?

Speaker 6

What I would add is the sales force expansion and the investment in non personal promotion, we're amidst that. So we're investing in the sales force expansion now and investing in, as I mentioned earlier, things like social media and the influencer campaign and getting ready to kick off DTC, particularly through channels like Connected TV, where we can be very precise around our ability to reach certain populations that are actually suffering with PPD using DTC, as well as disease state awareness to really not only highlight the importance of a medication like Sysuvate, but the importance of screening and diagnosis and when you have symptoms presenting those symptoms to your clinician, whether it's an OBGYN, a psychiatrist or a PCP. So all of those things are coming together right now and we believe will have impact as as we continue to build those out.

Speaker 1

We'll move to our next question from Brian Abrahams with RBC Capital Markets.

Speaker 13

Hi, this is Kevin on for Brian. Thanks for taking our question. Can you maybe talk a little bit about whether there's certain characteristics for OBGYNs that currently are not prescribing XERZUVA? Does it mostly come down to awareness or is there some other factor at play, maybe geographical location? Thank you very much.

Speaker 4

Yes, Kevin, let me ask Chris to comment on that.

Speaker 6

Yes. So I think as Barry noted, eighty percent or nearly eighty percent of our prescribers are OBGYNs who are on the forefront of care. These are the clinicians who see women throughout their peripartum journey and who have the best lens on what it is that they need when they express the signs and symptoms of PPD. What we see is that when we have an opportunity to engage in OB GYN with the safety and the efficacy profile of XERZUVE and they have the opportunity to try the medication that they respond very positively to that experience with more than sixty percent of those OBGYNs becoming multiple prescribers of the medication. So what I think it comes down to is just our ability to really increase our reach and to increase our frequency in order to deliver what is very compelling messaging from a product that is performing in the real world setting, much like it did in Robin and Skylark, our Phase III pivotal clinical studies.

Speaker 6

So very excited about the opportunity, as I noted about increasing the size of the sales force and the investment in non personal ultimately to get to the broader audience of clinicians that we can reach.

Speaker 4

Yes. Kevin, once an OB GYN office has been educated and uses XERZUVA, we're seeing a significant amount of rewriting and a significant amount of more over 300% actually more PPD in that practice area. So, we're excited as 2025 unfolds and we see the sales force expansion having an impact.

Speaker 1

Our next question comes from Laura Chico with Wedbush Securities.

Speaker 11

Hello. This is Dylan on for Laura Chico. Thanks very much for taking our question. Just one on PPD. Would you anticipate any near term revisions to treatment guidelines in the PPD setting from perhaps ACOG or AAP?

Speaker 11

I'm wondering how this might accelerate or impacts commercial uptake?

Speaker 4

Yes, Dylan, I'll start. ACOG, we've got phenomenal guidelines. Before Zuzuva was approved, there was ACOG guidelines that instructed OB GONs in their office screen diagnosing tree with pretty easy to use tools that don't require special training. And XERZUVAY as the drug to specifically mentioned in guidelines. So I've launched a lot of drugs in my day.

Speaker 4

It doesn't get any better than having your drug mentioned in guidelines before you launch. And ACOG has been a great partner. In terms of other congresses, we continue to work with others to update guidelines. The fact that ACOG did it so quickly is really helpful because as we've already talked about our prime audience here because they're at the beginning of the patient journey or OB GYNs.

Speaker 6

Yes. Barry, what I would add, I think as you noted, the ACOG guidelines were in place in and around the time of our approval and launch. There were a number of tailwinds, the ACOG guidelines being one of those tailwinds, the media behind us, the care ecosystem and how they really have enabled broad and equitable access to this medication. So a lot of things really supporting this launch out of the gate that really augment what we've been able to take advantage of with the ACOG guidelines.

Speaker 1

We'll take our next question from Douglas Tsao with H. C. Wainwright.

Speaker 9

Hi, Justin. Thanks for taking the questions. Just curious, you've obviously had a lot of success getting the over year ones to prescribe. Are you surprised that you haven't had more penetration with types? Thank you.

Speaker 4

Yes, Doug. Thanks for the question. So we're actually we're not surprised by the dynamic we're seeing at all. As we talked about, strategically in any drug launch, you want to focus on the front end of the patient journey. In this case, that front end is OB GYNs.

Speaker 4

Now and we're seeing tremendous penetration there and a tremendous uptake in OB GYNs. As we said, once an OBGYN is educated about XERZUVA and uses XERZUVA, we're seeing significantly more rewriting and coverage of this disease in their practice. So that's what we want to see. Now as Chris highlighted, of course, there are other healthcare providers that we want educated on PPD and XERZUVE, SYKES primary care because not every OB GYN picks up every mom and not every woman develops symptoms in the course of being seen by their OB GYN. It could happen two or three months after giving birth.

Speaker 4

So we are seeing the kind of dynamic exactly as we expected. And as we continue to expand use, OB GYNs will remain the front end of coverage here in care.

Speaker 9

Okay, great. And just as a follow-up, the question I've gotten from investors in terms of $3.19 and the fat and mad debt that you'll have this year. I'm just curious, I think it'd be helpful to provide some additional perspective on beyond just the exposure, but what types of information you'll get from that study that will give people confidence that you have an active drug. I mean, obviously, you won't have clinical data in terms of patients, but just in terms of what you'll see that should give people increased confidence that this will ultimately have success with the clinic? Thank you.

Speaker 4

Yes. Good point, Doug. Laura, I want to talk about the kind of EEG signal we'll have and then the safety database, which is both of which will be very helpful in instructing the path forward.

Speaker 7

So as we mentioned, we're conducting a Phase one program includes a SAD study and a MAD study, very conventional. The primary endpoints, of course, are safety and tolerability. But we know from preclinical data using extraceonopic preferring molecules that there's a different EEG signature that you can see in animals. And that different EEG signature represents a different type of engagement of brain circuitry. We are able to look in the clinic using EEG to look for that same signature.

Speaker 7

And so when we come to the end of these studies, we'll be able to say whether that differential signal that reflects different activation of brain circuitry that we see pre clinically also happens in patients.

Speaker 4

Thanks Doug.

Speaker 1

We'll take our next question from Oye Iyer with Mizuho.

Speaker 14

Hey guys, thanks for taking our question. Just breaking away a bit from the other questions. Just wondering what maybe could you help us understand a little bit what's going on with the agreement with your collaborator in Japan, Shionochi. Are you expecting any milestones or anything to that effect? I think they are expecting or there could be a decision on their MDD application sometimes in September.

Speaker 14

Thanks.

Speaker 4

Yes, absolutely. Thanks for going there. So I'll comment and then Chris can talk about milestones. So what our Japanese friends have shared is that they expect a decision on MDD from Japanese FDA later this year. And it's an MDD indication, which in Japan also includes women that have given birth.

Speaker 4

So it's folded under there as well. Chris, you want to talk about the milestones?

Speaker 6

Yes, sure, Barry. If approved, we're entitled to receive regulatory and commercial milestones from Shinogi. Regulatory milestones amount to a total of approximately $55,000,000 of which a portion would be achieved upon MDD approval. Now there are additional commercially related milestones, including upon first commercial sale. Currently no milestones have been assumed in our cash runway expectations into 2027.

Speaker 4

Yes. So if they're successful in getting approval and we get the milestones and royalties that's upside to our cash runway.

Speaker 14

Could you maybe just speak a little bit about the potential opportunity in Japan?

Speaker 9

It's for both reasons.

Speaker 4

I think what I can say is the way Japan works and you need to talk to them about it is if they get the KOLs behind them, they should have a pretty interesting commercial uptake. But we have to talk to them directly about what their expectations are.

Speaker 14

Okay. Thank you.

Speaker 4

Thank you.

Speaker 1

We'll take our next question from Joel Beatty with Baird.

Speaker 11

Hi. Thanks for taking the question. Can you give a sense of how sensitive the market is to marketing to physicians versus raising awareness among inpatients? And are scripts tending to come for patients who are already aware of XERZUVA and asking about it or more about patients who may not have heard of it before?

Speaker 4

Yes, Joel, I'll ask Chris to comment.

Speaker 6

So as I've already said, this is a promotionally responsive market. We see that whether it is the sales force or it is non personal promotion and the various different tactics that we talked about that really there is an impact of those. In terms of is it coming from physician behavior? Is it coming from directly engaging with patients either through DTP or DTC? The sense that we have is it's coming from really a balance of both of those things that this is a market in which as Barry noted, we have an activated group of healthcare professionals, OBGYNs, who are really willing recipients of this message and then are subsequently not only treating, but screening and diagnosing at a higher level.

Speaker 6

We also know that this is a market where patients are activated with the information that we provide and they're engaging their healthcare professionals in informed discussions that enable those clinicians to provide them with perspective on not only the importance of treating PPD, but using a medication like XERZUVE. So we believe that what we're doing right now is not only launching XERZUVE, but we're building an opportunity, expanding opportunity through increased screening and diagnosis through education and disease state awareness.

Speaker 8

Thank you.

Speaker 1

We'll move to our next question from Sumant Kulkarni with Canaccord.

Speaker 15

Good afternoon. Thanks for taking our question. Given what we know about the size of the PPD market in terms of patient and prescriber numbers, do you believe this collaboration is required to get commercialization right on XERZUVA? And how would you characterize the sales force's level of focus with all the stuff that's going on in the background?

Speaker 4

Yes. So the collaboration exists. So that's how we're operating. And I can tell you that on a day to day basis, the sales force and both commercialization teams are laser focused in helping as many moms in 2025 as possible. There are no distractions.

Speaker 4

Thanks.

Speaker 8

Thanks, Simone. Our next

Speaker 9

question comes from

Speaker 1

June Lee with Truist

Speaker 8

Securities. Thanks for taking our

Speaker 6

questions. What proportion of the patients who get DIRZUVE are getting it as their first line therapy? And for those who are diagnosed with PPD, but getting some form of pharmacotherapy other than TIRZUVAY, what are some of the challenges there? Is this an issue of access or something else like perception as a novel drug with relatively less safety data? Thank you.

Speaker 4

Yes, June, thanks. Chris, you want to start and then I'll loop back to fill

Speaker 6

in some other color. Yes. So what we've said is that with respect to all of the work that we've done with not only payers, but also with physicians, we want to ensure broad and equitable access. And in doing so, this has enabled physicians to use this medication, XERZUVE, as a first line treatment. What we've communicated in our prepared remarks is now that more than seventy percent of those that are receiving the medication through the targeted HCPs that we're calling on, they're able to get this medication as a first line medication, which is really incredible when you think about it to have that degree of first line use right out of the gate.

Speaker 6

So to me, I think that's something really to reflect on not only the work that we did with we've done with physicians, but also with payers. Now in terms of other patients who may not getting this in the first line, there are patients who come through who have a prior history on other antidepressants because perhaps they've been diagnosed with a condition by a clinician in the past. So those that aren't getting it in the first line position aren't getting it because they're being excluded from getting it. They typically come forward on another medication and that's the rationale

Speaker 4

for it. Yes. And as you said, June, in any novel drug launch, you have to overcome historical bias. Someone was used to using something one way, they've got to understand XERSUVY and how to use it. We're certainly seeing as we highlighted tremendous insurance coverage and very little, if any, out of pocket expenses.

Speaker 4

So it really is about historical bias more than anything else to continue to move to frontline. And just to emphasize, as Chris said, for those that we're targeting, I mean, we've educated, we've engaged, we're seeing significant frontline use for XERZUVAX.

Speaker 8

Thank you.

Speaker 1

We'll take our last question from Mark Goodman with Leerink Partners.

Speaker 12

Hi, this is Basa on for Mark. Thank you for taking our question. Can you provide some color on the growth to net in the quarter, given that there was higher greater demand, but the revenue kind of seemed to be flattish if you compare the fourth quarter to the third quarter? And also we have another question about, can you tell us now after one year from the launch, if any of the treated patient needed to receive more than one treatment course? If so, can you provide some color on the proportion of these patients and whether there has been any payer pushback?

Speaker 12

Thank you.

Speaker 4

Yes, Vasil, let me take that kind of in reverse order. So what we've seen and what we're hearing reported back is that the performance of ZERZUVE in the real world is good or better than we saw in our clinical trials. So it's a rapid and durable response. We're not picking up much, if any, kind of retreatment at all. We're seeing that the fourteen day course works rapidly and is helping moms and that response is maintained.

Speaker 4

In terms of the dynamic, we've talked about this a couple of times. The over 20% demand growth is encouraging in the fourth quarter. The revenue growth was really a matter of sort of channel management inventory, not really a matter of gross to net.

Speaker 12

I see.

Speaker 4

But again, we're excited by thank you. We're excited by the start to 2025 and where the launch is going.

Speaker 1

Thank you. 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 4

Thanks, Taryn, and thanks everyone for joining us on this afternoon to review our results from the fourth quarter and full year 2024. As we look ahead to the ongoing commercialization of XERZUVE and PPD and advancements in our focused pipeline, I'm confident we're making important progress for patients. We move forward with investments intended to power ongoing commercial success and create value for shareholders. Thanks everyone. Have a great evening.

Speaker 1

This concludes today's call. Thank you again for your participation. You may now disconnect and have a great day.

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Earnings Conference Call
Sage Therapeutics Q4 2024
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