Sage Therapeutics Inc (SAGE) Q2 2021 Earnings Call Transcript

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Sage Therapeutics Inc (SAGE 3.70%)
Q2 2021 Earnings Call
Aug 3, 2021, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good morning. Welcome to Sage Therapeutics Second Quarter 2021 Financial Results Conference Call. [Operator Instructions]. This call is being webcast live on the Investors and Media section of Sage's website at sagerx.com. This call is the property of Sage Therapeutics and recording, reproduction, or transmission of this call without the expressed written consent of Sage Therapeutics is strictly prohibited. Please note that this call is being recorded.

I would now like to introduce Jeff Boyle, Vice President, Investor Relations at Sage.

Jeff Boyle -- Investor Relations

Good morning and thank you for joining Sage Therapeutics Second Quarter 2021 Financial Results Conference Call. Before we begin, I encourage everyone to go to the Investor and Media section of our website at stagerx.com where you can find the press release related to today's call as well as the slides that contain supplemental details. I would like to point out that we will 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 consult the risk factors discussed in today's press release and in our SEC filings for additional details.

We will begin the call with Barry Greene, our Chief Executive Officer who will provide an overview of accomplishments during the quarter and some general context. Barry will be joined by Steve Kanes, our Chief Medical Officer, who will review recent clinical progress and Kimi Iguchi, our Chief Financial Officer, who will review second quarter financials and discuss financial guidance.

So with that, I'll turn the call over to Barry, Barry?

Barry Greene -- President, Chief Executive Officer & Director

Thanks, Jeff, and thank you everyone for joining us this morning. we've made tremendous progress over the first half of the year on our mission to become the leader in brain health as a top tier biopharmaceutical company by transforming the lives of patients with debilitating disorders of the brain. And with 4 positive data readouts in the first half of the year and multiple potential catalysts pending in the coming months, we are demonstrating the Sage methodology is working while executing across all three of our franchise, depression, neuropsych and neurology. Innovation drug development requires a flexible and thoughtful approach with the intention to provide the best patient impact and experience. Sage has been innovating since day one with the goal of delivering medicines that matter so people can get better sooner and stay better longer.

I'll start the call by reviewing the progress made this quarter and our approach to supporting the millions of patients worldwide with brain health disorders, who are need of innovative medicines. I'll then turn the call over to Steve to review the clinical implications and potential importance to patients from our recent data readouts in more detail. Kimi will then provide an update on our financial progress during the quarter.

In June we announced positive top line data from the Phase III WATERFALL study of zuranolone in patients with major depressive disorders for MDD. The study met its primary endpoint demonstrating a statistically significant and clinically meaningful reduction in depressive symptoms as measured by HAM-D 17 compared to placebo after the standard 2-week treatment regimen and as we've seen in all studies was Zuranolone in addition to day 15, a significant reduction HAM-D scores began at the first measurement during treatment. That's in this case day 3, and I'll remind you that, after only two doses. Reductions were also seen at day 8 and day 12. Perhaps just as importantly we saw clear maintenance of effect through day 42, four weeks after treatment was stopped. These data further support our belief in the potential for a differentiated benefit risk profile for zuranolone as demonstrated in the clinical development program to date, and as we believe the millions of people suffering depression deserve a treatment option with a rapid and sustained reduction in MDD symptoms.

Thinking about results from WATERFALL in the context of the entire landscape and development program, zuranolone has shown a remarkably consistent and differentiated profile. To date, three or four late stage pivotal studies with zuranolone have been positive with HAM-D reductions from baseline after two weeks of oral treatment ranging from around 12 to 18 points. These results in the context of the overall benefit-risk for an oral medication are unlike anything currently available or in development, and these data give us tremendous confidence in our belief of the regulatory path forward.

Notably, in addition to our announcement of the top data from the WATERFALL study results from zuranolone with the positive Phase III Robin study and PPD were recently published in JAMA Psychiatry. It's a striking paper that I suggest you read. With WATERFALL data and the totality of the landscape in this program to date we and Biogen are planning to discuss the potential NDA package and timing with the FDA. As we've said, we believe we have the efficacy data in hand to file the first NDA for zuranolone and our goal is to provide an update later this year including an update on potential timing of an NDA file if our discussions with the FDA to align with our expectations.

In addition to the ongoing clinical studies, we're also currently running clinical pharmacology studies at the 50 mg dose needed for an NDA. At this time, after discussions with the agency we do not believe the REDWOOD and studies, which were suspended in early 2020 need to be completed for an anticipated NDA filing package. As you may recall, REDWOOD was designed study fixed schedule intermittent dosing of zuranolone throughout the course of the year. We believe, data from the SHORELINE study address this question. Rainforest was designed to investigate the efficacy, safety of zuranolone in co-morbid MDD and insomnia where zuranolone has consistently improved sleep across clinical studies as measured by sleep component of the HAM-D scale, we do not believe Rainforest is required for initial filing.

Real innovation has been absent treatments for depression for decades. There been more than 35 treatments approved over the last 30 years with the benefit-risk profile and approach to treatment have been largely unchanged in rates of depression continue to rise steeply. Despite the available treatments, there are still more than 90 million adults who experienced at least one major depressive episode each year in the US alone and cases are increasing every year. Additionally, there has been as high as a four-fold increase in depressive symptoms during the COVID-19 pandemic. We firmly believe zuranolone has the potential to offer a unique and compelling profile, if approved, with clinical data to date showing clinically meaningful reductions in depressive symptoms with consistent improvements in mood, anxiety and sleep.

Rapid-onset, a 2-week treatment regimens that offers the potential to treat as needed with maintenance of response after treatment completed and a well-tolerated safety profile with no evidence of weight gain, sexual dysfunction,euphoria, GI upset or sleep disruption, symptoms that are typically the cause of treatment discontinuation with standard of care antidepressant drugs. Together with Biogen we are now taking the steps in building a best-in-class commercialization program for zuranolone to meet the needs of patients with depression, HCPs and payers. And if we're successful in our efforts to gain approval we've illustrated this on slide 19 and 20.

As we focused on our goal to bring zuranolone to market our commercialization work is imperative. We intend to revolutionize the way depression is thought about and treated. Current standard of care treatments for MDD can be slow for patients to experience response if any are chronic with most patients staying on some form of chronic treatment for at least two years, and are often accompanied by burdensome side effects causing adherence issues and drug regimen changes. We believe the target profile for zuranolone with clinical trial data to date showing a rapid clinically meaningful reduction in depressive symptoms, time-limited treatment regimen and well-tolerated safety profile will be welcomed by patients living with depression.

The work to create a paradigm shift in the treatment of depression has started. We look forward to sharing more on our approach to engaging and educating key stakeholders as we ramp up our disease education and launch planning efforts for zuranolone.

Now, let me remind you that Sage has a deep pipeline of programs invested in house and we've made great progress in expanding and accelerating our pipeline during the quarter. Our neurology franchise is led by SAGE-324 which is also part of our collaboration with Biogen, and in April we announced positive data from our Phase II Kinetic study in essential tremor. In the study SAGE-324 met the primary endpoint by demonstrating a statistically significant reduction from baseline in the TETRAS Item 4 Upper Limb Tremor Score at day 29 in the total study population compared to placebo. We also saw a statistically significant correlation between TETRA scores and activities of daily living at every time point. These observations are important as they may help provide future regulatory flexibility.

For patients essential tremor can affect nearly every aspect of day-to-day living and can make the simplest half task difficult if not impossible. We believe with pharmacologic characteristics of SAGE-324 are well suited to address unmet needs for these patients. We are progressing this program and expect to initiate the Phase II dose-ranging study in late 2021 with the goal of optimizing the dosing frequency with a good tolerability profile and a dosing schedule to maintain plasma concentrations that translate into sustained tremor symptom control.

Turning to our neuropsych franchise. We are evaluating SAGE-718 our wholly owned first-in-class NMDA receptor PAM as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction. In May, we announced positive data from Part A of the PARADIGM study and SAGE-718 in Parkinson's disease cognitive dysfunction. And I'm pleased to report the first patient has been dosed in Part D of that study. We believe that this four-week dosing arm will provide additional information about SAGE-718 to inform the development path forward. Additionally, the luminary study with SAGE-718 in Alzheimer's disease cognitive dysfunction remains on track to read out later this year. And also later this year we intend to initiate a randomized, placebo-controlled Phase 2 study in Huntington's disease, which is positive we expect will bring us one step closer and pursuing the initial regulatory indication for SAGE-718 as you can see so far in 2021 we've executed on the promised expansion and acceleration across our growing portfolio. We look forward to providing more updates, including additional analysis of previously reported data to allow key stakeholders and opportunity to further assess the data in detail. That's all going to come in the second half of this year and we expect to do a lot of education around those data.

With that, I'll turn the call over to Steve for more detail on the data we reported this quarter as well as our additional ongoing clinical programs. Steve?

Stephen Kanes -- Chief Medical Office

Thanks, Barry, and good morning everyone, I'm thrilled with the data we've generated to-date and the progress across all three franchises throughout 2021. Starting with our depression franchise led by zuranolone, our next generation positive allosteric modulator of GABAA receptors. We've seen remarkably consistent and differentiated data with zuranolone throughout the landscape and NEST clinical development programs that was further supported most recently by the positive outcome in the pivotal WATERFALL study, and as Barry mentioned, we believe the data we've generated to date along with the ongoing pharmacology studies and safety data from Coral supporting the NDA filing [Technical Issues] and specifically discuss these data and the regulatory NDA filing pathway.

In the WATERFALL study zuranolone met the primary endpoint demonstrating a statistically significant and clinically meaningful improvement compared to placebo and HAM-D scores at the end of the two-week dosing period. We also saw a rapid onset of activity beginning at day, the earliest time point measured. As a group patients who responded to zuranolone after two weeks of treatment retained on average more than 85% of their improvement through the end of the trial, in this case a full 30 days after the last dose of medication, with the majority of these patients maintaining most if not all of the improvement. As we continue to analyze the data from this study in the entire Landscape Program, we look forward to presenting additional data pertaining to the overall profile of zuranolone along with the patient reported outcomes to speak to the potentially paradigm-changing profile that's zuranolone may present for patients and we're successful.

What I can say is that the data to date tell us it's zuranolone has shown rapid onset, large improvements in overall depressive symptoms, prolonged benefit after completing the two-week treatment regimen and a well-tolerated safety profile. For example in the SHORELINE study, the largest naturalistic study conducted in an MDD development program we assume that nearly 50% of patients who responded to 30 mg only required one treatment and the 12-month period and roughly 70% of patients responded to 30 mg required no more than two 2-week treatments throughout the year. And as a psychiatrist I believe patients are looking for rapid and sustained reductions in depressive symptoms with the confidence that it is a treatment only when needed.

The safety profile of zuranolone has now been characterized in more than 3500 patients and the data from the WATERFALL study is consistent with this large and growing safety database. For example in the WATERFALL study, the vast majority of adverse events were mild-to-moderate in severity or most importantly, there were no deaths or a loss of consciousness. There were also no reports of weight gain, sexual dysfunction, or euphoria, all of which can be associated with current standard of care antidepressants and can lead to discontinuation. To that end. Importantly, very few patients discontinued from the study because of adverse events with 3.4% of those receiving zuranolone and 1.5% from placebo discontinuing because of AE's. There were only two serious adverse events in zuranolone group and two in the placebo group. As we continue to review the substantial amount of data from the WATERFALL study in the rest of the Landscape Program, we are also committed to sharing data a premier scientific forums as quickly as possible.

Slide 14 in our corporate presentation provides details on the types of data, we plan to present at upcoming congresses including patient reported outcomes, which we believe will be very insightful. The totality of the data seen with zuranolone date supports our view of its target profile is a rapid, durable and use as needed or episodic treatment that we believe has the potential to be meaningful for patients in our healthcare system overall. Recent health economics and outcomes Research conducted by Sage and published in the peer-reviewed journal pharmacoeconomics showed that the economic burden of MDD treatment with multiple lines of treatment for depression was much higher compared to a single line of treatment for depression, in fact there was an increased economic burden associated with delay of depressive episode resolution as early as the second line compared to the first-line in MDD. It's clear that a rapid-acting, well tolerated episodic treatment for depression is needed, and we believe zuranolone has the potential to fill that void in the market.

Turning to the three additional ongoing Phase III studies with zuranolone. The Coral and SHORELINE studies are on track to read out with data in late 2021. Coral is investigating the efficacy and safety of zuranolone 50 mg when co-initiated with new open label SSRI in patients with MDD. The positive results from the WATERFALL study, we believe, have sufficient efficacy data to support our first FDA filing for zuranolone, although consistent safety profile remains an important aspect to Coral. That said, of course, we expect to see consistent efficacy profile supporting the differentiated benefit risk of zuranolone in this trial including rapid onset of effect.

SHORELINE is designed as a naturalistic open-label safety and tolerability study to investigate as needed repeat treatment with zuranolone over a one-year period in patients with MDD. We expect to report top data cuts in the 50 mg, one year cohort and SHORELINE in late 2021. We're also continuing to enroll patients in the study following our announcement last quarter that we expanded the target enrollment to 500 patients and we're offering patients from the Coral Study the ability to roll over into SHORELINE following the completion of the Coral Study.

The other ongoing Phase III study of zuranolone is a Skylark study in postpartum depression. We're updating our guidance on the Skylark study, which is now expected to readout in mid 2022 as a result of a slower than anticipated pace of enrollment in the study due to a dramatically and unfortunate lower level the women diagnosed with PPD during the pandemic, possibly preventing women from accessing appropriate screening and diagnosis.

Also in our depression franchise today we announced top line data from the Chickadee study evaluating the safety and tolerability and pharmacokinetics of ZULRESSO in adoloscent females aged 15 to 17 with postpartum depression. This study was conducted as a post-marketing requirement to investigate ZULRESSO in adolescent females with PPD. The data showed that the safety and pharmacokinetic profile for ZULRESSO in this population was consistent with prior studies in adults and the FDA approved product label, importantly the efficacy seen a Chickadee study is consistent group will be seen in the clinical program in adults. We plan on working with the FDA to potentially add this broader age groups to the label.

Moving to our neurology franchise, which is led by SAGE-324, a novel treatment that we believe has incredible potential in the treatment of essential tremor. The data we announced in April for the Kinetic study, a 36% reduction in upper limb tremor amplitude from baseline to day 29 in the total study population seen with SAGE-324 the adverse events that were generally consistent with the safety profile of 324 seen previously are supportive of further development in the target product profile for 324 may potentially be very meaningful for patients. To that end, we plan to initiate a dose ranging Phase II clinical trial with SAGE-324 in essential tremor in late 2021. We also look forward to working with our collaborators at Biogen to optimize next steps for the continued development of SAGE-324 to identify the profile we expect to move into pivotal trials. As a reminder, at this time, we don't believe additional formulation work is necessary for SAGE-324.

We're confident our proposed Phase II B trial will result in the dose and frequency designed to optimize benefit risk as we continue to develop this novel product candidate for essential tremor. Beyond SAGE-324 our neurology franchise includes SAGE-689 a potent product candidate with rapid PK in solid formulation flexibility with potential in areas of high unmet need including acute agitation, mania or migraine. I'm pleased to share the first patient has been dosed in the Phase I program for SAGE-689 and we're on track to complete the Phase I SAM study in late 2021. Additionally, I'm pleased to share that IND enabling preclinical work is underway for SAGE-319, an oral extra synaptic GABA-A receptor preferring PAM. The advancement of the SAGE-689 and SAGE-319 programs represents meaningful expansion and acceleration of our SAGE developed wholly owned pipeline.

Turning to our neuropsych, where we are continuing to develop SAGE-718, our NMDA receptor PAM in development as a potential oral therapy for disorders where cognition is one of the main drivers of disability. Consistent with the data seen in Huntington's disease patients in our Phase I studies in patients with Parkinson's disease SAGE-718 is shown in an open label Phase II trial, the PARADIGM study, a positive impact on multiple domains of cognition including executive in learning and memory while not altering simple attention or reaction time. In the study, patient is 75 years old with mild cognitive impairment due the Parkinson's disease who received SAGE-718 3 mg daily for two weeks demonstrated improved performance from baseline on multiple tests of executive functioning of our 14 days of treatment. To our knowledge, there is nothing in clinical development that has generated data suggesting this kind of profile, the potential ability to augment key cognitive domains without the challenges often associated with other approaches. Within the safety data available, the rates of adverse events reported has been low with with the most frequently reported AE being headache. No serious adverse events have been recorded to-date. We're confident in the potential of SAGE-718 and today announced that we have dosed the first patient in a four -week dosing arm in the PARADIGM Study to gather additional data in the PD patient population and informed next steps.

As we previously announced, we are planning to initiate a double-blind, placebo-controlled Phase II study of SAGE -718 in Huntington's disease later this year and are on track to report top line data from the luminary study evaluating SAGE-718 in patients with AD, mild cognitive impairment and mild dementia later this year as well.

In addition to SAGE-718, our neuropsych franchise also includes SAGE-904, an NMDA receptor PAM product candidate being evaluated as a potential oral therapy for other disorders associated with NMDA hypofunction, we are on track to complete SAD and MAD studies late 2021. Our neuropsych franchise also includes SAGE-421, an oral NMDA PAM being evaluated for potential use in neuro developmental disorders and cognitive recovery and rehabilitation, which we expect to advance to preclinical studies this year.

Lastly, today we announced that we're terminating our Phase III study evaluating brexanolone in COVID-19 related acute respiratory distress syndrome or ARDS. The study did not meet enrollment expectations and was closed to further enrollment this quarter. We will report the data collected to date after full analysis of the results.

This was an important quarter for Sage marked by advancements across our pipeline, and we're excited about the second half of the year with several potential value creating catalysts expected. We believe our significant progress this quarter leaves us well positioned to build on our momentum and to advance our mission of making medicines that matter.

I'll now turn the call over to Kimi for a review of the financials. Kimi?

Kimi Iguchi -- Chief Financial Officer & Treasurer

Thanks, Steve. As you heard from Steven Barry we're executing well in 2021 are making decisions based on data that we believe will ultimately help us deliver medicines that positively impact patients. It's an exciting time for Sage and we're expanding and moving our pipeline forward for position of strength, underpinned by our strong financial position.

Let me start with the highlights from our second quarter financials and then close with some commentary on our financial guidance. We recorded $1.6 million in net revenue in the second quarter from the sales of ZULRESSO. That compares to $1.1 million of revenue from sales of ZULRESSO for the same period in 2020. We remain committed to our moms, their families and all those impacted by PPD. Our targeted commercial efforts including an integrated approach to engage key stakeholders, our moms with PPD, who may benefit from treatment with ZULRESSO gain access.

Selling, general and administrative expenses were $43.3 million in the second quarter compared to $38.2 million for the same period of 2020. This includes an increase in expenses of $8.6 million and a reduction in expenses of $3.5 million due to reimbursement from Biogen as part of our collaboration. The increase in expenses was driven by an increase in activities focused on disease awareness, increased launch readiness activities for our potential product launch, if our zuranolone development efforts are successful, and non-cash stock-based compensation expense from the achievement of a milestone for certain outstanding performance restricted stock in.

Research and development expenses were $56.2 million in the second quarter, that was compared to $73.3 million for the same period of 2020. This reflects an increase in expenses of $13 million and a reduction in expenses of $20.1 million due to reimbursement from Biogen as part of our collaboration. The increase in expenses was driven by clinical pharmacology studies that began in 2021 and non-cash stock-based compensation expense from the achievement of milestones for certain outstanding performance restricted stocking.

Additionally, we had no restructuring expenses in the second quarter of 2021 compared to $28.4 million in the second quarter of 2020. We recorded a net loss of $107.2 million for the second quarter. That was compared to a net loss of $136.3 million for the comparable period of 2020.

I'd like to highlight the components that we expect will continue to support and build our financial strength for the remainder of 2021 and beyond. Specifically, there are three areas that give me confidence in our financial strength in our potential to create value. First, we expect our cash on hand of $1.9 billion plus ongoing funding and resources from the Biogen collaboration will provide the financial flexibility to allow us to continue to make sound and strategic decisions designed to improve our probability of success. The Biogen collaboration provides ongoing cost sharing for R&D and SG&A expenses for agreed upon activities related to zuranolone and SAGE-324, and we have the potential for up to $1.6 billion if we meet development and commercial milestones. Second, our thoughtful and flexible R&D approach combined with our strategy to invest in near, mid and long term has led to a portfolio of multiple programs across three franchises, all of which have shown promising signs of long-term value potential for patients and shareholders. And third, we're working to build a best-in-class commercialization program designed to help us address patients, HCPs and payers if our products are approved. And with the potential if more successful to deliver significant shareholder value.

Separately, we are reiterating our prior financial guidance that we expect to have a cash balance of more than $1.7 billion at the end of 2021 and as a reminder, we did not expect to receive any milestone payments from collaborations for the remainder of 2021. It's sterling to see what's been achieved to date and we're just getting started. I'm confident that our strong financial position and flexibility will allow us to continue to drive the portfolio expansion as we work to develop innovative treatments with the potential to impact millions of lives.

I'll now turn it over to Jeff to handle Q&A with the operator. Jeff?

Jeff Boyle -- Investor Relations

Thanks, Kimi. Before I turn it over to the operator, I'll ask that you limit yourself to one question. If you have an additional question feel free to return to the queue. Now I will turn it over to the operator. Operator?

Questions and Answers:

Operator

[Operator Instructions] Our first question or comment comes from the line of Ritu Baral from Cowen. Your line is open.

Ritu Baral -- Cowen & Company -- A

Hi, good morning. Thank you for taking the question and congrats on the quarter, and maybe just to go back to the regulatory strategy, just to clarify, Coral to be successful to file in MDD, and in the decision to terminate REDWOOD and Rainforest, does that mean the FDA has indicated that SHORELINE will provide sufficient retreatment data for the filing? Thank you.

Barry Greene -- President, Chief Executive Officer & Director

Yeah, thanks, thanks for the question. So as we said on the call, we have sufficient efficacy data for filing. We take a step back. We've studied zuranolone in over 3500 patients in subjects to date and the profile of zuranolone has been consistent, which in a rapid onset of action advocacy as early as the first measured time point day three that's been consistent with day 12 and 15 significant clinically meaningful results. So it's really the totality of the efficacy data is filed. As we mentioned on the call with ongoing pharmacology studies, which also need to be complete, and then we believe that need to confirm this definitively with the agency that will take a snapshot of the safety data from our ongoing other clinical studies including Coral and then packaging totality will be sufficient for filing. We did and we have breakthrough status, so we're in ongoing dialoge and we were able to confirm REDWOOD and Rainforest would not be required for this filing, and then to your specific question with SHORELINE and we saw really important data with SHORELINE as Steve mentioned on the call 50% of the patients in the SHORELINE and that was the 30 mg dose required one 2-week treatment and the entire course of the year. and 70% patients only required one or two treatments in the entire course of the year, and then about 10% required 3, 4 and 10. So even at the most frequently study dose of 5 two-week treatments, we are talking about 10 weeks of drug versus 52 weeks of current antidepressant. So, we believe that those data are sufficient to provide the retreatment regime, Steve anything to add? Steve, you might be on mute.

Stephen Kanes -- Chief Medical Office

Okay. yeah, I'd say is with a big important factor of all of these for filing is making sure even appropriate safety database and now with more than 3500 individuals dosed in hand a very clear safety profile along with three positive trials, which includes WATERFALL we believe that we definitely have the efficacy as well as the safety information necessary for filing, and as Barry said will confirm that with our next meeting with the agency.

Ritu Baral -- Cowen & Company -- A

Got it, thank you for the helpful color.

Barry Greene -- President, Chief Executive Officer & Director

Thank you.

Operator

Thank you. Our next question or comment comes from of Salveen Richter from Goldman Sachs. Your line is open.

Salveen Richter -- Goldman Sachs -- Analyst

Hey, good morning and thank you for taking our question, this is Elizabeth on for Salveen. I'm just wondering if there are any additional steps that need to be taken ahead of the Phase II dose-ranging study for 324. Thank you.

Barry Greene -- President, Chief Executive Officer & Director

Yeah, it was. Thank you. And I'm really important that you mentioned that. So, you're taking the step that we started the year articulating to everybody that our intention this year based upon our strength and balance sheet we can stand and accelerate the pipeline and positive kinetic data where we were asking the question, can we treat essential tremor patients throughout the course of 30 days and see consistent reduction in essential tremor with a favorable safety profile without any technical lapses or untoward safety and thats exact results we had, which gives us confidence to move into a longer-term study of essential tremor. So, together with our partners advising we are designing that next step dose frequency study where we hope to come out with the dose to frequency that provides us the profile to move into Phase III. So all this news, is we've agreed with Biogen now is to work with the agency to make sure that we have the right, the frequency, and we plan on releasing that later this year and we will provide guidance and design details once we've initiated that study. So we're moving forward rapid.

Operator

Thank you. Our next question or comment comes from the line of Cory Kasimov from JP Morgan. Your line is open.

Cory Kasimov -- JPMorgan -- Analyst

This is Gavin on for Cory. Thanks for taking my question. I was curious about investor feedback that you've gathered since the topline WATERFALL readout and what aspects of the debt, if any, really stand out to to the KOLs? Thank you.

Barry Greene -- President, Chief Executive Officer & Director

Yeah, thanks, to answer that question, so since since we've had the WATERFALL readout we've integrated that with the totality of data and that we had great discussions with various investigators and KOLs. And I think what everybody is seeing is really a paradigm shift here. When we think about the last 35 to 50 years antidepressants, when we think about what's in development today, including some later stage programs nobody has seen an oral medicine that works after one or two doses, and as you know, we've seen statistical significance at day 3 with continued efficacy, and I'll ask Steve talked about the totality of data seen SHORELINE help to emphasize that point.

Stephen Kanes -- Chief Medical Office

Yeah, I think the profile itself is really unique, we talk a lot about the paradigm shift, but I'll just remind everybody that what we mean is something really substantial for patients. The typical treatment duration for first episode for depression is 6 months. Typically people are on their antidepressant for years and what we're offering, we're successful is a time limited treatment, 14 days, two weeks of therapy to treat a major depressive episode. That is a real revolution for I mean patients as well as physicians are looking for. The kinds of things that we are now working with is really integrating the data to be able to illustrate the overall benefit risk profile and working specifically with all of the KOLs that we're in touch with to both make sure they understand exactly what we're trying to do and then getting their feedback about how best to articulate that benefit risk profile. What we've seen so far is that most patients require no more than two treatments over the course of the year, that more weeks and we 48 weeks in the year, they are not taking medication, a real revolution in the treatment of depression when that patients themselves are really quite interested in. So, the kinds of things we'll be looking to go more deeply into our one of the patients who use of this treatment, how does that reflected in the overall outcome something that's very important to demonstrating clinical meaningfulness and using that with the KOLs and everybody else to really help everyone understand how this may be used in the treatment paradigm. It's, a very welcome new tool if approved and how best to then introduce it into clinical practice. So, it's exciting for me because it's something that's entirely new base and I haven't seen the data for years now, if I had this medicine my arm I was a practice that would have used it on everybody and finding ways to sort of educate and then ultimately change practice is kind of where we are right now and it's a really exciting opportunity.

Cory Kasimov -- JPMorgan -- Analyst

Great, thank you.

Barry Greene -- President, Chief Executive Officer & Director

Thanks for the question.

Operator

Thank you. Our next question or comment comes from the line of Paul Matteis from Stifel. Your line is open.

Paul Matteis -- Stifel, Nicolaus & Company -- Analyst

Hey, thanks so much for taking the question. Hey, I just wanted to clarify one thing and then ask one quick question after that. But on your comments, Barry, is there a scenario here where you could initiate and complete an NDA filing for zuranolone before we ever get the Coral data? Just trying to understand if that's one of the possible permutations, and then can you just remind us where you are on abuse liability work for zuranolone and kind of what your operating expectation is, as you approach a regulatory review. Thanks so much.

Barry Greene -- President, Chief Executive Officer & Director

Yes, Paul. Thanks for the question and I'll like context in that Steve to fill it in. So what we said is the efficacy data we have to-date, three out of four past Phase III including the data from SHORELINE are sufficient for an efficacy filing. We have ongoing pharmacology study, we did run the pharmacology studies at 30 mg but changing to now the 50 mg data from earlier Phase II learning for rerun pharmacology studies, including reviews that is as it happens, those will be completed later this year. So that those data will be part of the, the filing. In terms of other studies CORAL and SKYLARK, we believe and we need to confirm this with the agence that a blinded snapshot of safety data will be required to file. So it's conceivable that we are filing the regulatory package before other Phase III readout, but that's simply a matter of time. Steve anything to add?

Stephen Kanes -- Chief Medical Office

No, that the you have specifically about whether or not the ClinPharm package is complete and there are some ongoing as Barry said this at 50 mg obviously for any drug that gets into the CNS, there is an abuse liability package that you do. We'll certainly have that in time for the filing and there is nothing there that's giving us pause. We expect that we'll have all of there that we need to file that at the time of completion after our meetings with the FDA. As Barry said with the efficacy data as well as the safety data, it's really just a matter of the technical aspects of what goes into a filing that we need to sort of agree on.

Paul Matteis -- Stifel, Nicolaus & Company -- Analyst

Hey thanks.

Barry Greene -- President, Chief Executive Officer & Director

Thank you.

Operator

Our next question or comment comes from the line of Tazeen Ahmad from Bank of America. Your line is open.

Barry Greene -- President, Chief Executive Officer & Director

Mr Ahmad you may need to unmute your phone.

Tazeen Ahmad -- Bank of America -- Analyst

Sorry about that. Can you hear me now?

Barry Greene -- President, Chief Executive Officer & Director

Yeah.

Tazeen Ahmad -- Bank of America -- Analyst

Okay, great. Thanks for taking my question. And good morning. One question that I have about this discontinued Rainforest study. One thing that was being studied there of course was co-morbid insomnia, and for the time that we've looked at this drug one of the major benefits that physician checks have given us is that the ability of patients to be able to sleep better at night would be a big positive and would increase there wanted to prescribe zuranolone. And so, now that you've discontinued the study, I'm just curious how would we get a little bit more color on the ability to set help sleep structure and is that still something that you would want to have language in an ultimate label? Thank you.

Barry Greene -- President, Chief Executive Officer & Director

Yes, that's a great question. So I will remind you that through the MD scores and the patient reported outcomes in the completed clinical studies we have insight into not only mood, anxiety, but sleep and sleep architecture, and we believe we have data sufficient in understanding that patients sleep patterns have been improved. Now, obviously with label negotiations, [Indecipherable] matter of FDA negotiation, but we believe that we have those data. If we believe after we get the label that ongoing studies required to make more definitive statements we certainly can do our studies, but we think we've got data in hand that helps us understand that patients aren't back and many of these patients, as you know on sleep is the aren't back are sleeping better. Steve anything to add?

Stephen Kanes -- Chief Medical Office

Tazeen like you, we remain interested in the potential benefits of sleep, and how to get it that is something that we'll be looking into. Certainly we've seen consistently, when we look at the individual factors, that sleep is improved, not only sleep, of course, we're seeing improvements in the core symptoms of depression and so forth, which is what you need to be an antidepressant, but sleep is certainly a factor there and one that we think is going to be important as a benefit for patients. How we get to that, first focus on depression if the drug is approved, something that's absolutely important during a health pandemic where the rates of depression are going up through the roof. And, as we become successful you be able to take another look at that, but certainly from scientific data, data communication will be able to say words about that, obviously, we've done a lot of sleep work already and then through the individual factors from our trials will be able to articulate those benefits, and those are some of the things that we're planning to doing near term how we address that long-term is something that obviously we're working out with Biogen as we move forward.

Tazeen Ahmad -- Bank of America -- Analyst

Okay, thank you.

Barry Greene -- President, Chief Executive Officer & Director

Thank you.

Operator

Thank you. Our next question or climate comes from the line of Yasmeen Rahimi from Piper Sandler. Your line is open. Hi team.

Yasmeen Rahimi -- Piper Sandler & Co. -- Analyst

Hi Team, thank you for taking my questions and thank you for all the updates. I have questions on SHORELINE. The first one is can you tell me how many patients on the 50 mg dose where we'll have one year completed for the data late this year. And then 2, when you look so far is the rate of recourse are leading a second dose, the same in the 50 mg versus the 30 mg dose that you have reported. Thank you.

Barry Greene -- President, Chief Executive Officer & Director

Yeah. Yes, thanks for the question and thanks for asking about SHORELINE. This is a really important study that helps us understand the incredible durability that we're seeing in patients, and keep in mind that and people have to reflect on it. Patients are taking drug for two weeks. And as we've seen in our Phase III, the four weeks or more after-dose patients are still reporting that there is enormous of stage and SHORELINE further reflects the durability of the drug. I am going to turn over to Steve to get into the details, but SHORELINE is very important in the context of zuranolone.

Stephen Kanes -- Chief Medical Office

Yeah, yeah, the short answer. Of course is we'll know the actual number when the study is completed, and so we're following that and the goal is to have as many patients as we can at the end of the study as you continue to roll patients in, in fact were rolling patients from CORAL study into the trial and what you do with long-term trials like this is take data cuts along the way. What I can tell you is we're seeing very remarkable results in terms of response in remission in the SHORELINE study during those initial 50 mg doses and that's been true since the earliest cut. So in our estimates now or that 80% plus of patients are showing a response, meaning a 50% reduction and about 43%, a little bit more are showing full remission. And those have been rock solid since the earliest days to our program, they're not only higher than what we saw on 30 mg, but in the same general range. So, we're seeing really good response, that's been continuing both for first with 30 mg and now throughout the 50 mg dosing. We'll have the actual metrics and numbers when the study completes.

Yasmeen Rahimi -- Piper Sandler & Co. -- Analyst

Thank you, Steve. Are you able to come in as of right now, the size of SHORELINE just like how many patients are currently in SHORELINE.

Stephen Kanes -- Chief Medical Office

I can say that this is the last data cut it was more than 500 patients enrolled in the trial and this will be the equivalent of a long-term safety study where we expect attrition throughout the year. People are getting better. They're going about their business. They don't necessarily are interested, especially if they're feeling well to continue to to check in. So even the the rates of attrition in the trial are things that we look at, but what we're seeing is very high levels of retention. One of the points we like to make is is not only in SHORELINE are patients getting better, but only a small number of them are requiring additional retreatments. This would be the equivalent of a reverse placebo effect, meaning patients know they're not on therapy and only a fraction of them require additional treatments. And so, among other things, we get it, we start to understand what treatment in the real world would look like with our medicine and one treatment, but half of all patients only required that indexed treatment, another 20% required one more treatment in the course of a year. That's fundamental that you're not going to find out a literature of, and this is part of what we're doing, creating both a new approach to treatment, as well as the foundational data that's necessary in order to make treatment choices. So that's why SHORELINE is so important, and there's all there's a lot there, but those are from my perspective, those are the things that are really most important business program progresses.

Yasmeen Rahimi -- Piper Sandler & Co. -- Analyst

Thank you, Steve.

Operator

Thank you. Our next question or comment comes from the line of Andrew Tsai from Jefferies. Your line is open.

Andrew Tsai -- Jefferies -- Analyst

Hi, good morning and thanks for having me. So my question is on CORAL, as investors start to think about the likelihood of success and what the study could show at Day 15. Is it fair for us to assume the comparator arm, which is the typical SSRI could essentially be viewed as a traditional placebo arm since SSRIs takes 6 to 8 weeks to work or does co-initiated with an SSRI or still somehow change the calculus and then a corollary to that is, as we think about Day 42 could both arms improve on HAM-D as SSRI start to kick in. For some patients. Thanks.

Barry Greene -- President, Chief Executive Officer & Director

Andrew, thanks for the question. I'm going to ask Steve to talk about the rest of experience to multiple steps to help anaswer that question for an improved drug. But let me say this, a CORAL, as you highlighted as that an important question. What happens when we co-administer an antidepressant with patients with zuranolone and the data we have today have patients [Technical Issues] these are not patients that you assume experience from the horrific side effects that you might on antidepressant. So we're asking different question and we should learn from CORAL. Now. I will also say that as has done each and every time, but when we conduct clinical studies we learn from those clinical studies and we make adjustments for future studies based on those learnings. So if there is adjustments to be made to CORAL we will make those adjustments and work with the agency on any necessary adjustments, but your specific point, you're right, we do not expect that the antidepressant alone will confer any benefits for 4 to 6 weeks, but may in fact the side effects earlier and that will be very interesting to date because as Steve highlighted earlier while we have seen somnolence and sleepiness with zuranolone, we have not seen things like weight gain, sexual dysfunction, GI upset, some of the other side effects you see with with antidepressant. Steve maybe you can talk about how arms might come together multiple weeks up dosing when patients on on those drugs.

Stephen Kanes -- Chief Medical Office

Absolutely. We [Indecipherable] antidepressants when given over the course of several weeks may actually demonstrate benefit. And just like in our other clinical trials we do know that patients over time may improve even in the placebo arm. So we're not looking as we have it for placebo drug differences out to day 42 especially not in CORAL, this study is looking to address a very particular use case, which is how do you jump-start therapy when you co-initiating an antidepressant with SAGE-217 zuranolone with an antidepressant. In oncology, they call the induction with maintenance. How do you start people to get better more quickly, and so we're looking at this early time point, they've shown consistent differentiation from placebo or any other drug that's available. It's a 3 day, 8 day, 12 day 15 really early on. Are there non-specific effect that we think we have, of course, I mean we do that through the powering and we do that through the conduct of the trial and so forth, but we do think that if the study is successful just yet another use case where patients may or physicians may want to choose this as a treatment option. And the technicalities of it are obviously, we plan for success to ensure the powering is adequate to show those differences.

Andrew Tsai -- Jefferies -- Analyst

Very helpful color. Thank you, guys.

Operator

Thank you. Our next question or comment comes from the line of Lars Chico from Wedbush. Your line is open.

Laura Chico -- Wedbush Securities -- Analyst

Good morning. Thank you very much for taking my question. I have one on Zuranolone and PPD, so the Phase III JAMA paper shows a higher proportion of patients with symptom amount during the third trimester versus ZULRESSO studies and it seems like a bit of a shift in diagnosis, but not much time elapse between when the Zuranolone PPD and ZULRESSO PPD studies were conducted. So with SKYLARK pushing back. I'm just wondering if you can comment on whether you think these are more permanent changes in the PPD landscape. It's interesting because you're seeing elevated depression rates elsewhere, but not in postpartum depression. So I guess the question here is how does this impact, one on your PPD submission strategy, but then also how do you see this playing out in a commercial environment in terms of maybe who might be the primary point of care for zuranolone. Thanks.

Barry Greene -- President, Chief Executive Officer & Director

Yeah. Laura. Thank you. A few different questions in there. So let me try to unwind it and get hope Steve here so you. Thank you for highlighting the paper. We're really proud of the Robin study and as I highlighted in my prepared remarks just a beautiful paper in and a paper that really reflects just how well zuranolone works and do these moms with PPD. Let me start with the kind of the commercial landscape. So, if we're fortunate with our successful WATERFALL to file as we expect with the agency and get an indication for both MDD and PPD, which is what we expect we will be reaching out and making sure that all moms, particularly those with risk factors have a plan. Every mom as you know has a plan for when her water breaks, you knows where the bag is who is taking there in, who her position is going to be, where you're giving birth, but almost no momns have a plan for being depressed a week, two months, three months after the baby is born. So we're going to make sure that we work with patient advocates, we work with OB-GYNs, we work with psychiatry, community to ensure that that all moms have a plan after after giving birth. That is probably broader than just the prices in the news, there's other health concerns of moms have after after giving birth. So we will be aggressive in ensuring that that mom with depression has access to zuranolone. We heard some KOLs actually say that with certain mothers with risk factors they intend to those moms so actually leave the hospital with a scripted hand in case does the symptoms come up. So, I think it will be well prepared there, Steve, you want to talk about the timing differences that Laura highlighted?

Stephen Kanes -- Chief Medical Office

Oh sure. So, Laura, and I'm glad you did the close reading. We've always included patients that had an onset during third trimester. So we think there are few things that are going on, one of them is with the approval of ZULRESSO there is a heightened awareness among treaters both to identify and diagnose patients. And that's I believe is being reflected in the ability to at least identify patients prior to the being treated. Importantly, we are not enrolling patients in the study despite when their diagnosis was made until a full month after the delivery, that's to ensure that we're not medicalizing sort of the normal changes in mood immediately after delivery. I mean people have to have their onset of symptoms and they have to be maintained for several weeks, four weeks plus for them to really be appropriate for a diagnosis of MDD, and that's really important for us. I mean unless symptoms remain they're not MDD. So we think there is, awareness, screening, attention and a bit of know-how on how to how to identify these patients and that's important.

With regard to the epidemiology, well we know a few things, one rates of depression, if you just ask people their way up. We also know that births are down and we also surmise based on discussions with investigators and KOLs that new moms are much more reluctant to come into care during the pandemic. So all of those factors taken together speak to, one, the importance of of a portable treatment to modern treatment, time-limited treatment that doesn't require people coming into a center as well as the ongoing work related to the SKYLARK study. So as much as it's disappointing to change in timelines the importance of the work remains and we are really looking forward to give that study over the finish line. I would also add that as part of our filing strategy, we do intend to discuss the utility of our current package for getting both an MDD and a PPD label. So all of that as part of our current approach based on the outcomes from the JAMA Psychiatry paper and the study.

Laura Chico -- Wedbush Securities -- Analyst

Thanks guys.

Barry Greene -- President, Chief Executive Officer & Director

Thanks Laura,

Operator

Thank you. Our next question or comment comes from the line of Jay Olson from Oppenheimer. Your line is open.

Jay Olson -- Oppenheimer -- Analyst

Thank you for taking the questions. Appreciate the importance of a rapid response in MDD which we described earlier. Can you talk about how an early response correlates with positive longer-term outcomes in MDD, and also a comment on how the onset of response for Zuranolone compares to other novel anti-depressant such as esketamine. Thank you.

Barry Greene -- President, Chief Executive Officer & Director

Yes, Jay, thanks for the question, and really thank you for highlighting a really important point. So what we know about MDD, and there has been many studies from us and others, is that the earlier you diagnose and the more rapidly you get people better, the better the longer-term outcomes for depression and other comorbidities such as cardiovascular disease and diabetes. And there is literature from many that talk about the downstream effects of not treating a person with depression rather than get them better faster. Steve could you talk about some of the health economic data that's out there about not treating people earn back benefits to treating people early getting them better faster.

Stephen Kanes -- Chief Medical Office

Yeah, I mean the most important thing. Let's start with patients first. Everyone wants to get better quickly, that's kind of the goal of all medicine. There's a few things we know with depression though, which is the more quickly someone get better, the more likely they are to maintain those benefits, regardless of what the treatment is. So when we lean into getting patients better with a two-week course of therapy that very much builds on a well described phenomenon, which is get people better quickly and we know that we're going to be able to get them back into their life, their role functioning and be able to begin that journey of of true recovery. Right. I mean, we can just one thing to have symptomatic improvement, it's another to have improvement in your role functioning and really looking at whether it looks like for patients and from patient reported outcomes, is something that's really important for us. So those impacts are ones that we're really lookingto to get out into the real world, both from the WATERFALL study, but more importantly from landscape. With regard to other drugs including esketamine, while there are reports of very early onset the real statistical significance differences in this drug is really after multiple, multiple treatments. I would also point out that [Indecipherable] sending a very different patient population, important one which is treat just in depression. Our program is focusing on what I would, sometimes referred to as garden variety depression patients. We don't necessarily have multiple, multiple and very severe episodes but still deserve the opportunity to get better and get back on with their lives. So, and we see faster onset as early as day three, we're seeing maintain benefit after a time limited therapy, two weeks and a really, a really positive benefit risk profile. We think this is something that when it's approved will really revolutionize the treatment for many people. I'd only add that with greater than 30 drugs approved in the United States for MDD, there are still upwards of 19 million people here that have major depressive episode. So it's not just people view this as something that's relatively straightforward to treat, the unmet need is enormous and we think everybody deserves to get better quickly and get back on their feet.

Barry Greene -- President, Chief Executive Officer & Director

Thank you. And Jay, and that all the data out there, which would, Steve, just said, we know that of patients that have recurring depression that are treated on multiple medicines and stay depressed for long periods of time go on to develop diabetes, go on to develop cardiovascular disease and other co-morbidities, which yet not only group that individual but add cost in the whole healthcare system, and we were listening to one of the Wall Street on a panel where KOLs said these data are remarkable. I mean we give them my patients I need to get better, faster and that's why which patients don't need to get better, faster that physician was a bit dumbfounded. So everybody seems to get better faster.

Jay Olson -- Oppenheimer -- Analyst

Super helpful. Thank you very much.

Operator

Thank you. Our next question or comment comes from sumant kulkarni from Canaccord. Your line is open.

Sumant Kulkarni -- Canaccord -- Analyst

Good morning, thanks for taking my question. We've seen the durability and response data within potential real world usage of zuranolone is there anything particularly from a safety perspective that might limit an immediate second 14-day course of therapy, if that's required. I guess, asked another way this goes back to why a 14-day period was chosen in the first place and what the longest continuous safety period for zuranolone might be from a regulatory perspective?

Barry Greene -- President, Chief Executive Officer & Director

Yeah, let me start and then ask Steve to comment. So the science behind zuranolone was a belief that in depression we can by targeting positive analysis with modulated GABAA that we can reset patients to kind of a normative state, kind of rewire the brain, So the belief of going on with a presumably short duration therapy not a chronic or if that's paradigm shift we're talking about here. So what we've seen now are patients treated for two weeks to get better, faster and the SHORELINE data [Technical Issues] thus far about how often recruitment is required. So we have top studies that have animals on for longer-term without other diltrious effect, but the adverse event profile has been consistent effect includes over time as patients are retreated. So we think of this is coming as a treat as needed therapy and as Steve mentioned this earlier on the call very important. When when patients often go off antidepressant, typical antidepressants, and they're off drug, they know they're off drug and they ultimate seek to get back on drug. With the SHORELINE data we patient off drug and Steve highlighted this earlier and they say that they are not seeking to get back on drug even though they're off drug. So, we believe that as patients need the two-week therapy to be able to get additional two-week therapy kind of in the real world. Steve anything to add?

Stephen Kanes -- Chief Medical Office

Yeah. Just, just to speak specifically to your question. Obviously we don't have a label yet. We have been saying two-week therapy because when we do the modeling, and then we've talked about this before, most of the improvement happens within the first week. By the end of two weeks, we're really starting to show some incremental improvements, but really patients are doing well, and of course, these are really -I just want to point this out and you guys can go into your research, but these are remarkable data. We're seeing 80% responses and somewhere between 40% and 50% remissions, you are not seeing that with any drug, let alone after a limited course of therapy. And so, for us this is really transformative and part of what we're so excited about the program when we are getting started, is the opportunity to then use these data to think differently about a treatment paradigm which addresses patient needs who want to get better and not necessarily keep taking medication forever. So, assuming the drug is approved, we could potentially think about other kinds of dosing schemes. This already is a really important, and we've seen it very consistent in terms of actually in terms of safety in study after study after study, and it's quite frankly the time limited aspect of this is what got the FDA's attention and why we have breakthrough in the first place, it's a concept that I think will really add something unique to the treatment toolbox for patients with depression.

Sumant Kulkarni -- Canaccord -- Analyst

Got it, thanks.

Barry Greene -- President, Chief Executive Officer & Director

Thank you.

Operator

Thank you. We have time for one final question. Our final question comes from the line of Gary Nachman from BMO Capital Markets. Your line is open.

Gary Nachman -- BMO Capital Markets -- Analyst

Hi, thanks for taking my questions. Evan flaw filling in for Gary Nachman. I just had a quick question. So for SAGE-689 and SAGE-904 programs, are there any specific or potential indications you would be looking to target. Some color around that would be great. Thanks.

Barry Greene -- President, Chief Executive Officer & Director

Yeah, thanks for the question. Steve, you want to take that?

Stephen Kanes -- Chief Medical Office

For 904 we're obviously we usually start at the highest level. We look for disorders, where there is known or suspected NMDA hypofunction and were 718 we're looking at neurodegenerative disorders. For 904 we think this may very well be beneficial for neuro developmental disorders, whether that be autism or schizophrenia or other places or other disorders, where there is cognitive impairment and executive function deficits, a little bit different from from neurodegeneration. So that those are areas that we're looking at, as we understand more about the drug will be more specific. For 689, this is a rapid onset parenteral drug that's injectable, it could be formulated the lots of waste. So we're looking at places where rapid onset of GABA positive modulation be very will be helpful. So the kinds of things we've talked about, RSA, agitation where we know there remains an unmet need, whether it be an emergency settings or for people with severe dementia. Likewise, there is potential interest in areas like severe migraine or other places where people may come in for and need very rapid responses. So what be driven by the results of the Phase 1 and where we are in terms of benefit risk, but we're looking to identify differentiated molecules and then develop them in very different place than the molecules we have already thanks,

Barry Greene -- President, Chief Executive Officer & Director

Thanks Steve.

Operator

Thank you. At this time, I'd like to turn the conference back over to Mr Barry Greene for any closing remarks.

Barry Greene -- President, Chief Executive Officer & Director

Thank you and thanks everyone for joining us this morning, I'm thrilled with the substantial progress we've made in the first half of 2021 with several milestones achieved on our mission to become the leader in brain health. This is serious business. For example, a recent study noted that up to 30% of people with MDD have suicide and our depression, neurology, and neuropsych franchise has potential to help millions. We're taking on diseases that have massive impact on people, families, society and generations and we're committed to getting it right, even in the face of major paradigm shift and major expectation changes. And let me just put this out there many of us are getting prepared to send kids back to college and uncertain times. If you have a daughter in junior sophomore year and you discover that she hasn't left the room for a couple of weeks and you're fortunate enough to get her health and so you get the diagnosis of major depressive disorder, would you honor on a typical antidepressant that might take 4 to 6 weeks to work with unknown side effects potentially losing her semester per year or potentially her whole college career. would you rather have another drug that gets you better better after one or two days of investing classes. I know it's what I would pick. So that's what we're focused on despite some of the feedback we're hearing initially. The achievements of the age team this year have set us up for several potential near, mid and long-term paddles rest of the year, and into 2022. The safety will continue to work tirelessly to deliver on our vision of bringing medicines to patients so they get better sooner and stay better longer. Thanks again and have a great day, everyone. Bye.

Operator

[Operator Closing Remarks]

Duration: 51 minutes

Call participants:

Jeff Boyle -- Investor Relations

Barry Greene -- President, Chief Executive Officer & Director

Stephen Kanes -- Chief Medical Office

Kimi Iguchi -- Chief Financial Officer & Treasurer

Ritu Baral -- Cowen & Company -- A

Salveen Richter -- Goldman Sachs -- Analyst

Cory Kasimov -- JPMorgan -- Analyst

Paul Matteis -- Stifel, Nicolaus & Company -- Analyst

Tazeen Ahmad -- Bank of America -- Analyst

Yasmeen Rahimi -- Piper Sandler & Co. -- Analyst

Andrew Tsai -- Jefferies -- Analyst

Laura Chico -- Wedbush Securities -- Analyst

Jay Olson -- Oppenheimer -- Analyst

Sumant Kulkarni -- Canaccord -- Analyst

Gary Nachman -- BMO Capital Markets -- Analyst

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