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| Further, as we look at who is driving the prescribing, we believe that the strong engagement across specialties and providers, represent HCP appreciation for the need to treat PPD as an urgent medical condition, regardless of the practice setting |
| With added launch capabilities and both SAGE and Biogen sales representatives active in the field, we continue to be encouraged by the increasing number of prescriptions in early 2024 |
| So, as you heard yesterday from our colleagues at Biogen and we've commented on earlier, we're experiencing very positive payer dynamics |
| We've been in PPD for a long time, and the fact that mental health and maternal health are top of minds for payers, really provides positive tailwinds in the long |
| As you know, our goal is for ZURZUVAE to be the first line treatment for women suffering for PPD, and we’re excited and encouraged by the early progress to date |
| We're very excited for these readouts, and if positive, they will help demonstrate a path forward for Dalzanemdor, and importantly, bring us one step closer to helping patients |
| We’re happy with that kind of activity, and we're really excited that the prescriptions came not only from psychiatrists, but from OB-GYNs, as well as primary care |
| The early demand for ZURZUVAE is reflective of the strong enthusiasm we're hearing from HCPs and women with PPD for this medication |
| Now, the fact that we saw 120 scripts is exciting and encouraging in a very short period of time in December |
| We have a big year ahead of us and even greater potential to build a leadership position in brain health and a top tier biopharmaceutical company |
| I'd like to note that we have maintained a strong financial foundation as we enter a catalyst-rich year for the company |
| Not only are we seeing growing interest from HCPs to learn more about ZURZUVAE, but we believe the launch of ZURZUVAE is a catalyst for positive change in the screening, diagnosis, and treatment of PPD |
| The patient advocacy groups are certainly encouraged |
| Our early initiatives aimed at establishing ZURZUVAE as the first line therapy for women with PPD, have begun to translate into strong tailwinds for the launch of ZURZUVAE |
| We remain confident in our ability to continue to execute across our pipeline as we head into a catalyst-rich 2024 |
| Additionally, we're excited about the continued progress on our early-stage pipeline with SAGE 319 and SAGE 421 |
| So, the early feedback we've heard from the field has been positive and we're highly encouraged by the anecdotes of the early patient success stories |
| We believe in the potential of both molecules to help patients in need and to become significant drivers of long-term value creation as we aim to strengthen our leadership position in brain health |
| That's highly encouraging |
| While the launch remains our top priority, we're also excited by all that we have ahead of us in 2024, with multiple data readouts expected across our ongoing studies in Dalzanemdor, also known as SAGE-718, as well as SAGE-324 |
| A specialty distribution network is in place designed to provide a positive experience for patients with convenient home delivery |
| We're also pleased that we're hearing back from many healthcare providers, including OB-GYNs, primary care, and psychs, about ZURZUVAE |
| As Barry mentioned, we've made tremendous progress in these early days of ZURZUVAE’s launch in PPD, and I'm excited to discuss our recent achievements and ongoing initiatives |
| But as we also said, the vast majority of patients that are flowing through right now are actually covered patients, whether they are commercially insured or Medicaid patients, which again, is a very good sign or signal from payers around the support that they're providing for women with PPD |
| And we're excited to have readouts for both Huntington's, Parkinson's, and Alzheimer's this year |
| So, we're excited by and encouraged by what we're seeing |
| With that said, we're encouraged by what we're seeing so far |
| Yesterday on the Biogen earnings call, they mentioned positive payer dynamics |
| With that in mind, we are encouraged by the demand we saw in the initial days of the launch |
| As we look ahead to the ongoing launch of ZURZUVAE and enter a catalyst-rich 2024, with multiple data readouts expected, I'm highly confident that we're making important progress to deliver on our mission, to develop and launch life-changing brain health medicines so every person can thrive |
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| And I think there's just a concern amongst investors interested in this program that you might be losing momentum essentially as we get further and further out from actual approval and availability, and not pushing the button on something like another media push, especially given what you've said about patients themselves advocating for access to ZURZUVAE, when we found in our own checks, that many OB-GYN clinicians are unaware of the drug still, amazingly enough |
| The data from some of these programs has been negative and the programs have been stopped |
| Essential tremor has suffered from a lack of innovation, with no new approved treatments in more than 50 years, and it has a significant impact on an individual's ability to perform everyday tasks |
| disorders with cognitive impairment represent some of the greatest areas of unmet need in medicine, and we know that globally they continue to increase in prevalence and pose significant challenges to patients in their everyday lives |
| On one hand, there was a huge sort of flurry of news reports, et cetera, around first approval |
| You'd have to sort of be under a rock to not have seen the media attention, which has continued |
| We're not worried about that |
| We do not expect this gross margin trend to continue |
| Brain health diseases are one of the leading causes of disability worldwide, yet novel treatment options in care remain limited |
| We certainly haven't encountered that |
| So, that's really an engineering issue as we optimize the processes, payers come online, and healthcare providers get comfortable with exactly how to get ZURZUVAE to moms |
| So, do you feel like demand may be a bit choppy out of the gate, and has there been - or has there been any increased demand in January? Additionally, just wondering why you didn't guide to ZURZUVAE revs for 2024, and do you plan to guide in later quarters? Thank you |
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