Release Date: July 31, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Strong quarter-over-quarter growth in prescriptions and shipments of ZURZUVAE, with shipments nearly doubling from Q1 to Q2.
- ZURZUVAE is establishing itself as a first-line therapy and standard of care for postpartum depression (PPD), with increasing demand and prescriber momentum.
- Significant progress in commercial and government access for ZURZUVAE, with the majority of plans not imposing onerous prior authorizations or step edits.
- Encouraging legislative support, such as the new law in Louisiana allowing women with PPD to bypass step therapy requirements and gain direct access to FDA-approved treatments.
- Strategic expansion of the sales force planned for early Q4 to accelerate demand for ZURZUVAE in the treatment of PPD.
Negative Points
- Negative results from the KINETIC 2 study of SAGE-324 in essential tremor, leading to the discontinuation of further clinical development for this indication.
- Higher use of free goods programs in Q2, which may impact revenue until payer coverage improves.
- Ongoing challenges in optimizing the specialty pharmacy process to ensure rapid delivery of ZURZUVAE to patients.
- Net loss of $102.9 million for the second quarter of 2024, despite strong revenue growth.
- Uncertainty regarding the future development of SAGE-324 for other potential indications, pending further evaluation.
Q & A Highlights
Q: Could you just speak to the difference that we're seeing in sales versus shipments or demand for ZURZUVAE, and how the free drug dynamics play a role in this?
A: Barry Greene (CEO): We're highly encouraged by the launch dynamics to date, both in terms of prescription shipments and revenue. Chris Benecchi (Chief Business Officer) added that shipments reflect the movement of the product from the specialty pharmacy to the patient, and there was a 95% increase in shipments over the second quarter. The revenue reported was impacted by wholesalers bringing down inventory levels, which is typical as product launches progress. Free goods are part of the strategy to ensure rapid access to medication for mothers with PPD.
Q: How are you tracking relative to your initial expectations for ZURZUVAE in each of the physician segments?
A: Barry Greene (CEO): The dynamics are very much what we expected. OBGYNs are the front line for diagnosing and treating PPD, and we are seeing a major shift from suspecting depression and referring out to screening, diagnosing, and treating. This is exactly what we thought would happen. It's also encouraging to see prescriptions from psychiatrists and PCPs.
Q: Do you think the PPD market is an OBGYN market that needs to be unlocked, and how many target OBGYNs have been reached?
A: Barry Greene (CEO): OBGYNs are the right healthcare provider group to pick up PPD as they are closest to the source. We are seeing a paradigm shift where OBGYNs are now screening, diagnosing, and treating PPD. Chris Benecchi (Chief Business Officer) added that physicians who begin to prescribe ZURZUVAE start diagnosing more patients at the practice level, which is a positive sign for the treatment of PPD.
Q: Can you explain the thought behind the change in the Huntington endpoint and your confidence in the validity of this subcomponent of HD-CAB?
A: Barry Greene (CEO): The change to the Symbol Digit Modalities Test (SDMT) as the primary endpoint was based on data from the SURVEYOR study, which showed directionally positive signals. Laura Gault (Chief Medical Officer) added that the SDMT is a widely used clinical assessment of cognition in Huntington's disease and other disorders, and is considered a reliable measure of executive function.
Q: How do you plan to increase the diagnosis rate for PPD and expand the uptake of ZURZUVAE among psychiatrists and PCPs?
A: Barry Greene (CEO): The key interception point for PPD is the OBGYN. We are increasing our sales force and marketing efforts to better reach and educate OBGYNs. Chris Benecchi (Chief Business Officer) added that ACOG guidelines play an important role in increased screening and diagnosis, and there is an opportunity to broaden reach and deepen frequency with psychiatrists and primary care physicians through both personal and non-personal promotion.
Q: Can you quantify the ZURZUVAE prescriber base growth from Q1 to Q2, and how do you expect it to grow after the sales force expansion?
A: Barry Greene (CEO): We continue to see prescriber growth quarter to quarter, and we expect this to continue for many quarters. The sales force expansion will help educate more prescribers about ZURZUVAE and PPD. Chris Benecchi (Chief Business Officer) added that there is a lot of room in the market to reach more women suffering from PPD and to make ZURZUVAE a first-line treatment and standard of care.
Q: How has the timing evolved for when a physician writes a ZURZUVAE script to the point of delivery?
A: Barry Greene (CEO): We are continuously improving the time it takes for moms to receive the drug. Many moms get the drug in two to three days after diagnosis, but we aim to shorten this time further. We are doing well but always strive to get better.
Q: What are the next steps for SAGE-324 after winding down in essential tremor?
A: Laura Gault (Chief Medical Officer): We and Biogen are evaluating potential next steps for SAGE-324, if any, and will relay those decisions when they are made.
Q: With $647 million in cash and equivalents, at what point might it make sense to shop for outside assets to supplement your pipeline?
A: Barry Greene (CEO): We are intellectually curious and scanning for potential opportunities that fit our strategic focus. If we find something highly intriguing, we would consider making a move. Nothing active to report currently, but it's on our radar.
Q: How do you see the curve launch for ZURZUVAE shaping up in the second half of the year?
A: Barry Greene (CEO): We see strong coverage both on the government and commercial side. With the success we are seeing, particularly with OBGYNs, we believe that the expansion of our sales force in the fourth quarter will lead to an uptick in prescriptions and shipments next year.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
