Barry Greene: Sorry, as Chris said, it will be very fast. And from the prescription going through electronic medical system to the patients getting at their home will be very rapid, within days is the goal.
Tazeen Ahmad: Okay. Yes. That’s good to know and maybe just to wrap that up, what should we expect the gross to net in the early part of the launch to be?
Barry Greene: Kimi, you want to talk about that?
Kimi Iguchi: Yes. So Tazeen, it’s a little early to be providing that kind of guidance. When we can provide more, we’ll update you.
Operator: We go next to the line of Salveen Richter with Goldman Sachs.
Salveen Richter: With regard to your partnership here with Biogen, how has the partnership evolved since the CRO in MDD? And then what aspects of commercialization do you expect them to take the lead?
Barry Greene: Yes. Thanks for the question, Salveen. So when we issued our press release in early August announcing the approval of ZURZUVAE for PPD, we advise them together committed to having ZURZUVAE commercially available by the end of the year. And we’ve reaffirmed that on this call that we’ll have usually commercially available in December with the fuller complement of launch capabilities early next year. As Chris noted in his comments, we’ve been working diligently with Biogen to roll out and fully commercialize ZURZUVAE and work more hand-in-hand in that. We have not talked about the specific provision of labor as there are some things that we’re taking the lead on, others that they’re taking a lead on. But I think sitting here right now, we’re very well positioned for commercial availability of ZURZUVAE and the fuller launch on happening early next year.
Operator: Our next question or comment comes from the line of Jay Olson with Oppenheimer.
Jay Olson: Congrats on the progress. Can you talk about the total potential commercial opportunity for PPD? And when do you expect the ZURZUVAE P&L to become profitable?
Barry Greene: Yes. Thanks. I appreciate the congratulatory note. We certainly have made a lot of progress. Let me start with the opportunity. I’ll ask Chris to add any color there and then Kimi can follow up with how we’re thinking about the financials. So as we talked about, Jay, on the call, epidemiologically, approximately 1 in 8 live birth results in the potential for PPD. So that’s about 0.5 million women in the United States per year. Unfortunately, less than half of that is diagnosed and even far fewer are treated. Now if you think about the condition today kind of the as is, we have ZULRESSO out there, of course, to treat PPD. But as we all know, there are certain access hurdles given the IV infusion. But mostly those that have the good fortune of being diagnosed and treated or treated with antidepressants, that can take weeks to months to work if ever and ended up working through a very complex referral process.
As you heard Chris talk about earlier on the call, we believe that ZURZUVAE as a rapidly acting oral 14-day course of therapy fits into a physician’s practice pattern, whether it’s OB/GYN, psych, or PCP and there’s much more extensive to diagnose and screen. So we believe the opportunity is significant in the early years, but really continues to grow in the outer years as diagnosis and treatment rates should continue to increase. So we think it’s clearly got blockbuster potential and even more importantly, the ability to help all these women suffering from PPD. Chris, do you want to add some more color? And then Kimi follow up with some of our financial thinking?
Christopher Benecchi: Yes. Barry, what I would add is you covered the epidemiology and the blockbuster potential for this medication. But the thing that I would add to those comments is that when we received approval for ZURZUVAE at PDUFA, the media coverage was remarkable. The social media activity was really impressive. So what that really signals is that you have an active group of patients, clinicians and patient advocacy organizations waiting for this medication. And that’s an opportunity that we’re going to capitalize on at launch because as I said earlier, we know that patients can’t afford to wait for a medication like this and we’re going to do everything that we can to drive broad and rapid and equitable access to this medication at launch.
Kimi Iguchi: And just to follow up on the financials. We certainly are thinking big about the PPD opportunity, as Chris and Barry just talked about. But when we think about the commercialization strategy, we’re thinking that we’re going to start small and then scale it success. We don’t want to get ahead of ourselves with regards to building an infrastructure and building a cost structure. So we’re going to scale that as we see success.
Operator: We go next to Brian Abrahams with RBC Capital.
Leonid Timashev: This is Leonid on for Brian. I actually wanted to follow up on some of what you’ve been hearing on the ground with respect to providers and physicians. And you guys had mentioned the initial enthusiasm from the media coverage. And I guess I’m curious, has that been pulling through into a request for information from physicians and providers? And are there any challenges in having, I guess, the launch take place a few months after you had all the fanfare from the media and is there any efforts to sort of recapture that and rebuild it so you can pull that momentum into the launch?
Barry Greene: Yes. Thanks, Leonid. That’s a very insightful question. Let me start and I’ll ask Chris to comment further. So the quick answer is that the media attention clearly has spilled over into patients, patient advocacies, health care providers. There’s tremendous enthusiasm for improving diagnosis and to treat PPD in a whole new way. And now that we’ve announced that we’re making ZURZUVAE commercially available in December, I believe that uptick will continue. And we’ll also add before I turn it over to Chris, that the media attention was not by accident. There are very important outlets that are very interested in maternal mental health and we’re in constant dialogue with them and providing information that they importantly want to hear. So Chris, do you want to add some color there?
