Evofem Biosciences Inc (EVFM) 2020 Q4 法說會逐字稿

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  • Operator

  • Ladies and gentlemen, thank you for standing by, and welcome to Evofem's Fourth Quarter and Year-end 2020 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

  • I would now like to hand the conference over to your host, Amy Raskopf. Please, go ahead.

  • Amy Raskopf - Head of IR

  • Thank you. Hi, everyone. This is Amy Raskopf, and Evofem Biosciences' Vice President of Investor Relations. Thank you for participating in today's call. If you haven't done so already, I encourage you to access our Q4 and year-end 2020 presentation and the press release we issued earlier this afternoon, both of which are at evofem.investorroom.com/q4ye2020results.

  • During this call, we will make forward-looking statements regarding the company's future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those expressed in or implied by these forward-looking statements as a result of various important factors, including those noted on Slide 2 and described in the company's SEC filings, which are available at sec.gov and in the Investors section of evofem.com.

  • These forward-looking statements are made only as of today, March 4, 2021. The although the company may elect to update forward-looking statements from time to time in the future, we specifically disclaim any duty or obligation to do so, even as new information becomes available or other events occur in the future.

  • And with that, I'll turn the call over to Saundra Pelletier, Evofem's CEO.

  • Saundra Pelletier - President, CEO & Director

  • Thank you, Amy. Hello, everyone, and thank you so much for joining us. 2020 was a year of execution for Evofem. I like to use the term WACDAD inside the company, Words Are Cheap, Deeds Are Dear. And 2020 showcased our team's ability to execute. We achieved key objectives on every front. We secured FDA approval of Phexxi, our nonhormonal prescription contraceptive vaginal gel. We raised critical funds from respected institutional investors. We launched Phexxi in the U.S. We gained Orange Book listing for 2 Phexxi patents. And we initiated our pivotal Phase III STI trial.

  • While we are excited to report our first full quarter of Phexxi revenues today, we are even more excited about the meaningful growth that we're seeing in 2021. And in particular, since we've launched the Get Phexxi DTC campaign on Valentine's Day to propel the Phexxi uptake curve. This includes the 362% increase in direct searches for Phexxi.

  • I'm going to discuss those metrics, our expectations for 2021 and other initiatives intended to drive the g-term growth after our CFO, Jay File, reviews the financial results. Jay?

  • Justin J. File - CFO

  • Thank you, Saundra, and good afternoon, everyone. Before I start, I want to be clear that I'll be rounding all numbers in today's presentation. The fourth quarter of 2020 was our first full quarter of product sales following the U.S. commercial launch of Phexxi in September. For the year ended December 31, 2020, gross revenues on the 8,600 units shipped to our wholesalers were reduced by strong utilization of the Phexxi co-pay assistance program as well as fixed costs primarily associated with distributor fees.

  • We intentionally prioritize demand and increasing access to Phexxi for all women at commercial launch. We anticipated that our co-pay program would be our primary mechanism to achieve this near-term goal, and it is working effectively. With our strategic approach to maximize access and profitability, we will continue to assess the utilization of the various components of our co-pay program as we move forward.

  • Operating costs for both the fourth quarter and for the year ended December 31, 2020, either beat or met our guidance on these periods. As compared to the respective prior year periods, increased activity for both the fourth quarter and the full year results for 2020 reflect higher research and development costs for clinical trial expenses related to EVOGUARD, which we initiated in October 2020; increased sales and marketing costs associated with the establishment of our sales organization in 2020 and significantly higher media and advertising costs related to the commercial launch; and in general and administrative costs, higher legal, audit, financing advisory fees, sales force recruiting costs and payroll-related costs due to increased head count.

  • For the year ended December 31, 2020, net loss attributable to common stockholders increased to $142.3 million or a net loss of $2.12 per share. This is compared with a net loss of $80 million or $1.99 per share for the prior year. In Q4 2020, we raised $25 million from a strategic investment in Evofem by Adjuvant Capital, which for financial reporting purposes, is reflected within restricted cash on our balance sheet due to specific use requirements in that agreement. We closed the year with $48.9 million in unrestricted cash and cash equivalents and $22.2 million in restricted cash related to Adjuvant.

  • Now to remind everyone, our revenue recognition is based on unit shipments from our warehouse to distributors. In Q3, those shipments were the initial stocking orders for the Phexxi launch. Q4 shipments were lower with reorders coming mainly toward the end of the quarter to replenish inventory that was depleted by increasing shipments from the distributors to retail pharmacies during the quarter. As expected, unit shipments in Q1 2021 are on track to exceed total unit shipments last year.

  • We believe this reflects increased market demand even before the Get Phexxi DTC campaign launch and gives us confidence that gross revenues are moving firmly in the right direction for the current quarter. Also, I want to point out that we closed 2020 with approximately 6 months of inventory on hand, and we have ample manufacturing capacity to meet anticipated demand for the foreseeable future, including the expected impact of the Get Phexxi campaign.

  • With that, I'll turn it back to Saundra.

  • Saundra Pelletier - President, CEO & Director

  • Thanks, Jay. There are moments in time when categories change, when the culture and the climate of a given standard changes forever because it is no longer suitable. The time for women to have to take a hormone every single day when they don't have sex every day is quite frankly over. More importantly, this solution puts control in the hands of women. Men have had the option to have sex on demand safely for years but women have not had that same freedom or access to an FDA-approved on-demand method with no hormones. That's what makes this time right for Phexxi.

  • There are 21 million women in the U.S. that are at risk for pregnancy, who are not using hormonal birth control. They have demonstrated through their actions that they are not going to take hormones. Some women are using nonprescription contraceptions, such as barrier methods, withdrawal or periodic abstinence. Others are using no contraception at all despite the fact that they have an 85% relative risk of getting pregnant within 1 year if they continue to have unprotected sex.

  • We believe that a very conservative acquisition percentage of these 21 million women makes this potentially $1 billion opportunity. And in addition to these 21 million women, there's another 19 million currently using a prescription contraceptive, some of whom, particularly pill users, may already be considering moving to a hormone-free on-demand method. Factoring conservative levels of uptake from this segment as well, we believe that Phexxi's peak revenue potential could be as high as $1.4 billion to $2.3 billion. And again, this is based on only single-digit acquisition percentages of women in each of these groups.

  • Phexxi sales from wholesalers to pharmacies have established a very strong growth trend since launch. On average, we've seen greater than 20% unit growth in the last 3 months. This is the best leading indicator of demand. And I want to point out, February was a short month, hampered by weather events across the country that shut down several states. But despite that, it was our strongest sales volume month-to-date.

  • We reached a new high for weekly sales the last week in February following the launch of the Get Phexxi ad on television. Phexxi prescriptions continue to grow despite COVID-19, despite the holidays and the recent polar vortex. Since the Phexxi launched in September of last year, our marketing efforts have been growing and setting a strong foundation with a strong footprint with consumers. But it was crucial that we escalate those efforts to ensure that we drive the mass reach needed to breakthrough.

  • In 2021, our focus and goal is to rapidly increase awareness and to drive demand. In doing this, we'll bring more women to the top of the funnel and actively work to move them through the funnel all the way to conversion. We estimate every 1% increase in Phexxi awareness translates to approximately $30 million in gross revenue. As of today, we have IQVIA data through the week ending February 12. Total Phexxi prescriptions hit new weekly highs in each of the first 2 weeks of the month, leading into the launch of our DTC campaign on Valentine's Day, which we anticipate will have a very significant impact on the Phexxi growth curve.

  • As you know, we launched Phexxi in September of 2020, and we launched it with a hybrid commercial team. We have 59 Evofem representatives in the field, working with 11 regional managers and calling on roughly the top 3,500 accounts and 10,000 health care provider targets. They're complemented by a telesales team contracted with Archer Healthcare, that we're using to reach HCP targets in remote geographies or where in-person access has been rendered impossible during the COVID lockdown. Both our Evofem and Archer reps are focusing specifically on health care providers who are likely to write Phexxi based on their contraceptive prescribing history and attitudinal segmentation.

  • I am very pleased to say that our well trained, focused and committed sales organization continues to deliver impressive results. As of February 12, more than 2,650 healthcare providers have prescribed Phexxi. Jay and I both mentioned the Get Phexxi campaign and its impact already several times, but I want to take a step back. I want to make sure that you understand what we're referring to exactly.

  • This high-impact dynamic campaign is designed to reach women in a purposeful and a targeted manner. It encompasses television, streaming and digital channels and leverages influencers and partnerships with the ultimate goal of driving demand for Phexxi. The Get Phexxi ad highlights some of the struggles that women face when they choose among the many available methods of contraception, whether it's the lack of control with condom, constant daily use of the pill or abstinence required for cycle tracking. The women featured in the commercial represent realized drawback that Phexxi can help eliminate as a hormone-free on-demand birth control method.

  • In just the first 2 weeks after Get Phexxi launched, our ads generated 115 million views and impressions across all media channels. Phexxi brand awareness doubled from January. To put this in perspective, we were tracking at about 4%, and it was literally like flipping a switch. We went, boom, immediately to 8% in 1 month.

  • Organic searches for Phexxi have increased 362% since launch and direct web traffic, meaning people typing in phexxi.com in their browsers is up 200%. Actions on phexxi.com have also increased dramatically. Telehealth booking and fulfillment by our third-party mail order pharmacy reached new weekly highs for both weeks ending February 19 and February 26.

  • For the week ending February 26, over 300 telehealth appointments were booked, and 100% of those were completed, and Phexxi was prescribed and dispensed to 100% of these women. And again, we're not even really seeing the impact of big Get Phexxi DTC campaign on prescribers or total prescriptions yet because we only have data through February 12. So stay tuned.

  • Another initiative we expect that will positively impact Phexxi uptake is our collaboration with in NCODA. Our collective goal is to support female cancer patients as they decide which contraceptive option best meets their unique individual needs. There are more than 800,000 new cases of cancer reported in women in the U.S. every single year. Many cancer treatment protocols require female patients of reproductive age to use birth control while they undergo treatment. And the vast majority of oncologists will not permit their patients to use hormonal birth control. If you just look at breast cancer alone, the American Society of Reproductive Medicine recommends that all women who are suspected or known to have breast cancer or who have had it in the past should avoid hormonal contraception.

  • So if you consider the anticipated impact of the DTC campaign on Phexxi uptake as well as the heightened awareness that we aim to build among oncology pharmacy teams and the patients they serve, we expect the Phexxi uptake curve will increase dramatically from where it was in December and January.

  • Market access remains a priority. We're proud to have 55% of commercial life coverage and additional coverage to the Medicaid National Drug Rebate Program that covers 17 million women, aged 19 to 49. And already, we have multiple plans with Phexxi at 0 co-pay. We continue to offer our co-pay support program to women whose plans don't yet cover Phexxi or that have it on formulary with a co-pay of over $30 for Phexxi because access is our near-term priority.

  • Meanwhile, we're working diligently through multiple channels to achieve our goals of affordable access to Phexxi for all women. This includes advocating for the office of women's health to update and expand its contraceptive category to include new categories, vaginal pH modulator, to reflect Phexxi's unique mechanism of action. We believe this mandate will increase coverage for women of reproductive age under ACA. Contraceptive choice should not be a luxury available just for some women. Every woman deserves to choose the method that's right for her individual health and her unique circumstances.

  • So now I quickly want to pivot and just talk to you briefly about our STI prevention program, our next asset in development is EVO100 for the prevention of the 2 most common STIs, chlamydia and gonorrhea. This is a late-stage program and a near-term opportunity, and STI prevention is another potentially large market with a clear unmet medical need. STI prevention is critically important now more than ever because rates of chlamydia and gonorrhea have climbed in 2018 for the fifth consecutive year in a row in the United States with 1.8 million cases of chlamydia and 600,000 of gonorrhea. But here's why it matters.

  • Many STIs are asymptomatic, they go undiagnosed, they go untreated. And that's very problematic for 2 reasons: one, there are serious health consequences for infected people. If it's left untreated, some infections will cause -- inflammatory disease -- sorry, pelvic inflammatory disease, infertility or severe complications in pregnancy and for newborn. And the infected person can unknowingly infect sexual partners. That's why the CDC says, anyone who's sexually active can get gonorrhea or chlamydia. And in the U.S. alone, there are 78 million sexually active women, and they are all potentially at risk for STIs.

  • So in October, we initiated our pivotal Phase III trial for EVO100. This trial will enroll 1,730 women at 90 U.S. study sites, and 59 of these sites have already been activated. We continue on track to complete our enrollment by the end of this year, and we expect to report top line results in the first half of 2022. This will keep us on schedule to file the NDA for these potential indications by the end of next year. And again, I want to say it again, there are 78 million women at risk for these STIs in the U.S. alone. So we believe this makes us a significant market opportunity.

  • So I'd like to end with the word that I started with, execution. Yes, the pandemic is making our efforts challenging, but I want to assure you that we are an organization that continues to find solutions to create access to Phexxi no matter what. We're just getting started. And if you have any doubt about whether this is the right time for Phexxi, I want to remind you. In just 2 weeks of our Get Phexxi campaign, the search for Phexxi is up 362%.

  • So with that, I'd like to open the call for questions.

  • Operator

  • (Operator Instructions)

  • Our first question comes from the line of Jeff Hung with Morgan Stanley.

  • Jeff Hung - Equity Analyst

  • What was the average price per script in fourth quarter? And how do you view that changing over the course of 2021 as it relates to the DTC campaign and the dynamics and duration of the co-pay assistance program? And then I have a follow-up.

  • Saundra Pelletier - President, CEO & Director

  • Yes. No, thank you, Jeff, for the question. Jay -- I'm going to have our CFO, Jay File, address that.

  • Justin J. File - CFO

  • Sure. Thanks. Good to hear you, Jeff. Yes, no, great question. And you obviously heard Saundra and I talk rather extensively about how significant the co-pay program is for us to launch all the way through, obviously, building upon the DTC campaign. So with that, obviously, we've got a high TTM adjustment, at least through the end of the year.

  • Now ultimately, we do anticipate that, that is ultimately a moving target for us. And it's going to continue to shift depending on the ultimate mix of usage over time. And we do, though, expect that to improve as the year progresses and into 2022. So right now, just to straight off financials as presented, it was about an 80% adjustment. I'll do the math for you. Does that give you a little bit of clarity that you're hoping for?

  • Jeff Hung - Equity Analyst

  • Yes. That's helpful. And then I guess with regards to the NCODA collaboration, what proportion of the 800,000 new cases of cancer reported amongst women are of child-bearing age? And are there specific subgroups within these women that you think are easier to reach first?

  • Saundra Pelletier - President, CEO & Director

  • Yes. So basically, out of the 800,000, it's about 60% are child-bearing age. And to be candid, it really is that 60% that we think are the main target because right now, at the end of the day, before Phexxi was approved, the only other product that these oncologists had access to was the copper IUD. And in my own experience being a cancer conqueror, I don't say survivor, I say conqueror. But a lot of oncologists -- after women have gone through treatment, and they have suffered enough, the oncologists are very mindful to make sure that they want to give women something that they can tolerate. And a lot of women have had a lot of serious side effects with copper IUD.

  • And so frankly, when our product got to market, a whole oncology team that I spoke to myself personally said it's almost like you designed this for cancer patients in mind. Now certainly, these women are on top of these 21 million that we talk about that currently are not using hormones, and these are the women on top of what we believe are pill users who are looking for something different, but we really believe this is a low-hanging fruit. And the one thing I want to say is that being a cancer patient myself, I feel like I can speak to this audience in a way that's different that's authentic.

  • And the final thing I want to say is that one of the oncologists I spoke to, and we had this in the script, but I was encouraged to take it out. But now that you asked, Jeff, thank you, by the way, I can say it, is that the oncologist said to me, look, when men are in treatment for prostate cancer, the #1 thing they ask is will they still be able to get an erection. And can you imagine if a woman in cancer treatment started talking about her sexuality. Can you imagine if she started talking about her orgasms and what we would think of her.

  • So there's still inequities, even in cancer patients. The reality is these women have so much vaginal (inaudible). They have bleeding, they have pain with intercourse. So the lubricating properties of Phexxi make it so advantages for these patients. So I'm really proud. This is a bit of a passion project for me, but I'm very, very proud that these women need an option and they're still seeing their doctor no matter what.

  • Believe me when you're in cancer treatment, it doesn't matter what's happening in the world, you're still knowing your doctor. And so we are very excited that this is a bit of a low-hanging fruit that will add a lot of value to women, by the way, but I think it will also really deliver in the growth of access and our prescriptions.

  • Operator

  • Our next question comes from the line of Annabel Samimy with Stifel.

  • Annabel Eva Samimy - MD

  • I had a few. And I guess the first one is to what extent, for those patients who have started, are you able to convert these patients into repeat users? Do you have any kind of refill rate at this point? Are you on track with your expected per patient prescriptions per year?

  • And then, I guess, this somewhat goes hand-in-hand with the next question. But if you could give us a little bit more granularity on payer adoption, looks like it's still at 55%. What are your expectations for payer adoption going forward? And if there's any sense of what percent are unrestricted versus restricted and open-access preferred, nonpreferred and how might that play into the gross net at this point. So it's a little bit loaded, but I'll continue -- I'll follow-up later.

  • Saundra Pelletier - President, CEO & Director

  • Yes. No, no. Thank you, Annabel. That's great. So Russ, could I get you to start if you don't mind and talk about the refills and the patients in the conversion? And then we'll circle back to the payer question?

  • Russell Barrans - Chief Commercial Officer

  • Happy to do so. One of the things that we are so excited about is that we were able to do a small research project with 127 women who had completed their first full month of Phexxi. And the questions we asked them, they're relevant to this question where, specifically, is your intention to continue to use Phexxi, what's your intention around recommending it to a friend, et cetera.

  • So we saw 89%, which is right about almost what we saw coming out of the clinical trial, where it was about 90%, that said that they were intending on using Phexxi as they continue to move. But this is nice because it's real-world data, of course. And 82%, which is a very similar number to what we saw again with the clinical trial, said that they would recommend it to a friend.

  • Now one of the things that I have to kind of just caution everyone on in terms of the refill rate is that because Phexxi is an on-demand method that isn't like an oral contraception or a statin or something that you might be on an ongoing basis, we know that the refill rates will be different from women to women.

  • And we also know that what happens now that physicians are getting experience with Phexxi, they'll, for an example, say to the woman how often are you sexually active? And if she starts approaching in sexual activity of 10 or more times a month, what they will now do is write the prescription that says that the prescription is for 24 applicators, not to 12. And those don't get captured as refills because it's a size difference from the initial 12, one box in that regard.

  • So we're going to need data probably for 5 or 6 to 7 months in order to understand what the real refill rate looks like. So we're really focused now on the units. What are the units that are going forward and how much are new prescribers coming online and those kinds of metrics, and those are all really encouraging. So we do believe that the adherence and the continuation is going to be very high for Phexxi. But as of yet, we don't have the IQVIA data to really know for sure what that rate looks like.

  • Saundra Pelletier - President, CEO & Director

  • And then just to touch on the payer question. So a couple things, I want to say. And then we actually have our internal expert, Harry Jordan, who's in charge of all the payer initiatives. He perhaps got more about the payer initiatives than most of us will ever know. But I do want to say that, look, 55% coverage is -- of commercial lives is where we are today. And we do have our co-pay program in place so that health care providers and patients won't feel cost constraints around prescribing or obtaining Phexxi.

  • I'd like to see, Harry, if you're there, if you could jump in, so you could give Annabel much more crisp insight on what are our initiatives and steps that we plan to do to increase coverage?

  • Harry Jordan - VP of Market Access & Distribution

  • Yes. Absolutely. So thank you, Saundra. And hopefully, you can hear me okay. So I think your first question was about where do we expect our payer coverage to go? So we're at 55.1% right now. And as you know, the PBMs, the pharmacy benefit managers, they control roughly about half the life -- the top 3 PBMs control about half the lives across the U.S. We currently are working with them. We continue to have communication with them. However, they usually are looking for pretty deep discounts and rebates, especially when you have a new product and you don't have any market share. So our #1 goal is to drive demand and market share, and that will give us more leverage as we go into the year.

  • Second to that, we -- when you look at 0 cost right now, we roughly have about 4.6% of lives covered under $0, 0.7% under preferred and between covered, new-to-market and normal coverage at nonpreferred tier is roughly about 49% of those covered lives.

  • So we do have a lot of plans across the U.S. that have made positive coverage decisions in spite of what the PBMs do to try to get more market -- or get more rebates from a new product when it first launches.

  • Annabel Eva Samimy - MD

  • Just on that note, if there's any stalling in adoption by the PBMs, is there any thought to changing the co-pay assistance or the first prescription co-pay all the way down to 0 to maybe help with the gross to net and give you a little bit more juice as you're trying to work on the coverage?

  • Harry Jordan - VP of Market Access & Distribution

  • Yes. Absolutely. So we -- honestly, that's one of the nice things about a co-pay assistance program is that we can change the business rules as we see fit, right? So it's very important that we -- the payers see the demand. And so we work through the prior authorization so they see this demand. But we also don't want to hold up and [fort] the demand by holding up the process with PAs. So what we do is we make sure that, number one, that patients get the product, but then we work with prior authorizations on the back end, which we're finding out a lot of these prior authorizations are fairly simple and easy to handle.

  • Operator

  • Our next question comes from the line of David Amsellem with Piper Sandler.

  • David A. Amsellem - MD & Senior Research Analyst

  • So I just have a couple. So on the payer landscape, can you say what portion of covered commercial lives have access at 0 co-pay currently? And then in that 55% that you say have access, would you characterize that as hassle free? Or is there some utilization management involved that we should be aware of, at least in a meaningful sense in that 55%?

  • And then lastly, I want to make sure I got all your comments about the 19th pregnancy category -- sorry, contraception category straight. But I wanted to make sure I got those -- I was clear on that. So do you have sort of a sense of when we're going to hear on that? When we'll definitively know if Phexxi is going to get its unique category?

  • Saundra Pelletier - President, CEO & Director

  • Okay. So Harry, since you're warmed up in your role, would you like to start with David's question? And then once we get to the ACA, you and I can handle it in tandem?

  • Harry Jordan - VP of Market Access & Distribution

  • Absolutely. Yes. So thanks, David. Yes, $0 co-pay right now, roughly about 4.5% of those lives fall under that, roughly about 8.3 million lives across the U.S. that we know plans that have made decisions around it. There's also state laws. There's roughly 12 states that mandate either $0 co-pay or very low co-pay based on the patient. So -- and it's hard to track exactly what -- because you can have a plan that's covering in a nonpreferred tier, but because of the state laws, they supersede that.

  • So that 4.6% could be more, but that are just the plans that we're tracking. And I forget your second question around the -- I know it's ACA but you had a question before it.

  • David A. Amsellem - MD & Senior Research Analyst

  • It was on utilization management and just on the 55%, yes.

  • Harry Jordan - VP of Market Access & Distribution

  • Got it. So we roughly have about 18% of commercial lives that's unrestricted. And there is some restrictions. The restrictions that are typically prior authorizations that require to be used to label. And so -- and again, like I mentioned, it's -- they're fairly mundane prior authorizations that we work through.

  • Saundra Pelletier - President, CEO & Director

  • And then, David, to speak about or talking about ACA, and we're talking about the 19th category, and Harry, please feel free to add anything. I mean, look, one of the things that we feel is a positive lever for us is vaginal pH modulator. And the fact that there is a huge subset of women that are clinically contraindicated for hormones. This isn't just saying, let us put another product in the armamentarium that's #metoo like everybody else and like everything else.

  • We feel that there is serious clinical leverage, that there is a subset of women that do not have a suitable option. So we hired a well-known lobbyist. He has 35 years history working in the health care field and he has 28 years experience lobbying democrats in Congress and the democrat administration to help support awareness for Phexxi.

  • We also have been working with these very large, very serious advocacy risks that are very loud and very influential around making sure that women are prioritized and that they really believe that contraception is an essential tool in preventative health and economic well-being of U.S. women. And I can assure you that they are completely on the Phexxi bandwagon. They believe that it has been far too long that women have not had an option like this.

  • So we're working with this lobbyist. We're working with these advocacies, and we're actually working very heavily to trying to influence politicians. And I would tell you that it is -- I am optimistic about that. So we're encouraged, but here's what I would tell you. COVID has put everything -- and I'm not trying to make an excuse, but COVID has made this less of a priority for everybody.

  • So we've tried to continue to escalate this. We've tried to continue to push on all the doors that we can simultaneously. So I don't know if, Harry, you want to jump in? Because David's exact question was, what do you think about timing around this? And I don't know if you have any more clarity than I have about what would be a timing he could expect.

  • Harry Jordan - VP of Market Access & Distribution

  • Yes. Here's what I will say is that. We've gotten some really good responses from some several senators' offices they understand that the birth control chart is way behind being updated. It hasn't been updated since its inception 10 years ago. And so they are working with us to push the Office of Women's Health to update the chart.

  • As far as timing, that's something that's really out of our control. All we can do is keep the heat on and keep the pressure on. But our hope is that we would hear something this year and be able to obviously act on it from a payer perspective.

  • David A. Amsellem - MD & Senior Research Analyst

  • Okay. That's helpful. And just to be clear though, your -- in parallel, though, you're working with and having discussions with commercial plans of 0 co-pay coverage. So can you talk qualitatively how those discussions are going?

  • Harry Jordan - VP of Market Access & Distribution

  • Yes. Absolutely. I think our position is that Phexxi should fall under the mandate and be covered at $0. You can understand that the pharmacy benefit manager will take an opposition to that because they don't want to pay for anything they don't have to. So we continue to work and educate them about the product or mechanism of action. And we do it in a manner as we're in front of them as much as we can. We've brought in our Chief Medical Officer with many of those meetings. We recently had a meeting with one of the larger payers in the country. So we continue to have those conversations. Obviously, it's easier when -- if you have a mandate because then they can't fight that, but we continue to have those conversations moving forward.

  • Saundra Pelletier - President, CEO & Director

  • Well, just to say this -- yes. Sorry, and David, just one more thing just to say, is that look, I mean, the tough thing, right? The tough thing is balancing access versus these -- look, Harry is too politically correct to say this but some of these rebates that they're requesting are exorbitant. They are insane. And they want us to sign these contracts for 3 to 5 years with these deep discounts that it's just not responsible. It's not a responsible strategy for our shareholders. And so because of that, we have purposely put our heels on the ground to say, well, you just can't do that.

  • So we don't want to do it to the detriment of women. But what we're trying to do is push on this ACA door as hard as possible because should that come to fruition, by the way, then they're not going to have a choice. Then they're going to have to cover us, and we're not going to have to be -- held our teeth to the fire, which is the same rebates. So that's what the tough balance is. It's not that we couldn't get the coverage. We right now just don't think it's prudent, and we don't think it's a smart business strategy because they feel like they're getting these rebates from some players. So they think, well, you either play ball by our rules or forget it. So we're trying the opposite to get this ACA coverage first. And while we're continuing to try to influence them in every way that we get.

  • Operator

  • Our last question comes from the line of Ram Selvaraju with H.C. Wainwright.

  • Raghuram Selvaraju - MD of Equity Research & Senior Healthcare Analyst

  • Just 3 pretty quick ones. Firstly, I was wondering if there's likely to be a substantial difference in not only the level of demand, level of interest from both patients as well as prescribers within the cancer patient population but also whether there's like to be a substantial difference there with regard to willingness of commercial plans to cover the product or if you don't anticipate there being a significant difference between that subsegment versus the market as a whole.

  • Secondly, I wanted to ask if you have seen any clear indications emerging from among the practitioner group who have already written prescriptions for Phexxi regarding what percentage of that group are likely to be definitive repeat prescribers of the product?

  • And then lastly, I wanted to know if you could comment on specifically timing placement of TV ads for Phexxi during the day, what times do these ads typically air? Do you expect that to change over time, especially over the course of the next few?

  • Saundra Pelletier - President, CEO & Director

  • Great. Thank you so much Ram. Okay. So Russ, I'm going to ask you to answer Ram's question around the repeat prescribers and around the timing of the television ads and when those are placed. And I'm going to just start with the cancer question. Ram, I have to tell you, you have read behind the line, meaning that the short answer is, yes, an unbelievably key lever is this cancer population in getting these plans to open up their mindset around coverage.

  • Look, at first, everybody wants to say no. They're just no driven. They think the category of contraception is crowded. They think there's tons of generics out there. They, at first, out of the gate, wonder why there's even a new contraceptive product. But once we have the opportunity to not just talk about nonhormonal, but to talk about all of these women. And by the way, not just cancer patients, but there's a huge number of patients that have clinical contraindications, whether their BMI is high, whether they're a smoker, but the cancer patients because these women are so vulnerable, it has been such an important factor in our ability to influence decision-makers.

  • And look, at first, I will be candid, and Russ will tell you this, but at first, the commercial team, they wanted me to go away on a silent vacation. They were like Saundra, we are not going down the cancer road. And I kept saying we have to. We have to. And so anyway, finally, I think I wore them down. But in the end, the whole commercial team agrees now that it has been such a critical piece of the Phexxi story because it's just such an important thing to say, this is for every woman. And it doesn't matter what your BMI is, it doesn't matter what other medications that you're on, but particularly, if you are a cancer patient.

  • So yes, it's been an important lever, getting them to the site quicker and getting them to not have to be so controversial, right? It's easy. They almost feel like they're becoming the good guys because they're helping these poor cancer patients. And so it's been a very, very important.

  • Now the layer of your question, which was are there sometimes that they're just covering it for cancer patients? The short answer is yes. But we are trying to get those places to really share those stories and the oncologists to have more influence to say, this should be for a variety of different women because, by the way, there's a lot of young women that are worried about their health future. They're worried about what's going to happen if they use different medications for periods of time, and they should also have access to something nonhormonal. So we are definitely utilizing that to our benefit. And that was a long answer story about that.

  • But Russ, will you transition to the repeat prescribers and the TV ads?

  • Russell Barrans - Chief Commercial Officer

  • Sure. So as we mentioned, we currently have about 2,600 plus HCPs that have written a prescription. And about 40% of those have -- are repeat prescribers. As you start looking at the months from December, January, February, we start seeing that the numbers continue to be closer to 50% that have -- are writing a second prescription. So as the new prescribers come into the channel, we are seeing them continue to write. We've already seen a couple of prescribers that have written over 100 prescriptions each. So there -- it varies from those who have written few to those that have already adopted this into their armamentarium.

  • And then the other question is on the television and on where they all see this. And as Saundra already mentioned, this is across all media channels, both cable and over-the-air in like Hulu and places like that YouTube TV as well as on YouTube streaming. And what we've really selected to do is that we are going out to where our audience is. So majority of those are actually airing in evening hours. But it can start earlier depending on where you're at in the country.

  • But the key that's really interesting is we got some eyebrows raised by people who said, why did you go back to cables? Cable is so yesterday. And -- but what we knew is this is from our research, we had worked with our media placement partner, and they came back and said, because of COVID, we have this return that's going on, more people are spending more time, women are spending more time back in some of the traditional channels like cable.

  • And that has proven to be so true already for us as we've just gotten the antidotal responses from our target audience over and over again, saying, no, we're just watching the show and here was your ad. So it's primarily evening hours, but it is where our target audience is, and it's been resonating with them as Saundra already suggested with well over 350% increase in search for Phexxi.

  • Raghuram Selvaraju - MD of Equity Research & Senior Healthcare Analyst

  • Just as a clarificatory point there. I was wondering if you could confirm whether or not there are ads for Phexxi currently running on streaming platforms or not?

  • Russell Barrans - Chief Commercial Officer

  • Yes. There are.

  • Operator

  • This concludes today's question-and-answer session. I will now turn the call back to Saundra Pelletier for closing remarks.

  • Saundra Pelletier - President, CEO & Director

  • I just want to thank everybody for taking your time to listen to our update and for joining us, and we really appreciate your ongoing interest. We appreciate your support of women's health. And we look forward to speaking to you soon. And I hope you have a great rest of your day. Bye-bye.

  • Operator

  • Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.