Dawn Halkuff
Analyst · Cantor
Thanks, James. I will start with a quick overview of payer status and then review the performance seen across our product portfolio in this quarter. Let's start with payer access and updates on Slide 11. We have maintained all major payers across the product portfolio; improvement in commercial unrestricted coverage moves ANNOVERA to 78%, IMVEXXY to 76% and BIJUVA to 75%. Let's move to ANNOVERA, performance on Slide 13. Quarterly total prescriptions filled by patients is on the left hand side. As you can see, ANNOVERA continued to grow with total prescriptions increasing 15% over the third quarter, coming in at approximately 6000 total prescriptions for the fourth quarter. Net revenue per unit remained strong at 1336 and net revenue grew 42% quarter over quarter. Turning to Slide 14. To provide a bit more understanding of our progress, let's look at leading indicators across prescriber and consumer metrics. I'll start with prescribers. Growth in the prescriber base for ANNOVERA is a key level for long term trajectory. As we've mentioned, prescriber access has been limited during COVID. But we are navigating this and continue to see growth in the total number of prescribers writing, as indicated by the green bars and growth and depth of prescribing as seen by the total prescription shown on the blue line growing faster than the total number of writers. Turning to Slide 15, we have leaned into consumer activities given that 60% of birth control decisions are made by the consumer. In December, we launched our celebrity spokesperson portion of the consumer campaign with Whitney Cummings. The program called, Just say it Vagina. The interest has been significant the 2.7 billion impressions generated and placement in multiple significant media outlets, as shown in the column on the left. In addition, the early impact results are encouraging. Click through rates from our advertising to the website or above industry norms. Traffic to the website is growing with over 10,000 visits to the website a day. And in live tech on multiple platforms, after seeing our advertising intend to request ANNOVERA rises significantly to 60%. In other words, all leading indicators show the consumer strategy is working, and we believe it will increase the trajectory of antibiotic prescriptions in 2021. Turning to Slide 17. As you can see, we have figured out how to affordably attract consumer interest in ANNOVERA, where we need to improve and create the next step is converting this consumer interest to fill prescriptions. This progression from interest to conversion is a typical learning process for launch. And we believe we were on the right track to improve the conversion over the next month and quarters. Turning to Slide 17, now we'd like to talk about the value of each patient for ANNOVERA. Each woman on therapy creates a significant amount of revenue value for TXMD, because a full year of revenue is 13 cycles and is earned when the product is dispensed. As you can see by the slide, the cumulative value of ANNOVERA continues to grow with almost 16,000 women on therapy. In addition, we believe our strong retail rate of approximately 50% will create a strong compounded future revenue opportunity. Now let's move to the larger future opportunity for ANNOVERA on Slide 18. ANNOVERA fills the void in the marketplace, and we believe it can create a new segment in birth control. It is well understood that IUD or Implant are not for everyone. Close to half of women reject the offer of an IUD or implant because they do not want to undergo a procedure. In addition, over half of OB GYN don't conduct procedures and therefore are in need of a long acting option to provide their patient. The solution to both of these issues is ANNOVERA. Turn to Slide 19. A growing trend in the marketplace is procedure free at home solutions. One successful example of this is Cologuard, a procedure free at home solution for colorectal cancer screening. It removes the barriers to entry for many people reluctant to undergo a procedure. In fact, of the 3 million people screened with Cologuard, half of them have been previously untested. We believe ANNOVERA can expand the long acting segment for the birth control category in the same way. We're moving the barrier to entry for those that want a long acting product, but are reluctant to undergo a procedure. Turning to Slide 20. Let's look at the contraceptive continuum. On the left hand side of the chart are daily and monthly options that are procedure free but short acting and declining. And on the right are options that provide the benefit of long acting but require a medical procedure and are growing. ANNOVERA to the left of the long acting segment fills a market void of a long acting product that does not require a procedure. In filling that market void we believe ANNOVERA create a new segment and birth control as Cologuard did for colorectal cancer screening. Turning to Slide 21. In the evidence for ANNOVERA to become a new segment in the marketplace is in the data. On the left hand side of the chart are the main segments of birth control. Moving to the middle column here you see actual patient data from vitaCare and which birth control women were on prior to switching to ANNOVERA. Moving to the right hand column, this is survey data on where prescribers claim they switch patients from given the multiple benefits of ANNOVERA. The main takeaway from both sets of data is the same, over half of prescriptions are coming from products that are not NuvaRing as the benefits of ANNOVERA are more than the birth control form. Moving to Slide 22. Before closing on ANNOVERA, let's spend a few minutes grounding us in the larger financial opportunity. Birth control is a large market with 18 million women and 28 million new prescriptions annually. To put ANNOVERA opportunity in perspective, traditionally, leading products in this category over time have achieved 4% to 5% market share. As you can see in the middle column, Lola Western [ph] launched in 2011 and achieved the share and approximately four years. Cologuard which is in a different market but offers the procedure free at home benefits achieve the same share of 5% of the screening market in five years. And ANNOVERA achieved this level of success seen in the column on the right, it would mean approximately 720,000 prescriptions annually. Now, let's review our menopausal product. Turning to Slide 24. IMVEXXY quarterly total prescriptions filled by patients is on the left-hand side. Total prescriptions decreased 5.6% to approximately 123,000, a result of NRx decline in previous quarters, which was attributable to the pandemic. In good news, new prescriptions have begun to recover an increase 2.5% for the fourth quarter over the third quarter. Net revenue per unit improved to $54 and net revenue improved 29% Q4 over Q3. Moving to Slide 25. Our primary goal for IMVEXXY in 2021 is to improve the gross to net. To support net revenue per unit growth effective January 1, our cash pay program and high deductible patient's co-pay increased from $50 to $75. The expected positive impact on IMVEXXY gross to net is significant. The cast a program change was expected to put pressure on volume, but that same time we rolled out the cash pay program change. We also gained preferred status for IMVEXXY with a top PBM that covers approximately 20% of life to counterbalance. In January, the PBM removed key branded competitors including Premarin, which currently has 17% total prescription market share. In addition, we are continuing to focus on patient adherence to retail partnerships to drive higher retail rates across distribution channels. Turning to Slide 26, performance in January based on the combination of changes is as expected. In January, we saw short term impact on volume. However, early indicators for February show that volume is beginning to recover. In addition, we are seeing improvements in the dedication rate, net revenue and net revenue per unit. Today an approximately $17 improvement in cost per fill is being realized for those who use the co-pay program. Turning to Slide 27. Finally, a driver of growth is consumer demand. During the first quarter, we launched patient testimonials to help women better understand that symptoms of menopause are common and normal. Moving into the second quarter, we plan to launch a new consumer campaign grounded in self-care that is designed to educate menopausal woman under overall vaginal health, and encourage them to take charge during this new life stage with IMVEXXY. Moving to Slide 29, I'd like to quickly touch on BIJUVA. Even with our decision to deemphasize BIJUVA and with only seven sales representatives promoted BIJUVA in the field, we continue to see slight growth in TRx for the quarter at 3.3% while maintaining NRx. For the fourth quarter net revenue per unit improved to $52 and net revenue increased 36% over the prior quarter. I would now like to turn it over to Rob for closing remarks.