Barry P. Flannelly
Executive Vice President and General Manager-North America at Incyte
Thank you, Herve, and good morning, everyone. Starting with Opzelura. The launch in atopic dermatitis continues to be strong, and we are very pleased with the progress that we have made across a number of important metrics. To date, over 10,000 physicians have prescribed Opzelura with new writers being added each week. Physicians continue to report a high level of satisfaction with Opzelura with 67% stating that they are highly satisfied, up from 46% earlier this year. Additionally, in a recent poll, physicians indicated nearly half of their AD patients would be appropriate candidates for Opzelura, up from 37% earlier this year. Efficacy, including rapid age reduction, as well as tolerability and the ability to use Opzelura in sensitive areas remain the key product attributes, and we expect these attributes to continue to drive demand for Opzelura in AD. Turning to slide 10. Earlier this month, we announced that we now have signed contracts with the largest -- with the three largest PBM GPOs, an outstanding achievement 10 months into launch, and a key step towards reaching our steady-state gross to net goal. The contract with the third PBM became effective July 1st and individual plans will now be adding OPZELURA to their formularies. The charts shown on this slide is our internal 867 data, which is the number of Opzelura units shipped from wholesalers to pharmacies. With regards to IQVIA data, there has been an increased variability with the data in recent weeks. The overall trend shown by IQVIA data is representative of the actual kinetics. However, the number of filled prescriptions as reported by IQVIA are being over projected.
It is important to take away from this slide a couple of points, both on Q2 performance and on recent trends. In the second quarter, as NDC blocks were removed and Opzelura was added to formularies, pharmacists and dermatologists began to shift from the process of the free drug program to going through the formulary process. This shift has two different effects. One, is a temporary delay of filled prescriptions, which you saw in the second quarter; and two, is the positive impact on covered claims, the benefit of which will be more pronounced beginning in Q3. We are already seeing a return of 867 demand to within the range of our highest point since launch. Additionally, the percentage of covered claims, as shown by the red line, has risen rapidly from the mid-20% range at the end of June to nearly 55% today. We anticipate, with the combined effect of an increased number of filled prescriptions and improving gross to net, Opzelura will have a more meaningful contribution to net sales in the second half of this year. On slide 11, we're turning to vitiligo. This slide captures some of the highlights from Opzelura's FDA approved label as the first treatment or repigmentation in vitiligo. This is a historic approval for patients living with this disease, and the approved label includes a number of important points that will help to drive the success of the product in this indication. OPZELURA is approved for patients 12 years of age and older and can be applied to affected areas up to 10% BSA. The label allows for continuous use of OPZELURA anywhere on the body, including sensitive areas, with no limit on duration of use. The 52-week efficacy data, which has been included in the label, demonstrates the continued improvement in re-pigmentation with longer duration of treatment, highlighting the importance of staying on therapy.
The label also notes that a satisfactory patient response may require treatment with OPZELURA for more than 24 weeks. And lastly, OPZELURA was well-tolerated with application site acne as the most common AE in 6% of the patients. Turning to slide 12 for the launch in vitiligo. Remember, these are the same target physicians as with AD, where we'll be able to leverage our existing relationships with physicians and to be able to benefit from the high level of satisfaction and experience that may have -- that many already have with OPZELURA today. Our launch is underway with a comprehensive multichannel marketing campaign that will ensure broad and consistent reach to effectively drive awareness and importantly, to educate physicians on OPZELURA's mechanism of action, its impact on vitiligo, and its unique clinical profile. To support the launch of OPZELURA in vitiligo, from a patient perspective, we're focusing on raising awareness and providing best-in-class support. We plan to build awareness and activate patients living with vitiligo through a strong presence on social media, print, and eventually TV. We are also partnering with advocacy groups where there has been an enormous amount of excitement for OPZELURA in vitiligo. This will be the first treatment for re-pigmentation available for these patients and the safety and efficacy profile has been proven in the largest randomized clinical trial in this setting. It is important to drive patient adherence and compliance on OPZELURA. This will, of course, begin with physicians setting the right expectations and we will provide tools to help ensure patients have successful treatment experience. We will launch a new Vitiligo app, along with other tools designed to help patients track their treatment and response as well as provide appointment reminders, which we expect to have a positive impact on patient adherence. And of course, we will continue to provide access to OPZELURA with co-pays assistance that can lower co-pay as to as low as $10 a month. We see this launch in vitiligo as one of the largest opportunities for our franchise. We are starting with a very good label and we have heard from patients and advocacy groups around the country, there is a large established medical need.
This, together with the momentum from the launch in AD, will support a very successful launch. Moving on to Jakafi on slide 14. Jakafi net sales in the second quarter grew 13% year-over-year to $598 million. Total patient demand grew across all indications, and the growth in new patient starts continues to remain above pre-pandemic levels. GVHD patient growth of 18% year-over-year was driven mainly by the launch in the chronic setting. With strong demand for Jakafi, we are again raising the bottom end of our Jakafi full year net product revenue guidance from $2.33 billion to a new range of $2.36 billion to $2.4 billion. Turning to slide 15. Monjuvi net product sales in the US grew to $23 million in the second quarter with more use moving into the second-line setting and a gradual improvement in duration. Minjuvi net sales were $4 million, where the launch is ongoing in Germany and share in second line continues to increase. Pemazyre worldwide net sales were $19 million, with the launch currently ongoing in Europe and Japan. With that, I'll turn the call over to Steven.