Herve Hoppenot
Chairman, President and Chief Executive Officer at Incyte
Thank you, Christine, and good morning, everyone. I'm happy to report today on an important quarter for Incyte. But before we do that, I would like to take a moment to speak about the significant transformation our company has undergone over the past two years. From the third quarter of 2019 to today, Incyte has more than doubled its number of approved products, from 3 to 7, and has increased the number of approved indications from 5 to 12, a significant achievement for patients around the world.
Within the same time period, quarterly product and royalty revenues have grown nearly 50% from $534 million to $778 million in the most recent quarter. The $778 million in product and royalty revenue for Q3 2021 does not yet reflect revenue contribution from our two most recent U.S. approvals, Opzelura in atopic dermatitis and Jakafi in steroid-refractory chronic GVHD. In addition, we expect further growth from the recent approvals of Pemazyre in Europe and Japan, and Minjuvi in Europe, where the launch is ongoing in Germany and we will expand to other countries as reimbursement is secured.
As you see on slide 5, we have provided long-term guidance for some of these products and there is significant upside to the current set of numbers. Within hematology/oncology, our MPN/GVHD franchise, which includes Jakafi and other innovations, is expected to surpass $3 billion in peak sales. Additionally, Monjuvi, approved for the treatment of relapsed or refractory DLBCL, has the potential to reach $500 million in this indication in the U.S. While we have not provided guidance in Minjuvi, Pemazyre, and Iclusig, these products will present additional growth potential and generate further value to our business.
Turning to dermatology, over the past year, we have successfully established our dermatology commercial franchise in the U.S. Given the product profile of Opzelura and the talented commercial team we have in place, we are confident in the potential for Opzelura and we expect peak sales to reach at least $1.5 billion in the United States in atopic dermatitis. While still very early in the launch of the Opzelura, the initial uptake has been strong and Barry will be providing details in his prepared remarks.
Looking ahead into other areas of our portfolio, we are anticipating multiple regulatory decisions in 2022, including ruxolitinib cream in vitiligo in both the U.S. and Europe, Parsaclisib in three non-Hodgkin lymphomas indication in the U.S., as well as once-daily ruxolitinib late in 2022 or early 2023. This 2022 regulatory decision, which closely follows multiple product approvals in 2021, positions us well for further growth and diversification of our product revenues in the coming year.
Our partners are also making headway, with Novartis, ruxolitinib is currently under review in Europe and Japan for acute and chronic GVHD and capmatinib is under review in Europe for non-small cell lung cancer. In addition, Lilly is planning to submit an sNDA to the FDA for baracitinib in alopecia areata by the end of this year. If approved, these opportunities will provide valuable growth to our royalty revenues, which have already surpassed $400 million during the first nine months of this year. As you have seen, 2021 has been an important year of commercial, clinical and regulatory success for Incyte.
With that, I will hand over to Barry to cover the individual product performance. Thank you, Herve, and good morning, everyone. Jakafi sales grew 12% year-over-year to reach $547 million for the quarter and we are reiterating our full year guidance range of $2.125 billion to $2.170 billion. Jakafi was first approved -- was the first approved treatment in myelofibrosis, polycythemia vera, and steroid-refractory acute GVHD, and years later, remains the standard of care in each of these indications. Growth across MF, PV and GVHD continues to be strong. And as you can see on the left, new patient starts have returned to pre-pandemic levels. With patients staying on therapy longer and new patients coming in, the total number of patients on Jakafi continues to increase year-over-year. Myelofibrosis patients, the largest a portion of patients on Jakafi, comprised 45% of total patients, while polycythemia vera and GVHD patients accounts for 30% and 14% of total patients respectively. At the end of September, Jakafi was approved for its fourth indication for the treatment of steroid-refractory chronic GVHD. To put this recent approval into perspective, approximately 2,000 patients with graft-versus-host disease are currently using Jakafi, the majority of whom have acute form of the disease. There are over 14,000 patients in the U.S. living with chronic GVHD, of which half require therapy beyond systemic corticosteroids. We expect the recent approval to accelerate new patient starts with Jakafi. Turning to slide 8, Monjuvi sales grew 22% sequentially to $22 million in the third quarter with growth driven primarily by demand. We are seeing increase in the number of total accounts across both academic and community settings and there has been a swift shift towards adoption of Monjuvi earlier in the treatment paradigm. We now have a greater proportion of Monjuvi patients initiating therapy in the second line, which should result in patients experiencing longer and more durable responses, leading to a longer duration of therapy. Feedback from healthcare professionals continues to be positive with efficacy, duration of response, and safety being the key drivers of adoption. HCP awareness of Monjuvi's differentiated profile continues to increase and the L-MIND three-year results have been well received by the physician community. As patients continue to return to the office and as our reps continue to educate healthcare professionals on the clinical profile of Monjuvi, we are confident in our ability to build on this improving momentum. Turning to slide 9, we are very excited to receive the approval of Opzelura, the first FDA approved topical JAK inhibitor for the treatment of mild-to-moderate atopic dermatitis. Prior to launch, we had identified 11,000 dermatologists and high priority allergists, the top 20% of which are responsible for nearly 80% of atopic dermatitis prescriptions. Our patient assistance programs are in place to help reduce barriers to access for Opzelura and our negotiations with payers are advancing well. To date, we have made significant progress with our stakeholders in the launch of Opzelura. Since our launch on October 11, our field-based representatives have actively engaged with 76% of our target prescribers and have conducted 8,500 HCP calls in the first three weeks of launch, of which 90% are being conducted in person. We're also receiving a significant amount of interest in Opzelura from patients, and in the first two weeks of launch, we have approximately 61,000 unique website users and this number continues to climb, further highlighting the level of engagement from patients. There were over 1,500 patient registrations for our co-pay card program. And lastly on the payer front, our discussions with PBMs, which include the top three who account for nearly 80% of commercially insured patients in the U.S., have been very positive as they realize the value proposition of Opzelura. As a result, we expect to secure broad coverage in Q1 of next year. In the meantime, during this contracting period, we have multiple efforts underway to ensure patients are able to access their medication. Although it is still early in launch, our efforts are translating into the first signs of a very successful launch. As you know there are limitations to the accuracy of script data, it is important to note that IQVIA's capture rate of prescriptions are under-representative of actual demand, especially in the initial weeks of launch. Over time, the capture rate is expected to continue to improve. There are two different metrics that we're using to track performance consisting of new brand -- new-to-brand Rxs and 867 data. New Rx data, shown on the left, captures the patients who are either new to the market or have switched to Opzelura. In the first two weeks of launch, there have been close to 1,000 new-to-brand prescriptions, with nearly two-third of scripts coming from patients who were previously on topical corticosteroid therapy. On the right hand side, we are showing 867 data, which is the number of units of Opzelura 60-gram tubes that our wholesalers are shipping to pharmacies. While 867 data doesn't translate directly into scripts, we believe it captures demand appropriately, given the low level of inventory retail pharmacies typically hold for specialty dermatology products. Pharmacies order Opzelura when a prescription is received and approved by the patient's insurance or processed through our patient access programs. In its third week of launch, 1,115 tubes of Opzelura were shipped by wholesalers, bringing the total shipped since launch to over 2,200. Based on early data, we are now tracking towards 300 plus units shipped in the first four weeks of launch. Now, I'll turn the call over to Steven for a clinical update.
