Thank you, Tina, and good morning, everyone.
The first quarter was one with multiple achievements for Horizon.
First, we completed the acquisition of Viela Bio, advancing our position as a high-growth biotech by adding a deep, mid-stage biologics pipeline, expanding our R&D capabilities, particularly in early-stage research, and diversifying our portfolio with the on-market rare disease biologic UPLIZNA. We now have a total of 22 development programs in our pipeline, including eight trials scheduled to start this year. We initiated the relaunch of TEPEZZA in mid-April after receiving FDA approval in March for the increased scale manufacturing process for TEPEZZA. This followed the temporary supply disruption that began last December, which was the result of the U.S.-government mandated COVID-19 vaccine orders.
We are advancing our global expansion strategy with today’s announcement of our plan to build out our European infrastructure to launch UPLIZNA in Europe, if approved. We anticipate approval in the first quarter of 2022.
Our geographic expansion strategy includes introducing TEPEZZA in Japan as well as other markets, establishing a platform for the future launch of additional medicines outside the United States, and we made significant progress here as well. We generated strong growth from our orphan disease medicines KRYSTEXXA, RAVICTI, PROCYSBI and ACTIMMUNE.
We also received multiple best-workplace awards since the start of this year, including the number one ranking on Fortune’s Best Places in Biopharma 2021, and the number three ranking, the highest-ranked biopharma company on the prestigious Fortune’s Top 100 Places to Work list; a tribute to the strong engagement of our employees and an important factor in hiring and retaining talent in the highly competitive biotech sector. Starting with Viela, which brought us four candidates in nine development programs and considerably expanded our pipeline across all phases of clinical development, and is strategically aligned with our therapeutic areas of focus. Viela’s R&D team enhances our ability to innovate with its broad experience in biologics, its strong early-stage research and translational capabilities and its deep scientific knowledge of autoimmune and severe inflammatory diseases.
Finally, the acquisition diversifies our on-market medicine portfolio with the addition of UPLIZNA, an infused biologic medicine indicated for the rare disease neuromyelitis optica spectrum disorder or NMOSD.
We have been impressed by the talent and expertise the Viela team brings to Horizon. Since completing the acquisition in mid-March, our teams have been working together to successfully integrate the two companies, and this morning we finalized and rolled out our fully integrated organization.
We are advancing and refining our strategy for the Viela development portfolio to maximize its potential.
Our near-term commercial priority is to successfully relaunch UPLIZNA for NMOSD in the United States and prepare for the potential launch in Europe. UPLIZNA was approved by the FDA in June of last year as the first and only B-cell depleter for the treatment of adult patients with NMOSD. This is a severe, rare, relapsing, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord and the brain stem. Manifestations of the disease include loss of vision, paralysis and also respiratory failure. B cells play a critical role in the pathogenesis of NMOSD, and B-cell depletion is a mechanistic approach preferred by physicians. Because UPLIZNA was launched during the pandemic and with relatively minimal resources, we are planning a full relaunch of the medicine, including expanding the size of the commercial organization.
We are applying key learnings from the successful strategies we used to launch TEPEZZA and relaunch KRYSTEXXA. A key component of that strategy is to invest in the marketing and field-based teams to ensure optimal support for UPLIZNA.
We are well on our way in our relaunch preparations and expect the results of our efforts to accelerate as we move throughout the second half of the year.
Our next steps for UPLIZNA include, adding sales representatives to maximize the opportunity in NMOSD; adding and applying our comprehensive patient services, site of care and payer support teams to optimize patient pull-through, which as we know from TEPEZZA and KRYSTEXXA, is critical to the success of rare disease infused medicines.
We are also leveraging our extensive TEPEZZA site of care network to support physicians in referring their patients to infusion centers, which was a particular challenge for UPLIZNA in its early launch.
We are investing in medical and scientific engagement to establish scientific leadership in NMOSD. This includes conducting further analysis of UPLIZNA clinical programs to expand the understanding of its differentiation, as well as continuing to build a base of compelling real-world evidence supporting the use of UPLIZNA. Important new data were recently presented at two key medical meetings, which Liz will discuss in more detail. This type of clinical analysis is core to our medical affairs and clinical strategy at Horizon to engage, educate and collaborate with the treating community. KRYSTEXXA is an example of how we have successfully executed this strategy. Keys to our commercial strategy are ensuring that physicians are aware of the benefits of UPLIZNA and how it is differentiated from other on-market medicines.
For example, we see multiple opportunities to differentiate UPLIZNA from rituximab, an off-label treatment that has been used to treat NMOSD given the lack of an approved medicine for this devastating disease. One important distinction is that UPLIZNA is a humanized monoclonal antibody targeting the CD19 receptor, while rituximab is a chimeric molecule targeting the CD20 receptor, which does not deplete plasma cells or plasmablasts. In NMOSD, autoantibodies are secreted by plasmablasts and plasma cells, and UPLIZNA depletes these pathogenic cells.
Additionally, UPLIZNA has shown a relatively low rate of anti-drug antibodies and infusion reactions, with recent data also confirming its long-term efficacy. Other benefits of prescribing UPLIZNA are resonating with physicians, including its convenience, favorable safety profile and well-understood mechanism of action.
Moving to TEPEZZA. TEPEZZA is the only approved medicine for the treatment of Thyroid Eye Disease, which is a serious, progressive and vision-threatening rare autoimmune disease.
As you are aware, we were in a temporary supply disruption of TEPEZZA throughout the first quarter with no supply since the end of December. This was due to U.S. government-mandated COVID-19 vaccine orders at our third-party drug product manufacturer, Catalent. This was very challenging for TEPEZZA patients and treating physicians, and certainly for our business. We understand how critical it was to accelerate COVID-19 vaccine production to save lives and hopefully end this pandemic.
Fortunately, we had already begun a process early last year to increase the scale with which we could fill and finish vials at Catalent. This increased scale allowed us to manufacture many more vials with each manufacturing run. This new manufacturing change required FDA approval and we submitted a prior approval supplement in January to the FDA. We were pleased to announce the FDA approval of that supplement in March, and we also announced resupply of TEPEZZA in mid-April.
While this has certainly been a very difficult situation for TED patients who had to stop TEPEZZA in the middle of their treatment and continue to live with the debilitating effects of TED, we appreciate the incredible commitment from the FDA, HHS, the White House and Catalent to work with us to expedite FDA approval and resupply TEPEZZA for patients as quickly as possible.
In addition to obtaining approval for the new increased-scale production at Catalent, we continue to make progress on our strategy to expand supply capacity, which includes adding a second drug product manufacturer by the end of this year. TEPEZZA has been available for about two weeks now, and we are extremely pleased with the progress we have seen. Patients are eager to resume or start therapy, and physicians are reengaging with their patients to help them get on treatment. The feedback has been overwhelmingly positive so far.
As we’ve seen since our launch, TED patients have built strong communities on various social channels and many have posted about how deeply thankful they are to resume treatment again. TEPEZZA is making a huge difference in their lives. We now have two types of patients who are now starting on TEPEZZA; disrupted patients who were on therapy, but had to stop treatment due to the supply shortage; and new patients who are starting TEPEZZA for the first time. With disrupted patients, we are making great progress early in the relaunch. To-date, about half of disrupted patients have already scheduled their infusions. Based on physician and patient research we conducted during the supply shortage, we expect the vast majority of disrupted patients to resume therapy.
While we’re only two weeks in, we are seeing evidence that this is happening as expected. The remaining disrupted patients continue to move through the process to get their treatment scheduled. The re-verification and scheduling processes can take up to a few months depending on the patient, their physician and their insurance provider. We planned for this, and our patient services team continues to do an incredible job communicating with each TEPEZZA patient throughout their journey.
We are very encouraged with the progress we have seen in the first few weeks.
Regarding new patients, as I mentioned on our last earning’s call at the end of February, despite the supply disruption, we continued to promote TEPEZZA and saw continued strong growth of patient enrollment forms or PEFs. We completed the expansion of our TEPEZZA commercial and field-based organization in the fourth quarter last year, which included the addition of sales representatives, patient access liaisons, regional reimbursement liaisons, site of care managers and medical liaisons. This expanded team continued to drive demand for new patients during the disruption, communicating frequently with their customers. Since our resupply announcement at the end of March, we have seen an acceleration in that PEF growth, and an impressive number of new prescribers are prescribing TEPEZZA each week.
In fact, since our last update at the end of February, the total number of PEFs has increased significantly, and we hit an all-time high for total monthly PEFs in April.
We have already seen a good number of new patients, whose PEFs were generated in the fourth and first quarter of this year, scheduled their first infusion.
While the accumulation of disrupted patients resuming treatment, along with the new PEFs generated in the fourth and first quarters, we have a unique dynamic occurring as we relaunch TEPEZZA. This will result in an unusual quarterly net sales progression, with the third quarter expected to be TEPEZZA’s highest net sales quarter of this year as we work through treating disrupted patients and adding the new accumulated patients.
As we have said, we are significantly increasing our investment in TEPEZZA this year, including in the first quarter, to drive awareness of TED and TEPEZZA, targeting not only TED patients but also those with Graves’ disease, to raise awareness of the connection between Graves’ and TED, and to increase the speed to diagnosis and treatment.
Our unbranded direct-to-consumer television campaign last year was highly successful, as evidenced by the fact that patients continued to search for TED specialists on the TED and TEPEZZA websites during the temporary supply disruption. On Monday, in addition to resuming our unbranded television campaign, we also launched our first branded TEPEZZA television campaign, which we expect to drive even broader reach and awareness for TED and TEPEZZA, motivating patients to seek treatment more quickly.
We expect the new DTC campaigns, which are national campaigns and will run through the rest of the year, to drive increased uptake of TEPEZZA as we progress toward our 2021 TEPEZZA net sales guidance of more than $1.275 billion.
We are highly confident in the growth prospects for TEPEZZA and continue to expect peak annual global net sales of more than $3.5 billion.
On the clinical development front, we expect to begin enrollment in our trial in chronic TED patients mid-year. In the meantime, we continue to see positive data published by physicians who have used TEPEZZA in treating their chronic TED patients as well as presentations of case studies at medical meetings.
We continue to expect more data to emerge throughout this year. With KRYSTEXXA, we reported first quarter net sales of $107 million, an increase of 14% versus the prior year despite the ongoing challenges associated with COVID-19.
We are encouraged by a recent increase we have seen in patient visits to rheumatologists, as well as the highest number of in-person calls by our sales team since the onset of the pandemic. Key to the long-term success of KRYSTEXXA is our immunomodulation strategy, and we continue to see increased use of KRYSTEXXA with immunomodulators as physicians become increasingly aware of the significantly higher response rate for KRYSTEXXA plus immunomodulation compared to KRYSTEXXA alone; between 35% and 40% of new patients are now using KRYSTEXXA plus immunomodulation. We attribute this to higher levels of clinical conviction for KRYSTEXXA among physicians who co-prescribe immunomodulators.
Our strategy for KRYSTEXXA is working, and it supports our expectation for strong growth again this year, with full-year 2021 net sales guidance of more than $500 million. It also supports our peak U.S. annual net sales estimate of more than $1 billion.
Our rare disease medicines, RAVICTI, PROCYSBI and ACTIMMUNE, all generated strong growth in the first quarter, driven by durable active shipping patient growth and continued high rates of compliance and adherence. I will now turn the call over to Liz.