Helen Torley
Analyst · Corinne Jenkins. Your line is open
Thank you, Tram and good afternoon everyone. I'll begin on slide three. Our accomplishments in the first half of the year are illustrative of the many opportunities Halozyme has to continue to enhance our growth. With the acquisition of Antares, which further expanded our growth opportunities, adding a best-in-class auto-injector vector platform and a specialty commercial business, thereby augmenting Halozyme's strategy. These additions further strengthened our position as a leading drug delivery company and expanded our strategy to include specialty products. And we continue to deliver operational excellence, achieving multiple drug delivery, commercial and corporate development milestones. I'm happy to report that integration activities are proceeding to plan as we approach the 90-day time point, and we're on track to achieve the goals we established. It is this combination of opportunity and execution that gives us confidence in our differentiated growth story. Focusing now on the financial performance highlights, we reported second quarter revenues, inclusive of Ontario's revenue post the May 24th acquisition close of $152.4 million, a 12% year-over-year increase. This resulted in GAAP earnings per share of $0.16, and non-GAAP adjusted earnings per share of $0.53. Our strong second quarter revenue results were driven by continued growth in royalty revenues from ENHANCE and the addition of the post-close royalty revenues from auto-injector devices and product sales as a result of the Antares acquisition. Based on the recent close of the Antares transaction and strong year-to-date results, together with the latest information from collaboration partners and planned expenditures for the year, we are raising our guidance for 2022. For full year 2022, we expect total revenues of $655 million to $685 million, an increase from our prior guidance range of $530 million to $560 million. This represents growth of 48% to 55% over 2021 total revenue. GAAP diluted earnings per share is updated to $1.20 to $1.25, a decrease from our prior guidance of $1.90 to $2.05, mainly due to acquisition-related costs in the current year. Adjusting for acquisition-related costs and other adjustments, we expect non-GAAP earnings per share to be $2.10 to $2.25, an increase from our prior guidance range of $2.05 to $2.20, representing an increase of 5% to 12% over 2021, non-GAAP diluted earnings per share. Let me now move to slide 4, and I'll provide some more detail on royalty revenue performance. We continue to see and project robust growth in this high-margin recurring revenue stream. In the second quarter, total royalty revenue was $85.3 million, representing 86% growth over the second quarter of 2021 and 23% sequential growth. These results include ENHANZE royalty, and we encourage drug-device royalty stream for the portion of the quarter that follows the May transaction close. Royalty revenue growth continues to be driven by our Wave 2 product launches, led by the successful ongoing global launches of Janssen's subcutaneous formulations of DARZALEX and also by Roche’s Phesgo. Based on strong momentum, we project an increase in royalty revenues for 2022. Year-over-year growth is now projected to be greater than 65%, resulting in royalty revenue of $340 million to $350 million, an increase from our prior projection of 50% growth. This increased growth is driven by the addition of the ENHANZE device royalty revenues and DARZALEX subcutaneous performance. Turning now to slide 5. I will provide some more color on DARZALEX and DARZALEX subcutaneous performance. Janssen’s parent Johnson & Johnson reported second quarter worldwide sales of DARZALEX, including both the IV and subcutaneous forms of $2 billion, an increase of more than 46% year-over-year on an operational basis. The company notice that DARZALEX sales was driven by share gains in all regions, strong continued uptake and increased use of subcutaneous formulation. Moving to subcutaneous DARZALEX, SC share continues to grow in the United States during the second quarter with an 83% end of quarter share based on Symphony data. This is an increase from 80% share at the end of the first quarter. Additionally, Johnson & Johnson reported SC conversion grew to 80% in Europe. Moving now to the recent results by our partner Roche for the second quarter of 2022, Roche reported strong sales of Phesgo their combination treatment for patients with breast cancer that utilizes the ENHANZE technology. As a result of ongoing conversion and geographic expansion, second quarter sales of Phesgo were CHF325 million, an increase of 241% year-over-year. Phesgo with a short five to eight minute subcutaneous administration plan is proven to be an attractive option for patients with healthcare systems, especially in countries where infusion capacity is limited with some countries now reporting up to 90% adoption. We continue to expect strong quarter-over-quarter growth as a result of the ongoing launches in Europe and rest of world and through continued penetration in oncology accounts in the United States. We're also excited that Roche is initiating a study of Phesgo with giredestrant in frontline encouraging positive, ER positive metastatic breast cancer patients, opening up the potential for a future oral and subcu treatment regimen. And just a brief comment on Wave 1 products, which include MabThera subcutaneous, which is also called Rituxan Hycela or subcutaneous Herceptin or Herceptin Hylecta. We continue to project a modest decline in royalties from these mature products as a result of the ongoing impact related to biosimilar competition to the IV product. I will note that these products are still contributing nicely as a recurring source of revenue. Illustrated on Slide 6 is an overview of the ENHANZE portfolio. I'll focus your attention on Wave 3 and 4, which represent new royalty revenue opportunity for Halozyme. Our Wave 3 products represent the next set of opportunities with potential launches protected between 2023 and 2025. You will note that we've expanded Wave 3 to four products, as we are now including OCREVUS following the recent update from both the top line data from the Phase 3 SC study will be available in 2023.
.: The study showed non-inferior levels of Tecentriq in the blood were injected subcutaneously compared with intravenous infusion in immunotherapy-naive patients with advanced or metastatic non-small cell lung cancer for whom prior platinum therapy has failed. The safety profile of the subcutaneous formulation was also consistent with IV Tecentriq. We believe these positive results further demonstrate the opportunity for our core formulation of ENHANZE to potentially benefit patients by reducing the treatment time for Tecentriq to three to eight minutes as a subcu delivery, down from 30 to 60 minutes for IV treatment. Roche plans to serve findings of the study at an upcoming medical meeting and submit for regulatory approval to health authorities globally, including the US Food and Drug Administration and European Medicines Agency. During the first half of 2022, Tecentriq administered intravenously, had revenues of CHF1.8 billion, growing 11% year-over-year, with Roche reporting strong uptick in lung cancer in the adjuvant setting. I'll move now to argenx and efgartigimod. Following positive results announced in March of 2022, argenx is on track to submit the biologics license agreement for efgartigimod with ENHANZE in Myasthenia Gravis to the US Food and Drug Administration by the end of this year. We believe efgartigimod SC is on track to be the first of our Wave 3 potential partner launches with potential approval anticipated in 2023. efgartigimod IV, which has a brand named Five Guard, was approved by the FDA in December of 2021 and in Japan in January of 2022 for the treatment of adult patients with generalized Myasthenia Gravis. On their recent second quarter call, Argenx reported a strong global launch for byproduct with Q2 revenues of $75 million, with an estimated 1,400 patients on treatment, up from approximately 400 patients in Q1. argenx management further commented that efgartigimod with ENHANZE is currently being evaluated in four additional indications with multiple data readouts projected in 2023 including data in idiopathic thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy and Penthagus [ph]. With analyst consensus of almost $3 billion in sales for efgartigimod in 2026, we were excited to be partnering with argenx on this important new therapy for auto immune diseases. In closing, out of the Wave 3 products, BMS continues with their evaluation of nivolumab subcu in their Phase III study. I'll move now to Slide 8, illustrated on Slide 8 is the enhanced pipeline by stage of development. Our goal remains to continuously expand the number of products that are in development and to advance products to major stages of development and launch with many of these events resulting in milestone revenue payments to Halozyme. Highlighted on this slide are the wave four potential launches. These products, if they continue in development have the potential to launch in the 2025 to 2027 time frame. 11 partner products are an ongoing Phase I clinical testing or has completed Phase I testing. Let me provide some key updates during the quarter. Chugai initiated a Phase I study to evaluate the pharmacokinetics, pharmacodynamics and the safety of a targeted antibody administered subcutaneously with ENHANZE. It is notable that we announced our collaboration and licensing agreement with Chugai in March of this year, making this the fastest time to Phase I dosing in our history at just over two months. This is a strong signal that this collaboration is off to a great start. In June, our partner ViiV initiated enrollment in a Phase I single-dose escalation study to evaluate pharmacokinetics, safety and tolerability of long-acting cabotegravir administered subcutaneously with ENHANZE. This is the second target and the third trial to be initiated since we announced this agreement just over a year ago. Additionally, our partner Takeda recently reported positive top line results for their Phase III ADVANCE-1 clinical study of HYQVIA, which is Immune Globulin 10% with ENHANZE in patients with chronic inflammatory demyelinating polyneuropathy, which is also called CIDP, and is a rare autoimmune disease. The clinical study met its primary endpoint for maintenance treatment of CIDP and Takeda plans to submit applications for HYQVIA's regulatory approval in the United States and European Union by the end of 2022. In addition to these significant advances in the first half of the year, we continue to expect further pipeline progress and expansion for the remainder of the year. We project this will result in more than 10 new study starts in 2022, including more than six new Phase II or Phase III trial starts for existing enhanced partner programs and two new products entering the clinic this year. You may also have noted that we recognized $15 million in collaboration revenue in the second quarter. This is related to an anticipated study start by a partner in the third quarter. And concluding this ENHANZE development program overview, I'm pleased to announce that in June, BMS nominated an undisclosed target, resulting in a $5 million payment. This will add to BMS' ongoing portfolio, which includes a subcutaneous version of nivolumab, which is in Phase III testing and a subcutaneous nivolumab relatlimab combination which is in Phase I development. We are very pleased with the progress over to the partner development pipeline, and we look forward to supporting the significant enhanced growth opportunities that these represent. And I'll give you a bit more color regarding the Antares acquisition and our integration progress since this transaction closed on May 24. Summarized on slide nine is the current Antares portfolio. Our excitement regarding the new opportunities that the Antares portfolio brings is high, with decades of experience in device development, engineering, we gained a strong internal development team who specialize in creating custom-design drug delivery devices that are tailored to the patient and their therapeutic need. We’ve activated teams made up of individuals from both companies whose goal it is to expand the number of companies licensing our auto-injector technology. Work is also underway to design and create a large volume auto-injector, which, by combining the innovative Antares auto-injector platform with ENHANCE, will offer a unique approach for patient-friendly subcutaneous treatment delivery. What is so exciting is that we see opportunity for large volume subcutaneous delivery across the spectrum of disease areas for both small molecule drugs and biologics. The strong cultural fit across our companies, including a focus on innovation for patients have meant that the teams are hitting the ground running. We are also excited to have added three proprietary products, XYOSTED TLANDO, and NAPTURNA [ph]. Our focus with XYOSTED, our weekly virtually painless subcutaneous testosterone replacement treatment, which is delivered by auto-injector is to grow share through gaining patients who previously have been receiving intramuscular treatment. I'm pleased that XYOSTED achieved its highest number of weekly prescription is recently, a sign of its continued growth. And with our field force expense and executed, we launched TLANDO several weeks ago in June. Our access team is focused on gaining and then expanding payer coverage as our field team is educating physicians on TLANDO a twice-a-day oral testosterone replacement treatment that does not require dose titration. Moving now to slide 10, the acquisition of Antares through revenue resulting from commercial product sales and from the innovative autoinjector platform, is projected to add durable revenue and revenue growth on top of the already strong revenue growth to can we see for ENHANZE. Our projected ENHANZE growth is resulting from growth in royalty revenues from the multiple waves of potential new launches we have just discussed. Moving now to slide 11, the Antares acquisition fully aligned with our previously announced capital allocation priorities. These priorities were to invest maximize ENHANZE revenue growth and durability, to continue to return capital to our shareholders through share repurchases, and to seek to acquire a platform technology that would add to and further extend our revenue durability. As you can see from the updated guidance for the year and in line with our prior comments, the transaction is expected to be accretive to Halozymes' 2022 revenue and non-GAAP earnings and supports our growth strategy to 2027 and beyond. I'll now turn the call over to Nicole to discuss our second quarter financial results. I'll provide more detail on the combined company guidance. Nicole?