Peter Greenleaf
Analyst · Cantor Fitzgerald. Your line is now live
Hey, thanks, Glenn, and I want to thank everybody for joining us this afternoon. So, through the first half of 2021, we've made significant progress against all aspects of our company strategy. And today, we're going to walk you through the four major areas of focus for Aurinia and provide you with details on our execution and results achieved to-date. The first and by far the most important at this stage is our progress at the U.S. launch of LUPKYNIS for the treatment of patients with active lupus nephritis. We will briefly walk you through the work we are doing to expand access to LUPKYNIS, which includes our global regulatory filings and our continued focus on generating new data for patients living with LN. From there, we'll provide you with an update on our financial position and runway as a company and then lastly, we will touch on where we see Aurinia strategically and operationally by the end of 2021. After all this, will open up the microphone to you all to see what questions you may have. So, here we are, we're well into the summer and just over five months into the LUPKYNIS launch. I guess needless to say that we generated a lot of data points up to this point to supplement our prelaunch research and continue to learn more now that we actually have entered the real-world environment including lupus nephritis patient characteristics and healthcare professional attitudes and behaviors. With this ongoing understanding of the market and just under two quarters of commercial availability, our confidence with LUPKYNIS remains undiminished. Let's start with the primary key metric for the second quarter, patient start forms, which as a reminder, equates to LUPKYNIS prescriptions being written for patients. There were 415. That's up approximately 60% from the first quarter. We see this as a clear signal of generating momentum in the adoption of LUPKYNIS. As you know, lupus nephritis is a rare disease. We've said that from the outset. The majority, if not all of the medications used by physicians to treat the disease are unapproved generic treatments that have been used for the last 20 to 50 years. So, prior treatment regimens are all the healthcare professionals and patients have known historically. Education and new products and adoption of new treatment approaches takes time, but I'm happy to tell you that our data and promotional efforts to date are having real impact. Next, let me walk you through our revenue performance for the quarter and provide some context because there is a positive message here as well. In Q2, we generated $6.6 million in net sales. This number exceeded consensus expectations for the quarter and shows the type of ramp we have expected with the new drug and an indication that did not historically have an FDA-approved treatment. We believe this in combination with the prevailing wins of the COVID environment is a significant result. Okay, let's move on to some other positive trends. As of today, patient start forms are well north of 800 to-date and our conversion rate to patients on therapy continues to increase from what we last reported at the end of Q1. On the payer coverage front, LUPKYNIS is currently covered for over 110 million lives in the United States and we are continuing to pursue further coverage. To provide some added granularity behind that number, there are, as of today, at least 50 published LUPKYNIS clinical coverage policies. Importantly, the prior authorization requirements across these policies are very much in-line with the package insert and in fact, the restrictions are less onerous than what we had originally expected. All are reasons to be optimistic. We believe this trend will continue to grow for the remainder of 2021 and drive down our time to starting therapy and drive up our overall conversion rates. In addition, I can also report that the rate of prescription abandonment to date so far has been low and so far, albeit it is early on in the launch, our rate of compliance is also exceeding our initial launch expectation. In the face of these results, we have also experienced some challenges and acted on many key in-market learnings. The most prominent of these of course is the pandemic. Now, I think you've all heard the impact of COVID on patients either postponing or canceling care and treatments for all types of conditions, but I'm here to tell you that the impact on lupus nephritis patients has been particular problematic. Treatment used by patients is down, no matter which metric you look at. Almost 10% of LN patients completely exited the healthcare system in 2020, while diagnostic kidney biopsies which is how lupus patients are diagnosed with lupus nephritis, are down 22% compared to before the pandemic. So, the addressable population of lupus nephritis patients was reduced by a material extent just as we were approved for use. Of course, this impacts the initial rate by which things can initially ramp up. But regardless, the pandemic-related factors that have been impeded [ph] access to healthcare today will recede and hopefully refer back to pre-pandemic levels over time. And we are also being proactive and have implemented definitive steps to help identify more patients more rapidly and drive LUPKYNIS adoption. Our sales, marketing and medical affairs effort have together made an important impact for patients. The team has conducted more than 30,000 calls on target clients to date. This is due in part by us taking an early stand on vaccination and I'm glad to report that nearly all of our field force has been vaccinated. The Aurinia team is also gaining greater access to healthcare professionals as COVID restrictions begin to ease, which is especially noticeable in the northeast and out in the west regions. The percentage of live calls also increased from the first quarter to 80% of interactions versus where we were the last quarter. And internal and external market research has reported that LUPKYNIS efficacy message is resonating favorably with healthcare professionals with a high level of recall. The implication of that is that more clinicians we can visit and communicate this powerful message to, the more prescribing will result. Through all of these efforts, we have seen the physician intent to treat continue to increase. We are seeing both the community and the large lupus centers and increased responses from both rheumatologists and nephrologists. While we only aspire for more, I can tell you that our efforts to date have been on target. Knowing there is more to do, we will continue to execute with tremendous urgency and our entire Aurinia team remains committed to realizing the true potential of LUPKYNIS for patients living with lupus nephritis. So, with all this in mind, I want to provide some guidance on where we feel the full-year will shake out. I'm often asked this and why we still think it's very early in the game. We would like to provide some steer on how we see the first year revenue landing. Based upon a number of factors including the current growth rates, expected conversion rate improvements, payer reimbursement, attrition rates, and our compliance estimates, we believe that our 2021 net revenue will land in the range of consensus and currently forecast net revenue between $40 million and $50 million for kindness after the first 11 months of marketing. Now I'd like to shift our focus beyond the U.S. and onto our efforts to make Voclosporin the global therapy. We're pleased to announce that in June, that our ex-U.S. partner Otsuka submitted the MAA for Voclosporin seeking regulatory approval for the treatment of adults with active lupus nephritis in Europe. With the application filed, we still expect a standard 12-month review cycle, meaning that a CHAMP opinion should be made around mid-2020, followed by an EMA decision anticipated in the third quarter of 2022. Just as a reminder approval in the EMA will result in the achievement of additional milestone payments of up to $30 million to Aurinia, as well as the ability to earn low double-digit tiered royalties on sales along with further revenue for supplying the product to Otsuka. This all has potential to significantly strengthen our future financial position as a company. With regards to regulatory support and work going on for the JNDA filing in Japan, we, alongside of Otsuka are currently engaged in discussions with the PMDA. These early conversations have been encouraging and we look forward to providing updates as definitive filing timeline is determined. So alongside of our globalization efforts, we continue to drive new data for LUPKYNIS in 2021 and beyond. We see this as key to our objective of evolving the treatment paradigm. So, let me recap. This past May we announced a supportive interim analysis of the AURORA-2 continuation study, showing that individuals that were treated with LUPKYNIS sustained meaningful reductions in proteinuria with no change in EGFR at 104 weeks of treatment. The Aurinia team remains on track to achieve database lock for the AURORA-2 blinded two-year continuation study by the end of 2021. We are therefore updating our guidance and we'll report topline data from AURORA-2 by the end of this calendar year. We believe AURORA-2 will be critically important to support the longer-term treatment of LN with LUPKYNIS. In addition to AURORA-2, the team is finalizing the protocol and working to initiate VOCAL, which is the adolescent trial of Voclosporin in lupus nephritis. As well as the protocol for a lactation study with Voclosporin, which is all in alignment with our FDA post-marketing commitments. Additional Phase 4 work includes a lupus nephritis registry that we are initiating to explore additional real-world usage of LUPKYNIS and the research team is also evaluating novel-dosage formulations of Voclosporin including both oral and topical applications. Now moving on to the financials. Obviously, one important question is how much cash do we have on hand and is it enough to actually get us what we need to accomplish? With a cash position in excess of $320 million, we remain sufficiently capitalized to fund our current operations and execute on our longer-term strategy. While we don't run a static business year, things can always change, of course. We have no immediate needs to raise money. Something I'm proud to say that not every company in our position can report at this early stage of a launch. Our earlier cash runway guidance into 2023 remains consistent. Outside of performance, I'd like to take a moment to highlight some recent Board changes. One of our long-term Directors, Dr. Michael Hayden retired during the second quarter, which provided us with an opportunity to appoint Dr. Brenda Balakrishnan to fill the seat. Dr. Balakrishnan is a Group Vice President of Corporate and Business Development at BioMarin, where she leads initiatives on Corporate Strategy, mergers and acquisitions, partnering and licensing. We look forward to her contributions to the Board and leveraging her experience and guidance as we continue to build Aurinia. Finally, on the long-term strategy front, the company continues to evaluate strategic opportunities through external business development. We remain focused on identifying the right autoimmune disease assets for the right indication in an effort to provide our stakeholders with long-term value. We remain committed to building out and diversifying our pipeline and we expect to make progress on this key objective by the end of 2021. So, to sum it all up, we are seeing positive trends across almost every aspect of our business. We remain confident that we have a significant commercial opportunity with LUPKYNIS and we know that we have the right team, the right product and approach in place to get there. While I'll circle back at the end of the call to close things out, I'd like to now pass the baton over to Joe Miller, our CFO, to provide more color on the financials. Joe?