Aurinia Pharmaceuticals Inc

Greetings and welcome to Aurinia Pharmaceuticals' third quarter 2021 results conference call. At this time, our participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Dana Lynch, Aurinia's Investor Relations and Corporate Communications. Thank you. You may begin.

Thank you, LaTanya, and thank you to those joining today's call to discuss ARINIA's third quarter financial results. Leading the call this morning are Peter Greenlee, President and CEO, and Joe Miller, Chief Financial Officer. Other members of the ARINIA Executive Team, Max Kalal, Chief Commercial Officer, Neil Solomons, Chief Medical Officer, and Robert Heisiger, Executive Vice President of Research, are also on the call and available for the Q&A portion of the agenda. Today, Peter will begin with an update on our progress with loop kinase commercialization, review recent and anticipated clinical and regulatory milestones for buccal sporen, as well as provide an update on the arrhenia pipeline. Then, Joe will discuss our financial performance in more detail. At this point, our participating executive team members are available for your questions. Today's press release announcing our financial results and recent operational highlights is accessible from our website at www.IraniaPharma.com and has been filed on a Form 8K with the U.S. Securities and Exchange Commission. This afternoon, we plan on filing our financial statements and accompanying management discussion and analysis in the quarterly report on Form 10Q. During this call, we may make forward-looking statements based on our current expectations These forward-looking statements are subject to a number of significant risks and uncertainties, and our actual results may differ materially. For a discussion of factors that could affect our future financial results and business, please refer to the disclosures in our press release and our quarterly report on Form 10-Q once filed, along with our recent filings with the U.S. Securities and Exchange Commission and Canadian securities authorities. Please note that all of the statements made during today's call are current as of today, November 3rd, 2021, unless otherwise noted, and are based upon information currently available to us at this time. Except as required by law, we assume no obligation to update any such statements as of this date. Let me now turn the call over to Arunia's President and CEO, Peter Greenlee. Peter.

So thanks Dana, and I want to thank everyone for joining us today. We're now well into the launch in the U.S., and I'm happy to report strong results for the third quarter. We continue to execute on our commercial strategy and increase access to and adoption of Leukinus for the treatment of adults with active lupus nephritis. This morning, I'll take you through our performance results, as well as provide you with some Leukinus clinical and regulatory updates. I'll also provide you with an overview of two exciting pipeline assets we've recently acquired. Finally, we will report our financial position and answer any questions that you may have. So let's start with our business performance related to the launch, starting first with the quarter. In Q3, we generated $14.7 million in net sales, which exceeded analysts' expectations and represents a 122% increase over the prior quarter. Since the launch in late January, our total recognized revenue is $22.2 million. Based on our current metrics and anticipated year-end results, we maintain our guidance in the range of $40 to $50 million for 2021. In the third quarter, we added 412 new patient start forms. While COVID-19 challenges with the Delta variant in southern states impacted PSF prescribing early in the summer, it should be noted that we saw a steady increase in prescribing rates throughout September and continuing into October. As of this week, we have now logged a total of more than 1,265 patient start forms year-to-date and remain optimistic that this upward momentum will continue. We also continue to see improvements in movement from patient start forms to patients on therapy, with a conversion rate in excess of 68% currently. This is up from approximately 50% in Q2. In addition, our time to convert is shrinking. Both 30 and 60-day conversion rates have continued to improve each month. On the payer coverage front, we continue to make progress, especially with regional and local plans. As of early October, we have confirmed Loop Kindness coverage through published payer policies for 65% of total lives in the market. Through patients gaining access to Loop Kindness, we have now confirmed coverage in plans covering 87% of total lives. While our goal is to ensure there are specific policies in place, healthcare professionals and patients are gaining access to Loop Kindness through medical justifications and working in conjunction with Arrhenius personalized patient support resources. We continue to work to make the access process as seamless as possible for providers and patients so that patients can quickly gain access and start our treatment. just over nine months post launch we're not slowing down our team continues to work tirelessly to educate professional and both professional and patient audience about lupkinis and the urgent need to diagnose and treat lupus nephritis patients as quickly as possible the most recent healthcare provider market research shows that lupkinis awareness has increased significantly with both rheumatologists and nephrologists and is on par with the competition, which, by the way, this competition has been on the market for over 10 years. Leukinus' remarkable clinical results continue to differentiate our product and bolster this awareness and confidence in prescribing. This week, Irinia has five presentations at two key medical meetings, the American College of Rheumatology and the American Society of Nephrology. These include data from our pivotal AURORA-1 study showing lupkinus efficacy in newly diagnosed patients and patients with severe lupus nephritis. An oral presentation at ACR will also feature an updated analysis of the AURORA-2 continuation study, assessing the safety and tolerability of lupkinus at 30 months. As a reminder, we expect to announce results from this continuation study looking at the final data from two additional years of lupkinase treatment, or three years in total, by the end of this year. This will represent the longest lupus nephritis treatment duration in recent studies. Lupus nephritis is a lifelong condition, and this long-term data will provide necessary support for HCPs, patients, and payers to safely continue lupkinus treatment beyond one year. So let's now shift to a look at the ongoing work to establish voxosporin as a global therapy. The EMA marketing authorization application, which as you recall was filed in June with our licensing partner Otsuka, remains on track for review. We continue to expect a CHMP opinion around mid-2022 and a final EMA decision sometime in the third quarter of 2022. As part of this submission, on October 1st of this year, Otsuka filed an MAA with the Swiss Agency for Therapeutic Products, or Swiss Medic, seeking approval for the use of Baclosporin in the treatment of adult patients living with active lupus nephritis. Additionally, Otsuka continues to work towards finalizing the timeline for the Japanese NDA regulatory filing with the PMDA to seek approval for Baclosporin in the treatment of LN in Japan. We continue to be pleased with this progress and look forward to supporting Atsuka in launching our therapy in these markets. And as we said before, reaching these milestones will provide us with opportunities to continue to strengthen our company's financial position as we work to globalize Loopkinus. Moving now to R&D updates. on august 17th of this year we announced the acquisition of two exciting and innovative additions to our pipeline the first of these compounds is aur 200 which is an fc protein targeting bath or b cell activating factor and april or a proliferation inducing ligand As you may know, both BAS and APRIL play a key role in B-cell-mediated autoimmune disease, and while this mechanism of action has been widely studied and we have proof of concept, we believe this compound has differentiated properties compared to those in development, and we're eager to establish those preclinically and then, of course, advance into clinical development. The IND for AUR200 is expected to be filed in late 2022. The second compound that we acquired is AUR300. AUR300 is a novel peptide therapeutic that modulates M2 macrophages, which is a type of white blood cell via the CD206 receptor. While there's less research with this mechanism of action, it has been established that dysregulation of M2 macrophages causes fibrosis, and with AUR300, the goal will be to reduce M2 dysregulation early and decrease fibrosis and inflammation. The IND filing for this compound is targeted for the first half of 2023. These transactions allow us to leverage our existing R&D capabilities in growing commercial experience. We strive to further diversify and grow our pipeline, which is a key strategic imperative for us and our goal to provide stakeholders with long-term value. In summary, we're making significant progress as we work to expand adoption of LoopKindness in the U.S., as well as other parts of the world. At the same time, in parallel, our R&D teams are committed to advancing our new pipeline assets and addressing autoimmune diseases beyond lupus nephritis. I'll be back to close out the call, but for now, let me ask Joe Miller to get into more specifics regarding our financial position. Joe?