Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) Q4 2022 Earnings Call Transcript

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) Q4 2022 Earnings Call Transcript February 28, 2023

Operator: Greetings, and welcome to the Aurinia Pharmaceuticals Fourth Quarter and Full Year 2022 Results Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Dana Lynch, Aurinia’s Director of Corporate Communications and Corporate Affairs. Thank you. You may begin.

Dana Lynch: Thank you, Melissa, and thank you all for joining today’s call to discuss Aurinia’s 2021 fourth quarter and year-end financial results. Joining me this morning are Peter Greenleaf, President and CEO; and Joe Miller, Chief Financial Officer, who will be leading the call. Other members of the executive team, specifically, Max Colao, Chief Commercial Officer; and Dr. Neil Solomons, Chief Medical Officer, will be available at the conclusion of our presentation for the Q&A portion of the call. This morning, we issued a press release announcing our financial results and recent operational highlights and filed our Annual Report on Form 10-K. For more information, please refer to our filings with the U.S. Securities and Exchange Commission, which are also available on our website at www.auriniapharma.com.

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 Annual Report on Form 10-K, along with all of our recent filings with the U.S. Securities and Exchange Commission and Canadian Securities Authorities. Please note that all statements made during today’s call are current as of today, February 28, 2022, unless otherwise noted and are based upon the information currently available to us at this time. Except as required by law, we assume no obligation to update any such statements.

Let me now turn the call over to Aurinia’s President and CEO, Peter Greenleaf. Peter?

Peter Greenleaf: Thanks, Dana, and thanks to everyone for joining us today. 2021 was a transformational year for Aurinia. Across every part of the company, we achieved major strategic and operational milestones. With these achievements, we evolved from being a small drug development company with limited capabilities to become a fully integrated revenue-producing biopharmaceutical company. To start the year, we received U.S. FDA approval for LUPKYNIS in lupus nephritis, a serious and life-threatening rare disease, by demonstrating superior clinical results over the current standard of care. We jumped immediately into launching our first commercial product. And with that, we shifted from strictly cash utilization to cash generation and the ability to now treat and serve patients and health care professionals in the community.

In June, we hit another major milestone with the filing of a marketing authorization application for approval of voclosporin with the European Medicines Agency. This was a key step in globalizing our business alongside our partner, Otsuka, and in furthering our ability to serve patients beyond the U.S. To establish our leadership in lupus nephritis, we recognize that clinical evidence and the ongoing data generation is paramount to driving LUPKYNIS adoption, as well as establishing its duration of therapy. In June of last year, the Lancet published the LUPKYNIS pivotal registrational study, and in December, we also unveiled the positive results of the AURORA 2 continuation study. LUPKYNIS is now the first and only FDA-approved medicine for lupus nephritis with three years of pivotal trial results, including long-term safety data.

The AURORA 2 results will be submitted to the FDA in connection with our post-marketing commitments in the first half of this year, and will also be added to our package of information being submitted to the EMA, supplementing our already filed MAA. We filed this additional data, and we believe it will be important to prescribers in assessing the long-term benefits of using LUPKYNIS in the treatment of lupus nephritis. Finally, we took the first big step in 2021 towards diversifying our pipeline and driving new innovation with the acquisition of two preclinical compounds. With the addition of these assets, as well as building out our capabilities in research, translational medicine and process development, we have moved forward from a single-asset company to a now diversified integrated biopharma organization.

In a year of major milestones, I’m most proud of the team’s accomplishments in realizing our vision to serve patients impacted by this rare autoimmune disease. I’m confident that this work will, in progress, puts us in a position of strength to drive future growth. With that, all this context, I’m now going to move to provide further detail on, first, our fourth quarter and full year commercial results, followed by our outlook for 2022 with LUPKYNIS revenue guidance. I’ll then provide an update on our globalization efforts for voclosporin. And I’ll also touch on the status of our pipeline and give a preview of our anticipated business milestones. Finally, I’ll roll that all up and review our current financial position. So let’s begin with our business performance relative to the U.S. launch of LUPKYNIS.

In the fourth quarter, we generated $23.4 million in net sales, representing an increase of 60% from the prior quarter, bringing total recognized revenue for 2021 to $45.6 million, which is right on target with where we guided for 2021. We are very pleased with these strong results, especially considering we built our commercial team, launched our product and achieved all of these results while managing the impact and unpredictability of the ongoing and unprecedented COVID-19 global pandemic. Our commercial launch metrics and impact continue to improve across multiple dimensions. In Q4, we added 477 new patient start forms, ending the total year with 1,572 patient start forms. The months of October and November showed notable PSF growth over the prior quarter.

While December, we did see a slowdown in PSF, as the Omicron variant of COVID started to impact our prescriber and patient universe. In addition, we continue to see progress in moving PSFs to patients on therapy. 60-day PSF conversion rates are now in excess of 70%. We are also on track with ongoing improvements in both 30 and 60-day conversion rates each month. On the patient access front, we are making great headway. Aurinia has confirmed patient access to LUPKYNIS through payers and plans that represent roughly 90% of U.S. total lives. This notable improvement reflects the efforts of our access team and working with payers to develop more LUPKYNIS specific coverage policies and the efforts of our personalized patient support team to ensure that patients can begin treatment as quickly as possible.

Of course, and unfortunately, as more patients begin treatment with LUPKYNIS, we can expect to see some more patients discontinuations. While it’s still too early to see statistically significant trends in overall drop-off rates, thus far, discontinuations are aligned with what we tracked in our clinical trials, which is about 25% to 30%. When we look at patient adherence with LUPKYNIS, here, too, it is too early to cite emerging trends. Remember, the emerging LUPKYNIS patients on drug started treatment in mid-Q3 and Q4 of 2021. Obviously, in most cases, these patients have only been on treatment between three to six months, so we will need more time to understand overall adherence rates. As we gather more information on patient adherence and persistence, we will continue to work with our advocacy partners and through our personalized patient support resource, Aurinia Alliance, and direct-to-consumer activities to provide education, tools and support to ensure patients adhere to their treatment and to improve the continuity of their overall lupus nephritis care.

When we look at 2022, we have, thus far, experienced the same circumstances that most other specialty pharma companies worked through at the beginning of the calendar year. Changes in employer-covered insurance carriers and policies and patient co-pay resets can slow things down when getting patients off to a start or refilling their medications at the start of the year. And of course, the COVID pandemic, and in particular, Omicron variant, has significantly impacted our patient base and continues to impact access and continuity to overall treatment and care. This is reflected in our overall PSFs numbers to date, 1,773 since launch through last week. These results point to our strong first year, coupled with the slowdown during the early start of the second year.

We have confidence that our commercial capabilities that delivered on quarter — quarter-over-quarter growth in 2021, and we will continue to execute and drive growth. Building on the strong momentum we saw in Q4, and in spite of the challenges we’re seeing in Q1, we are setting guidance for revenue from sales of LUPKYNIS to be in the range of $115 million to $130 million for the fiscal year of 2022. This range represents an increase of more than 150% to 200% in revenue, which we see as aggressive growth year-over-year in light of the challenging environment we’re currently facing. We are confident we can achieve these results by driving new prescriptions and ensuring efficient and seamless conversion of patient starts to patients on treatment.

Our guidance does not include milestone payments, royalty or manufacturing revenue or anticipated ex-US sales related to our licensing agreement with Otsuka to market voclosporin in the European Union and Japan. As a reminder, Aurinia will receive up to $30 million upon EMA approval, contingent upon the favorability of the approved label as well as double-digit royalties — low double-digit royalties on sales and supply cost recovery through a cost-plus arrangement. As reported previously, we filed our marketing authorization application in Europe in June of 2021, and we’re working closely with Otsuka to support the approval process. This includes submission of answers to the standard 120-day questions posed by the European Medicines Agency as well as sharing our most recent AURORA 2 data with them.

We are pleased that the process has been moving along as expected, and we continue to expect EMA approval in the second half of 2022. Let’s now shift gears to research and development work we’re doing here at Aurinia. As I’ve mentioned, in December, we reported on the final positive results of the AURORA 2 continuation study. Data from this study, which looked at 216 patients continuing from AURORA 1 study for an additional 24 months of treatment, reinforces the favorable risk-benefit profile of LUPKYNIS over a three-year period with safety comparable to that seen in the original AURORA 1 as well as sustained efficacy. We plan to submit a manuscript for peer review publication in the first half of this year as well as abstract submissions for presentations at major scientific conferences throughout 2022 and 2023.

All of this activity should provide further support for healthcare professionals, patients and payers to safely continue LUPKYNIS treatment beyond one-year of therapy. Other LUPKYNIS clinical work will be ongoing this year as well with the continued recruitment of patients into the vocal pediatric study and the setup of trial sites for the ENLIGHT-LN REGISTRY. To remind you, we aim to initiate up to 75 sites in the US for this registry study and plan to leverage real-world data collected to gain further knowledge about patients and LUPKYNIS. The insights we gained from this study would then be shared with clinicians and payers to improve patient care and ensure access to therapy. Our research team continues to drive IND-enabling work on our pipeline assets, AUR200 and AUR300, and we plan to submit INDs for both compounds in 2023.

As you can imagine, these are important next steps in the build-out of our pipeline for the future. I’m happy to report that all of this work achieved, we continue to operate with a healthy balance sheet, including approximately $466 million of cash equivalents and investments on hand and no outstanding debt. With the strength of our balance sheet and the cash flows incoming from LUPKYNIS, we can fund our business for the next few years. I will now turn the call over to Joe Miller for more detail on these activities in our financials. I’ll return at the end of the call to recap and also to answer any questions you might have. Joe?

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Joe Miller: Thank you, Peter, and good morning, everyone. As Peter previously stated, as of December 31, 2021, Aurinia had cash and cash equivalents and investments of $466.1 million compared to $422.7 million at December 31, 2020. The increase was primarily due to the receipt of net proceeds from the company’s ATM offering, cash receipts from the sale of LUPKYNIS and cash proceeds from the exercise of stock options and warrants, offset by the commercial infrastructure spend to support the launch of LUPKYNIS. It also includes payments for inventory and upfront payment made as part of our collaboration agreement with Lonza to build a dedicated manufacturing capability for our monoplant and an upfront license payment related to our recently acquired developmental programs, AUR200 and AUR300.

As a reminder, in the prior year, the company was still in the FDA pre-approval phase of LUPKYNIS and was only in the beginning phase of building out its commercial and back-office infrastructure. Regarding the ATM mentioned early, we raised net proceeds of $196.7 million in the fourth quarter at an average price of $19.91. The company has terminated this ATM effective as of today. There will be no more sales under the ATM. We believe that we have sufficient financial resources to fund our current plans, which include funding commercial activities, including FDA-related post-approval commitments, manufacturing and packaging of commercial drug supply, funding our supporting commercial infrastructure, conducting planned research and development programs, investing in our pipeline, executing on our business development strategy and funding our operating activities for at least the next few years.

Total net revenue was $23.4 million and $50 million for the quarters ended December 31, 2021, and December 31, 2020, respectively. Total net revenue was $45.6 million and $50.1 million for the years ended December 31, 2021, and 2020, respectively. The net revenue for the quarter ended and year ended December 31, 2021, primarily consisted of commercial sale of LUPKYNIS following FDA approval in January of 2021. Total revenue for the quarter and year ended December 31, 2020, was primarily due to an upfront payment from Otsuka of $50 million, resulting from entering into our collaboration agreement with them. Cost of sales were $500,000 and zero for the quarters ended December 31, 2021 and December 31, 2020, respectively. Cost of sales were $1.1 million and zero for the years ended December 31, 2021, and December 31, 2020, respectively.

In 2020, the company did not have any drugs approved for commercial sale and the upfront payment from Otsuka did not have cost of sales associated with it. Gross margins for the 3 and 12 months ended December 31, 2021, was approximately 98%. Selling, general and administrative, SG&A expenses were $44.2 million and $38.8 million for the quarters ended December 31, 2021, and December 31, 2020, respectively. For the years ended December 31, 2021, and 2020, SG&A expenses were $171.4 million and $96 million, respectively. The increase for both periods was due to an increase in employee-related costs associated with the expansion of the commercial and administrative functions to support the launch and commercialization of LUPKYNIS, which ramped up during the third quarter of 2020.

Also contributing was an increase in travel, trade shows and sponsorships connected to sales activity occurring throughout 2021. Non-cash SG&A share-based compensation expenses was $7.2 million and $4.5 million for the quarters ended December 31, 2021, and December 31, 2020, respectively. For the years ended December 31, 2021, and 2020, SG&A non-cash share-based compensation expense was $26.4 million and $13.6 million, respectively. For the quarters ended December 31, 2021, and December 31, 2020, research and development expenses were $11.1 million and $13.2 million. The primary driver for the decrease was due to the decrease in employee-related costs due to the allocation of certain costs post-FDA approval to SG&A and the termination of certain programs in late 2020.

For the years ended December 31, 2021, and December 31, 2020, R&D expenses were $51.1 million and $50.3 million, respectively. The primary drivers for the increase were due to an upfront license and accrued milestone expenses related to our recently acquired developmental programs, AUR200 and AUR300, and higher clinical research organization expenses related to its new clinical programs, offset by a decrease in voclosporin development costs following the approval of LUPKYNIS. Non-cash R&D share-based compensation expense was $1.2 million and $600,000 for the quarters ended December 31, 2020, and December 31, 2020 €“ I’m sorry, for the quarters ended December 31, 2021, and December 31, 2020, respectively. For the years ended December 31, 2021, and 2020, R&D-related non-cash share-based compensation expense was $4.4 million and $3.7 million, respectively.

For the quarters ended December 31, 2021, Aurinia reported a net loss of $33.3 million or $0.25 net loss per common share as compared to a net loss of $8.1 million, or $0.06 net loss per common share for the quarter ended December 31, 2020. For the years ended December 31, 2021, Aurinia reported a net loss of $181 million or $1.40 net loss per common share as compared to a net loss of $102.7 million or $0.87 net loss per common share for the previous period. With that, I would like to hand the call back over to Peter for some closing remarks. Peter?

Peter Greenleaf: Thanks, Joe. As you heard throughout the call, made a profound impact in 2021, delivering a safe and effective treatment to a patient population with high underserved needs and growing our company to ensure continued commitment to our mission of serving patients for the years to come. I want to thank everyone again for joining us today. We’ll now open up the microphone to your questions.

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Q&A Session

Operator: Thank you. Our first question comes from the line of Alethia Young with Cantor Fitzgerald. Please proceed with your question.

Alethia Young: Hey guys. Thanks for taking my question. Maybe just one and maybe 1.5. Just could you talk a little bit more maybe about the potential cadence of the COVID-19 impacts that you’re seeing. Do you expect it to kind of be sustained over the year? Is that what you’re factoring in? And then also, can you just characterize how these impacts are different than what you may have seen in the first 12 months of launch last year versus what’s been going on with Omicron? Thank you.

Peter Greenleaf: Thanks, Alethia, and appreciate the question. So the way — because we’re not giving quarter-on-quarter guidance, but we try to be pretty clear in the call that most like any specialty pharma company out there in the space, we’re seeing the typical start of year impact of things like patients having insurance plan changes, copay resets, et cetera. And then on top of that, of course, we had the Omicron variant impact, which impact the last couple of weeks of December and into January, which we do see starting to improve. So there’s two ways, I guess, I would think about this with respect to giving annual guidance, but not quarterly guidance. We hope the Omicron variant impact will start to lessen. And then on a year-on-year basis, I think every January, early February time period in our business, this will be a continuing impact, just like it is for any company that’s marketing and selling drugs in our space today.

So if I were thinking about it from a gating standpoint, we anticipate the first quarter being impacted and then getting back to a healthy growth pattern into Q2 through Q4 of the year.

Alethia Young: Okay. And just to clarify because I’ve gotten this question already. You guys feel confident about the trends that are underlying? The launch besides the things that you’ve highlighted like COVID and payer dynamics in the first quarter, but you feel like the trends and growth are still there for this product that begins ?

Peter Greenleaf: That’s correct.

Alethia Young: Awesome. Thank you, guys.

Peter Greenleaf: Thanks, Alethia.

Operator: Thank you. Our next question comes from the line of Maury Raycroft with Jefferies. Please proceed with your question.

Maury Raycroft: Hi, good morning and thanks for taking my questions. I was just wondering if you could provide more specifics around reasons for discontinuation and adherence challenges, and how this compared to what you saw in clinical studies? And if you can talk more about your assumptions for 2022 and how you talked a little bit about managing some of these issues throughout the year. Can you talk more about how you’re planning on doing that?

Peter Greenleaf: Sure. So on discontinuations and adherence, I would tell you that the reasons are across the Board. What I would underscore is, they’re not payer related. It’s not like we’re getting PSFs that come in and then the payer is not paying for the drug. That’s not been one of the ones we’ve seen. But to try to range in on a host — from a host of different reasons as to why patients might be discontinuing their product, it’s kind of across the board right now. Everything from tolerability to patients just not picking up prescriptions, which we are trying to flesh out more. Remember, we’re dealing with primarily a patient population that’s an African-American, Hispanic and Asian female population in the U.S., and we can look to other disease states as analogs to understand that adherence and longer-term compliance are a challenge with that population in general.