Greetings, and welcome to the Aurinia Pharmaceuticals Fourth Quarter And Full Year 2021 Results Conference Call. At this time, all 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 Director of Corporate Communications and Corporate Affairs. Thank you. You may begin.
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 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 Administrators. 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 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.
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 US 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 healthcare 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 in 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 they'll 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 pre-clinical 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 and progress puts us in a position of strength to drive future growth.
With that all as context, I'm now gonna 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 pre-preview of our anticipated business milestones. Finally, I'll roll that all up and review our current financial position. 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 PSFs 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 in 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 patient discontinuations. While it is 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%-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 drugs 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 work through at the beginning of a 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 a year. Of course, the COVID pandemic, and in particular, the 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-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-$130 million for the fiscal year 2022. This range represents an increase of more than 150%-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-U.S. 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 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 U.S. for this registry study and plan to leverage real-world data collected to gain further knowledge about patients and LUPKYNIS. The insights we would gain 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 and our financials. I'll return at the end of the call to recap and also to answer any questions you might have. Joe?
Thank you, Peter, and good morning, everyone. As Peter previously stated, as of December 31st, 2021, Aurinia had cash and cash equivalents and investments of $466.1 million, compared to $422.7 million at December 31st, 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, an 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 and 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 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 thousand and $0 for the quarters ended December 31, 2021 and December 31, 2020, respectively.
Cost of sales were $1.1 million and $0 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 three 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 with the 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, 2021, 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 quarter 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 year 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?
Thanks, Joe. As you heard throughout the call, we've 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 wanna thank everyone again for joining us today. We'll now open up the microphone to your questions.
Thank you. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. In the interest of time, we ask that you each keep to one question and one follow-up. Thank you. Our first question comes from the line of Alethia Young with Cantor Fitzgerald. Please proceed with your question.
Hey, guys. Thanks for taking my question. Maybe just one and maybe a one and a half. Just could you talk a little bit more maybe about the potential cadence of the COVID-19 impact that you're seeing? Like, do you expect it to kinda 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, you know, what's been going on with Omicron? Thank you.
Thanks, Alethia, and appreciate the question. The way, 'cause we're not giving quarter-on-quarter guidance, but we tried to be pretty clear in the call that, most like any, you know, specialty pharma company out there in the space, we're seeing the typical, you know, start of year impact of things like, you know, patients having insurance plan changes, copay resets, etc. Then on top of that, of course, we had the Omicron variant impact, which impacted the last couple weeks of December and into January, which we do see starting to improve. 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.
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. If I were thinking about it from a gating standpoint, we anticipate you know the first quarter being impacted and then getting back to a strong you know a healthy growth pattern into Q2 through Q4 of the year.
Okay. Just to clarify, 'cause 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, you know, payer dynamics in the first quarter, but you feel like the trends and growth are still there for this product. Thank you.
That's correct.
Awesome. Thank you, guys.
Thanks, Alethea.
Thank you. Our next question comes from the line of Maury Raycroft with Jefferies. Please proceed with your question.
Hi, good morning, and thanks for taking my questions. I was just wondering if you can provide more specifics around reasons for discontinuation and adherence challenges. Excuse me. How these compare 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?
Sure. On discontinuations and adherence, I would tell you that the reasons are across the board. You know, what I would underscore is they're not payer- related. It's not like we're getting, you know, PSFs that come in and then, you know, the payer is not paying for the drug. That's not been one of the ones we've seen. To try to range in on, you know, 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, you know, tolerability to, you know, patients just not picking up prescriptions, which we are trying to flesh out more.
You know, remember, we're dealing with primarily a patient population that's an African American, Hispanic, and Asian female population in the U.S. We can look to other, you know, disease states as analogs to understand that adherence and, you know, longer term compliance are a challenge with that population in general. We're, you know, looking at this one closely, and when we have more data, especially on the adherence side, you know, the long-term persistency, we'll provide some guidance and steer there. As we said, since the majority of patients have gone on in the third and fourth quarter of this year to really report out on what three and six months persistency looks like, I don't think it'd be really a good characterization of where we are or where we're potentially going.
It's across the board, Maury. You know, it pretty much maps to what we saw in our clinical trials.
Got it. Okay. Maybe just a quick question. In your 10-K, you note that Sun filed an IPR against your 036 patent. I'm just wondering if you can comment on your latest thoughts on IP positioning and also this particular issue.
Sure. Let me actually take a minute to address this one. I want to thank you for the question. We did receive notice of an inter partes review or IPR petition being filed on February 24, with respect to our patent that has claims directed at LUPKYNIS, the LUPKYNIS dosing protocol for lupus nephritis used in our clinical trials. As you'll all recall, that patent has a term extending out to December 2037. At this stage, it's really too preliminary to give a full assessment of this IPR as a petition that was filed from Sun Pharmaceuticals, who you all may recall, if you've been reading our case, we are suing for patent infringement in a separate matter, which I'll talk about in a second, was really just received.
We're looking at it, but we're confident in our process to prosecute all our patents. This patent, in particular, had significant review, as we've mentioned previously at the U.S. Patent and Trademark Office, before being approved as being an actual valid patent by that office. We're putting together our reply, and as I've said before, we'll vigorously defend this patent and other challenges we get again from any party that bring any challenge to our patents. With respect to the separate litigation we have with Sun that I just mentioned, and as has been disclosed in our 10-K, in December of 2020, we actually commenced an action in the U.S. District Court in New Jersey against Sun and certain of their affiliates.
In summary, the action is a claim for patent infringement under U.S. patent laws arising relating to Sun's CEQUA product, which is a CNI immunosuppressant ophthalmic solution prior to the expiration of our patents relating to voclosporin's ophthalmic solution. Basically, in our action, we requested relief in form of an order confirming that Sun has infringed those patents and injunction preventing Sun from manufacturing, using or selling CEQUA and monetary relief, including costs. Obviously, Sun has responded by denying infringement and or asserting that the patents here are valid. We and Sun actually have exchanged initial pleadings and patent disclosures, and we're in the process of what lawyers call claim construction, and that's all ongoing. Trial action on this one is probably somewhere on or around March 2023.
That gives the full backgrounder on the previously mentioned Sun litigation and the IPR side of the equation.
Got it. Okay, that's helpful. Thanks for taking my questions.
Thanks, Maury.
Thank you. Our next question comes from line of Joseph Schwartz with SVB Securities. Please proceed with your question.
Hi, thanks very much. I was wondering if you could help us understand the main assumptions underlying your 2022 revenue guidance for LUPKYNIS in terms of things like patient start forms, conversion rates and times, and discontinuations, either on an absolute basis or relative to what you've been seeing. I think, Peter, a couple weeks ago at our healthcare conference, you had shared some plans to issue aggressive guidance. Are there particular aspects of this revenue guidance that are aggressive or more aggressive than, you know, others?
Yeah. Well, let me start there, and I underscored it in our call today. I think 150%-200+% growth year-on-year is aggressive in light of you know the challenges everyone is facing in the start of the year with the Omicron variant, its impact on offices or individual companies and our reps, the patients themselves, et cetera. Most companies are I think guiding to challenges in that area. I think that kind of growth doubling you know more than doubling our business year-on-year is aggressive. That was the context for my comments going into the conference, and it's my context for the comments given today.
In terms of how to think about how the forecast gets through the year, obviously we don't give quarter-over-quarter, you know, guidance. What underlies us achieving these numbers is getting to, you know, after the first quarter, getting back to significant growth in PSF or prescription start forms and maintaining an adherence level at or around what we're seeing currently. Again, you know, as we estimated somewhere around that 25%-30% that we've seen coming out of our clinical trials. In addition, you know, I think we have to see, you know, good persistency over time. As I said earlier, it's, you know, with respect to how long patients have already been on drug, it's sort of hard to qualify, you know, what we've seen and what we need to hold to.
All of those are factors, Joe.
Okay, thanks for that color. Maybe just a quick housekeeping question, if I could, on the EU approval, hopefully later this year. I think the range of milestones that you stand to gain is $15 million-$30 million. I was wondering, and that depends on the label, as I understand it. Can you share with us any more color on, you know, what kind of factors would determine whether you come out at the high or the low end of that milestone range?
Yeah, I'll try to oversimplify it. If we come with a label that's very similar to what we see in the U.S., you can, you know, feel confident that we'll get a full $30 million. There are other areas, such as length of therapy, et cetera, that if those were more constrained in Europe, we might get the lower end of that range. We feel really confident because of the AURORA 2 continuation study and the way that the 120-day comments came back, that, you know, we should be on the upper end of that. You know, obviously you never know until we actually get the approval, which is targeted for the back half of this year.
Makes sense. Thanks very much for the help.
Thanks, Joe.
Thank you. Our next question comes from line of Stacy Ku with Cowen and Company. Please proceed with your question.
Good morning. Thanks for taking our questions. We have one around the net pricing per patient for LUPKYNIS. How should we be thinking about Q4? As we adjust the pricing to stay consistent with the Q4 metrics you provided around enrollment forms and conversion, it would imply that the pricing is much better than our initial $65,000 placeholder net pricing annually. In our rough math, we're getting closer to $100,000. Any guidance would be appreciated. Also related to this question, given the potentially stronger pricing as we think about Q1 and given all your commentary, do we expect to see the conversion of enrollment forms to drop significantly down from Q4? Thank you.
Let me start with the first. On net pricing, we maintain the previous guidance of $65 net or higher. The reason that we are not giving sort of quarterly adjustments to this is it almost aligns directly with my previous commentary on patient persistency. Until we really know what the average dose is gonna look like on a monthly basis, but more importantly, how the average length of therapy is gonna look per patient, it's hard to estimate and not give the street overconfidence in a number that could vary, right? What we can tell you is that, we're confident that right now our $65 net estimate or above is where we're tracking, and it seems like that should stay consistent throughout.
We've not commented on, you know, sort of breaking down net versus, you know, total number of patients on therapy, et cetera, because those numbers can swing around. Lastly, your question on patient start forms and how we should be thinking of that first quarter versus rest of the quarters of the year. As I said to previous questions, I think it's safe to say, while we're not giving quarterly guidance, that, you know, we see a softness in the first quarter in patient start forms, and we would estimate that we're gonna need to see a pickup in patient start forms as we move into Q2 and Q3 and Q4, obviously for the rest of the year. We feel confident that those trends are starting to move in the right direction.
Thank you.
Thank you. Our next question comes from the line of Ed Arce with H.C. Wainwright. Please proceed with your question.
Hi. Thanks for taking my questions and congrats on a strong end to the year. Couple questions for me. First-
Could you discuss, you know, what you believe to be the key headwinds to further sales growth in 2022, perhaps even beyond your strong guidance? You know, obviously given, as you said, the COVID and Omicron variant issue as well as the 90% payer coverage at this point. Some of the key headwinds going through the year as well as, you know, perhaps key drivers that may factor in as a key swing for the upside. I have a follow-up.
Yeah. I think it's twofold. One is obviously this COVID environment. Listen, I'm sure investors have heard plenty of other companies characterize this, but from our perspective, it impacts the entire ecosphere, right? Like, our direct representatives, it's their ability to get access to institutions and to offices. Inclusive of that, it's the way patients, or excuse me, physicians and physicians office staff are operating today. Then lastly, and I think most importantly, which will bleed into my second comment, is the fact that, you know, patients and how they relate to the healthcare system, how aggressively they are at, you know, keeping their visits on the books to picking up their medications, et cetera, have all been impacted.
You know, we previously quoted, you know, growth or lack of growth in 2020 to 2021 in new diagnoses for lupus nephritis, at least from our ICD-9 code poll data. It showed almost a 30% drop in new patient diagnoses. That just as one example. You know, COVID is the only thing we can point to to say why these numbers have declined. Obviously, there have been other companies who've come out and even said that cancer therapies, cancer diagnosis, adherence to chemotherapeutic regimens have seen direct impact as well. I won't belabor that one anymore because I think that by and large is the largest swing factor. As I said, I think we're seeing some really good signs of life that we're moving out of that.
The second part for me is if we can continue to, which we fully expect we will, identify new patients and patient start forms, is how long we're keeping patients on therapy. Of those patients who actually do get the drug approved, how many are actually picking up the prescription and adhering to the profile. As we've said right now, at least adherence and you know discontinuations as it pertains to cancellations and discontinuations were about 25%-30% of our overall patient start forms. It'll be interesting and a big swing factor in our forecast this year or a meaningful one to know how long those patients are actually staying on therapy over time because it just compounds the effect of getting new patients on drug if patients are staying on drug.
One that, you know, we look forward to talking more about as we get more data.
Okay. All right. Thanks for that. Related to what you just said, second question is around discontinuations. You've, as you've said a couple of times already, 25%-30% is where you're tracking now, similar to your phase III. Question is, you know, given it seems like some ability or at least effort to improve that over time, where do you think discontinuations could settle into further down the line as sort of a steady state? Related to that, I'm wondering if there's any expectations or if you could help us understand the potential impact of any patients that may have dropped off and that may come back later on. Is that something that you think about in factoring as well? Thanks so much.
Yep. Two things here. On discontinuations, barring having any new data, at least from a company mindset, we're carrying that number forward. While we always hope to improve upon it with all of the things that I mentioned in terms of our tactical activity, probably the safest estimate is to look to our trials and what we've seen early on, but know that we've got good effort against trying to improve upon it. At least that just gives you sort of our current view. We see improvement there, we'll be the first to report it to you. The second part of your question was centered around. Can you repeat it one more time?
Yeah, no problem. Patients that may drop off for whatever reason, and you see them come back.
Yeah. Yeah.
you know, is that a meaningful proportion? You know, given some of these things had nothing to do with the drug at all, like just not picking it up, and maybe they went to the doctor again and decided to really start the program.
What we do know from just tracking sort of the surrogate drugs that these patients have been on historically and pulling data all the way back to, say, 2017 up until today is, you know, if you look at the actual prescription activity, patients do, you know, miss doses here or there. They do seem to cycle on and off of the drug. I think as many know, that does not align with either the EULAR, ACR or KDIGO guidelines that, you know, once proteinuria is in control, these guidelines are fairly silent on length of therapy. They say, "Keep patients in control." I think, you know, the reason for that is what we've talked about earlier, that patients, you know, can miss a prescription and end up coming back on the drug.
At least that's what we've seen through the data. Now, how to qualify that against our own data, our hope is that we're gonna see more adherence over time. Then, you know, as I said, I think we need to see more than three months of therapy or six months of therapy before we, you know, really give any steer on what we think the average adherence will look like. I think that the net of your question is once a patient's on drug, are they forever lost to the system? At least the data would say no, that physicians seem to actively put patients back on drug if they've missed picking up a prescription or have fallen out for some reason.
Great. Thanks, Peter. That's helpful. Appreciate it.
Thanks, Ed.
Thank you. Our final question this morning comes from the line of David Martin with Bloom Burton. Please proceed with your question.
Yes. Most of my questions have been answered, but I have kind of a follow-on to the last question. So the discontinuation is 25%-30%. You've said it's not the payers, and it sounds like most physicians are encouraging patients to stay on, or go back on if they've dropped off. Are any physicians using this kind of as an induction therapy but not a maintenance therapy?
At least what we've seen so far is the answer to that would be no. I think it will. We wouldn't really find that out, David, in you know, sort of tracking through Aurinia Alliance why patients might not be picking up their prescription. I think it'll bear out more in what we see in terms of the persistency trends over time. I can tell you sort of qualitatively that when we talk to physicians, no one is telling us that they're looking to use this as an induction and then bridging them to some other therapy. That's not what the intent of the prescriber is or what we believe they're doing. You know, when I say there's a host of different reasons that patients you know, either discontinue or cancel you know, a prescription, it is a host.
There is no actual, you know, one trend of consistency there. It's everything from, you know, the office didn't follow through or the patient didn't follow through, or the patient didn't pick up the prescription, decided not to stay on therapy, couldn't tolerate the therapy. It is a host of different reasons, including, you know, sort of a loss to follow-up. Patients change addresses, they change phone numbers. You know, making sure that we're able to continue to track them down and work very closely as well as we can through our efforts commercially, you know, through in a compliant way, is gonna remain to be something that's top of our list of activities we need to try to drive.
Okay, thanks. My second question is, do you have any idea of how your LUPKYNIS starts and discontinuations compare to BENLYSTA in lupus nephritis? Any idea what's driving the decision of physicians to treat with one or the other drug?
The first part of your answer. I always hesitate to speak about other drugs, but I will tell you just from what we track, again, through coding and prescribing data, is they see the same sort of challenges. Difference being is they started at a little bit of a higher base. I think if you go back and look at BENLYSTA utilization and you tag it to ICD-9 codes, they've been getting pretty active treatment of lupus nephritis patients long before they had approval for the drug.
I think, you know, again, this is a question for them, but, you know, my review of that is that's about patients who have been on the drug for SLE that stay on it through a lupus nephritis bout and whether the patient, the physician decides to discontinue the drug or not is TBD. Their, you know, new patient growth and their adherence, at least from what we can see, and discontinuation results are in line with what we're seeing right now. I do think it's population and not drug-based from what I can see. How physicians are making a decision on BENLYSTA versus our drug is a little bit across the board.
What we do know is that physicians have a unique patient in mind for our drug, that's different than BENLYSTA. We do know that our messaging around the results we've produced in AURORA 1 and in the AURORA 2 continuation study resonate with physicians. I mean, they directly align with what the treatment goals are for therapy here. Right now, at least from what we can see, our data best aligns to the guidelines that are out there in terms of treatment outcomes. We think we got a good position there, David.
Okay, thanks.
Thank you. This concludes our question and answer session and thus concludes our call today. We thank you for your interest and participation. You may now disconnect your lines.