Earnings Labs

Exagen Inc. (XGN)

Q2 2022 Earnings Call· Sat, Aug 6, 2022

$2.72

-0.91%

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Transcript

Ryan Douglas

Management

Good afternoon, and thank you for joining us today. Earlier today, Exagen Inc. released financial results for the quarter ended June 30th, 2022. The release is currently available on the company's website at www.exagen.com. Ron Rocca, President and Chief Executive Officer; Kamal Adawi, Chief Financial Officer; Mark Hazeltine, Chief Operating Officer, will host this afternoon's call. Before we get started, I'd like to remind everyone that management will be making statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements, including, without limitation, statements regarding our business strategy and future financial and operating performance, including 2022 guidance, the impact of COVID-19 pandemic on our business, our current and future product offerings, and reimbursement and coverage are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31st, 2021, and subsequent filings. The information provided in the conference call speaks only to the live broadcast today, August 4th, 2022. Exagen disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections or other forward-looking statements, whether because of new information, future events or otherwise. I'll now turn the call over to Ron Rocca, President and CEO of Exagen.

Ron Rocca

Management

Thanks, Ryan, and thank you to everyone joining the call. Today, I will discuss our Q2 business highlights and give updates on payers, our pipeline, the newly published CAPSTONE study and the initiation of our TiGER clinical experience study for RADR platform. I'll then hand the call over to Kamal, our CFO, for details on our financial results. As always, we appreciate your continued support of Exagen. In the second quarter of 2022, we achieved a record of 2,273 total ordering health care providers and a record of 797 adopters for our flagship AVISE CTD and AVISE Lupus tests. We had a record of 34,919 AVISE CTD tests delivered for the quarter and a record of 65,822 AVISE CTD tests delivered year-to-date. Once again, we saw a high retention rate of approximately 99% among adopting health care providers from the prior quarter. This marks the eighth quarter in a row with at least 99% stickiness and the eighth quarter in a row that we have set a record for adopters, as well as the sixth quarter in a row setting a new record for ordering health care providers. We are pleased with all these achievements, which demonstrate the value our brands provide patients and physicians. Last quarter, we disclosed that effective April 1st, 2022, CMS agreed to recognize a PLA code for our protein-based test AVISE Lupus. Noridian, our MAC priced this PLA code at $1,085 per test. The process for obtaining and maintaining consistent reimbursement for new tests can be uncertain, lengthy and time-consuming. During the quarter ended June 30th, 2022, we submitted to Noridian 3,749 claims for Medicare Part B reimbursement under our PLA code for AVISE Lupus. As of August 1st, 76 of these claims have been paid, 335 claims have been denied and 2,778 claims are…

Kamal Adawi

Management

Thank you, Ron, and good afternoon, everyone. As mentioned earlier, we continue to see the number of ordering health care providers increase. This quarter, we achieved another record of 2,273 ordering health care providers, compared with 1,934 in the second quarter of 2021 and 2,175 in Q1 2022. We also saw the testing volumes for AVISE CTD, including AVISE Lupus, set new records. In the second quarter, the test grew approximately 6% year-over-year and 13% quarter-over-quarter to a record 34,919 tests delivered, compared with 33,328 in the second quarter of 2021 and 30,903 in Q1 2022. Even with these record volumes, total revenues in the second quarter of 2022 were $9 million, compared to $12.8 million in the second quarter of 2021, this represents a decrease of 30% over the second quarter of 2021. Of the $3.8 million year-over-year decrease, $3.2 million is from AVISE CTD, $300,000 is from other testing and another $300,000 is from the termination of the Janssen agreement. The decrease of $3.2 million of AVISE CTD revenue is attributable to a decrease in average reimbursement per AVISE CTD test, due to a decrease in estimated collections, as well as our revenue accrual process of writing down AR balances for claims greater than 12-months. We identified changes in the expected collection patterns with certain payers related to performance obligations satisfied in 2021 and the first quarter of 2022, which resulted in a change in the estimated transaction price. Furthermore, a decrease in revenue recognized from Medicare was also a contributing factor. AVISE CTD test revenue was $7.2 million in the second quarter of 2022, compared with $10.4 million in the second quarter of 2021. Other testing revenue was $1.8 million in the second quarter of 2022, compared with $2.1 million in the second quarter of 2021. Our…

Operator

Operator

Thank you. The floor is now open for questions. [Operator Instructions] Our first question comes from Brian Weinstein with William Blair. Please state your question.

Griffin Soriano

Analyst

Hey, guys. Good afternoon. This is Griffin on for Brian. Thank you for the questions. Maybe just to start to get a little bit more clarity on the guidance and the pricing dynamics here. Can you just talk about what the assumptions are underlying this updated guidance in terms of where ASPs are going to come in and whether or not there should be any impact to test volumes here rest of the year?

Kamal Adawi

Management

Yes, Griffin, thanks for the question. In regards to ASPs, we did note that there is uncertainty around Medicare. So there is an assumption in there that we're not putting in Medicare for the rest of as 2022. As we stated, there were some increased need for medical necessity with some payers, which slows down the collection process and has an impact on the change of estimate for the rates.

Griffin Soriano

Analyst

Okay. And then from a volume perspective, I mean, understanding that the ASPs are going to be coming down here. But in terms of CMS volume or just total volumes, do you expect any impact to those as a result of this reimbursement change?

Ron Rocca

Management

Actually not. Doctors usually will write the product that's best for the patient, which is usually our AVISE brand. So I don't think the volume will be impacted, they'll continue to write it. This is clearly a Medicare reimbursement issue that we're dealing with, and it should not impact volume at all. In fact, our CAPSTONE study has been heralded very well by many of the physicians, largest study ever done in lupus diagnostic and the results of it have been incredible. The fact that it was published in the top managed care journal also helps, too. So Griffin, I don't think volume is going to be impacted at all. In fact, we're going to do everything we can to accelerate it.

Griffin Soriano

Analyst

Okay. Understood. And maybe just last one for me. In terms of adopters, it's been record adopters here, but the numbers trended kind of that mid-30% range for the last couple of years, realizing it's on a growing base. But how do you drive that higher, I guess? Could you just talk a little bit about plans to really drive a little bit more depth and breadth there?

Ron Rocca

Management

Sure, a couple of things. One is good science leads to good decisions. And this CAPSTONE study was very, very important. I don't know if I can impress that enough on you how big it was, that showed that you need less lab visits, 5 times less ANA testing. I mean it was just a lot of really good things in this large study. That should enable us to drive it. As well as the fact that the adopters continuing to grow and stick with the brand as we add new adopters. So I'm feeling good about the demand part of the equation.

Griffin Soriano

Analyst

Okay. Thanks for the questions.

Operator

Operator

Our next question comes from Ross Osborn with Cantor Fitzgerald. Please state your question.

Ross Osborn

Analyst · Cantor Fitzgerald. Please state your question.

Hi, congrats on the record set during the quarter. Thanks for taking our questions. Maybe just one more on guidance. Outside of the pricing headwinds, are you seeing any headwinds associated with the broader operating environment? Couple of other companies have called out prolonged vacation by doctors around the 4th of July and Labor Day. So just curious if you're seeing that. And then lastly, on guidance, do you include any of the $4 million of outstanding claims with Medicare and the high end? Or is that completely taken out?

Ron Rocca

Management

Yes, I'll do the first part here, which is -- yes, vacations are always an issue in the summer, probably more so than normal because post-COVID, a lot of doctors didn't take vacation. We continue to monitor the situation. The fortunate thing here is that even though the doctor goes on vacation, these patients are still out there, and they usually end up with a PA in the office and so forth, but we'll continue to monitor that as we go forward. As far as the $4 million --

Kamal Adawi

Management

Yes, Ross, in regards to the $4 million of Medicare being whether or not it's included in the high end of the guidance range. No, that is not included in any of the guidance range.

Ross Osborn

Analyst · Cantor Fitzgerald. Please state your question.

Okay. Great. And then just last one for me. Could we walk through the cadence of the quarter in terms of testing volumes and how July shaped up relative to June?

Ron Rocca

Management

Okay, it ended up being a record quarter with over 34,000 in demand. 4th of July being 4th of July, that was always a bad week, but the cadence is still going on as normal. The great thing about the adopters are they stick. I mean they don't go away. And the fact that we've added more of those and so forth that gives us confidence that there's no retreating there. Our asset provides value. Of course, we're going to talk a lot about Medicare reimbursement today, but we got to remember there's over 600,000 tests since launch. That's 600,000 people that got an answer they probably wouldn't have got as good an answer if they didn't use our test. So July, as far as the demand, it kept going. And the breakdown was, other than July 4th, because obviously, that we could take out, it was the month we expected.

Ross Osborn

Analyst · Cantor Fitzgerald. Please state your question.

Okay. Great. Thanks for taking my questions.

Ron Rocca

Management

Thank you.

Operator

Operator

That was our final question. I'll turn the call back over to Ron.

Ron Rocca

Management

Great. Thank you. We are a patient-focused, discovery-driven company. We're proud of doing over 680,000 tests of our AVISE Lupus and our AVISE CTD tests, and we'll continue to work on reimbursement, not only the Medicare reimbursement, but also on the commercial side. We've gotten great momentum there with roughly 100 million covered lives. We'll continue to work on the commercial payers for this. We know there's great demand for our product that it's filling an unmet need, and it's a true solution for these patients that have autoimmune disorders that are often mixed. So we'll continue to drive that. And on the Medicare front, we'll continue to work with Medicare, our MAC Noridian, to be able to resolve this issue as soon as possible. I want to thank you for your time and attention and your continued support of Exagen is much appreciated. Thank you, and have a great day.