Aurinia Pharmaceuticals Q2 2025 Earnings Call Transcript

Key Takeaways

  • Positive Sentiment: For Q2 and H1 2025, total revenue grew 22% and 23% to $70 M and $132.5 M, driven by a 21% and 23% increase in Loop Kinus net product sales as lupus nephritis market penetration expands.
  • Positive Sentiment: Cash flow from operations turned positive at $45.5 M (versus –$2.8 M last year) and, excluding restructuring payments, was $57 M; the company held $315.1 M in liquidity and the board approved an additional $150 M share buyback.
  • Positive Sentiment: 2025 guidance was raised: total revenue is now expected at $260–270 M (up from $250–260 M) and net product sales at $250–260 M (up from $240–250 M).
  • Positive Sentiment: The Phase I single ascending dose study of Aratinacept, a dual BAFF/APRIL inhibitor, showed positive results and the company remains on track to initiate multiple clinical studies in two autoimmune indications in H2 2025.
  • Positive Sentiment: Operational efficiency improved as gross margins expanded to 90% in Q2 (88% H1) and operating expenses fell by over 15% year-over-year following strategic restructuring.
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Earnings Conference Call
Aurinia Pharmaceuticals Q2 2025
00:00 / 00:00

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Operator

Greetings, and welcome to the Aurinia Pharmaceuticals Second Quarter twenty twenty five Earnings 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, Joe Miller, Chief Financial Officer for Aurinia. Thank you. You may begin.

Joe Miller
Joe Miller
CFO at Aurinia Pharmaceuticals

Thank you, operator, and thank you, everyone, for joining today's call and webcast. Joining me on the call this morning are Peter Greenleaf, Aurinia's President and Chief Executive Officer and Doctor. Greg Keenan, Aurinia's Chief Medical Officer. Today, we will review and discuss Aurinia's second quarter twenty twenty five financial results and provide an update on recent corporate progress as communicated in the company's press release and quarterly report on Form 10 Q issued this morning. For more information, please refer to Aurinia's filings with the U.

Joe Miller
Joe Miller
CFO at Aurinia Pharmaceuticals

S. Securities and Exchange Commission and Canadian Securities Authorities, which are also available on Aurinia's website at auriniapharma.com. During today's call, Aurinia may make forward looking statements based on current expectations. These forward looking statements are subject to a number of significant risks and uncertainties, actual results may differ materially. For a discussion of factors that could affect Aurinia's future financial results and business, please refer to the disclosures in Aurinia's press release, quarterly report on Form 10 Q and all other filings with the U.

Joe Miller
Joe Miller
CFO at Aurinia Pharmaceuticals

S. Securities and Exchange Commission and Canadian Securities Authorities. Please note that all statements made during today's call are current as of today, 07/31/2025, unless otherwise noted and are based upon information currently available to us. Except as required by law, Aurinia assumes no obligation to update any such statements. Now let me turn the call over to Aurinia's President and CEO, Peter Greenleaf. Peter?

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Thanks, Joe, and good morning, everyone. I want to thank everybody for joining us today. On this morning's call, I'll provide an update on our second quarter results and provide an update on all corporate initiatives. I'll then turn the call back over to Joe to provide additional detail on our financial results. We continue to achieve strong growth in total revenue and net product sales in the three and six months ended 06/30/2025.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

For the three and six months ended 06/30/2025, total revenue was $70,000,000 and $132,500,000 up 2223% respectively from $57,200,000 dollars and $107,500,000 respectively in the same periods of 2024. For the three and six months ended 06/30/2025, net product sales of Loop Kinus, the first FDA approved oral therapy for treatment of adult patients with active lupus nephritis or LN were $66,600,000 and $126,500,000 up 2123% respectively from $55,000,000 and $103,100,000 in the same periods of 2024. The increase for both periods is primarily due to an increase in the number of loop kinase cartons sold to specialty pharmacies driven by further LN market penetration. For the six months ended 06/30/2025, cash flow generated from operations was $45,500,000 This is compared to a negative $2,800,000 in cash flow used in operations in the same period of 2024. Excluding $11,500,000 in cash payments made in 2025 in connection with the November 2024 restructuring, cash flow generated from operations was $57,000,000 for the six months ended 06/30/2025.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

As of 06/30/2025, we have cash, cash equivalents, restricted cash and investments of $315,100,000 This is compared to $358,500,000 at 12/31/2024. For the six months ended 06/30/2025, the company repurchased $11,200,000 of its common shares for $90,800,000 including commissions and excise tax. As a result of the sustained growth we've seen in the 2025, we are increasing our full year 2025 total revenue guidance from a range of $250,000,000 to $260,000,000 to a range of $260,000,000 to $270,000,000 and our net product sales guidance from a range of $240,000,000 to $250,000,000 to a range of $250,000,000 to $260,000,000 Finally, we reported positive results from our Aratinacept Phase one single ascending dose study on 06/30/2025. Aratinacept is a dual BAF April inhibitor. It contains a BCMA engineered extracellular binding domain that's optimized for superior affinity to April and BAF.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

We remain on track to initiate further clinical studies for Aratinecercept in at least two autoimmune diseases in the second half of this year. We are very excited about the wide range of therapeutic possibilities for our atinircept, but for competitive reasons we'll not be disclosing further detail about our future plans at this time. I'd now like to turn the call back over to Joe for more detailed review of the second quarter twenty twenty five financial results. I'll then return at the end of the call for a quick recap and to open up the line for any questions you might have. Joe?

Joe Miller
Joe Miller
CFO at Aurinia Pharmaceuticals

Thank you, Peter. Let's take a few minutes to discuss the second quarter twenty twenty five financial results. For the three and six months ended 06/30/2025, total revenue was $70,000,000 and $132,500,000 up twenty two percent and twenty respectively from $57,200,000 and $107,500,000 in the comparable periods of 2024. As Peter mentioned, we had cash, cash equivalents, restricted cash and investments of $315,100,000 as of 06/30/2025 and generated cash flows from operations of $45,500,000 compared to $2,800,000 in cash flow used in operations in the same period of 2024. Excluding $11,500,000 of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $57,000,000 for the six months ended 06/30/2025.

Joe Miller
Joe Miller
CFO at Aurinia Pharmaceuticals

We are continuing to be opportunistic with our share repurchase plan and expect to fund any future discretionary share repurchases with cash flows from operations and cash currently on hand. The company repurchased $18,300,000 of its common shares for $138,400,000 excluding commissions and excise tax since the launch of the program in the 2024 through today. Additionally, today we announced that the Board has approved an increase in the share repurchase plan of up to an additional $150,000,000 of common shares over the initially approved $150,000,000 Board authorization. For the three and six months ended 06/30/2025, cost of revenue was $7,100,000 and $15,700,000 respectively, compared to $8,900,000 and $16,700,000 in the comparable periods in 2024. The decrease for both periods is primarily due to a decrease in sales of loop kinase inventory to Otsuka, which is sold under a cost plus arrangement and has a lower gross margin than our other Luke Kinus sales.

Joe Miller
Joe Miller
CFO at Aurinia Pharmaceuticals

For the three and six months ended 06/30/2025, gross margin was 9088% respectively compared to 8485% in the same periods in 2024. For the three and six months ended 06/30/2025, total operating expenses were $49,900,000 and $90,500,000 respectively compared to $58,700,000 and $122,300,000 in the comparable periods of 2024. The decrease for both periods is primarily due to lower personnel expenses including share based compensation and overhead costs as a result of our strategic restructuring efforts in 2024. This was partially offset by an increase in R and D related expenses as we continue to advance our development activities for Artinacept and voclosporin and other non cash expenses related to the remeasurement of our Swiss franc denominated monoplant finance lease liability and changes in our fair value assumptions related to our deferred compensation liability. For the three months ended 06/30/2025, net income was 21,500,000.0 or $0.16 of earnings per share compared to $722,000 or $01 of earnings per share in the same period of 2024.

Joe Miller
Joe Miller
CFO at Aurinia Pharmaceuticals

For the six months ended 06/30/2025, net income was $44,900,000 or $0.33 of earnings per share compared to a net loss of $10,000,000 or $07 net loss per share in the same period of 2024. With that, I'd like to hand the call back over to Peter for some closing remarks. Peter?

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Thanks, Joe. In summary, we continue to drive growth in the commercial loop kinase business, move forward with the clinical development of aritinircept and maintain excellent operational efficiency. I want to thank you all for your time today. We'll now open the lines for any questions you may have. Operator?

Operator

Thank you. We will now be conducting a question and answer session. Our first question comes from the line of Stacy Kew with TD Cowen. Please proceed with your question.

Vishwesh Shah
Vishwesh Shah
Biotech Equity Research Associate at Cowen

Thanks. Hi team. This is Vish on for Stacy. Congrats on a great quarter and thanks for taking our questions. So you reported some encouraging data for erotinircept and I understand that you're not for competitive reasons disclosing any details, but could you at least guide us to how you were thinking about the potential for erotinircept?

Vishwesh Shah
Vishwesh Shah
Biotech Equity Research Associate at Cowen

Where do you think it could generate or add the most value so that us and investors could appreciate how you're thinking about the development? And based on the PKPD data from the SAD study, how are you thinking about maybe potentially doses to be moved forward for the POC studies? Thanks. And I have one follow-up.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Yes. I mean, I'll start and I'll ask Greg to jump in where I might miss or where he sees some add on here. Listen, I think the potential of these B cell mediated diseases and April Bass potential ability to affect these B cell mediated disease is apparent today obviously in the data that's been rolled out in areas like IGAN. But we as a company have done our own assessment internally. We think there is upwards of 20 to north of 20 different B cell mediated diseases that you could look at for potentially for these compounds.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

So while we're not disclosing exactly where we're going in our exact approach for competitive reasons at this stage, know that we see a pretty wide open field in terms of other areas that could potentially be addressed even outside of the kidney indications that have been explored to date. So we'll look forward to talking more about that in the future. But at this point, as we've said, we're not disclosing for competitive purposes. But no, we're looking at a range of indications. Greg, do want to talk maybe a little bit about the dose side of the single ascending dose study?

Greg Keenan
Greg Keenan
SVP & Chief Medical Officer at Aurinia Pharmaceuticals

Sure. Thank you, Peter. Yes. Well, based on the evidence from the single ascending dose study, we're very confident now that a Q4 week dosing schedule is justified with evidence especially with regard to kinetics, the pharmacokinetics and the pharmacodynamics of that we've demonstrated with a single ascending dose. So we think Q4 week dosing will be something we can explore and confidently be able to demonstrate some important evidence as we move forward into the multiple ascending dose studies.

Vishwesh Shah
Vishwesh Shah
Biotech Equity Research Associate at Cowen

Got it. Thank you. And then my follow-up was on the kindness actually clearly the sales are doing well and you're increasing guidance. So can you just detail some effects that you're seeing of the updated ACR guidance on the kindness adoption? Maybe discuss how rheumatology versus nephrology prescribing is going and what that looks like right now? Thanks.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Yes. I think we're encouraged by the guidelines. And I think two evidence points, I guess, I would give you that the guidelines are having some impact, albeit they're not quantitative. They'll give you a directional feel for how they're impacting our business. We've seen a really strong uptick in the number of rheumatology prescribers.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

The guidelines themselves alongside of we've got the two year extension of the original AURORA study that's been out there. We had the biopsy sub study that was published in a rheumatology journal. I think that in combination with the guidelines has driven higher prescribing that we're seeing in rheumatology offices, so an increase there. And then in addition, we're seeing an increase in our hospital business. And I think that's a direct reflection of, the academic setting and fellows and teaching institutions adopting those guidelines and using them more proactively.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

So while it's not a quantitative answer, it can give you a really good feel for how we think they're impacting. Rheumatologists are using more of our drug. They're growing at a faster rate than nephrologists right now. And then in addition, our hospital business has been growing in a healthy way since the guidelines have been published.

Vishwesh Shah
Vishwesh Shah
Biotech Equity Research Associate at Cowen

Got it. Thank you very much.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Thanks, Vish.

Operator

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

James Vane-Tempest
Equity Research Analyst at Jefferies & Company Inc

Hi, this is James on for Maury. Congrats on the progress and thank you for taking our questions. Just another question on leukemias and then I have a follow-up question. For the RAISE guidance, can you talk more about the drivers and what you're seeing from new patient starts and hospital restarts trends in the initial four weeks in 3Q and learning some prior summer months that informs your commercial outlook for 2025?

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Yes. I'd like to start and then Joe if I miss anything please jump in. So I think the best way to think about our guidance range is on the lower end to the midpoint of our revised guidance, you'd have to see either a flattening of our business or a declining of our business in the summer months and back to growth in the back half of the year. The higher end of our guidance range is continued growth through 3Q and 3Q and 4Q. If you look historically James at how our sales have progressed and as we've said on previous calls, we now think history is probably the best way to predict how this business moves forward.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

The summer months have we've seen a slowing in some of our metrics. In particular, the PSFs have been a little lighter historically in the summer months. And our revenue has been relatively flat to the previous quarter, so flat to 2Q, using history. So the way we're looking at our guidance range is the low to mid, you see the historical trends, the high to beat above is we keep growing quarter on quarter. And we're really encouraged by everything we're seeing in the business right now.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

So we're excited to take up the guidance range and that's kind of how we're thinking about it James.

James Vane-Tempest
Equity Research Analyst at Jefferies & Company Inc

Got it. Thanks. And then second one for your BAF April inhibitor, Aratinecept. Can you talk more about when we can see the next data update from the MAD phase? And more on rare orphan autoimmune diseases that you aim to pursue.

James Vane-Tempest
Equity Research Analyst at Jefferies & Company Inc

What are the gating factors to picking specific disease settings to pursue? Are you waiting for competitor updates? Or is it more related to evolving internal strategy?

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Well, I mean, wouldn't assume that we're waiting and I wouldn't assume that we're ruminating on any of this. I would say, I would assume we're moving forward. We're just not communicating externally for public reasons, exactly what our approach is going to be or the timing of those programs. As we've said, we want to go after at least two B cell mediated diseases. We were going to get those enrolling by this year by the end of this year.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

And we'll look forward in the future to talking more about it. But at this stage that's all we're giving James.

James Vane-Tempest
Equity Research Analyst at Jefferies & Company Inc

Got it. Thanks for taking our questions. I'll hop back in the queue.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Thanks.

Operator

Thank you. Our next question comes from the line of Joseph Schwartz with Leerink Partners. Please proceed with your question.

Will Soghikian
Vice President - Equity Research at Leerink Partners

Hey guys, this is Will on for Joe. Thanks for taking our questions today and congrats on the progress this quarter. So I just have one on the B cell program and then a quick follow-up. So on the prior data call, you had mentioned that you were doing some formulation work for AUR-two hundred. Is this work still ongoing?

Will Soghikian
Vice President - Equity Research at Leerink Partners

Or is it going to be completed prior to the initiation of these future studies later this year? And can you just help us understand the point of this formulation work? Is it specifically to do an auto injector? Or what's the ultimate goal here? And I have a quick follow-up. Thanks.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Yes. As we said on our previous call, Will, our goal would be to try to get it in the most patient friendly potential formulation and device possible and that could include an auto injector. And we actually think looking at the doses we've seen to date, the molecular size that we have we could have the possibility to do that. But obviously once you're in single ascending dose studies, you're not optimized towards or at least we haven't to those formulations yet. And that's it's parallel pathing with the development work that we're doing.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

But everything points to us being able to from what we've seen in the single ascending dose and in the preclinical work group done up to this point that those goals would be attainable.

Will Soghikian
Vice President - Equity Research at Leerink Partners

Great. Thank you. And then just quickly a question for Joe. As we see the development of AUR 200 ramp up, how should we be thinking about R and D spend moving forward? And can you help us put some brackets or kind of general commentary around the cost for these trials?

Will Soghikian
Vice President - Equity Research at Leerink Partners

And do you expect to remain cash flow positive during the development of this asset? Thank you.

Joe Miller
Joe Miller
CFO at Aurinia Pharmaceuticals

Thanks for the question, Will. We haven't provided any specific guidance on operating expenses and or cash flows going forward. Obviously, as we are moving through 2025, the trial costs were fairly manageable and you would expect as you kind of move from Phase one into two and on that costs will increase. But as of right now, we're not giving any specific long term guidance on OpEx, R and D expenses and or cash flows.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Yes. I think that's right Joe. And the only thing I would say is it should be evident to investors that efficient operations and cash flow from operations however we decide to deploy it is in a priority for us as an organization. So that won't change on a go forward basis.

Will Soghikian
Vice President - Equity Research at Leerink Partners

Great. Thanks for the color and congrats again.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Thanks, Will.

Operator

Thank you. Our next question comes from the line of Arthur He with H. C. Wainwright. Please proceed with your question.

Yu He (Arthur)
Equity Research Vice President at H.C. Wainwright & Co., LLC

Hey, good morning guys. Congrats on the beat and raise. I just have two questions regarding the 200. So Grant, do you guys plan to present the detailed data at any medical conference, from the, SAAS study?

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Greg, have I mean Greg maybe can talk to what our intentions are. I think you should just appreciate that obviously we have ongoing patent work etcetera with the compound. So what's publicly detailed we would have that ability to do, but stuff that has not yet been publicly talked Greg, any intentions?

Greg Keenan
Greg Keenan
SVP & Chief Medical Officer at Aurinia Pharmaceuticals

No, nothing more than that. That they will be presented in an upcoming meeting, but we haven't determined which meeting at this point.

Yu He (Arthur)
Equity Research Vice President at H.C. Wainwright & Co., LLC

Okay. Got you. And the second question on the 200 is the so maybe, Peter, I just want to gauge, like, at what kind of situation or circumstance you guys would be feel comfortable to disclose the information about the the the details of indication going after for the 200? Just curious.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Well, I mean, the obvious answer is when we move into a certain phase of development, it becomes public information and available on clinicaltrials.gov. So that would be my absolute answer. We haven't really discussed it with our Board, Arthur, or we have and we've deduced concluded that for competitive purposes, obviously, we've got people that are ahead of us and behind us and we want to hold what we're doing close the vest and ensure that we don't lead people down the path of exactly what we're doing. We haven't determined yet when we would disclose, but do realize from the line of questioning here and on our previous call, but there's a lot of appetite to understand what our plans are.

Yu He (Arthur)
Equity Research Vice President at H.C. Wainwright & Co., LLC

Got you. Thanks for that. Talk to you.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Thank you.

Operator

Thank you. Our next question comes from the line of Doug Meehan with RBC Capital Markets. Please proceed with your question.

Douglas Miehm
Douglas Miehm
Healthcare Analyst at RBC Capital Markets

Yes. Good morning, Peter, Joe. Just with respect to paragraph four filers, there's no change there. No change as it stands right now in terms of the exclusivity period and adding pediatric on to that, any updates?

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

No. And just to clarify that the pediatric trial work that we're doing was part of the original filing, but was not an extension body of work. So the July 2028 worst case scenario is not inclusive of six months of pediatric exclusivity Doug. No, no changes. We still have patents going all the way out to 02/1937.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

We still have our method of use patents and we continue to do more work around both patents and other work in the company to ensure the longevity I would just reinforce that the longevity of this asset to us is paramount and comes to defending the IP that we have around the compound it's an A priority for the company. So we'll update you when we have more to talk about. But as you know, the legal process on ANDA filings and subsequent patent infringement lawsuits is pretty protracted. So I wouldn't expect to hear weekly updates from us.

Douglas Miehm
Douglas Miehm
Healthcare Analyst at RBC Capital Markets

No. Okay. Second question just has to do with the buyback and you're aggressive there. There's an obvious opportunity today. As we think about the future though, given the amount that you're likely to spend on the R and D side, being it's going to increase probably fairly materially, when we think that we could see scaled back buybacks as we think about beyond 2025. I'll leave it there.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Doug, as we've said, it's up to the Board's discretion and as to how they deploy that cash. Obviously management gives input to our belief as to what we should do. I wouldn't miss that. Lupinus continues to grow for us. And the cash flows we reported in this quarter, if you carry those forward and you carry forward continued growth to Luke Kynes, the amount of cash flow from operations is becomes fairly significant.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

Now we're not giving long term or even mid to short term guidance on cash flows, but you can do the math. And I think it gives us a very unique position as a biotech company in this space to pay our bills. We have cash on our balance sheet. We have cash flows from operations. So we can pay for the things we want to do continuing to drive Loop Kindness and developing our pipeline.

Peter Greenleaf
Peter Greenleaf
President, CEO & Director at Aurinia Pharmaceuticals

And we have the unique ability to either collect cash more cash on our balance sheet and grow that over time or deploy it towards buying back shares, which is positive for all shareholders. So while we're not giving anything for 2026 and I don't disagree that obviously your R and D expenses go up as you move into further clinical trials, Don't miss the fact that if lube kinase which we fully believe will continue to grow grows, our cash flow from operations and our balance sheet are still very, very strong.

Douglas Miehm
Douglas Miehm
Healthcare Analyst at RBC Capital Markets

Great. Thank you.

Operator

Thank you. And this concludes we have reached the end of the question and answer session. And this also concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation, and have a great day.

Executives
Analysts
    • Vishwesh Shah
      Biotech Equity Research Associate at Cowen
    • James Vane-Tempest
      Equity Research Analyst at Jefferies & Company Inc
    • Will Soghikian
      Vice President - Equity Research at Leerink Partners
    • Yu He (Arthur)
      Equity Research Vice President at H.C. Wainwright & Co., LLC
    • Douglas Miehm
      Healthcare Analyst at RBC Capital Markets