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Alnylam Pharmaceuticals, inc (NASDAQ:ALNY)
Q2 2021 Earnings Call
Aug 3, 2021, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Alnylam Pharmaceuticals Q2 2021 Earnings Call. [Operator Instructions]

I would now like to turn the call over to your host, Christine Lindenboom. You may begin.

Christine Regan Lindenboom -- Senior Vice President, Investor Relations and Corporate Communications

Good morning. I'm Christine Lindenboom, Senior Vice President of Investor Relations and Corporate Communications at Alnylam. With me today on the phone are John Maraganore, Chief Executive Officer; Tolga Tanguler, Chief Commercial Officer; Akshay Vaishnaw, President of R&D Jeff Poulton, Chief Financial Officer; and Yvonne Greenstreet, President and Chief Operating Officer. For those of you participating via conference call, the accompanying slides can be accessed by going to the Events section of the Investors page of our website, investors.alnylam.com/events. During today's call, as outlined in Slide 2, John will provide some introductory remarks and provide general context. Tolga will provide an update on our global commercial progress. Akshay will review recent clinical and preclinical updates, Jeff will review our financials, and Yvonne will provide a brief summary of upcoming milestones before opening the call to your questions.

I would like to remind you that this call will contain remarks concerning Alnylam's future expectations, plans and prospects, which constitute forward-looking statements for the purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our most recent quarterly report on file with the SEC.

In addition, any forward-looking statements represent our views only as of the date of this recording and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. With that, I'd like to turn the call over to John. John?

John Maraganore -- Chief Executive Officer, Director

Thanks, Christine, and thank you, everyone, for joining the call today. In the second quarter and recent period, we made tremendous progress bringing RNAi therapeutics to patients around the world with our commercial, medical and R&D efforts while delivering solid financial performance.

To start, our teams delivered steady ongoing commercial execution and continued revenue growth, including 12% quarterly growth for ONPATTRO and strengthening of GIVLAARI performance and the continued impressive uptake for OXLUMO. On our pipeline efforts, highlights include excellent progress building our ATTR amyloidosis franchise. We completed enrollment in the APOLLO-B Phase III study of patisiran and expect to complete enrollment in the HELIOS-B Phase III study of vutrisiran within the next two weeks, significantly ahead of schedule and already with more than 600 patients enrolled.

We also submitted our vutrisiran NDA based on the HELIOS-A results in patients with hATTR amyloidosis with polyneuropathy and the FDA accepted our submission assigning a PDUFA date in April of 2022. Furthermore, we initiated a biannual dosing study of vutrisiran and we introduced a new preclinical program ALN-TTRsc04, which we believe could enable an annual dosing regimen. We also advanced programs in our earlier stage clinical pipeline, including new positive interim data from the Phase I study of zilebesiran, our investigational RNAi therapeutic for hypertension, which is now advanced into the cardia Phase II program.

We believe all of these achievements represent meaningful progress toward our Alnylam P^5 times25 goals, a bold vision for Alnylam with transformative medicines in both rare and common diseases for patients around the world. And a robust and high-yielding pipeline of first and/or best-in-class product candidates from our organic product engine, all this while delivering exceptional financial performance. So with that, let me now turn the call over to Tolga for a review of our commercial results. Tolga?

Tolga Tanguler -- Chief Commercial Officer

Thanks, John, and good morning, everyone. We're very pleased with our second quarter performance. For ONPATTRO, we achieved $114 million in global net product revenues, representing approximately 12% quarter-on-quarter growth compared with the first quarter. We ended the quarter with over 1,725 patients on commercial treatments. In the U.S., we continue to see strength on many fronts, including 12% growth in demand and notable growth in new prescribers.

We have also seen encouraging signs of the healthcare system reopening. For example, in the second quarter, we received more start forms for ONPATTRO in the U.S. than we have since early 2019. We're also seeing an uptick in face-to-face interactions between our field team and healthcare professionals, which is an indicator that the healthcare system is continuing to open up. Further, Speed to patient diagnosis is continuing to improve with ongoing growth in the use of PYP scans, which is often the start of the patient journey toward a polyneuropathy diagnosis.

Patient compliance also remains high and stable at pre-COVID levels. And we continue to observe a trend in concomitant use of ONPATTRO to treat the polyneuropathy of hATTR early doses along with the use of a TTR stabilizer to treat the cardiomyopathy of this disease in mixed phenotype patients. With regard to the rest of the world, market access has now been achieved in over 30 countries worldwide. In Q2, we saw significant 17% quarter-on-quarter growth in our rest of world markets with particular strength in Europe and Canada. We're also observing a good balance of first-line use and switches from stabilizers in these markets. Moving to GIVLAARI, we achieved $31 million in global net product revenues in the second quarter, representing approximately 24% quarter-on-quarter growth compared with Q1.

And as of June 30, we attained over 270 patients worldwide on commercial therapy. This quarter, we saw significant growth driven by net new patient adds. This was an improvement relative to the first quarter in which the performance was softer than anticipated, likely due to reduced patient flow through the U.S. healthcare system caused by COVID. We're also seeing continued expansion of the prescriber base, including new riders, particularly from community centers in addition to porphyria centers of excellence. In the U.S., we continue to make strong progress toward establishing VBAs with over 10 finalizes to date with commercial payers.

We also have confirmed access for over 98% of covered U.S. lives with no significant headwinds. We continue to make great progress with market access efforts for GIVLAARI across the CEMEA region with the recent launch in Italy, ongoing launch in Germany, temporary authorization for use or ATU supply in France as well as named patient sales in other countries. In addition, we were pleased to recently receive approval of GIVLAARI in Japan for the treatment of AHP in adults as well as adolescents aged 12 and older with a launch expected in September. Moving to OXLUMO, we're seeing continued demand strength in the drug's second full quarter of launch.

We achieved $60 million in global net product revenues in the second quarter and attained approximately 100 patients on commercial OXLUMO treatment in the U.S. and EU as of June 30. As we're still early in the launch, OXLUMO performance is also being modestly benefited by the dynamics of a loading dose. Our market access efforts are progressing very well with no access headwinds and confirm medical policy inclusions for over 80% of covered U.S. lives and seven VBAs finalized to date with commercial payers. Geographic expansion of OXLUMO is moving along nicely with a recent approval in Brazil, and launch underway in Germany and ATU supply in France, supported by early transitions from our expanded access program, we're very pleased to see broad utilization of OXLUMO at this early stage of launch, including across age groups.

In conclusion, we believe we had a great second quarter of 2021 as we continue to make steady and continued growth across our wholly owned commercial portfolio, driven by the focus and hard work of our teams, improved patient flows through the healthcare system, improve disease awareness and new patient finding. In the case of GIVLAARI and OXLUMO, we also experienced growth partially fueled by new market expansion due to reimbursement and regulatory decisions. With that, I will now turn it over to Akshay to review our recent R&D and pipeline progress. Akshay?

Akshay Vaishnaw -- President, Research & Development

Thanks, Tolga, and good morning, everyone. I'll start with our efforts in ATTR amyloidosis, where we're advancing two clinical-stage product candidates patisiran and vutrisiran. Also ONPATTRO is currently approved in multiple markets around the world to treat the polyneuropathy associated with hereditary ATTR amyloidosis, we're committed to expanding the product's label for the treatment of cardiomyopathy in both hereditary and wild-type ATTR amyloidosis patients.

To this end, we're conducting the APOLLO-B Phase III study. During the second quarter, we completed enrollment in APOLLO-B and expect to report top line results in mid-2022. We're also advancing vutrisiran, an investigational therapy, which is delivered by a quarterly subcutaneous injection, and is also in development for ATTR amyloidosis. Here, we're conducting two Phase III studies. The first is HELIOS-A, evaluating vutrisiran in hATTR amyloidosis patients with polyneuropathy. At the AAN conference in April, we presented our positive 9-month HELIOS-A results.

Based on those results, we submitted our NDA to the FDA, which was accepted and signed a PDUFA date of April 14, 2022. Patient dosing continues in HELIOS-A, and we look forward to reporting top line results from the 18-month endpoint in late 2021, which will also further characterize vutrisiran's impact on the exploratory cardiac endpoints. We plan to make additional regulatory submissions, including in the EU, in the late 2021 period based on the HELIOS-A results. The other Phase III vutrisiran study is HELIOS-B, which is our ongoing Phase III cardiac outcome study with vutrisiran in hereditary and wild-type ATTR amyloidosis with cardiomyopathy.

We're excited to have announced this morning that due to high interest among physicians and patients, we now expect to complete enrollment within the next two weeks, well ahead of schedule and with more than 600 patients randomized to date. HELIOS-B has a 30-month endpoint of all-cause mortality and CV events, and we can now expect the full results in early 2024. The study design includes the potential for an interim analysis, and we'll consider this following results from APOLLO-B and alignment with regulatory authorities. Lastly, for vutrisiran, we're very excited about the potential opportunity for biannual dosing regimen, which could further differentiate vutrisiran from other products and provide yet another dosing regimen option for patients.

We're now generating the clinical data to potentially advance this additional 50-milligram biannual dosing schedule for vutrisiran. Specifically, we've provided the open-label extension period of the HELIOS-A study to now include a randomized treatment extension where patients from the HELIOS-A study will be randomized to receive vutrisiran at a dose of either 25 milligrams every three months or 50 milligrams biannually. These data intended to demonstrate the safety and efficacy of the 50-milligram biannual regimen are expected in 2022.

Beyond patisiran and vutrisiran, we have a new addition to the ATTR amyloidosis franchise we're building, specifically using our IKARIA platform, we've generated a new TTR targeting siRNA, ALN-TTRsc04 that we believe could support an annual dosing regimen of greater than 90% TTR knockdown. We intend to share more detail on the IKARIA platform and our preclinical work at an upcoming scientific meeting in mid-2021. Let's now move on to lumasiran. Our RNAi therapeutic recently approved in the EU and U.S. as the first treatment for primary hyperoxaluria type one or PH1. We were very pleased to announce positive top line results from ILLUMINATE-C just last week.

As a reminder, ILLUMINATE-C is a single-arm multinational Phase III study designed to evaluate the efficacy and safety of lumasiran in PH1 patients of all ages with severe renal impairment, including patients on dialysis. A total of 21 patients were enrolled in the study and lumasiran was found to achieve substantial reductions in plasma oxalate relative to baseline both in patients who are not yet on dialysis and patients who are hemodialysis-dependent. Elevated plasma oxalate can result in systemic oxalosis with severe clinical consequences impacting the heart, bones, eyes, skin and other organs.

Moreover, lumasiran demonstrated an encouraging safety and tolerability profile with no deaths or drug-related SAEs. The most common AEs were ISRs, all of which were mild. There are two discontinuations from treatment during the extension period due to AEs that neither was drug related. We now intend to submit supplemental regulatory filings with the FDA and EMA in late 2021 with the goal of strengthening the label supporting OXLUMO. As we have noted previously, we're also excited about the potential for lumasiran for patients with recurrent renal stones and later this year.

We plan to start a Phase II trial to evaluate that potential. As you know, we have two additional late-stage programs that are in development with partners. This includes Leqvio or inclisiran partnered with Novartis, which was approved last year in the EU for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. Leqvio marks the first RNAi therapeutic approved for a prevalent condition. Recently, Novartis resubmitted its NDA for Leqvio in response to a complete response letter it received from the FDA due to the inability of FDA inspectors to visit a third-party manufacturing facility in Europe due to COVID. Importantly, the FDA has not raised any concerns related to the efficacy or safety of inclisiran. Novartis announced that the FDA has accepted the resubmission and has signed a PDUFA date of January 1, 2022.

Our late-stage programs also include fitusiran in department hemophilia A or B with or without inhibitors, partnered with Sanofi, who is leading development of fitusiran in the ATLAS Phase III program. Sanofi announced substantial progress with fitusiran and now expects to share data from initial pivotal trials as early as beginning of next year with a potential regulatory submission later in 2022. Now in addition to our late-stage clinical programs, we believe we have also been making great progress with our early and mid-stage programs. One of the exciting parts of our story now is the potential expansion of RNA therapeutics beyond rare disease into prevalent disease opportunities.

We believe now is the time to address many unmet needs in common disease settings such as hypertension, NASH, gout, diabetes, among others. And we believe the pharmacological properties of RNAi therapeutics provide the foundation for success. Our program for hypertension is a great example. So zilebesiran formerly known as LNAGT our investigational RNAi therapeutic targeting the genetically validated target angiotensinogen for the treatment of hypertension.

In the second quarter, we reported interim results from the Phase I study in which patients treated with single days of zilebesiran at 100 milligrams or higher doses experienced durable reductions in serum AGT of more than 90% throughout to weeks. Reductions in 24-ounce systolic blood pressure of greater than 10 millimeters of mercury were observed at week aid after single doses of 100 milligrams or higher. This antihypertensive affected persistent through week 12. In the highest dose group, greater than 15 millimeters of mercury reduction in blood pressure was observed.

We believe these durable pharmacologic effects may support tonic control of blood pressure with a once quarterly and potentially biannual dosing regimen. In the study, zilebesiran has been generally well-tolerated with an encouraging safety profile observed to date. The Phase I study has two parts that are designed to assess the tolerability of zilebesiran during potential augmented pharmacology inducing either by a low-salt diet or by co-administration of the conventional RAS inhibitor of zilebesiran. These cohorts have completed dosing with data readout expected later this year.

We also recently initiated our KARDIA Phase II program with zilebesiran. The first of the two studies KARDIA-1 is designed to evaluate the efficacy and safety of zilebesiran's the monotherapy in patients with mild to moderate hypertension. This study is currently enrolling patients. In late 2021, a we plan on initiating KARDIA-2, which is designed to evaluate the efficacy and safety of zilebesiran as an add-on therapy in patients with uncontrolled hypertension while receiving treatment with standard of care.

Moving on, we're also advancing ALN-HSD in collaboration with our partner, Regeneron, for the treatment of NASH. We believe that RNAi mediated knockdown of HSD17B13 or phenocopying the genetic loss of function findings reducing hepatic inflammation, injury and fibrosis in NASH patients. Enrollment and dosing continues in the Phase I study of ALN-HSD, which is now transitioned to dosing in Part B with NASH patients. Let's turn briefly to our ALN-HBV02 program, also known as VIR-2218 in partnership with Vir. At the EASL meeting in June, Vir presented results from the Phase II study of ALN-HBV02, showing a positive safety profile and reduction of hepatitis B surface antigen.

When combined with PEGylated interferon alpha for 12 weeks, a more rapid and substantial hepatitis B surface antigen decline was observed in the co-administration cohort compared to HBV02 alone. As a reminder, Alnylam has retained a free opt-in right to co-develop and co-commercialize HBV02 or to receive milestones and royalties we consider to be quite attractive. We have also made great progress with our preclinical program, ALN-XDH, in development for the treatment of Gal and plan to file a CTA for this program in late 2021. A significant unmet need for new treatments to address recurrent gas attacks are very painful and debilitating condition and our scientists pioneered RNA therapeutics for this condition with broad intellectual property protection. We also continue to make great progress on our many preclinical RNAi therapeutic opportunities beyond the liver.

Notably, we continue to advance our CNS and ocular assets with Regeneron. This includes our ALN-APP program, in development for the treatment of -- for autosomal dominant Alzheimer's disease and cerebral amyloid angiopathy. We now plan to file a CTA for ALN-APP in late 2021, representing a small shift in our time line. Finally, in our press release this morning, we announced our decision to discontinue our ALN-COV or ALN-COV program in development for the treatment of COVID-19. This was a portfolio decision based on the availability of highly effective vaccines and alternative treatment options for COVID-19. With that, let me now turn it over to Jeff to review our financial results. Jeff?

Jeffrey V. Poulton -- Executive Vice President, Chief Financial Officer

Thanks, Akshay, and good morning, everyone. I'm pleased to be presenting Alnylam's Q2 2021 financial results, which reflect another strong quarter of operational excellence across the business. Turning to our results first for ONPATTRO. We generated $113.8 million in net revenue for the quarter, representing 12% growth from the first quarter of 2021 and 71% growth compared with Q2 2020.

This marks the fourth consecutive quarter of double-digit quarter-on-quarter growth following one quarter of flat in growth that we experienced during the onset of the pandemic in Q2 of last year. U.S. ONPATTRO sales increased 6% versus Q1 2021 and were primarily impacted by the following: an approximate 12% increase in demand representing an acceleration from the 4% demand growth delivered in Q1, with the increase driven by the addition of new patients on therapy and continuation of greater than 90% patient treatment compliance.

Demand growth was offset by a higher level of gross to net deductions and less inventory stocking in the quarter compared with Q1 2021. In our international markets, ONPATTRO performance remains very strong with growth of 17% versus Q1 2021 and 79% versus Q2 2020, primarily driven by increased patient demand broadly across our markets in Europe and Canada. Sales from our international markets comprised 54% of our global total in Q2, clearly reflecting the benefit of our global commercial footprint.

Turning to our results for GIVLAARI. We generated $30.6 million in net revenue in Q2, representing 24% growth compared to the first quarter of 2021, driven by ongoing launches in the U.S. and Europe. Reported results in the U.S., in particular, improved during the quarter with quarter-on-quarter growth of 26% compared to 6% quarter-on-quarter growth in Q1 as we benefited from improved patient flow through the U.S. healthcare system. With OXLUMO, we had an excellent second full quarter of sales generating $16.3 million in net revenue in the quarter, up from $9.1 million in Q1, with growth contributions from both U.S. and rest of world markets.

Turning now to a summary of our full P&L results for the quarter. Total combined product sales in the second quarter were $160.8 million, representing 107% growth versus Q2 2020. Net revenue from collaborations for the quarter was $59.4 million, a significant increase from Q2 last year, primarily due to revenue recognized from our Regeneron collaboration. We recognized $0.3 million in royalty revenues during the quarter, representing our initial recognition of royalties earned on Novartis' sales of Leqvio. Gross margin on total revenues was 82.4% for the quarter, a slight improvement from prior year.

Our combined non-GAAP R&D and SG&A expenses for the quarter increased 19% versus Q2 2020. Key drivers of the increase continue to be additional R&D investment in advancing our late-stage pipeline programs and increased SG&A investment to support our three commercial brands, including the launch of OXLUMO. Also recall that last year in Q2, operating expenses were at the lowest quarterly level in 2020 and were impacted by the onset of the pandemic.

Our non-GAAP operating loss for the quarter decreased by approximately $51 million versus the same period in 2020, driven by strong top line growth and more moderate growth in operating expenses. Q2 also represents the sixth consecutive quarter that we've delivered an improvement in our non-GAAP operating loss, and we believe this clearly signals the path we're on toward profitability. Cash, cash equivalents and marketable securities were $1.9 billion as of June 30, 2021, compared to $1.87 billion as of December 30, 2020, with the increase primarily due to the second drawdown of our credit facility with Blackstone, which occurred during Q2 and cash received from the exercise of employee equity awards and purchases of shares under our employee stock purchase plan, offset by cash used in our operations to support overall growth.

Lastly, turning to our financial guidance. We believe our results for the second quarter continue to demonstrate successful commercial execution. As a result of the strength of our first half 2021 results, we are increasing our full year 2021 combined net product revenue guidance from $610 million to $660 million to $640 million to $665 million, representing a 3% increase from the midpoint of the prior range to the midpoint of the new range. Our guidance for net revenue from collaborations and royalties and for combined non-GAAP R&D and SG&A expenses remain unchanged. With that, I'll now turn the call over to Yvonne to review our upcoming milestones. Yvonne?

Yvonne Greenstreet -- Chief Operating Officer

Thanks, Jeff, and hello, everyone. Let me start by reviewing exciting partnership we announced with PeptiDream. PeptiDream is an industry leader in the discovery and optimization of peptide ligands against a wide variety of receptors. Through this collaboration, we and PeptiDream will discover and develop peptide siRNA conjugates to create multiple opportunities to deliver RNAi therapeutics to tissues outside the liver.

The collaboration has the potential to yield multiple treatment opportunities by targeting disease-causing mRNA transcripts in a wide variety of tissue types. Let me now turn to a review of the remaining goals for 2021. For starters within our TTR programs, we plan to present 18-month top line results from the HELIOS-A Phase III study with vutrisiran. We also plan additional regulatory submissions for vutrisiran in the EU, Japan and Brazil in late 2021. Based on the excellent progress in enrollment, we also plan to complete enrollment in HELIOS-B in the coming weeks as we announced today.

With zilebesiran, as actually mentioned, we plan to present additional data from the Phase I study later this year, hopefully, at the American Heart meeting in November, pending abstract acceptance, and plan to initiate the KARDIA-2 Phase II combination study later this year as well. For lumasiran, we plan to initiate a Phase II study for renal stone events in late 2021. We believe this Phase II study represents meaningful life cycle management of OXLUMO with the potential to significantly expand the overall opportunity.

We also plan to submit supplemental regulatory applications in both the U.S. and EU based on the ILLUMINATE-C results. With ALN-HSD, we expect to report initial safety results in healthy volunteers from the Phase I study. Turning to cemdisiran for complement-mediated diseases. Our partner, Regeneron, plans to initiate a Phase III study of cemdisiran, and pozelimab combination in myasthenia gravis, in addition to multiple Phase II studies in PNH. We believe the combination of cemdisiran and pozelimab represents an attractive therapeutic strategy for complement mediated diseases.

We're very excited to file our first CNS CTA for AI and APP, now expected in late 2021 in development for the treatment of autodermal-dominant Alzheimer's disease and cerebral amyloid angiopathy. This sets us up for potential initial POC data in 2022. And given the exciting preclinical progress, we plan to advance ALN-XDH in development for the treatment of gout toward a CTA filing in late 2021. Let me now turn it back to Christine to coordinate our Q&A session. Christine?

Christine Regan Lindenboom -- Senior Vice President, Investor Relations and Corporate Communications

Thank you, Yvonne. Operator, we will now open the call for questions. To those dialed in, we would like to ask you to limit yourself to one question each and then get back in the queue if you have any additional questions.

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from Gena Wang with Barclays.

Gena Wang -- Barclays -- Analyst

Thank you for taking my question. And also, congrats on the very strong quarter. So I have one big-picture question. Alnylam has been very successful as a stand-alone company with established platform, several approved drugs and also numerous high-quality pipeline assets. So just wondering, going forward, are you willing to be under a bigger umbrella? Or do you want to continue being a stand-alone company and to grow into a top five biotech company as your goal?

John Maraganore -- Chief Executive Officer, Director

Hi Gena, that's -- thank you, first of all, for your comments on the quarter. And thank you for your comments on what we've been able to achieve as a company. And I think it's fair to say that we believe that we have a path forward as a company to build significant value. It's very evident in the P^5 times 25 5-year goals and plans that we outlined earlier this year as to how we believe that we can build a top five biotech company in market cap over the next 5-year period, by execution with our organic product engine and our capabilities to achieve sustainable innovation.

So it's certainly our plan to continue on that path. But of course, we have a fiduciary duty to shareholders. And obviously, we'll always consider that component of how we have an obligation to our shareholders. But our plans right now are very focused on our P^5 times25 goals and our abilities to execute continuously on that sustainable source of innovation. So that's how we're focused, Gena.

Gena Wang -- Barclays -- Analyst

Thank you.

John Maraganore -- Chief Executive Officer, Director

Thank you.

Operator

Our next question comes from Alethia Young with Cantor Fitzgerald.

Alethia Young -- Cantor Fitzgerald -- Analyst

Hey, guys. Thanks for taking the question. You guys crushed it this quarter. I guess I wanted -- it's another kind of big picture, but I just wanted to talk a little bit about as you start to do bigger programs like in hypertension and even ones beyond as you build out your business, like how do you kind of think about the balancing act of making that investment and kind of the commitment to profitability because some of these programs are pretty big opportunities. So I know I just wanted to kind of get a flavor would you go ahead alone? Or do you think that these are opportunities for potential partnership? Thanks.

John Maraganore -- Chief Executive Officer, Director

Yes. Well, first of all, thanks, Alethia, for the comments on the quarter. We're really pleased with the results, obviously, and it's a real credit to our overall organization for delivery as they did. Look, we're very excited about the opportunities for RNAi therapeutics in more prevalent diseases. I think the data with zilebesiran really points to the ability to reimagine the treatment of hypertension, a leading cause of cardiovascular morbidity and mortality around the world. So I mean, how can you not get excited about transformational medicines that can make a fundamental impact on a major issue of public health globally with the potential, obviously, over time to help many, many people.

So we're very excited about that direction. There is really no reason why we aren't able to advance these assets on our own. We have a great team. We have a proven track record of execution on the R&D side. And there's simply no reason why we have any need for capabilities or even funding from third-party partners. But obviously, we also want to make sure that we navigate our path toward sustainable and ultimately profitable business in a responsible manner. So we are very thoughtful about how we balance our opex investments along with the growth in our revenues toward a sustainable -- financially sustainable, self-sustainable profile. And so that is a core part of our strategy.

Let me -- with those intros, let me first start with Jeff and then transfer over to Yvonne to comment a little bit more about our sort of going forward views. But Jeff, do you want to talk first on the financials and then Yvonne with a little bit about our perspectives on growth in the prevalent disease markets.

Jeffrey V. Poulton -- Executive Vice President, Chief Financial Officer

Yes. I think I agree with everything you said, John, and one of the metrics in P^5 times25 goals is getting to profitability across the period, and we're committed to doing that. I think the one other comment that I would make as it relates to zilebesiran is from a commercial standpoint, our hope is that we'll be able to leverage, infrastructure that hopefully we will have built by them from a perspective of supporting an expansion of the TTR franchise if we're successful in the APOLLO-B and HELIOS-B studies to get into a larger sort of cardiomyopathy footprint. So that's one factor as well.

John Maraganore -- Chief Executive Officer, Director

And Yvonne, do you want to comment a little bit more strategically going forward, how we think of this?

Yvonne Greenstreet -- Chief Operating Officer

No, I think actually, both of you have covered this well. We believe we're a unique company. and we have every intention of building a top five biotech. And we have every intention of progressing all of our opportunities, obviously, in a thoughtful fashion.

John Maraganore -- Chief Executive Officer, Director

Thank you, Yvonne. Did that answer your question, Alethia?

Alethia Young -- Cantor Fitzgerald -- Analyst

Yes. It's great. Thank you, guys.

John Maraganore -- Chief Executive Officer, Director

Thank you.

Operator

Our next question comes from Joseph Stringer with Needham & Company.

John Maraganore -- Chief Executive Officer, Director

Joseph, I can't hear you. Are you on mute?

Operator

Joseph, your line is open, you can ask your question.

John Maraganore -- Chief Executive Officer, Director

Maybe we should go to the next question.

Operator

Okay. Our next question comes from Maury Raycroft with Jefferies.

Maury Raycroft -- Jefferies -- Analyst

Hi. Good morning, everyone. Congrats on the quarter. Thanks for taking my question. I was wondering if you can talk about the parallels between zilebesiran and inclisiran and investors should be thinking about? And is there anything additional you could say about the KARDIA-2 design, including whether it's going to be dosing every three months or six months? And lastly, if you can provide any perspective into what time lines look like for both KARDIA-1 and 2.

John Maraganore -- Chief Executive Officer, Director

Fantastic. Let me start my comments, and then maybe, Akshay, you can chime in here on some more of the specifics on the KARDIA program and the dosing regimen. For starters, I mean, look, we're very -- again, very excited about zilebesiran and its potential to reimagine the treatment of hypertension. And you're very right, Maury, to point to the analogy with inclisiran because both sRNAs are designed to address both very prevalent diseases. One is in hypercholesterolemia with inclisiran, the other hypertension with zilebesiran.

And both, of course, enable a very infrequent dose regimen to control these leading causes of CD morbidity mortality in both cases, right, with HDL and LDL. I'd say from a development program standpoint, what's attractive strategically about both efforts is that the biomarker or the clinical marker that we're measuring in our Phase I studies and our Phase II studies in the case of zilebesiran blood pressure and in the case of inclisiran LDL cholesterol. Those are the exact same endpoints that will be used in our Phase III trials in support of an approval.

And so it is attractive that we have completely derisked the primary endpoint of what will ultimately be a Phase III study with zilebesiran. And that's a very analogous situation to what we had with inclisiran in the setting of hypercholesterolemia. So a very attractive profile. And of course, we're very, very encouraged by the safety profile that we saw with inclisiran in thousands of patients that were studied, and we're obviously aiming to achieve a similar result with zilebesiran as we do further studies with that agent.

So at a high strategic level, that is -- those are some of the reasons why there's a lot of analogies between inclisiran and zilebesiran. So with that, Akshay, maybe you can talk a little bit about more of the KARDIA program, some of the time lines there as well as some of the dosing approaches Q3 monthly or Q6 monthly. So Akshay, take it away.

Akshay Vaishnaw -- President, Research & Development

Yes. Thanks, John. So Maury, as zilebesiran we'll execute two Phase II studies, KARDIA-1 is looking at zilebesiran in -- as a monotherapy in patients with multimode hypertension, about just shy of 400 patients, 375 or so in that study orthodox randomized controlled study. And that will be comp -- that study is up and running, that we complemented by KARDIA-2, which will kick off in the months to come later this year. And there, we will evaluate in KARDIA-2 the combination of zilebesiran with other antihypertensial medications. And of course, that will include RAS inhibitors, calcium channel blockers, diuretics.

There are more details to come. That study will be larger about 650 patients or so. We're not guiding right now to the exact completion date of both studies. They're just getting going, as I said, and more details to come later in the year as recruitment ramps up. But this is hypertension. So we're anticipating enrollment will go relatively quickly. And so we're looking forward to an exciting outcome building on the very promising data from the Phase I that John has already commented on.

With reference to dose and regimen that there'll be a spectrum of doses evaluated again, more details to follow. But I can reiterate that we'll be looking at both three and six monthly dosing regimens in these studies. And so we'll have a conference if you look at pharmacology of the drugs and put us in a good position to select the right dosing regimen for further development in Phase III. So I hope that's helpful, Maury.

Maury Raycroft -- Jefferies -- Analyst

Very helpful. Thanks for taking my question.

John Maraganore -- Chief Executive Officer, Director

Thanks, Maury.

Operator

Our next question comes from Salveen Richter with Goldman Sachs.

Salveen Richter -- Goldman Sachs -- Analyst

Good morning. Thanks for taking my question. Just given your agreement with PeptiDream, could you just talk about extrahepatic targets that you're -- or tissues that you're looking to target beyond CNS?

John Maraganore -- Chief Executive Officer, Director

Yes. Thanks, Salveen. Let me start, and then I'll hand it over to Akshay to talk a little bit further. We're obviously very excited about the agreement that we formed last week with PeptiDream as Yvonne said in her remarks, PeptiDream is really a leading company in peptide design and synthesis and obviously, working with them is part of our continued investment in extrahepatic delivery where we've already been very successful in CNS and ocular. So we're very excited about that. So Akshay, do you want to talk a little bit about how we look at the future of extrahepatic delivery and tissues of interest.

Akshay Vaishnaw -- President, Research & Development

Yes. So Salveen, of course, we're interested in a range of organs for several reasons. One is that RNAi as a pharmacologic activity can be conducted in any tissue, any cell in the body. So we can take an sRNA to any cell type and expect to see target lock down, and we can say that with confidence. And if you combine that with the possibility that they're genetically validated and oncologically validated targets in many, many different tissues, we've got broader ambitions with PeptiDream beyond the liver.

So of course, we're already in the CNS NI that we have several options there in terms of the kind of conjugates we've built. I'm sure we can add to those with PeptiDream. And then there'll be new tissues you'll be hearing about from us. But you can remain confident that this collaboration is being conducted to really maintain and extend our leadership position in RNAi. And we believe that -- by the end of the decade, we'll see RNAi in many, many different tissues beyond the liver and approved programs associated with that.

Salveen Richter -- Goldman Sachs -- Analyst

Thank you.

John Maraganore -- Chief Executive Officer, Director

Thanks, Salveen.

Operator

Our next question comes from Paul Matteis with Stifel.

Paul Matteis -- Stifel -- Analyst

Great. Thanks so much. I was wondering if you could give any comments on the expansion of the Chair role? And if there's any sort of back story to that or any relationship to the prior ONPATTRO investigation that was announced earlier this year in terms of marketing? And then, just one question on APOLLO-B. What do you assume for the number of events in that study in terms of mortality and hospitalization and do you think that there's a chance to show at least some sort of convincing numerical difference versus placebo? Thanks so much.

John Maraganore -- Chief Executive Officer, Director

Well, I'll take the first part, Paul, and then Akshay, you should obviously address the APOLLO-B thing. So yes, we announced this morning the appointment of Mike Bonney in an expanded role. He's obviously been our Chairman, but we've now expanded his role as the Executive Chair of the company.

And this is really to help us continue and further strengthen our overall ethics and compliance function within the company, an area that we're extremely committed to having a high-quality, best-in-class type of organization and its integration within the business. So that's what we've done. Mike is an extremely experienced commercial leader, I have worked with Mike for many, many years.

I know him, obviously, extremely well. And so we welcome him in this new governance role in a way that really is just aimed to help us continue to be the best company we could possibly be across every dimension of what we do. And Mike brings a lot of experience to that side of it. So Akshay, do you want to handle the APOLLO-B question?

Akshay Vaishnaw -- President, Research & Development

Yes, Paul, I think it's clear to everybody in the primary endpoint 6-minute walk distance, and that's how we powered the study from the beginning. It's the most efficient way to show potentially the benefit of patisiran in the ATT cardiomyoptahy population. So we're looking forward to that result in the middle of next year.

The study is fully enrolled, of course and that's exciting. Now vis-a-vis the specifics of mortality and hospitalization study wasn't powered around that. And we look forward to seeing those data. It's hard to tell right now, of course, because the study is blinded and so forth to comment on the exact nature of those data and what we'll see. We hope to see a trend, but that's something we'll have to wait for next year.

John Maraganore -- Chief Executive Officer, Director

Does that answer your questions?

Paul Matteis -- Stifel -- Analyst

Fair enough. Yes. Absolutely. Thanks.

Operator

Our next question comes from Ritu Baral with Cowen.

Ritu Baral -- Cowen -- Analyst

Hi, guys. Thanks for taking the question. Given the rapid time lines for HELIOS-B, especially relative to APOLLO-B versus initial expectations. John, what are your, I guess, current thoughts on a potential interim continue to be a point of client conversations and also obviously feeds into the whole breakeven question.

And then a very quick follow-up for Tolga and Jeff. Q2 was great, but apparently, since we can't have nice things. The Delta variant is going to be hitting Q3. What are you seeing so far? And what might the impact be there? Thanks.

John Maraganore -- Chief Executive Officer, Director

Okay. That's great. Let me start with the IA then we'll -- Akshay, you may want to comment on the IA after that, and then we'll go to Tolga on your question for Delta variant and perspectives on Q3. We obviously aren't going to foreshadow Q3, but we can give you some sense from a -- at least our view. So regarding the interim analysis, Ritu, when we designed HELIOS-B, we included the -- and with alignment of both the FDA and EMA, we included the ability to do an interim analysis that was not at that time specified.

Because we wanted to have more time in the study to basically understand how and what type of interim analysis we might do. We continue to believe that an interim analysis could be useful in the study. But obviously, we have the beautiful benefit of the APOLLO-B readout that will occur sometime this time next year that will give us line of sight on mortality and CV events that are happening in that study and the wisdom and any trends that we might see in the wisdom of doing an earlier interim analysis in HELIOS-B as it relates to that study.

Now it's extremely good that we also have killed it on the enrollment of HELIOS-B as it relates to the study and the fact that the ultimate ending data of that study has now been accelerated significantly. So obviously, all these things will factor into our decision. But that decision, which includes regulatory alignment of course, won't be really happening until next year. Akshay, anything to add to the IA side of things?

Akshay Vaishnaw -- President, Research & Development

No, I think you covered it, John.

John Maraganore -- Chief Executive Officer, Director

Okay. Terrific. And so let's now go to Tolga to comment a little bit on his perspectives on Q3 as it relates to the Delta variant. Tolga?

Tolga Tanguler -- Chief Commercial Officer

Yes, absolutely. Thank you for that question. Look, I mean, we obviously, as an organization, learned a lot and built a lot of capabilities that includes alternative sites of care, home care, when it's possible. and how we have been able to continue to engage with physicians and other important customers. And that will stay with us regardless of where the Delta variant is going to go.

We clearly were able to take advantage of the healthcare systems opening up. And that has obviously been reflected on our ability to inform and communicate with our key stakeholders. In the near term, we don't anticipate a significant impact given the success of the vaccine. But obviously, like everyone else, we are observing and continuing to build our capabilities and the learnings that we've had since 2020. John, I don't know if you have anything else to add to that.

John Maraganore -- Chief Executive Officer, Director

No, I think you nailed it. I would just say, obviously, Ritu, our confidence is partially reflected in our new guidance range, which we upped to $640 million to $665 million this morning. So obviously, we wouldn't have done that if we felt -- didn't feel confident around our ability to continue to perform for the rest of the year. And I think that speaks for itself.

Ritu Baral -- Cowen -- Analyst

Great. Thanks.

John Maraganore -- Chief Executive Officer, Director

Great. Thanks to you too.

Operator

Our next question comes from Tazeen Ahmad with Bank of America.

Tazeen Ahmad -- Bank of America -- Analyst

Hi. Good morning. Thanks for taking my question.

John Maraganore -- Chief Executive Officer, Director

Good morning.

Tazeen Ahmad -- Bank of America -- Analyst

So mine is going to also be on ATTR. Can you give us some color about why you think the enrollment rate of HELIOS-B is much faster than you might have anticipated initially. And then can you give us any idea of the profile of the patients that are being enrolled in HELIOS-B? Are they in any way really different from the profile that's been enrolled in APOLLO-B. And I guess I'm trying to get a little bit of color on whether or not we can make any read-through as estimates based on what you show for APOLLO-B as read-through to HELIOS-B. Thank you.

John Maraganore -- Chief Executive Officer, Director

Those are great questions, Tazeen. I'm going to just pass them both over to Akshay. Akshay, why don't you handle them?

Akshay Vaishnaw -- President, Research & Development

Yes. So the enrollment in HELIOS-B has gone extremely well. And I think few of the major factors are, we obviously have a validated platform. We get excellent TTR knockdown, TTR knockdown is a proven approach in hATTR amyloidosis with peripheral neuropathy, it's of great interest in the cardiomyopathy space, as you know. The data from the original APOLLO study would suggest that in the cardiomyopathies in hATTR patients that are these important effects on biomarkers post-hoc analysis showing mortality and hospitalization.

So all of these bode well and I think are very promising in terms of the hope for both patisiran and vutrisiran in the various studies, including HELIOS-B for vutrisiran. So I think that's helped a lot this great interest. Of course, vutrisiran is once every three months subcutaneously, and we're also investigating once every six months. So that's a very exciting value proposition for patients it's convenient and an effective way we hope to treat the disease. I'm sure that's an attractive factor.

We've heard that from folks. And that's especially important in these COVID times so you don't have to see patients as much. And then finally, we have enormous experience in the TTR space in terms of working with investigators, working with patients and working globally at triple-digit, couple of sites that we now know through our work. And so that's been very effectively leveraged by our clinical development team and clinical operations team. So those are some of the factors, and we look forward to the results in due course. Now your other question related to similarity of the patient population.

At a high level, I would say, yes, indeed, they are largely similar, and they are basically patients with ATTR cardiomyopathy, which could be hereditary or wild type. Ithink we anticipate seeing more wild-type patients in the -- in both studies, and they'll have a substantial burden of disease in terms of patients with 1, two in some patients with Class III disease. So I think the APOLLO readout and as John emphasized on an earlier question for regarding the interim analysis for HELIOS-B is an important readout will give us the great insight that will then leverage to make decisions around the IA for HELIOS-B.

Tazeen Ahmad -- Bank of America -- Analyst

Okay. Thanks for that. Maybe just to follow up, Akshay. Sometimes when studies enroll faster than expected and investors can get a little concerned about whether or not the quality of the patients being enrolled is ideal. Now obviously, you can only give a limited amount of information on this question, but is that a concern at all for you? Thank you.

Akshay Vaishnaw -- President, Research & Development

Yes. I mean, we monitor the quality of our study is obviously very, very carefully just for the reasons that you say. I think we've established a good track record, we have three approved drugs that we've executed numerous Phases 1, two and three studies now. And so we're confident that the quality control systems we have in place when we do clinical trials are adequate.

And you can rest assured that we've been paying a lot of attention to these studies, patients coming into APOLLO-B and HELIOS-B studies, inclusion/exclusion criteria, the patient management through the studies. And of course, we do a lot of work ourselves and in collaboration with our CRO. So there are numerous points of control and so I think really the rapid enrollment is more a reflection of the tremendous work by my colleagues and the attractiveness of the hypothesis and vutrisiran as a drug as opposed to something awry in the study. So we're feeling good.

John Maraganore -- Chief Executive Officer, Director

I'm going to be less British. There should be 0 concern about that.

Tazeen Ahmad -- Bank of America -- Analyst

Okay. Thank you.

John Maraganore -- Chief Executive Officer, Director

Thank you.

Operator

Our next question comes from Mani Foroohar with SVB Leerink.

Mani Foroohar -- SVB Leerink -- Analyst

Hey, guys. Thanks for taking my question. First, let's start with the PeptiDream collaboration. We've seen some early but interesting data with other oligo approaches using an antibody targeting approach, specifically in skeletal muscle. Do you want to give us a little bit sense of how you think about that data versus the unique advantage of PeptiDream approach and sort of the scope of extra hepatic targets? Are there specific tissue types that you think the PeptiDream collaboration are especially well-suited for?

And then secondarily, more -- sort of a more commercial question. Presuming that we continue to see reasonable vaccine protection against the Delta variant with booster doses that we've seen from there from Pfizer and J&J. Where are we in terms of how many innings in are we in terms of the recovery in clinical volumes? And is there additional tailwind to be had there commercially on growth acceleration across the existing pipeline? I'm sorry, across the commercial platform.

John Maraganore -- Chief Executive Officer, Director

Could you -- Mani, could you repeat the second part of your question again, COVID impact and -- yes.

Mani Foroohar -- SVB Leerink -- Analyst

Yes, it's how much -- presuming that we don't have a -- that we don't have -- a return to lockdown sort of dynamic. How much runway is there any of the rebounds in clinical volumes? And how much of the tailwind remains?

John Maraganore -- Chief Executive Officer, Director

Good. Okay. All right. So Akshay, do you want to handle the PeptiDream question? And then Tolga, maybe you can address Mani's question on tailwinds on that side. So go ahead, Akshay.

Akshay Vaishnaw -- President, Research & Development

Yes. So Mani, broadly speaking, we ourselves have invented a number of delivery systems for RNAi therapeutics to deliver to the nervous system in the eye. Of course, we've been very open with the lit nanoparticle approach from ONPATTRO and then the GalNAc conjugates for the liver and then we have novel conjugates, which we haven't shared as many details for the central nervous system in the eye.

And so I'm confident that over the period of time that there'll be many, many approaches that we and others will come up with, as you said, a published on antibody targeting via the transient receptor for muscle. Some of the advantages of peptide-based approaches, of course, are screening, specificity, ease of manufacture, COGS. There are many, many advantages, I think, will probably have a much more diverse library that we can tap.

In fact, we know we have a much more diverse library we with PeptiDream. And so we can -- we'll be able to reach a vast array of receptors for internalization of RS RNAs. And so it's really a very exciting collaboration we ourselves have some pilot data. They have pilot data. And so more details to come. But I think this really opens up an enormous number of possibilities from now.

John Maraganore -- Chief Executive Officer, Director

Tolga, do you want to handle the second question?

Tolga Tanguler -- Chief Commercial Officer

Sure, absolutely. Mani, look, obviously, having seen the healthcare systems opening up, we've been able to generate a pretty healthy growth of quarter-over-quarter. And due to that, we were able to increase our guidance for the full year. Now looking at the future, obviously, we're very pleased with the capabilities that we've built, which helps us a lot tremendously. If you look at our accuracy rates, if you look at how we've been able to engage with our customers, those numbers have been relatively steady.

The big -- remaining question is going to be, depending on our ability to find new patients is if the healthcare systems close down significantly, which we don't anticipate, obviously, that impacts some category growth. But what we've been able to achieve so far in the first half of the year and through 2020, I think should demonstrate that we've been able to navigate in an environment were rather limited with the healthcare systems. The more it opens up, it will certainly help us to be able to continue to grow at that state rate that we've been able to demonstrate.

John Maraganore -- Chief Executive Officer, Director

Yes. And I would just add -- thanks, Tolga. And I would just add, Mani, to your question that we know that there's still going to be more and more patients that come back into the healthcare system. I think we all know it that people have stayed out because of concerns. And as time goes on, we're going to see more coming back. So I think this is an opportunity for more headwinds -- more tailwinds rather for the future. Because of just return into the healthcare system in normal care cycles that are going to be important going forward.

Mani Foroohar -- SVB Leerink -- Analyst

Great. Thanks for answering the question, guys.

John Maraganore -- Chief Executive Officer, Director

Thank you.

Operator

Our last question comes from Luca Issi with RBC Capital.

Luca Issi -- RBC Capital -- Analyst

Well, fantastic. Thanks for squeezing me in. Congrats on all the progress. Two quick ones here. The first, can you maybe talk a little bit more about the IKARIA platform here? I find it interesting that in your press release, you mentioned that the platform is both long-acting and reversible.

So wondering if you can offer any color on how you're planning to do both. And then the second one on fitusiran, obviously, data in early 2022, but wondering if you can comment on the ultimate commercial opportunity for this product given the evolving competitive landscape in both hemophilia A and hemophilia B. Thank you.

John Maraganore -- Chief Executive Officer, Director

Great. Thanks, Luca. Two great questions. Let me answer both, and then Akshay, you can jump in if you have additional views. Look, we're very excited about the IKARIA platform. IKARIA, by the way, is an island in Greece. That's one of these booze-on islands where people live for a long time. So we like Greek Islands, and we like people living for a long time. But the foundation -- the scientific foundation for this is going to be something that we present relatively soon, sometime in the fall at a scientific meeting.

And I think what you're going to see is really continued evidence of Alnylam innovation and Alnylam and Genuity as it relates to RNA interference. So the reason it's both long-acting and reversible is it's RNAi. We're targeting RNA. We're not targeting DNA, which has got a lot of uncertainties and risks associated with it. And so by targeting RNA with our RNAi platform and with some adjustments that we made to it, we're able to achieve both long-acting and reversible.

And I think importantly as well, Luca, a deeper level of knockdown. So it's really got many attributes that we think are exciting. And TTRsc04 will be the first program, providing annual dosing almost a vaccine for the treatment of hATTR and more broadly, ATTR amyloidosis. So very, very exciting. Now on fitusiran, that's our program in hemophilia, what Sanofi has said is that they're planning to have a filing -- a regulatory filing in the second half of next year. They continue to be very excited about the program as are we. And while the landscape in hemophilia certainly is evolving and has evolved with the introduction of Hemlibra.

It's fair to say that there are many aspects of the fitusiran profile, including its effectiveness -- potential effectiveness in hemophilia B, where there is no subcutaneous treatment option today. And that's a -- while smaller than hemophilia A, it's still a very sizable market opportunity. And some of the longer-acting factors that were being developed for hemophilia B have not panned out as successfully, namely IDELVION from CSL.

So there really is a very nice opportunity just in hemophilia B alone. And then obviously, the opportunity to compete in the hemophilia A market against Hemlibra is something which Sanofi is quite keen on doing as well. Gene therapy is coming as well, but I think that's going to really be niched in the whole hemophilia segment at the end of the day. So Akshay, anything to add to those two comments I just made?

Akshay Vaishnaw -- President, Research & Development

No, you covered it, John.

Luca Issi -- RBC Capital -- Analyst

Thanks so much.

John Maraganore -- Chief Executive Officer, Director

Excellent. Excellent. All right. Thank you. So I think that was the last question. So let me thank everybody for joining us on this call. We're obviously, really happy with our second quarter results and overall results in 2021. And we're really looking forward to the next six months of the year and what we can deliver from our science as well as our commercial execution. And we're very much on our way toward P^5 times25. So it's an exciting time for Alnylam by all accounts. Thank you, and have a great day.

Operator

[Operator Closing Remarks]

Duration: 65 minutes

Call participants:

Christine Regan Lindenboom -- Senior Vice President, Investor Relations and Corporate Communications

John Maraganore -- Chief Executive Officer, Director

Tolga Tanguler -- Chief Commercial Officer

Akshay Vaishnaw -- President, Research & Development

Jeffrey V. Poulton -- Executive Vice President, Chief Financial Officer

Yvonne Greenstreet -- Chief Operating Officer

Gena Wang -- Barclays -- Analyst

Alethia Young -- Cantor Fitzgerald -- Analyst

Maury Raycroft -- Jefferies -- Analyst

Salveen Richter -- Goldman Sachs -- Analyst

Paul Matteis -- Stifel -- Analyst

Ritu Baral -- Cowen -- Analyst

Tazeen Ahmad -- Bank of America -- Analyst

Mani Foroohar -- SVB Leerink -- Analyst

Luca Issi -- RBC Capital -- Analyst

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