Q2 2024 Office Properties Income Trust Earnings Call

August 1, 2024

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Operator: Good morning, and welcome to the Iona Second Quarter 2024 Financial Results Conference Call. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Wade Wok, Senior Vice President of Investor Relations, to lead off the call. Please begin.

Wade Walke: Good morning, and welcome to the eye on our second quarter 2024 financial results Conference call. As a reminder, this call is being recorded at this time I would like to turn the call over to Wade Walke Senior Vice President of Investor Relations to lead off the call. Please begin.

Wade Wok: Thank you, Danielle. Before we begin, I encourage everyone to go to the Investors section of the IOMIS website to view the press release and related financial tables that we will be discussing today, including a reconciliation of GAAP to non-GAAP financial measures. We believe non-GAAP financial results better represent the economics of our business and how we manage our business. We've also posted slides on our website that accompany today's call. With me on this morning's call are Brett Monia, Chief Executive Officer; Richard Geary, Chief Development Officer; Kyle Genet, Chief Global Project Strategy Officer; and Beth Haugen, Chief Financial Officer.

Wade Walke: Thank you Danielle before we begin I encourage everyone to go to the investors section.

Speaker Change: Website to view, the press release and related financial tables.

Speaker Change: Today.

Speaker Change: A reconciliation of GAAP to non-GAAP financials.

Speaker Change: non-GAAP financial results better represent the economics of our business and how we manage our business.

Speaker Change: Posted slides on our website that accompany today's call.

Speaker Change: With me on this morning's call are Brett ammonia, our Chief Executive Officer, Richard Gere, <unk>, Chief Development Officer Al <unk> Global Project strategy Officer, Beth Hougen, Chief Financial Officer.

Speaker Change: Eric Swayze Executive Vice President of Research Eugene Schneider, Chief Clinical Development Officer, Jonathan Virtual Chief Commercial officer, Walter join Us for the Q&A portion of our call.

Wade Wok: Eric Swayze, Executive Vice President of Research, Eugene Schneider, Chief Clinical Development Officer, and Jonathan Birchall, Chief Commercial Officer, will also join us for the Q&A portion of our call. I would like to draw your attention to slide three in our presentation, which contains our forward-looking language statement. During this call, we will be making forward-looking language statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors contained in our SEC filings for additional detail. And with that, I'll turn the call over to Brett.

Speaker Change: I would like to draw your attention to slide three in our presentation, which contains our forward looking language statement during this call.

Speaker Change: Forward looking language statements are based upon current expectations and beliefs.

Speaker Change: These statements are subject to certain risks and uncertainties and our actual results may differ materially I encourage you to consult the risk factors contained in our SEC filings for additional detail.

Speaker Change: I'll turn the call over to Brett.

Brett Monia: Thanks, Wade. Good morning, everyone, and thanks for joining us on today's call. We've achieved a great deal during the first half of this year, delivering many significant milestones as we continue to execute on our vision to bring better futures to people with serious diseases. Today, Pionis Discovered and Developed medicines are reaching more and more people, bolstered by two recent launches. Winua, for people with hereditary APCR polyneuropathy in the U.S., and Calcadi, the first approved treatment for a genetic cause of ALS, currently available in the U.S. and now approved and available in Europe.

Brett: Thanks, Wade and good morning, everyone and thanks for joining us on today's call.

Brett: We've achieved a great deal during the first half of this year delivering.

Brett: The milestones as we continued to execute on our vision to bring better futures to people with serious diseases.

Speaker Change: Tonight.

Speaker Change: Honest discovered and developed medicines are reaching more and more people bolstered by two recent launches we knew what could people with hereditary <unk> Polyneuropathy U S. <unk>, Saudi the first approved treatment for genetic cause of Pls currently available in the U S and now approved and available in Europe.

Brett Monia: With the progress we're making across our pipeline, our medicines are well positioned to continue reaching more and more patients for years to come. The U.S. launch of our first Ionis co-branded medicine, Waynua, is progressing well with AstraZeneca. And we expect to bring Waynua to even more patients across the globe with the recent approval in Canada, an anticipated approval decision in Europe later this year, and with additional regulatory submissions completed in many other geographies, with more coming.

Speaker Change: With the progress, we're making across our pipeline our medicines are well positioned to continue reaching more and more patients for years to come.

Speaker Change: The U S launch of our first co branded Patterson Manila is progressing well with Astrazeneca.

Speaker Change: Back to Greenway like even more patients across the globe with the recent approval in Canada.

Speaker Change: We anticipate an approval decision in Europe this year and.

Speaker Change: With additional regulatory submissions completed.

Speaker Change: The geographies with more coming.

Brett Monia: Today, we are even more confident in the potential of WENUA to address the larger ATTR cardiomyopathy population. At the largest study ever conducted in this patient group, our ongoing landmark cardio-transformed trial is on track to deliver the most comprehensive and the most robust dataset in this patient population. We believe WENDUA has the potential to be the treatment of choice for the global APTR population.

Speaker Change: Today, we are even more confident in the potential of window here to address the larger HDR cardiomyopathy population.

Speaker Change: At the largest study ever conducted in this patient group are ongoing landmark cardio transform trial is on track to deliver the most comprehensive and the most robust data set in this patient population.

Speaker Change: We believe winter, where it has the potential to be the treatment of choice for the global population.

Brett Monia: Our confidence is based on when we knew a strong efficacy profile as demonstrated in hereditary ATTR polyneuropathy and the freedom of simple at-home self-administration, together with AstraZeneca's global cardiovascular commercialization leadership, along with our leadership in ATTR amyloidosis. As the Wynua launch accelerates, we're also preparing for the launch of Olizarsin in FCS later this year All this represents one of the most meaningful opportunities in our pipeline today as we prepare to first launch FCS, a severe rare disease with no approved treatments in the U.S., and then to expand to the much larger SHTG patient population.

Speaker Change: Our confidence is based on we knew its strong efficacy profile as demonstrated in hereditary <unk> polyneuropathy and the freedom of simple at home self administration together with Astrazeneca global cardiovascular commercialization leadership, along with our leadership in <unk> amyloidosis.

Speaker Change: How do we know what watch accelerate we're also preparing for the launch of Ozarks in FCS later this year, our first independent launch of a hold on medicine for eye on it.

Speaker Change: Oh of course represents one of the most meaningful opportunities in our pipeline today as we prepare to first launch FCS are severe rare disease with no approved treatments in the U S. And then expand to the much larger S. H T G patient population.

Brett Monia: Our NDA submission for Olazarsan was recently accepted with priority review, and our PDUPA date is set for December 19, and we're ready to bring this groundbreaking medicine to people with FCS. We also recently completed enrollment in our SH2G Phase 3 program, keeping us on track for data in the second half of next year.

Speaker Change: Our NDA submission for <unk> was recently accepted for priority review.

Speaker Change: <unk> date set for December 19, and we're ready to bring this ground breaking has people.

Speaker Change: Yes.

Speaker Change: We also recently completed enrollment for our <unk> Phase III program is on track for data in the second half next year.

Brett Monia: Based on our significant first-mover advantage and our positive results demonstrated to date, if approved, we believe Olazarsen could be the standard of care for both FCS and SHTG. We're building on the capabilities we've established for Eula and Olazarsan in preparation for our anticipated launch of Dominoversion for HAE prophylaxis next year. In our comprehensive clinical program, Don Doloresan has demonstrated strong evidence of meaningful benefit across multiple measures of disease, with a favorable safety and tolerability profile.

Speaker Change: Based on our significant first mover advantage in our positive results demonstrated to date.

Speaker Change: Prove we believe holds are some could be the standard.

Speaker Change: Standard of care for both FCS and S. H D G.

Speaker Change: We're building on the capabilities, we have established for you want and Ozark and preparation for our anticipated launch of Domino version.

Speaker Change: A J a prophylaxis next year.

Speaker Change: And our comprehensive clinical program that the worst has demonstrated strong evidence of meaningful benefit across multiple measures of disease.

Speaker Change: Favorable safety and Tolerability profile.

Brett Monia: These data, together with the potential for monthly or every two months self-administration using an auto-injector, strengthen our belief that, if approved, Donna Borson has the potential to advance the treatment paradigm for people living with HAE. With positive phase 3 data in hand, we expect to submit the NDA for Donald Wilson soon as we look to independently bring Donald Wilson to patients in the U.S. Outside the U.S., our commercial partner, Absuca, is preparing to file for marketing approval in Europe later this year. And with our recently expanded license agreement, HATSUKA is also working to bring down doors to people with HAE in the Asia-Pacific region.

Speaker Change: These data together with the potential for monthly or every two months self administration <unk>.

Speaker Change: Auto injector strengthened I believe that if approved an abortion has the potential to advance the treatment paradigm for people living with HIV.

Speaker Change: With positive phase three data in hand, we expect to submit the NDA for <unk> as we looked at independent brings out the worst of the patients.

Speaker Change: In the U S.

Speaker Change: Outside the U S. Our commercial partner Otsuka is preparing to file for marketing approval in Europe later this year.

Speaker Change: And with our recently expanded license agreement that soup is also working to bring down the worst to people with a J.

Speaker Change: Asia Pacific region.

Brett Monia: Following Wynua, Olisarson, and Donagel-Orson, our next wave of whole young opportunities includes our program for Angelman Syndrome. Based on the positive results from the HALOS Phase 1-2 study that we presented last week, we are advancing this potentially transformational medicine into a Phase 3 study, which we anticipate will begin in the first half of next year. ION 582 is positioned to become the cornerstone of our wholly owned neurology franchise, which today includes five wholly owned medicines and clinical development, with more to come by the end of the year.

Speaker Change: Following my New Oh, it's our sand on abortion. Our next wave of opportunities includes our program for Angelman syndrome.

Speaker Change: Based on the positive results from the Halos phase one two study that we presented last week. We are advancing this potentially transformational medicine into a phase III study, which we anticipate will begin in the first half of next year.

Speaker Change: I am 582 is positioned to become the cornerstone of our wholly on the rheology franchise, but today, which today includes five wholly owned medicines in clinical development.

Speaker Change: More to come.

Speaker Change: You ended the year.

Brett Monia: Our accomplishments so far this year and the investments we're making move us closer to achieving our goal of bringing a steady cadence of new transformational medicines to patients for years to come and generating next-level value for all Iona stakeholders. With that, I'll turn the call over to Richard to discuss our recent pipeline progress and preview key upcoming events. Next, Kyle will review the Waynoa launch and our launch plans and progress for Olazarsan and Bonneville-Orasan, and then he will review our financial results. I'll then wrap up things before taking your questions.

Speaker Change: Our accomplishments so far this year and the investments, we're making and move us closer to achieving our goal of bringing a steady cadence of new transformational medicines to patients for years to come and generating next level value Oh, I honest stakeholders.

Speaker Change: With that I'll turn the call over to Richard to discuss our recent pipeline progress and preview key upcoming events.

Speaker Change: Kyle will review the way no launch and our launch plans and progress for all the towers and the worse.

Speaker Change: And Beth will review our financial results.

Speaker Change: Wrap up things before taking your questions.

Richard: And with that, over to Richard. Thank you, Brad. We are pleased that our pipeline delivered many important achievements to date this year, with Wynua reaching more and more people with respiratory HDR polyneuropathy. I am proud of all that our IONOS team has accomplished to discover and develop this important new medicine and bring it to patients in need. Recent ATTR cardiomyopathy data further reinforce our confidence in the potential of Wynua to improve cardiovascular outcomes in this estimated worldwide patient population of approximately 300,000 to 500,000. With over 1,400 patients enrolled, our ongoing Cardio T-Transform study is the largest and most comprehensive study ever conducted in ATTR cardiomyopathy.

Speaker Change: With that over to Richard.

Richard: Thank you Brad.

Richard: We are pleased that our pipeline delivered many important achievements to date this year.

Richard: With my new reaching more and more people much registry age TR Polyneuropathy I am proud of all that our team.

Richard: As accomplished to discover and develop this important new medicine and bring it to patients in need.

Speaker Change: Recent ATT, our cardiomyopathy data further reinforces our confidence in the potential of Guangdong to improve cardiovascular outcomes. In this estimated worldwide patient population of approximately 300 to 500000.

Speaker Change: With over 1400 patients enrolled.

Speaker Change: Growing cardio T. Transform study is the largest and most comprehensive study ever conducted at H T. T E N. A T T R cardiomyopathy and as a result, we expect the data we generate will enable physicians and payors to make informed treatment decisions in this dynamic treatment landscape.

Richard: And as a result, we expect the data we generate will enable physicians and payers to make informed treatment decisions in this dynamic treatment landscape. In addition, as part of our Phase III program, we're conducting advanced cardiac imaging sub-studies, including an MRI sub-study and a centigraphy sub-study, which will generate valuable data about the potential benefits of Waynua in cardiomyopathy patients. We were delighted that our recent Olusarsen NDA submission was accepted by the FDA for priority review, highlighting the potential of this medicine to make a profound difference in the lives of patients. Our submission was based on the positive Phase 3 results in FCS that we presented and published earlier this year. Endophage Rebalance Study in Patients with FCS.

Speaker Change: In addition, as part of our Phase III program, we are conducting advanced cardiac imaging some studies, including an MRI sub study and our scintigraphy sub study.

Speaker Change: Which will generate valuable data.

Speaker Change: About the potential benefits of waning in cardiomyopathy patients.

Speaker Change: We were delighted that our recent oldest harsh and NDA submission was accepted by the FDA for a priority.

Speaker Change: Highlighting the potential of this medicine to make a profound difference in the lives of patients.

Speaker Change: Our submission was based on the positive phase III results in FCS that we presented and published earlier this year.

Speaker Change: And the phase III balanced study in patients with Fcs.

Richard: All assortments showed substantial and durable triglyceride reductions, and importantly for patients, physicians, and payers alike, Allisarson demonstrated substantial and clinically meaningful reductions in acute pancreatitis attacks. A remarkable 84% reduction in hospitalizations and a favorable safety and tolerability profile. We look forward to our upcoming December PDUCA day and, assuming approval, bringing all of this hope to people with FCS who currently have no approved treatments in the U.S. We are also developing olocarcin for the much larger, severe, high triglyceride patient population.

Speaker Change: <unk> showed a substantial and durable triglyceride reductions.

Speaker Change: And importantly for patients physicians and payers alike.

Speaker Change: All sorts and demonstrated substantial and clinically meaningful reductions in acute pancreatitis attacks.

Speaker Change: Mark about 84% reduction in hospitalizations, and a favorable safety and Tolerability profile.

Speaker Change: We look forward to our upcoming December Paducah date and.

Speaker Change: Assuming approval, bringing their own sourcing people with FCS who currently have no approved treatments in the U S.

Speaker Change: We are also developing <unk> for the much larger severe triglyceride patient population. We recently completed enrollment in our extensive phase III program for <unk> with more than 2500 patients enrolled across three studies.

Richard: We recently completed enrollment in our extensive Phase III program for SHTG with more than 2,500 patients enrolled across three studies. This puts us on track for data in the second half of next year, maintaining our multi-year first-mover advantage for this wholly-owned blockbuster opportunity. Following closely behind all of Sarson is Donna DeLores, for the prophylactic treatment of hereditary angioedema.

Speaker Change: This puts us on track for data in the second half of next year, maintaining our multiyear first mover advantage and this wholly owned blockbuster opportunity.

Speaker Change: Following closely behind <unk> and started the Washington for the prophylactic treatment of hereditary Angioedema, We recently presented and published in the New England Journal of Medicine positive phase three data from a way you can say Gee, our placebo controlled trial. Additionally, we also presented positive.

Richard: We recently presented and published in the New England Journal of Medicine positive phase three data from OASIS-HAE, our placebo-controlled trial. Additionally, we also presented positive data from OASIS-PLUS, our trial that includes an open-label cohort for patients rolling over from the phase three study and a separate cohort that we refer to as the switch study, where out-of-the-warsome treatment significantly reduced HAE attacks. The reduction in HAE attacks translated into significant and clinically meaningful improvements in quality of life across multiple validated measures and high levels of disease control in a vast majority of patients.

Speaker Change: Hum Oasis plus our trial that includes an open label cohort for patients rolling over from the Phase III study.

Speaker Change: And a separate cohort and we referred to as the switch study.

Speaker Change: Donna divorced from treatment significantly reduced HIV attacks the reduction in attacks.

Speaker Change: Translated into significant and clinically meaningful improvements in quality of life across multiple validated measures and high levels of disease control and the vast majority of patients.

Richard: And with longer-term treatment, patients improve further on all these measures. Additionally, as of our most recent data cutoff in February, 98% of oiling patients remain in the study. These positive data were further bolstered by the encouraging switch results. In the switch study through week 17, patients showed a substantial reduction in their HAD attack rate with Donna DeLorsen treatment compared to baseline on their previous treatment. Donna Doloresan treatment also resulted in improved quality of life measures and increased disease control.

Speaker Change: And with longer term treatment patients improve further on all of these measures.

Speaker Change: Additionally, as of our most recent data cut off in February 98%.

Speaker Change: <unk> patients remained in the study.

Speaker Change: These positive data were further bolstered by the encouraging switch results. The switch study through week 17 patients showed a substantial reduction in their H any attack rate with donatella washing treatment compared to baseline on their previous treatment.

Speaker Change: Got divorced some treatment also resulted in improved quality of life measures and increased disease control.

Richard: Importantly, more than 80% of patients surveyed reported a preference for Donna Doloresan over their prior prophylactic treatment, and nearly 90% of switch study patients remain in the study as of the data cutoff in February. In addition to strong clinical results, Donna Doloresan offers the potential for simple monthly or every two months self-administration via an auto-injection.

Speaker Change: Importantly, more than 80% of patients surveyed.

Speaker Change: Preference for dominant orphan over their prior prophylactic treatment.

Speaker Change: And nearly 90% of switch study patients remained in the study as of the data cut off in February.

Speaker Change: In addition to strong clinical results donut divorce and offers the potential for simple monthly or every two months self administration.

Speaker Change: A lot of injector.

Richard: Based on these data, we believe Donna Doloresan could become a preferred prophylactic treatment for people with HAE. In our NDA, which we plan to submit soon, we'll include data from OASIS-HAE, OASIS+, OLE Study Switch, and our Phase 2 study. Outside the U.S., OPSUCA is preparing to submit for marketing approval in Europe later this year.

Speaker Change: Based on these data, we believe Donna divorce, it could become a preferred prophylactic treatment for people with HIV.

Speaker Change: Our NDA, which we plan to submit soon.

Speaker Change: Well include data from always and say Gee Oasis plus.

Speaker Change: O L E study switch in our phase III study.

Speaker Change: Outside the U S. South suk is preparing to submit for marketing approval in Europe.

Speaker Change: After this year.

Richard: And with the recent expansion of our license agreement, Otsuka also plans to bring Donna Dolores to patients in the Asia-Pacific region. The rest of our RICH Phase III pipeline is also advancing, positioning us to continue delivering a steady cadence of potentially transformational medicines to patients. We recently completed enrollment in the pivotal arm of our Zildjian Nursing Study for Alexander Disease, keeping us on track for a Phase III readout next year. And GSK recently completed enrollment in the Phase 3 program for the peer person for chronic hepatitis B, which keeps the program on track for data in 2026.

Speaker Change: And with the recent expansion of our license agreement.

Speaker Change: <unk> also plans to bring Donegal, Washington patient from the Asia Pacific region.

Speaker Change: The rest of our rich phase III pipeline is also advancing.

Speaker Change: <unk> needs to continue delivering a steady cadence of potentially transformational medicines to patients.

Speaker Change: We recently completed enrollment in the pivotal arm of our zone zoomed in nursing study for Alexander disease, keeping us on track for a phase III readout next year.

Speaker Change: And GSK recently completed enrollment in the phase III program to appear in person for.

Speaker Change: For chronic hepatitis B, which keeps the program on track for data in 2026.

Richard: Coming right behind these programs, we have our next wave of medicines, including a number of medicines to treat both rare and broad neurological diseases, five of which are wholly owned, and we expect our wholly owned pipeline to expand later this year when two more medicines from our neurodisease franchise enter clinical development. ION582, our medicine for Angelman Syndrome, has transformational potential for the tens of thousands of people living with this serious rare disorder who are in need of disease-modifying treatments.

Speaker Change: Coming right behind these programs, we have our next wave of medicines, including a number of medicines to treat rare and broad neurological diseases.

Speaker Change: I looked which are wholly owned and we expect our wholly owned pipeline to expand later this year two more medicines from her.

Speaker Change: Oh franchise enter clinical development.

Speaker Change: I don't find it too medicine for Angelman syndrome has transformational potential for the tens of thousands of people living with this serious rare disorder, who are in need of disease modifying treatment for this reason I don't find it too is.

Richard: For this reason, ION582 is poised to become the cornerstone of our Holy On neurology pipeline. We're encouraged by the recently presented positive early results from the HALO study of ION582 and people with Angelman syndrome. In the study, we demonstrated evidence of consistent and meaningful improvement on all key functional areas across multiple assessments. This included 97% of participants showing clinically meaningful improvement in overall Angelman Syndrome symptoms on the SAS CGI assessment. Results showed improvements in measures of communication, cognition, and motor function exceeding natural history on the Bayley-4, Vineland-3, and ORCA Assessors. Additionally, we observed consistent improvements across ages and genotypes. And we saw favorable safety and tolerability at all dose levels, including no discontinuations or adverse events that were considered related to study drugs. Bye.

Speaker Change: Poised to become the cornerstone of our wholly on neurology pipeline.

Speaker Change: We're encouraged.

Speaker Change: Recently presented positive early results from Halo study.

Speaker Change: 1582, and people with Angelman syndrome.

Speaker Change: In this study we demonstrated evidence of consistent and meaningful improvement on all key functional areas across multiple assessments.

Speaker Change: This included 97% of participants showing clinically meaningful improvement in overall angelman syndrome symptoms.

Speaker Change: On the SaaS CGI assessment.

Speaker Change: And freedom Chin measures of communication cognition and motor function exceeded natural history on the Bailey for my Lendingtree.

Speaker Change: The orca assessments.

Speaker Change: Additionally, we observed consistent improvements across ages and tumor types.

Speaker Change: And we saw favorable safety and Tolerability at all dose levels, including no discontinuation or adverse events that were considered related to study drug.

Speaker Change: Based on these positive data.

Richard: We plan to advance ION 582 and do a well-controlled Phase 3 study in the first half of next year. Alongside the positive phase 1-2 data for Angelman syndrome, several recent events have also occurred in our mid-stage pipeline. We were pleased to present positive phase 2 data at ESL for ION224, our medicine targeting EGAD2 for the treatment of metabolic dysfunction associated steatohepatitis or MAD.

Speaker Change: We plan to advance I don't find a two well controlled phase three study in the first half of next year.

Speaker Change: Alongside the positive phase one two data for Angelman syndrome. Several recent events have also occurred in our mid stage pipeline.

Speaker Change: We were pleased to present positive phase II data that is all for my own two two for our medicine targeting began two for the treatment of metabolic dysfunction associated see I don't have the tightest or mash. Additionally.

Richard: Additionally, based on the encouraging Phase 1b data from IONIS-MAP-TRX, also known as BID-80, that were presented late last year by Internet, they recently announced that they amended the ongoing Phase 2 CELIA study with the goal to accelerate a potential proof-of-concept outcome. As a result of this change, they are now projecting data in 2026. Also, we and our partners recently discontinued development for ION 541 targeting taxa 2 for ALS and IONISFB LRX for geographic atrophy.

Speaker Change: Additionally, based on the encouraging phase one data for my honest Max T. Rx also known as did 80.

Speaker Change: They were presented late last year by Internet.

Speaker Change: Our recently announced amended the ongoing phase <unk> study with the goal to accelerate our potential proof of concept outcome. As a result this Tom this change we are now projecting data in 2026.

Speaker Change: Also we and our partners recently discontinued development of her eye on time for one targeting detection to realize.

Tom: My honest F B L Rx for geographic atrophy.

Richard: Both programs showed good target engagement and favorable safety, but they did not meet their primary efficacy endpoints. However, importantly, Roche continues to advance the IONIS FDL-Rx IgA Property Phase 3 study that it initiated last year based on positive Phase 2 data. Looking ahead, we have several important milestones still to come this year. These include presenting new Phase 2 Open Label Extension data for Donna Delorsen and data from the DEVOTE study, which is evaluating a higher dose of Spinraza, as well as anticipated regulatory approvals and launches for Waynoa and Noah Sarsen and regulatory filings for Donnie DeLorso. With that, I'll turn the call over to Kyle.

Speaker Change: Both programs showed good target engagement and favorable safety, but did not meet the primary efficacy end points.

Speaker Change: Importantly, Roche continues to advance the I honest at the L. Rx Iga nephropathy phase III study that they initiated last year based on positive phase two data.

Speaker Change: Looking ahead.

Speaker Change: Several important milestones still to come this year. These include presenting new phase two open label extension data for Dana to Washington, and data from the devote study, which is evaluating a higher dose of spin master.

Speaker Change: As well as anticipated regulatory approvals and launches for way, Noah and old starches and regulatory filings for Tony Dorsett.

Speaker Change: With that I'll turn the call over to Scott.

Kyle: Thank you, Richard. We are pleased with the initial results of the way NUA launched with AstraZeneca following U.S. approval at the end of last year, including significant growth quarter over quarter. With an estimated 40,000 patients worldwide and fewer than 20% of patients on an approved treatment, people with hereditary ATTR polyneuropathy remain underdiagnosed and largely underserved. As a result, a high unmet need remains that we at AstraZeneca are uniquely positioned to address.

Scott: Thank you Richard we are pleased with the initial results of the way new launch with Astrazeneca. Following U S approval at the end of last year.

Scott: Including the significant growth quarter over quarter.

Speaker Change: With an estimated 40000 patients worldwide and fewer than 20% of patients on an approved treatment.

Speaker Change: People with hereditary <unk> polyneuropathy remained under diagnosed and largely underserved.

Speaker Change: As a result of high unmet need remains that we and astrazeneca are uniquely positioned to address.

Kyle: The combined team is working together seamlessly with a shared goal to make Wainua the preferred choice for patients with ATTR polyneuropathy. We continued to see good uptake among patients in the second quarter, with an encouraging mix of new patient starts, including some who were new to this class of medicine, some switching from other treatments, and some using Waynua as an add-on treatment to their existing therapy. Prescribers and patients are recognizing Waynua's strong clinical profile, and patients value the ability to easily self-administer Waynua from their home.

Speaker Change: <unk> team is working together seamlessly with a shared goal to make when do the preferred choice for patients with <unk> Polyneuropathy.

Speaker Change: We continued to see good uptake among patients in the second quarter with an encouraging mix of new patient starts, including some who are new to this class of medicine. Some switching from other treatments and some using <unk> as an add on treatment to their existing therapy.

Speaker Change: Prescribers and patients are recognizing we noticed a strong clinical profile and patients value the ability to easily self administer window up from their home.

Kyle: We expect to reach a growing number of patients as we continue to educate prescribers about the value that we know it brings. With our increased confidence in our ongoing cardio transform study for ATTR cardiomyopathy, we and AstraZeneca are progressing our pre-commercialization activities and investments to support the potential substantial opportunity when NOAA represents. We are leveraging and building upon our efforts for the WENUA launch to prepare for our upcoming independent launches of Ola Zarson and Donnie DeLorso.

Speaker Change: We expect to reach a growing number of patients as we continue to educate prescribers about the value that we know of brink's.

Speaker Change: Our increased confidence in our ongoing cardio transform study for <unk> cardiomyopathy.

Speaker Change: <unk> and Astrazeneca are progressing our pre commercialization activities and investments to support the potential substantial opportunity window represents.

Speaker Change: We are leveraging and building upon our efforts for the window of launch to prepare for our upcoming independent launches of <unk> and <unk>.

The Larson: The Larson.

Kyle: As Richard mentioned, we are developing all this for two indications, the Rare FCS Indication and the Broader SHTG Indication with Anticipated First Mover Advantage in both settings. We are pleased to receive positive feedback from key opinion leaders on the Phase 3 FCS data that we presented at ACC. They were particularly impressed with the reduction in acute pancreatitis attacks and the substantial reductions in hospitalizations and inpatient hospital days. We expect that these data will also be important in securing access from payers. In addition, the U.S.

Speaker Change: As Richard mentioned, we are developing all of darshan for two indications no rare Fcs indication and the broader <unk> indication with anticipated first mover advantage in both settings.

Speaker Change: We are pleased to receive positive feedback from key opinion leaders on the phase III FCS data that we presented at ACC.

Speaker Change: We were particularly impressed with the reduction in acute pancreatitis attacks and a substantial reductions in hospitalization and inpatient hospital days.

Speaker Change: Expect that these data will also be important in securing access from payers.

Kyle: The Expanded Access Program for Alzheimer's is in place, enabling patients to have access to treatment ahead of potential approval. We are putting the final touches on our independent launch plans to bring OLSARS to patients as soon as possible after anticipated approval. Our medical affairs team has been meeting with physicians and working to improve disease awareness through disease education. Earlier this year, we hired our first Ionis National Sales Director.

Speaker Change: In addition, the U S expanded access program for <unk> is in place.

Speaker Change: Enabling patients to have access to treatment ahead of potential approval.

Speaker Change: We are putting the final touches on our independent launch plans to bring <unk> to patients as soon as possible after anticipated approval.

Speaker Change: Our medical Affairs team has been meeting with physicians and working to improve disease awareness through disease education.

Speaker Change: Earlier this year, we hired our first I honest national sales director and now with the December 19th Paducah dates that we have recently hired and are now training our customer facing team with extensive rare disease experience in preparation for the FCS launch.

Kyle: And now, with the December 19th BDUCA date set, we have recently hired and are now training our customer-facing team with extensive rare disease experience in preparation for the FCS launch. To bolster our field team's efforts, we are deploying a tailored omnichannel strategy to further enhance our relationships with patients and healthcare professionals. Finally, we are building a world-class patient and caregiver support team to provide a seamless customer experience to help patients initiate treatment and remain on therapy long term.

Speaker Change: To bolster our field team's efforts we are deploying a tailored omnichannel strategy to further enhance our relationships with patients and health care professionals.

Speaker Change: Finally, we are building a world class patient and caregiver support team to provide a seamless customer experience to help patients initiate treatment and remain on therapy long term.

Kyle: We plan to further scale our commercial capabilities as we prepare for the SHTG indication to realize the full blockbuster potential of a Lazarus. Donnie Doloresan for the Prophylactic Treatment of HAE is our next planned launch after Olazarsan, and based on the positive results we have seen in the Comprehensive Development Program, we are excited about what Donnie Doloresan could mean for people with HAE. HEE is a well-defined patient population with an estimated 20,000 people affected in the U.S. and Europe. While prophylactic treatment in the U.S. is well accepted by patients and physicians, there continues to be a need, and the market continues to grow. Outside the U.S., acute treatments have historically been the standard of care.

Speaker Change: We plan to further scale, our commercial capabilities as we prepare for the U S. H T G indication to realize the full blockbuster potential of all of those arson.

Speaker Change: So I ended the war for the prophylactic treatment of AG as our next planned launch after <unk> and.

Speaker Change: And based on the positive results, we have seen in the comprehensive development program. We are excited with what <unk> could mean for people with EG.

Speaker Change: <unk> is a well defined patient population with an estimated 20000 people affected in the U S and Europe, while prophylactic treatment in the U S is well accepted by patients and physicians there continues to be a need in the market continues to grow.

Speaker Change: Outside the U S acute therapies have historically been the standard of care. However, prophylactic treatments are gaining ground, especially in Europe.

Kyle: However, prophylactic treatments are gaining ground, especially in Europe. Many people in HEE are unsatisfied with current treatments and are looking for an option that reduces the frequency and severity of attacks that also offers good tolerability and convenience. This is a disease that typically appears in childhood, so patients have to manage their disease throughout most of their lives.

Speaker Change: Many people with H E. R. Unsatisfied with current treatments and are looking for the option that reduces frequency and severity of attacks that also offers good tolerability and convenience. This is a disease that typically appears in childhood. So patients have to manage their disease throughout most of their life.

Kyle: As a result, patients have a history of switching treatments, seeking to find the best therapy for them. We believe Donnie Doloresan could be a preferred prophylactic treatment for both patients new to therapy and patients currently on available therapy. With strong clinical data, including switch data, and the simplicity of monthly or every two-month self-administration via an auto-injector, we believe Dye-Doloresan combines the attributes that people with HEA are looking for in a single, attractive treatment, assuming approval.

Speaker Change: As a result patients have a history of switching treatments seeking to find the best therapy for them.

Speaker Change: We believe that the worst thing could be a preferred prophylactic treatment for both patients new to therapy and patients currently on available therapy.

Speaker Change: With strong clinical data, including switch data and.

Speaker Change: Simplicity of monthly or every two months self administration via auto injector.

Speaker Change: We believe died lorson combines the attributes that people with <unk>, you're looking for in a single attractive treatment assuming approval.

Kyle: Today, I'm pleased to share that we are right where we should be in preparing for our upcoming launches, our infrastructure to support commercialization is in place, and we will be ready to begin delivering our medicines to people in need as these new therapies come to market. Now, I'll turn it over to Beth.

Speaker Change: Today I'm pleased to share that we are right, where we should be preparing for our upcoming launches our infrastructure to support commercialization is in place and we.

Speaker Change: We'll be ready to begin delivering our medicines to people in need as these new therapies come to the market.

Speaker Change: Now I'll turn it over to Beth.

Beth: Thanks, Kyle. Our results in the second quarter and first half of this year reflect the excellent progress we've made toward our goal to bring a steady stream of medicines to the market. We continue to generate meaningful revenue while investing our capital to independently launch several new medicines over the next few years that have a combined multi-billion dollar peak sales potential. We are also investing in advancing our next wave of wholly owned medicines, which have continued to make great progress in the first half of this year.

Beth: Thanks Kyle.

Beth: Our results in the second quarter and first half of this year reflect the excellent progress we've made toward our goal to bring a steady cadence of medicine to the market.

Beth: Continued to generate meaningful revenue, while investing our capital to independently launch several new medicine over the next few years.

Speaker Change: On a combined multibillion dollar peak sales potential.

Speaker Change: We're also investing in advancing our next wave of wholly owned medicines, which continued to make great progress in the first half of this year.

Beth: In addition to our recent pipeline achievements, we delivered strong financial results, keeping us on track to achieve our financial guidance. We earned revenues of $225 million and $345 million for the second quarter and first half of this year, respectively.

Speaker Change: In addition to our recent pipeline achievements, we delivered strong financial results keeping us on track to achieve our financial guidance.

Speaker Change: We earned revenues of $225 million and $345 million.

Speaker Change: Second quarter and first half of this year respectively.

Beth: Finraza remained the primary source of our commercial revenue, with $57 million and $95 million of royalties in the second quarter and year to date, respectively. Notably, Spinraza product sales increased 25% from the first quarter to the second quarter due to growth from both the U.S. and ex-U.S. markets. Additionally, in the second quarter of the Waynewa launch, product sales were $16 million, bringing year-to-date sales to $21 million. As a result, our Waynewa royalty revenue increased quarter over quarter to $4 million for the second quarter and $5 million for the year-to-date period.

Speaker Change: It has to remain the primary source of our commercial revenue.

Speaker Change: $57 million and $95 million at royalties in the second quarter and year to date.

Speaker Change: Notably the product sales increased 25% from the first quarter to the second corner does it grow from both the U S and ex U S market.

Speaker Change: Additionally, in the second quarter of the way new on launch products sales were $16 million, bringing year to date sales to $21 million as a result, our way new royalty revenue increased quarter over quarter.

Speaker Change: $4 million for the second quarter and $5 million for the year to date period.

Beth: R&D revenue also increased in the second quarter and year-to-date, reflecting the value that our pipeline and technology continue to generate. As planned, our non-GAAP operating expenses for the second quarter and year to date increased over the same periods last year, driven by higher SG&A expenses. Our SCNA expenses increased 46% and 31% for the second quarter and first half of this year, respectively, as we continue to make investments to prepare for our upcoming independent launches of Olufsarsson and Danny DeLarsen.

Speaker Change: R&D revenue also increased in the second partner in year to date, reflecting the value that our pipeline and technology continue to generate.

Speaker Change: As planned our non-GAAP operating expenses for the second quarter and year to date increased over the same period last year driven by higher SG&A expenses.

Speaker Change: Our SG&A expenses increased 46% and 31% for the second quarter and first half of this year respectively.

Speaker Change: As we continue to make investments to prepare for upcoming independent marches, along with Patterson and tankage alerts that.

Beth: Notably, we built out our commercial team, including our field organization, and they're enthusiastically preparing for FCS launch. Our SG&A expenses also included our minority portion of Waynewa's U.S. launch expenses. And, as planned, our R&D expenses decreased slightly for the second quarter and were flat for the first half of this year compared to the same period last year.

Speaker Change: Notably, we built out our commercial team, including our field organization.

Speaker Change: We are enthusiastically preparing for launch.

Speaker Change: Our SG&A expenses also included a minority portion of <unk> U S launch expenses.

Speaker Change: And as planned our R&D expenses decreased slightly for the second quarter and were flat for the first half of this year compared to the same period last year.

Beth: Our results for the first half of the year keep us on track to meet our 2024 financial guidance, including revenue of more than $575 million, of which approximately $175 million will come from non-cash amortization of partner payments we received in prior years. Looking to the second half of this year, we expect our total revenue to be slightly lower compared to the first half and weighted more to Q4. We expect commercial revenue to increase as the launches ramp up for Wayne Newa and Calfatti and from higher anticipated spinrods of royalties as our tiered royalty rate increases.

Speaker Change: Our results for the first half of the year keep us on track to meet our 'twenty 'twenty four financial guidance.

Speaker Change: Including revenue of more than $575 million of.

Speaker Change: Of which approximately $175 million will come from noncash amortization of partner payments received in prior years.

Speaker Change: Looking to the second half of this year, we expect total revenue to be slightly lower compared to the first half and weighted more to Q4.

Wayne: We expect commercial revenue to increase as the Washington ramp for Wayne do you, let in Cal Party and from higher anticipated spin rods and royalties as a tiered royalty rate increase.

Beth: Additionally, we expect our R&D revenue, which often fluctuates from quarter to quarter due to the timing of achieving various collaboration milestones, to be lower in the second half of the year. Importantly, however, we still have the opportunity to earn sizable payments, including a $30 million milestone payment from AstraZeneca, if we knew it was approved in the EU. We continue to project our full-year 2024 operating expenses to increase by a mid to high single-digit percentage compared to 2023, excluding the impact of one-time costs last year. And, similar to the first half of this year, the increase will be driven primarily from sales and marketing expenses as we prepare for our back-to-back independent launches of Ola Zarsen and Donny DeLores.

Speaker Change: Additionally, we expect our R&D revenues, which often fluctuate from quarter to quarter.

Speaker Change: The timing of achieving various collaboration milestones.

Speaker Change: Would be lower in the second half of the year. Importantly, however, we still have the opportunity to earn sizable payments, including $30 million milestone payment from Astrazeneca.

Speaker Change: It's approved in the EU.

Speaker Change: We continue to project our full year 2020 for operating expenses to increase mid to high single digit percentage compared to 2023.

Speaker Change: Excluding the impact of onetime costs last year.

Speaker Change: And similar to the first half of this year the increase will be driven primarily from sales and marketing expenses as we prepare for our back to back independent watch it almost person and I hate to lose that.

Speaker Change: We are on track to end the year with $1 $7 billion in cash as we continue to make strategic investments in the substantial opportunity before us today.

Beth: We are on track to end the year with $1.7 billion in cash as we continue to make strategic investments in the substantial opportunities before us today, including our late-stage program and our next wave of innovative medicine. As you can see, we delivered a strong second quarter and first half. Before I turn it back to Brett, though, I'd like to provide you with a look beyond this year at our path to revenue growth and increasing value as we deliver on our goal to bring more medicine to more people.

Speaker Change: In our late stage program and our next wave.

Speaker Change: Got it.

Speaker Change: So as you can see we delivered a strong second quarter and first half.

Frank: Before I turn it back to Frank now I'd like to provide you with a look beyond this year half two revenue growth and increasing value as we deliver on our goal to bring more medicines to more people.

Beth: With our strong development and regulatory progress, Ionis is at a critical inflection point. We have several near-term commercial opportunities with significant potential to help patients in need. In parallel, we are advancing our next wave of potentially transformational medicines and our technology. As a result, we plan to continue to strategically invest our capital resources to ensure we unlock the full potential of our promising near and longer-term portfolio. Our investments are focused on four key areas in our go-to-market activities, enabling us to realize the full value of our medicine, which includes investing in our upcoming independent launches for Ola Sarsen and Donna DeLores.

Frank: With our strong development and regulatory progress I own. It is at a critical inflection point, we have several near term commercial opportunities.

Speaker Change: Significant potential to help patients in need.

Speaker Change: In parallel.

Speaker Change: Advancing our next wave of potentially transformational medicines and our technology as a result, we plan to continue.

Speaker Change: Strategically invest our capital resources to ensure we unlock the full potential of our promising near and longer term portfolio.

Speaker Change: Our investments are focused in four key areas.

Speaker Change: Alright, and our go to market activity activity.

Speaker Change: I believe that's can realize the full value of our medicines, which includes investing in our upcoming independent launches for all with our son and daughter doesn't worsen.

Beth: Our expenses in this area also include our much newer cost share with AstraZeneca for the hereditary ATTR polyneuropathy launch in the U.S. As we approach the anticipated Olazarsan launch for the broader severe high triglyceride population, we will scale our capabilities and increase our go-to-market expenses to support the larger opportunities.

Speaker Change: Expenses in this area ultimately.

Speaker Change: Iranian like caution of Astrazeneca for the hereditary <unk> Polyneuropathy watch any of that.

Speaker Change: As we approached the anticipated almost back in March for the broader severe high triglyceride population, we will scale, our capabilities and increase their go to market expenses.

Speaker Change: The larger opportunity.

Beth: And as we in AstraZeneca approach a potential ATTR cardiomyopathy launch for Wynua, our expenses will increase consistent with the much larger cardiomyopathy opportunity. Importantly, our planned investments are right-sized for the combined multibillion-dollar revenue potential that these important medicines represent. Second, we continue to advance our late-stage pipeline. All of our ongoing large Phase III studies are fully enrolled with more than 4,000 patients in all and are currently in the heaviest period of investment.

Speaker Change: And as we and Astrazeneca are approaching potential ATT, our cardiomyopathy and watch for when you.

Speaker Change: Our expenses will increase consistent with our much larger cardiomyopathy opportunity.

Speaker Change: Importantly, our planned investments are right sized for the combined multibillion dollar revenue potential.

Speaker Change: Important benefits for that.

Speaker Change: Second we continue to advance our late stage pipeline.

Speaker Change: All of our ongoing large phase III studies are fully enrolled with more than 4000 patients in all and are currently in the heaviest period of investment. We expect these investments to fuel our continued value generation in Robinson crowd at the data readout and we bring new medicines to patients over the next couple of years.

Beth: We expect these investments to fuel our continued value generation and revenue growth as the data reads out and we bring new medicines to patients over the next couple of years. Third, we are increasing our investments in our next wave of benefits, including development and pre-commercialization expenses for our growing wholly-owned pipeline of potentially groundbreaking neurology medicines, such as ION 582 for Angelman Syndrome. And finally, we are investing in cutting-edge technologies to ensure we continue to deliver innovative medicines with competitive profiles well into the future.

Speaker Change: Third we are increasing our investment in our next wave is bad.

Speaker Change: Clearly development and pre commercialization expenses for crummy wholly owned pipeline.

Speaker Change: It's really groundbreaking neurology medicine.

Speaker Change: I, just I asked fighting for Angelman.

Speaker Change: Jonathan.

Speaker Change: And finally, we are investing in cutting edge technologies to ensure we continue to deliver innovative medicines.

Speaker Change: How does this profile well into the future.

Beth: As you can see, we are strategically investing our capital toward growth opportunities. Importantly, we expect our investments to power strong revenue growth and positive cash flow as our medicines reach more and more patients in need, positioning us to deliver next-level value for all Iona stakeholders for years to come.

Speaker Change: So as you can see we are strategically investing our capital towards growth opportunity.

Speaker Change: Accordingly, we expect our investments to power strong revenue growth and positive cash flow.

Speaker Change: <unk> reach more and more patients in need positioning us to deliver a next level of value for all I honest stakeholders for years to come.

Speaker Change: I will turn the call back over to Brett.

Brett Monia: Thank you, Beth. As just summarized, we have made great progress in the first half of this year, and in the second quarter alone, we've achieved a great deal with many important successes, which include, continued strong start to the renewal launch for hereditary ATTR polyneuropathy in the United States, approval in Canada, and submissions under review in many additional territories, positive FCS data for Olazarsan, which we presented at ACC, which were the basis for our MDA submission, which was recently accepted by the FDA with priority review.

Brett: Thank you Pat.

Brett: I will just summarize we've made great progress in the first half of this year and the.

Brett: Second quarter alone, we've achieved a great deal with many important successes which include.

Brett: Continued strong start the way new launch for hereditary Polyneuropathy in United States approval in Canada and submissions under review any additional territories.

Brett: Positive FCS data for all resources, which we presented at ACC, which were the basis for our NDA submission submission, which was recently accepted by the FDA with priority review.

Brett Monia: Positive HAE data for Donna Daworson was presented at IACHI. That will be the basis of our upcoming regulatory submission. And we completed enrollment for the Phase 3 Olds Arch and SHTG program this past quarter, keeping us on track for data next year. We also presented positive data from the HALOS Phase 1-2 study in people with Angelman syndrome.

Speaker Change: I'm going to be J E data for data presented at <unk>.

Brett: That will be the basis of our upcoming regulatory submissions.

Brett: And we completed enrollment for the phase III <unk> S. H D. D program this past quarter, keeping us on track for data next year.

Speaker Change: We also presented positive data from the Halo phase one two study in people with Angelman syndrome.

Brett Monia: And we are well along in preparing for our end of Phase 2 meeting with the FDA scheduled for this fall, with plans to advance this important medicine into Phase 3 development next year. And we delivered solid second quarter and first half financial results, keeping us on track to achieve our 2024 financial guidance. Based on the strong progress we've made across our business this year, we are well positioned to continue building on our positive momentum as we execute towards achieving all of our strategic priorities.

Speaker Change: Well along in preparing for our end of phase two meeting with the FDA scheduled for this fall.

Speaker Change: To advance this important medicine phase III development next year.

Speaker Change: And we delivered solid second quarter, and first half financial results keeping us on track to achieve our 2024 financial guidance.

Speaker Change: Based on the strong progress we've made across our business. This year, we are well positioned to continue building on our positive momentum as we execute towards achieving all of our strategic priorities.

Brett Monia: We've arrived where we are today by being focused on a clear vision and a clear set of strategic objectives, which include building and advancing our pipeline and delivering medicine that we conceive, discover, and develop directly to patients.

Speaker Change: We've arrived where we are today about being focused on a clear vision and a clear set of strategic objectives, which include building and advancing our pipeline.

Speaker Change: So we can see discover and develop directly to patients.

Speaker Change: Our pipeline is delivering we achieved multiple marketing approvals and positive data readouts over the past year and we are poised to build on the strong momentum in the near term.

Brett Monia: We achieved multiple marketing approvals and positive key data readouts over the past year, and we are poised to build on this strong momentum in the near term. We have prioritized building our wholly owned pipeline and are now advancing several of these medicines toward the market. In parallel, our park and programs are progressing on track with important phase readouts next year and beyond. We are also focused on extending our leadership position in organ and glutide therapeutics by expanding and diversifying our technology, further optimizing our capabilities for existing therapeutic areas, and opening up new areas for drug discovery.

Speaker Change: <unk> building, our wholly owned pipeline and are now advancing several of these medicines towards the market.

Speaker Change: Parallel parking programs are progressing on track with important phase III Readouts next year and beyond.

Speaker Change: We are also focused on extending our leadership position in obesity therapeutics by expanding and diversifying our technology corner optimizing our capabilities for existing therapeutic areas and opening up new areas for drug discovery.

Brett Monia: All of this sets us up to continue bringing a steady cadence of new medicines to patients for years to come. We're looking forward to sharing our progress as we build on our recent achievements and accomplish our strategic objectives. And with that, I'll now open the call up for questions before moving into the Q&A portion of our meeting. I'll just ask that our analysts please limit themselves to a single question as we have quite a long, long queue.

Speaker Change: All of this sets us up to continue bringing a steady cadence of new medicines to patients for years to come.

Speaker Change: We're looking forward to sharing our progress as we build on our recent achievements and accomplish our strategic objectives.

Speaker Change: With that I'll now open the call up for questions before moving to the Q&A portion of our of our meeting.

Speaker Change: Past that our analysts please limit yourselves to a single question is we have quite a long queue and we'd like to get as many people in the queue and ask your question as much as possible so with that Danielle.

Brett Monia: And we'd like to get as many people into the queue and ask their questions as possible. So with that, Danielle, you can open up for questions. Thank you. To ask a question, you may press star then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.

Speaker Change: Our questions. Thank you well now begin the question and answer session to ask a question you May Press Star then one on Italian Touchtone phone here you think he's speakerphone. Please pick up your handset before pressing the keys.

Operator: If at any time your question has been answered and you would like to withdraw your question, please press star then 2. Again, it's star 1 to ask a question. The first question comes from Akash Tiwari from Jeffries. Please go ahead. Hey, this is Aimee Ansarakash. Thanks so much for taking our questions. So one on ATTR-CM, there's been some debate on whether you need a certain level of TTR to have a cardioprotective effect. Have you seen anything in your own data around this theory?

Speaker Change: But anytime Youre question has been addressed and you would like to withdraw your question. Please press Star then two again its star one to ask a question. The first question comes from a cash Tory from Jefferies. Please go ahead.

Amy: Hey, this is Amy unfair Cai. Thank you so much for taking our question. So one on herc and there's been some debate on if you need a certain level of P T or to have a cardio protective effect have you seen anything in your own data around this theory and do you expect any differences with a silencer approach using an all cause.

Amy: And do you expect any differences with a silencer approach using an all-cause mortality versus a CD mortality composite primary endpoint? Finally, do you have the flexibility to change your primary endpoint if needed? Thanks so much.

Speaker Change: Mortality versus the C V mortality composite primary endpoint finally, do you have the flexibility to change your primary endpoint if needed. Thanks, so much.

Brett Monia: Thank you, Amy. So, as we have seen, we don't believe that there's any evidence of a threshold effect for TTR lowering to achieve benefit in either polyneuropathy or cardiomyopathy endpoints. We're very pleased with the magnitude of TTR reductions that we have seen in all of our studies for Waynua in polyneuropathy. I'm very pleased with the level of magnitude of TTR lowering we're getting, but I don't believe that there's any believable evidence out there that suggests a specific threshold effect for TTR lowering to produce benefit either in polyneuropathy or in cardiomyopathy.

Speaker Change: Thank you Amy so.

Speaker Change: We have seen it we don't believe that there's any evidence of a threshold effect for GTR lowering.

Speaker Change: Did you benefit in either a polyneuropathy or cardiomyopathy.

Speaker Change: The end points.

Speaker Change: We're very pleased with the magnitude of T T or reductions.

Speaker Change: We have seen in our in all of our studies for window for Polyneuropathy.

Speaker Change: Please level magnitude of detail that we were getting but I don't believe that there's any believable evidence out there that suggest a specific threshold effect.

Speaker Change: For keeps you are going to produce benefit either in polyneuropathy.

Brett Monia: We believe our primary endpoint is cardiovascular mortality and hospitalizations, and that's what we're laser-focused on. We also have, as secondary endpoints, specifically, CV mortality as well as all-cause mortality, and we think they're both very important, next next study our next question. Please go ahead. Hi, just on the timing of the Cardio TTR Transform readout, I mean, is it fair to say that you're at least waiting for data at ESC in London that might have read through to your trial, and if that is the case, you know, what exactly would you be looking for out of that data set to stick with the decision that you're going to read that out early or just wait until the full 140 weeks are over? Thanks, Miles.

Speaker Change: Cardio myopathy.

Speaker Change: Uh huh.

Speaker Change: We believe our primary endpoint.

Speaker Change: Cardio vascular mortality and hospitalization and that's what we're laser focused on.

Speaker Change: We also have a secondary endpoint.

Speaker Change: Typically CV mortality as well as all cause mortality, we think they're both very.

Speaker Change: Very important.

Speaker Change: Next.

Speaker Change: Our next question.

Speaker Change: The next question comes from Myles Minter from William Blair. Please go ahead.

Myles Minter: Hi, just on the timing of the cardiac TCR transform right out I mean is it fair to say that you're at least widen for diet or at a S. A in London that might have read 30 or trial added and if that is the case, what exactly what you'd be looking for out of that dataset to stick with the decision that you're going to write that out or L. A or just stop.

Speaker Change: In total the full 140 weights are not studies, thanks very much.

Speaker Change: <unk>.

Brett Monia: So, we're very pleased with the way the CardioTransform study is advancing. We are particularly pleased with the blinded events that we're continuing to evaluate, both CV hospitalizations as well as mortality. It's going very well and is on track.

Speaker Change: Thanks, Myles so we're very pleased with the way the cardio transform studies.

Speaker Change: Advancing.

Speaker Change: I'm, particularly pleased with the.

Speaker Change: The blinded events that were continuing to.

Speaker Change: Evaluate.

Speaker Change: Oh God in CV hospitalizations as well as.

Speaker Change: Mortality.

Speaker Change: It's going very well and on track.

Brett Monia: As the first silencer to read out in this indication, we're very much looking forward to any and all additional data that we can see, which we think will be a very nice read-through to our CardioTransform study. As you know, we have the largest, by far, study ever conducted in the patient population. And we think that anything we see from other molecules in the silencer class is going to be very good read-throughs to what we expect to see in our study.

Speaker Change: As the first silencer to read out in this indication were very much looking forward to any and all additional data that we can.

Speaker Change: C, which we think will.

Speaker Change: It will be a very nice read through to our cardio transform study.

Speaker Change: As you know.

Speaker Change: We have the largest by far Ah study ever conducted in this patient population and we think.

Speaker Change: Is that anything we see from other.

Speaker Change: Other molecules in silence with class are going to be very very good returns to what we expect to see in our study.

Brett Monia: So we're very much looking forward to any and all data that comes from future presentations on the silencer class. Next question, please. The next question comes from Manny Fuhar from Lear, Inc. Partners. Please go ahead. Hey, guys, you have Ryan on for Monty.

Speaker Change: So we're very much looking forward to any and all data that comes from from a future presentation. So I'm, sorry, I'm a silencer class.

Speaker Change: Next question please.

Speaker Change: The next question comes from Manny.

Manny: So who are from Leerink partners. Please go ahead.

Speaker Change: Hey, guys you have Ryan on for Bonnie. Thanks for taking our question can you just talk a little bit about any early insights from the way new a launch and how you see that and forming a potential launch strategy in cardiomyopathy and kind of alongside that you know maybe what pre commercialization activities you guys are undertaking in cardiomyopathy.

Ryan: Thanks for taking our question. Can you just talk a little bit about any early insights from the way new will launch and how you see that informing a potential launch strategy in cardiomyopathy and kind of alongside that, you know, maybe what pre-commercialization activities you guys are undertaking in cardiomyopathy? Thanks.

Speaker Change: Oh I'm.

Jonathan: Im sorry, Jonathan Yeah.

Speaker Change: Thanks for your question we were.

Speaker Change: Very pleased with the early insights, we're getting with them.

Speaker Change: P M launch.

Kyle: As Kyle referenced, we're seeing patients who are new to treatment. We're seeing patients who are switching from existing treatments, and we're seeing patients having something way newer added on to their current treatment. So we're super pleased with what we're seeing. It's very early days.

Speaker Change: But it is kind of referenced.

Speaker Change: We're seeing patients to reduce treatment, we're seeing patients switching from existing treatments and we're seeing patients.

Speaker Change: Have you drawn to their current treatment.

Speaker Change: So we're super pleased with what we're seeing it's very early days. This is a foundation year.

Kyle: This is the foundation year for the launch of Waynewa, but we think there's certainly significant opportunity here when you think through the potential patient population of both PN and CM. And the number of patients who are potentially underdiagnosed and fundamentally the relatively small numbers today who are actually treated. What we're pleased with is that we're seeing prescribing from both urology and cardiology and both centers of excellence as well as in the community, and that I think bodes well not just for the PM launch and that progression but also the transition, obviously, into future indications.

Speaker Change: But we think there's significant opportunity.

Speaker Change: Turning to the potential patient population.

Speaker Change: <unk> P M M C.

Speaker Change: The number of patients who are potentially under diagnosed.

Speaker Change: Fundamentally the relatively small numbers today.

Speaker Change: Yeah.

Speaker Change: Treated.

Randy: Please Randy.

Randy: Same prescribing.

Randy: Prescribing from both neurology and cardiology.

Speaker Change: A list of excellence as well as we can.

Speaker Change: The community and that I think bodes well not just for the <unk>.

Speaker Change: The progression, but also the transition obviously into a future indications.

Kyle: Obviously, when it comes to some of those future indications, it's very premature to speculate as to what might happen there. We'll have to wait for future data readouts from our own pretty comprehensive program. Yeah, two quick things to add.

Speaker Change: When it comes to some of those future indications, it's very premature to speculate.

Speaker Change: What might happen and we will.

Speaker Change: Well have to wait.

Speaker Change: Some future data readouts of our own a pretty comprehensive programs.

Kyle: First, on the payer access side of things, we're seeing payers cover Waynua very quickly. So from the prescription process, the patient's actually starting on the drug is going very, very well. That tells us that the right types of patients are being identified, and it's also telling us that physicians are justifying the prior authorization process with a sense of urgency, which tells you that these patients need treatment, and they see the value in Waynua.

Speaker Change: Yeah, two quick things to add our first on the payer access side of things, but we're seeing payers cover a window up very quickly. So the prescription process patients actually starting on drug is going very very well that tells us that the right types of patients are being identified and it's also telling us that physicians are justifying the.

Speaker Change: A prior authorization process with a sense of urgency, which tells you that these patients need treatment and they see the value and the second thing I'll just mention is around our patient engagement team RPM team is directly interacting with these patients and getting feedback on a real time basis Ah patients are extremely pleased when they start we know at the ability to self.

Kyle: The second thing I'll just mention is patient engagement. Our PIMM team is directly interacting with these patients and getting feedback on a real-time basis. Patients are extremely pleased when they start Waynua with the ability to self-inject with the auto-injector.

Speaker Change: With the auto injector, a very well tolerated very easy to use a very convenient for those patients and the profile of Wayne who is really playing out the way that we expected it to in the market.

Kyle: Very well-tolerated, very easy to use, very convenient for those patients, and the profile of Waynua is really playing out the way that we expected it to in the marketplace. Next question, please. The next question comes from Yanan Zhu from Roth Fargo Securities. Please go ahead.

Speaker Change: Next question please.

Speaker Change: The next question comes from Yanan, Zhu from Wells Fargo Securities. Please go ahead.

Yanan Zhu: Great. Thanks for taking our questions. I'd like to know your takeaway from Roshi's recent presentation of their Andromeda Syndrome Phase II data at the ASF meeting. And also, separately, given the similar development timeline of your Andromeda Syndrome Program and Ultragenics Program, do you think FDA will want to apply the same pivotal endpoint to both programs? Or is there a possibility that the agency could allow different primary endpoints based on the strengths of the data?

Yanan Zhu: Great. Thanks for taking our questions are wondering about what's your takeaway from Roche's recent presentation.

Speaker Change: And from our phase two data at the S. F meeting and also separately.

Speaker Change: Similarly, our development timeline of your Enckelman single program and Ultra Gannett.

Speaker Change: Program do you think FDA will want to apply the same pivotal endpoint both programs or is there a possibility that the agency could allow different primary endpoints based on the strength data. Thank you.

Brett Monia: Thank you. Thank you, Janine. I'll take the first question and then I'll ask Eugene to comment on the primary endpoint and any harmonization of the primary endpoints for Angelman.

Speaker Change: Thanks, Dan and I'll take the first question and then I'll ask Jim to comment on.

Jim: The primary endpoint and any harm in organization.

Speaker Change: And the primary endpoint for Angelman so.

Brett Monia: So, we were very pleased to see the data that Roche presented on their Angelman's program. And, particularly, we were pleased with the fact that the data further supported our confidence in our Phase I-II data that we presented at ASF. Specifically, the rank order of improvements that they reported with respect to the magnitude of improvement was exactly what we reported. The biggest magnitude that they reported was in expressive communication, followed by expressive-receptive communication, followed by cognition, followed by motor function, and so on.

Speaker Change: We were very pleased to see the data that Roche presented on the Angelman program and generally we were pleased with the fact that.

Speaker Change: The data are further supported.

Jim: Our our confidence and our phase one two data that we presented at AAN stuff specifically.

Speaker Change: The rank order them.

Speaker Change: Improvements that they reported with respect to the magnitude of improvement was exactly what when you reported.

Speaker Change: Biggest magnitude that they reported was intercept was an expressive communication followed by expression.

Speaker Change: Reception communication, followed by cognition followed by.

Speaker Change: Motor function and so on and that's exactly what we reported which could bolster further confidence that you.

Brett Monia: And that's exactly what we reported, which bolstered further confidence in our results to date. We were also pleased with the magnitude of benefit we're seeing compared to their program, which really looks like when you really compare apples to apples, and you compare Bayley 3 to Bayley 4 outcomes, it bodes very well. We look like we have even better efficacy at lower doses compared to what Warrosch presented, but we were pleased to see what they showed because of the consistency in subdomain benefit between the two programs. Eugene?

Speaker Change: No.

Speaker Change: And in our in our results to date.

Speaker Change: We were.

Speaker Change: Also pleased with the magnitude of benefit we're seeing compared to their program, which really it looks like when you really compare apples to apples and you can be fairly treated fairly for outcomes.

Speaker Change: It's very well, we look like we have even better efficacy at lower doses.

Speaker Change: Roche presents but we were pleased to see what these but they showed because it'll be consistency and sub domain benefit.

Speaker Change: The two programs.

Eugene: Yeah, well, regarding the primary endpoints and conversations to be had with the agency, of course, we're looking forward to updating you after we've had our discussion. But there is, from our standpoint, this will be data-driven. We certainly do believe that the data and consistency of what we see in our Phase 1-2 studies. This study gives us a pretty good idea of what we would like to see in a pivotal study, but it's still to be seen what the specific primary endpoint will end up being. We will certainly give you an update. ATTRCM. That's another example where primary employment is not a benefit.

Speaker Change: Yeah, well regarding the primary endpoint in.

Speaker Change: Conversations to be had with the agency of course, we're looking forward to updating you after we got our discussions.

Speaker Change: There is from our standpoint.

Speaker Change: This will be data driven we certainly do believe that.

Speaker Change: The data on consistency of what we see in our phase one two.

Speaker Change: Uh-huh gives us pretty good.

Speaker Change: Ideally, what we would like to see.

Speaker Change: But it's still to be seen what the specific primary endpoint.

Speaker Change: Well certainly give you give you an update is there a precedence.

Speaker Change: To have a slightly different for different primary endpoint of course theres plenty of precedent.

Speaker Change: In neurology space as well.

Speaker Change: If you look at.

Speaker Change: Hum.

Speaker Change: For example, our program point, it's not identical.

Speaker Change: So.

Eugene: Stay tuned; we will certainly be happy to provide you with more information. Thanks, Yannick. Next question. Very helpful.

Speaker Change: Stay tuned we will certainly we'll be happy to provide you an update.

Speaker Change: Thanks, Dana next question are helpful.

Jessica Fye: The next question comes from Jessica Fye from J.P. Morgan. Please go ahead. Hey there, thanks for taking my question. On the back of the top line Helios feed data, what's your latest expectation for whether silencers in TTR cardiomyopathy will mainly be used in combination with stabilizers versus as monotherapy? Yeah, I'd be happy to talk about that. This is Kyle.

Speaker Change: The next question comes from Jessica Fye from Jpmorgan. Please go ahead.

Jessica Fye: Hey, there thanks for taking my question.

Jessica Fye: On the back of the topline Helios B data.

Jessica Fye: What's your latest expectation for whether silencers and teach you a cardiomyopathy.

Speaker Change: In combination with stabilizers versus as mono therapy. Thank you.

Kyle: Thanks, Jessica. The data is ultimately going to drive this, we believe. That is a starting point, but I think ultimately it will come down to physicians and patients making a decision around the profile of treatment that they want in that decision. But when we see it right now, we are seeing Weynua Youth in combination, obviously as an HHETR polyneuropathy indication combined with cardiomyopathy indication for the stabilizers currently. So we're seeing it happen now.

Speaker Change: Yes, I'd be happy to talk to that this is Kyle.

Jessica Fye: Thanks Jessica.

Speaker Change: The data ultimately is going to drive this we believe.

Speaker Change: That is the starting point I think ultimately it will come down to physicians and patients, making a decision around the profile of the treatment that they want and that decision.

Speaker Change: But when we see it right now we are seeing we knew it used in combination obviously is.

Speaker Change: H a G GTR polyneuropathy indication combined with a cardiomyopathy indication for the stabilizers currently.

Jessica Fye: So we're seeing it happen now we think that that will continue to progress overtime.

Brett Monia: We think that that will continue to progress over time. And we also believe that based on the data and the way that that data plays out, there will be justification for physicians to be able to justify that to payers whenever they submit these requests and try to get the drugs approved. So I think it's ultimately data driven by physicians and patients. And just to add to that, as you know, Jess, we have the – we're positioned to have the richest data set across the board on primary as well as secondary and sub-endpoints and subgroups.

Jessica Fye: And we also believe that based on the data and the way that that data plays out will be justification for physicians to be able to justify that to the payers whenever they submit these requests and trying to get the drugs approved so I think it's ultimately data and driven by physicians and patients and just add to that.

Jess: Jess we have.

Jess: They should have the richest data set across the board on primary and secondary endpoints.

Jess: The end points and sub groups and we're gonna have.

Brett Monia: And we're going to have a great deal of data on combination usage as well as monotherapy, second to none. And that includes data on, you know, key endpoints, clinical endpoints, such as hospitalizations, mortality, six-minute walk tests, biomarkers, and so on, but also in imaging studies.

Jess: A great deal of data and combination usage as well as a monotherapy second to none.

Jess: And that includes data on.

Jess: Key endpoints clinical endpoints, such as hospitalizations mortality six minute walk test biomarkers and so on but also in the imaging studies, we had several imaging studies in process and we think that.

Kyle: So we have several imaging studies in process, and we think that if anyone is going to be able to show really meaningful improvements in combination versus monotherapy across the board, whether it be imaging or clinical endpoints, we're going to be in the best position to do so. And we think that, as Kyle said, because this is a data-driven, you know, environment, we're going to be in the best position to actually have the data to support combination use. Next question. The next question comes from Allison Bratzel of Pepper Fandler. Please go ahead. Hey, good morning, guys.

Speaker Change: Anyone to be able to show.

Speaker Change: Improvements the combination versus the monotherapy.

Speaker Change: Across the board, but of the imaging or clinical endpoints, where we're going to be the best.

Speaker Change: To do so and we think that that is kind of sad because this is a data driven.

Speaker Change: Environment.

Speaker Change: We've got the best position to actually have the data to support combination usage.

Speaker Change: Next question please.

Speaker Change: The next question comes from Allison that's it that's all from Piper Sandler. Please go ahead.

Allison Bratzel: And thanks for taking my question. Maybe one on Pella Carson, since that phase three data and regulatory filing are coming up next year. Could you just talk about or frame what you'd like to see in that readout? And maybe, in broad strokes, you know, what gives you confidence in the differentiation of this asset? You know, and what could be a competitive space?

Allison: Hey, good morning, guys and thanks for taking my question.

Allison: Maybe one on until of course, and does that phase III data and a regulatory filing coming up next year could you just talk to our airframe like what you are seeing that read out and maybe in broad strokes. You know what gives you confidence and differentiation of the fact that.

Speaker Change: Yeah, and what could be a competitive space you know color on that or then the next Gen program would be helpful. Thank you.

Brett Monia: You know, coloring in that or the next gen program would be helpful. Thank you. Yeah, Allison, so, you know, the only news on telecarson is really that the study is on track to read out as scheduled next year. Everything is going very well, and our partner Novartis is well positioned with a first mover advantage in this first to market patient population, this enormous patient population. Everything we're seeing in the phase 3 study is very supportive of this being set up for a successful... First mover advantage is really important, and we, with Novartis, have a substantial lead in the market. The program that our follow-on program to Novartis, with Novartis on the follow-on program, is advancing well. Maybe I'll ask Eric Swayze to comment on how things are going.

Allison: Yeah Allison so.

Speaker Change: No there's not.

Speaker Change: The only Moody's on pellet Carson is really that the study is on track to reach.

Speaker Change: Now as scheduled next year.

Allison: Everything is going very well.

Speaker Change: And.

Speaker Change: You know our partner Novartis.

Speaker Change: <unk> is well positioned with first mover advantage in niche in this first to market Ah patient population.

Speaker Change: Relation with enormous patient population everything we're seeing in the phase III study is very supportive of this thing.

Speaker Change: And set up for a successful.

Speaker Change: Outcome first mover advantage is really important.

Novartis: And we would novartis are substantially.

Speaker Change: Substantially all of it.

Speaker Change: To the market.

Speaker Change: Yeah the program that.

Speaker Change: Follow on program to Novartis with Novartis on the follow on program is advancing well.

Eric Swayze: Maybe I'll ask Eric Swayze to comment on how the how things are going.

Eric Swayze: Things are going great. We've been working closely with Novartis, looking at a variety of ways to extend the dosing interval and make a great LP lowering drug. And I'm sure we'll discuss it at some time as the program advances further, but I can't really say more than that at this time. But I'm very pleased with the progress we've been making on new technologies, siRNAs in particular, and a broad range of other things beyond what would be meant for the LPA program.

Eric Swayze: Thank you Sir.

Eric Swayze: We've been working closely with Novartis.

Eric Swayze: A variety of ways to extend the dosing interval.

Speaker Change: And make it a great help in Oregon.

Speaker Change: I'm sure, we'll discuss it and sometimes the program advances further, but I can't really say more than that at this time.

Speaker Change: Very pleased with the progress we've been making on new technologies SA RNA is in particular and a broad range of other things beyond what would be minimal.

Eric Swayze: We feel very comfortable that we're going to achieve our objectives with Novartis on a pharma molecule. Things are going very well. There are obviously a lot of benchmarks out there today, so there's a lot to compare to.

Speaker Change: We feel very comfortable that we're going to achieve them.

Speaker Change: Or objectives with Novartis on a farm a molecule and things are going very well, there's obviously a lot of benchmarks out there today.

Brett Monia: We're pleased. Next question. The next question comes from Yaron Werber from KB Cohen. Please go ahead.

Speaker Change: A lot of lots of compared to.

Speaker Change: Please.

Speaker Change: Next question please.

Speaker Change: The next question comes from Yaron Werber from TD Cowen Please.

Speaker Change: Please go ahead.

Yaron Werber: Thanks for taking my question. I also have just a quick follow-up on Waynua, and as you look at the Helios B data, and I'm totally aware that you're probably going to be waiting for the full Helios B results, but as you think about with a much-powered trial design, where can you potentially differentiate, And how important will that combo data be, just given that, overall, Umbutcha will get a broad label for TTR? Thank you.

Yaron Werber: Right also thanks for taking my question I also have just a quick follow up on a way new and as you look at the Helios B data and I'm totally obviously, you are well aware of that you're probably going to be waiting for the full Helios b results, but as you think about where the much powered.

Speaker Change: Trial design, what what could you potentially differentiate.

Speaker Change: And how important will dot combo data that would be just given that overall in virtual will get a broad label for T. T. R. Thank you.

Brett Monia: Well, thanks Jan. As the largest study ever conducted in this patient population, by far, we think we have the opportunity to differentiate in several different areas. It will be very interesting to see, you know, the onset of action for silencers and whether or not our onset of action is going to be similar or faster. It's going to be very interesting to see the combined data, as you alluded to just now and as we touched on earlier.

Speaker Change: Well.

Yaron Werber: Thank you Yaron.

Speaker Change: As the largest study ever conducted in this patient population by far we think we have the opportunity to differentiate in several different areas.

Speaker Change: It'll be very interesting to see.

Speaker Change: No.

Speaker Change: The onset of action.

Speaker Change: For silencers, and whether or not our onset of action is going to be similar.

Speaker Change: Similar or faster, it's gonna be very interesting to see the combination data as you alluded to just now as we touched on earlier our combi.

Brett Monia: Combination data is going to be very important in this patient population, and despite having a broad label, which we expect to have as well, cardiologists are data-driven, and they're going to need to see data before advocating for combination usage. I think we're doing well. New York health class categories are going to be very important to see how mild patients are doing, moderately ill patients, and severely ill patients are doing. All of this, when you have a well-powered study and are set up to have a rich data set, you have the potential ability to differentiate across the board. Anything to add to that, Eugene? No, not really, Brett.

Speaker Change: Combination data it can be very important patient population and despite having a broad label, which.

Speaker Change: We expect to have as well.

Speaker Change: Cardiologists are data driven and they are going to see data.

Speaker Change: Before advocating for combination usage I think we're well positioned.

Speaker Change: Have that data.

Speaker Change: You know New York Health class.

Speaker Change: Our categories are going to be very important to see how mild patients are doing moderately ill patients and severely ill patients who are doing all of this when you have when you have a well powered study of rich data and providing set up have the rich dataset.

Speaker Change: The potential ability to differentiate it across the board.

Speaker Change: To answer that.

Speaker Change: No not really.

Eugene: You characterized it. I think the power really comes from the size of the study and also the ability to look at subpopulations, which were really... Law Professionals. Thank you, Aaron. Next question. The next question comes from Jason Gerberry from Bank of America. Please go ahead.

Speaker Change: Characterize it I think that I don't know.

Speaker Change: It really comes from the size of the study and also an ability to look at subpopulations, which we're really well positioned.

Speaker Change: We're going to do.

Speaker Change: Right.

Aaron: Thank you Aaron next.

Aaron: Next question.

Speaker Change: The next question comes from Jason Goodbye from Bank of America. Please go ahead.

Jason Gerberry: Hey guys, thanks for taking my question. I wanted to come back to the cardio transform timing question, so it sounds like we're going to get pretty detailed and granular data from Mount Nile at EFC in terms of multiple curves on overall mono. Subgroups with a feminist background, including mortality, so it seems like you'll have everything you need to know post-AESC on whether or not the 2025 interim is in the cards. So is it fair for investors to get or expect maybe a clear message as of the third quarter update on which way you're going to go as the base case, 2026, or whether or not you'll look to 2025? Thanks, Jason.

Jason Goodbye: Hey, guys. Thanks for taking my question I wanted to come back to the cardio transform timing question. So it sounds like we're going to get pretty deep detailed and granular data for mountain, Iowa at ESC in terms of multiple curves that overall mono and.

Speaker Change: Subgroups with tech famous background, including mortality. So it seems like you'll have everything you need to know post H E S C on whether or not.

Speaker Change: Yeah 25 interim is in the cards. So is it fair for investors to get or expect maybe a clear message as of the third quarter update on on which way youre going to go as it is the base case, 26, or whether or not you'll you'll look to 'twenty five interim thanks.

Brett Monia: So Ionis and our partner AstraZeneca have been thinking about this quite a bit. Our base case remains under 40 weeks of treatment, which brings us to mid-2026 if the study were to go to completion. But you know, we are committed to bringing Wynua to patients as fast as possible, if it makes sense to do so. And certainly, as I mentioned earlier, following up on our blinded events and following up on the studies that we're running is most important, but any new information that we get from other treatments in the same class, as long as the class is gonna be informative about what we do. With that said, we can't get ahead of regulators.

Jason: Thanks, Jason so.

Speaker Change: And our partner Astrazeneca.

Speaker Change: I have been thinking.

Speaker Change: How about this quite a bit our.

Speaker Change: Our base case remains down or 40 weeks of treatment, which brings us to mid 2026.

Speaker Change: It was a study where to go to completion.

Speaker Change: But you know we are committed to bringing it to patients as fast as possible.

Speaker Change: Makes sense.

Speaker Change: To do so.

Speaker Change: And certainly.

Speaker Change: As I mentioned earlier.

Speaker Change: Following up on a blinded events and following up on the on the study that we're running.

Speaker Change: It's important for any new information that we get from our other.

Speaker Change: Uh-huh treatments.

Speaker Change: And class a class is going to be informative.

Speaker Change: Hum work, we do.

Speaker Change: With that said.

Speaker Change: We can't get ahead of regulators.

Brett Monia: We're gonna want to get a buy-in on anything we do with respect to an earlier readout with the FDA and the EMA before making any proclamations out there publicly. So timing is a bit uncertain right now, but rest assured that we in AstraZeneca are working on this very thoughtfully. Thanks so much.

Speaker Change: I don't want to get are.

Speaker Change: Our buying anything we do with respect to an earlier readout.

Speaker Change: With the FDA and EMA in.

Speaker Change: Before before making any.

Speaker Change: Formations out there publicly so timing is a bit uncertain right now, but rest assured that we and astrazeneca are working on this very thoughtfully.

Speaker Change: Okay. Thanks, so much.

Jay Olson: The next question comes from Jay Olson from Oppenheimer. Please go ahead. Oh, hey, congrats on all the progress, and thanks for taking the question. Can you talk about your launch preparation for Olazarsan and FCS, and what should we expect the launch uptake and eventual opportunity in the FCS? Also, the Early Access Program, how many patients you have, and will those patients switch over to the commercial product soon after approval? Thank you. Yeah, thanks for your question.

Speaker Change: The next question comes from Jay Olson from Oppenheimer. Please go ahead.

Jay Olson: Oh, Hey, congrats on all the progress and thanks for taking the question can you talk about your launch preparation for all of US are sitting in F. C S and how should we expect the.

Jay Olson: Launch uptake and eventual opportunity and F C S and.

Speaker Change: Also the early access program, how many patients you have and where those patients switch over to a commercial product.

Speaker Change: Product soon after approval. Thank you.

Jonathan Birchall: We're really pleased with the progress we're making and have continued to make. Obviously, our preparation started a couple of years ago with the medical affairs team, and subsequent to that, we've built out all the commercial functions that you would expect, whether that's marketing, market access, or patient support that Kyle referenced. We're trying to build out industry-leading support there for our patients. And to bring you right up to date, we've now started hiring and training our field teams ready to engage with customers.

Speaker Change: Yeah. Thanks for your question, where are we really pleased with the progress we're making.

Jay Olson: We have continued to make.

Jay Olson: Obviously, our preparation started.

Speaker Change: He is a guy with a medical affairs team and subsequent to that we build towers.

Jay Olson: The commercial functions that you would expect whether that's marketing market access patient support.

Speaker Change: Carl referenced where we're trying to build out.

Carl: Our industry leading support.

Carl: For all patients and to bring you brought up today, we started hiring and training.

Carl: Our field teams.

Carl: Ready to engage.

Carl: With customer service.

Jonathan Birchall: So the build has gone very well, and it's certainly on track, aligned with our regulatory progress, which with breakthrough designation has been, at this point, very timely. And that, we think, sets us up for a positive launch. Obviously, to your question specifically about the expanded access program, we've got patients, let's be honest, before that who've been in our pivotal registration studies that are obviously patients that will launch.

Speaker Change: The bell.

Speaker Change: It's gone.

Speaker Change: Very well and it's certainly on track aligns with our regulatory progress, which with breakthrough designation knows.

Speaker Change: At this point a very timely.

Speaker Change: And that we think sets us up for a for a positive launch.

Speaker Change: Obviously to your question specifically about the expanded access program, we got patients, let's be honest before that.

Speaker Change: Our pivotal registration studies that are obviously patients.

Speaker Change: Uh huh.

Jonathan Birchall: We hope to provide the opportunity to move on to commercial drugs, and the EAP is now in the hands of our medical team, and they're talking to customers today, and patients are progressing through the administration or the administrative side of getting access to OLSRs and through that program. So, all in all, we are doing a lot of work, as you can imagine. They're very much on track to be ready to launch just as soon as the FDA provides approval. Fingers crossed.

Speaker Change: To provide the opportunity to move on to commercial drug.

Speaker Change: Hey.

Speaker Change: Now in the hands of our medical team talking to customers today and patients are progressing through.

Speaker Change: The administration Oh on the administrative side of getting access to all its OSM turned that program. So all in all we are doing a lot of work as you can imagine.

Speaker Change: But very much on track to be ready for launch.

Speaker Change: Just as soon as the FDA.

Speaker Change: So it's a critical thing is cost.

Jonathan: Thanks, Jonathan.

Operator: Okay, next question, please. The next question comes from Mike Holtz from Morgan Family. Please go ahead.

Speaker Change: Jay next question please.

Speaker Change: The next question comes from Mike <unk> from Morgan Stanley. Please go ahead.

Speaker Change: Okay.

Mike Holtz: Hey, guys, thanks for taking the question. Maybe just one on the neurology pipeline, you know, with Angelman sort of emerging as your lead program. Can you maybe highlight what you view as the next key opportunity there? And if there's any potential read through from what you learned in Angelman?

Mike: Hey, guys. Thanks for taking the question maybe just one on the neurology pipeline, you know with Angelman and sort of emerging as your lead program can you maybe highlight what you view as the next key opportunity there and if there's any potential read through from what you've learned in angelman. Thanks.

Speaker Change: Yeah sure happy to thanks for your question certainly we are delighted to have Andrew.

Eugene: Yeah, sure, happy to. Thanks for your questions. Certainly, we are delighted to have Angel Mendes serve as kind of the linchpin of the neuroscience portfolio. It is a very rich portfolio following, and the Des Moines State Street Program.

Speaker Change: Service is kind of the linchpin.

Speaker Change: <unk> portfolio.

Speaker Change: It's a very rich portfolio following oh.

Speaker Change: It's a big program.

Eugene: Just to name a few that are most advanced currently, certainly Zilker-Nursing, which is now fully enrolled in its pivotal study. As we recently announced, this is the next molecule that we're super excited about. It's an ultra rare disease.

Speaker Change: Just to name a few kind of mouse the bounds currently certainly the Hilda knutsen.

Speaker Change: Which is now fully enrolled in the pivotal study.

Speaker Change: As we recently announced the next molecule that we're super excited about it it's an ultra rare disease that fits very well with our.

Eugene: It fits very well with our neurology portfolio. The study is progressing well. There's great feedback from sites and investigators on the kind of quality of the study conduct.

Speaker Change: Urology.

Speaker Change: Portfolio.

Speaker Change: The study is progressing well, there's great feedback from sites and investigators on kind of the quality of the study conduct.

Eugene: And behind Logan Nursen, of course, we are delighted to have our FOSS ALS program progressing well, our PREON program really making great strides in the first-in-human experiments that we're now conducting. So we're looking forward to sharing lots of data with you over the coming months and certainly years in that rich area of research and development. Our wholly owned neurology pipeline, thanks to Eugene, is positioned to grow and expand in addition to the programs that are in the clinic today.

Speaker Change: And behind the nurse and of course, we are delighted to have.

Speaker Change: I'll say a loss program progressing well pre owned program really making great strides in person human experiments that we're now conducting so we're looking forward to sharing.

Speaker Change: Lots of data with you over the coming months.

Speaker Change: Two years.

Speaker Change: Rich.

Speaker Change: Area of research and development for Us.

Eugene: Our wholly owned neurology pipeline thanks Eugene.

Speaker Change: Positioned to grow and expand in addition to the programs that are in the clinic today, you would expect to start two additional <unk>.

Eugene: We expect to start two additional wholly owned neurology programs by the end of this year and more next year for both rare as well as larger indications, more highly prevalent indications. I also want to highlight the great progress we're making to extend our leadership technologically in neurology. Our most advanced backbone chemistry, MSPA, is expected to enter clinical development and seek a CNS indication later this year, which is focused on reducing dose frequency very meaningfully. We're also making great progress in traversing the blood-brain barrier using subcutaneous or intravenous infrequent administration. And we're looking forward to maybe our first candidates overcoming the BBB in early 2025.

Speaker Change: <unk> wholly owned neurology programs by the end of this year.

Speaker Change: And in more next year.

Speaker Change: Provoke a rare as well as larger indications mark highly prevalent indications I also want to highlight the great progress, we're making to extend our leadership technologically and neurology.

Speaker Change: R R.

Speaker Change: Our most advanced backbone chemistry M. S. P. A enter is expect to enter clinical development and cheaper CNS indication later this year, which is which is focused on producing dose frequency.

Speaker Change: Very meaningfully.

Speaker Change: We're also making great progress and traversing the blood brain barrier subcutaneous or intravenous administration of infrequent administration.

Speaker Change: And we're looking forward to maybe our first candidates are overcoming the bvd.

Speaker Change: Our early 2025, and we're looking forward to talking about that as well. So CNS is here and now and where we.

Brett Monia: And we're looking forward to talking about that as well. So CNS is here and now. We're leaving this space, and we continue to expect to extend our leadership. Thanks, Mike.

Speaker Change: Leading in this space and we continue to expect to extend our leadership position going forward.

Speaker Change: Thanks, Mike next question please.

Gary Nachman: Next question, please. The next question comes from Gary Nachman from Raymond James. Please go ahead.

Speaker Change: The next question comes from Murray I'm, sorry, excuse me, Gary Nachman from Raymond James. Please go ahead.

Eugene: Great. Thanks, guys. For Donny, when you submit the NDA, what indication will you be looking for on the label? And are you optimistic that switch data will actually be included on the label, which will be so important for these HAE patients? Any chance you could get a priority review, or is it likely to be a standard review?

Gary Nachman: Great. Thanks, guys.

Speaker Change: Dani.

Gary Nachman: When you submit the NDA what indication of what you'd be looking for in the label and are you optimistic the switch data will actually be included on the label, which will be so important.

Speaker Change: <unk> H a N patients.

Speaker Change: Any chance you could get a priority review or is it likely a standard review and when will you start building out that commercial team.

Eugene: And when will you start building out that commercial team? And how much could you fully leverage what you're doing currently with Ola Darson? Thanks. Thanks Gary. Eugene will take the first couple of questions, and then Jonathan can touch on the build out of the commercial. With regard to the indication, of course, we're seeking a broad indication for prophylaxis of attacks in hereditary angioedema, and we're pretty comfortable with how things are progressing. Obviously, it is... to be determined what the final label looks like. We are, um, sorry. What was the second part of the subquestion? We expect to have switched data. Switched data, that's right.

Speaker Change: How much could you fully leverage what you're doing currently with Ola Csar Seth. Thanks.

Speaker Change: Okay.

Speaker Change: Thanks, Gary Eugene I'll take the first couple of questions and then Jonathan Johnson.

Speaker Change: The build out of the commercial team now with regard to the indication of course, we're seeking a broad indication for prophylaxis of attacks and congratulate Judy Meilin and we're pretty we're pretty comfortable with how things are progressing obviously it has.

Speaker Change: To be determined what the final label looks like on the indication statement.

Gary Nachman: We are.

Speaker Change: I'm sorry, what was the second part of the question, we expect to add switch data, which David will try it and yeah.

Eugene: And, yeah, along the same line, again, it's really early to speculate on what the final label will be. We will do our best to, um... We believe our program... Our pillow program is very comprehensive, and we also believe that the data that we collected in the switch populations is important for physicians to be aware of. So we'll make sure that data is shared broadly, whether it's publication or it ends up on the label. We can't really speculate.

Speaker Change: Along the same line again, it's really early to speculate on what the final label and we will do our best to.

Speaker Change: We believe that our program.

Speaker Change: Little program is it's very comprehensive them. We also believe that the data that we collected amount switch populations. It's important for physicians to be aware of so we'll make sure that this.

Speaker Change: Sure it broadly whether its publication or ends up in the label.

Speaker Change: Can't really speculate today.

Eugene: Yeah, I'll just touch on that a little bit more, Gary. You know, the switch data is very important, we believe, from a safety standpoint, which we think bodes very well for including it in the label. I mean, these patients switch all the time, right?

Speaker Change: Now I'll just.

Speaker Change: Touch on that.

Speaker Change: A little bit more Gary.

Gary Nachman: The switch data.

Gary: It is very important and we believe from a safety standpoint, which we think bodes very well for including it in the label I mean, these patients switch all the time right and and and.

Brett Monia: And actually having data that informs physicians on how to safely switch patients such that they avoid getting a gap in their protection against HAE attacks is going to be very important. And we think that will, and, of course, the FDA is focused on safety and protection against, you know, disease progression. So we think that that bodes very well for us to get on the label. But as Eugene said, it's, you know, it's risky to get ahead of regulators on what the label will look like.

Gary: Actually having data.

Gary: That informs physicians on how to safely switch patients.

Gary: That.

Gary: Boyd.

Gary: GAAP in their protection against each of your taxes are going to be very important and we think that will and of course. The FDA is focused on safety and protection against disease progression. So we think that that bodes very well for us to get in the label, but that's Eugene said.

Speaker Change: It's we don't know.

Eugene: It's it's it's risky to get ahead of regulators on what.

Jonathan Birchall: But we think that we have a pretty good shot at that. Jonathan, how's the launch prep going? Launch prep is going well. As you can imagine, this is coming hot on the heels of the potential Olisarsen launch that we've talked about. But the launch preparation on the commercial side for Donny is well advanced.

Eugene: We think that we have a pretty good shot at that Jonathan has a lot to launch Prep College launch prep is going well.

Speaker Change: As you can imagine that this is coming.

Speaker Change: Maggie.

Eugene: Potential all this awesome launch that we talked about but they.

Speaker Change: Launch prep on the commercial side for <unk>.

Speaker Change: <unk> is well advanced or a lot of capabilities that we built.

Jonathan Birchall: There are a lot of capabilities that we've built for Olisarsen that we can leverage for Donny, whether that's the medical affairs function, first and foremost, that's been well established for Olisarsen that's now leading in the HAE space. We've got brand teams, and access teams building out the value dossiers. Patient services is also well advanced and ready to support patients in the HAE space. And omni-channel as well is a capability that we feel very confident that we've built well at Ionis now and is a capability that's very applicable both to the FCS launch but also to the HAE launch.

Eugene: For all that we can.

Eugene: Leverage for Dani, whether that's the medical affairs function first and foremost that's been well established for all the files from what's now lead again.

Speaker Change: In the HIV space, We've got brand teams our access teams building out the body of adult for you guys.

Eugene: Patient.

Eugene: Service is also.

Eugene: Well advanced and ready to support patients.

Speaker Change: <unk> space and Omnichannel as well, it's a capability that we feel very confident that we do.

Gary: Wow.

Gary: Now is a capability that's very applicable both to the FCS launch, but also the entry Evo and <unk>.

Jonathan Birchall: So there's a lot of synergy there on the commercial side, albeit a lot of that is being appropriately built to best serve each of those launches and the markets and the challenges that they present. We're also very pleased with the progress ATSUKA is making on submission and preparing for launch in Europe, so stay tuned for that as well. Next question, please. The next question comes from Salveen Richter of Goldman Sachs. Please go ahead. Good morning, thanks for taking my question, or good afternoon, thanks for taking my call.

Gary: There's a lot of synergy.

Speaker Change: So five, albeit a lot of that is getting appropriately built the.

Sebastian: Sebastian that'd be true for each of those launches and the market challenges.

Speaker Change: We're also very pleased.

Speaker Change: With the progress actually because making a pre submission and preparing for launch in Europe, So stay tuned for that as well.

Speaker Change: Next question please.

Speaker Change: The next question comes from solving Pittsburgh from Goldman Sachs. Please go ahead.

Salim Syed: Good morning, Thanks for take or good afternoon. Thanks for taking my question could you just speak to the work Youre doing here on Alagoas with next generation backbones and and the other modalities, you're looking at and when these programs might enter the clinic. Thank you.

Salveen Richter: Could you just speak to the work you're doing here on oligos with next-generation backbones and the other modalities you're looking at and when these programs might enter the clinic? Thank you.

Eric Swayze: So, as Brett mentioned earlier, the first compound that incorporates our MSPA backbone will enter the clinic for a neurology indication later this year. The objectives there are to try and extend the dosing interval with the enhanced stability of that backbone, which it provides, and we'll see how it performs. We also have a compound in development with a partner, AstraZeneca, that uses our Bi-Cycle program to deliver a drug to the cardiac muscle, in this case.

Speaker Change: Sure so.

Speaker Change: Earlier the.

Speaker Change: First compound it incorporates our M S P a backbone.

Gary: We will enter the clinic for neurology indication later this year and.

Speaker Change: The objectives, there are to try and extend the dosing interval would be enhance stability of that back on which we should provide and we'll see how it performs we all we also have compounds in development with our partner Astrazeneca. It uses our lifecycle program to deliver drugs to the car.

Speaker Change: Muscle in this case of that program.

Eric Swayze: That program is moving forward, and we look to start IND talks this year. And that's progressing nicely, and that's an siRNA coupled to the Bi-Cycle program. And we also have an internal siRNA program for a follow-on indication for a liver target that we anticipate getting headed towards development this year. And then beyond that, we've been making some really nice progress in our blood-brain work, both with our Bi-Cycle collaboration and also the Vectoris Collaboration, which we announced earlier this year, very late last year. And we had some scientists from the team present some of that data at a recent TIDES meeting with early mouse data from the Vectoris Collaboration. It looks fantastic.

Speaker Change: It's moving forward and we look to start R&D talks this year and that's progressing nicely that's when SA RNA coupled to the lifecycle program and we also have an internal program for a follow.

Speaker Change: An indication for liver targets that we anticipate getting added towards development this year.

Speaker Change: And then beyond that we've been making some really nice progress and our blood brain worth both with our lifecycle collaboration.

Speaker Change: And also the back towards collaboration which we are.

Speaker Change: Announced earlier this year and very late last year, and we had some scientists from the team present some of that data at a recent tides meeting with early months' data and of course collaboration it looks fantastic and we will continue to provide some more data updates them hopefully.

Eric Swayze: And we'll continue to provide some more data updates, and hopefully, if everything goes according to plan, we can get some molecules that cross the blood-brain barrier program for our whole neurology pipeline into development early next year. Thanks, Eric, and I'll just add to that, Salvin; you can expect to see in the not-too-distant future new programs advancing towards development focused on neuromuscular diseases, skeletal muscle specifically, to further extend our readership in neurology.

Speaker Change: If everything goes according to plan, we can get some molecules that are cross the blood brain barrier program for our wholly owned neurology pipeline into development.

Speaker Change: Early early next year.

Speaker Change: And I'll just add to that.

Speaker Change: So I mean, you can expect to see in the not too distant future.

Speaker Change: New programs advancing towards development focused on neuromuscular diseases in skeletal muscle specific cleantech further extend our leadership in neurology.

Speaker Change: And also we're pleased with the progress, we're making with meta genomics.

Eric Swayze: And also, we're pleased with the progress we're making with metagenomy on gene editing. We have several programs there that are advancing very nicely preclinically, and I think next year could be a very informative and very interesting year in our gene editing program with respect to new information coming out as to what our strategy is and what our first molecules will be. So stay tuned for that.

Speaker Change: Gene editing, we have several programs there that are advancing very nicely pre clinically and I think next year could be very informative year very interesting year.

Gary: In our gene editing program with respect to <unk>.

Speaker Change: Information coming out.

Speaker Change: What our strategy is and what our first molecules will be so stay tuned for that we're making great progress across the board in diversifying and expanding our technological capabilities.

Brett Monia: We're making great progress across the board in diversifying and expanding our technological capabilities. And with that, I think we have time for one more question. The next question comes from Acostas Bilioras from BMO Capital Markets. Please go ahead.

Speaker Change: And with that I think we have time for one more question.

Speaker Change: The next question comes from a cost is Billy Auris from BMO capital markets. Please go ahead.

Acostas Bilioras: Hello, thanks for taking our question and congrats on the progress. Can you talk a little bit about the cardio-transformed enrolled population and specifically the differences between the geographies and the follow-up from the originally enrolled population and the population who... were enrolled after the changes you made to the statistical design, and if you expect any impact from the differences between these two populations? Thank you. Thanks, Kostas. So, we, of course, haven't shared the demographics for our Cardio Transformed Study yet.

Billy Auris: Hello, Thanks for taking out pricing and congrats on the progress can you talk a little bit about a date.

Speaker Change: How do we transform enrolled population and specifically the differential between the geography and the follow up from the original enrolled population and the population who.

Speaker Change: We're adding we're all after the changes you've made to the artistic all design.

Speaker Change: And if you expect any impact from the differences between these two populations. Thank you.

Carsten: Thanks, Carsten so.

Speaker Change: We of course have been shared the demographics for our cardio transform study yet we look forward to doing that in the future. We really are pleased with the enrollment.

Brett Monia: We look forward to doing that in the future. We are really pleased with the enrollment in this study. And as we've said, we have a nice balance in this big study, the largest study ever conducted in PTR cardiomyopathy, a nice balance between monotherapy patients as well as patients on combination treatment. We're also very pleased with, you know, very small percentage of drop-ins in families in the study. It's going exactly as planned. We're pleased with the percentages of patients we have with New York Health Class I, II, and III in the study.

Speaker Change: In this study.

Speaker Change: And and as we've said we have a nice balance.

Speaker Change: And this big study the largest study ever conducted in cardiomyopathy nice bounce between monotherapy patients as far as.

Speaker Change: Ah patients on combination treatment.

Speaker Change: We're also very pleased with.

Speaker Change: Very small percentages or drop in families and studying it's going exactly as planned we are pleased with the bank with the percentages of patients we have New York Health class, one two and three in the study.

Speaker Change: And you know we everything we've seen.

Brett Monia: And, you know, everything we've seen that has come out in this space with respect to other people's patient demographics supports our decision to expand our study to take into account a patient population that's been diagnosed much earlier in their disease. So, you know, we couldn't be more pleased with the way the study is going, including our patient demographics. Thanks for the question, Costas.

Speaker Change: That has come out in this space with respect to other People's patient demographics supports our decision tree.

Speaker Change: <unk> our study to take in account for a patient population that's been diagnosed.

Speaker Change: Much earlier in their disease.

Speaker Change: So.

Speaker Change:

Speaker Change: We couldn't be more pleased with the with the way the study is going including our Ah patients.

Speaker Change: Graphics so.

Brett Monia: I think it's time to wrap things up. I really want to thank everybody who joined us today for your participation and your questions. We're very proud of everything we've accomplished this past quarter and in the first half of this year. And we're planning to build on this momentum to achieve even greater successes in the second half of this year. And we're very much looking forward to providing you with updates on the progress we continue to make this year, as well as into next year. So, thank you very much, everybody, and have a great day. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect. Goodbye.

Cosmos: Thanks for the question Cosmos and I think.

Speaker Change: It's time to wrap things up I'm really really want to thank everybody who joined US today for your participation and your questions. We're very proud of everything we've accomplished this past quarter and first half of this year.

Cosmos: And we plan to build on its momentum.

Cosmos: To achieve even greater successes in the second second half of this year I am very much looking forward to providing updates on the progress we continue to make this year as well as into next year. So thank you very much everybody and have a great day.

Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Speaker Change: Goodbye.

Speaker Change: Yeah.

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