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Akcea Therapeutics, Inc. (AKCA)
Q3 2019 Earnings Call
Nov 5, 2019, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon and welcome to the Akcea Therapeutics Third Quarter 2019 Conference Call. [Operator Instructions]
I will now turn the call over to Kathleen Gallagher Akcea's Vice President of Corporate Communications and Investor Relations. Ms. Gallagher please begin.
Kathleen Gallagher -- Vice President, Corporate Communications and Investor Relations
Thank you Sade [Phonetics]. Hello everyone. Thank you for joining today's call. With me today are Damien McDevitt our Interim Chief Executive Officer; Mike MacLean our Chief Financial Officer; and Kyle Jenne; our Chief Commercial Officer.
As a reminder this conference call includes forward-looking statements regarding the financial outlook for Akcea Akcea's business and the therapeutic and commercial potential of Akcea's products and development. Any statement describing Akcea's goals expectations financial or other projections intentions or beliefs including the commercial potential of TEGSEDI WAYLIVRA and our pipeline drugs is a forward-looking statement and should be considered an at-risk treatment. Such statements are subject to certain risks and uncertainties particularly those inherent in the process of discovering developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs.
Akcea's forward-looking statements also involve assumptions that if they never materialize or prove correct could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Akcea's forward-looking statements reflect the faith judgment of its management these statements are based only on facts and factors currently known by Akcea.
As a result you're cautioned not to rely on these forward-looking statements. These and other risks concerning Akcea's programs are described in additional detail in Akcea's most recent Quarterly Report on Form 10-Q and in the most recent Annual Report on Form 10-K on file with the SEC. Copies of these and other documents are available from the company. In addition earlier today we issued a press release and related financial tables including a reconciliation of GAAP to our reported non-GAAP financial measures that we will discuss today. To read this release and access the slides that accompany today's call please visit the Investors section of our website.
Now I will turn the call over to Damien.
Damien McDevitt -- Interim Chief Executive Officer, Director
Thank you Kath. Good afternoon everyone and thank you joining today's call. I want to start off by sharing how excited I am to lead Akcea. I believe in our mission our team and our innovative medicines. Since being appointed interim CEO a little more than a month ago I've worked alongside our dedicated employees and I've heard firsthand the real and positive impact we're having on patient's lives. I have now seen the strong foundation that has been built here and I'm impressed with the talent and engagements across the organization. I've also spent time with our key partners Novartis PTC and now Pfizer and have been impressed with their commitments to our medicines.
Our strategy is to continue to execute on our two commercial launches as well as deliver on the transformational programs that we currently have in developments. I look forward to leveraging this infrastructure as we expand our pipeline and build upon our relationship with Ionis. As we announced when I joined Akcea we have firm commitments from Ionis to license Rare Disease medicines that are complementary to our pipeline, and we will continue to evaluate licensing additional third party assets. To ensure we can successfully execute this strategy we've added a key member to our executive team. I'm pleased to introduce our new chief Commercial Officer Kyle car has been with access since 2017, leading the US Commercial organization for both tech SETI and WAYLIVRA and has deep knowledge of the ATTR and FCS communities. He brings a wealth of experience to his new role including more than 20 years in the industry of which almost half were in the rare diseases space. With the team we have in place we have the backgrounds and experience to drive our company's growth.
This quarter we also entered into a worldwide exclusive licensing agreement with Pfizer for AKCEA-ANGPTL3-LRx to treat patients with certain cardiovascular and metabolic diseases. Through this agreement Akcea and Ionis will receive a $250 million upfront license fee and are eligible to receive development regulatory and sales milestone payments of up to $1.3 billion and tiered double-digit royalties. Disagreement is still subject to HSR clearance.
We were thrilled to announce this deal. Akcea and PTL3-LRx has the potential to treat very broad patient populations and advancing this medicine to patients is a task well-suited for a large pharma company. Pfizer is the ideal partner for this program because of their expertise in both cardiovascular health and in commercializing therapies targeting large markets.
TEGSEDI continues with steady progress. We reported approximately $12 million in sales for the third quarter which is an approximately 20% growth quarter-over-quarter. We are seeing some promising progress in the market which Kyle will speak to in more detail.
In the third quarter we launched WAYLIVRA in Germany. WAYLIVRA is the only treatment approved for patients with FCS and we are now treating our first patients with commercial drug. We've made a lot of progress with the pipeline which I will discuss later in the call.
There is a strong sense of momentum across the company. Even in my short tenure we have had several positive achievements. Commercially we've launched TEGSEDI in additional countries and we've had success with a number of European pricing negotiations. We had further validation of our LICA technology with the recent Pfizer licensing of AKCEA-ANGPTL3-LRx and we're progressing quickly toward the start of the Phase 3 program for AKCEA-TTR-LRx. Also we've added experienced leaders to our team and we have a strong balance sheet that allows us flexibility to continue to build the business. Together these events and this momentum are positioning us for a promising future.
I'll now turn the call over to Kyle to discuss our commercial efforts for the quarter.
Kyle Jenne -- Chief Commercial Officer
Thank you Damian and hello everyone. It's a pleasure to be here and I'm looking forward to meeting with you in person very soon. Over my last couple of years at Akcea I've had the opportunity to build the U.S. commercial team launching TEGSEDI. I've had the pleasure of working with the Akcea team to build the foundation that will support the future launches for WAYLIVRA and additional medicines that received regulatory approvals.
The focus has always been on ensuring that patients have access to TEGSEDI and WAYLIVRA and we have done that through building partnerships with physicians patient advocacy organizations and payers. I believe in listening to the patient and physician communities to understand how we can best serve them. I will lead with that core philosophy as I take on this new role.
Last month marks one year since we launched TEGSEDI. We're seeing steady progress. Looking back at the last year the team has executed well in an unprecedented competitive environment for a rare disease launch. Through Q3 TEGSEDI has generated revenue from the U.S. and Germany and is now commercially available in seven additional countries. In the U.S. we continue to have success with market access for TEGSEDI. We continue to help patients gain access to our treatment through broad reimbursement coverage from commercial and government payers. Importantly patients are being treated with TEGSEDI with low out-of-pocket costs.
We have continued to focus on raising awareness of the disease. We are seeing our efforts pay off with both neurologists and cardiologists better understanding the urgency to treat the polyneuropathy of hATTR amyloidosis and the importance of starting treatment early. Our strategy to focus on academic centers and community-based physicians and institutions has resulted in an increase in new physicians prescribing TEGSEDI.
We are also seeing this increase in diagnosis from our genetic testing program hATTR Compass. We now have over 1000 physicians using the program. Compass allows physicians to diagnose patients locally and TEGSEDI allows them the independence to treat patients locally as well. This means physicians can treat patients in their local practice and patients don't have to travel far distances for diagnosis or treatment. This is especially important for patients who are experiencing the debilitating symptoms of autonomic neuropathy which makes travel incredibly difficult.
This past quarter more than 40% of our new prescriptions were from first-time prescribers. Importantly prescriptions from both cardiologists and neurologists are growing and we are seeing repeat prescriptions from physicians who have experience with TEGSEDI. Coupled with new and repeat prescriptions we are pleased with patient's compliance and persistence rates.
Outside of the U.S. we have completed the initial free pricing period and finalized pricing negotiations in Germany. We have received acceptance by both nice and the Scottish medicines consortium with access and all four UK countries. We are now treating patients there with tech setting. In addition, we successfully completed our reimbursement associations in Sweden and Austria and have launched in both countries. As expected we are following the typical launch sequence in Europe and anticipate launching in additional countries in 2020.
AKCEA CONNECT is now a global program. We believe we are providing the highest level of patient and physician support across all commercial geographies. We continue to hear feedback that the AKCEA CONNECT teams are strong partners for both patients and physicians. In the countries where we are pursuing reimbursement we have early access programs up and running.
Our partners in Latin America PTC Therapeutics recently announced the approval in Brazil. We are pleased to be the first approved RNA targeted therapy for patients with the polyneuropathy of hATTR amyloidosis in Brazil and the only hATTR therapy globally for patients suffering with polyneuropathy to have quality of life mentioned in the indication statement.
PTC immediately started launch activities for TEGSEDI in Brazil. Our partnership strategy has been a great way to accelerate the delivery of TEGSEDI to patients in Latin America and they are working toward additional approvals and reimbursement in other countries. We are very pleased with all we have achieved with TEGSEDI in the past year and we are looking forward to growing the business in 2020 and beyond.
Turning to WAYLIVRA the team achieved a major milestone by launching and treating patients in Germany this past quarter. We have begun an ATU which is a reimbursed early access program in France. We have a strong EAMS program in the U.K. as well as a number of early access programs in other European countries as we pursue reimbursement. Preparations are under way to launch in additional EU countries in 2020 and in Latin America with our partner PTC. Our team is executing on both the TEGSEDI and WAYLIVRA launches and the foundation that we have in place internationally is setting us up to commercialize additional products from our pipeline in the coming years.
I'll now turn the call over to Mike to discuss our financials.
Mike MacLean -- Chief Financial Officer
Thank you Kyle and good afternoon everyone. For Q3 we had total revenue of approximately $21 million and an operating loss of approximately $36 million on a non-GAAP basis including non-GAAP operating expenses of $57 million. Our revenue includes approximately $12 million of product sales from TEGSEDI which as Damian mentioned is an approximately 20% growth on a quarter-over-quarter basis.
In addition this quarter we launched the WAYLIVRA in Germany where the maintenance price of WAYLIVRA is approximately EUR429000 per year for a biweekly treatment regimen. WAYLIVRA will be sold as a single-dose and pre-filled syringes priced at EUR16500. Our market access team is now working with the German authorities to agree the reimbursement price for WAYLIVRA after the first 12 months.
As Kyle mentioned we have an ATU program for WAYLIVRA in France. We are building and collecting for the product under the ATU program and once we finalize our price in France we will be able to recognize revenue. We generated a substantial upfront payment of $250 million when we licensed AKCEA-ANGPTL3-LRx to Pfizer last month. While we split all the economics under this agreement 50-50 with Ionis we will settle our obligation to Ionis with $6.9 million shares of Akcea common stock resulting in an ownership by Ionis of approximately 77%. Of the $250 million payment we anticipate receiving from Pfizer we plan to recognize substantially all this revenue in the fourth quarter.
Further PTC announced in October that they received approval for TEGSEDI in Brazil. With the approval we earned a $4 million milestone 60% of that amount will go to Ionis for the terms of our profit share agreement. We ended the third quarter with $253 million in cash and short-term investments. When added to the $250 million upfront license fee from our worldwide exclusive license agreement with Pfizer expected upon coming completion of the HSR review we will have approximately $500 million in cash and short-term investment. With our substantial liquidity we are well-positioned to continue to execute on our strategy and broaden our pipeline.
I will now turn the call back to Damien.
Damien McDevitt -- Interim Chief Executive Officer, Director
Thank you Mike and Kyle. Let me start with an update on WAYLIVRA in the U.S. We remain encouraged by the safety and efficacy profile demonstrated by WAYLIVRA in Europe. In the U.S. we are continuing to work to find a path forward and we believe that our experience in Europe could be helpful in progressing our discussions. WAYLIVRA's Phase 3 APPROACH Study was published in the August 8 issue of the New England Journal of Medicine. We were pleased to see the journal recognize the significance of the approach data and the potential of WAYLIVRA to address an area of significant unmet need in the treatment of FCS. We also announced positive results from the BROADEN study in Familial Partial Lipodystrophy or FPL on our last earnings call. We continue to review the data with key experts in the field as we define our next steps.
Moving to AKCEA-TTR-LRx Akcea and Ionis presented data from the Phase 1 clinical trial in a poster presentation of the Heart Failure Society of America Annual Meeting as well as at the European Amyloidosis Meeting. AKCEA-TTR-LRx has been developed with Ionis and will be studied in patients with both the hereditary and the wild-type forms of TTR amyloidosis or ATTR. The Phase 1 data demonstrates an impressive and meaningful reduction in the TTR protein while maintaining a positive safety and tolerability profile. With monthly treatments we saw TTR reductions of up to 94% at the highest dose.
Importantly adverse events were mild with the exception of one moderate headache. No adverse events led to an interruption and treatments and there were no severe adverse events. These results are encouraging as we expand our commitments to the TTR amyloidosis community through the development of AKCEA-TTR-LRx. We continue to hear from physicians that the convenience of monthly self-administration would represent a significant advantage for patients living with this debilitating and fatal disease.
We also presented the design of a Phase 3 program for AKCEA-TTR-LRx. The program includes two studies one in patients with their hereditary form of TTR polyneuropathy and the other in patients with wild-type and hereditary forms of TTR cardiomyopathy. The hereditary polyneuropathy study will consist of 140 patients and we'll compare AKCEA-TTR-LRx to the historical placebo from TEGSEDI's neuro TTR study. The primary endpoint analysis on this study is at 66 weeks to align with the placebo group from neuro TTR.
The cardiomyopathy study is an event-driven outcome study. It will enroll approximately 750 patients and we'll compare AKCEA-TTR-LRx against standard of care including patients taking Tafamidis. In both studies we are close to having sites up and running. We anticipate the first patients will be treated soon.
Finally just touching briefly on the rest of the pipeline Novartis is initiating the AKCEA-APO(a)-LRx Phase 3 Cardiovascular Outcome study and continues to anticipate treating patients early in 2020. Phase 2 studies of AKCEA-APO(a)-LRx and AKCEA-ANGPTL3-LRx are ongoing and we anticipate data from both early in 2020. With over 1100 patients treated across all LICA programs we are very impressed with the robust efficacy with the safety and tolerability profile of the platform today. We are executing on our two commercial launches. We are initiating are two Phase 3 programs and we have two drugs nearing Phase 2 data as we head toward the end of the year. With launches in additional countries on the horizon for TEGSEDI and WAYLIVRA the commitment from Ionis to license us additional rare disease medicines that are complementary to our pipeline and the progression of our current pipeline Akcea is well-positioned for the future.
I'll now open up the line for questions.
Questions and Answers:
Operator
[Operator Instructions] Our first question comes from the line of Gil Blum from Needham & Company. Your line is open.
Gil Blum -- Needham and Company. -- Analyst
Hello everybody and thanks for taking my questions. Just the first one for Kyle do we have any indication of maybe the proportion of patients on TEGSEDI who come from the community safe setting versus the academic?
Kyle Jenne -- Chief Commercial Officer
Hey first.
Damien McDevitt -- Interim Chief Executive Officer, Director
This is Damien. Handing it over to Kyle go for it Kyle.
Kyle Jenne -- Chief Commercial Officer
Yes. Thanks for the question and definitely look forward to connecting with you in person here in the near future. So our efforts have been split between the academic settings as well as the community settings as I referenced in my comments. We're not going to get into specific numbers in terms of where those are coming from but we are seeing both community-based and academic-based physicians treating with TEGSEDI within the hATTR polyneuropathy space. So we're excited about that and pleased with the progress that we're making.
Gil Blum -- Needham and Company. -- Analyst
All right and a bit about -- so as you might have noted Pfizer released some interesting numbers about the diagnosis ratio and the wild type and it appears that they're getting to a pretty significant amount of diagnosed patients. Do you guys think that in a longer term sense this is growing the overall TTR market faster than expected?
Kyle Jenne -- Chief Commercial Officer
Yes. So we are seeing the market expand. I think as Pfizer referenced we're seeing growth and not only in the wild type space but we are seeing increased diagnosis in the hereditary space as well. I think it's a competitive marketplace. There's a lot of education around the hereditary forms of the disease and polyneuropathy specifically and we're seeing physicians began to understand and diagnose patients earlier with neurologic symptoms and looking to treat patients with hereditary forms of the disease sooner than what we had expected prior.
Gil Blum -- Needham and Company. -- Analyst
Great and just one last one I know that the CIFA ADCOM [Phonetics] is coming up next week and are you guys expecting any read-throughs to your own triglyceride-lowering programs?
Damien McDevitt -- Interim Chief Executive Officer, Director
I'm going to hand that -- thanks for the question I'm going to hand that over to Kath.
Kathleen Gallagher -- Vice President, Corporate Communications and Investor Relations
I'm going to hand that -- thanks for the question I'm going to hand that over to Kath.
Gil Blum -- Needham and Company. -- Analyst
Got you. All right guys thank you very much for taking my questions and best of luck.
Kathleen Gallagher -- Vice President, Corporate Communications and Investor Relations
Thanks Gil.
Operator
Your next question comes from the line of Do Kim from BMO Capital Markets. Your line is open.
Jamison Phillips-Crone -- BMO Capital Markets -- Analyst
Guys this is Jamison on for Do. Thanks for taking our questions and congrats on the quarter. So a quick question on ANGPTL3 what indications are you thinking about going after and how the talks have been with Pfizer? Thanks.
Damien McDevitt -- Interim Chief Executive Officer, Director
Thanks Jamison. This is Damien here. I'll take I'll take the question. So we're very excited about the transaction with Pfizer for ANGPTL3. As you heard we're receiving $250 million upfront. This sets a new high watermark for medicine at this stage of development with our technology. We're eligible to receive very significant milestones development regulatory and sales milestones up to $1.3 billion and we're getting tiered double-digit royalties on sales. And so Pfizer is a great partner for this medicine because this medicine can address broad patient populations. So we're looking at both cardiovascular and metabolic diseases and -- because this is Pfizer's medicine we're going to leave it to them to disclose which indications they're going to progress the medicine forward for.
Jamison Phillips-Crone -- BMO Capital Markets -- Analyst
Thank you.
Operator
Your next question comes from the line of Jim Birchenough from Wells Fargo. Your line is open.
Jim Birchenough -- Wells Fargo -- Analyst
Hi guys and congrats on all the progress in the quarter. A couple of questions I guess first just with TEGSEDI could you maybe comment on any leading indicators of continued growth either with specifics or just general comments if you think about patients in the queue patients that have been captured by AKCEA CONNECT patients that have been identified and you look at how those patients in prior quarters have flowed to becoming paying patients? Could you maybe comment on the trends if you can't give specific numbers? Thanks. Then I have a follow-up.
Damien McDevitt -- Interim Chief Executive Officer, Director
Thanks Jim. Thanks for the question. I'll hand that over to Kyle.
Kyle Jenne -- Chief Commercial Officer
Yes Jim. Look forward to meeting you as well in person here hopefully fairly soon. As it relates to the progress that we're making leading indicators obviously we're very pleased with the progress we've got 20% quarter-over-quarter growth in terms of revenue. So we're starting to see the build and it's happening with existing prescribers it's happening with new prescribers it's happening across specialties in cardiology as well as neurology and we are obviously broadening and deepening the physician experience with TEGSEDI. So we are optimistic about the repeat prescriptions that we're seeing and the growth that we've seen quarter-over-quarter in terms of revenue.
Mike MacLean -- Chief Financial Officer
Jim Mike here. I thought I would just add Kyle also pointed out that we are moving through the reimbursement cycle in EU countries. So those countries will start to come online here in late '19 and throughout 2020.
Jim Birchenough -- Wells Fargo -- Analyst
And then just any comments on if you look at the U.S. market in particular as you're heading into the fourth quarter are you seeing good growth in patients identified and patients moving through the AKCEA CONNECT system just trying to get a sense of those type of leading indicators?
Kyle Jenne -- Chief Commercial Officer
Yes and I'll speak specifically to the Compass Genetic Testing program. I think the fact that we have over 1000 physicians now utilizing that program and we're continuing to add new patients identified through that program and positive patients being found through that program are indicators that the education around diagnosis as well as the effort from the physician community to actually seek out hereditary forms of the disease is working so from an education standpoint. On the AKCEA CONNECT side of things we're very pleased with the way that the program is operating in the United States. We're getting very good feedback from physicians and patients as it relates to the support that AKCEA CONNECT provides and the difference that it's making for them to be able to get on and stay on therapy.
Jim Birchenough -- Wells Fargo -- Analyst
And then maybe just a question for Damien just strategically as you think about your ability to bring in additional assets from either Ionis or third-parties could you maybe talk about the decision criteria you have for assessing an asset and whether you choose one from Ionis or from a third-party?
Damien McDevitt -- Interim Chief Executive Officer, Director
Sure Jim. Thanks for the question. So in terms of the Ionis pipeline medicines so we're having discussions with Ionis about their wholly owned candidate medicines many of which I'm very familiar with having worked at Ionis before. Our focus is really on rare disease medicines that complements our infrastructure our pipeline and our business focus. Yes we're keeping an open minds and as we work through the evaluation of the medicines with Ionis. So as you know this will be an [Indecipherable] business development transaction and we're not giving sort of a timeline on this but we're making good progress and we'll announce when the transaction is completed. In terms of third-party medicines we're looking again for medicines that will be complementary to our pipeline our rare disease business focus. We again are keeping a very open minds as you know the stage of the medicine the modality of the medicine and we'll update you in due course on progress with that.
Jim Birchenough -- Wells Fargo -- Analyst
Maybe just to spread it around one final question for Mike could you just remind me or remind us rather how revenues are booked in Brazil with PTC?
Mike MacLean -- Chief Financial Officer
Yes. So for PTC the way that that's going to work is there's an initial period. So it's 25% royalty but there's a period at the time of the launch that goes to the either 12 months or $10 million. So for the first 12 months if they don't exceed $10 million we do not get a royalty and the first 12 months if they go over $10 million we get a royalty for the amount -- 25% of the amount that's over $10 million and then it kicks into just a regular royalty stream.
Jim Birchenough -- Wells Fargo -- Analyst
Great thanks for taking the questions.
Mike MacLean -- Chief Financial Officer
Thank you Jim.
Operator
Your next question comes from the line of Paul Matteis from Stifel. Your line is open.
Nate Tower -- Stifel Nicolaus -- analyst
Hey thanks for taking the question. This is Nate on for Paul. On the cardiomyopathy Phase 3 study for TTR LICA I notice it's on top of standard of care and I m just wondering how are you going to handle Tafamidis usage. Do you have a cap on the number of patients that can have baseline usage or any requirements around the duration of therapy prior to enrollment?
Damien McDevitt -- Interim Chief Executive Officer, Director
So thanks for the question Nate. Yes so this study is a large study 750 patients looking at cardiovascular deaths and cardiovascular clinical events. It's got wild type and hereditary ATTR patients and they're going to be as you mentioned on available standard of care. And then half of them are going to have TTR LICA and the other half are going to have placebo added. And then it's 120 week readouts on this. So that's the design of the study. That's what we're set up ready to go.
Kathleen Gallagher -- Vice President, Corporate Communications and Investor Relations
Nate this is Kath just following up on that I think there isn't a cap on the number of patients that can be on Tafamidis. And I think the study design where we're excited about the standard of care arm is that we'll get a number of different readouts from this study. So we'll see some combination data we'll see some direct head--to-head data. And that is part of the design because obviously we'll be doing a study in a number of countries where Tafamidis is available and a number of countries where it's not. So I think that is really part of the design that we're really excited about.
Nate Tower -- Stifel Nicolaus -- analyst
Got you. That's helpful Kath. And then for both of Phase 3s can you guys talk about powering have you -- what's the story there?
Kathleen Gallagher -- Vice President, Corporate Communications and Investor Relations
No we haven't gotten into any of the powering yet Nate. And I'm sure we'll be sharing more on the study of not necessarily powering but we'll be sharing more on the study as it actually launches here imminently.
Nate Tower -- Stifel Nicolaus -- analyst
Got you. All right thanks guys.
Operator
[Operator Instructions] Your next question comes from the line of Ritu Baral from Cowen. Your line is open.
Ritu Baral -- Cowen & Company -- Analyst
Good afternoon everyone. Thanks for taking the questions. First one I guess Damien can you -- just to follow-up on Jim's question about how you plan on building out the pipeline -- is there stage of developments that you think is ideal for the Akcea value proposition and even more specifically within their disease are you guys thinking about commercial synergies with the existing promotional efforts or are you willing to sort of strike out in a new direction? And then I've got a follow-up.
Damien McDevitt -- Interim Chief Executive Officer, Director
Okay. Thank you Ritu for the question. Yes I mean I think we're keeping an open mind to the stage of developments obviously closer to the market is more interesting and with the Ionis pipeline we're looking at their mid-stage pipeline of wholly owned assets with them together. In terms of yes we're staying focused on rare diseases. That's where our strength is. That's where our mission is and looking for medicines that will complement our infrastructure our commercial capabilities and the business focus.
Ritu Baral -- Cowen & Company -- Analyst
Got it. And then as you think about your LICA TTR Phase 3 both the FAP and the FAC in wild type study are there sort of -- are there elements that from a commercial aspect will differentiate LICA TTR from other knockdown agents? Are there any secondary endpoints where you believe will contribute to a differential profile?
Damien McDevitt -- Interim Chief Executive Officer, Director
Let me start on that. If I understand the question right is around TTR LICA Phase 3 so I think what I would say is that we're excited about the fact that it's a monthly injection and we've heard from physicians community that monthly is most convenient for patients. Also what we're very excited about is that it's basically TEGSEDI with a GalNAc and that gives us great confidence given the pulse of improvements we've seen for patients taking TEGSEDI.
Ritu Baral -- Cowen & Company -- Analyst
Got it. As far as secondary endpoints or anything within the trial design anything to differentiate it from potential seek [Phonetics] for competition in the field whether we're talking TTR [indiscernible]?
Damien McDevitt -- Interim Chief Executive Officer, Director
Okay. I'll ask Kathleen to handle that.
Kathleen Gallagher -- Vice President, Corporate Communications and Investor Relations
Hi Ritu. So I don't think there's anything specific in there Ritu I mean to some degree these are -- TEGSEDIs are what they are I think what's important is that we brought all of our collective learning. At this point we have a lot of knowledge on TTR and we can take everything that we've learned especially from the patient experience and we can put back into the study in a way that it is typical in rare disease. We didn't have that information when we launched the NEURO-TTR study. And so I think that this puts us in a pretty good position of strength going in thinking about quality of life metrics and really thinking about what are the important things that we're looking at which I think in general as a community we've learned more over the last few years to kind of strengthen these future trial design.
Ritu Baral -- Cowen & Company -- Analyst
Got it thanks for taking the question.
Operator
And that concludes our Q&A session. I would now like to turn the conference back to you Mr. Damien McDevitt.
Damien McDevitt -- Interim Chief Executive Officer, Director
Thank you for joining today. We look forward to keeping you updated on our progress as we continue to execute on the TEGSEDI and WAYLIVRA launches and build upon the strong foundation at Akcea. Have a great afternoon.
Operator
[Operator Closing Remarks]
Duration: 36 minutes
Call participants:
Kathleen Gallagher -- Vice President, Corporate Communications and Investor Relations
Damien McDevitt -- Interim Chief Executive Officer, Director
Kyle Jenne -- Chief Commercial Officer
Mike MacLean -- Chief Financial Officer
Gil Blum -- Needham and Company. -- Analyst
Jamison Phillips-Crone -- BMO Capital Markets -- Analyst
Jim Birchenough -- Wells Fargo -- Analyst
Nate Tower -- Stifel Nicolaus -- analyst
Ritu Baral -- Cowen & Company -- Analyst
