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Akcea Therapeutics, Inc. (NASDAQ:AKCA)
Q2 2020 Earnings Call
Aug 4, 2020, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon, and welcome to the Akcea Therapeutics Incorporated Second Quarter 2020 Conference Call. [Operator Instructions]

I would now like to turn the conference over to Angelyn Lowe, Akcea's Vice President of Corporate Communications and Investor Relations. Ms. Lowe, please begin.

Angelyn Lowe -- Executive Director, Corporate Communications and Investor Relations

Thank you, Chuck. Hello, everyone. Thank you for joining today's call. With me today are Damien McDevitt, our Chief Executive Officer; Kyle Jenne, our Chief Commercial Officer; and Michael Price, our Chief Financial 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 projections, intentions or beliefs, including the commercial potential of TEGSEDI, WAYLIVRA and Akcea's other medicines in development, is a forward-looking statement and should be considered an at-risk statement.

Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics and in the endeavor of building a business around such medicines. Akcea's forward-looking statements also involve assumptions that, if they never materialize or proved 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 a good faith judgment of its management, these statements are based only on facts and factors currently known by Akcea.

In particular, we caution you that our forward-looking statements are subject to the ongoing and developing circumstances related to the COVID-19 pandemic, which may have a material adverse effect on our business, operations and future financial results. As a result, you are 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 press release and access the slides with accompany today's call, please visit the Investors section of our website.

Now I'll turn the call over to Damien.

Damien McDevitt, Ph.D. -- Chief Executive Officer

Thank you, Angelyn, good afternoon, everyone, and thank you for joining today's call. We performed well in the second quarter. We continue to grow revenue for both TEGSEDI and WAYLIVRA, we advanced our robust pipeline of transformational medicines, and we added toward leadership team despite the challenging COVID-19 environment. We ended Q2 with $319 million in cash and short-term investments on the balance sheet giving us the financial flexibility to execute on our short- and longer-term strategic priorities. We are a commercial-stage biopharmaceutical company that is committed to developing and commercializing transformational and life-changing medicines to treat patients with serious and rare diseases.

In just five years we are proud to have already launched two commercial medicines TEGSEDI and WAYLIVRA, built a strong cash position and built an exciting late stage differentiated pipeline of antisense oligonucleotide medicines covering the multiple, well-validated targets. This allows us to capitalize on our strength in supporting patients who are currently underserved as well as healthcare professionals and caregivers in treating serious and rare diseases.

We are advancing six medicines from the groundbreaking Ionis ASO platform and are pleased with the progress. TEGSEDI and WAYLIVRA already launched commercially. And our four next generation LICA medicines in the pipeline, AKCEA-TTR-LRx and AKCEA-APO(a)-LRx have begun Phase III studies. AKCEA-APOCIII-LRx is moving into Phase III and vupanorsen is moving into Phase IIb. The consistent performance across the LICA programs in terms of efficacy, safety and tolerability further validates to see advantages of the platform.

During the pandemic, our patients have been able to stay on therapy and to quickly access our medicines. Our approved antisense medicines are subcutaneous self-injections for our patients can choose to take the therapy at home. This is one of the important benefits of TEGSEDI and WAYLIVRA along with their demonstrated efficacy and manageable and well understood safety profiles.

In the second quarter, we continue to see revenue growth with both TEGSEDI and WAYLIVRA. Total product revenue was $16 million, an increase of 66% from the second quarter of 2019, and an increase of 8% from the first quarter of 2020. We are making excellent progress in expanding into new countries for both medicines. TEGSEDI first launched in the third quarter of 2018, and is now commercially available in 15 countries. WAYLIVRA, after launching in the third quarter of 2019, is now commercially available in four countries. We expect these new countries to fuel revenue growth going forward. Kyle will talk more about the progress we're making with TEGSEDI and WAYLIVRA later on the call.

During the quarter, we and Ionis announced the publication of long-term clinical data for TEGSEDI and patients with polyneuropathy, driven by hereditary trends by recent amyloidosis. Results from the ongoing open label extension study of the pivotal NEURO-TTR trial published in the European Journal of Neurology show that patients treated with TEGSEDI experienced sustained improvements and measures of neuropathy progression at 39 months of therapy compared to the natural history of the disease. Patients were administered -- who were administered TEGSEDI, also experienced clinically relevant improvements measures of quality of life compared to the natural history of the disease.

And no new safety signals were identified. This further establishes the favorable risk benefit profile seen in hATTR patients treated with TEGSEDI for their polyneuropathy. These data also demonstrate how important it is for patients with the debilitating disease have access to a treatment that can deliver long-term clinical benefits.

Since taking over as CEO last September, I have made it a priority to enhance and build upon the strength of our management team. In the second quarter, we added several new members of the team, and I'm extremely happy to report that the new senior leadership team is now fully in place. We added Michael Price as Executive Vice President and Chief Financial Officer, who you will hear from later on the call. We also added Carla Poulson as Senior Vice President and Chief Human Resources Officer; Dr. Kia Motesharei, as Senior Vice President of Business Development and Corporate Strategy; Tracy Palmer Berns as Chief Compliance Officer; And most recently, Dr. Christophe Hotermans, as Senior Vice President of Global Medical Affairs; and Dr. William Andrews as Chief Medical Officer. Dr. Andrews is taking over from Louis O'Dea, who recently retired, and who will continue to serve as an advisor to the company to ensure a smooth transition.

We're excited to have the full team in place and look forward to their many contributions as we move the company forward and execute on our rare diseases strategy. For this year with our commercial medicines we are anticipating a number of upcoming events, including additional WAYLIVRA and TEGSEDI country launches throughout the year.

Now turning to WAYLIVRA, in the US. We had an encouraging meeting with the FDA this spring. Based on feedback from the meeting, we are preparing the resubmission, which will include real world data. While we do not need to conduct a new clinical study, we need to complete some administrative steps to access data that supports our refiling. We will keep you posted on the timing of this refiling.

Now moving to the pipeline. We are on schedule to begin a Phase III study in FCS this year for AKCEA-APOCIII-LRx. For vupanorsen the program has advanced toward Phase IIb dose-ranging study that will be led by Pfizer. And then the subsequent Phase III Pfizer-led program is planned to include studies to support an indication for severe hypertriglyceridemia as well as a cardiovascular outcome trial to support a cardiovascular risk reduction indication. We will be presenting the late-breaking clinical trial abstracts for both vupanorsen and AKCEA-APOCIII-LRx at a medical congress this quarter. With AKCEA-APO(a)-LRx, also known as TQJ230, the outcome study is progressing well and the trial readout is currently expected in 2024. And for AKCEA-TTR-LRx, we are on track for data readouts in 2023.

In addition, we're looking to expand our portfolio of medicines by closely collaborating with Ionis to identify and potentially license a novel rare disease medicine from the wholly owned pipeline, and we are searching for potential third-party medicines that complement our rare diseases focus and capabilities.

With that, I'll now turn the call over to Kyle to discuss our commercial efforts in more detail.

Kyle Jenne -- Chief Commercial Officer

Thank you, Damien, and good afternoon, everyone. We achieved exciting commercial milestones in the second quarter with TEGSEDI and WAYLIVRA, including securing pricing and reimbursement in several key markets across Europe. And we are making good progress with pricing and reimbursement discussions in other European markets. TEGSEDI is now commercially available in 15 countries. We are competing effectively in countries where we have launched and patient growth continues to accelerate. WAYLIVRA is commercially available in Germany, Austria, Greece and through an ATU in France.

Let's start with TEGSEDI. We saw continued revenue growth from the first to the second quarter. We are growing the number of patients on commercial TEGSEDI across both North America and Europe. Patients and doctors are looking for an alternative solution to hospitals or infusion centers for treatment. TEGSEDI is a subcutaneous self-injection, which means patients can take TEGSEDI in the comfort of their own homes. In the second quarter, we had patient switched from other therapies to TEGSEDI, and doctors are seeing the value of TEGSEDI for patients naive to treatment with hATTR with polyneuropathy. This advantage coupled with the demonstrated efficacy and manageable safety profile continues to be the driver of TEGSEDI's growth.

Let's now turn to our progress with TEGSEDI in the US, where we are competing effectively for naive patients. We continue to see more new patient start on TEGSEDI in the second quarter. This highlights the unique value this medicine brings to the US market as an at-home treatment. Patients have stayed on therapy and we are seeing patients remain on therapy due in part to our patient support program AKCEA CONNECT. Our hATTR compass genetic testing program now has more than 2,000 physicians testing and over 10,000 genetic tests have been administered since launching less than two years ago. We experienced a slowdown in testing in the second quarter. However, we continue to see newly diagnosed hATTR patients of polyneuropathy start on TEGSEDI. As a result of our robust physician outreach, we are continuing to see new physicians prescribe TEGSEDI, and those with TEGSEDI experience are choosing this medicine for additional patients.

In terms of market access, we have 96% of total US commercial lives covered today and we have negotiated long-term coverage that secure 75% of commercial lives through 2023. These positive signs of continued progress with our US payer strategy demonstrate our ability to provide TEGSEDI to a broad population of patients in need of treatment. Q2 was an exciting quarter for TEGSEDI in Europe. We continue to grow the number of patients on commercial therapy in the markets where we have already launched. We secured final pricing and reimbursement in Portugal, Italy and Spain, and we are in the process of converting patients currently being treated with TEGSEDI from early access programs over to commercial therapy.

These markets have significant potential, especially Portugal due to its endemic population. In Austria, we recently announced the TEGSEDI was officially approved for reimbursement. TEGSEDI is the only medicine available for hATTR with polyneuropathy patients in Austria for at-home subcutaneous injection. In Canada, we concluded negotiations with the pan-Canadian Pharmaceutical Alliance with a Letter of Intent and we have secured listings in several provinces clearing the path for reimbursement for the majority of our current patients.

In addition, we have secured multiple agreements with private payers in Canada. And in Brazil, launch activity continues to progress with new patient finding and PTC remains engaged in pricing discussions with CMED. Overall, we made significant progress with TEGSEDI in the US, Europe and Canada in Q2, and we look to carry this positive momentum forward for the balance of the year and beyond.

Turning to WAYLIVRA. WAYLIVRA is the only approved treatment for FCS patients in Europe. WAYLIVRA is commercially available in Germany, Austria, and Greece, and we continue to enroll patients in our ATU in France. We have continued to grow the number of patients on commercial WAYLIVRA in the markets where it is commercially available. All four markets added patients on commercial therapy in the second quarter, including our first patient on commercial therapy in Greece. Our team is focused on building FCS awareness with HCPs, supporting patient advocacy groups, identifying additional patients and securing market access as we follow the typical launch sequence in Europe.

In Germany, we concluded pricing negotiations and we now have secured a fixed price for the duration of the contract. In the UK, we are in the negotiation process with NICE to secure reimbursement after a temporary pause due to the COVID-19 pandemic. In Italy, pricing and reimbursement negotiations are ongoing and patients have access to WAYLIVRA through law three-two, six an early access program. And we're advancing toward pricing and reimbursement in several other markets in Europe.

In Brazil, the PTC team announced the marketing authorization application has been submitted to ANVISA. PTC continues to work to provide access to WAYLIVRA to patients across Latin America. And in the US, as Damien mentioned earlier, we had an encouraging meeting with the FDA this spring and we are preparing the resubmission. We'll keep you posted on the timing of the refiling. Our team is working diligently as we execute on both the TEGSEDI and deliver launches. And we look forward to keeping you updated on our progress.

I'll now turn the call over to Damien to discuss our pipeline.

Damien McDevitt, Ph.D. -- Chief Executive Officer

Thanks, Kyle. I'll start with AKCEA-TTR-LRx, the CARDIO-TTRansform and NEURO-TTRansform Phase III studies are under way with both the hereditary and wild-type forms of TTR amyloidosis. This represents another important milestone in further demonstrating Akcea and Ionis' commitment to bringing new treatment option to patients living with TTR amyloidosis or ATTR around the world. Both the wild-type and hereditary forms of ATTR are under-diagnosed and fatal with limited treatment options available. After a brief pause in studies, we are enrolling patients and on track for data readout in 2023.

Next is an update on AKCEA-APO(a)-LRx. This medicine was recently granted Fast Track Designation by the US Food and Drug Administration, underscoring the significant unmet medical need of patients with Lp(a)-driven cardiovascular disease. The Phase III HORIZON study is a 7,500 patient cardiovascular outcomes trial and it's up and running with Novartis and is progressing well. The trial readout is currently expected in 2024. Novartis is heavily invested in this program and in its success.

Turning to vupanorsen, which is partnered with Pfizer. Earlier in the year we announced positive top-line results from the Phase II study in a population of the patients with hypertriglyceridemia, type two diabetes and non-alcoholic fatty liver disease or NAFLD. The Phase II data will be presented at a medical congress this summer. Given the results of this study we see a lot of potential for this medicine. The program has advanced toward the Phase IIb starts that will be led by Pfizer.

Finally AKCEA-APOCIII-LRx, which we are also very excited about, in January we announced positive top-line results from the Phase II study of AKCEA-APOCIII-LRx in the treatment of patients with hypertriglyceridemia who are at risk for or who have established cardiovascular disease. A more detailed data for this medicine will be presented at a medical congress this summer. We are on track to begin a Phase III study in FCS later this year, the patient community and in market we know very well. We're committed to investing heavily in this medicine and we're also exploring the potential for use in other rare and broad disease indications.

Overall, with our pipeline AKCEA-TTR-LRx and AKCEA-APO(a)-LRx have begun Phase III studies. AKCEA-APOCIII-LRx is moving to Phase III and vupanorsen is advancing into Phase IIb. The consistent performance across our LICA programs in terms of efficacy, safety and tolerability further validate the advantages of the next generation LICA technology platform.

I'll now turn it over to Mike to discuss our financials.

Michael D. Price -- Executive Vice President, Chief Financial Officer

Thanks, Damien, and good afternoon, everyone. It's a pleasure to be a part of the team here at Akcea, and I look forward to meeting everyone soon. In the second quarter, we had total revenues of $22 million. The revenues include $16 million of commercial product sales from TEGSEDI and WAYLIVRA, which is an increase of 66% year-over-year, and an increase of 8% on a sequential basis. Research and development and license revenue under our collaborative agreements, totaled $6 million in the second quarter. Combined operating expenses were $57 million. We had an operating loss of $35 million. And we ended the second quarter with a net loss of $33 million, all on a non-GAAP basis.

We had a net loss of $0.49 per basic and diluted share of common stock owned by both Ionis and other shareholders. And we look forward to continued growth as we continue to launch both commercial medicines in additional countries this year. We ended the quarter with $390 million of cash and short-term investments and with our strong balance sheet, we are well positioned to execute on our current strategic objectives and our vision for the future.

I'll now turn the call back over to Damien.

Damien McDevitt, Ph.D. -- Chief Executive Officer

Thank you, Mike. To wrap up, we executed well in the second quarter. We achieved important commercial milestones and continue to see revenue growth with TEGSEDI and WAYLIVRA, we further advanced our broad pipeline of transformational medicines, and we strengthened our management team. We have life changing medicines that we believe can have a significant impact on patients who are currently underserved. We look forward to presenting the Phase II Pulp of data for both vupanorsen and AKCEA-APOCIII-LRx at an upcoming medical congress.

With additional country launches on the horizon for TEGSEDI and WAYLIVRA, the commitment from Ionis potentially license additional these medicines that are complementary to our pipeline and capabilities. And with our impressive additions to the management team, we are very excited about the future of our company. I want to close by thanking all of our employees, patients, caregivers and advocates for their shared dedication to advancing and supporting new therapies in serious and rare diseases.

I'll now open up the line for questions.

Questions and Answers:

Operator

We will now begin the question-and-answer session. [Operator Instructions] And our first question will come from Chad Messer with Needham & Co. Please go ahead.

Chad Messer -- Needham and Company -- Analyst

Great. Good afternoon and thanks for taking my questions. If you could just start with diving a little bit deeper here on me Pfizer's plans with vupanorsen, and I probably just picture that. But the Phase II dose ranging, is that specifically going to look at higher doses? I think I remember from the data back in January that did comment that the safety profile would potentially support looking at higher doses, and there might have been some interest. And then when you say that the focus of Phase III development is going to be on severe hypertriglyceridemia and CV outcomes, is that, I mean, should I think of that as sort of guidance toward doing CV outcomes trial in that patient population? Or is there, look, may be other studies and things that would be of interest?

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes. Thanks, Chad. Thanks for the question. It's Damien here. And it's -- vupanorsen is a mouthful. So look, we're obviously very excited about this program and the targets -- genetically validated target, and the Phase II data was excellent. The study met its primary endpoint and multiple secondaries. And we are very pleased with the clear evidence of reduction of risk factors for cardiovascular disease. There were no reductions in liver fat or hemoglobin A1C.

And yes, also it was very well tolerated and very favorable safety, tolerability profile, so very excited about the program. Pfizer have talked about advancing the program now, which is the Phase IIb dose-ranging study. And the objective of this study is to identify the right dose for Phase III. And so that's great. We've been sort of helping them take through that. They have not sort of -- we haven't disclosed the dose range of doses that we're trying to look at it in the Phase IIb study. I think that sort of information will come in due course.

Chad Messer -- Needham and Company -- Analyst

Okay. Fair enough. Can you remind me what doses have already been looked at?

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes. So I think I can come back to you on that, but it's sort of in the 50 milligram to 80 milligram range, is my recollection. But I'll come back to you on that, if that's incorrect.

Chad Messer -- Needham and Company -- Analyst

I'm sure I can find it too. And then just on TEGSEDI, there were comments that testing -- the genetic testing sort of slowed in the second quarter. Just wanted to confirm, I presume that was COVID-related. And was wondering if, as we've seen with a lot of sort of return to normalcy among people seeking care of all sorts, whether that trended higher at the end of the second quarter into the third quarter or not?

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes. So that was COVID-related. And as you can imagine patients staying at home and not going to physicians and not going to get genetic tested. So the decrease was due to COVID-19. I'll hand it over to Kyle give some more information about that.

Kyle Jenne -- Chief Commercial Officer

Yes, Chad. Good afternoon and thanks for the question. The short answer is yes, it was COVID-related. We did see a bounce back at the end of Q2, and we've seen it pick up as well here as we've kicked off Q3. But we're continuing to that program to identify positive patients. And obviously then be able to connect with the physicians, provide the right education and help support those patients transition on the TEGSEDI, if and when appropriate as the physicians and patients choose to do so. So very encouraged by, hopefully the state's opening back up and the ability for patients to get in and see their physicians can be treated for hATTR.

Chad Messer -- Needham and Company -- Analyst

Yes, great. That makes a lot of sense to me. I saw doctors for the first time in June myself. All right. Congratulations on the quarter and thanks for the update.

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes. Thank you, Chad.

Operator

Our next question will come from Jamison Crone with BMO Capital. Please go ahead.

Jamison Crone -- BMO Capital -- Analyst

Thanks for taking our questions, and congrats on the progress. So a question on APOCIII and your pivotal FCS study. When do you expect to release the study design and protocol? And where do you anticipate the majority of clinical sites will be located and the geographic mix of patients, US versus back to US? And a follow-up to that is how should we be thinking about that study potentially taking away patients from WAYLIVRA? Thanks.

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes. Thank you, Jamison for the question. Again APOCIII, I'm very excited about the program. This is in the target -- it is an independent risk factor for cardiovascular disease. The study met its primary endpoints with robust triglyceride lowering. 90% of patients reached normal triglyceride levels below 150 meet the best leader in the study at the highest monthly dose of 50 megs per month. And the study also met its multiple secondary and exploratory endpoints, and also very favorable safety and tolerability profile. So it's a really good lucky medicine. We're very excited about it. And we plan to invest heavily in this medicine.

In terms of the protocol, so finalizing the protocol. And our goal plan is still to start the Phase III this year. I will share with you the details of the protocol later on the year. I think in terms of sites, it's a mix of sites, US and European sites. I can get back to you with sort of more detailed information about that. And, absolutely, eventually, we see this as a next -- we think in terms of franchises here. So WAYLIVRA is the commercial product, doing well in the marketplace.

And with time of the next-generation medicine comes through APOCIII, in the 2023-2024 time frame, we see patients moving over from WAYLIVRA to APOCIII like FCS patients, because it's going to be a stronger medicine in terms of lower dose, lower dosing frequency. So most likely it will be a low-dose -- once-a-month low-dose volume and very clean from safety perspective is our hope. And so we would expect to see patients move over when APOCIII gets approved for this patient population.

Jamison Crone -- BMO Capital -- Analyst

Great. Thanks for the update. And congrats again on all the progress.

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes. Thanks a lot, Jamison.

Operator

Our next question will come from Jim Birchenough with Wells Fargo Securities. Please go ahead.

Nick -- Wells Fargo Securities -- Analyst

Good afternoon. It's Nick [Phonetic] on for Jim this afternoon. First question, would you be willing to split out the sales between the two drugs?

Damien McDevitt, Ph.D. -- Chief Executive Officer

Hi, Nick. Nice to talk to you again. We are not splitting out the sales to medicines at this point.

Nick -- Wells Fargo Securities -- Analyst

Okay. Let me try another. How about in terms of specifically for TEGSEDI then US, EU new starts [Indecipherable] switches?

Damien McDevitt, Ph.D. -- Chief Executive Officer

No. I'm very consistent. We are still not splitting out. Yes, yes.

Nick -- Wells Fargo Securities -- Analyst

Let's go for three now is going to a row here. So, you mentioned in your prepared comments you have patients on EAP and you're transitioning those on to commercial drug. Do you have a timeline for that? And what the impact could be on sales in terms of patient numbers that are on the EAP programs in Europe?

Damien McDevitt, Ph.D. -- Chief Executive Officer

For WAYLIVRA, you're asking about or for TEGSEDI?

Nick -- Wells Fargo Securities -- Analyst

TEGSEDI.

Damien McDevitt, Ph.D. -- Chief Executive Officer

TEGSEDI. Yes, so in most countries we have patients on EIP programs, for example, in Portugal we have many patients -- Portuguese patients on the EIP, and so now that we've got pricing reimbursement in Portugal. We are starting to see these patients move over to commercial medicine. And so that's going to be the same in Italy and Spain where we also just recently received pricing reimbursement as well. Kyle would you like to add anything to those comments?

Kyle Jenne -- Chief Commercial Officer

Yes, just a couple of quick comments around it. It's going to take a little bit of time as you would expect. It's depending upon country in terms of how that process will unfold. Sometimes you have to get region-specific hospitals in line and things like that. So we anticipate it -- it's already started by the way so the really good news is we're already seeing commercial revenues in July, coming out of Spain and Portugal and Italy, for example, growth in the UK and Germany and Canada. So we're seeing a lot of progress already.

But in the Southern Europe countries, we anticipate it will probably take a couple of months so on into probably mid-Q4 -- mid to end of Q4 before we finalize all of those transitions of patients. But keep in mind, not only are we focused on the existing patients that are being treated, but we're also identifying new patients and trying to make sure that any and all patients that need access to TEGSEDI and WAYLIVRA in Europe have access to it. So it's kind of a dual path that we are focused on, not only with the EAP, but also with new patients as they are identified.

Nick -- Wells Fargo Securities -- Analyst

Okay. And then, just last one for me. In terms of the NEURO study for TTR LICA, presumably, there was a patient who would be eligible for commercial TEGSEDI. So are you -- is there any impact as you're seeing on commercial sales by patients going onto the trial?

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes, it's the same patient population hereditary -- for hereditary patients, hATTR polyneuropathy, symptoms of polyneuropathy. So it is a similar patient population. The study of 140 patients, 120 will go on AKCEA-TTR-LRx 20 will go onto inotersen randomized six to one as we've described before. So yes, I mean that they are competing commercial patients with clinical trial patients, that is true. But TEGSEDI is here and now, it's on the market. It's available. It's doing well. And it's up to physicians and patients to make a choice between one of two options that we're providing both TEGSEDI that's available commercially or to go on the clinical trial if they're eligible for the trial.

Nick -- Wells Fargo Securities -- Analyst

Okay, great. Thank you very much.

Operator

And our next question will come from Paul Matteis with Stifel. Please go ahead.

Alex -- Stifel -- Analyst

Hi, thanks for taking the question. This is Alex [Phonetic] on for Paul. Just a couple for us. I guess, first off, given your positive commentary around ROA specifically in the time of COVID. I'm curious if you would describe from a competitive perspective, whether they're not COVID is a headwind or a tailwind, and I guess qualitatively, are you seeing more switching than you had historically? And then second, I was wondering if you could give us a little bit more info on the timeline of the way we refiling in the US. I think last quarter you had mentioned that you are on track for this year. Just curious if your lack of timeline update this time is COVID-related or what's going on there? Thanks.

Damien McDevitt, Ph.D. -- Chief Executive Officer

Sure. Thanks, Alex, for the questions. Yes, so in terms of COVID-19 being a headwind or a tailwind for TEGSEDI sales, it's sort of certain netting itself out I would say. The advantages of TEGSEDI are clearly at-home subcutaneous therapy. And we have switches. And we're doing well competing for naive patients, and we've also seen combination use. So that's good. And however the patients are not going to the physicians or not getting genetic tested as Kyle mentioned. So they probably are netting themselves out of this point, but happy for Kyle to add in some additional commentary to that.

Kyle Jenne -- Chief Commercial Officer

Yes. Just a quick comment just around the growth. I mean, I was very pleased to see from Q1 to Q2 that we added new patients that we found new patients through our genetic testing program, and that we increased our net revenues quarter-over-quarter. And we've done that consistently since the launch of TEGSEDI. So while COVID is real and it's been a challenge and it had some limitations, I think that we're operating effectively through it. And we've been able to secure pricing reimbursement in some of these countries, which has allowed us to launch commercially in these countries sooner than what we had expected, especially in the face of some of the complexities. And overall, I think the execution of the team and the focus on the patient has really served us well. So it's great to see actually.

Damien McDevitt, Ph.D. -- Chief Executive Officer

And then, Alex, your second question was around WAYLIVRA, and our plans to refile. And I mentioned in the script that we had an encouraging meeting with the FDA in Spring. And based on this feedback, we're tracking the resubmission. And what we're adding this time is real world data. So that's exciting. We've got a lot of it now to add to these to refile. And we are conducting some procedural work to include this real word -- that real world data, longitudinal data. And so we're not going to declare the timing at this point. We'll keep you posted on the timing of the refile. But the important point here is that all of the data exists today. So we're filing on the basis of existing data. And we're just working today to sort of get the data collected and analyzed for the refile.

Alex -- Stifel -- Analyst

Great. Thank you.

Operator

Our next question will come from Yaron Werber with Cowen. Please go ahead.

Yaron Werber -- Cowen -- Analyst

Yes, hi. So if you don't mind, I have a follow-up to the last question just on WAYLIVRA. The longitudinal data that you're looking to collect, can you give us a sense. Obviously, I would assume it's probably efficacy, but probably more relevant safety wise. Is this data that is in some kind of a registry that you have an access to or is this data, real world data from providers that you need to collect and analyze? And then I have a follow-up as well.

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes. Thanks, Yaron. Nice to catch up. So this is early access data. In the UK, we have an EAMS program, which is an early access program, where we have data from patients who have been on the medicine. And so we're excited about the data and it's -- we're collecting it now and analyzing, as I mentioned.

Yaron Werber -- Cowen -- Analyst

And is there a certain amount of follow up that you need from patients, let's call it a year or so? Or is it just collecting data from as many patients as you can or certain number of patients' kind of best effort based on what's available in submitting that?

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes. So, it's collecting data -- the existing data from patients and we've done a cut-off of the data. So now it's just collecting the data. And, of course, there is -- compared to the original filing, there is additional time that the patients have been on therapy. And there's also additional data looking back over the treatment of the patients. So it's a definitely a stronger package of data that will be submitted here.

Yaron Werber -- Cowen -- Analyst

Okay, great. And just a quick question on APO(a) with Novartis, the horizon Phase III. Can you just remind us the powering for the primary endpoint? And are there any interims along the way, interim looks? Thank you.

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes. So there is an interim time point for this study, and that Novartis has mentioned, and so that's great. In terms of the hiring for the study, I'm going to ask it back to you on that. We will follow-up. I don't have it off of the top of my head, anybody on the team on this call has it either. No. So we'll follow up Yaron on that.

Yaron Werber -- Cowen -- Analyst

Thank you.

Damien McDevitt, Ph.D. -- Chief Executive Officer

Yes. No. Appreciate questions.

Operator

[Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to Damien McDevitt for any closing remarks. Please go ahead, sir.

Damien McDevitt, Ph.D. -- Chief Executive Officer

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 everybody.

Operator

[Operator Closing Remarks]

Duration: 42 minutes

Call participants:

Angelyn Lowe -- Executive Director, Corporate Communications and Investor Relations

Damien McDevitt, Ph.D. -- Chief Executive Officer

Kyle Jenne -- Chief Commercial Officer

Michael D. Price -- Executive Vice President, Chief Financial Officer

Chad Messer -- Needham and Company -- Analyst

Jamison Crone -- BMO Capital -- Analyst

Nick -- Wells Fargo Securities -- Analyst

Alex -- Stifel -- Analyst

Yaron Werber -- Cowen -- Analyst

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