Akcea Therapeutics, Inc. (NASDAQ:AKCA) Q4 2019 Earnings Conference Call February 25, 2020 4:30 PM ET
Company Participants
Kathleen Gallagher – VP of Corporate Communications and IR
Damien McDevitt – Interim Chief Executive Officer
Mike MacLean – Chief Financial Officer
Kyle Jenne – Chief Commercial Officer
Alex Howarth – Chief Operating Officer
Conference Call Participants
Chad Messer – Needham & Company
Nick Abbott – Wells Fargo Securities
Nate Tower – Stifel
Operator
Good afternoon, and welcome to the Akcea Therapeutics Fourth Quarter and Full Year 2019 Conference Call. As a reminder, this call is being recorded.
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
Thank you, Katrina. 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; Kyle Jenne; our Chief Commercial Officer and Alex Howarth, our Chief Operating 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 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 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
Thank you, Kath. Good afternoon everyone, and thank you joining today’s call. I would like to start the call by I’d like to start the call by highlighting our achievements for 2019 and our plans for 2020. After that, Kyle will discuss our commercial efforts and Mike will discuss our financials. I will wrap up with some comments on the pipeline and provide a closing thoughts as we look ahead to 2020.
2019 was a special year for Akcea as we continue to advance from delivering transformative treatments to control living with us and rare diseases. We ended the year with $464 million of cash on the balance sheet putting us in a strong position to execute on our strategic priorities for 2020 and beyond. Our focus in 2019 was on the 2-2-2 plan, two commercial products, two Phase 3 programs and two medicines nearing Phase 2 data. I am happy to achieve this plan and exceeded it with our two positive Phase 2 data readouts.
Let’s start with our two commercial products TEGSEDI and WAYLIVRA. We generated $42 million in product revenue in 2019. TEGSEDI is commercially available in over 10 countries and WAYLIVRA is approved in Europe and is commercially available in Germany.
We are pleased with the progress we have already made and we expect to continue to expand our launch for both products in additional countries in 2020. Kyle will provide more details later on the call.
Our Phase III studies are initiated and enrolling for AKCEA-TTR-LRx for both the CARIO-TTRansform and NEURO-TTRansform studies in patients with TTR-mediated amyloid cardiomyopathy and polyneuropathy. These studies expand our commitment to the TTR community and we are seeing a lot of enthusiasm from the physician and patient communities for this new therapy from a broadly addressed TTR amyloidosis.
In addition, we are pleased that Novartis was able to rapidly initiate their AKCEA-APO(a)-LRx Phase 3 study in patients with LPA-driven heart disease. Novartis is also administrating medication to patients in this study and with its potential first-in-class mobile cardiovascular therapy there is a tremendous amount of interest in the program.
To close out 2-2-2 initiatives, we reported positive Phase 2 results for both AKCEA AKCEA-APOCIII-RX and AKCEA-ANGPTL-LRx. With the completion of these two studies we now have data from over 1100 people treated in a clinical setting with LICA medicines to-date, over 500 of whom are from the Akcea pipeline. Of those 1100, a substantial amount of patients have been treated for one year. We are consistently seeing positive efficacy, safety and tolerability across the LICA platform.
Another important highlight from 2019 was our successful expansion of our strategic partnerships. In addition to Novartis’ license of AKCEA-APO(a)-LRx at the beginning of the year, in the third quarter, we entered into a partnership with Pfizer for AKCEA-ANGPTL3-LRx. We chose these partners for their ability to accelerate the development and the commercialization of these two important medicines and their investment in the life of technologies could have a significantly impact on these large patient communities.
We also announced that we retained the rights of AKCEA-APOCIII-LRx. We are thrilled to now be able to drive the developments and commercialization strategy for this medicine. We plan to focus our efforts on developing AKCEA-APOCIII-LRx for FCS, initiating a Phase III study this year, as well as evaluating other indications that could be positively impacted by reducing APOCIII and triglycerides.
As we look to 2020 and beyond, our strategy is to successfully execute on our two commercial launches, and to progress the transformational programs that we currently have in developments. In particular, we plan to aggressively pursue development of AKCEA-APOCIII-LRx in FCS while also adding additional rare disease medicines to our pipeline both from Ionis and from third-parties.
Critical to our strategy is ensuring that we have a strong team in place. On the third quarter call, I announced that we promoted Kyle Jenne to Chief Commercial Officer. In December we added another key leader to the executive team. We announced that Alex Howarth joined as Chief Operating Officer overseeing a broad range of operational areas including, corporate strategy, business developments, alliance management, legal and compliance and product supply chain.
In addition, we announced the appointments of Lynne Parshall as Chair of the Akcea Board of Directors as well as the addition of Barbara Yanni and Amber Saltzman new members of the Board. As we build on the strength of the existing leadership team and Board of Directors, we have a strong foundation in place to execute on our strategy and drive our company’s growth.
Looking ahead, we are excited about the number of upcoming milestones in 2020. We anticipate additional WAYLIVRA and TEGSEDI launches throughout the year. For WAYLIVRA in the U.S., our goal is to refile and we hope to provide an update on this in the coming months.
For the pipeline, we anticipate sharing more detailed development plans for AKCEA-APOCIII-LRx as we look to initiate the Phase III study for FCS this year. We will also be presenting the Phase II data for both AKCEA-APOCIII-LRx and AKCEA-ANGPTL3-LRx later this year.
Furthermore, we continue to closely collaborate with Ionis to identify and potentially license on novel rare disease medicine from their wholly-owned pipeline and to search for potential third-party medicines that complements our rare disease focus and capabilities.
With that, I’ll now turn the call over to Kyle to discuss our commercial efforts in further detail.
Kyle Jenne
Thank you, Damien, and good afternoon, everyone. We continue to make steady progress with our two commercial products TEGSEDI and WAYLIVRA. 2019 was a productive year for our team. TEGSEDI is commercially available in over ten countries. In North America, our focus was on launching TEGSEDI, while our team in Europe was launching TEGSEDI and WAYLIVRA.
2019 was about physician education, patient finding market access and rolling out the Akcea Connect program internationally. We built a strong foundation for both commercial products as we entered 2020. Of the $42 million of total product revenue Damien mentioned earlier, $14 million was generated in Q4, a 15% increase from Q3 which is a continuation of the steady quarter-over-quarter growth we saw throughout 2019.
Let’s start with our progress with TEGSEDI in the U.S. I am very pleased with the growth that we saw from Q3 to Q4 in TEGSEDI new patient starts. In addition, we achieved a 42% increase in new prescribing physicians. TEGSEDI has positive momentum in the U.S. market and we continue to see a mix of cardiology, neurology and hematology prescribing physicians in both the academic and community setting.
We are encouraged that physicians who have experience with TEGSEDI are continuing to prescribe it and that physicians who are new to TEGSEDI are choosing TEGSEDI over other options for their patients. We saw a 17% increase in units shipped to U.S. patients in Q4 over the prior quarter. We attribute this growth to the team’s continued execution and to our strategic approach of focusing on a balance between the amyloidosis centers and community-based physicians.
One thing I am very pleased with is how we are competing when it comes to prescribers choosing TEGSEDI for newly diagnosed patients. We see prescribers choosing TEGSEDI for the polyneuropathy of hATTR for newly diagnosed patients over other medicines based on the benefits of efficacy and the ability to self inject outside of a medical facility and we see patients choosing to switch to TEGSEDI.
In addition, we see physicians prescribing TEGSEDI in combination with other medicines. Our success in finding new patients and bringing them on to TEGSEDI is impart due to our execution of the hATTR Compass genetic testing program. We now have over 1400 physicians using hATTR Compass.
Physicians are excited to diagnose locally with hATTR Compass, rather than having to send a patient to an academic center and to treat patients locally with TEGSEDI.
The convenience of local diagnosis and treatment is also a benefit for patients experiencing the debilitating symptoms of autonomic neuropathy, which makes travel difficult for patients and for their caregivers. Once patients are being treated with TEGSEDI, Akcea Connect is there to provide high levels of support to patients.
Patients are able to realize the benefits of the program and are doing well on therapy which we attribute in part to the individualized support that the field-based Akcea Connect team provides. We continue to hear very positive feedback around their experiences with Akcea Connect, which is an international program across all commercial geographies.
From a market access standpoint, today we have 94% of total U.S. commercial lives covered for TEGSEDI. Not only do we have coverage for TEGSEDI today, but our contracting efforts are going extremely well and we have negotiated long-term coverage that secures 75% of commercial lives through the year 2023.
Outside of the U.S., we continue to work toward reimbursement in additional countries. In Canada, we received a positive listing recommendation from both Health Technology Assessment or HTA bodies. We have initiated provincial negotiations and have shipped commercial products. We continue to engage with physician and patient groups across Europe and Canada.
Last month in Portugal, which has one of the largest populations of patients with hATTR, we sponsored an hATTR EU preceptorship program, which provided physicians with an opportunity to connect with clinicians from different specialties and to learn best practices for managing patients diagnosed with hATTR amyloidosis with polyneuropathy.
In addition, last quarter, we hosted an hATTR Southern Europe Summit in Rome, where international experts stressed the importance of early diagnosis of polyneuropathy, differential diagnosis, and involvement in the management of patient by multiple specialists. We continue to roll out TEGSEDI across Europe and look forward to launching in additional countries throughout the year.
Finally, PTC Therapeutics is launching in Brazil and continues to work toward access in additional Latin American countries. Overall with TEGSEDI, we continue to be optimistic about the steady progress we are making and the momentum we are seeing in terms of new patient starts, as well as the breadth and depth of physicians prescribing TEGSEDI.
Turning to WAYLIVRA, as you remember, we launched WAYLIVRA in Germany at the end of Q3 and we are continuing to enroll patients in our ATU in France, which is a reimbursed early access program. As we continue to broaden the launch for WAYLIVRA into additional countries, it’s important to remember that while there are no endemic populations in Europe, there are countries that have larger populations than others.
So, while there are not many people living with the FCS in Germany, there are larger number of people with FCS in France and the U.K. Our team is focused on disease education, patient finding, and securing market access as we follow the typical launch sequence in Europe.
In the U.K., we are in the early stages of our process to secure reimbursement with NICE. NICE issued an evaluation and consultation document or ECD that did not recommend WAYLIVRA, which is not unusual at this stage of the process. We went through a very similar process with TEGSEDI, which was eventually recommended.
We are committed to continuing discussions with NICE and with the HTA bodies across Europe, as we are working to bring this only approved treatment to people living with FCS.
Beyond Europe, the PTC team continues to work to provide access to WAYLIVRA to patients across Latin America and are working toward approval for WAYLIVRA in Brazil by the end of this year. Our team is working diligently as we execute on both the TEGSEDI and WAYLIVRA launches and we look forward to keeping you updated on our progress.
I’ll now turn the call over to Mike to discuss our financials.
Mike MacLean
Thank you, Kyle. In 2019, we had total revenue of approximately $489 million, including approximately $42 million in product revenue, and $436 million in revenue from collaborations. For the year, we had operating income of approximately $75 million on a non-GAAP basis, including non-GAAP operating expenses of $413 million.
In addition, higher revenue is driven by the Novartis option exercise for the license of AKCEA-APO(a)-LRx and the Pfizer license of AKCEA-ANGPTL3-LRx resulted in net income on a GAAP and non-GAAP basis for the year.
As we discussed on our last earnings call, we generated a substantial upfront payment of $250 million when we licensed AKCEA-ANGPTL3-LRx to Pfizer. We recognized almost the entirety of this payment as revenue in the fourth quarter.
We split all economics of this arrangement 50:50 with Ionis and settled our obligation to Ionis for half of the upfront payment with 6.9 million shares of Akcea common stock. In addition, PTC announced in October that they received approval for TEGSEDI in Brazil.
With the approval, we earned $4 million milestone, which was recognized during the fourth quarter. 60% of that amount went to Ionis per the terms of our profit share agreement.
Product revenues relates to our sales of TEGSEDI and WAYLIVRA. TEGSEDI has been approved in the U.S., Canada and EU since 2018, and WAYLIVRA is only approved in the EU since Q2 of this year. Specifically, WAYLIVRA has only been sold commercially in Germany thus far, starting late in Q3. Therefore, the preponderance of our product revenues come from sales of TEGSEDI.
Our product revenues of $14 million in the fourth quarter represent a 15% increase over the third quarter, driven by the expansion and penetration uptake setting and the launch of WAYLIVRA in Germany. We ended the year with approximately $164 million in cash and short-term investments. With our substantial liquidity, we are well positioned to continue to run our business and potentially broaden our pipeline.
I’ll now turn the call over to Damien.
Damien McDevitt
Thank you, Mike. Let me begin with the two positive data readouts that were recently announced for AKCEA-APOCIII-LRx and AKCEA-ANGPTL3-LRx. In January, we announced positive top-line results from the Phase 2 study of AKCEA-APOCIII-LRx in the treatment of patients with hypertriglyceridemia, who are at risk for or have established cardiovascular disease. We met the primary endpoint triglyceride lowering, as well as multiple secondary endpoints.
At the highest monthly dose, we saw more than 90% of patients reach triglyceride levels below the recognized threshold for cardiovascular risk, which is 150 mgs per deciliter. AKCEA-APOCIII-LRx also had a favorable safety and tolerability profile. The most common adverse events were injection site reactions, which were mostly mild and infrequent.
Importantly for AKCEA-APOCIII-LRx and for the broader LICA platform, there were no safety signals. We plan to present a more detailed top-line data at a conference later in the year. These data are very encouraging as we finalize our plans to rapidly start a Phase 3 study in FCS this year in markets and patient community we know really well.
We plan to share a more detailed development plans for FCS later this year and we are also looking at other indications in rare and common diseases associated with elevated triglycerides.
Next, let’s turn to AKCEA-ANGPTL3-LRx, which is partnered with Pfizer. We announced positive top-line results from the Phase 2 study in a population of patients with hypertriglyceridemia, Type-2 diabetes, and non-alcoholic fatty liver disease or NAFLD.
We met the primary endpoints, triglyceride lowering, as well as significant reductions in additional lipid parameters and ANGPTL3. While we did not see reductions in liver fat or hemoglobin A1c, we are pleased with the clear evidence of cardiovascular risk modification.
From a safety standpoint, AKCEA-ANGPTL3-LRx was generally well-tolerated with the favorable safety and tolerability profile. Again, the most common adverse event was injection site reactions, which were mostly mild. We plan to present detailed results at a future medical congress.
Given the results of this study, we see a lot of potential for AKCEA-ANGPTL3-LRx in treating cardiovascular disease and we are now working with Pfizer to design the best development path for this medicine.
Both Phase 2 studies further validate the advantages of the LICA technology platform for large indications like cardiovascular disease. We are pleased that we continue to see consistent performance across our LICA programs in terms of efficacy, safety and patient tolerability.
Moving to AKCEA-TTR-LRx, the CARDIO-TTRansform and NEURO-TTRransform Phase 3 studies, are under way in patients with both the hereditary and wild-type forms of TTR amyloidosis. This represents another important milestone and further demonstrating Akcea and Ionis’ commitment to bring new treatment options for patients around the world living with TTR amyloidosis or ATTR.
Both the wild-type and hereditary forms of ATTR are under-diagnosed and stable with little bit treatment options available. After talking to experts, we believe that TTR lowering has potential to be more impactful for patients suffering from ATTR than current treatments, which stabilize the protein.
We continue to build on our established expertise in this area and we are expanding our commitment to the TTR community. We remain very encouraged by the progress of our clinical studies with AKCEA-TTR-LRx thus far, and look forward to working with our team of outstanding global investigators to continue to advance this clinical program in the months ahead.
Finally, the AKCEA-APO(a)-LRx Phase 3 Lp(a)HORIZON study is up and running with Novartis and the first patients have been treated. Novartis continues to be a great partner and they are heavily invested in this program and in its success.
To wrap up, we had a successful 2019. We achieved our 2-2-2 plan, further advanced our broad pipeline of products, and strengthened our management team and Board of Directors. We have a set of life-changing medicines that we believe can have a significant impact on patients who are currently underserved.
The positive results from AKCEA-APOCIII-LRx and AKCEA-ANGPTL3-LRx are the latest in the series of data readouts that continue to support the commercial potential of the LICA technology platform. With launches in additional countries on the horizon for TEGSEDI and WAYLIVRA, the commitment from Ionis to potentially license those additional rare disease medicines that are complementary to our pipeline and capabilities, Akcea is well positioned in 2020 and beyond.
We will be celebrating Rare Disease Day on Friday. I want to close by thanking all of our employees, patients, caregivers, and advocates in the rare disease community for their shared dedication to advancing and supporting new therapies in unaddressed diseases.
I’ll now open up the line for questions.
Question-and-Answer Session
Operator
[Operator Instructions] For the first question, we have Chad Messer from Needham. Chad, Your line is open.
Chad Messer
Great, thanks. Good evening. And thanks for taking my questions. Let me just start with WAYLIVRA. You said you made the decision to refile in the U.S. for FCS. I think that’s – I think that’s great. Can you maybe talk a little bit about what factors may have led you to or want to refile? And then also, how are you thinking about that drug versus in the APOC, which I presume is going to be a follow-on in a similar way to the TR program? Those two will be a couple of years apart, I think, and you’ll have one out there for patients and then try to get some on the LICA. But just wondering your thoughts about how to handle that.
And then, just one more on that, and that’s on FCL. You had positive data back in the summer. I know this is a less important indication for you to be talked about. But I am at least not aware of you ever formally saying you wouldn’t pursue it. So, I am just wondering what your plans are there.
Damien McDevitt
Okay. Thank you, Chad for the questions. Let me sort of restate the comment around refiling WAYLIVRA in the U.S. So that’s – our goal is to refile this year. That’s our goal. We – our discussions are continuing with the FDA and we are going to be providing an update in the coming months. So that’s WAYLIVRA.
APOCIII, we’re absolutely very excited about progressing that forward in the FCS patient population, also looking at other rare disease indications. We have a goal of starting Phase 3 in FCS by the end of the year and we’ll describe the study design and more information around that study as we – in the coming months, as well. In terms of FCL, we are still talking to our advisors, our KOLs and internally around sort of what’s the best path forward with that indication.
Chad Messer
All right. Great. Thanks. So, some stuff to stay tuned there. And then, just on TEGSEDI, you made some – what I took is very encouraging remarks about the market dynamic there. I mean, you guys are always very, very careful to be polite respectful of your competition, but reading between the lines, it sounds like you are seeing some news on top of Tafamidis and maybe some patients switching from ONPATTRO and maybe some encouraging signs for doctors choosing it over ONPATTRO for new patients.
Can you give us any idea even qualitatively, I mean, are there a lot of doctors out there that use both and want to try to decide between them based on patients? Or – and when you look at the different at a practitioner, a physician today, do they often choose one? I’ve talked to several docs myself. They are all aware of both. But I haven’t really gotten a sense of sort of in the market at large, how that’s playing out and how you can affect that dynamic?
Damien McDevitt
Yes, I am going to hand that question over to Kyle.
Kyle Jenne
Yes. Thanks, Chad. I appreciate the question and the first thing I’ll say about competing in the market right now is we are very pleased with our performance and the progress that we’ve made. We’ve got our focus on new patient starts. So patients that are actually naïve to therapy. That’s really who we want to bring the drug to, to begin with.
I believe that that is where we are going to win this battle over time is with the naïve patient population. Keeping in mind that a lot of these patients with hereditary forms of the disease and polyneuropathy, they, number one aren’t even aware that they have the disease until we go out and educate the physician community and then get them diagnosed through our Compass Genetic Testing program.
And number two, then they have to be aware of the benefits of TEGSEDI being a subcu self-inject, as well as an effective product with a manageable safety profile in order to get them initiated on therapy. In terms of use with other therapies, obviously, we will see patients moving from other therapies over to TEGSEDI. And we are seeing, as I mentioned, TEGSEDI being used with other medicines.
So, overall, I think it’s kind of – there are variables in the marketplace right now. But we are really focused on winning that battle with naïve patients in the market.
Chad Messer
Okay, all right. Great. Thank you.
Operator
For the next question, we have Jim Birchenough from Wells Fargo. The line is open.
Nick Abbott
Good afternoon. It’s Nick on for Jim this afternoon and thanks for taking our questions. First one, Damien is for APOCIII-LRx. Obviously, Novartis passed on this. There are some large pharma indications i.e., called the common indications. What is the current strategy for how you might address those? And then, I have a follow-up.
Damien McDevitt
Yes. Thanks, Nick. Thanks for the question. So, we’re really excited about the data that came out in the Phase 2 and clearly the medicine has got potential, not just in rare disease indications, but also big disease indications, because of the profile that we are seeing with significant reductions, not just in APOCIII and triglycerides, but also additional lipid parameters, including the LDL-C and remnant cholesterol. And also, we are seeing increase in very high-density lipoprotein as well, which is really exciting.
So, it’s a very, very exciting medicine and we are focused on trying to understand what indications we could use the medicine for. We’ve made a decision on FCS. So, we are going to move forward with Phase 3 in FCS. But we are also thinking about bigger disease indications and the teams are working through that right now.
And it’s clearly got potential beyond the rare disease indications, but it’s just going to take a few months here to figure out the best course of action for the big disease indications.
Nick Abbott
And just a follow-up Damien, I mean, after Novartis declined, was there an increased level of interest from other potential partners? Or are you waiting to the time we did the program, it looks like before you seek additional partnership opportunities?
Damien McDevitt
Yes. No, I mean, it’s been a lot of interest in the program since Novartis decided not to exercise their option and when folks have seen the data, as well. And so, we are still at the early stages of figuring out what to do there. But there has been a lot of interest.
Nick Abbott
Thanks. And then, in terms of some of the comments for expanding the pipeline, is there a particular target or a particular compound within the Ionis pipeline that you are very desirous of or are you just going to be looking to see what’s the best fit? And then, outside of Novartis, what are you thinking of absolute not be amenable to 9% plus strategy, given the level of expertise within the company and the predictability of development now of LICA conjugates?
Damien McDevitt
Yes. So, on your first question, we are working closely with Ionis on trying to determine medicines that would be most appropriate for Akcea’s interest and capabilities. And there are a number of medicines. Obviously, you are familiar with that pipeline. There is a number of medicines that would fit very well into Akcea and our focus as a rare diseases company.
And it’s too early to say what exactly those medicines will be. We will provide you some more information in due course.
In terms of additional third-party medicines, we are keeping an open mind. Obviously, we are sort of modality-agnostic. It doesn’t have to be an antisense oligonucleotide, but really it has to fit into our capabilities and expertise for to make sense for Akcea. And so, we are keeping an open mind and we continue to look for potential additional assets.
What I would say is that, they would be later-stage assets rather than sort of early-stage, pre-clinical or early-stage clinical. And they are probably too far away for us to be very interested in them. So we are looking at Phase 3 or close to approval or even approved medicines.
Nick Abbott
It’s very helpful. Thanks, Damien.
Damien McDevitt
Yes. You are welcome.
Operator
[Operator Instructions] We have a question from Paul Matteis from Stifel. Your line is open.
Nate Tower
Hey guys. Thanks for taking the question. This is Nate on for Paul. Maybe just two from me. Firstly, on FCS, can you just talk about how big that market is, first versus prevalence? And then, second on, you’ve been approaching the market for a while, how many patients are identified out there today?
And then just secondly, I know you can’t provide guidance on TEGSEDI, but how are you thinking about what successful 2020 might look like for that drug? Thanks.
Damien McDevitt
Thank you, Nate, for the questions. On FCS, we believe that there are 3,000 patients to 5,000 patients and that number hasn’t changed. And of course, yes, we’ve identified patients that could be appropriate for WAYLIVRA in the U.S. and in Europe. And in terms of guidance for TEGSEDI 2020, we are not giving guidance out for TEGSEDI for 2020. Thank you.
Operator
I am showing no further questions at this time. I would now like to turn the conference back to Mr. Damien McDevitt.
Damien McDevitt
Okay. Thank you for joining today. Akcea will be attending the upcoming conferences, the Cowen Annual Healthcare Conference next week and the Wells Fargo Biotech Corporate Access Day, as well as the Needham & Company Healthcare Conference, both which are in April. We invite you to visit us at these conferences or at our headquarters in Boston.
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 good afternoon.
Operator
Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation and have a wonderful day. You may all disconnect.
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