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Akcea Therapeutics, Inc.  (NASDAQ:AKCA)
Q4 2018 Earnings Conference Call
Feb. 26, 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 Fourth Quarter and Year-end 2018 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 -- Vice President of Corporate Communications and Investor Relations

Thank your, Ashley. Good afternoon, everyone, and thanks for joining us today. With me on today's call are Paula Soteropoulos, our Chief Executive Officer, Sarah Boyce, our President; Jeff Goldberg, our Chief Operating Officer; and Mike MacLean, our Chief Financial Officer. As a reminder, this conference call includes forward looking statements regarding the financial outlook for Akcea's business and the therapeutic and commercial potential of Akcea's products and developments.

Any statements describing Akcea's goals, expectations, financial or other projection, intentions or believe including the commercial potential of TEGSEDI, WAYLIVRA and our pipeline drug is a forward-looking statement and should be considered as 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 reflects the good 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 our GAAP to our reported non-GAAP financial measures that we will discuss today. To read this release and to keep up to date on our latest company news, please visit the Investor section of our website. Today, we also have slides to accompany our call. To access these slides and our press release, please visit the Investor section of our website.

Now I'll turn the call over to Paula.

Paula Soteropoulos -- Chief Executive Officer

Thank you, Kath. Good afternoon, everyone, and thank you for joining us this afternoon. Reflecting on 2018, what a pivotal year it was for Akcea with the approval and launch of TEGSEDI in the US, Germany and Canada. We are now a global commercial company. Our track record of execution, broad pipeline, strategic partnership with Novartis and our foundational relationship with Ionis, provide a solid base for our future. In April, we completed the TTR franchise agreement with Ionis and with that we expanded our focus beyond the cardiometabolic because of the specialized rare disease capabilities that we built in the first three years since the company's inception, we were able to rapidly launch TEGSEDI only six months after closing that TTR franchise agreement. We grew from about 90 employees to 250 and expanded our footprint from five countries to 12.

We have hired a driven team across the globe who have launched drugs before and now want the opportunity to do that in a more entrepreneurial environment which we are uniquely positioned to offer. TEGSEDI is an important drug for the TTR community and it is already the choice for many TTR patients. TEGSEDI is a drug with strong efficacy that allows patients the independents to treat themselves on their own terms. Physicians and patients are excited about TEGSEDI due to its impact on quality of life for patients with polyneuropathy associated with hATTR amyloidosis. Sarah will talk in more detail shortly, but we're very pleased with the launch so far.

We announced our Q4 financial results for TEGSEDI of $2.2 million in Q4 global product sales, which compares favorably with the Street consensus. And other important highlight from last year with our AKCEA-APO(a)-LRx, the longest and largest study to date using Ionis' LICA technology platform. These data as strong lowering of (inaudible) with convenient monthly dosing in a favorable safety and tolerability profile. We always APO(a) results and the consistency that we and Ionis have seen across all of them like the programs to date should read through to the product that are like a pipeline. This includes people like which are now in clinical development and allows us to expand our commitment to the TTR community including patients with (inaudible) type cardiomyopathy.

Novartis has exercised its option to license AKCEA-APO(a)-LRx referred to by Novartis as TQJ230 and will now bring important medicines for the cardiovascular community board and gives us important funding to continue to grow Akcea. Novartis is a global leader in cardiovascular drug development and commercialization and we believe we are the best partners to bring this present forward. This drug could positively impact millions of patients.

Basic planning and initiation activities are under way. Four years ago, we founded Akcea to be the trusted patients global company delivering innovative solutions that improve the lives of those affected by serious diseases. Based on the strong foundation from Ionis, we are well on our way to realizing that vision. We are of course focused on executing the TEGSEDI launch and moving our pipeline forward. But we are also thinking about what comes next. We will continue to build out our global infrastructure as we launched TEGSEDI in additional countries. We make those our own infrastructure in some countries and for others, we may choose strategic partnerships like minded patient focused company.

We chose to expedite our presence in Latin America and to bring this important drug to patients in need by partnering with PTC Therapeutics. Within a few months after signing our agreements, we have worked with PTC to file WAYLIVRA and have received priority review particularly in Brazil, a region with one of the largest populations of hATTR patients. Rare Disease Day is this week and we will be showing our support for -- and partnership with the rare community including those affected with all the diseases that we focus on. Take Mark for example, Mark noticed that he was not able to keep up with his athletic lifestyle, with long distance bike riding and swimming. He sought medical advice. He had some carpal tunnel neuropathy issues and GI (ph) issues which slowly worsened. Mark tested positive for hATTR, having been involved in a clinical trial, MArk was -- has been on TEGSEDI for four years and has now been able to return to his very active lifestyle, which includes swimming and a master swim program and continuing to work full time in the financial services practice.

We've been able to accomplish a lot since our founding. We're executing on our plan. We're delivering important therapy and we're making a difference already in the lives of patients with hATTR.

I'll now turn the call over to Sarah to speak about TEGSEDI and how our launch is progressing so far. Sarah?

Sarah Boyce -- President

Thank you, Paula. It is early days and I'm very pleased with how our launch is progressing. In the US TEGSEDI was approved on Friday, October 5th. We launched straight away resulting in our first patients receiving reimbursement and being on commercial drug just two months later in mid-December. In order for that first treatment to happen, we had to have a full infrastructure in place. Our supply chain was up and running and fully integrated with our specialty pharmacy Accredo.

We have treated naive patients as well as patients from our early access and Open Label Extension program. We have received reimbursement from both private and public payers. We believe this is due to the relationship building and outreach done by our market access team prior to launch and the fact that TEGSEDI is a self injectable. That makes it a straightforward drug for payers to administer under their pharmacy benefit and it does not require additional billing codes, but administration. We are in active dialogue with payers covering over 75% of life. The TEGSEDI message has resonated well and there have been commercial reimbursement from the top 10 payers. A key aspect of our launch and our patient centered approach is Akcea Connect, our drug treatment program, which help patients with every step of their journey. On thus case managers are specially trained to help get patients started on therapy including guiding patients and physicians through reimbursement support, creating a monitoring routine, but it's straightforward and simple. This talented team is all field based which allows them to work effectively with both patients and physicians, so they can provide the level of support needed. Our field team is calling on neurologists, hematologist and cardiologists. We are seeing prescriptions for patients with hATTR polyneuropathy coming from all three of these specialties.

Our team is actively updating physicians on the data that doctor gets presented from the TEGSEDI Open Label Extension program and an oral presentation late last year at the ASH meeting. Key takeaways from the presentation were, we've now treated patients for over five years. Importantly our OLE data underscores the urgency to start treating patients as treatment with TEGSEDI earlier leads to better outcomes a measures of neuropathy progression and quality of life. Long-term exposure resulted in continued efficacy. Patients who switch from placebo show disease stabilization after six months and no new safety concerns have been identified in the Open Label Extension study, platelet and renal monitoring were shown to be effective.

In addition to the data on our two co-primary endpoint, the data presented of ASH included details on the SF-36 quality of life survey from the NEURO-TTR study that breaks down what improvement looks like on TEGSEDI. We found that patients had significant improvement in day to day activities when on TEGSEDI. More patients were able to lift and carry groceries, walk several hundred yards, bath and dress themselves. We even saw patients taking less sick time from work. These simple things are major improvements for patients living with hATTR. There are 50,000 patients with hATTR worldwide, of those approximately 60% have symptoms of polyneuropathy. We continue to see that hATTR is often under diagnosed or misdiagnosed due to it systemic presentation. The diagnosis rate is 10% to 30%. What this means is that the typical patient journey is a long one and often requires seeing five or more physicians, take Lane for instance. Her father passed away due to hATTR. She watched him suffer and when she started to present with symptom cardiomyopathy, neuropathy, bilateral carpal tunnel, her physician told her even with her family history that she couldn't possibly have hATTR (inaudible).

To enable faster diagnosis, we've launched our hATTR Compass Genetic Testing program. To date nearly 500 patients have been diagnosed through hATTR Compass. Just recently, we shared a video showing Dr. Kayla of Pain Medicine partner with hATTR patient Angel and 27 of her family members who also got tested through the hATTR Compass program. We continue to see a very positive reception from the physician and patient community and we are excited to see it continue to grow.

In Europe, we have been treating patients on commercial drug in Germany since the first week of October. Again it's early days. We are -- but we are very happy with how things are going there. Most TTR patients that are treated in centers of excellence where we have been able to build great relationships, in the short time our German team has been on the ground. Our Akcea Connect program is up and running in Germany and we believe we are providing the highest level of patient and physicians support allowed. Our European launch will follow a traditional sequence as we continue to secure reimbursement in each country. We will update you on our progress as we move through the year.

In Canada, TEGSEDI is now available and is the first and only drug approved to treat polyneuropathy caused by hATTR amyloidosis. We are thrilled that Canadian patients and physicians have access to TEGSEDI as well as our Akcea Connect program.

As we look to potential for TEGSEDI beyond the US, EU and Canada, we are working closely with PTC Therapeutics. They announced earlier this year that they have filed for approval of TEGSEDI in Brazil and have received priority review. And of course, as Paula mentioned earlier, we are looking beyond these initial launches as we continue to build a deliver strategy for global patient access to TEGSEDI.

In closing, while early days, we are pleased with the launch so far. TEGSEDI is an important drug for the hATTR amyloidosis community. We have the patient -- the people, the system and the processes all in place to ensure that patients who need TEGSEDI have access to it.

Now over to Jeff.

Jeffrey M. Goldberg -- Chief Operating Officer

Thank you, Sarah. Let me start with a quick update on WAYLIVRA. Our process is ongoing in Europe and we're continuing our dialogue with the CHMP. In the US, we're working with the FDA getting clarity on next steps. One thing we know for sure is that this drug is very important to patients. The FCS community continues to speak out about the disease burden and the lack of treatment option. They just pick data from the ongoing study in patients with familial partial lipodystrophy or FPL in the middle of this year.

We continue to progress our pipeline, which is geared at serving rare and broad patient populations. We have four clinical stage novel therapies in development for multiple indications. All of our pipeline programs are based on Ionis LICA technology. Yesterday, we announced that Novartis has exercised its option to license AKCEA-APO(a)-LRx. This drug is being studied to treat patients with elevated levels of lipoprotein(a), or Lp(a) and established cardiovascular disease. This drug is potential game changer. The part of Phase II data were presented at AHA, where we showed that AKCEA-APO(a)-LRx significantly reduced Lp(a) levels below the recognized threshold for cardiovascular risk of 50 milligrams per deciliter.

We are incredibly pleased with the efficacy, safety and tolerability profile of this program. Novartis this decision further validates the exciting potential of this medicine and technology impact millions of lives. These data along with data from the other lipo programs that LRx Alcea have in development continue to show consistent efficacy, tolerability and safety profile and we believe read through all of the LIFO drug development. The other drug in our strategic collaboration with Novartis is AKCEA-APOCIII-LRx. As a reminder, APOCIII is an independent genetically validated risk factor for cardiovascular disease. Our Phase II study is ongoing and we anticipate data in the first half of 2020.

The target patient population includes individuals with hypertriglyceridemia and established cardiovascular disease. (inaudible) to be more than 8 million patients globally. Toward the process we just went through a (inaudible), Novartis will have the option to license the drug at completion of the Phase II activity. We're developing AKCEA-TTR-LRx to treat patients with hereditary and volanesorsen ATTR amyloidosis. Our Phase I/II study is ongoing and we expect data later on this year. We're currently in the process of designing the Phase III studies for both of these populations. The goal initiating the program this year.

And last but certainly not least in development is AKCEA-ANGPTL3-LRx. ANGPTL3 is a genetically validated target as a regulator of a number of metabolic parameter. We're very excited about ANGPTL3-LRx, a substantial drug for the WAYLIVRA space. We're currently running at 100 patients Phase II study in patients with NAFLD with metabolic

complications. Patients with WAYLIVRA also often have symptoms of hyperlipidemias. ANGPTL3 has a potential to impact all of these parameters makes it a very interesting target for the Nash base. We're taking data from the Phase II study in the first half of 2020.

To conclude. We're excited about the potential for a pipeline have a positive impact on patients with both rare and broad diseases. There's multiple upcoming milestones for 2019 2020.

Now I'll turn the call over to Mike to discuss the financials.

Mike MacLean -- Chief Financial Officer

Thank you, Jeff. With the launch of TEGSEDI, this is our first quarter reporting revenue from product set. While it is early in the launch, as Sarah has noted, we are pleased that many patients are choosing TEGSEDI. We expect that our European launch will follow a traditional sequence as they work diligently to secure reimbursement in the target country.

For 2018, we are reporting total revenue of $65 million and an operating loss of approximately $187 million on a non-GAAP basis. Including non-GAAP operating costs of $251 million. Our revenue include $2.2 million of product sales from TEGSEDI. We had a fourth quarter total revenue of $10 million and then operating loss of approximately $59 million on a non-GAAP basis, including non-GAAP operating expenses of $69 million.

We ended 2018 with $253 million in cash and short term investments. This amount does not include the $150 million in cash, we will receive from Novartis in Q1, as a result of their decision to exercise their option to license AKCEA-APO(a)-LRx. As we have reported, Akcea will retain the entire $150 million and we'll settle its obligation to our units by issuing $75 million in common shares at $26.43 per share. This is calculated using the trailing 20-day trading day average, which will result in 2.8 million shares of common stock being listed to our unit, increasing our unit as equity ownership in Akcea to approximately 76%.

Since we are now reporting revenue from TEGSEDI, let me provide some detail on how we recognize product sales. We recognize revenue in the US and Germany when our distributor has taken title and assumes the risk with ownership. This is often referred to as a felon or title model. Given the dynamics of this patient population, we have clear visibility into our distribution channel. We use this information to ensure that the sales into the channel are in line with the number of patients on therapy. Further, with TEGSEDI and (inaudible), its sales increment is recognized as revenue on that basis. In addition, I would like to provide a quick review of the financial impact of our TTR franchise transaction with Ionis.

From an accounting perspective, we report all product sales related to TEGSEDI and all commercial expenses related to the TTR franchise, plus our share of the AKCEA-TTR-LRx developing cost. The impact of the profit loss share with our units will be included in determining our operating income or law. Under the profit last year, we and Ionis there are profits and losses of TEGSEDI 60% to Ionis and 40% to Akcea. Also related to the TTR legacy upon approval of TEGSEDI and the EU in the third quarter and the US in the fourth quarter, we incurred a $90 million related to milestone payments to IRR (ph), which we settled through the issuance of 3.3 million shares.

Turning to our financial guidance, the $253 million in cash at the end of 2008, up $150 million from Novartis. We believe we have sufficient cash on hand to carry out our commercial activities, as well as fund progression of our current pipeline decision event.

Now I will turn the call back over to Paula.

Paula Soteropoulos -- Chief Executive Officer

Thank you, team. As you heard from today's update, we have a tremendous amount going on as a company. We are now a commercial company and we're focused on launch and clinical development execution. We're pleased with the TEGSEDI launch and continue to hear positive feedback from the field. With TEGSEDI and our broad pipeline, we have a set of potentially life changing medicines that we believe can have a significant impact on patients communities that are currently underserved. The solid results from our APOCIII -- AKCEA-APOCIII-LRx the Phase II study are the latest in a series of data points that continue to validate the promise of like a technology.

This increase our confidence as we further expand our commitment to ATP our patients, the cardiomyopathy through AKCEA-TTR-LRx. The team running Akcea as experienced and dedicated. We are partnering with patients, physicians and payers and using our flexible and nimble organization to build an infrastructure that will make us the trusted partner of choice. Our work is already having an impact on patients and the hATTR community. In 2019, we are focused on executing across our business while we build a strong company to deliver to steady and our pipeline of transformative medicine. We'll be celebrating Rare Disease Day on Thursday, and I want to close by thanking all of the patients and advocates in the rare community for their tireless efforts to raise awareness and gain support for new medicines to help patients with rare diseases. And we're proud to be doing our part.

Now I will open up the line to question.

Questions and Answers:

Operator

(Operator Instructions) Our first question comes from the line of Chad Messer. Your line is open.

Chad Messer -- Needham & Company -- Analyst

Great. Good afternoon. Thanks for taking my question and congrats on all the progress and in particular the recent opt-in by Novartis. I'm assuming the answer is yes. But just to check in, if Novartis does opt-in on APOCIII, could you also settle Ionis' half of that payment with shares? And is that solely at your discretion? Or is there another way to that decision is made?

Paula Soteropoulos -- Chief Executive Officer

Hey, Chad, thanks for the congrats. That is something that at the time we will make a decision just based on where the company is in the needs. And it will be a conversation that we join with Ionis.

Chad Messer -- Needham & Company -- Analyst

Okay, great, thanks. And then just a couple on WAYLIVRA, as we head into the FPL readout. Just wondering how you -- assuming that's a positive solid readout. How you feel that may influence some of your ongoing regulatory discussions? And then also, are there any factors about FPL and/or that study that make you more or less optimistic about WAYLIVRA chances for approval in FPL as compared to FCS?

Paula Soteropoulos -- Chief Executive Officer

Chad, I'm going to have Jeff take those questions.

Jeffrey M. Goldberg -- Chief Operating Officer

Sure, thanks, Paula, thanks, Chad. So Chad, I think, the way to think about this is, it's early days, right? We don't have the data yet and the data are obviously, going to be thing that really drive that conversation with regulators and is always is. We are actively as you -- as we've discussed, we're continuing our dialogue around FCS. The patient populations are a little bit different in the way they behave and the way they respond to the drug, in the way that their issues manifest. But again, data is going to be the thing that really tells the story. And if so we have those data, it's really premature to say whether it's better rewards or otherwise.

Chad Messer -- Needham & Company -- Analyst

All right. Great. I guess we'll check back in on that mid-year. Thank you.

Paula Soteropoulos -- Chief Executive Officer

Thanks, Chad.

Operator

Our next question comes from the line of Ritu Baral. Your line is open.

Subbu Nambi -- Cowen & Company -- Analyst

Hi. This is the Subbu Nambi on for Ritu Baral. Thanks for taking my question. So what is the current number of discrete prescribers certified by REMS? And what is the split between neuro, cardio and metallurgist? And how did the -- how long did the process take? And I have a follow-up.

Paula Soteropoulos -- Chief Executive Officer

Yes, Subbu, some of that detail, we're not going to be providing that level of detail. And we do, as Sarah said, you have a split between the difference of treating physicians, neurologists, cardiologists. But that level of detail, we're not providing at this time. We really feel safe and confident with our launch as the way that things are going. And to your question about the timing of how long does it take. Because it's early in the launch and if that's becomes variable and as things settle out, we'll have a better sense of our metrics and be able to determine when we share that with you.

Subbu Nambi -- Cowen & Company -- Analyst

Got it. And given that your insight on the sell in, what is your estimate of inventory currently? Or you are not giving out that detail?

Jeffrey M. Goldberg -- Chief Operating Officer

Hi, Subbu. Yes, we're not giving out the details of that. But we actually can -- through the REMS program, we see patients who are kind of signing up through the REMS program. So we have a pretty good idea what should be in the channel and we monitor it with that and other information.

Subbu Nambi -- Cowen & Company -- Analyst

Okay, thank you.

Operator

Our next question comes from the line of Jim Birchenough. Your line is open.

Jim Birchenough -- Wells Fargo Securities -- Analyst

Hi guys. Let me add my congratulations. A few questions for me. I guess, first, just on the Novartis opt-in and expectations for the Phase III. You maybe comment on the thoughts on platelet monitoring and FDA, you want that and whether that might inform other likely drugs, just want to see what kind of breakthroughs might there be for the like of platform broadway from both the FDA meeting and the Novartis opt-in? And then I have a follow-up.

Paula Soteropoulos -- Chief Executive Officer

Sure, Jim, thanks. We did have and at the end of Phase II meeting that we like to Novartis with the Phase II data and the Phase III preliminary study design. And we're very pleased to come out of that meeting with no requirements for monitoring platelets or renal. So that was obviously something that we were all anticipating, and it was a result of that meeting. Given the fact that many of the LICA that we've been looking, we have obviously the four in our pipeline, Ionis is I think is about -- a total of 13, and we have the exact of there. And we've seen a very consistent performance of the like a drug. And so our expectation is that it would readout. But obviously, data will tell, but given the performance so far, we're fairly confident. And that -- as I mentioned, earlier most excited about, obviously, TTR lifeline being able to expand into a broader community there.

Jim Birchenough -- Wells Fargo Securities -- Analyst

And then you may not be able to give a lot of detail on this. But I'm wondering if you could comment on the number of patients in Akcea, in Akcea Connect program? And if you can't comment specifically, maybe if you could comment on what proportion of the target prescriber base has had patients go into your system?

Paula Soteropoulos -- Chief Executive Officer

Well, all of the patients that come on drugs oriented, if that's the question. Maybe I missed heard your question.

Jim Birchenough -- Wells Fargo Securities -- Analyst

Yes, I guess, I'm wondering; A, if you can say how many patients are in the queue for TEGSEDI? And if you can, I'm just wondering if you could comment on the proportion of prescribers that -- if you look at your target audience, how many have actually said patients into the queue?

Paula Soteropoulos -- Chief Executive Officer

No, so we're not giving a number of patients in the queue. And obviously, not the number of prescribers that we're targeting that have already signed a patient. Because, again, the patients that sign up for Akcea Connect and send it to create and would have the prescription.

Jim Birchenough -- Wells Fargo Securities -- Analyst

And then maybe one final question. Just early success and identifying patients with the genetic testing, and if the number was 500, can you may be talk in general terms at least on the disposition of those patients when you identify them? Do they tend to preferentially come to Akcea? Or what's been the disposition of those patients once identified?

Paula Soteropoulos -- Chief Executive Officer

I'll let have Sarah talk maybe a little qualitatively about the Akcea Connect program, and the value that we're seeing.

Sarah Boyce -- President

Jim, it's really early days on Akcea Connect to go into some of the disposition and what that happens when patients are identified. Although, what I would say is the program has been very well received by those physicians and academic centers and community, doctors as well, in particular, because it's a broad panel. The test for other diseases not just hATTR to help patients actually get to a diagnosis, and that's been well received as well also the availability of genetic counselors at a state level, whose also been well received. We view it as a really important program because there's so much work that is needed to be done on helping hATTR patients actually get to a diagnosis. And as we get into more of a rhythm and more of how we see that pull-through in relations to patients starting on treatment. We'll share it at an appropriate time. But we're a long way from that.

Paula Soteropoulos -- Chief Executive Officer

Yes, and I think, let me add just one point Jim, that -- the early release data that Sarah had talked about earlier where we chose that getting patients on drug earlier makes a difference in terms of their disease. This is something that is resonating, with physicians. And they're more excited about using the Compass program as an opportunity to get patients diagnosis early as possible because it does make a difference with their disease.

Jim Birchenough -- Wells Fargo Securities -- Analyst

Great. Well thanks for taking the questions and congrats again.

Paula Soteropoulos -- Chief Executive Officer

Thank you, Jim.

Operator

Our next question comes from the line of Paul Matteis. Your line is open.

Benjamin Burnett -- Stifel -- Analyst

Hey, this is Ben Burnett on for Paul Matteis. Thank you for taking our questions. Just -- so one on TEGSEDI. We're just trying to get a sense, what the early trends are for how patients are using TEGSEDI? Are most patients choosing to dose at home? Or are you seeing some patients dose in the physician's office?

Paula Soteropoulos -- Chief Executive Officer

TEGSEDI is dose at home. And that's what patients do. They -- it's something that they can easily do on their own time. So it's not necessarily to be done in a physician's office.

Benjamin Burnett -- Stifel -- Analyst

Okay, OK. Go ahead.

Paula Soteropoulos -- Chief Executive Officer

I was just going to say, Paul, just to go through Akcea Connect, and a nurse case manager, is one of the things that we do is that training on self injection, and can actually has a nurse case managers to be the patient as they're training them on how to self inject. So...

Benjamin Burnett -- Stifel -- Analyst

Okay, thank you, that's a good color. And then I guess just a question on selling TEGSEDI. So selling into the channel. Are you selling TEGSEDI dose-by-dose? Or do you sell like a four-pack, for example? I'm just trying to get a sense of when my expectations to sort of redose and then for the cadence of that?

Mike MacLean -- Chief Financial Officer

Yes, hi, Ben, it's Mike. It's sold as a four-pack. And so it arrives at the patient's home as a four-pack. But it's kind of -- that's how it goes to the distributor and goes through the channel operating to the patient. And I think I pointed out in my comments that, that's how the revenue gets recognized too.

Benjamin Burnett -- Stifel -- Analyst

Okay. Thank you. Makes sense.

Paula Soteropoulos -- Chief Executive Officer

Thanks, Ben.

Operator

Our next question comes from the line of Tyler Van Buren. Your line is open.

Tyler Van Buren -- Piper Jaffray -- Analyst

Hey good afternoon, guys. Thanks for taking the question. I found your -- with respect to your TEGSEDI launch, I found your comments on the Compass program interesting. And I believe you mentioned 500 patients of -- with hATTR have been diagnosed. So I was just curious to get some details on that? I guess, perhaps over what period of time those patients were diagnosed? Or how that rate has been increasing as of late? And if all those patients are essentially potentially eligible for TEGSEDI treatment?

Paula Soteropoulos -- Chief Executive Officer

Sarah, you want take that?

Sarah Boyce -- President

Yes. So I'm trying to recall when we started the hATTR Compass program. And it's probably over a year now. So that's been over that period of time where we have that program up and running. And chances as to help what that dispositions looks like in the breakdown, we're not going into that level of detail at this point. But certainly, one of the things where it's a program that is used by hematologists, neurologists and cardiologists, and it's where they expect hATTR and low doses and what patients, what they -- where they want to actually get someone to a diagnosis.

Paula Soteropoulos -- Chief Executive Officer

I think the important thing that adds with this program is our hope is that we're shortening the diagnosis time for these patients that you can diagnose hATTR multiple ways, and it's really much simpler to just do a genetic test. So I think we're seeing the beginning of what is the power of this program can do as a tool for physicians to get patient diagnosed early. And hopefully for patients, it means, they are not going to be balanced around from five physicians anymore, and they can get a diagnose as much earlier. So I think there's a lot of potential with this program.

Tyler Van Buren -- Piper Jaffray -- Analyst

Great, that's helpful. And with respect to the other programs in development, ANGPTL3 mechanistically and scientifically looks potentially really interesting. So can you guys may be describe some of the preclinical data that gets you all so excited about the program? And then when we could get initial a human NASH clinical data? And what we should expect from that?

Paula Soteropoulos -- Chief Executive Officer

Jeff?

Jeffrey M. Goldberg -- Chief Operating Officer

So Tyler, we don't have time to get into all of the detail. But let me give you the really high-level view. We've actually seen in a number of preclinical models the ability to lower liver fat, and also affect a number of other metabolic parameters. As you remember, we also had a Phase I, where we showed significant changes in a bevy of lipid parameters. So you put all that together, and we've got a really interesting opportunity both from the data perspective. But also as you say, from the scientific and underpinning that it will come from. Again, we can go through in more detail at a later date. But that's kind of the high-level view.

Tyler Van Buren -- Piper Jaffray -- Analyst

Great, thanks for taking the questions and congrats on the opt in.

Paula Soteropoulos -- Chief Executive Officer

Thank you, Tyler.

Operator

Next question is from the line of Do Kim. Your line is open.

Neil Elliot -- BMO Capital Markets -- Analyst

Hi, how are you doing? This is Neil filling in for Do. Thanks for taking my question. I have two questions. Number one is, can you just comment on how you guys are viewing the competitive environment for TEGSEDI? How you're looking at it now compare to prior to launch? And are there any opportunities that you didn't see before or any trends that you think maybe are unappreciated or were not factored in previously? And then the second would be -- are you able to comment on the turnaround time? And if you've noticed any changes during the quarter? Thank you.

Paula Soteropoulos -- Chief Executive Officer

Neil, I'm going to have Sarah take that.

Sarah Boyce -- President

Yes, thanks, Neil. So in terms of -- as I said, we're really pleased as to how the launch is progressing. It's still early days, so getting into details around turnaround time that's probably too early to get into that. And one of the things that we've seen and what particularly pleasing actually is how consistent the market research was and what we had from physicians as we were developing our launch plans, and where we hear from the physicians today. And there is this physicians and patients both find having a treatment that is what patients can inject themselves is something that's really important and really important from an independence perspective. And that's being very well received by both physicians and patients. And that's something that we feel consistently in the prelaunch phase. So I think from that aspect, we're very pleased to what we're seeing albeit if being early days.

Neil Elliot -- BMO Capital Markets -- Analyst

Okay, great. Thanks for the question.

Paula Soteropoulos -- Chief Executive Officer

Thank you.

Operator

Our Q&A is over. I'll now turn the call over back to Paula.

Paula Soteropoulos -- Chief Executive Officer

All right. Thank you very much of those who are listening and today. We have an exciting year ahead and we look forward to keeping you updated as we continue to focus on the launch of TEGSEDI and advance our pipeline. Thank you.

Operator

This concludes today's conference call. Thank you for joining. Have a wonderful day. You may all disconnect.

Duration: 40 minutes

Call participants:

Kathleen Gallagher -- Vice President of Corporate Communications and Investor Relations

Paula Soteropoulos -- Chief Executive Officer

Sarah Boyce -- President

Jeffrey M. Goldberg -- Chief Operating Officer

Mike MacLean -- Chief Financial Officer

Chad Messer -- Needham & Company -- Analyst

Subbu Nambi -- Cowen & Company -- Analyst

Jim Birchenough -- Wells Fargo Securities -- Analyst

Benjamin Burnett -- Stifel -- Analyst

Tyler Van Buren -- Piper Jaffray -- Analyst

Neil Elliot -- BMO Capital Markets -- Analyst

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