Advertisement
Canada markets open in 5 hours 30 minutes
  • S&P/TSX

    22,011.72
    +139.76 (+0.64%)
     
  • S&P 500

    5,070.55
    +59.95 (+1.20%)
     
  • DOW

    38,503.69
    +263.71 (+0.69%)
     
  • CAD/USD

    0.7312
    -0.0009 (-0.12%)
     
  • CRUDE OIL

    83.33
    -0.03 (-0.04%)
     
  • Bitcoin CAD

    91,168.92
    +560.55 (+0.62%)
     
  • CMC Crypto 200

    1,416.52
    -7.58 (-0.53%)
     
  • GOLD FUTURES

    2,334.80
    -7.30 (-0.31%)
     
  • RUSSELL 2000

    2,002.64
    +35.17 (+1.79%)
     
  • 10-Yr Bond

    4.5980
    -0.0250 (-0.54%)
     
  • NASDAQ futures

    17,725.50
    +118.75 (+0.67%)
     
  • VOLATILITY

    15.77
    +0.08 (+0.51%)
     
  • FTSE

    8,077.25
    +32.44 (+0.40%)
     
  • NIKKEI 225

    38,460.08
    +907.92 (+2.42%)
     
  • CAD/EUR

    0.6838
    +0.0002 (+0.03%)
     

Akcea Therapeutics, Inc. (AKCA) Q2 2019 Earnings Call Transcript

Logo of jester cap with thought bubble.
Logo of jester cap with thought bubble.

Image source: The Motley Fool.

Akcea Therapeutics, Inc. (NASDAQ: AKCA)
Q2 2019 Earnings Call
Aug 6, 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 Second Quarter 2019 Conference Call. [Operator Instructions]

I will now like to 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 you, Nora. Hello, everyone. Thanks for joining us today's call. With me today are Paula Soteropoulos, our Chief Executive Officer; Sarah Boyce our President; and Mike MacLean, our Chief Financial Officer and Jeff Goldberg, our Chief Operating Officer.

ADVERTISEMENT

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 in that risk treatment.

Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.

Akcea's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although, Akcea's forward-looking statements reflect the faith judgment of its management, these statements are based only on facts and factors currently known by Akcea.

As a result, you're cautioned not to rely on these forward-looking statements. These and other risks concerning Akcea's programs are described in additional detail in Akcea's most recent Quarterly Report on Form 10-Q, and in the most recent Annual Report on Form 10-K on file with the SEC. Copies of these and other documents are available from the company.

In addition, earlier today, we issued a press release and related financial tables including a reconciliation of GAAP to our reported non-GAAP financial measures that we will discuss today. To read this release and access the slides that accompany today's call, please visit the Investors section of our website.

Now I'll turn the call over to Paula.

Paula Soteropoulos -- Chief Executive Officer

Thank you, Kath. Good afternoon, everyone. Thank you for joining us. Last month marks two-years since our IPO. In that time, we've delivered on an aggressive agenda of launching two rare diseases, while progressing a large pipeline of therapies that have the potential to address severe diseases that are currently under served.

For our rare disease drugs, we've launched TEGSEDI in the US, Germany and Canada. We recorded $10 million in sales for TEGSEDI in Q2, which aligns with consensus. We see momentum building in the launch and growth in the hATTR market. And patients and physicians are gaining experience with TEGSEDI, we continue to hear positive feedback about the importance of this efficacious drug that gives patients the independence to treat on their own terms.

For WAYLIVRA, we will be launching in Germany this month and we are preparing to launch in additional countries in Europe in 2020. For the pipeline earlier today, we announced the top-line results from our study of WAYLIVRA in patients with familial partial lipodystrophy or FPL. We're encouraged by these results and we'll discuss them in further detail in the call.

We have delivered a positive Phase II result for AKCEA-APO(a)-LRx or TQJ security, which resulted in Novartis exercising their oxygen to that product. Novartis shares our enthusiasm and urgency to bring AKCEA-APO(a)-LRx to patients experiencing cardiovascular disease due to high levels of Lp(a). Novartis is in the final stages of a Phase III initiation for the AKCEA-APO(a)-LRx study. We will talk more about that trial design later in the call.

With AKCEA-TTR-LRx, we are expanding our commitment to the TTR community including patients with wild-type and hereditary cardiomyopathy and we are on track to initiate our Phase III program with Ionis by the end of this year.

The rest of our pipeline is progressing with the Phase II studies for both AKCEA-APO(a)-LRx and AKCEA-ANGPTL3-LRx reporting data early in 2020. All of this keeps us on track to close up to 2019 with two commercial products, two programs in Phase III development and two drugs nearing Phase II data. We remain focused on delivering innovative solutions that improve the lives of those affected by serious and rare diseases.

And I will turn the call over now to Sarah.

Sarah Boyce -- President

Thanks, Paula. We are seeing growth in the number of patients diagnosed with hATTR. We're also seeing increased physicians and patients interest in TEGSEDI. This cautious growth is primarily [Technical Issues]

Paula Soteropoulos -- Chief Executive Officer

Sarah, you come on mute, so...

Sarah Boyce -- President

Thank you, Paula. We are seeing growth in the number of physicians and patients hATTR. We are also seeing increased physicians and patients interest in TEGSEDI. This cautious growth is primarily driven by the United States. So we anticipate that the EU and Canada will play a larger role as we continue to work toward reimbursement in each country.

In the US, we are continuing our focus on the community physicians, presume disease education is critical to diagnose and support patient finding. Data from our marketing efforts support that there is a lot of potential for growth in diagnosis of polyneuropathy of hATTR.

Our sales team continues to call on cardiologists, hematologists and neurologists. And we have seen in particular we are pleased to see that we are gaining additional traction with the neurology community. This is important and a testament to the work of our sales teams, who are spending a great deal of time focused on the neurology community, where we are seeing our messages on the urgency to treat hATTR early resonate. The efforts of our sales team are paying off and this quarter we saw an increase in TEGSEDI prescriptions in the United States of 50%.

At this point essentially all patients have converted from early access programs NCOLA to commercial drug. This past quarter -- as we look forward we are confident that we are highly competitive with bringing our naive patients, who are identified and also seeking treatment. We are also seeing an increase in diagnosis from our genetic testing program hATTR Compass. We've recently announced the one-year anniversary of the Compass program and there are now over 800 physicians using this program. Compass allows physicians to diagnose patients locally and TEGSEDI allows them the independence to treat their patients locally as well. This is great for physicians, who can keep their patients in their local practice and for patients, who do not have to travel far distances to get their treatment.

Our market access team continues to do a great job working with patients and payers to make TEGSEDI available. This is excellent especially at this point in rare disease launch. We attribute this success to the hard work of our market access team and leading up to and since launch, as well as that our Akcea Connect team, a 30-day time from trip from prescription to prescription being fulfilled is really excellent and something that's great to see.

Akcea Connect, our program of sales based nurse case managers have an expertise in assisting patients and physicians to all aspects of TEGSEDI. Outside of the US, they are working toward reimbursement in multiple European countries and in Canada with the highly specialized technology guidance from NICE now implemented by the NHS, we will begin treating our first patients in England imminently.

In addition, we are seeing positive momentum in Canada. Our Akcea Connect program is up and running in England and Canada and consistent with our global commitment. We believe we are providing the highest level of patient and physician support. We are working toward access in additional European countries and we will update those as we launch.

Finally, the team at PTC is working toward the approval for TEGSEDI across Latin America. We are confident that they are the right partner with the right expertise to deliver TEGSEDI to patients in Latin America efficiently. And in ways that align with our patient centered focus.

This month we are launching WAYLIVRA in Germany. WAYLIVRA is the only treatment available for patients with FCS. We believe there are approximately a 1,000 patients eligible for treatment in Europe. The hallmark of FCS is extremely high triglycerides, which puts patients at risk of unpredictable and potentially fatal acute pancreatitis. Symptoms of FCS also include chronic complications, due to permanent organ damage, as well as major emotional and psychosocial issues. There are many synergies across Europe with the infrastructure result for TEGSEDI. Our team will be calling on lipid specialists including specialized endocrinologist and cardiologists.

In Europe, most patients with FCS will be treated at academic centers. We expect to launch WAYLIVRA in additional countries following the typical European launch sequence. In the US and Canada, our regulatory discussions are ongoing. PTC is also gearing up to deliver WAYLIVRA to patients in Latin America. Across the board, the team has made great progress to-date. We see a lot of opportunity in both rare diseases and we are investing in disease education as we work to build for the long-term. We are executing on our multiple launchers by ensuring access to TEGSEDI and WAYLIVRA. And as always keeping our focus on patients.

Now over to Mike.

Michael MacLean -- Chief Financial Officer

Thank you. As you heard from Sarah, the team is executing on the TEGSEDI launch and we look forward to adding additional sources of revenue from TEGSEDI, as we gain access in other European markets. For Q2, 2019, we had total revenue of approximately $27 million and an operating loss of approximately $24 million on a non-GAAP basis, including non-GAAP operating expenses of $51 million.

Our revenue includes approximately $10 million of product sales from TEGSEDI. As we now disclosed, our sales of TEGSEDI were generated in the US and Germany. Our revenue growth is predominantly driven by adding naive patients in the US. At $10 million in revenue from TEGSEDI sales, we are on line with consensus. We are pleased with the growth that we are seeing in our hATTR franchise.

Looking forward, we expect to add revenue in 2019 from WAYLIVRA, as we begin to roll out our European launch, starting with Germany. For clarity, WAYLIVRA will be sold as a single prefilled syringe. We will recognize revenue for WAYLIVRA under the title model similar to TEGSEDI. We anticipate our first revenue from WAYLIVRA will occur in Q3, 2019. Just like TEGSEDI, we set our price for the first year in Germany, while we worked with the authorities to agree on an ongoing price for WAYLIVRA starting after the first year.

We will share the initial WAYLIVRA price when we launch and we expect to be in the typical rare disease price range. We ended Q2 with $296 million in cash and short-term investments. This includes a $6 million milestone payment from PTC on approval of WAYLIVRA, which we split 50:50 with Ionis.

Turning to our financial guidance. With $296 million in cash at the end of Q2, we believe we have sufficient cash on hand to carry our commercial activities for our products, as well as to fund progression of our current pipeline into 2021. We are uniquely positioned with having two products on the market, as well as the potential license fee under our collaboration with Novartis. Further, we have a pipeline with drugs for both broad and rare diseases that represent meaningful economic opportunities for our company.

I will now turn the call over to Jeff to discuss the pipeline in further detail.

Jeffrey M. Goldberg -- Chief Operating Officer

Thanks Mike. We announced earlier today the results of our study of WAYLIVRA in patients with familial partial lipodystrophy or FPL. The BROADEN study was a global study of 40 patients with FPL. The primary endpoint was reduction in triglycerides and a key secondary endpoint was reduction hepatic fat and we hit both of those end points in the study. While there were significantly lower triglycerides baseline by 88% at three months, compared to 22% reduction in placebo treated patients with a p-value less than 0.001. Significant glyceride lowering was maintained throughout the 12-month of the study.

In addition, there was a statistically significant mean reduction from baseline of 51.9% of liver fat in liver treated patients at 12-months, compared to 1.5% increase in placebo group with a p-value of 0.004. Overall, we're encouraged by the safety and efficacy profiles demonstrated by WAYLIVRA in patient with FPL. Most frequent adverse events have BROADEN were all mild or moderate severity and included injection site reactions, the common cold, urinary tract infections and reductions in platelet levels. Importantly, there were no serious or severe platelet count decreases.

These are the top-line results as we obtain additional data or reviewing its totality and discussed it with key experts in the fields to define our next steps. We are so grateful to the patients and physicians in the FPL community for their time and participation. We and Ionis have always focused on diseases where we can transform patients' lives. We are proud to add the body of evidence around FPL and we remain committed to sharing what we have learned with a patient and medical communities.

Switching to AKCEA-APO(a)-LRx also known as TQJ230. This drug is intended for patients who have high levels of lipoprotein little A or LP little A, a genetic risk factor for cardiovascular disease that cannot be treated by existing lipid lowering therapies or controlled by diet and exercise. Novartis is in the final stages of initiation for the Phase III outcome study and the team there has done a great job moving quickly and efficiently to get this large study under way. The global study will be in approximately 7,500 patients, who have elevated healthy little A 70 milligrams per deciliter or higher and have an established history of cardiovascular disease.

The study is designed with two primary outcome measures. One, focuses on patients with an LP little A measurement greater than or equal to 70 milligrams per deciliter. And one for patients with a healthy little A measurement greater than or equal to 90 milligrams per deciliter. The goal of the overall study is to reduce the risk of expanded major adverse cardiovascular events or MACE.

Secondary outcomes include reducing risk of CD death, non-fatal MI and non-fatal stroke, coronary heart disease, as well as hospitalization and all cause death. Doses of 80 milligrams monthly in a prefilled syringe. We're very excited about the study and look forward to supporting Novartis as they work to enroll first patients probably next year.

We and Ionis are on track to initiate Phase III program for AKCEA-TTR-LRx in patient with TTR. We plan to initiate two studies; one in patients with hATTR with polyneuropathy and one in patients with both hereditary and wild-type TTR cardiomyopathy. Our Phase I, II study for AKCEA-TTR-LRx is ongoing. We plan to present the initial data in September first of the upcoming European Amyloidosis meeting in Berlin and then again at the Heart Failure Society of America annual meeting in Philadelphia.

Looking ahead with enrollment complete in both Phase II studies of AKCEA-APOCIII-LRx and AKCEA-ANGPTL3-LRx, we continue to anticipate data early in the first half of 2020

I'll now the call back over to Paula.

Paula Soteropoulos -- Chief Executive Officer

Thanks Jeff. We are pleased with the progress the team has made in raising awareness and elevating the urgency to treat hATTR, as well as the commercial execution of the TEGSEDI launch. We have two commercial products with TEGSEDI and the upcoming launch of WAYLIVRA. Our Phase III programs are on track to initiate this year for AKCEA-APO(a)-LRx and AKCEA-TTR-LRx. And further AKCEA-APOCIII-LRx and AKCEA-ANGPTL3-LRx are moving toward data early next year.

We are looking forward to closing out 2019 with two commercial products, two Phase III programs initiated and two Phase II products nearing data. We continue to see momentum and growth in the hATTR market and are working to build the FCS market in Europe as well. We have a solid pipeline with exciting rare and broad indications that we believe can make a positive impact on patients' live. We look forward to sharing our continued progress with you as we go into the second half of the year.

And now I'll open up the line for questions. You can go ahead Nora.

Questions and Answers:

Operator

[Operator Instructions] We have a quest -- first question from the line of Chad Messer of Needham & Company. Your line is open.

Chad Messer -- Needham & Company -- Analyst

Great. Thanks for taking my questions and congratulations on the quarter and on the positive pivotal data in FCL. I could just start with TEGSEDI. Have you guys run across any candidate patients yet maybe switching or combining?

Paula Soteropoulos -- Chief Executive Officer

Hey, Chad. Thanks for the question. We -- as we -- I think noted last year we continue to see some patients switch and from a more competitive drugs.

Chad Messer -- Needham & Company -- Analyst

Okay. Sure then maybe just on the FPL data, very impressive especially that liver fat reduction and the safety profile seems to corroborate something that you and Ionis have been saying for a while, which is that the chromobo seen in FPS appears to be something that's a lot worse than that indication and others. And I think having this exact same drug now in two indications can really help that. What -- can you talk about the regulatory strategy here? I mean in Europe going for a label expansion seems to make a lot of sense, but how do you approach the US regulatory authorities with this positive study?

Paula Soteropoulos -- Chief Executive Officer

Yes, Chad. We agree regarding the platelets and inherent volatility in FPS different from other populations, but I'll have Jeff to take that question.

Jeffrey M. Goldberg -- Chief Operating Officer

Yes. As we've think about leveraging these data for regulatory purposes, certainly what we see that it as we said expands the database and reinforces the safety profile we have been talking about. In terms of next steps, this is just top-line data we're collecting up all of the data from the study. We're going to evaluate that with the Kol and a top leader community and then we'll take it forward. As you say, the next step in Europe could be to do a follow-on top of the program we've already got. In the US, as you know, we've got ongoing dialogue and certainly this will be included in that conversation. And we'll see where that goes.

Chad Messer -- Needham & Company -- Analyst

All right, great, we'll stay tuned there. And then just real quick and I apologize I'd missed something along the way, but for the ANGPTL3, I thought there were some small studies in rare lipid disorders that were also out there. What's the status on those?

Paula Soteropoulos -- Chief Executive Officer

Yes. We talked about the ANGPTL3 in rare, we talked about having data in mid-year and so we're still analyzing data. I will say that we had prioritized the FPL with Novartis. So we're working through that. So yes that will be coming.

Chad Messer -- Needham & Company -- Analyst

All right, great, we'll look for that, yes, I get it NASH is a much more potentially exciting indication. All right thanks for taking my questions.

Paula Soteropoulos -- Chief Executive Officer

Thanks, Chad.

Operator

Your next question comes from the line of Do Kim of BMO Capital Markets. Your line is open.

Do Kim -- BMO Capital Markets -- Analyst

Great. Thanks for taking my questions and congrats also on the positive BROADEN study data. Just starting on that perhaps you could talk a little bit more about the platelets declines that you did see. How does that compare to the placebo arm? And does that mean that FPL patients won't require the monitoring Rams that you have for FCS patients?

Paula Soteropoulos -- Chief Executive Officer

Thanks Do. We did see some platelets declines, but as we said they were all mild to moderate. We had no serious or severe drop. So different than what we saw in FCS and we also did monitor patients and we anticipate that they would need to continue to be managed with platelet monitors. There is an effect, but not to the same extent as an FCS.

Do Kim -- BMO Capital Markets -- Analyst

Okay, thank you. And were there any clinical or functional endpoints of the studies? Like you had for FCS pancreatitis and what would physicians care about in the results?

Paula Soteropoulos -- Chief Executive Officer

Jeff can you take that?

Jeffrey M. Goldberg -- Chief Operating Officer

Sure. So, obviously, we're really excited about the triglycerides and liver fat. Those are pretty big and significant endpoints for us to be able to hit. And as we look at the data there will be other factors looking at quality of life, looking at other parameters to really ensure that we've assessed this disease as fully as we can given the study that we've got. So lots of -- lot more data to come.

Do Kim -- BMO Capital Markets -- Analyst

And final question on the TEGSEDI sale, its growth was primarily driven by the US. Does that suggest that there wasn't any growth in Germany? That you saturated TEGSEDI in that market?

Paula Soteropoulos -- Chief Executive Officer

Sarah, you want to take that.

Sarah Boyce -- President

Sure. So we saw as I said 50% increase in prescriptions in the United States that we're really pleased with our progress. And most of us from naive patients. Within Europe, we have as you know launched in Germany and we have good progress and pleased with how Germany is going. And we're also expanding out into additional country. So we have patients treated in Italy, Spain, Portugal. Although we're working through the reimbursement processes. So they're currently free of charge. And then in the UK, we're really looking forward to being able to have the first patients dosed with TEGSEDI in England, which should happen imminently. So I think you'll see more of Europe coming into the next quarter, Do, but very, very pleased with the new prescription growth in the US, as well as the growth in the Compass program, which was also great to see.

Do Kim -- BMO Capital Markets -- Analyst

Okay. Thank you very much.

Sarah Boyce -- President

Thanks, Do.

Operator

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

Ben Burnett -- Stifel -- Analyst

Hey, thank so much. This is a Ben Burnett on Paul Matteis. One on just FCL [Technical Issues] have you see this? Hello?

Paula Soteropoulos -- Chief Executive Officer

Ben, that's better, you have a real tough clarity [Phonetic] that's better try again.

Ben Burnett -- Stifel -- Analyst

Okay, let me say that again. Question on just FPL and the diagnose rate today and how you see the diagnosis rate evolving over time. And I guess what changes that?

Paula Soteropoulos -- Chief Executive Officer

So regarding diagnosis right this is a complex disease from the diagnosis perspective, because these patients as you know have the disease caused by defective adipose tissue, which causes the amount distribution of fat that's why they also have high triglycerides, high liver fat and also cardiovascular disease, but many of the manifestations that doctors struggle with these patients start with women for example with very significant PCOS, so they're being seen by reproductive endocrinologists. They also have a pretty difficult insulin resistance, so being seen by diabetologist. So lot of the work that would be needed for this patient population is to really educate and get these patients more formally diagnosed, because they are looked at by their specific symptom or manifestation rather than a disease in totality.

There are very few experts in the world that I can count on my hands. And so it requires a lot more education and broadening out the understanding of this disease to these other types of physicians, who tend to see these patients. Again in those singular areas that they're changing, but there really are very few physicians looking at the totality of the disease. So it's a long winded way to say that we have to influence that diagnosis rate that it will have to evolve over time for people to recognize that this is one disease not these separate symptoms.

Ben Burnett -- Stifel -- Analyst

Right, OK, OK. And then I guess kind of on the same topic did you disclose the discontinuation rate of the FPL study? And I guess could you also comment on just the percentage of patients who enrolled over to the open label extension portion?

Paula Soteropoulos -- Chief Executive Officer

No. We didn't talk about that level of data yet and again as we analyze the rest of the data and bring forward more that data we'll share that.

Ben Burnett -- Stifel -- Analyst

Got it. Okay. Alright, thanks so much.

Paula Soteropoulos -- Chief Executive Officer

Thanks, Paul. Oh, Ben, sorry.

Operator

And your next question comes from the line of Subbu Nambi of Cowen. Your line is open.

Subbu Nambi -- Cowen and Company -- Analyst

Hi, congrats on a great quarter. So my question was what drives the 22% knockdown that you observed in the BROADEN trial in the placebo group?

Paula Soteropoulos -- Chief Executive Officer

Hi, Subbu. Jeff?

Jeffrey M. Goldberg -- Chief Operating Officer

So, Subbu, it's a fair question. Remember, these individuals have whole bunches, Paula said a whole bunch of metabolic derangement. We also mandated a strict diet during the trial. So it's possible that some of that was natural chance; it's also possible that some of that was due to the diet and just being in control and being aware of what's going on. But it's part of what will dig deeper into the data as we go forward. But either way it was a very significant reduction in triglycerides with drug on board.

Subbu Nambi -- Cowen and Company -- Analyst

I see, thank you for that. And I have a follow-up question on the APO C3 trial. I know it's early, but how would you define a successful trial for Novartis to opt in for this program as well?

Paula Soteropoulos -- Chief Executive Officer

So, Subbu, I think we based on Phase II data we expect that we're going to hit the knockdown of APO C3 and triglycerides are pretty, I could say we're pretty confident in that. So the study is really designed for of course to hone in on a dose, as well as safety and so of course we'd be looking at the same things that we looked at with a blain. I'm sure Novartis will as well and given the confidence that we have with the reproducibility, or I should say consistency with like a drug and we anticipate seeing the same type of profile that we saw for APO, so we'll be looking at a clean profile of platelets and renal etc. So I think those are two key important factors.

Subbu Nambi -- Cowen and Company -- Analyst

Got it. Thank you, guys.

Paula Soteropoulos -- Chief Executive Officer

Thank you, Subbu.

Operator

[Operator Instructions] Your next question comes from the line of Jim Birchenough of Wells Fargo. Your line is open.

Unidentified Participant

Good afternoon. It's Nick on for Jim this afternoon. And congratulations from FPL elevation. Can you comment with all patients receiving WAYLIVRA benefited from a reduction in liver fat?

Paula Soteropoulos -- Chief Executive Officer

Was it -- was the question if all patients benefited from a reduction in liver fat?

Unidentified Participant

Who receive WAYLIVRA?

Jeffrey M. Goldberg -- Chief Operating Officer

So I think maybe the best way to answer that is we saw 50 something percent reductions in liver fat in the mean. And variation is obviously some individual variation we'll take a look at that part of the totality of the data. But very significant reduction at the mean call.

Unidentified Participant

And then of those 1,000 patients in Europe how many of those are currently in care for FPL? And what proportion of those has been educated or aware of WAYLIVRA?

Paula Soteropoulos -- Chief Executive Officer

Yes. I would say of the patients, the 1,000 patients in Europe, it is a low number in terms of awareness of the disease itself in terms of formal diagnosis. Many of these patients have a very long journey to diagnosis. Again, as I mentioned that many of them were treated for the specific disease manifestations. Again it could be QTS; it could be the severe insulin resistance. And it takes time for someone to extricate weight. These all connect and you have familial partial lipodystrophy. So there is still ongoing work for education and awareness.

So typical of a rare disease where you don't have many options for a patient. You see a low awareness and that part of educating as may be an option comes forward that will influence the awareness and hopefully getting patients to the right type of pressure to compete their disease.

Unidentified Participant

Great. Thank you. And when might we see this data presented in a medical meeting?

Paula Soteropoulos -- Chief Executive Officer

Again, we just announced top line, so we need a bit of time to get through all of the data. So we don't have a timeline yet on when we would be sharing that at a medical meeting.

Unidentified Participant

Okay. Thank you very much.

Paula Soteropoulos -- Chief Executive Officer

Thank you.

Operator

You have a follow-up question from the line of Paul Matteis from Stifel. Your line is open.

Ben Burnett -- Stifel -- Analyst

Hey, thanks for the follow-up. This is Ben Burnett on for Paul Matteis. I apologize if this has already been addressed, but I wanted to ask about TEGSEDI. You mentioned that there was growth that you're seeing in sales primarily coming from the US. And can you comment on just kind of the split of up scripts of whether they are now coming from cardiologists versus neurologists and kind of the mix there?

Paula Soteropoulos -- Chief Executive Officer

Yes. We're getting prescriptions from neurologists, cardiologists, hematologist and we aren't talking about the specific split, but we're seeing growth in all of those specialties. And most especially the additional growth from neurologist as Sarah had mentioned.

Ben Burnett -- Stifel -- Analyst

Okay. And I guess could you -- it's still early days I understand, but is there anything you could say about the persistence on TEGSEDI?

Paula Soteropoulos -- Chief Executive Officer

Sarah do you want to take that?

Sarah Boyce -- President

Sure. While we're not commenting specifically one thing I would say is how pleased we are with Akcea Connect. And the work that they're doing both on educating patients and physicians and setting expectations and also helping our patients establish a routine. And all of that has by far exceeded our expectations. And we're really pleased with how that's going.

Ben Burnett -- Stifel -- Analyst

Okay very cool. Thanks so much for the follow-up. I appreciate it.

Paula Soteropoulos -- Chief Executive Officer

Thanks, Ben.

Operator

[Operator Instructions] I'm showing no further questions at this time. I would now like to turn the conference back to the presenters.

Paula Soteropoulos -- Chief Executive Officer

All right. Thanks Nora. Well, thank you everyone for joining today. With our multiple ongoing launches and broad pipeline, we have a number of upcoming catalysts. We look forward to sharing updates with you as we continue to execute across the business. Have a great afternoon.

Operator

[Operator Closing Remarks]

Duration: 35 minutes

Call participants:

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

Paula Soteropoulos -- Chief Executive Officer

Sarah Boyce -- President

Michael MacLean -- Chief Financial Officer

Jeffrey M. Goldberg -- Chief Operating Officer

Chad Messer -- Needham & Company -- Analyst

Do Kim -- BMO Capital Markets -- Analyst

Ben Burnett -- Stifel -- Analyst

Subbu Nambi -- Cowen and Company -- Analyst

Unidentified Participant

More AKCA analysis

All earnings call transcripts

AlphaStreet Logo
AlphaStreet Logo

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.

Motley Fool Transcribers has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

This article was originally published on Fool.com