Akcea Therapeutics, Inc. (AKCA) Q1 2019 Earnings Call Transcript

Image source: The Motley Fool. Contents:

Prepared Remarks

Questions and Answers

Call Participants

Prepared Remarks:

Operator

Good afternoon, and welcome to your Akcea Therapeutics First Quarter 2019 Conference call. As a reminder, this call is being recorded. I would now like to turn the call over to Kathleen Gallagher, Akcea’s Vice President of Corporate Communications and Investor Relations. Ms. Gallagher, please again.

Kathleen Gallagher — Vice President, Investor Relations & Corporate Communications

Thank you, Nova. 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; and Mike MacLean, our Chief Financial Officer.

As a reminder, this conference call includes forward-looking statements regarding the financial outlook for Akcea, Akcea’s business and the therapeutic and commercial development 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 statement.

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 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 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 and the company’s today’s call, please visit the Investors section of our website.

Now, I’ll turn the call back over to Paula.

Paula Soteropoulos — Chief Executive Officer

Thank you, Kath. Good afternoon, everyone. Thank you for joining us. We had a highly productive start to 2019. WAYLIVRA’s approval earlier this week officially makes us a multi-product global commercial company. So far in 2019, along with a conditional approval for WAYLIVRA in Europe, we have completed our first full quarter of the TEGSEDI launch. We successfully licensed AKCEA-APO-LRX to Novartis and $150 million and we continue to make progress on our pipeline.

It’s amazing to think that just 12 months ago, we brought the TTR franchise to Akcea. By the end of 2019, we will have two commercial products, two programs in Phase 3 development and two drugs nearing Phase 2 data. With this and the commercial capability that we have built since our founding, (inaudible) we are closer than ever to realizing our vision of delivering innovative solutions that improve the lives of those affected by serious and rare diseases. Today, we’ll be talking about the positive momentum we are seeing in TEGSEDI’s launch and our plans for WAYLIVRA in Europe. We’ve reported $7 million in sales for TEGSEDI in Q1.

We consistently hear physicians and patients recognizing the benefits of TEGSEDI’s strong efficacy coupled with the independence of subcutaneous injection where patients can treat themselves on their own terms. We are working to make TEGSEDI in additional countries in Europe throughout the year as well as working closely with PTC Therapeutics to make TEGSEDI available to patients in Latin America. We will also touch on our launch plans for WAYLIVRA in Europe. WAYLIVRA is the only drug for patients with FCS. FCS is a devastating disease. Take Diane for example. She has spent the last — by suffering from the burden of FCS. Diane has come close to death several times because of the life threatening consequences of pancreatitis. She has had more than 30 surgeries on her stomach and multiple hospitalizations that are taking her away from having normalcy in her daily life. Because of stories like Diane, the patients and physician community across the globe have shared their excitement and relief that WAYLIVRA will be available to patients in Europe. This outcry of support reinforces the importance of WAYLIVRA and the impact that it can have for FCS patients.

In addition, we continue to execute on our pipeline program. We’re thrilled with the Novartis partnership and believe they are the right partner with the depth and reach to develop AKCEA-APO(a)-LRx to the millions of patients with risk of cardiovascular disease due to Lp(a). For AKCEA-TTR-LRx, we are confident in this program and focus on expanding our commitment to the TTR community including patients with wild type and hereditary cardiomyopathy. We and Ionis are looking forward to sharing data from the ongoing Phase 1/2 study of AKCEA-TTR-LRx in the second half of this year as well as initiating the Phase 3 program this year.

We also recently completed enrollment in both Phase 2 studies of AKCEA-ANGPTL3-LRx and AKCEA-APOCIII-LRx and we continue to expect data from both programs in the first half of next year. Our team continues to deliver on our ambitious agenda. As we look to the rest of 2019, we will continue to execute on our launches and our pipeline as we deliver these important therapies to patients.

I’ll now turn the call over to Sarah.

Sarah Boyce — President

Thank you, Paula. Patients and physicians are choosing TEGSEDI. This quarter we have seen prescriptions coming from both naive and patients coming from our early access and open label extension programs. In the US, the prescriptions are coming from cardiologists, neurologists and hematologists. We are getting deeper insight into the dynamics of the launch and the physicians treating hATTR. For instance, cardiologists tend to act with urgency to get their patients on treatment as they have seen their patients rapidly decline and pass away due to hATTR. In neurology, there is more variability. Some treaters are acting with great urgency while others require a lot of education on the importance of treating now as opposed to waiting a few months until the patient’s next scheduled appointment. To underscore the urgency of treating this progressive disease, our field team is focused on showing the data from our open label extension study which shows that earlier treatment with TEGSEDI leads to better outcomes on measures of neuropathy progression and neuropathy related quality of life. These data were shared with the neurology community yesterday in an oral presentation by Dr. Brannagan from the Columbia Amyloidosis Center at the American Academy of Neurology or AAN annual meeting.

These data underscore why we are also seeing patients switched on TEGSEDI from both competitive drugs in the US and Europe. Along with education on the importance of treating early, the team continues to focus on disease education. Our genetic testing program, hATTR Compass is playing a critical role here, especially as we look at community physicians who are less familiar with the disease and are motivated to take advantage of a genetic test that can easily and quickly help diagnose their patients. We continue to see the hATTR Compass program and we now have over 550 physicians using the hATTR Compass program. The community physicians are important in the ongoing launch.

There are approximately 50,000 patients worldwide and only about 10% to 30% of those patients are diagnosed. The patients who are diagnosed are primarily treated in academic centers, but a significant number of patients remain undiagnosed. By educating the community physician, we are enabling faster diagnosis and allowing them to treat the patients in the local community with TEGSEDI subcutaneous delivery versus being referred to an academic center.

Finally, the community hospitals are not participating in the ongoing ATTR clinical trials including ours. We continue to see reimbursement from both private and public payers who have had a positive response to TEGSEDI as an efficacious drug administered under a pharmacy benefit. Outside of the US, we are working toward reimbursement in multiple European countries. We are continuing to work with agencies in France and Germany to attain the appropriate value for TEGSEDI. We have received a positive final evaluation document from NICE. This is fantastic news for patients suffering from polyneuropathy due to hATTR amyloidosis in England who have had very limited treatment options.

This is the first reimbursement process completed for TEGSEDI in Europe and we’re pleased with the team’s work there. The PTC team continue to work to facilitate access to TEGSEDI for patients in Brazil and Latin America. We continue to roll out Akcea Connect, our drug treatment programs across all geographies. Akcea Connect epitomizes our patient focused values coupled with our rigorous and robust approach to execution. We have heard from physicians and patients that Akcea Connect has […]

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