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Ionis Pharmaceuticals, Inc. (IONS)

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Ionis Pharmaceuticals, Inc. (IONS)

Q1 2019 Earnings Conference Call

May 09, 2019, 11:30 ET

Company Participants

Wade Walke - VP, IR

Stanley Crooke - Founder, Chairman, CEO & President

Elizabeth Hougen - SVP, Finance & CFO

Brett Monia - Founder, COO, SVP, Translational Medicine & Director

Frank Bennett - SVP, Antisense Research

Conference Call Participants

Chad Messer - Needham & Company

Benjamin Burnett - Stifel, Nicolaus & Company

Rick Bienkowski - SVB Leerink

David Lebowitz - Morgan Stanley

Yanan Zhu - Wells Fargo Securities

Ritu Baral - Cowen and Company

Eliana Merle - Cantor Fitzgerald & Co.

Jessica Fye - JPMorgan Chase & Co.

I-Eh Jen - Laidlaw & Company

Presentation

Operator

Good morning and welcome to the Ionis Pharmaceuticals Q1 2019 Financial Results Conference Call. As a reminder, this call is being recorded.

At this time, I would like to turn the call over to Wade Walke, Vice President, Investor Relations, to lead off the call. Please begin.

Wade Walke

Thank you, Gary. Before we begin, I encourage everyone to go to the Investor section of Ionis website to find the press release and related financial tables, including a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today. We believe non-GAAP financial results better represent the economics of our business and how we manage our business.

We've also posted slides on our website that accompany our discussion today. With me on the call are Stan Crow, Chairman of the Board and Chief Executive Officer; Beth Hougen, Chief Financial Officer; Brett Monia, Chief Operating Officer; and joining us for Q&A will be Damien McDevitt, Chief Business Officer; and Frank Bennett, Senior Vice President of Research. I would like to draw your attention to Slide 3, which contains our forward-looking luggage statement. We'll begin - we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially.

I encourage you to consult the risk factors discussed in our SEC filings for additional detail. And with that, I'll turn the call over Stan.

Stanley Crooke

Thanks, Wade, and good morning, everyone, and thank you for joining us on today's culture. We've had a busy week of various calls, so thanks. You may have noticed that this week, we unveiled our new brand. We think it better expresses our commitment to patients and the passion that we have for the science that creates life transforming of medicine.

It depicts and reinforces our culture, our technology, our business model and our position as a force for life. So now let's turn to Q1. We are off to a strong start, building on the momentum from last year. Our first quarter financial results significantly outperformed the first quarter of 2018 putting us well on track to achieve or perhaps more likely, potentially, exceed our 2019 financial guidance. Importantly, we achieved these strong financial results while investing aggressively and broadly in our business, including commercializing two medicines through early in next year and advancing our pipeline in technology.

SPINRAZA's blockbuster performance continued in the first quarter and continued to significantly contribute to our financial results. SPINRAZA has placed new ground in - of the - and is the established standard-of-care in the treatment of previously fatal and untreatable disease, SMA. Even today, 2-plus years after marketing, Biogen is continuing to generate new results and gain further understanding of SPINRAZA's benefited patients with all forms of SMA.

Recent clinical experience continues to demonstrate durability of benefit in patients with SMA, with some of these patients having been treated for over six years. With that, these results demonstrate that the benefit is not only durable, but is also increasing over time with the longer treatment resulting in even better benefit.

So in some, all of the information that we have about SPINRAZA leases here. That is that if we treat infants before they become symptomatic, most of those infants seem to develop like normal, healthy babies. So the earlier we treat, the better. And the longer we treat, the better. In addition, we are working with Biogen on follow-on medicines for SMA with the potential to offer the same exceptional benefit as SPINRAZA with less frequent dosing. We anticipate moving this new medicine into development soon.

Having completed the first full quarter of the TEGSEDI launch, we are encouraged by the initial sales and the feedback that we're getting from physicians and patients. Payers in the U.S. have been receptive to TEGSEDI, and we are also seeing good progress in expanding access in the EU.

WAYLIVRA is now our third antisense medicine approved in just over two years. We and Akcea are very pleased that the EU recognizes the value WAYLIVRA can bring to patients with FCS, and we look forward to making this new medicine available to FCS patients who desperately need it. Our pipeline of Phase III and near Phase III programs also achieved significant value-driving milestones in this quarter. Our medicines targeting SOD1-ALS and Huntington's disease entered Phase III development. And new data from ongoing clinical trials of - on these medicines continue to support potential of these medicines to improve the lives of patients with these fatal and debilitating diseases.

The next wave of medicines advancing toward Phase III this year include our LICA programs for LP(a)-driven cardiovascular disease and our LICA program for TTR amyloidosis. These two programs are examples of advances in our technology that have enhanced the performance of our medicines in the clinic and enabled us to broaden our pipeline to address, not only rare diseases but, many of the common diseases that affect millions of patients. Including these four medicines, we have at least 10 more medicines that have the potential to enter Phase III trials by the end of next year, and of course, that's a very exciting agenda for us and those patients.

Read the rest of this transcript on seekingalpha.com