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Ionis Pharmaceuticals, Inc. (IONS)

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Ionis Pharmaceuticals, Inc. (IONS)

Q4 2018 Earnings Conference Call

February 27, 2019 11:30 AM ET

Company Participants

Wade Walke - Vice President, Investor Relations

Stan Crooke - Chairman of the Board & Chief Executive Officer

Beth Hougen - Chief Financial Officer

Brett Monia - Chief Operating Officer

Damien McDevitt - Chief Business Officer

Conference Call Participants

Chad Messer - Needham & Company

David Lebowitz - Morgan Stanley.

Tyler Van Buren - Piper Jaffray

Ritu Baral - Cowen

Paul Matteis - Stifel

Jessica Fye - JPMorgan

Rick Bienkowski - SVB

Yanan Zhu - Wells Fargo Securities

Gena Wang - Barclays

Yale Jen - Laidlaw & Company

Presentation

Operator

Good morning, everyone and welcome to Ionis Pharmaceuticals 2018 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, William. Before we begin, please note that we are now using non-GAAP in place of pro forma when discussing our financial results that exclude non-cash compensation expense related to equity awards. This is merely a change in the description of our adjusted results and not a change in the calculation.

As always, I encourage everyone to go to the Investors section of the Ionis website to find the press release and related financial tables, including a reconciliation of 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 have also posted slides on our website that accompany our discussion today.

With me on today's call are Stan Crooke, Chairman of the Board and Chief Executive Officer; Beth Hougen, Chief Financial Officer; Brett Monia, Chief Operating Officer; and Damien McDevitt, Chief Business Officer, who will join us for Q&A.

I would like to draw your attention to slide 3, which contains our forward-looking language statement. We will begin making forward-looking statements on this call, 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.

With that, I'll turn the call over to Stan.

Stan Crooke

Thanks, Wade, and good morning, everyone. Thank you for joining us on today's call. Today we are in our strongest financial position to-date. With growth in every element of our business, we achieved an all-time high in revenue in 2018, enabling us to substantially exceed our 2018 non-GAAP operating income guidance.

And 2018 was our third consecutive year of operating income, enabling us to realize our long-term goal of sustainable profitability. Importantly, we achieved these strong results while investing in commercial activities and continuing to advance our pipeline of first-in-class medicines, as well as continuing to invest in our technology.

SPINRAZA's blockbuster performance in 2018 continued to be a major driver of our strong financial performance, with our revenue from SPINRAZA royalties more than doubling compared to 2017. SPINRAZA is a transformational medicine, fundamentally changing the lives of patients with SMA.

We continue to see that SMA patients live longer, grow stronger and do better the longer they are treated with SPINRAZA. And with thousands of patients on treatment and years of real-world experience, SPINRAZA is the standard of care for people with SMA.

Not so early, the TEGSEDI global launch is off to a strong start, thanks to the efforts of our affiliate Akcea. In the first partial quarter of launch, TEGSEDI generated over $2 million in sales with revenue coming from both the U.S. and the EU.

We're pleased with the positive feedback from physicians and patients in both the U.S. and the EU, who are excited about TEGSEDI's impact on these patients' quality of life. We and Akcea are aiming to make TEGSEDI available to hATTR patients globally.

We're accomplishing that in part through our partnership with PTC Therapeutics in Latin America. Late last year, PTC filed for marketing authorization for TEGSEDI in Brazil, in which landed priority review. As a region with one of the largest populations of hATTR patients, potential approval in Brazil is an important milestone for TEGSEDI.

We have numerous potentially transformative medicines across our pipeline that we believe will drive growth in 2019 and beyond. Today, we have more than -- we have 10 or more medicines with the potential to advance into pivotal trials before the end of 2020. And all of these 10, we expect to have pivotal programs underway for at least four of these medicines by the end of this year.

These include our LICA medicines targeting APO(a)-LRx, targeting APO(a), TTR, and neurodegenerative medicines for Huntington's disease and ALS, all of which have achieved significant value-driving catalyst already this year.

On Monday, we earned $150 million from Novartis when they licensed Akcea APO(a)-LRx. And the Novartis decision to advance this medicine is an important additional validation of our LICA platform. As our most advanced LICA medicine, APO(a)-LRx demonstrates the potential of this game-changing technology to treat very large patient populations such as the millions of people with LP(a)-driven cardiovascular disease.

After meeting with the FDA, we and Akcea are moving rapidly to initiate the first Phase 3 study in the pivotal program for Akcea TTR LRx and which we plan to initiate in the second half of this year.

We earned a $35 million milestone payment from Roche as they enrolled the first patient in the Phase 3 study of IONIS-HTTRx in patients with Huntington's disease. Biogen licensed IONIS-SOD1 based on the positive data from the Phase 1/2 study in ALS patients with mutations in the SOD1 gene.

Read the rest of this transcript on seekingalpha.com