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Ionis Pharmaceuticals, Inc. (IONS)

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Ionis Pharmaceuticals, Inc. (IONS)

Q3 2018 Earnings Conference Call

November 06, 2018 11:30 AM ET

Executives

Wade Walke - 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

Analysts

Tyler Van Buren - Piper Jaffray

Ben Burnett - Stifel

Chad Messer - Needham & Company

Gena Wang - Barclays

Jessica Fye - JPMorgan

Yanan Zhu - Wells Fargo

Vincent Chen - Bernstein

Ritu Baral - Cowen & Company

Yale Jen - Laidlaw & Company

David Lebowitz - Morgan Stanley

Presentation

Operator

Good morning, and welcome to the Ionis Pharmaceuticals Third Quarter 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, Cole. Before we begin, I encourage everyone to go to the Investor section of the Ionis website to find our press release and the related financial tables, including the reconciliation of the GAAP to pro forma financial measures that we will discuss today. We believe pro forma 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 the call are today are Stan Crooke, Chairman of the Board and Chief Executive Officer; Beth Hougen, Chief Financial Officer; Damien McDevitt, Chief Business Officer; and Brett Monia, Chief Operating Officer. I would like to draw your attention to slide three which contains our forward-looking language statement which we'll be making today, forward-looking language 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 details.

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

Stan Crooke

Thanks, Wade, and good morning, everyone. Thanks for joining us. In the third quarter, we achieved a number of important milestones, and in the aggregate that results in continued financial strength for the Company. We're on track for our third consecutive year of pro forma operating income, and we're doing this while launching TEGSEDI and preparing to launch WAYLIVRA. Our solid financial performance results from more sources of revenue including growing SPINRAZA revenue on top of our substantial base of R&D revenue from numerous successful partnerships. With the TEGSEDI launch under way, we look forward to adding commercial revenue from this drug and potentially WAYLIVRA. We expect SPINRAZA sales to continue to grow globally, given the positive new data Biogen reported from the nature study in pre-symptomatic infants.

We also expect to see continued growth in key patient segments such as the adult patients in the US which make up 60% of the SMA population, with only a fraction of those patients now being treated. Positive impact of SPINRAZA has now been recognized with several Prix Galien awards around the world, and was also recently recognized again by the scientific community with the awarding of the breakthrough prize in life sciences to Frank Bennett, our SVP of Research and Head of Neurological Disease Franchise. Frank shared this honor with Dr. Adrian Krainer of Cold Spring Harbor Laboratory. The TEGSEDI launch is now under way in multiple countries, and we and our affiliate Akcea are encouraged by the continuing enthusiasm we are seeing from the amyloidosis community for this drug with strong team, the necessary infrastructure and global strategy in place, we are confident in Akcea's ability to successfully launch TEGSEDI.

With WAYLIVRA, we and Akcea are in active discussions with EMA, and we continue our conversations for path forward with the FDA. All of these review processes are progressing. Our EAP program is going well, and we continue to work to bring all the patients with FCS, the first-ever treatment of this ultra-rare, debilitating and potentially fatal disease. In the Phase 2 study of AKCEA-APO(a)-LRx, the drug demonstrated substantial dose-dependent reductions in a Lp(a) in patients with established cardiovascular disease and elevated Lp(a). We also observed the favorable safety and tolerability profile. We're very encouraged by the drug's performance using convenient low-volume monthly doses.

We and Akcea, along with our partner Novartis, now have what we need to select a dose and advance the drug into a large cardiovascular outcome study to demonstrate the cardiovascular benefits of lowering Lp(a), genetically validated driver cardiovascular disease affecting millions of patients worldwide. Phase 2 study of APO(a)-LRx is the largest and the longest study of a LICA drug today, with nearly 300 patients dosed up to 12 months. Robust target reduction and favorable safety and tolerability profile observed in this study adds to our confidence in the potential of LICA drugs to treat a broad range of diseases with convenient dosing regimens.

Roche expects to initiate the Phase 3 program for IONIS-HTTRx in patients with Huntington disease before the year-end, including a pivotal study and a natural history study. Building on our successful relationship with Roche, we entered a new collaboration to the development of Ionis factor B LRx. For the treatment of patients with a broad range of complement-mediated diseases beginning with geographic atrophy, the advanced stage of dry age-related macular degeneration.

We believe Roche is the right partner to maximize the potential for success of this program, and the substantial level of participation we retain in the drug's commercial success is another example of the strong value of our antisense platform. Beyond these important highlights, we've had numerous other pipeline achievements which not only contribute to our significant financial strength, but more importantly show that important new drugs we are advancing closure to patients who desperately need it. Our focus remains on delivering innovative new medicines to patients in need, while positioning the Company for continued growth.

Read the rest of this transcript on seekingalpha.com