Alder Biopharmaceuticals Inc. (NASDAQ:ALDR) Q3 2018 Earnings Conference Call Transcript

Nov 06, 2018 • 05:00 pm ET

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Alder Biopharmaceuticals Inc. (NASDAQ:ALDR) Q3 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good afternoon, and welcome to the Alder BioPharmaceuticals Third Quarter 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that the call is being recorded by the company's request.

At this time, I'd like to turn the call over to Michael Schaffzin of Stern Investor Relations. Please proceed.

Executive
Michael Schaffzin

Thank you, operator. Good afternoon, and thank you for joining us. Just after today's market close, we filed our Form 10-Q for the third quarter of 2018 with the Securities and Exchange Commission and issued a press release reporting on our third quarter 2018 financial and operating results, both of which are available in the Investors section of our website at www.alderbio.com. You may listen to a live webcast and listen to a replay of today's call on the Investors section of the website.

Today in our call, we have Bob Azelby, CEO; Dr. Eric Carter, Interim CMO; and Larry Benedict, EVP and Principal Accounting Officer; as well as Elisabeth Sandoval, Chief Commercial Officer and EVP of Corporate Strategy.

(Forward-Looking Cautionary Statements)

With that, let me pass the call over to Bob.

Executive
Robert Azelby

Thank you, Michael, and welcome, everyone, to our call to discuss Alder's third quarter highlights and results. As we approach our anticipated BLA filing for eptinezumab in the first quarter of 2019, we recently announced positive results for our PK comparability study, which demonstrated the comparability of epti between our clinical trials and commercial supply. Eric will discuss the results in more detail, but in short, we are pleased with the outcome. Importantly, these results, together with our chemistry, manufacturing, and controls and clinical data packages, puts us in a position to prepare a robust, high-quality BLA. Additionally, we have had constructive engagement with the FDA during our pre-BLA meetings and remain encouraged by the strength of our data package.

Now I'd like to provide an in-depth look at why we think epti is uniquely positioned to capture a distinct segment of the market, if approved by the FDA. To start, of the 13 million patients who are migraine prevention candidates, it's estimated that only 3.5 million are currently receiving treatment, which equates to an approximately 25% treatment penetration rate for a highly symptomatic and debilitating disease. It's been estimated that prior to the launch of anti-CGRPs, despite the many treatment options available, only 40% of prophylactically-treated patients were satisfied with their current treatment plan.

Based on these dynamics, there is clearly a large unmet need for preventative therapies, and we believe both migraine treatment penetration and anti-CGRP class share will grow significantly over the coming years. This has been further validated by the recent anti-CGRP launches, with prescription data from the first few months of launch suggesting over 100,000 patients have already been prescribed an anti-CGRP. Taken together, these factors reinforce our confidence and in the potential size of the prevention market and the market opportunity for epti,