- Presented new eptinezumab Phase 3 clinical trial data in episodic and chronic migraine demonstrating robust efficacy that is sustained and further improved after repeat quarterly treatments -
- Biologics License Application (BLA) submission on track for Q1 2019 -
- Conference call today at
“During the second quarter, the new data we presented from our Phase 3 clinical trials in episodic and chronic migraine further highlighted eptinezumab’s encouraging clinical profile for migraine prevention, including increased efficacy following additional quarterly infusions,” said
Recent Company Highlights
- Presented new PROMISE 1 and PROMISE 2 Phase 3 clinical trial data for eptinezumab, Alder’s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP), at the
American Academy of Neurology(AAN) and the American Headache Society Meeting (AHS) during the second quarter. Highlights include:
- One-year data from the PROMISE 1 Phase 3 trial demonstrated long-term and increasing efficacy in episodic migraine following the third and fourth quarterly infusions.1
- Six-month data for eptinezumab from the PROMISE 2 Phase 3 trial demonstrated improved efficacy for chronic migraine following the second quarterly infusion.1
- These data from PROMISE 1 and PROMISE 2 continue to reinforce eptinezumab’s potential competitive clinical profile.
- Alder’s one-year safety study of eptinezumab was completed with a safety profile consistent with previous eptinezumab studies.
- All milestones remain on track for Alder’s planned BLA submission in Q1 2019.
Second Quarter 2018 Financial Results
- As of
June 30, 2018, Alder had $536.1 millionin cash, cash equivalents, investments and restricted cash compared to $587.0 millionas of March 31, 2018.
- Research and development expenses for the second quarter ended
June 30, 2018totaled $52.8 million, compared to $65.3 millionfor the same period in 2017. The decrease in expenses was primarily due to lower eptinezumab clinical trial expense as the company nears completion of patient treatments for several clinical trials, offset by an increase in compensation as a result of an increase in internal headcount, and consulting fees to support manufacturing activities and the planned BLA submission.
- General and administrative expenses for the second quarter ended
June 30, 2018totaled $12.2 million, compared to $9.5 millionfor the same period in 2017. The increase in spending was primarily due to an increase in stock-based compensation and expenses to support commercial readiness activities.
- Net loss applicable to common stockholders for the second quarter ended
June 30, 2018totaled $70.7 million, or $1.04per share, compared to net loss of $74.6 million, or $1.48per share on a fully-diluted basis, for the same period in 2017.
- Alder believes its available cash, cash equivalents, short-term investments and restricted cash will be sufficient to meet the company’s projected operating requirements into 2020.
1. For additional details regarding the trial results, please refer to Alder’s previous data press releases, which can be found at https://investor.alderbio.com/press-releases
Conference Call and Webcast
Alder will host a conference call today at
This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical, therapeutic and commercial potential of eptinezumab; the planned BLA submission with the
|Condensed Consolidated Balance Sheets|
|(Amounts in thousands)|
|June 30,||December 31,|
|Cash, cash equivalents, investments and restricted cash||$||536,142||$||286,240|
|Prepaid expenses and other assets||12,208||16,896|
|Convertible notes, net of discount||$||176,052||$||—|
|Convertible preferred stock||101,095||—|
|Total stockholders’ equity||239,666||279,275|
|Total liabilities, convertible preferred stock and stockholders’ equity||$||548,350||$||303,136|
|Condensed Consolidated Statements of Operations|
|(Amounts in thousands, except share and per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Collaboration and license agreements||$||—||$||683||$||—||$||683|
|Cost of sales||—||683||—||683|
|Research and development||52,818||65,276||126,866||155,965|
|General and administrative||12,154||9,548||23,816||19,529|
|Total operating expenses||64,972||75,507||150,682||176,177|
|Loss from operations||(64,972||)||(74,824||)||(150,682||)||(175,494||)|
|Other income (expense), net||(3,417||)||195||(4,738||)||537|
|Dividends on convertible preferred stock paid in kind||(2,302||)||—||(3,385||)||—|
|Deemed dividend on convertible preferred stock related to accretion of beneficial conversion feature||—||—||(29,460||)||—|
|Net loss applicable to common stockholders||$||(70,691||)||$||(74,629||)||$||(188,265||)||$||(174,957||)|
|Net loss per share applicable to common stockholders - basic and diluted||$||(1.04||)||$||(1.48||)||$||(2.77||)||$||(3.47||)|
|Weighted average number of common shares used in net loss per share - basic and diluted||67,966,066||50,427,865||67,905,804||50,411,837|
Investor Relations Contact:
Vice President, Corporate Strategy
Stern Investor Relations, Inc.
Source: Alder BioPharmaceuticals, Inc.