- Biologics License Application (BLA) submission on track for Q1 2019 -
- Robust manufacturing package for BLA submission to include
positive results from pharmacokinetic comparability study -
- Conference call today at
“We are pleased to have recently announced the positive results from our pharmacokinetic (PK) comparability study for eptinezumab as we are now in the final stages of compiling the integrated data package for our BLA submission, which continues to be on track for the first quarter of 2019,” said
Recent Company Highlights
- Announced positive results from a PK study intended to support the comparability evaluation of the clinical supply for eptinezumab and its planned commercial supply. Both the primary and key secondary PK results met the standard pre-specified acceptance criteria for drug product comparability. Further, the test and reference products were well-tolerated with a similar adverse event profile, and this safety profile was consistent with what has previously been reported for eptinezumab.
- Remains on track to complete a robust and integrated BLA submission in the first quarter of 2019, including chemistry, manufacturing, and controls (CMC) processes, positive results from the comparative PK study and data from eptinezumab’s PROMISE 1 and PROMISE 2 pivotal Phase 3 clinical trials, as well as the long-term safety study.
- Continued to conduct commercial readiness activities, including expanding the Company’s Medical Science Liaison team; recruiting commercial personnel; and building its reimbursement and distribution services in anticipation of eptinezumab’s potential launch in the first quarter of 2020.
Third Quarter 2018 Financial Results
- As of
September 30, 2018, Alder had $484.7 millionin cash, cash equivalents, investments and restricted cash compared to $536.1 millionas of June 30, 2018.
- Research and development expenses for the third quarter ended
September 30, 2018totaled $47.8 million, compared to $52.2 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 manufacturing activities and consulting fees to support the planned BLA submission and the production of commercial supply.
- General and administrative expenses for the third quarter ended
September 30, 2018totaled $10.7 million, compared to $8.2 millionfor the same period in 2017. The increase in spending was primarily due to headcount growth and expenses to support commercial readiness activities.
- Net loss applicable to common stockholders for the third quarter ended
September 30, 2018totaled $62.2 million, or $0.91per share, compared to net loss of $59.6 million, or $0.92per share on a fully-diluted basis, for the same period in 2017.
- Alder believes its available cash, cash equivalents, investments and restricted cash will be sufficient to meet the company’s projected operating requirements into 2020.
Conference Call and Webcast
Alder will host a conference call today at
This press release contains forward-looking statements, including, without limitation, statements relating to: the planned BLA submission with the
|Condensed Consolidated Balance Sheets|
|(Amounts in thousands)|
|September 30,||December 31,|
|Cash, cash equivalents, investments and restricted cash||$||484,684||$||286,240|
|Prepaid expenses and other assets||12,069||16,896|
|Convertible notes, net of discount||$||179,038||$||—|
|Convertible preferred stock||101,095||—|
|Total stockholders’ equity||184,032||279,275|
|Total liabilities, convertible preferred stock and stockholders’ equity||$||496,753||$||303,136|
|Condensed Consolidated Statements of Operations|
|(Amounts in thousands, except share and per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Collaboration and license agreements||$||—||$||—||$||—||$||683|
|Cost of sales||—||—||—||683|
|Research and development||47,793||52,188||174,659||208,153|
|General and administrative||10,685||8,236||34,501||27,765|
|Total operating expenses||58,478||60,424||209,160||236,601|
|Loss from operations||(58,478||)||(60,424||)||(209,160||)||(235,918||)|
|Other income (expense), net||(2,442||)||859||(7,180||)||1,396|
|Dividends on convertible preferred stock||(1,279||)||—||(4,664||)||—|
|Deemed dividend on convertible preferred stock related to accretion of beneficial conversion feature||—||—||(29,460||)||—|
|Net loss applicable to common stockholders||$||(62,199||)||$||(59,565||)||$||(250,464||)||$||(234,522||)|
|Net loss per share applicable to common stockholders - basic and diluted||$||(0.91||)||$||(0.92||)||$||(3.68||)||$||(4.25||)|
|Weighted average number of common shares used in net loss per share - basic and diluted||68,232,765||64,526,519||68,015,989||55,168,433|
Investor Relations Contact:
Stern Investor Relations, Inc.
Source: Alder BioPharmaceuticals, Inc.