- Acute study planned for potential eptinezumab label expansion -
- Conference call today at
“The recent acceptance by the
First Quarter 2019 Highlights
April 22, 2019, Alder announced its BLA submission for eptinezumab, the company’s investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and lead commercial candidate, was accepted by the FDA. The FDAhas set the Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2020. The BLA includes, and is supported by, positive data from Alder’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials, open-label safety study, pharmacokinetic (PK) comparability study and chemistry, manufacturing, and controls (CMC) data packages.
- In April, Alder announced the appointment of
Nadia Dacas chief commercial officer. Ms. Dac brings more than two decades of U.S. and global commercial experience in neurology with both large and small publicly traded biopharmaceutical companies, with extensive expertise across all commercial functions including marketing, market access and promotion, sales, pipeline management, business development and partnerships. She joins Alder from AbbVie, where she served as vice president of global specialty commercial development.
- In March, Alder closed an underwritten public offering and concurrent private placement in which the company received net proceeds of
$159.3 million(which included the exercise of an over-allotment option granted to the underwriters in the public offering).
- In January, Alder announced the appointment of Dr.
Paul Streck, M.D. as chief medical officer. He brings more than 25 years of experience in drug development, regulatory and medical affairs leadership across both large and small publicly traded biopharmaceutical companies. Dr. Streck previously served as chief medical officer at Insmed Incorporated, where he played an instrumental role as a member of the executive leadership team and successfully led the Arikayce® regulatory filing, approval and launch.
- In January, an amendment to Alder’s contract manufacturing agreement with
Sandoz GmbHfor the production of eptinezumab became effective. Pursuant to this amendment, Sandozwill manufacture and supply guaranteed quantities of eptinezumab drug substance for a five year term, running through 2023. Alder anticipates the guaranteed quantities will be sufficient to supply U.S. and ex-U.S. markets beyond 2023, if eptinezumab is approved.
Upcoming Anticipated Milestones
- Alder plans to initiate a Phase 3 clinical trial evaluating eptinezumab as a treatment for acute migraine in the second half of 2019. The trial will seek to leverage eptinezumab’s 100% bioavailability and rapid onset of prevention demonstrated in clinical testing, with the objective of securing an indication for the acute treatment of migraine and positioning eptinezumab as the only anti-CGRP monoclonal antibody for the treatment and prevention of migraine, if approved for these indications.
- Alder remains on track for the potential commercial launch of eptinezumab in the first quarter of 2020, and continues to advance its manufacturing and commercial readiness activities in anticipation of launch. Currently, Alder is advancing its supply chain, building commercial inventory, continuing to build out its commercial and operational infrastructure, and executing against other key pre-launch initiatives.
- Alder continues to advance its pre-clinical candidate, ALD1910, a monoclonal antibody targeting PACAP-38 (pituitary adenylate cyclase-activating peptide-38). ALD1910 is currently undergoing Investigational New Drug (IND)-enabling preclinical studies and Alder expects to initiate a first in-human clinical study by the end of 2019.
First Quarter 2019 Financial Results
- As of
March 31, 2019, Alder had $498.5 millionin cash, cash equivalents, investments and restricted cash, compared to $412.4 millionas of December 31, 2018.
- Research and development expenses for the first quarter ended
March 31, 2019totaled $69.6 million, compared to $74.0 millionfor the same period in 2018. The year-over-year decrease was primarily due to lower clinical trial costs, partially offset by expenses related to securing manufacturing capacity and the initial build of commercial inventory in preparation for the launch of eptinezumab.
- General and administrative expenses for the first quarter ended
March 31, 2019totaled $44.5 million, compared to $11.6 millionfor the same period in 2018. The year-over-year increase reflects a $26 millionloss contingency provision relating to a dispute over a contract we terminated for breach by the other party, as well as Alder’s continued ramp-up of the commercial organization and infrastructure required for the anticipated commercialization of eptinezumab.
- Net loss applicable to common stockholders for the first quarter ended
March 31, 2019totaled $119.2 million, or $1.63per share, compared to net loss of $117.6 million, or $1.73per share on a fully-diluted basis, for the same period in 2018.
Alder continues to expect that full-year 2019 net cash used in operating activities and purchases of property and equipment will be in the range of
Alder believes its available cash, cash equivalents, investments and restricted cash will be sufficient to meet its projected operating requirements through the anticipated launch of eptinezumab and into the latter part of 2020.
Conference Call and Webcast
Alder will host a conference call today at
This press release contains forward-looking statements, including, without limitation, statements relating to: the potential approval by the
|Condensed Consolidated Balance Sheets|
|(Amounts in thousands)|
|March 31,||December 31,|
|Cash, cash equivalents, investments and restricted cash||$||498,508||$||412,369|
|Prepaid expenses and other assets||14,660||13,870|
|Convertible notes, net of discount||$||185,146||$||182,104|
|Convertible preferred stock||103,755||103,755|
|Total stockholders’ equity||157,053||109,976|
|Total liabilities, convertible preferred stock and stockholders’ equity||$||513,168||$||426,239|
|Condensed Consolidated Statements of Operations|
|(Amounts in thousands, except share and per share data)|
|Three Months Ended|
|Collaboration and license agreements||$||—||$||—|
|Research and development||69,589||74,048|
|General and administrative||44,498||11,553|
|Total operating expenses||114,087||85,601|
|Loss from operations||(114,087||)||(85,601||)|
|Other income (expense), net||(3,847||)||(1,430||)|
|Dividends on convertible preferred stock||(1,311||)||(1,083||)|
|Deemed dividend on convertible preferred stock related to accretion of beneficial conversion feature||—||(29,460||)|
|Net loss applicable to common stockholders||$||(119,245||)||$||(117,574||)|
|Net loss per share applicable to common stockholders - basic and diluted||$||(1.63||)||$||(1.73||)|
|Weighted average number of common shares used in net loss per share - basic and diluted||73,056,907||67,844,872|
Investor Relations Contact:
Stern Investor Relations, Inc.
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Source: Alder BioPharmaceuticals, Inc.