Loading, Please Wait...
- Completes eptinezumab’s Biologics License Application (BLA) submission -
- Remains on track for eptinezumab’s commercial launch in Q1-2020 -
- Strengthens leadership team with the appointments of Carlos Campoy as Chief Financial Officer and Dr. Paul Streck as Chief Medical Officer
- Strong cash position to meet projected operating requirements into 2020 and the anticipated launch of eptinezumab -
- Conference call today at 5:00 p.m. ET -
BOTHELL, Wash., Feb. 25, 2019 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today provided a corporate update and reported its financial results for the fourth quarter and full year ended December 31, 2018. Alder also noted that it announced the completion of its Biologics License Application (BLA) submission for eptinezumab, the company’s investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide and lead commercial candidate, with the Food and Drug Administration (FDA) on February 22, 2019.
“2018 was a seminal year for Alder, capped by the completion of eptinezumab’s BLA submission to the FDA last week,” said Bob Azelby, president and chief executive officer of Alder. “We achieved all of the significant milestones we targeted for the year including positive top-line data from our PROMISE 2 Phase 3 clinical trial and positive PROMISE 1 and PROMISE 2 Phase 3 data demonstrating sustained or increased migraine prevention following subsequent infusions, as well as positive results from a pharmacokinetic study, to name a few. The achievement of these milestones further demonstrates eptinezumab’s differentiated profile, which we believe will allow Alder to compete in the highly impacted migraine patient segment.”
Mr. Azelby added, “As we look ahead to 2019, we continue to make substantial progress advancing our supply chain, building commercial inventory, expanding our commercial and operational infrastructure, and executing on key pre-launch initiatives to enable a successful commercial launch of eptinezumab in the first quarter of 2020, if approved. Additionally, consistent with our commitment to forever change migraine treatment and give patients their lives back, we are focused on advancing our pre-clinical candidate, ALD1910. The totality of our pre-clinical data to date gives us confidence that we will be positioned to initiate a first in-human clinical trial by the end of 2019.”
2019 Highlights and Upcoming Milestones
2018 Company Milestones
Fourth Quarter and Year-End 2018 Financial Results
Conference Call and Webcast
Alder will host a conference call today at 5:00 p.m. ET to discuss these financial results and recent corporate highlights. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers and providing conference ID number 7655239. The webcast will be broadcast live and can be accessed from the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The webcast will be available for replay following the call for at least 30 days.
About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals is a clinical-stage biopharmaceutical company focused on transforming the migraine treatment paradigm through the discovery, development and commercialization of novel therapeutic antibodies. Alder’s lead product candidate, eptinezumab, is a monoclonal antibody (mAb) that inhibits calcitonin gene-related peptide (CGRP) and is currently in late-stage clinical development for the prevention of migraine. Unlike other CGRP inhibitors, eptinezumab was specifically designed as an infusion therapy to address significant patient need. Alder is also developing ALD1910, a preclinical mAb that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) for migraine prevention. For more information, please visit www.alderbio.com.
This press release contains forward-looking statements, including, without limitation, statements relating to: the potential approval by the FDA of the BLA submission for eptinezumab; the anticipated commercial launch of eptinezumab and Alder’s progress with advancing manufacturing, commercial readiness and other activities and initiatives to prepare for such launch; Alder’s ability to compete in the highly impacted migraine patient segment; the clinical, therapeutic and commercial potential of eptinezumab and ALD1910; Alder’s commitment to forever change migraine treatment and give patients their lives back; the development of ALD1910, including the planned initiation of a first in human clinical trial; the anticipated benefits to Alder under its settlement and global license agreement with Teva Pharmaceuticals International GmbH; and Alder’s financial outlook, including the expected range of full-year 2019 net cash used in operating activities and purchases of property and equipment and Alder’s belief that its available cash, cash equivalents, investments and restricted cash will be sufficient to meet the company’s projected operating requirements into 2020 and the anticipated launch of eptinezumab. Words such as “on track,” “projected,” “anticipated,” “differentiated,” “believe,” “will,” “continue,” “enable,” “confidence,” “expects,” “clarity,” “outlook,” “sufficient,” or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Alder's current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the clinical, therapeutic and commercial value of eptinezumab and ALD1910; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; risks related to the potential failure of ALD1910 to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of ALD1910 sufficient to achieve a positive completion; the availability of data at the expected times; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption "Risk Factors" in Alder's Annual Report on Form 10-K for the fiscal year ended December 31, 2018, which was filed with the Securities and Exchange Commission (SEC) on February 25, 2018, and is available on the SEC's website at www.sec.gov. Additional information will also be set forth in Alder's other reports and filings it will make with the SEC from time to time. The forward-looking statements made in this press release speak only as of the date of this press release. Alder expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Alder's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
|Consolidated Balance Sheets|
|(Amounts in thousands)|
|December 31||December 31,|
|Cash, cash equivalents, investments and restricted cash||$||412,369||$||286,240|
|Prepaid expenses and other assets||13,870||16,896|
|Convertible notes, net of discount||$||182,104||$||—|
|Convertible preferred stock||103,755||—|
|Total stockholders’ equity||109,976||279,275|
|Total liabilities, convertible preferred stock and stockholders’ equity||$||426,239||$||303,136|
|Consolidated Statements of Operations|
|(Amounts in thousands, except share and per share data)|
|Three Months Ended||Years Ended|
|December 31||December 31|
|Collaboration and license agreements||$||—||$||936||$||—||$||1,619|
|Cost of sales||—||936||—||1,619|
|Research and development||64,449||44,749||239,108||252,902|
|General and administrative||12,973||10,337||47,474||38,102|
|Total operating expenses||77,422||56,022||286,582||292,623|
|Loss from operations||(77,422||)||(55,086||)||(286,582||)||(291,004||)|
|Other income (expense), net||(2,667||)||729||(9,847||)||2,125|
|Dividends on convertible preferred stock||(1,381||)||—||(6,045||)||—|
|Deemed dividend on convertible preferred stock|
|related to accretion of beneficial conversion||—||—||(29,460||)||—|
|Net loss applicable to common stockholders||$||(81,470||)||$||(54,357||)||$||(331,934||)||$||(288,879||)|
|Net loss per share applicable to common stockholders - basic and diluted||$||(1.19||)||$||(0.80||)||$||(4.87||)||$||(4.95||)|
|Weighted average number of common shares used in net loss per share - basic and diluted||68,345,744||67,780,176||68,099,105||58,347,284|
Investor Relations Contact:
Stern Investor Relations, Inc.