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Data presented at American Academy of Neurology and American Headache Society Annual Meetings continue to support eptinezumab’s differentiated clinical profile and impact on quality of life measures
Core commercial leadership team secured, including field payer team, in anticipation of expected eptinezumab U.S. launch in 1Q 2020, assuming FDA approval
Key milestones anticipated in 2H 2019, including completed commercial footprint, start of acute study and advancement of second product candidate, ALD1910, into clinical development
Conference call today at 5:00 p.m. ET
BOTHELL, Wash., Aug. 06, 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 second quarter ended June 30, 2019.
“We continue to make significant progress toward the potential launch of eptinezumab in the U.S. in the first quarter of 2020. We have our commercial leadership team in place, with experienced personnel leading sales, marketing and market access. The team is sharpening our go-to-market strategy and expects to complete our commercial footprint later this year. We recently presented additional data further confirming eptinezumab’s differentiated clinical profile and benefits in patient-reported outcomes at the 2019 American Headache Society and American Academy of Neurology Annual Meetings,” said Bob Azelby, Alder’s president and chief executive officer. “Looking forward, we believe there is a large opportunity to build value at Alder in the latter half of the year, with the initiation of eptinezumab’s acute study and the advancement of our product candidate, ALD1910, into the clinic. These collective activities align with our mission to forever change the migraine treatment landscape and give people with migraines their lives back.”
Second Quarter 2019 Highlights and Recent Developments
Upcoming Anticipated Milestones
Second Quarter 2019 Financial Results
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 $285 to $315 million. The majority of the spend is focused on ensuring that Alder is prepared for the potential launch of eptinezumab in the first quarter of 2020, including advancing eptinezumab’s supply chain, building commercial inventory, continuing to build out Alder’s commercial footprint and other pre-launch market readiness activities.
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 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 6561825. 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 migraine treatment through the discovery, development and commercialization of novel therapeutic antibodies. The company’s mission is to forever change migraine treatment and give people with migraine their lives back. In 2019, Alder was ranked 19th among the top 100 fastest growing companies in Seattle by Growjo.
Eptinezumab, Alder’s lead product candidate for migraine prevention, is an investigational monoclonal antibody (mAb) that is delivered via IV and designed for 100% bioavailability with high specificity and strong binding for suppression of calcitonin gene-related peptide (CGRP). If approved by the U.S. Food and Drug Administration, it will be the first IV therapy for migraine prevention. Alder is also developing ALD1910, a preclinical mAb designed to inhibit pituitary adenylate cyclase-activating polypeptide (PACAP) 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 for eptinezumab; the continued development of eptinezumab and the development of ALD1910, including the planned initiation of a first in human clinical trial; the clinical, therapeutic and commercial potential of eptinezumab and ALD1910; the anticipated commercial launch of eptinezumab and Alder’s commercialization plans and readiness activities to prepare for such launch; the planned Phase 3 clinical trial of eptinezumab for the acute treatment of migraine and Alder’s objective relating thereto; the belief that eptinezumab has the potential to be a compelling treatment option; the belief that there is a large opportunity to create value at Alder; Alder’s financial outlook, including the expected range of full-year 2019 net cash used in operating activities and purchases of property and equipment; Alder’s belief that its available cash, cash equivalents, investments and restricted cash will be sufficient to meet the company’s projected operating requirements through the anticipated launch of eptinezumab and into the latter part of 2020 and Alder’s mission to forever change migraine treatment and give people with migraine their lives back. Words such as “will,” “expected,” “anticipated”, “differentiated”, “compelling”, “benefits,” “build,” “continue,” “prepare,” “mission,” “initiate,” “sufficient,” “objective,” “advance,” “outlook,” “projected,” “potential,” “option,” “can,” “plan”, “believe,” “looking forward,” 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 build out of Alder’s commercialization infrastructure; risks and uncertainties relating to the manufacture and supply of eptinezumab; 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 Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, which was filed with the Securities and Exchange Commission (SEC) on August 6, 2019, 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.
|Condensed Consolidated Balance Sheets|
|(Amounts in thousands)|
|June 30,||December 31,|
|Cash, cash equivalents, investments and restricted cash||$||440,652||$||412,369|
|Prepaid expenses and other assets||21,915||13,870|
|Convertible notes, net of discount||$||188,323||$||182,104|
|Convertible preferred stock||106,546||103,755|
|Total stockholders’ equity||110,305||109,976|
|Total liabilities, convertible preferred stock and stockholders’ equity||$||462,567||$||426,239|
|Condensed Consolidated Statements of Operations|
|(Amounts in thousands, except share and per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Collaboration and license agreements||$||—||$||—||$||—||$||—|
|Research and development||34,125||52,818||103,714||126,866|
|General and administrative||21,633||11,911||66,131||23,464|
|Total operating expenses||55,758||64,729||169,845||150,330|
|Loss from operations||(55,758||)||(64,729||)||(169,845||)||(150,330||)|
|Other income (expense), net||(2,653||)||(3,660||)||(6,500||)||(5,090||)|
|Dividends on convertible preferred stock||(1,480||)||(2,302||)||(2,791||)||(3,385||)|
|Deemed dividend on convertible preferred stock related to accretion of beneficial conversion feature||—||—||—||(29,460||)|
|Net loss applicable to common stockholders||$||(59,891||)||$||(70,691||)||$||(179,136||)||$||(188,265||)|
|Net loss per share applicable to common stockholders - basic and diluted||$||(0.72||)||$||(1.04||)||$||(2.29||)||$||(2.77||)|
|Weighted average number of common shares used in net loss per share - basic and diluted||83,479,867||67,966,066||78,297,180||67,905,804|
Investor Relations Contact:
Stern Investor Relations, Inc.
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