On February 25, 2019 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported its financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Alder Biopharmaceuticals, FEB 25, 2019, View Source [SID1234533649]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

r 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

On February 22, Alder announced it completed its BLA submission for eptinezumab with the FDA. The BLA submission was supported by positive results from Alder’s two positive Phase 3 trials of eptinezumab, positive results from an open-label safety study and a pharmacokinetic (PK) comparability study, and chemistry, manufacturing, and controls (CMC) data packages.

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 its first in-human clinical study by the end of 2019.

In January, Alder announced the appointment of Dr. Paul Streck 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.

2018 Company Milestones

In December, Alder announced the appointment of Carlos Campoy as Chief Financial Officer. He brings nearly 30 years of financial leadership and expertise across global publicly-traded companies, including more than 20 years in the biopharmaceutical and healthcare sectors. Mr. Campoy previously served as Vice President of Finance, International at Allergan plc, where he had financial responsibility for $3B in sales and drove significant growth across all product divisions, including Neurosciences and BOTOXÒ.

In October, Alder announced positive results from a comparative PK study that supported 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.

In June, new data from Alder’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials for eptinezumab in episodic and chronic migraine patients, respectively, were presented at the American Headache Society Meeting. The new data highlighted the strength of eptinezumab’s efficacy data by showing sustained or increased efficacy following subsequent quarterly administrations of eptinezumab.

In April, new data from Alder’s PROMISE 1 Phase 3 clinical trial for eptinezumab in episodic migraine patients were presented at the 70th Annual AAN Meeting. The new data demonstrated long-term and sustained or further increased efficacy in episodic migraine following the third and fourth quarterly infusion, as well as increased migraine-free intervals and improved quality of life outcomes.

Also in the second quarter of 2018, Alder completed a one-year safety study of eptinezumab, which generated favorable safety and tolerability data and demonstrated a favorable safety profile consistent with previous eptinezumab studies.

In January, Alder announced eptinezumab significantly reduced migraine risk and met the primary and all key secondary endpoints in its pivotal PROMISE 2 Phase 3 clinical trial for chronic migraine prevention.

Also in January 2018, Alder entered into a settlement and global license agreement with Teva Pharmaceuticals International GmbH, which provided clarity regarding Alder’s freedom to develop, manufacture and commercialize eptinezumab in the U.S. and globally.

Fourth Quarter and Year-End 2018 Financial Results

As of December 31, 2018, Alder had $412.4 million in cash and cash equivalents, short-term investments and restricted cash, compared to $484.7 million as of Sept. 30, 2018 and compared to $286.2 million as of December 31, 2017.

Research and development expenses for the fourth quarter ended December 31, 2018 totaled $64.4 million, compared to $44.7 million for the same period in 2017. For the full year 2018, research and development expenses totaled $239.1 million, compared to $252.9 million for the full year 2017. The year-over-year decrease was primarily due to lower clinical trial costs in 2018 as a result of the completion of several clinical trials.

General and administrative expenses for the fourth quarter ended December 31, 2018 totaled $13.0 million, compared to $10.3 million for the same period in 2017. For the full year 2018, general and administrative expenses totaled $47.5 million, compared to $38.1 million for the full year 2017. The year-over-year increases reflect Alder’s continued commitment to advance the eptinezumab program and position Alder for commercialization.

Net loss applicable to common stockholders for the fourth quarter ended December 31, 2018 totaled $81.5 million, or $1.19 per share, compared to net loss of $54.4 million, or $0.80 per share on a fully-diluted basis, for the same period in 2017. For the full year 2018, net loss applicable to common stockholders totaled $331.9 million, or $4.87 per share on a fully-diluted basis, compared to net loss of $288.9 million, or $4.95 per share, for the full year 2017.

Financial Outlook

Alder expects 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 dollars. 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, short-term investments and restricted cash will be sufficient to meet the company’s projected operating requirements into 2020 and the anticipated launch of eptinezumab.

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.