- 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
- Strong cash position to meet projected operating requirements into 2020 and the anticipated launch of eptinezumab -
- Conference call today at
“2018 was a seminal year for Alder, capped by the completion of eptinezumab’s BLA submission to the
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
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 Streckas 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 Campoyas 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 $3Bin sales and drove significant growth across all product divisions, including Neurosciences and BOTOX®.
- 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 millionin cash and cash equivalents, short-term investments and restricted cash, compared to $484.7 millionas of Sept. 30, 2018and compared to $286.2 millionas of December 31, 2017.
- Research and development expenses for the fourth quarter ended
December 31, 2018totaled $64.4 million, compared to $44.7 millionfor the same period in 2017. For the full year 2018, research and development expenses totaled $239.1 million, compared to $252.9 millionfor 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, 2018totaled $13.0 million, compared to $10.3 millionfor the same period in 2017. For the full year 2018, general and administrative expenses totaled $47.5 million, compared to $38.1 millionfor 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, 2018totaled $81.5 million, or $1.19per share, compared to net loss of $54.4 million, or $0.80per 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 $4.87per share on a fully-diluted basis, compared to net loss of $288.9 million, or $4.95per share, for the full year 2017.
- 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 $315 million dollars. The majority of the spend is focused on ensuring that Alder is prepared for the potential launch of eptinezumab in the first quarter of 2020, including advancing eptinezumab’s supply chain, building commercial inventory, continuing to build out Alder’s commercial footprint and other pre-launch market readiness activities.
- Alder believes its available cash, cash equivalents, short-term investments and restricted cash will be sufficient to meet the company’s projected operating requirements into 2020 and the anticipated launch of eptinezumab.
Conference Call and Webcast
Alder will host a conference call today at
This press release contains forward-looking statements, including, without limitation, statements relating to: the potential approval by the
|Consolidated Balance Sheets|
|(Amounts in thousands)|
|December 31||December 31,|
|Cash, cash equivalents, investments and restricted cash||$||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.
Source: Alder BioPharmaceuticals, Inc.