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`February 25, 2019 at 4:05 PM EST
`
`Alder BioPharmaceuticals® Reports Fourth Quarter and Full Year
`2018 Financial and Operating Results
`
`- 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 Ocer and Dr. Paul
`Streck as Chief Medical Ocer -
`        
`- 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 nancial 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
`
`EX2259
`Eli Lilly & Co. v. Teva Pharms. Int'l GMBH
`IPR2018-01423
`
`1
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`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 ocer of Alder. “We achieved all of the signicant
`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 dierentiated prole, 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 rst 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 condence that we will be positioned to initiate a rst 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 rst 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 rst in-human clinical study
`by the end of 2019.
` 
`In January, Alder announced the appointment of Dr. Paul Streck as Chief Medical Ocer. He brings more
`than 25 years of experience in drug development, regulatory and medical aairs leadership across both
`large and small publicly traded biopharmaceutical companies. Dr. Streck previously served as Chief
`Medical Ocer at Insmed Incorporated, where he played an instrumental role as a member of the
`executive leadership team and successfully led the Arikayce regulatory ling, approval and launch.
`®
`2018 Company Milestones
`
`In December, Alder announced the appointment of Carlos Campoy as Chief Financial Ocer. He brings
`nearly 30 years of nancial 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 nancial responsibility for $3B in
`sales and drove signicant 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-specied acceptance criteria for drug
`
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`

`

`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 ecacy data by showing sustained or
`increased ecacy 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 ecacy 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 prole consistent
`with previous eptinezumab studies.
`
`In January, Alder announced eptinezumab signicantly 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 reect 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 rst 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
`sucient to meet the company’s projected operating requirements into 2020 and the anticipated launch
`of eptinezumab.
`
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`Conference Call and Webcast
`Alder will host a conference call today at 5:00 p.m. ET to discuss these nancial 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 specically designed as an infusion therapy to address
`signicant 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. 
`
`Forward-Looking Statements
`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 rst in human clinical trial; the anticipated benets to Alder under its settlement and
`global license agreement with Teva Pharmaceuticals International GmbH; and Alder’s nancial 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
`sucient to meet the company’s projected operating requirements into 2020 and the anticipated launch of
`eptinezumab. Words such as “on track,” “projected,” “anticipated,” “dierentiated,” “believe,” “will,” “continue,”
`“enable,” “condence,” “expects,” “clarity,” “outlook,” “sucient,” 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 dier 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 ecacy in clinical
`testing; Alder's ability to conduct clinical trials and studies of ALD1910 sucient 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 suciency 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 scal
`year ended December 31, 2018, which was led 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 lings 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,
`
`4
`
`

`

`obligation or undertaking to release publicly any updates or revisions to any forward-looking statements
`contained herein to reect 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
`(Unaudited)
`(Amounts in thousands)
` 
` 
` 
`Cash, cash equivalents, investments and restricted cash
`Prepaid expenses and other assets
`Total assets
` 
`Convertible notes, net of discount
`Other liabilities
`Convertible preferred stock
`Total stockholders’ equity 
`Total liabilities, convertible preferred stock and stockholders’ equity
` 
`
`
` 
` 
` 
`
` 
`
`$
`
`$
`
` 
`   
` 
`   
` 
`   
` 
`December 31   December 31,
` 
`2018
` 
`2017
` 
` 
` 
` 
`  412,369   $
`  286,240  
`13,870  
`16,896  
`  426,239   $
`  303,136  
`   
`   
`  182,104   $
`—  
`  30,404  
`  23,861  
`  103,755  
`  —  
`  109,976  
`  279,275  
`  426,239   $
`  303,136  
`   
` 
`
`$
`
`$
`
`Consolidated Statements of Operations
`(Unaudited)
`(Amounts in thousands, except share and per share data)
` 
` 
` 
` 
` 
`Revenues
`Collaboration and license agreements
`Operating expenses
`Cost of sales
`Research and development
`General and administrative
`Total operating expenses
`Loss from operations
`Other income (expense), net
`Net loss
`Dividends on convertible preferred stock
`Deemed dividend on convertible preferred stock
`related to accretion of benecial conversion
`feature
`Net loss applicable to common stockholders
`Net loss per share applicable to common stockholders -
`basic and diluted
`Weighted average number of common shares used in net
`loss per share - basic and diluted
`
`   
`   
`
`   
`
` 
` 
` 
`$
` 
` 
` 
` 
` 
` 
` 
`$
` 
` 
` 
` 
`$
`
`$
`
`       
`       
`       
`       
`Three Months Ended 
`December 31 
`2018
`     
`2017
`       
`       
`   —     $
`       
`  —      
`  64,449      
`  12,973      
`77,422      
`(77,422 )    
`  (2,667 )    
`(80,089 )   $
`  (1,381 )    
`       
`  —      
`       
`(81,470 )   $
`
`       
`       
`       
`       
`   
`   
`     
`       
`       
`936     $
`       
`936      
`44,749      
`10,337      
`56,022      
`(55,086 )    
`729      
`(54,357 )   $
`  —      
`       
`  —      
`       
`(54,357 )   $
`
`       
`       
`       
`       
`Years Ended 
`December 31 
`2018
`     
`2017
`       
`       
`   —     $
`       
`  —      
`  239,108      
`  47,474      
`286,582      
`(286,582 )  
` 
`  (9,847 )  
` 
`(296,429 )   $
`  (6,045 )  
` 
`     
` 
`  (29,460 )  
` 
`     
` 
`(331,934 )   $
`
`   
`   
`   
`   
`   
`   
`   
`     
`     
`1,619    
`     
`1,619    
`252,902    
`38,102    
`292,623    
`(291,004 )  
`2,125    
`(288,879 )  
`  —    
`     
`  —    
`     
`(288,879 )  
`
` (1.19 )   $
`
`(0.80 )   $
`
`(4.87 )   $
`
`(4.95 )  
`
`  68,345,744       67,780,176       68,099,105    
`
`  58,347,284    
`
`5
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`

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`       
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`     
`
` 
`
`     
`
` 
`
`Investor Relations Contact:                                        
`Michael Schazin
`Stern Investor Relations, Inc.
`212-362-1200
`michael@sternir.com
`
`Media Contact: 
`Ashley Cadle
`TogoRun
`a.cadle@togorun.com
`310.463.0143
`
`Source: Alder BioPharmaceuticals, Inc.
`
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`© 2019 ALDER BIOPHARMACEUTICALS INC. ALL RIGHTS RESERVED.
`
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