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Axovant Announces Third Fiscal Quarter 2018 Financial Results and Corporate Updates

BASEL, Switzerland, Feb. 07, 2019 (GLOBE NEWSWIRE) — Axovant Sciences (NASDAQ: AXON), a clinical-stage company developing innovative gene therapies, today provided financial results and corporate updates for its third fiscal quarter and nine months ended December 31, 2018.

“With the addition of new investigational gene therapies for the treatment of GM1 gangliosidosis, Tay-Sachs, and Sandhoff diseases, we are excited about having built a deep pipeline of potentially transformative gene therapies addressing serious conditions. Over the last year, Axovant has become leaner and more cutting-edge in its scientific approach, but we are no less ambitious in our drive to make a difference for patients,” said Pavan Cheruvu, M.D., Chief Executive Officer of Axovant. “We look forward to continuing this momentum with a rich set of clinical development milestones this quarter, including the first data readouts in our AXO-Lenti-PD and AXO-AAV-GM2 programs next month, and additional milestones across our pipeline throughout 2019.”

Key Highlights and Development Updates

Third-Quarter Financial Summary

For the third fiscal quarter ended December 31, 2018, research and development expenses were $21.5 million, of which $10.0 million was attributable to the upfront licensing fee paid to UMass Medical School and $1.9 million was attributable to non-cash, share-based compensation expense, net of forfeitures. General and administrative expenses for the third fiscal quarter ended December 31, 2018 were $10.9 million, of which $2.6 million was non-cash, share-based compensation expense. Net loss for the quarter ended December 31, 2018 was $34.3 million, or $0.27 per share.

Nine-Months Financial Summary

For the nine months ended December 31, 2018, research and development expenses were $80.4 million, of which $25.0 million was attributable to the upfront licensing fee paid to Oxford BioMedica, $10.0 million was attributable to the upfront licensing fee paid to Benitec Biopharma, $10.0 million was attributable to the upfront licensing fee paid to UMass Medical School and $3.3 million was attributable to non-cash, share-based compensation expense, net of forfeitures. General and administrative expenses for the nine months ended December 31, 2018 were $33.3 million, of which $9.6 million was attributable to non-cash, share-based compensation expense. Net loss for the nine months ended December 31, 2018 was $120.0 million, or $1.01 per share.

As of December 31, 2018, the Company had $84.9 million of cash and cash equivalents, working capital of $46.2 million, and long-term debt of $28.3 million. Net cash used in operating activities was $121.5 million for the nine months ended December 31, 2018, which includes the $30.0 million upfront payment to Oxford BioMedica, $5.0 million of which was applied as a credit against the process development work and clinical supply that Oxford BioMedica will provide to us, the $10.0 million upfront payment to Benitec BioPharma and the $10.0 million upfront payment to UMass Medical School.

About Axovant Sciences

Axovant Sciences is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurological and neuromuscular diseases. The company’s current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis (including Tay-Sachs disease and Sandhoff disease), Parkinson’s disease, oculopharyngeal muscular dystrophy (OPMD), amyotrophic lateral sclerosis (ALS) and frontotemporal dementia. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visit www.axovant.com.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “might,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” or “well-positioned” and other similar expressions are intended to identify forward-looking statements. For example, all statements Axovant makes regarding the initiation, timing, progress, and reporting of results of its preclinical programs, clinical trials, and research and development programs; its ability to advance its gene therapy product candidates into and successfully initiate, enroll, and complete clinical trials; the potential clinical utility of its product candidates; its ability to continue to develop its gene therapy platforms; its ability to develop and manufacture its products and successfully transition manufacturing processes; its ability to perform under existing collaborations with, among others, Oxford BioMedica, Benitec and UMass Medical School, and to add new programs to its pipeline; its ability to enter into new partnerships or collaborations; its ability to retain and successfully integrate its leadership and personnel; the timing or likelihood of its regulatory filings and approvals, and the timing of its expected name change and ticker symbol change are forward-looking. All forward-looking statements are based on estimates and assumptions by Axovant’s management that, although Axovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Axovant expected. Such risks and uncertainties include, among others, the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of its gene therapy product candidates and platforms; Axovant’s scientific approach and general development progress; and the availability or commercial potential of Axovant’s product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Axovant’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on February 7, 2019, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Axovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:

Media and Investors

Tricia Truehart
(631) 892-7014
media@axovant.com
investors@axovant.com

SOURCE Axovant Sciences


AXOVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share amounts)

                 
    Three Months Ended
December 31,
  Nine Months Ended
December 31,
    2018   2017   2018   2017
Operating expenses:                
Research and development expenses(1)                
(includes total share-based compensation expense of $1,910 and $2,453 for the three months ended December 31, 2018 and 2017 and $3,299 and $14,625 for the nine months ended December 31, 2018 and 2017, respectively)   $ 21,483     $ 37,346     $ 80,403     $ 119,613  
General and administrative expenses(2)                
(includes share-based compensation expense of $2,648 and $8,186 for the three months ended December 31, 2018 and 2017 and $9,575 and $26,954 for the nine months ended December 31, 2018 and 2017, respectively)   10,933     18,032     33,309     69,662  
Total operating expenses   32,416     55,378     113,712     189,275  
Other expenses:                
Interest expense   1,906     1,950     5,808     5,702  
Other expense (income)   (78 )   550     275     324  
Loss before income tax expense   (34,244 )   (57,878 )   (119,795 )   (195,301 )
Income tax expense   52     24     224     953  
Net loss   $ (34,296 )   $ (57,902 )   $ (120,019 )   $ (196,254 )
Net loss per common share — basic and diluted   $ (0.27 )   $ (0.54 )   $ (1.01 )   $ (1.83 )
Weighted average common shares outstanding — basic and diluted   128,771,900     107,719,476     119,183,117     107,241,043  

(1) Includes total costs allocated from Roivant Sciences Ltd. (“RSL”), Roivant Sciences, Inc. (“RSI”) and Roivant Sciences GmbH (“RSG”) of $0 and $409 for the three months ended December 31, 2018 and 2017, respectively, and $(450) and $5,667 for the nine months ended December 31, 2018 and 2017, respectively.

(2) Includes total costs allocated from RSL, RSI and RSG of $698 and $1,440 for the three months ended December 31, 2018 and 2017, respectively, and $2,772 and $4,936 for the nine months ended December 31, 2018 and 2017, respectively.


AXOVANT SCIENCES LTD.
Condensed Consolidated Balance Sheets
(in thousands)

    December 31, 2018   March 31, 2018
Assets   (unaudited)    
Current assets:        
Cash and cash equivalents   $ 84,939     $ 154,337  
Prepaid expenses and other current assets   4,883     2,174  
Income tax receivable   1,580     1,751  
Total current assets   91,402     158,262  
Other non-current assets   3,449      
Property and equipment, net   1,365     2,524  
Total assets   $ 96,216     $ 160,786  
         
Liabilities and Shareholders’ Equity        
Current liabilities:        
Accounts payable   $ 1,018     $ 3,949  
Due to RSL, RSI and RSG   693     1,011  
Accrued expenses   22,911     31,862  
Current portion of long-term debt   20,583     9,753  
Total current liabilities   45,205     46,575  
Long-term debt   28,251     42,925  
Total liabilities   73,456     89,500  
         
Shareholders’ equity:        
Common shares, par value $0.00001 per share, 1,000,000,000 shares authorized, 155,527,771 and 107,788,074 issued and outstanding at December 31, 2018 and March 31, 2018, respectively   2     1  
Additional paid-in capital   699,064     628,110  
Accumulated deficit   (676,970 )   (556,951 )
Accumulated other comprehensive income   664     126  
Total shareholders’ equity   22,760     71,286  
Total liabilities and shareholders’ equity   $ 96,216     $ 160,786