Document


UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
 
FORM 8-K
 
CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  November 2, 2017
 
Axovant Sciences Ltd.
(Exact name of registrant as specified in its charter)
 
Bermuda
 
001-37418
 
98-1333697

(State or other jurisdiction of
incorporation)
 
(Commission File No.)
 
(I.R.S. Employer Identification No.)
 
 
Suite 1, 3rd Floor
11-12 St. James's Square London SW1Y 4LB, United Kingdom
 
Not Applicable
 
 
(Address of principal executive office)
 
(Zip Code)
 
 
Registrant’s telephone number, including area code:  +44 203 318 9708
 


(Former name or former address, if changed since last report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

x









Item 2.02 Results of Operations and Financial Condition.
 
On November 2, 2017, Axovant Sciences Ltd. (the “Registrant”) issued a press release announcing its financial results for the three and six months ended September 30, 2017. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

 
 
Item 9.01   Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit No.
 
Description
 
 
 
99.1

 





SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
Axovant Sciences Ltd.
 
 
 
 
Date:
 
By:
/s/ Gregory Weinhoff
November 2, 2017
 
Name:
Gregory Weinhoff
 
 
Title:
Principal Financial Officer
 
 
 
 




Exhibit


Exhibit 99.1

http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=11869110&doc=3

Axovant Announces Second Fiscal Quarter Financial Results and Corporate Updates

BASEL, Switzerland, Nov. 2, 2017 - Axovant Sciences (NASDAQ: AXON) today announced financial results for its second fiscal quarter and first half ended September 30, 2017, and provided an update on its clinical programs.

Key Highlights
Strong balance sheet with $235.4 million of cash as of September 30, 2017 supports Company's current clinical development plans and business development activities.

Intepirdine
The Company is reevaluating endpoints for the Phase 2b HEADWAY trial evaluating 35mg and 70mg doses of intepirdine in patients with dementia with Lewy bodies (DLB), and plans to have a discussion with the U.S. Food and Drug Administration (FDA) to help determine the most feasible and expeditious pathway to potential registration for this indication which has received Fast Track designation. Given this planned FDA interaction, top-line data are expected to be reported in January 2018.
Top-line data from the Phase 2 study of the effects of intepirdine on gait and balance in subjects with Alzheimer’s disease, DLB and Parkinson’s disease dementia (PDD) are expected to be reported in January 2018.
The Company has decided to keep the open-label extension (OLE) study of MINDSET open while it evaluates the feasibility of studying higher doses of intepirdine in the OLE study population, an analysis that may be influenced by any potential signals seen at the 70 mg intepirdine dose in the HEADWAY study.

Nelotanserin
Top-line data from the Phase 2 study evaluating nelotanserin for treatment of subjects with Lewy Body Dementia (LBD) who experience frequent visual hallucinations are expected to be reported in January 2018.
Top-line data from the Phase 2 study evaluating nelotanserin for treatment of REM Behavior Disorder in subjects with LBD are expected in the second quarter of 2018.

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Second-Quarter Financial Summary
For the second fiscal quarter ended September 30, 2017, research and development expenses were $38.6 million, of which $5.9 million was attributable to non-cash, share-based compensation expense. General and administrative expenses for the second quarter were $30.1 million, of which $9.4 million was attributable to non-cash, share-based compensation expense. Net loss for the quarter ended September 30, 2017 was $69.1 million, or $0.64 per share.

First-Half Financial Summary
For the first fiscal half ended September 30, 2017, research and development expenses were $82.3 million, of which $12.2 million was attributable to non-cash, share-based compensation expense. General and administrative expenses for the first half ended September 30, 2017 were $51.6 million, of which $18.8 million was attributable to non-cash, share-based compensation expense. Net loss for the six months ended September 30, 2017 was $138.4 million, or $1.29 per share.

Axovant held cash of $235.4 million at September 30, 2017. Net cash used in operating activities was $109.6 million for the six months ended September 30, 2017.

About Axovant Sciences
Axovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative medicines to broadly address multiple forms of dementia and related neurological disorders. Axovant is developing a pipeline of product candidates that focuses on the cognitive, functional and behavioral aspects of debilitating conditions such as Alzheimer’s disease, Lewy body dementia and other neurological disorders. For more information, visit www.axovant.com.













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Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Axovant’s expectations about timing of the results for the Phase 2b HEADWAY-DLB study of intepirdine in patients with DLB, the Phase 2 gait and balance study in patients with Alzheimer’s disease, DLB and PDD, the Phase 2 study of nelotanserin in patients with LBD suffering from visual hallucinations, the Phase 2 study of nelotanserin in patients with LBD suffering from RBD, the proof of concept and related studies of RVT-104 in patients with Alzheimer's disease and DLB; evaluation of the feasibility of studying higher doses of intepirdine in the OLE study population, including the potential influence on such evaluation by the results of the HEADWAY study; and other elements of its clinical development and regulatory strategy. Forward-looking statements can be identified by the words “believe,” “anticipate,” “continue,” “estimate,” “project,” “expect,” “plan,” “potential,” “intends,” “will,” “would,” “could,” “should” or the negative or plural of these words or other similar expressions that are predictions or indicate future events, trends or prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of our product development activities and clinical trials; the approval and commercialization of our product candidates intepirdine, nelotanserin and RVT-104; and increased regulatory requirements. These statements are subject to the risk that clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share Axovant’s views of the clinical study data. There can be no assurance that the clinical programs for intepirdine, nelotanserin or RVT-104 will be successful in demonstrating safety and/or efficacy, that we will not encounter problems or delays in clinical development, or that any of our product candidates will ever receive regulatory approval or be successfully commercialized. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Axovant’s business in general, see the “Risk Factors” section of our quarterly report on Form 10-Q to be filed with the Securities and Exchange Commission on or about November 2, 2017, and other filings that Axovant makes with the SEC from time to time. These forward-looking statements are based on information available to Axovant as of the date of this press release and speak only as of the date of this release. Axovant disclaims any obligation to update these forward-looking statements, except as may be required by law.







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



 
 
Three Months Ended September 30,
 
Six Months Ended September 30,
 
2017
 
2016
 
2017
 
2016
Operating expenses:
 
 
 
 
 
 
 
Research and development expenses
 
 
 
 
 
 
 
(includes share-based compensation expense of $5,916 and $4,473 for the three months ended September 30, 2017 and 2016 and $12,172 and $9,437 for the six months ended September 30, 2017 and 2016, respectively)
$
38,555

 
$
32,074

 
$
82,267

 
$
57,350

General and administrative expenses
 
 
 
 
 
 
 
(includes share-based compensation expense of $9,424 and $3,464 for the three months ended September 30, 2017 and 2016 and $18,768 and $10,061 for the six months ended September 30, 2017 and 2016, respectively)
30,112

 
9,449

 
51,630

 
22,080

Total operating expenses
68,667

 
41,523

 
133,897

 
79,430

 
 

 
 
 
 
 
 
Interest expense
1,878

 

 
3,752

 

Other expense (income)
131

 

 
(226
)
 

 
 
 
 
 
 
 
 
Loss before provision for income taxes
(70,676
)
 
(41,523
)
 
(137,423
)
 
(79,430
)
 
 
 
 

 
 
 
 
Income tax (benefit) expense
(1,590
)
 
729

 
929

 
877

 
 

 
 

 
 
 
 
Net loss
$
(69,086
)
 
$
(42,252
)
 
$
(138,352
)
 
$
(80,307
)
 
 

 
 

 
 
 
 
Net loss per common share — basic and diluted
$
(0.64
)
 
$
(0.43
)
 
$
(1.29
)
 
$
(0.81
)
Weighted average common shares outstanding — basic and diluted
107,593,609

 
99,160,445

 
107,000,519

 
99,155,251



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




 
September 30, 2017
 
March 31, 2017
Assets
 

 
 

Current assets:
 

 
 

Cash
$
235,373

 
$
212,573

Prepaid expenses and other current assets
4,587

 
6,457

Income tax receivable
2,813

 
658

Total current assets
242,773

 
219,688

Property and equipment, net
3,367

 
142

Deferred tax assets

 
2,709

Total assets
$
246,140

 
$
222,539

 
 
 
 
Liabilities and Shareholders’ Equity
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
2,860

 
$
8,551

Due to Roivant Sciences Ltd. and Roivant Sciences, Inc.
4,242

 
2,919

Accrued expenses
33,794

 
34,796

Total current liabilities
40,896

 
46,266


 
 
 
Long term debt
52,068

 
51,436

 
 
 
 
Total liabilities
92,964

 
97,702

Total shareholders’ equity
153,176

 
124,837

Total liabilities and shareholders’ equity
$
246,140

 
$
222,539





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Contact:

Investors & Media
Samina Bari
Vice President, Corporate Affairs
investors@axovant.com or media@axovant.com
 



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