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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K
 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16
OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of August, 2015

Commission File Number: 001-36582

 

Auris Medical Holding AG

(Exact name of registrant as specified in its charter)

 

Bahnhofstrasse 21

 6300 Zug, Switzerland

 (Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F

X 

   Form 40-F

 

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

 

Yes   No

X

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

Yes   No

X  

 

 

 

 
 

 

INCORPORATION BY REFERENCE

 

Exhibits 99.1 and 99.2 to this report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-198037 and 333-200805) of Auris Medical Holding AG and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished. 

 

 
 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

    Auris Medical Holding AG  
       
       
      By: /s/ Thomas Meyer  
        Name: Thomas Meyer  
        Title: Chief Executive Officer  

 

Date: August 19, 2015

 

 

 

EXHIBIT INDEX

 

Exhibit
Number		 Description
99.1 Unaudited Condensed Consolidated Interim Financial Statements
99.2 Management’s Discussion and Analysis of Financial Condition and Results of Operations
99.3 Press Release dated August 19, 2015

 

 

 

 

Exhibit 99.1

 

Unaudited Condensed Consolidated Interim Financial Statements as of June 30, 2015 and December 31, 2014 and for the Three and Six Months Ended June 30, 2015 and 2014

 

Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income (Loss)
Condensed Consolidated Interim Statement of Financial Position
Condensed Consolidated Interim Statement of Changes in Equity
Condensed Consolidated Interim Statement of Cash Flows
Notes to the Condensed Consolidated Interim Financial Statements

 

 
 

Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income (Loss) (unaudited)
For the Three and Six Months Ended June 30, 2015 and 2014 (in CHF)

 

   THREE MONTHS ENDED
 JUNE 30		  SIX MONTHS ENDED
 JUNE 30
   2015  2014  2015  2014
Research and development   -8,750,891    -4,200,778    -14,980,787    -8,350,008 
General and administrative   -980,187    -845,223    -1,910,106    -2,554,288 
Operating loss   -9,731,078    -5,046,001    -16,890,893    -10,904,296 
Finance expense   -1,288,060    -16,595    -2,299,623    -68,031 
Finance income   60,712    71,374    179,979    121,144 
Net loss before tax and attributable to                     
owners of the Company   -10,958,426    -4,991,222    -19,010,537    -10,851,183 
Other comprehensive income (loss):                    
Items that will never be reclassified to                    
profit or loss                    
Remeasurement of defined benefit liability,   -306    -407,300    -229,170    -423,811 
net of taxes of CHF 0.00                    
Items that are or may be reclassified to                    
profit or loss                    
Foreign currency translation differences,   38,501    -2,673    56,863    2,817 
net of taxes of CHF 0.00                    
Other comprehensive income (loss),   38,195    -409,973    -172,307    -420,994 
net of taxes of CHF 0.00                    
Total comprehensive loss attributable
to owners of the Company		   -10,920,231    -5,401,195    -19,182,844    -11,272,177 
                     
Basic and diluted loss per share   -0.34    -0.26    -0.62    -0.59 

 

 

The accompanying notes form an integral part of these condensed consolidated interim financial statements

 

 
 

Condensed Consolidated Interim Statement of Financial Position (unaudited)
As of June 30, 2015 and December 31, 2014 (in CHF)

 

    Note     JUNE 30,
2015		    DECEMBER 31,
2014		 
ASSETS               
Non-current assets               
Property and equipment        244,125    235,427 
Intangible assets        1,482,520    1,482,520 
Deferred tax asset        —    32,761 
Total non-current assets         1,726,645    1,750,708 
                
Current assets               
Other receivables        528,373    542,538 
Prepayments        19,793    265,170 
Cash and cash equivalents        61,009,855    56,934,325 
Total current assets         61,558,021    57,742,033 
                
Total assets         63,284,666    59,492,741 
                
EQUITY AND LIABILITIES               
Equity               
Share capital   3    13,717,556    11,604,156 
Share premium        112,635,377    93,861,171 
Foreign currency translation reserve        5,754    -51,108 
Accumulated deficit        -71,243,140    -52,131,426 
Total shareholders’ equity attributable to owners of the Company         55,115,547    53,282,793 
                
Non-current liabilities               
Employee benefits        1,700,380    1,410,598 
Deferred tax liabilities        327,637    360,398 
Total non-current liabilities         2,028,017    1,770,996 
                
Current liabilities               
Trade and other payables        2,109,513    3,234,384 
Accrued expenses        4,031,589    1,204,568 
Total current liabilities         6,141,102    4,438,952 
                
Total liabilities         8,169,119    6,209,948 
                
Total equity and liabilities         63,284,666    59,492,741 

 

 

The accompanying notes form an integral part of these condensed consolidated interim financial statements

 

 
 

Condensed Consolidated Interim Statement of Changes in Equity (unaudited)
As of June 30, 2015 and 2014 (in CHF)

 

ATTRIBUTABLE TO OWNERS OF THE COMPANY
   NOTE  SHARE
CAPITAL		  SHARE
PREMIUM		  FX
TRANSLATION
RESERVE		  ACCUMULATED
DEFICIT		  TOTAL
EQUITY
Balance at January 1, 2014        6,487,130    35,608,210    53,995    -33,115,689    9,033,646 
Total comprehensive loss                               
Net loss         —    —    —    -10,851,183    -10,851,183 
Other comprehensive income (loss)        —    —    2,817    -423,811    -420,994 
Total comprehensive loss         —    —    2,817    -11,274,994    -11,272,177 
Transactions with owners of the Company                              
Conversion of convertible loan        1,043,180    12,717,655    —    —    13,760,835 
Share issuance costs        —    -136,699    —    —    -136,699 
Share based payments        —    —    —    95,197    95,197 
Share options exercised   3    6,200    43,400         —    49,600 
Balance at June 30, 2014        7,536,510    48,232,566    56,812    -44,295,486    11,530,402 
Balance at January 1, 2015         11,604,156    93,861,171    -51,109    -52,131,426    53,282,792 
Total comprehensive loss                              
Net loss         —    —    —    -19,010,537    -19,010,537 
Other comprehensive income (loss)        —    —    56,863    -229,170    -172,307 
Total comprehensive loss         —    —    56,863    -19,239,707    -19,182,844 
Transactions with owners of the Company                              
Capital increase from follow-on offering        2,110,000    19,604,877    —    —    21,714,877 
Transaction costs        —    -643,796    —    —    -643,796 
Share issuance costs        —    -210,675    —    —    -210,675 
Share based payments        —    —    —    127,993    127,993 
Share options exercised   3    3,400    23,800    —    —    27,200 
Balance at June 30, 2015        13,717,556    112,635,377    5,754    -71,243,140    55,115,547 

 

 

The accompanying notes form an integral part of these condensed consolidated interim financial statements

 

 
 

Condensed Consolidated Interim Statement of Cash Flows (unaudited)
For the Six Months Ended June 30, 2015 and 2014 (in CHF)

 

   Note   SIX MONTHS ENDED
JUNE 30, 2015		  SIX MONTHS ENDED JUNE 30, 2014
Cash flows from operating activities               
Net loss        -19,010,537    -10,851,183 
Adjustments for:               
Depreciation        44,551    34,006 
Unrealized net foreign currency exchange loss        2,272,314    2,835 
Net interest (income)/expense        -10,096    19,750 
Share option compensation   5    127,993    95,197 
Employee benefits        60,611    -6,713 
                
Changes in:               
Other receivables        14,059    -169,492 
Prepayments        245,377    -530,752 
Trade and other payables        -1,124,859    150,901 
Accrued expenses        2,827,018    -332,923 
                
Changes in net working capital        1,961,595    -882,266 
                
Cash used in operating activities         -14,553,569    -11,588,374 
                
Cash flows from investing activities               
Purchase of property and equipment        -53,249    -89,185 
Interest received        10,096    29,885 
Net cash used in investing activities         -43,153    -59,300 
                
Cash flows from (used in) financing activities               
Proceeds from share capital increase        27,200    49,600 
Share issuance costs        -210,675    -136,699 
Proceeds from follow-on offering        21,071,081    — 
Net cash from (used in) financing activities         20,887,434    -87,099 
                
Net increase (decrease) in cash and cash equivalents         6,290,883    -11,734,772 
Cash and cash equivalents at beginning of the period        56,934,325    23,865,842 
Net effect of currency translation on cash        -2,215,353    -116 
Cash and cash equivalents at end of the period         61,009,855    12,130,954 

 

 

The accompanying notes form an integral part of these condensed consolidated interim financial statements

 

 
 

AURIS MEDICAL HOLDING AG

 

Notes to the Condensed Consolidated Interim Financial Statements

as of June 30, 2015 and December 31, 2014 and for the Three and Six Months Ended June 30, 2015 and 2014 (in CHF)

 

1.Reporting entity

 

Auris Medical Holding AG (the “Company”) is domiciled in Switzerland. The Company’s registered address is at Bahnhofstrasse 21, 6300 Zug. These condensed consolidated interim financial statements comprise the Company and its subsidiaries (together referred to as the “Group” and individually as “Group entities”). The Company is the ultimate parent of the following Group entities:

 

§Auris Medical AG, Basel, Switzerland (100%)

§Otolanum AG, Zug, Switzerland (100%)

§Auris Medical Inc., Chicago, United States (100%)

§Auris Medical Ltd., Dublin, Ireland (100%)

 

The Group is primarily involved in the development of pharmaceutical products for the treatment of inner ear disorders, in particular tinnitus and hearing loss. Its most advanced projects are in the late stage of clinical development.

 

2.Basis of preparation

 

Statement of compliance

 

These condensed consolidated interim financial statements as of June 30, 2015 and December 31, 2014 and for the three and six months ended June 30 2015 have been prepared in accordance with International Accounting Standard Interim Financial Reporting (“IAS 34”) and should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2014.

 

These condensed consolidated interim financial statements include all adjustments, which are necessary to fairly state the results of the interim period and the Group believes that the disclosures are adequate to make the information presented not misleading. Interim results are not necessarily indicative of results to be expected for the full year. Management does not consider the business to be seasonal or cyclical.

 

Certain information and footnote disclosures normally included in financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board, have been condensed or omitted as permitted by IAS 34. The condensed consolidated interim statement of financial position as of December 31, 2014 was derived from the audited consolidated financial statements.

 

The interim financial statements were authorized for issuance by the Company’s Audit Committee on August 13, 2015.

 

Functional and reporting currency

 

These condensed consolidated financial statements are presented in Swiss Francs (“CHF”), which is the Company’s functional currency (“functional currency”) and the Group’s reporting currency.

 

Segment reporting

 

A segment is a distinguishable component of the Group that engages in business activities from which it may earn revenues and incur expenses, including revenues and expenses that relate to transactions with any of the Group’s other components. Management has determined that there is only one operating segment under the requirements of IFRS 8 (“Operating Segments”).

 

Significant accounting policies

 

The accounting policies applied by the Group in these condensed consolidated interim financial statements are the same as those applied by the Group in its audited consolidated financial statements as of and for the year ended December 31, 2014 and have been applied consistently to all periods presented in these condensed consolidated interim financial statements, unless otherwise indicated.

 

 
 

New standards, amendments and interpretations adopted by the Group

 

The Group has not early adopted any standard, interpretation or amendment that was issued but is not yet effective.

 

A number of new standards, amendments to standards and interpretations are effective for the Group’s 2015 reporting year, and have not been applied in preparing these condensed consolidated interim financial statements. Management does not believe that the adoption of these standards, interpretations, or amendments will have a material impact on the financial statements of the Group.

 

3.Capital and reserves

 

Share capital

 

The issued share capital of the Company consisted of:  

 

  

Common Shares

(Number)

 

Preferred Shares 

(Number)

   2015  2014  2015  2014
As of January 1   29,010,391    72,600    —    16,145,225 
Common shares with a nominal value of CHF 0.40 each   8,500    15,500    —    — 
Preferred shares “C” issued for conversion of convertible loan with a nominal value of CHF 0.40 each   —    —    —    2,607,950 
Common shares issued for the follow-on offering with a nominal value of CHF 0.40 each   5,275,000    —    —    — 
Total, as of June 30, 2015 and June 30, 2014   34,293,891    88,100    —    18,753,175 

 

All shares are fully paid in.

 

   June 30, 2015  December 31, 2014
    Number    CHF    Number    CHF 
                     
Common shares with a nominal value of CHF 0.40 each   34,293,891    13,717,556    29,010,391    11,604,156 
Total, as of June 30, 2015 and December 31, 2014   34,293,891    13,717,556    29,010,391    11,604,156 

 

 

Issue of common shares upon exercise of options

 

On January 21, 2014, three beneficiaries of the Option Plan A exercised their right to acquire common shares of the Company at CHF 3.20 per share. This resulted in an increase in the number of outstanding common shares of 15,500 and an increase in the share capital of CHF 6,200. Total proceeds from the exercise to the Company were CHF 49,600.

 

On January 23, 2015 and on April 2, 2015, beneficiaries of the Option Plan A exercised their right to acquire common shares of the Company at CHF 3.20 per share. This resulted in an increase in the number of outstanding common shares of 8,500 and an increase in the share capital of CHF 3,400. Total proceeds from the exercise to the Company were CHF 27,200.

 

Follow-On Offering on NASDAQ Global Market

 

On May 20, 2015, the Company completed a public offering of 5,275,000 shares, yielding net proceeds after underwriting discounts of USD 23.6 million (CHF 21.7 million). Following the offering (and settlement of the aforementioned employee options) there were 34,293,891 common shares of the Company outstanding.

 

 
 

IPO on NASDAQ Global Market

 

In August 2014 the Company completed its Initial Public Offering (“IPO”) issuing 10,113,235 shares, including the underwriter’s overallotment option, yielding total net proceeds of CHF 51.3 million (USD 56.4 million). Following the IPO there were 28,954,510 common shares of the Company outstanding. At December 31, 2014 there were 29,010,391 shares outstanding following the exercise of options.

 

Pursuant to agreements with holders of preferred shares, all preferred shares outstanding at the time of the IPO converted automatically into common shares at the ratio of 1:1 upon consummation of the IPO.

 

Issuance of preferred shares

 

In January 2014, a convertible loan was converted into 2,607,950 preferred shares Series C with a nominal value of CHF 0.40 at a conversion price of CHF 5.28 each.

 

4.Employee benefits

 

 

   SIX MONTHS ENDED
JUNE 30, 2015		  SIX MONTHS ENDED
JUNE 30, 2014
           
Salaries   1,222,644    980,518 
Pension costs   140,103    59,547 
Other social benefits   79,749    82,149 
Share based compensation expense   127,993    95,197 
Other   7,735    97,869 
Total employee benefits   1,578,224    1,315,280 

 

 

5.Share based compensation expense

 

Share based compensation expense of CHF 127,993 was recognized during the six month period ended June 30, 2015 (for the six months ended June 30, 2014: CHF 95,197). A total of 95,750 options were granted in the six month period ended June 30, 2015. The exercise price of the options granted was the quoted share price at the grant date, which was USD 5.98 (CHF 6.01). The methodology for computation of share based compensation expense for the period is consistent with the methodology used in 2014.

 

6.Loss per share

 

   Three months ended June 30,  Six months ended June 30,
   2015  2014  2015  2014
Loss attributable to owners of the Company   (10,958,426)   (4,991,222)   (19,010,537)   (10,851,183)
Weighted average number of shares outstanding   32,121,477    18,841,275    30,569,142    18,448,274 
Basic and diluted loss per share   (0.34)   (0.26)   (0.62)   (0.59)

 

For the six months ended June 30, 2015 and June 30, 2014 basic and diluted loss per share is calculated based on the weighted average number of shares issued and outstanding and excludes shares to be issued under the stock option plans, as they would be anti-dilutive. As at the date hereof, the Company has 506,260 options outstanding under its stock option plans. The average number of options outstanding between January 1, 2015 and June 30, 2015 was 462,635 (345,880 for the period between January 1, 2014 and June 30, 2014). The average number of options outstanding between April 1, 2015 and June 30, 2015 was 462,260 (419,010 for the period between April 1, 2014 and June 30, 2014).

 

 

 

 

Exhibit 99.2

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements as of and for the three and six month periods ended June 30, 2014 and 2014 included as Exhibit 99.1 to this Report on Form 6-K, which have been prepared in accordance with International Accounting Standard (“IAS”) 34, Interim Financial Reporting. We also recommend that you read our management’s discussion and analysis and our audited consolidated financial statements and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2014 (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the U.S. Securities and Exchange Act of 1934, as amended.

 

Unless otherwise indicated or the context otherwise requires, all references to “Auris Medical” or the “company,” “we,” “our,” “ours,” “us” or similar terms refer to Auris Medical AG and its subsidiaries prior to the completion of our corporate reorganization in connection with our initial public offering, and Auris Medical Holding AG and its subsidiaries as of the completion of our corporate reorganization and thereafter.

 

We prepare and report our consolidated financial statements and financial information in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (the “IASB”). None of our financial statements were prepared in accordance with generally accepted accounting principles in the United States. We maintain our books and records in Swiss Francs. We have made rounding adjustments to some of the figures included in this management’s discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them. Unless otherwise indicated, all references to currency amounts in this discussions and analysis are in Swiss Francs.

 

This discussion and analysis is dated as of August 19, 2015.

 

Overview

 

We are a clinical-stage biopharmaceutical company focused on the development of novel products for the treatment of inner ear disorders. Our most advanced product candidate, AM-101, is in Phase 3 clinical development for acute inner ear tinnitus under a special protocol assessment, or SPA, from the FDA. In two Phase 2 clinical trials, AM-101 demonstrated a favorable safety profile and statistically significant improvement in tinnitus loudness and other patient reported outcomes. We expect to have top-line Phase 3 clinical data for AM-101 in the second quarter of 2016. We are also developing AM-111 for acute inner ear hearing loss. We are preparing two pivotal clinical trials in the treatment of idiopathic sudden sensorineural hearing loss, or ISSNHL, titled HEALOS and ASSENT. We expect to start enrollment in HEALOS in the fourth quarter of 2015 and in ASSENT in the first half of 2016. In addition, we are preparing a Phase 2 trial titled REACH in order to test AM-111 in the treatment of cochlear implantation surgery-induced hearing loss. We intend to seek grant funding for REACH and expect to start enrollment for the trial in the third quarter of 2016. Both acute inner ear tinnitus and hearing loss are conditions for which there is high unmet medical need, and we believe that we have the potential to be the first to market in these indications.

 

To date, we have financed our operations through public offerings of our common shares, private placements of equity securities and short term loans. We have no products approved for commercialization and have never generated any revenues from royalties or product sales. As of June 30, 2015, we had cash and cash equivalents of CHF 61.0 million. Based on our current plans, we do not expect to generate royalty or product revenues unless and until we obtain marketing approval for, and commercialize AM-101, AM-111 or any of our other product candidates.

 

Since inception, we have incurred significant operating losses. We incurred net losses (defined as net losses attributable to the owners of the Company) of CHF 18.2 million and CHF 15.0 million for the years ended December 31, 2014 and 2013, respectively. As of June 30, 2015, we had an

 

 

 

accumulated deficit of CHF 71.2 million. We expect to continue incurring losses as we continue our clinical and preclinical development programs, apply for marketing approval for our product candidates and, subject to obtaining regulatory approval of our product candidates, build a sales and marketing force in preparation for the potential commercialization of our product candidates.

 

On May 20, 2015 we completed a public offering of common shares pursuant to a Registration Statement on Form F-1, as amended (Registration No. 333-203554). Under the registration statement, we sold an aggregate of 5,275,000 common shares at a price to the public of US$4.75 per share. The underwriting discounts and offering expenses totaled US$0.7 million. The offering expenses included SEC registration fees, FINRA filing fees, Nasdaq listing fees and expenses, legal fees and expenses, printing expenses, transfer agent fees and expenses, accounting fees and expenses, as well as other miscellaneous fees and expenses. In addition to offering expenses, the proceeds of the offering were subject to 1% stamp duty taxes. The net proceeds of the public offering after underwriting discounts were US$23.6 million (CHF 21.7 million).

 

Recent Developments

 

Patent Interference Proceedings

 

The United States Patent and Trademark Office has declared a patent interference involving our issued patent No. 9,066,865 and Otonomy Inc.’s (OTIC’s) patent application No. 13/848,636. Patent Interference No. 106,030 was declared on July 20, 2015 and identifies our claims No. 1-9 in US Patent No. 9,066,865 as interfering with OTIC’s claims No. 38, 43, and 46-50. Our US Patent No. 9,066,865 relates to methods of treating inner or middle ear diseases with intratympanic injections of poloxamer-based compositions. The claims are directed to the use of fluoroquinolone antibiotics in poloxamer 407 compositions under certain specifications. We do not expect the proceedings to impact our intellectual property portfolio relating to AM-101 and AM-111.

 

Collaboration and License Agreements

 

There have been no material changes to our collaboration and license agreements from those reported in “Item 5—Operating and Financial Review and Prospects–Operating results—Collaboration and License Agreements” in the Annual Report.

 

Research and Development Expense

 

Our research and development expense is highly dependent on the development phases of our research projects and therefore may fluctuate substantially from period to period. Our research and development expense mainly relates to the following key programs:

 

·AM-101. We are conducting a Phase 3 program of AM-101 comprising of two Phase 3 clinical trials (TACTT2 and TACTT3) as well as two open label extension studies (AMPACT1 and AMPACT2). We expect top-line data from the TACTT trials in the second quarter of 2016. We anticipate that our research and development expenses in connection with these clinical trials will be substantially higher in 2015 than in the previous financial year.

 

·AM-111. We are preparing two pivotal clinical trials in the treatment of idiopathic sudden sensorineural hearing loss, or ISSNHL, titled HEALOS and ASSENT. We expect to start enrollment in HEALOS in the fourth quarter of 2015 and in ASSENT in the first half of 2016. In addition, we are preparing a Phase 2 trial titled REACH in order to test AM-111 in the treatment of cochlear implant surgery-induced hearing loss. We intend to seek grant funding for REACH and expect to start enrollment in the third quarter of 2016. We anticipate that our research and development expenses will increase substantially in connection with commencement of these clinical trials.

 

·Other development programs. Other research and development expenses mainly relate to our preclinical studies with AM-102 and AM-123, including costs for production of the preclinical compounds and costs paid to academic research institutions in conjunction with preclinical testing.

 

 

 

For a discussion of our other key financial statement line items, please see “Item 5—Operating and Financial Review and Prospects–Operating results—Financial Operations Overview” in the Annual Report.

 

Results of Operations

 

The numbers below have been derived from our unaudited condensed consolidated interim financial statements as of and for the three and six month periods ended June 30, 2015 and 2014. The discussion below should be read along with this financial information, and it is qualified in its entirety by reference to them.

 

Comparison of three months ended June 30, 2015 and 2014

 

   Three months ended June 30,
   2015  2014  Change
   (in thousands of CHF)  %
Research and development   (8,751)   (4,201)   108%
General and administrative   (980)   (845)   16%
Operating loss   (9,731)   (5,046)   93%
Finance expense   (1,288)   (17)   7662%
Finance income   61    72    (16)%
Net loss before tax and attributable to   (10,958)   (4,991)   120%

 

Research and development expense

 

   Three months ended June 30,
   2015  2014  Change
   (in thousands of CHF)  %
Clinical projects   (7,642)   (2,757)   177%
Pre-clinical projects   (122)   (587)   (79)%
Drug manufacturing and substance   (339)   (159)   113%
Employee benefits   (440)   (428)   3%
Other research and development expenses   (208)   (270)   (23)%
Total   (8,751)   (4,201)   108%

 

Research and development expense increased 108% from CHF 4.2 million in the three months ended June 30, 2014 to CHF 8.8 million in the three months ended June 30, 2015. The variance in expense between the three months ended June 30, 2015 and the corresponding period in 2014 is mainly due to the following:

 

·Clinical projects. In the three months ended June 30, 2015 we incurred significantly higher clinical expenses than in the three months ended June 30, 2014, primarily due to higher service and milestone costs charged by contracted service providers in connection with the late stage AM-101 clinical trials, reflecting higher patient enrollment rates when compared with the previous reporting period and trial progress.

 

·Pre-clinical projects. In the three months ended June 30, 2015, pre-clinical expenses decreased primarily due to fewer ongoing preclinical studies.

 

·Drug manufacture and substance. In the three months ended June 30, 2015, we incurred higher costs primarily due to fluctuations in the timing of raw material purchases and the manufacture of clinical trial supplies.

 

 

 

·Employee benefits. Employee expenses were broadly in line in the three months ended June 30, 2015 and in the same period 2014 due to similar headcount.

 

General and administrative expense

 

General and administrative expense was CHF 1.0 million in the three months ended June 30, 2015 compared to CHF 0.9 million in the three months ended June 30, 2014, as a result of higher administration costs (CHF 0.5 million vs 0.4 million).

 

We expect that general and administrative expense will increase in the future as our business expands and we continue to incur costs associated with operating as a public company.

 

Finance income

 

Finance income decreased from CHF 0.07 million in the three months to June 30, 2014 to CHF 0.06 million in the three months ended June 30, 2015 due to lower interest income.

 

Finance expense

 

Finance expense increased from CHF 0.2 million in the three months to June 30, 2014 to CHF 1.3 million in the three months ended June 30, 2015, primarily due to the marked appreciation of the Swiss Franc against the US Dollar and the Euro, which resulted in substantial unrealized currency losses on cash and cash equivalents held in foreign currency.

 

Comparison of six months ended June 30, 2015 and 2014

 

   Six months ended June 30,
   2015  2014  Change
   (in thousands of CHF)  %
Research and development   (14,981)   (8,350)   79%
General and administrative   (1,910)   (2,554)   (25)%
Operating loss   (16,891)   (10,904)   55%
Finance expense   (2,300)   (68)   3,280%
Finance income   180    121    49%
Net loss before tax and attributable to               
owners of the Company   (19,011)   (10,851)   75%

 

Research and development expense

 

   Six months ended June 30,
   2015  2014  Change
   (in thousands of CHF)  %
Clinical projects   (12,940)   (5,161)   151%
Pre-clinical projects   (250)   (1,152)   (78)%
Drug manufacturing and substance   (488)   (784)   (38)%
Employee benefits   (896)   (797)   12%
Other research and development expenses   (407)   (454)   (11)%
Total   (14,981)   (8,350)   79%

 

Research and development expense increased 79% from CHF 8.4 million in the six months ended June 30, 2014 to CHF 15.0 million in the six months ended June 30, 2015. The variances in expense between the six months ended June 30, 2015 and the corresponding period in 2014 are mainly due to the following:

 

 

 

·Clinical projects. In the six months ended June 30, 2015 we incurred significantly higher clinical expenses than in the six months ended June 30, 2014, primarily due to higher service and milestone costs charged by contracted service providers in connection with the late stage AM-101 clinical trials, reflecting higher patient enrollment rates when compared with the previous reporting period and trial progress.

 

·Pre-clinical projects. In the six months ended June 30, 2015, pre-clinical expenses decreased primarily due to fewer ongoing preclinical studies.

 

·Drug manufacture and substance. In the six months ended June 30, 2015, we incurred lower costs primarily due to fluctuations in the timing of raw material purchases and the manufacture of clinical trial supplies.

 

·Employee benefits. Employee expenses increased in the six months ended June 30, 2015 compared to the same period in 2014 due to an increase in headcount.

 

General and administrative expense

 

General and administrative expense decreased 25% from CHF 2.6 million in the six months ended June 30, 2014 to CHF 1.9 million in the six months ended June 30, 2015. While employee costs increased over the previous reporting period, administration expenses decreased (due to lower legal and auditing expenses) from CHF 1.9 million to CHF 1.0 million as substantial costs incurred in connection with preparations for our initial public offering were expensed in the six months ending June 30, 2014.

 

We expect that general and administrative expense will increase in the future as our business expands and we continue to incur costs associated with operating as a public company.

 

Finance income

 

Finance income increased from CHF 0.1 million in the six month to June 30, 2014 to CHF 0.2 million in the six months ended June 30, 2015, due to a higher cash balance following our August 2014 initial public offering, partially offset by a lower interest income.

 

Finance expense

 

Finance expense increased significantly from CHF 0.07 million to CHF 2.3 million in the six months ended June 30, 2015 primarily due to the strong appreciation of the Swiss Franc against the US Dollar and the Euro, which resulted in substantial unrealized currency losses on cash and cash equivalents held in foreign currency.

 

Cash flow

 

Comparison of six months ended June 30, 2015 and 2014

 

The table below summarizes our consolidated statement of cash flows for the six months ended June 30, 2015 and 2014:

 

   Six months ended June 30,
   2015  2014
   (in thousands of CHF)
Cash used in operating activities   (14,554)   (11,588)
Net cash used in investing activities   (43)   (59)
Net cash from / (used in) financing activities   20,887    (87)
Net effect of currency translation on cash   (2,215)   0 
Cash and cash equivalents at beginning of the period   56,934    23,866 
Cash and cash equivalents at end of the period   61,009    12,132 

 

 

 

The increase in cash used in operating activities from CHF 11.6 million in the six months ended June 30, 2014 to CHF 14.6 million in the six months ended June 30, 2015, was mainly due to higher research and development expenses, which more than offset the increase in accrued liabilities and unrealized net foreign currency loss.

 

Net cash used in investing activities decreased in the three months ended June 30, 2015 due to lower costs incurred in connection with purchases of equipment and lower interest income.

 

Net cash from financing activities of CHF 20.9 million in the six months ended June 30, 2015 represents proceeds from our public offering of 5,275,000 common shares at a price of US$4.75 per share. These proceeds were partially offset by issuance costs associated with the offering. In the six months ended June 30, 2014 net cash used in financing activities was CHF 0.1 million reflecting the net effect of proceeds from the exercise of stock options that were more than offset with stamp duty charges related to the conversion of a convertible bond.

 

Cash and funding sources

 

As of June 30, 2015, we had no long term debt and had no ongoing material financial commitments, such as lines of credit or guarantees that are expected to affect our liquidity over the next five years, other than leases.

 

Funding requirements

 

We believe that after the closing of our public offering on May 20, 2015, our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements at least until fall 2017. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:

 

·the scope, rate of progress, results and cost of our clinical trials, nonclinical testing, and other related activities;

 

·the cost of manufacturing clinical supplies, and establishing commercial supplies, of our product candidates and any products that we may develop;

 

·the number and characteristics of product candidates that we pursue;

 

·the cost, timing, and outcomes of regulatory approvals;

 

·the cost and timing of establishing sales, marketing, and distribution capabilities; and

 

·the terms and timing of any collaborative, licensing, and other arrangements that we may establish, including any required milestone and royalty payments thereunder.

 

We expect that we will require additional capital to commercialize our product candidates AM-101 and AM-111. If we receive regulatory approval for AM-101 or AM-111, and if we choose not to grant any licenses to partners, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

 

We may raise additional capital through the sale of equity or convertible debt securities. In such an event, your ownership interest will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect your rights as a holder of our common shares.

 

For more information as to the risks associated with our future funding needs, see “Item 3—Key Information—Risk factors” in the Annual Report.

 

 

 

Contractual Obligations and Commitments

 

There have been no material changes to our contractual obligations outside the ordinary course of our business from those reported in “Item 5—Operating and Financial Review and Prospects—Tabular disclosure of contractual obligations” in the Annual Report.

 

Off-Balance Sheet Arrangements

 

As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, off-balance sheet arrangements except for the Operating Lease mentioned in “Item 5—Operating and Financial Review and Prospects—Tabular disclosure of contractual obligations” in the Annual Report.

 

Significant Accounting Policies and Use of Estimates and Judgment

 

There have been no material changes to the significant accounting policies and estimates described in “Item 5—Operating and Financial Review and Prospects–Operating results—Significant accounting policies and use of estimates and judgment” in the Annual Report.

 

Recent Accounting Pronouncements

 

Except for IFRS 9 for which the impact cannot be determined with sufficient reliability, there are no IFRS standards as issued by the IASB or interpretations issued by the IFRS interpretations committee that are effective for the first time for the financial year beginning on or after January 1, 2015 that would be expected to have a material impact on our financial position.

 

JOBS Act Exemption

 

On April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company”. As an emerging growth company, we are not required to provide an auditor attestation report on our system of internal controls over financial reporting. This exemption will apply for a period of five years following the completion of our initial public offering (2019) or until we no longer meet the requirements of being an “emerging growth company,” whichever is earlier. We would cease to be an emerging growth company if we have more than US$1.0 billion in annual revenue, have more than US$700 million in market value of our common shares held by non-affiliates or issue more than US$1.0 billion of non-convertible debt over a three-year period.

 

Cautionary Statement Regarding Forward Looking Statements

 

Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to of various factors, including, but not limited to, those identified under the section entitled “Item 3—Key Information—Risk factors” in the Annual Report. These risks and uncertainties include factors relating to:

 

·our operation as a development stage company with limited operating history and a history of operating losses;

 

·our need for substantial additional funding before we can expect to become profitable from sales of our products;

 

·our dependence on the success of AM-101 and AM-111, which are still in clinical development and may eventually prove to be unsuccessful;

 

 

 

·the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or in the commercial stage;

 

·the chance our clinical trials may not be completed on schedule, or at all, as a result of factors such as delayed enrollment or the identification of adverse effects;

 

·uncertainty surrounding whether and when any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized;

 

·if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory overview;

 

·enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization;

 

·the chance that we do not obtain orphan drug exclusivity for AM-111, which would allow our competitors to sell products that treat the same conditions;

 

·dependence on governmental authorities and health insurers establishing adequate reimbursement levels and pricing policies;

 

·our products may not gain market acceptance, in which case we may not be able to generate product revenues;

 

·our reliance on our current strategic relationships with INSERM or Xigen and the potential failure to enter into new strategic relationships;

 

·our reliance on third parties to conduct our nonclinical and clinical trials and on third-party single-source suppliers to supply or produce our product candidates; and

 

·other risk factors discussed under “Item 3—Key Information—Risk factors” included in the Annual Report.

 

  Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.

 

 

 

 

 

Exhibit 99.3

 

https://cdn.kscope.io/5b5ab6fbe551fef5dfda5f4fee951ab6-logo_farb.jpg

 

 

Auris Medical News Release

 

Auris Medical Holding AG Reports Second Quarter 2015 Financial Results
and Provides Business Update

 

Zug, Switzerland, August 19, 2015 – Auris Medical Holding AG (NASDAQ: EARS) today provided an update on the Company’s business and announced financial results for the second quarter ended June 30, 2015.

 

"Auris Medical made strong progress in the second quarter of 2015," commented Thomas Meyer, the Company’s founder, Chairman and CEO. "Our tinnitus program with AM-101 continued to advance, and our capital raise enabled us to move decisively forward with AM-111, our second late-stage program. We are very excited about the potential of AM-111, which has shown to be a highly potent otoprotectant and is one of the most clinically advanced cell-penetrating peptides. AM-111 previously received orphan drug designation by both the FDA and EMA, is highly synergistic to AM-101, and we believe the compound represents a significant commercial opportunity.”

 

Second Quarter and Recent Business Highlights

 

·Expanded U.S. institutional ownership base. Through a follow-on share offering in May 2015 Auris Medical significantly extended its cash runway while also expanding the Company’s institutional ownership base in the U.S. The net proceeds of the public offering (USD 22.9 million) will be used to support the AM-111 Phase 3 clinical development program.

 

·Progressed towards the start of the HEALOS Phase 3 trial. Preparations for HEALOS, the first of two pivotal studies with AM-111 in the treatment of acute sensorineural hearing loss (ASNHL), advanced well. HEALOS will enroll patients suffering from severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL). HEALOS will be conducted in several European and Asian countries and will test a single intratympanic dose of AM-111 0.4 mg/mL or 0.8 mg/mL against placebo. The first trial approvals have been obtained from competent authorities and ethics committees, paving the way for enrolment to begin in the fourth quarter of this year. Based on market research, the Company believes ISSNHL to be the most frequent type of ASNHL.

 

·Began preparations for ASSENT Phase 3 trial. Auris Medical initiated preparations for a second pivotal trial with AM-111 in ISSNHL. The trial, called ASSENT, will be conducted primarily in North America and is expected to begin enrolling patients in the first half of 2016. ASSENT will be very similar to HEALOS in design, the primary difference being the allowance of oral glucocorticoids as background therapy.

 

·Entered into clinical trial collaboration with Cochlear Ltd. Auris Medical and Cochlear Ltd. agreed to collaborate on a Phase 2 trial with AM-111 (REACH), which will assess the drug’s otoprotective effects in cochlear implant (CI) surgery induced hearing loss. Cochlear Ltd. is the global leader in implantable hearing solutions, and will support preparations for REACH and provide expertise in CIs and hearing preservation. Auris Medical intends to seek grant funding for REACH and expects enrollment to begin in the third quarter of 2016.

 

·Advanced enrolment into TACTT2 and TACTT3 trials. Auris Medical’s Phase 3 clinical program with AM-101 in acute inner ear tinnitus continued to progress, with approximately 60% of the target patient number having been enrolled. The Company expects top line data from both the TACTT2 and TACTT3 trials in the second quarter of 2016.

 

Auris Medical Holding AG · Bahnhofstrasse 21 · CH-6300 Zug · Tel. +41 41 729 71 94 · www.aurismedical.com

 

 
 

 

·Continued to raise profile within the ENT community. Auris Medical continued to raise its profile within the international ENT (ear, nose and throat) community through a significant presence at the 3rd Congress of European ORL-HNS in Prague, Czech Republic, one of the largest events of its kind. Auris Medical’s Corporate Symposium “Towards Novel Tinnitus Treatments” featured presentations by leading experts on the pathophysiology of tinnitus, outcome measures, health economics as well as clinical development.

 

·Expanded intellectual property portfolio. Auris Medical continued to expand its intellectual property portfolio. The U.S. Patent and Trademark Office (“USPTO”) granted U.S. Patent No. 9,072,662, titled “Methods for the Treatment of Tinnitus Induced by Cochlear Excitotoxicity”. It is the third issued U.S. patent covering the use of AM-101 for the treatment of tinnitus. In addition, the USPTO issued U.S. Patent No. 9,066,865 relating to methods of treating inner or middle ear diseases with intratympanic injections of poloxamer-based compositions.

 

·Expanded leadership team. The Company expanded its leadership team through the promotion of Anne Sabine Zoller to General Counsel and member of the Executive Management Committee. Ms. Zoller is responsible for legal affairs, compliance, information technology, human resources and general administration; in addition she serves as the Secretary of the Board of Directors.

 

Financial Results

 

As of June 30, 2015, the Company had CHF 61.0 million in cash and cash equivalents. Operating expenses for the three months ended June 30, 2015 were CHF 9.7 million, with CHF 8.8 million attributable to research and development. This compares to operating expenses of CHF 5.0 million and research and development expenses of CHF 4.2 million for the same period in 2014. The Company reported a net loss for the quarter ended June 30, 2015 of CHF 11.0 million, or CHF 0.34 per share. This compares to a net loss of CHF 5.0 million, or CHF 0.26 per share, for the same period in 2014.

 

For the six month period ended June 30, 2015, operating expenses were CHF 16.9 million, with CHF 15.0 million attributable to research and development. This compares to operating expenses of CHF 10.9 million and research and development expenses of CHF 8.4 million for the same period in 2014. The Company reported a net loss for the six months ended June 30, 2015 of CHF 19.0 million, or CHF 0.62 per share. This compares to a net loss of CHF 10.9 million, or CHF 0.59 per share, for the same period in 2014.

 

The increases in operating expenses, and resulting increases in net loss, for the three- and six-month periods ended June 30, 2015 over the comparable periods in 2014 reflect primarily the progression of the AM-101 Phase 3 clinical development program and preparations for the late stage AM-111 clinical program.

 

The Company maintains its previous full-year guidance and expects operating expenses for the 2015 financial year to be in the range of CHF 30.0 to 35.0 million. After the follow-on offering, Auris Medical’s existing cash and cash equivalents are expected to fund its operating expenses at least until fall 2017. This outlook is based on management’s current expectations and beliefs.

 

Page 2 of 7

 

Conference Call / Webcast Information

 

Auris Medical will host a live conference call and webcast to discuss the Company's financial results and provide a general business update. The call is scheduled for August 19, 2015 at 8:00 a.m. Eastern Time (2:00 p.m. Central European Time). To participate in this conference call, dial 1 855 217 7942 (USA) or +1 646 254 3376 (International), and enter passcode 2647674. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Auris Medical website at: www.aurismedical.com. A replay will be available approximately two hours following the live call also on the Company’s website.

 

About Auris Medical

 

Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the development of treatments for acute inner ear tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of the parent company Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol "EARS".

 

Forward-looking Statements

 

This press release may contain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of Auris Medical’s product candidates, the clinical utility of Auris Medical’s product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s Annual Report on Form 20-F, the prospectus dated May 14, 2015 relating to its Registration Statement on Form F-1 and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

 

Company: Dr. Thomas Meyer, Chairman and CEO, +41 41 729 71 94, ear@aurismedical.com

 

Investors: Matthew P. Duffy, Managing Director, LifeSci Advisors, 212-915-0685, matthew@lifesciadvisors.com

 

Page 3 of 7

 

Auris Medical Holding AG

 

Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income (unaudited)

 

(in CHF thousands, except share and currency data)

 

   Three Months Ended
June 30,		  Six Months Ended
June 30,
   2015  2014  2015  2014
Research and development expenses   (8,751)   (4,201)   (14,981)   (8,350)
General and administrative expenses   (980)   (845)   (1,910)   (2,554)
Operating loss   (9,731)   (5,046)   (16,891)   (10,904)
Finance income / expense (net)   (1,227)   55    (2,120)   53 
Loss before tax   (10,958)   (4,991)   (19,011)   (10,851)
Net loss attributable to owners of the Company   (10,958)   (4,991)   (19,011)   (10,851)
Other comprehensive income:                    
Items that will never be reclassified to profit or loss:                    
Remeasurements of defined benefits liability   (0)   (407)   (229)   (424)
Items that are or may reclassified to profit or loss:                    
Foreign currency translation differences   39    (3)   57    3 
Other comprehensive income   38    (410)   (172)   (421)
Total comprehensive loss attributable to owners
of the Company		   (10,920)   (5,401)   (19,183)   (11,272)
Loss per share, basic and diluted   (0.34)   (0.26)   (0.62)   (0.59)
Weighted average common shares outstanding, basic and diluted     32,121,477    18,841,275    30,569,142    18,448,274 
Currency rate CHF / USD   0.9470    0.8888    0.9498    0.8907 
                     

Page 4 of 7

 

Auris Medical Holding AG

 

Condensed Consolidated Interim Statement of Financial Position (unaudited)

 

(in CHF thousands)

 

   June 30, 2015  December 31, 2014
Assets          
Non-current assets          
Property and equipment   244    235 
Intangible assets   1,483    1,483 
Deferred tax asset   —      33 
Total non-current assets   1,727    1,751 
Current assets          
Current financial assets and other receivables   528    543 
Prepayments   20    265 
Cash and cash equivalents   61,010    56,934 
Total current assets   61,558    57,742 
Total assets   63,285    59,493 
Equity and Liabilities          
Equity          
Share capital   13,718    11,604 
Share premium   112,635    93,861 
Foreign currency translation reserve   6    (51)
Accumulated deficit   (71,243)   (52,131)
Total shareholders’ equity attributable to owners of the Company   55,116    53,283 
Non-current liabilities          
Employee benefits   1,700    1,411 
Deferred tax liabilities   328    360 
Total non-current liabilities   2,028    1,771 
Current liabilities          
Trade and other payables   2,110    3,234 
Accrued expenses   4,032    1,205 
Total current liabilities   6,141    4,439 
Total liabilities   8,169    6,210 
Total equity and liabilities   63,285    59,493 
Currency rate CHF / USD   0.9355    0.8841 

Page 5 of 7

 

Auris Medical Holding AG

 

Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income (unaudited)

 

(convenience presentation in USD thousands, except share data)

 

   Three Months Ended
June 30,		  Six Months Ended
June 30,
   2015  2014  2015  2014
Research and development expenses   (9,354)   (4,490)   (16,014)   (8,926)
General and administrative expenses   (1,048)   (903)   (2,042)   (2,730)
Operating loss   (10,402)   (5,394)   (18,055)   (11,656)
Finance income / expense (net)   (1,312)   59    (2,266)   57 
Loss before tax   (11,714)   (5,335)   (20,321)   (11,599)
Net loss attributable to owners of the Company   (11,714)   (5,335)   (20,321)   (11,599)
Other comprehensive income:                    
Items that will never be reclassified to profit or loss:                    
Remeasurements of defined benefits liability   (0)   (435)   (245)   (453)
Items that are or may reclassified to profit or loss:                    
Foreign currency translation differences   41    (3)   61    3 
Other comprehensive income   41    (438)   (184)   (450)
Total comprehensive loss attributable to owners
of the Company		   (11,673)   (5,774)   (20,505)   (12,049)
Loss per share, basic and diluted   (0.36)   (0.28)   (0.70)   (0.63)
Weighted average common shares outstanding, basic and diluted     32,121,477    18,841,275    30,569,142    18,448,274 
                     

Solely for the convenience of the reader, unless otherwise indicated, all Swiss Franc amounts stated in the Condensed Consolidated Statement of Profit and Loss for the 3 and 6 months ended June 30, 2015 and June 30, 2014, have been translated into U.S. dollars at the rate on June 30, 2015 of USD 1.0689 / CHF 1.00. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.

 

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Auris Medical Holding AG

 

Condensed Consolidated Interim Statement of Financial Position (unaudited)

 

(convenience presentation in USD thousands)

 

   June 30, 2015  December 31, 2014
Assets          
Non-current assets          
Property and equipment   261    252 
Intangible assets   1,585    1,585 
Deferred tax asset   —      35 
Total non-current assets   1,846    1,871 
Current assets          
Current financial assets and other receivables   565    580 
Prepayments   21    283 
Cash and cash equivalents   65,216    60,860 
Total current assets   65,802    61,723 
Total assets   67,648    63,595 
Equity and Liabilities          
Equity          
Share capital   14,663    12,404 
Share premium   120,401    100,333 
Foreign currency translation reserve   6    (55)
Accumulated deficit   (76,155)   (55,726)
Total shareholders’ equity attributable to owners of the Company   58,916    56,956 
Non-current liabilities          
Employee benefits   1,818    1,508 
Deferred tax liabilities   350    385 
Total non-current liabilities   2,168    1,893 
Current liabilities          
Trade and other payables   2,255    3,457 
Accrued expenses   4,310    1,288 
Total current liabilities   6,565    4,745 
Total liabilities   8,732    6,638 
Total equity and liabilities   67,648    63,595 
           

Solely for the convenience of the reader, unless otherwise indicated, all Swiss Franc amounts stated in the Condensed Consolidated Statement of Financial Position as at June 30, 2015 and December 31, 2014, have been translated into U.S. dollars at the rate on June 30, 2015 of USD 1.0689 / CHF 1.00. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.

 

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