EX-99.1 2 d34303dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

Nexvet Reports Financial Results for First Quarter of Fiscal Year 2016

DUBLIN, Ireland – November 5, 2015 – Veterinary biologic therapy developer Nexvet Biopharma (Nasdaq: NVET) today announced its financial results for the three month period ended September 30, 2015.

Corporate Highlights

 

    Commenced a research and development collaboration with leading Japanese animal health company, Zenoaq (Nippon Zenyaku Kogyo Co., Ltd.)

 

    Secured a dedicated biologics manufacturing facility in Tullamore, Ireland

 

    Received $3.1 million cash under the Australian Government’s Research and Development (R&D) Tax Incentive program

In July 2015, Nexvet announced the commencement of a research and development collaboration with Zenoaq (Nippon Zenyaku Kogyo Co., Ltd.), a leading animal health company based in Japan. The collaboration entails developing a number of therapeutic biologics in the areas of immuno-oncology and allergy/inflammation. Nexvet is applying its PETization platform technology to convert monoclonal antibodies (mAbs) identified by Zenoaq into 100% species-specific product candidates for conditions where there is currently a significant unmet medical need. Nexvet will retain marketing rights outside Europe and Asia to any resulting approved products.

A key highlight during the quarter was the securing of a dedicated biologics manufacturing facility in Tullamore, Ireland. In September 2015, Nexvet agreed to pay $1.98 million to secure the manufacturing assets within the 20,000 square foot facility. The Company entered into a 10-year lease on the facility and has the option to purchase the building. As part of the transaction, Nexvet is eligible for non-dilutive grant support from the Irish Government. This acquisition affirms Nexvet’s commitment to internalize manufacturing, a key element in the development and commercialization of innovative biopharmaceuticals.

Nexvet continues to maintain important research and development operations in Australia and in September 2015 announced receipt of $3.1 million in cash under the Australian Government’s Research and Development (R&D) Tax Incentive program. The incentive was included as a receivable in Nexvet’s annual report on Form 10-K, for the fiscal year ended June 30, 2015.

Recent Developments

In October 2015, Nexvet announced the initiation of a pilot field study of NV-02, its mAb therapy in development for the control of pain associated with osteoarthritis in cats. The study will target enrolment of 90 feline patients with naturally occurring osteoarthritis. Nexvet expects data from the study will be available in the second quarter of 2016. Nexvet believes this is the most advanced clinical study of a feline mAb therapy. Chronic pain management is an area of significant unmet need in cats, given that non-steroidal anti-inflammatory drugs (NSAIDs), a leading class of analgesics for dogs and cats, are not approved for chronic use in cats in the United States due to concerns over toxic side effects.

First Quarter FY2016 Financial Results

As of September 30, 2015, Nexvet had cash of $47.7 million.

For the three months ended September 30, 2015, Nexvet reported a net loss of $4.0 million, compared to $2.3 million for the three months ended September 30, 2014. Net loss per share attributable to ordinary shareholders (basic and diluted) for the three months ended September 30, 2015 and 2014 was $0.35 and $2.13 respectively.

 

Page 1 of 5


The net loss of $4.0 million for the three months ended September 30, 2015 included operating expenses of $5.6 million, reflecting $3.7 million in research and development expenses and $1.9 million in general and administrative expenses. Other income comprised $1.6 million, principally research and development incentive income of $0.6 million and an exchange gain of $1.0 million.

The net loss of $2.3 million for the three months ended September 30, 2014 included operating expenses of $5.4 million, reflecting $2.5 million in research and development expenses and $2.8 million in general and administrative expenses. Other income comprised $3.0 million, principally research and development incentive income of $0.7 million, government grant income of $0.3 million and an exchange gain of $2.0 million.

The increased operating expenses for the three month period ended September 30, 2015, compared to the corresponding period in 2014, primarily related to increased program development costs associated with the pivotal safety and efficacy study for NV-01 and proof-of-concept studies for NV-02, offset by a $1.0 million reduction in general and administrative costs due to costs associated with preparation for our initial public offering of $0.6 million and Irish reorganization costs of $0.4 million in the three months ended September 30, 2014.

About Nexvet (www.nexvet.com)

Nexvet is a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals, such as dogs and cats, by developing and commercializing novel, species-specific biologics. Nexvet’s proprietary PETization™ platform is designed to rapidly design monoclonal antibodies (“mAbs”) that are recognized as “self” or “native” by an animal’s immune system, a property Nexvet refers to as “100% species-specificity.” Nexvet’s product candidates also build upon the safety and efficacy data from clinically tested human therapies, thereby reducing clinical risk and development cost.

Nexvet is leveraging diverse global expertise and incentives to build a vertically integrated biopharmaceutical company, through conducting drug discovery in Australia, clinical development in the United States and Europe and biomanufacturing in Ireland.

Further information

Investors

Candice Knoll

Blueprint Life Science Group

+1 415-375-3340 Ext. 4

cknoll@bplifescience.com

Company

Damian Lismore

CFO, Nexvet Biopharma plc

+1 415-606-5744

damian.lismore@nexvet.com

Media

David Salisbury

Berry & Company Public Relations

+1 212-253-8881

dsalisbury@berrypr.com

 

Page 2 of 5


CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

(in thousands, except share and per share amounts)

 

     September 30,
2015
    June 30,
2015
 

Assets

    

Current assets

    

Cash

   $ 47,660      $ 52,033   

Other income receivable

     822        3,301   

Prepaid expenses and other

     1,249        607   
  

 

 

   

 

 

 

Total current assets

     49,731        55,941   
  

 

 

   

 

 

 

Noncurrent assets

    

Prepaid expenses

     159        163   

Other income receivable

     81        —     
  

 

 

   

 

 

 

Total noncurrent assets

     240        163   
  

 

 

   

 

 

 

Property, plant and equipment, net

     2,590        549   

Intangible assets, net

     15        19   
  

 

 

   

 

 

 

Total assets

   $ 52,576      $ 56,672   
  

 

 

   

 

 

 

Liabilities and Shareholders’ Equity

    

Current liabilities

    

Accounts payable

   $ 1,078      $ 658   

Accrued expenses

     2,637        2,352   

Deferred grant income

     73        —     

Deferred lease incentive

     21        23   
  

 

 

   

 

 

 

Total current liabilities

     3,809        3,033   
  

 

 

   

 

 

 

Noncurrent liabilities

    

Deferred grant income

     78        —     

Deferred lease incentive

     51        61   
  

 

 

   

 

 

 

Total noncurrent liabilities

     129        61   
  

 

 

   

 

 

 

Total liabilities

   $ 3,938      $ 3,094   
  

 

 

   

 

 

 

Commitments and contingencies (Note 11)

    

Shareholders’ equity

    

Ordinary shares, $0.125 nominal value per share,100,000,000 shares authorized as of September 30, 2015 and June 30, 2015—11,457,921 and 11,406,916 shares issued and outstanding as of September 30, 2015 and June 30, 2015, respectively

   $ 1,432      $ 1,426   

Euro deferred shares, €100 nominal value per share, 400 shares authorized as of September 30, 2015 and June 30, 2015—400 shares issued and outstanding as of September 30, 2015 and June 30, 2015

     13        13   

Additional paid-in capital

     80,730        80,275   

Accumulated other comprehensive (loss)

     (5,922     (4,481

Accumulated deficit

     (27,615     (23,655
  

 

 

   

 

 

 

Total shareholders’ equity

     48,638        53,578   
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ 52,576      $ 56,672   
  

 

 

   

 

 

 

 

Page 3 of 5


CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

(in thousands, except share and per share amounts)

 

     Three Months Ended
September 30,
 
     2015     2014  

Revenue

    

Other

   $ —        $ 25   
  

 

 

   

 

 

 

Total revenue

     —          25   
  

 

 

   

 

 

 

Operating Expenses

    

Research and development

     3,725        2,539   

General and administrative

     1,870        2,818   
  

 

 

   

 

 

 

Total operating expenses

     5,595        5,357   
  

 

 

   

 

 

 

Loss from operations

     (5,595     (5,332

Other Income (Expense)

    

Research and development incentive income

     567        741   

Government grant income

     4        297   

Exchange gain

     1,027        1,984   

Interest income

     37        13   
  

 

 

   

 

 

 

Net loss

   $ (3,960   $ (2,297
  

 

 

   

 

 

 

Net loss per share attributable to ordinary shareholders, basic and diluted

   $ (0.35   $ (2.13
  

 

 

   

 

 

 

Weighted-average ordinary shares outstanding, basic and diluted

     11,442,552        1,078,166   
  

 

 

   

 

 

 

Comprehensive Loss

    

Net loss

   $ (3,960   $ (2,297

Net loss in foreign currency translation adjustments

     (1,441     (2,141
  

 

 

   

 

 

 

Total comprehensive loss

   $ (5,401   $ (4,438
  

 

 

   

 

 

 

 

Page 4 of 5


Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements consist of all statements other than statements of historical fact, including statements regarding our future results of operations and financial position, ability to reach a statistically significant endpoint at the primary assessment of the NV-01 pivotal safety and efficacy study, results of the current, new or any future NV-01 or NV-02 study, future expenditures relating to our lead product candidates, the time for completion of any of our studies, business strategy, prospective products, ability to obtain product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The words “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “plan,” “potential,” “predict,” “project,” “position,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors.

Factors that could cause actual results to differ materially from our expectations expressed in this press release include those summarized under Risk Factors in our reports on Forms 10-Q and 10-K and the other documents we file from time to time with the Securities and Exchange Commission. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this press release. Except as required by law, we do not intend, and undertake no obligation, to revise or update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

Unless otherwise stated or the context otherwise indicates, references to “we,” “us,” “our,” “Nexvet,” “Nexvet Biopharma plc” or the “Company” refer to Nexvet Biopharma public limited company and its consolidated subsidiaries.

 

Page 5 of 5