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
November 5, 2015
Date of report (Date of earliest event reported)
Nexvet Biopharma
public limited company
(Exact Name of Registrant as Specified in Its Charter)
Ireland | 001-36828 | 98-1205017 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
National Institute for Bioprocessing Research and Training
Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland
(Address of principal executive offices, including Zip Code)
+353 (1) 901 0339
(Registrants Telephone Number, Including Area Code)
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)) |
Item 2.02 | Results of Operations and Financial Condition. |
On November 5, 2015, Nexvet Biopharma public limited company (the Company) reported its financial results for the first quarter of fiscal year 2016 (the quarterly period ended September 30, 2015). The Companys earnings release for this period is furnished herewith as Exhibit 99.1.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit |
Description | |
99.1 | Earnings release dated November 5, 2015 announcing the Companys financial results for the first quarter of fiscal year 2016. |
SIGNATURES
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 hereunto duly authorized.
Nexvet Biopharma public limited company | ||
By: | /s/ Mark Heffernan, Ph.D. | |
Name: | Mark Heffernan | |
Its: | Chief Executive Officer |
Date: November 5, 2015
Exhibit 99.1
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 Governments 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 Nexvets 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 Governments Research and Development (R&D) Tax Incentive program. The incentive was included as a receivable in Nexvets 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.
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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. Nexvets proprietary PETization platform is designed to rapidly design monoclonal antibodies (mAbs) that are recognized as self or native by an animals immune system, a property Nexvet refers to as 100% species-specificity. Nexvets 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
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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 | ||||||
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|
|
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Noncurrent assets |
||||||||
Prepaid expenses |
159 | 163 | ||||||
Other income receivable |
81 | | ||||||
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|
|
|||||
Total noncurrent assets |
240 | 163 | ||||||
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|
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Property, plant and equipment, net |
2,590 | 549 | ||||||
Intangible assets, net |
15 | 19 | ||||||
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|
|
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Total assets |
$ | 52,576 | $ | 56,672 | ||||
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Liabilities and Shareholders Equity |
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Current liabilities |
||||||||
Accounts payable |
$ | 1,078 | $ | 658 | ||||
Accrued expenses |
2,637 | 2,352 | ||||||
Deferred grant income |
73 | | ||||||
Deferred lease incentive |
21 | 23 | ||||||
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Total current liabilities |
3,809 | 3,033 | ||||||
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Noncurrent liabilities |
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Deferred grant income |
78 | | ||||||
Deferred lease incentive |
51 | 61 | ||||||
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Total noncurrent liabilities |
129 | 61 | ||||||
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Total liabilities |
$ | 3,938 | $ | 3,094 | ||||
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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, 201511,457,921 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, 2015400 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 | ) | ||||
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Total shareholders equity |
48,638 | 53,578 | ||||||
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Total liabilities and shareholders equity |
$ | 52,576 | $ | 56,672 | ||||
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands, except share and per share amounts)
Three Months Ended September 30, |
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2015 | 2014 | |||||||
Revenue |
||||||||
Other |
$ | | $ | 25 | ||||
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Total revenue |
| 25 | ||||||
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Operating Expenses |
||||||||
Research and development |
3,725 | 2,539 | ||||||
General and administrative |
1,870 | 2,818 | ||||||
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|
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Total operating expenses |
5,595 | 5,357 | ||||||
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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 | ||||||
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Net loss |
$ | (3,960 | ) | $ | (2,297 | ) | ||
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Net loss per share attributable to ordinary shareholders, basic and diluted |
$ | (0.35 | ) | $ | (2.13 | ) | ||
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Weighted-average ordinary shares outstanding, basic and diluted |
11,442,552 | 1,078,166 | ||||||
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Comprehensive Loss |
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Net loss |
$ | (3,960 | ) | $ | (2,297 | ) | ||
Net loss in foreign currency translation adjustments |
(1,441 | ) | (2,141 | ) | ||||
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Total comprehensive loss |
$ | (5,401 | ) | $ | (4,438 | ) | ||
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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 managements 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 managements 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.
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