UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

Pursuant to Section 13a-16 or 15d-16 of the Securities Exchange Act of 1934

 

For the month of March 2016

 

Commission File Number:  001-37569

 

STRONGBRIDGE BIOPHARMA plc

(Exact name of Registrant as specified in its charter)

 

900 Northbrook Drive

Suite 200

Trevose, PA 19053

(Address of principal executive offices)

 

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 o

 

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): o

 

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): o

 

 

 



 

On March 24, 2016, Strongbridge Biopharma plc (the “Registrant”) issued a press release regarding financial results for 2015.

 

The information contained in the press release is being furnished to the Commission and shall not be deemed incorporated by reference into any of the Registrant’s registration statements or other filings with the Commission.

 

Exhibits

 

Exhibit
Number

 

Exhibit Table

 

 

 

99.1

 

Press Release issued by Strongbridge Biopharma plc, dated March 24, 2016.

 

2



 

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.

 

Dated:  March 24, 2016

STRONGBRIDGE BIOPHARMA PLC

 

 

 

 

 

 

By:

/s/ Stephen Long

 

 

Stephen Long

 

 

Chief Legal Officer

 

3


Exhibit 99.1

 

 

Strongbridge Biopharma plc Reports Full-Year 2015 Financial Results

 

March 24, 2016 — Dublin, Ireland and Trevose, Pa., — Strongbridge Biopharma plc (Nasdaq: SBBP), a global rare disease biopharmaceutical company focused on the development and commercialization of novel therapeutic options, today announced its full-year 2015 financial results.

 

“Strongbridge made significant strides in 2015 executing its strategic plan to build a global rare disease biopharmaceutical company. With the recent strategic prioritization of our rare endocrine disease portfolio, we are focused on advancing development of COR-003 and COR-005, and look forward to providing updates on our progress toward reaching respective near-term development milestones for these cornerstone Cushing’s syndrome and acromegaly assets. We continue to believe that the Company’s current cash resources are sufficient to fund planned operations into the fourth quarter of 2017, which is after the expected receipt of data from the COR-003 Phase 3 SONICS trial,” said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma.

 

Full-Year 2015 Results

 

For the year ended December 31, 2015, net loss attributable to common shareholders was $43.6 million, or $2.62 per basic and diluted share, compared to $9.7 million, or $1.20 per basic and diluted share, for the same period in the prior year.  Basic and diluted weighted-average shares outstanding for the year ended December 31, 2015 reflected new shares issued in the October 2015 U.S. initial public offering, as well as new shares issued to investors in June 2015 and February 2015 in conjunction with private placement financings.

 

Research and development expenses were $20.1 million for the year ended December 31, 2015, compared to $5.8 million for the year ended December 31, 2014. The increase was primarily attributable to expenses related to the global Phase 3 SONICS clinical trial and supporting development activities for COR-003, the up-front licensing payment and initial development spending for COR-004, formulation development activities for COR-005, and compensation and related personnel costs.

 

General and administrative expenses were $22.7 million for the year ended December 31, 2015, compared to $4.6 million for the year ended December 31, 2014. The increase was primarily due to an increase in professional and consulting services incurred in connection with the re-domiciliation of the Company to Ireland, preparation for the October 2015 U.S. initial public offering and recruitment of personnel, as well as transaction and due

 



 

diligence expenses related to the acquisition of COR-005 and license of COR-004, non-cash stock-based compensation costs, and compensation and related personnel costs.

 

Strongbridge had cash and cash equivalents of $51.6 million and no outstanding debt as of December 31, 2015, compared to cash and cash equivalents of $15.6 million as of December 31, 2014.  The increase was primarily attributable to net proceeds received from the U.S. initial public offering in October 2015, as well as the private placements completed in June 2015 and February 2015. The Company believes it has sufficient existing cash and cash equivalents to fund planned operations into the fourth quarter of 2017.

 

About Strongbridge Biopharma

 

Strongbridge Biopharma is a global rare disease biopharmaceutical company focused on the development and commercialization of novel therapeutic options. Strongbridge’s lead product candidate, COR-003 (levoketoconazole), is a cortisol inhibitor currently being studied in the global Phase 3 SONICS trial for the treatment of endogenous Cushing’s syndrome. Strongbridge’s rare endocrine disease franchise also includes COR-005, a next-generation somatostatin analog (SSA) being investigated for the treatment of acromegaly, with potential additional applications in Cushing’s disease and neuroendocrine tumors. Both COR-003 and COR-005 have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. For more information, visit www.strongbridgebio.com.

 

Forward-Looking Statements

 

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements. These statements relate to future events and involve known and unknown risks, including, without limitation, uncertainties regarding Strongbridge’s strategy, plans, future financial position, timing of clinical study results, outcomes of product development efforts and objectives of management for future operations. The words “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “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 and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.

 



 

STRONGBRIDGE BIOPHARMA plc

Consolidated Statement of Operations and Comprehensive Loss

(In thousands, except share and per share data)

 

 

 

December 31,

 

 

 

2014

 

2015

 

 

 

(in thousands, except share and

 

 

 

per share data)

 

Consolidated Statement of Operations Data:

 

 

 

 

 

Operating expenses:

 

 

 

 

 

Research and development

 

$

5,844

 

$

20,135

 

General and administrative

 

4,588

 

22,719

 

Total operating expenses

 

10,432

 

42,854

 

Operating loss

 

(10,432

)

(42,854

)

Other income (expense), net:

 

 

 

 

 

Foreign exchange loss

 

(204

)

(124

)

Other income (expense), net

 

486

 

(1,105

)

Total other income (expense), net

 

282

 

(1,229

)

Loss before income taxes

 

(10,150

)

(44,083

)

Income tax benefit

 

480

 

450

 

Net loss

 

(9,670

)

(43,633

)

Net loss attributable to non-controlling interest

 

 

53

 

Net loss attributable to Strongbridge Biopharma

 

$

(9,670

)

$

(43,580

)

Net loss attributable to common shareholders, basic and diluted

 

$

(9,670

)

$

(43,580

)

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

 

$

(1.20

)

$

(2.62

)

Weighted-average shares used in computing net loss per share attributable to common shareholders, basic and diluted

 

8,043,175

 

16,606,669

 

 

STRONGBRIDGE BIOPHARMA plc

Select Consolidated Balance Sheet Information

(in thousands, except share and per share data)

 

 

 

December 31,

 

 

 

2014

 

2015

 

 

 

( in thousands)

 

Consolidated Balance Sheet Data:

 

 

 

 

 

Cash and cash equivalents

 

$

15,632

 

$

51,623

 

Total assets

 

23,689

 

97,330

 

Total liabilities

 

4,868

 

6,403

 

Total shareholders’ equity

 

18,821

 

90,927

 

 



 

Contacts:

 

Corporate and Media Relations

Elixir Health Public Relations

Lindsay M. Rocco

+1 862-596-1304

[email protected]

 

Investor Relations

ICR Inc.

Stephanie Carrington

+1 646-277-1282

[email protected]

 

USA

900 Northbrook Drive

Suite 200

Trevose, PA 19053

Tel. +1 610-254-9200

Fax. +1 215-355-7389