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Post Earnings Coverage as Strongbridge Loss Narrowed; Acquires US Rights for KEYEVIS and Announced Equity Financing

Upcoming AWS Coverage on Acorda Therapeutics

LONDON, UK / ACCESSWIRE / January 5, 2017 / Active Wall St. announces its post-earnings coverage on Strongbridge Biopharma PLC (NASDAQ: SBBP) ("Strongbridge"). The Company released its third quarter fiscal 2016 financial results on December 23, 2016. The late-stage biotech Company, which is developing therapies for rare endocrine disorder, did not generate any revenue during the reported period. Register with us now for your free membership at: http://www.activewallst.com/register/.

One of Strongbridge Biopharma's competitors within the Biotechnology space, Acorda Therapeutics, Inc. (NASDAQ: ACOR), is estimated to report earnings on February 09, 2017. AWS will be initiating a research report on Acorda Therapeutics in the coming days.

Today, AWS is promoting its earnings coverage on SBBP; touching on ACOR. Get our free coverage by signing up to:

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http://www.activewallst.com/registration-3/?symbol=SBBP

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Earnings Reviewed

For the three months ended September 30, 2016, Strongbridge posted net loss attributed to ordinary shareholders of $7.6 million, or $0.36 per basic and diluted share, compared to $9.7 million, or $0.51 per basic and diluted share, for Q3 2015. For the nine months ended September 30, 2016, net loss attributed to ordinary shareholders was $32.7 million, or $1.54 per basic and diluted share, compared to $33.2 million, or $2.18 per basic and diluted share, for the same period in the prior year.

For Q3 2016, Strongbridge's Research and development expenses were $4.5 million compared to $4.1 million for the same period in the prior year. The increase was primarily attributed to expenses related to the global Phase 3 SONICS clinical trial and supporting development activities for COR-003, and compensation and related personnel costs of increased employee count. Research and development expenses were $15.9 million for the nine months ended September 30, 2016, compared to $14.3 million for the same period in the prior year.

General and administrative expenses were $3.1 million for Q3 2016 compared to $5.5 million for Q3 2015. General and administrative expenses were $11.3 million for the nine months ended September 30, 2016, compared to $18.2 million for the prior year's same quarter.

Rare Disease Portfolio Expansion

In a separate press release on December 23, 2016, Strongbridge announced that it has acquired the US rights to KEVEYIS from a subsidiary of Taro Pharmaceutical Industries Ltd ("Taro"). The product is the first and only US Food and Drug Administration (FDA)-approved product to treat hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis, which is a group of rare hereditary disorders that causes potentially severe episodes of muscle weakness and/or paralysis. KEVEYIS has orphan drug exclusivity status in the US through August 07, 2022.

Under the terms of the purchase agreement, Strongbridge will provide Taro with upfront and deferred payments of $8.5 million in two installments. Strongbridge expects to commercially launch KEVEYIS in the US in April 2017.

SONIC Update

The global Phase 3 SONICS clinical trial evaluating COR-003 (levoketoconazole) for the treatment of endogenous Cushing's syndrome is more than two-thirds enrolled. Based upon an analysis of recent enrollment trends, Strongbridge anticipates that the study will be fully enrolled in Q2 2017, with top-line data for the primary efficacy analysis available in Q1 2018.

In October 2016, at the fourth semi-annual Data and Safety Monitoring Board (DSMB) review of the SONICS data, the DSMB recommended that the SONICS study continue as planned.

In addition, the Company plans to initiate LOGICS, a second global Phase 3 study of COR-003 for the treatment of endogenous Cushing's syndrome. The LOGICS study will supplement the long-term efficacy and safety data from the ongoing SONICS study in a randomized, double-blind, placebo-controlled study that will enroll approximately 35 patients, of which approximately two-thirds will have completed the SONICS study. LOGICS enrollment is anticipated to begin mid-year 2017 and top-line data are expected in Q3 2018.

Equity Financing worth $35 Million

Strongbridge in a separate press release on December 23, 2016, announced that the Company has entered into a definitive securities purchase agreement for $35 million equity. According to terms of the definitive agreement, the Company will issue 14,000,000 ordinary shares to the investors at a price of $2.50 per ordinary share as well as warrants to purchase 7,000,000 shares. The warrants are exercisable at a price of $2.50 per share and expire five years from the date of issuance.

The Company stated that it is also in the process of finalizing credit documentation for a $40 million credit facility, of which $20 million would be borrowed initially. Under the credit facility, the Company anticipates having access to two additional tranches of $10 million each, which would be available to the Company subject to the achievement of certain specified milestones. It is anticipated that the credit facility would mature after 48 months, provide interest-only payments initially for the first 18 months of the loan followed by an amortization period of 30 months, provide for a final payment fee equal to 8% of the amount borrowed, and bear interest at a rate equal to the sum of 8.22% plus the greater of 0.53% or the 30-day US LIBOR rate.

Cash Position

Strongbridge's pro-forma cash and cash equivalents balance as of September 30, 2016, was $77.1 million, inclusive of estimated net proceeds from the equity financing and the initial $20 million borrowing under the credit facility. The Company believes it has sufficient financial resources, excluding any additional borrowings under the credit facility, to fund planned operations at least through 2018.

Stock Performance

At the close of trading session on January 04, 2017, Strongbridge Biopharma's stock price declined 2.13% to end the day at $2.30. A total volume of 166.68 thousand shares were exchanged during the session, which was above the 3-month average volume of 25.21 thousand shares. The stock currently has a market cap of $46.76 million.

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SOURCE: Active Wall Street