In The Spotlight: Strongbridge Biopharma

(RTTNews) - Shares of Strongbridge Biopharma plc (SBBP) have gained 11% in the last 5 trading days compared to a mere 2.83% return by the iShares NASDAQ Biotechnology Index (ETF) during the same period.

Strongbridge is a rare disease biopharmaceutical company with commercial and late-stage product portfolio.

The marketed drug of the Company is KEVEYIS, the first and only FDA-approved drug for ultra-rare Primary Periodic Paralysis, which is a group of rare hereditary disorders that causes potentially severe episodes of muscle weakness and/or paralysis.

KEVEYIS was approved by the FDA in August 2015, and it was launched by Taro Pharmaceutical Industries Ltd. (TARO), a subsidiary of Sun Pharmaceuticals Industries, in September of that year.

Strongbridge acquired the U.S. rights to KEVEYIS from Taro Pharmaceutical in December 2016, and relaunched it in April 2017.

There is a significant market demand for KEVEYIS as can be seen from the sales figures.

The net product sales of KEVEYIS were $2.5 million during the third quarter of 2017, a 67% increase, compared to $1.5 million in the second quarter of 2017 (i.e., the quarter in which the drug was launched by Strongbridge).

According to the Washington Post, KEVEYIS, which had a list price of $13,650 for 100 pills in 2015, when it was under the aegis of Sun Pharma, now costs $15,001 for a bottle of 100 pills.

The most advanced investigational product in the Company's pipeline is RECORLEV, which is under phase III testing for the treatment of endogenous Cushing's syndrome.

Cushing's syndrome can develop either when the body produces too much glucocorticoid (endogenous) or due to taking corticosteroid medications for a long time (exogenous). Rapid weight gain, particularly in the trunk and face, stretch marks and bruising, bone loss, muscle weakness and changes in mood are some of the hallmarks of this disease.

Two phase III trials with RECORLEV in endogenous Cushing's syndrome, dubbed SONICS and LOGICS, are underway.

Top-line results from the SONICS study are expected in the second quarter of 2018 and that from the LOGICS trial are anticipated in the fourth quarter of 2018.

Next in the pipeline is Veldoreotide, which is under phase II testing, for the treatment of patients with acromegaly.

Acromegaly, which literally means enlarged extremities, is condition that is nearly always caused by a pituitary adenoma, a tumor of the pituitary gland. (Source: UCLA Health).

A series of pre-clinical studies that seek to determine additional differentiating features of Veldoreotide in endocrine and non-endocrine conditions are also being initiated by the Company in order to optimally focus any future investments in the compound.

Balance Sheet - Q3, 2017

On an adjusted basis, the net loss attributable to ordinary shareholders for the third quarter ended September 30, 2017, widened to $13.05 million or $0.35 per share from $6.5 million or $0.31 per share in the year-ago quarter. The net product sales of KEVEYIS were $2.5 million in the recent third quarter while no revenue was reported by the Company in the comparable year-ago quarter.

Strongbridge ended September 30, 2017, with cash of $44.4 million and outstanding debt of $40.0 million. The following month, i.e. in October 2017, the Company raised $23.4 million in a public offering, and so that brings the Company's cash on hand to nearly $68 million.

SBBP touched a new 52-week high of $7.85 yesterday (Jan.4, 2018) before closing the day's trading at $7.55, up 4.14%.