Strongbridge Biopharma plc Announces Preliminary Fourth Quarter and Total-Calendar year 2020 Financial …

~ Expects to Report KEVEYIS® (dichlorphenamide) Fourth Quarter 2020 Earnings of Somewhere around $8.2 Million and Entire-Yr 2020 Revenue of Around $30.7 Million, a 41.5 % Enhance around 2019 Income of $ $21.7 Million ~

~ Targets Total-Yr 2021 KEVEYIS
®
(dichlorphenamide) Revenue Guidance of Somewhere around $34 Million to $36 Million ~

~ Company on Keep track of to Post New Drug Software (NDA) for RECORLEV® (levoketoconazole) to the FDA in the Initial Quarter of 2021 ~

~ Enterprise Exercised its Choice to Draw-Down an Supplemental $10 Million Under its Current Debt Facility in the Fourth Quarter of 2020 Somewhere around $87.5 Million in Money on Hand is Envisioned to Fund Operations Into and Potentially Beyond the First Quarter of 2023 ~

DUBLIN, Eire and TREVOSE, Pa., Jan. 06, 2021 (World NEWSWIRE) — Strongbridge Biopharma plc, (Nasdaq: SBBP), a international industrial-stage biopharmaceutical organization focused on the enhancement and commercialization of therapies for rare illnesses with important unmet demands, now declared preliminary and unaudited fiscal benefits for the fourth quarter and entire-12 months 2020 and presented an update on pick corporate priorities for 2021.  

“Our preliminary fourth quarter and comprehensive-12 months 2020 economic success, along with the formerly-introduced accomplishment of positive and statistically substantial prime-line results from the pivotal Stage 3 LOGICS analyze of RECORLEV® (levoketoconazole), show the enthusiasm and motivation of the whole Strongbridge team to productively execute against the Company’s strategic programs even with the many troubles connected with the ongoing COVID-19 pandemic,” said John H. Johnson, main govt officer of Strongbridge Biopharma. “We are self-assured in the lengthy-time period growth prospective customers for Strongbridge and imagine that our development this past year supplies a persuasive foundation for ongoing achievement in 2021. We are on monitor to post a New Drug Application to the U.S. Food items and Drug Administration for RECORLEV for the treatment method of Endogenous Cushing’s Syndrome in the initial quarter of 2021 and are getting ready for the probable start in the initially quarter of 2022. In parallel, we remain centered on further growing KEVEYIS® (dichlorphenamide) revenue and pursuing patent security for KEVEYIS based upon medical pharmacology scientific studies that we conducted.”

Preliminary and Unaudited Fourth Quarter and Comprehensive-Calendar year 2020 Economical Results, Cash Place, and 2021 KEVEYIS®(dichlorphenamide)   Profits Guidance

• The Corporation anticipates that it will report KEVEYIS web solution profits of approximately $8.2 million for the fourth quarter finished, December 31, 2020, and approximately $30.7 million for the whole-calendar year finished December 31, 2020, exceeding its projected $28 million to $29 million direction selection, and representing a 41.5 percent maximize more than 2019 revenue of $21.7 million.
• The Firm is concentrating on entire-12 months 2021 income steerage of close to $34 million to $36 million for KEVEYIS.
• Next completion in September 2020 of a $25 million equity raise and a current 12 months-conclusion borrowing of an added $10 million below the Company’s current personal debt facility, Strongbridge expects to report around $87.5 million of money and funds equivalents as of December 31, 2020.
• The Business thinks it can fund operations as now planned into and potentially beyond the to start with quarter of 2023.

Select Company Priorities for 2021

• The Organization is on-keep track of to post a New Drug Software (NDA) for RECORLEV to the U.S. Food items and Drug Administration in the to start with quarter of 2021 if permitted, the start of RECORLEV is predicted in the 1st quarter of 2022, assuming a projected 10-month overview cycle.
• Moreover, Strongbridge is executing towards its in depth pre-commercialization strategies for RECORLEV.
• Primarily based on scientific pharmacology studies that we conducted, the Corporation proceeds its efforts to go after daily life cycle extension opportunities for KEVEYIS as a result of prosecution of the patent estate.

Approaching Activities

• Strongbridge administration ideas to existing at two impending virtual trader healthcare conferences:
  • The Solebury Trout Virtual Management Obtain Function getting held January 6 – 15, 2021. The Company’s presentation will be out there on January 7, 2021 at 7:00 a.m. ET.
  • H.C. Wainwright Virtual BioConnect 2021 Conference, which will be accessible on-demand from customers from January 11 – 14, 2021.
  • Both of these impending displays will be accessible on the Company’s web page: https://traders.strongbridgebio.com/upcoming-gatherings.

About Strongbridge Biopharma
Strongbridge Biopharma is a world wide industrial-phase biopharmaceutical company targeted on the progress and commercialization of therapies for uncommon diseases with considerable unmet requires. Strongbridge’s scarce endocrine franchise features RECORLEV® (levoketoconazole), a cortisol synthesis inhibitor now staying studied in Section 3 clinical scientific tests for the remedy of endogenous Cushing’s syndrome, and veldoreotide prolonged release, a preclinical subsequent-generation somatostatin analog getting investigated for the procedure of acromegaly and prospective added apps in other conditions amenable to somatostatin receptor activation. Equally RECORLEV and veldoreotide have obtained orphan drug designation from the Food and drug administration and the European Medications Agency. The Company’s unusual neuromuscular franchise features KEVEYIS® (dichlorphenamide), the initial and only Food and drug administration-approved treatment method for hyperkalemic, hypokalemic, and connected variants of main periodic paralysis. KEVEYIS has orphan drug exclusivity in the United States.

About KEVEYIS
KEVEYIS® (dichlorphenamide) is indicated for the therapy of primary hyperkalemic periodic paralysis, key hypokalemic periodic paralysis, and similar variants. In clinical scientific studies, the most common side outcomes of KEVEYIS have been a numbness or tingling, difficulty imagining and paying out interest, variations in flavor, and confusion. These are not all of the attainable facet outcomes that you might practical experience with KEVEYIS. Discuss to your medical doctor if you have any signs that trouble you or do not go away. You are encouraged to report aspect effects to Strongbridge Biopharma at 1-855-324-8912, or to the Fda at 1-800-Food and drug administration-1088 or visit  www.fda.gov/medwatch. For additional KEVEYIS important protection facts and the whole prescribing facts visit  www.keveyis.com.

About RECORLEV
RECORLEV® (levoketoconazole) is an investigational cortisol synthesis inhibitor in progress for the cure of patients with endogenous Cushing’s syndrome, a uncommon but really serious and most likely deadly endocrine sickness caused by long-term elevated cortisol publicity. RECORLEV is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. RECORLEV has demonstrated in two thriving Phase 3 studies to drastically suppress serum cortisol and has the probable to be a subsequent-technology cortisol inhibitor.

The Period 3 application for RECORLEV contains SONICS and LOGICS: two multinational scientific studies created to assess the security and efficacy of RECORLEV when used to take care of endogenous Cushing’s syndrome. The SONICS analyze fulfilled its most important and secondary endpoints, demonstrating a statistically important normalization fee of urinary absolutely free cortisol at six months. The LOGICS study, which met its primary endpoint, is a double-blind, placebo-controlled randomized-withdrawal examine of RECORLEV that is created to nutritional supplement the very long-expression efficacy and protection details equipped by SONICS. The ongoing lengthy-time period open up label OPTICS research will acquire even further useful information related to the extended-time period use of RECORLEV.

RECORLEV has acquired orphan drug designation from the Fda and the European Medicines Agency for the procedure of endogenous Cushing’s syndrome.

Forward-Wanting Statements
This push launch contains ahead-wanting statements inside the that means of the federal securities guidelines. The terms “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” or the detrimental of these terms or other identical expressions are meant to recognize ahead-searching statements, while not all ahead-looking statements include these identifying terms. All statements, other than statements of historic information, contained in this push launch, are ahead-looking statements, like statements relevant to the Company’s fourth quarter and comprehensive-12 months 2020 revenue assistance, predicted dollars balances and income runway, possible long term borrowings, prospective strengths of RECORLEV, the anticipated timing for the submission of an NDA for RECORLEV to the Fda and the opportunity start of RECORLEV (if approved), Strongbridge’s strategy, options, results of merchandise growth endeavours and objectives of management for long run operations. Ahead-looking statements require dangers and uncertainties that could lead to real outcomes to differ materially from those expressed in these kinds of statement, like pitfalls and uncertainties affiliated with scientific enhancement and the regulatory acceptance method, the reproducibility of any claimed effects showing the positive aspects of RECORLEV, the adoption of RECORLEV by doctors, if authorised, as remedy for any disorder and the emergence of surprising adverse gatherings following regulatory approval and use of the item by people. Further hazards and uncertainties relating to Strongbridge and its organization can be observed underneath the heading “Risk Factors” in Strongbridge’s Once-a-year Report on Form 10-K for the calendar year ended December 31, 2019 and its subsequent Quarterly Reviews on Kind 10-Q as nicely as its other filings with the SEC. These forward-seeking statements are based on present anticipations, estimates, forecasts and projections and are not assures of upcoming functionality or progress and involve acknowledged and unknown threats, uncertainties and other factors. The forward-hunting statements contained in this push launch are produced as of the date of this push release, and Strongbridge Biopharma does not think any obligation to update any forward-seeking statements apart from as essential by relevant regulation.

Contacts:

Corporate and Media Relations
Elixir Wellness Public Relations
Lindsay Rocco
+1 862-596-1304
[email protected]

Investor Relations
Solebury Trout
Mike Biega
+1 617-221-9660
[email protected]