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

 


 

Date of Report (Date of earliest event reported): November 1, 2019

 

STRONGBRIDGE BIOPHARMA plc

(Exact name of registrant as specified in its charter)

 

Ireland
(State or other
jurisdiction of incorporation)

 

001-37569
(Commission
File Number)

 

98-1275166
(I.R.S. Employer
Identification No.)

 

 

 

 

900 Northbrook Drive, Suite 200
Trevose, PA
(Address of principal executive offices)

 

19053
(Zip Code)

 

Registrant’s telephone number, including area code: (610) 254-9200

 


 

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 (see General Instruction A.2. below):

 

o  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities Registered Pursuant to Section 12(b) of the Exchange Act:

 

Title of Each Class

 

Trading Symbol

 

Name of each exchange on which registered

Ordinary shares, par value $0.01 per share

 

SBBP

 

The NASDAQ Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company                                            x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x

 

 

 


 

Item 2.02                                           Results of Operations and Financial Condition.

 

On November 5, 2019, Strongbridge Biopharma plc (the “Company”) issued a press release reporting preliminary third quarter financial results and providing several corporate updates, including those described below.  A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

 

The information contained in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 is being furnished to the Commission and shall not be deemed “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing. The information set forth herein will not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.

 

Item 5.02                                           Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Directors.

 

On November 1, 2019, the Board of Directors (the “Board”) of the Company and Matthew Pauls, Chief Executive Officer of the Company (“CEO”), mutually agreed on a CEO transition plan resulting in his resignation from his positions as CEO and member of the Board, effective immediately.  His resignation was not the result of any dispute or disagreement with the Company or any matter related to the Company’s operations, policies or practices.  In connection with his resignation, Mr. Pauls will be paid termination benefits as set forth in his employment agreement.

 

In addition, on November 1, 2019, the Board appointed John H. Johnson, who has served as Chairman of the Board since 2015, as Executive Chairman of the Company, effective immediately.  Mr. Johnson will lead the Company while the Board conducts a formal search to identify a new CEO.  In connection with Mr. Johnson’s new role, any changes to his existing compensatory arrangement will be determined at a later date.

 

On November 5, 2019, the Company announced the CEO transition plan in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 7.01                                           Regulation FD.

 

The response to Item 2.02 is incorporated herein by reference to this Item 7.01.

 

Item 8.01                                           Other Events.

 

The Company has received a notice from Novo Nordisk Inc. (“Novo”) that indicates as of December 1, 2019 Novo intends to cease the use and funding of the Company’s field team for the promotion of MACRILENä (macimorelin) in the United States.  A subsidiary of the Company and Novo are parties to a December 2018 agreement pursuant to which Novo funds the costs of 23 of our field-based employees to provide full-time ongoing services to Novo, including the promotion of Macrilen, for a period of three years.  The Company has objected to the notice from Novo and the parties are engaged in discussions regarding the notice and the ongoing services.

 

Item 9.01                                           Financial Statements and Exhibits.

 

(d)   Exhibits

 

Exhibit
Number

 

Exhibit Table

 

 

 

99.1

 

Press Release issued by Strongbridge Biopharma plc, dated November 5, 2019

 

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.

 

 

STRONGBRIDGE BIOPHARMA PLC

 

 

 

By:

/s/ Robert Lutz

 

Name:

Robert Lutz

 

Title:

Chief Financial Officer

 

 

Date: November 5, 2019

 

 

3


Exhibit 99.1

 

Strongbridge Biopharma plc Announces CEO Transition Plan and Provides Preliminary Third Quarter 2019 Financial Results and Corporate Updates

 

Dublin, Ireland and Trevose, Pa., November 5, 2019 — Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that Matthew Pauls is stepping down as president, chief executive officer (CEO) and director, effective immediately. The Board of Directors (Board) and Mr. Pauls have mutually agreed that now is the right time to transition leadership of the Company.

 

John H. Johnson, who has served as chairman of Strongbridge since 2015, has assumed the position of executive chairman, effective immediately, and will lead the organization while the Board conducts a formal search to identify a new CEO.

 

Mr. Johnson is a recognized leader in the biopharmaceutical industry with more than 30 years of experience at leading global organizations, including Johnson & Johnson, Eli Lilly & Company, ImClone, and Pfizer, Inc. Mr. Johnson currently serves as a member of the board of directors of Portola Pharmaceuticals, Inc. Mr. Johnson previously served on the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA), the Health Section Governing Board of Biotechnology Industry Organizations (BIO), and BioNJ. Mr. Johnson holds a B.S. from the East Stroudsburg University of Pennsylvania.

 

Additionally, Strongbridge today reported preliminary and unaudited financial results and provided a corporate update for the third quarter ended September 30, 2019. The Company will announce its full third quarter 2019 financial results on November 7, 2019.

 

Preliminary Third Quarter 2019 Financial Results and Corporate Updates

 

Rare Neuromuscular Franchise: KEVEYIS® (dichlorphenamide)

 

·                  Strongbridge anticipates that it will report KEVEYIS® (dichlorphenamide) net product sales of $5.7 million during the third quarter of 2019, a 36 percent increase compared to $4.2 million during the third quarter of 2018.

 

·                  The Company remains on track to meet or exceed the top end of the full-year 2019 KEVEYIS revenue guidance of $18M to $20M.

 

Rare Endocrine Franchise: RECORLEV™ (levoketoconazole)

 

·                  Enrollment in the Phase 3 LOGICS study of RECORLEV™ (levoketoconazole) in endogenous Cushing’s syndrome is approximately two-thirds complete. The Company projects that all of the patients required to complete enrollment have been identified, with most in titration and

 


 

maintenance, and the remainder in screening. Top-line results are now anticipated in the second or third quarter of 2020.

 

·                  The Company plans to submit a New Drug Application for RECORLEV to the U.S. Food and Drug Administration approximately six months after reporting top-line LOGICS results.

 

Corporate:

 

·                  Strongbridge also expects to report quarter-end cash and cash equivalents of approximately $79.6 million, and no outstanding debt, as of September 30, 2019.

 

·                  Strongbridge and NovoNordisk are engaged in discussions following receipt of a notice from NovoNordisk that indicates as of December 1, 2019, it intends to cease the use and funding of the Strongbridge field team for the promotion of MACRILENä (macimorelin) in the U.S.

 

“As executive chairman, I will continue to work closely with the board of directors, executive management and the broader team to lead the organization while a formal search is conducted to identify a new CEO. We look forward to providing additional details on our financial results and corporate updates when we report full third quarter results later this week.  On behalf of the board of directors, we would like to thank Matt for his contributions to the Company and we wish him well in his future endeavors,” said John H. Johnson, executive chairman of Strongbridge Biopharma.

 

Third Quarter 2019 Reporting and Conference Call Details

 

Strongbridge will announce its full third quarter 2019 financial results and host a conference call on Thursday, November 7 at 8:30 a.m. ET. To access the live call, dial 844-285-7153 (domestic) or 478-219-0180 (international) with conference ID 1074065. The conference call will also be audio webcast from the Company’s website at www.strongbridgebio.com under the “Investor/Webcasts and Presentations” section. A replay of the call will be made available for one week following the conference call. To hear a replay of the call, dial 855-859-2056 (domestic) or 404-537-3406 (international) with conference ID 1074065.

 

About Strongbridge Biopharma

 

Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge’s rare endocrine franchise includes RECORLEV™ (levoketoconazole), a cortisol synthesis inhibitor currently being studied in Phase 3 clinical studies for the treatment of endogenous Cushing’s syndrome, and veldoreotide extended release, a pre-clinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation. Both RECORLEV and veldoreotide have received orphan drug designation from the FDA and the European Medicines Agency. The Company’s rare neuromuscular franchise includes KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis. KEVEYIS has orphan drug exclusivity in the United States.

 

About RECORLEV

 

RECORLEV™ (levoketoconazole) is an investigational cortisol synthesis inhibitor in development for the treatment of patients with endogenous Cushing’s syndrome, a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. RECORLEV is the pure 2S,4R

 


 

enantiomer of ketoconazole, a steroidogenesis inhibitor. RECORLEV is believed to significantly suppress serum cortisol in healthy subjects and has the potential to be a next-generation cortisol inhibitor.

 

The Phase 3 program for RECORLEV consists of SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoints, demonstrating a statistically significant normalization rate of urinary free cortisol at six months. The ongoing LOGICS study is a double-blind, placebo-controlled randomized-withdrawal study of RECORLEV that is designed to supplement the long-term efficacy and safety information supplied by SONICS.

 

RECORLEV has received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing’s syndrome.

 

About KEVEYIS

 

KEVEYIS® (dichlorphenamide) is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. In clinical studies, the most common side effects of KEVEYIS were a numbness or tingling, difficulty thinking and paying attention, changes in taste, and confusion. These are not all of the possible side effects that you may experience with KEVEYIS. Talk to your doctor if you have any symptoms that bother you or do not go away. You are encouraged to report side effects to Strongbridge Biopharma at 1-855-324-8912, or to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch/. For additional KEVEYIS important safety information and the full prescribing information visit www.keveyis.com.

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the federal securities laws. 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. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements, including statements related to the anticipated timing for the release of top-line data from the LOGICS study and the submission of an NDA for RECORLEV to the FDA, Strongbridge’s strategy, plans, status and results of clinical trials, outcomes of product development efforts and objectives of management for future operations. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in such statement, including risks and uncertainties associated with clinical development and the regulatory approval process, the reproducibility of any reported results showing the benefits of RECORLEV, the adoption of RECORLEV by physicians, if approved, as treatment for any disease and the emergence of unexpected adverse events following regulatory approval and use of the product by patients.  Additional risks and uncertainties relating to Strongbridge and its business can be found under the heading “Risk Factors” in Strongbridge’s Annual Report on Form 10-K for the year ended December 31, 2018 and subsequent filings with the SEC. 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.

 


 

Contacts:

 

Corporate and Investor Relations
Strongbridge Biopharma plc
Marcy Nanus
+1 484-312-3744
[email protected]

 

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