Strongbridge Biopharma plc Reports Third Quarter 2019 Financial Results and Provides Corporate Update
~ KEVEYIS® (dichlorphenamide) Achieved
~ Phase 3 LOGICS Study of RECORLEV™ (levoketoconazole) has Achieved Approximately Two-Thirds Target Enrollment To-Date; Top-line Results Anticipated in Second or Third Quarter 2020 ~
~ Novo Nordisk Will Pay Strongbridge
~ Strongbridge Extends Cash Runway Guidance; Cash Sufficient to Fund Operations Through Second Quarter 2021 ~
“As I step into the role of executive chairman, my initial key priorities are to identify a new chief executive officer, ensure a quality new drug application submission for RECORLEV™ (levoketoconazole), and improve the Company’s financial performance through cost savings initiatives,” said
Third Quarter 2019 and Recent Corporate & Financial Highlights
Rare Neuromuscular Franchise: KEVEYIS® (dichlorphenamide)
- Achieved KEVEYIS 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; Company remains on track to meet or exceed the top end of the full-year 2019 KEVEYIS revenue guidance range of
$18 million to $20 million . - Achieved a positive contribution margin for KEVEYIS in the third quarter, approximately six months ahead of previous projections.
- In October, long-term efficacy and safety characterization results for KEVEYIS were presented at the
American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting inAustin, Texas .
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 it has identified all of the remaining patients required to complete enrollment, with most in the titration and maintenance phase, 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.
- In October, the Company held a routine bi-annual data and safety monitoring board (DSMB) meeting for LOGICS, at which the DSMB recommended that the Phase 3 LOGICS study continue as planned.
- In September, comprehensive results from the positive pivotal Phase 3 SONICS study of RECORLEV for the potential treatment of endogenous Cushing’s syndrome were published online in The Lancet Diabetes & Endocrinology.
Rare Endocrine Franchise: MACRILEN™ (macimorelin)
- Strongbridge and
Novo Nordisk have reached an agreement in principle to terminate, effectiveDecember 1, 2019 , the services agreement between the parties that provides for the use and funding byNovo Nordisk of Strongbridge’s field team for the promotion of MACRILEN in the United States. - In connection with the termination of this agreement,
Novo Nordisk will pay Strongbridge$6 million and the Company will no longer provide services toNovo Nordisk . - Given that Strongbridge will no longer be supporting
Novo Nordisk , Strongbridge will eliminate all commercial costs related to MACRILEN, including the approximately 23 Strongbridge field-based positions related to the MACRILEN sales efforts, effectiveDecember 1, 2019 .
Corporate:
- Strongbridge had
$79.6 million of cash and cash equivalents and no debt outstanding as ofSeptember 30 , 2019. - The Company extended its cash runway guidance by at least three months, and now believes it can fund operations as currently planned through the second quarter of 2021.
- In September, the Company appointed
Richard S. Kollender , who previously served on the Company’s board of directors, to chief operating officer and promotedRobert Lutz from chief business officer to chief financial officer. Additionally,David Gill was appointed to the board of directors and as chairman of the audit committee following Richard’s resignation from the Board. - On
November 5 , the Company announced thatMatthew Pauls stepped down as president, chief executive officer (CEO) and director.John H. Johnson , who has served as chairman of Strongbridge since 2015, assumed the position of executive chairman, and is leading the organization while the Board of Directors conducts a formal search to identify a new CEO.
Third Quarter 2019 Financial Results
For the three months ended September 30, 2019, basic net loss attributable to ordinary shareholders on a GAAP basis was
For the three months ended
Net revenues were
Selling, general and administrative expenses were
Research and development expenses were
Year-to-Date
For the nine months ended September 30, 2019, basic net loss attributable to ordinary shareholders on a GAAP basis was
For the nine months ended
Net revenues were
Selling, general and administrative expenses were
Research and development expenses were
Conference Call Details
Strongbridge will host a conference call on
About
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
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
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 potential advantages of RECORLEV, discussions with regulators regarding the approval process for RECORLEV, the anticipated timing for the release of top-line data from the LOGICS study and the submission of an NDA for RECORLEV to the
Contacts:
Corporate and Investor Relations
Marcy Nanus
+1 484-312-3744
[email protected]
Media Relations
Elixir Health Public Relations
+1 862-596-1304
[email protected]
STRONGBRIDGE BIOPHARMA plc | |||||||
Select Consolidated Balance Sheet Information (unaudited) | |||||||
(in thousands, except share and per share data) | |||||||
September 30 | December 31, | ||||||
2019 | 2018 | ||||||
( in thousands) | |||||||
Consolidated Balance Sheet Data: | |||||||
Cash and cash equivalents | $ | 79,608 | $ | 122,490 | |||
Total assets | 122,960 | 170,285 | |||||
Total liabilities | 43,319 | 57,330 | |||||
Total stockholders’ equity | 79,641 | 112,955 |
STRONGBRIDGE BIOPHARMA plc | ||||||||||||||||
Consolidated Statement of Operations (unaudited) | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Consolidated Statement of Operations Data: | ||||||||||||||||
Revenues: | ||||||||||||||||
Net product sales | $ | 5,677 | $ | 5,347 | $ | 16,083 | $ | 13,513 | ||||||||
Royalty revenues | 7 | - | 23 | - | ||||||||||||
Total revenues | 5,684 | 5,347 | 16,106 | 13,513 | ||||||||||||
Cost and expenses: | ||||||||||||||||
Cost of sales (excluding amortization of intangible assets) | $ | 1,001 | $ | 1,441 | $ | 2,836 | $ | 2,861 | ||||||||
Selling, general and administrative | 12,806 | 19,564 | 37,088 | 47,137 | ||||||||||||
Research and development | 7,552 | 7,198 | 22,874 | 17,532 | ||||||||||||
Amortization of intangible assets | 1,255 | 1,876 | 3,766 | 5,517 | ||||||||||||
Total cost and expenses | 22,614 | 30,079 | 66,564 | 73,047 | ||||||||||||
Operating loss | (16,930 | ) | (24,732 | ) | (50,458 | ) | (59,534 | ) | ||||||||
Other income, net | ||||||||||||||||
Income from field services agreement | 1,725 | — | 5,466 | — | ||||||||||||
Expense from field services agreement | (1,672 | ) | — | (5,659 | ) | — | ||||||||||
Unrealized gain on fair value of warrants | 3,202 | 7,131 | 10,079 | 16,448 | ||||||||||||
Interest expense | — | (3,387 | ) | — | (9,550 | ) | ||||||||||
Loss on extinguishment of debt | — | — | — | (500 | ) | |||||||||||
Other income, net | 576 | 430 | 1,869 | 932 | ||||||||||||
Total income, net | 3,831 | 4,174 | 11,755 | 7,330 | ||||||||||||
Loss before income taxes | (13,099 | ) | (20,558 | ) | (38,703 | ) | (52,204 | ) | ||||||||
Income tax expense | (691 | ) | — | (1,768 | ) | (1 | ) | |||||||||
Net loss | (13,790 | ) | (20,558 | ) | (40,471 | ) | (52,205 | ) | ||||||||
Net loss attributable to ordinary shareholders: | ||||||||||||||||
Basic | $ | (13,790 | ) | $ | (20,558 | ) | $ | (40,471 | ) | $ | (52,205 | ) | ||||
Diluted | $ | (16,992 | ) | $ | (27,690 | ) | $ | (50,550 | ) | $ | (68,653 | ) | ||||
Net loss per share attributable to ordinary shareholders: | ||||||||||||||||
Basic | $ | (0.25 | ) | $ | (0.44 | ) | $ | (0.75 | ) | $ | (1.14 | ) | ||||
Diluted | $ | (0.31 | ) | $ | (0.55 | ) | $ | (0.91 | ) | $ | (1.37 | ) | ||||
Weighted-average shares used in computing net loss per share attributable to ordinary shareholders: | ||||||||||||||||
Basic | 54,192,710 | 46,978,472 | 54,174,629 | 45,916,177 | ||||||||||||
Diluted | 54,540,646 | 50,317,423 | 55,844,719 | 49,985,483 | ||||||||||||
STRONGBRIDGE BIOPHARMA plc | ||||||||
Reconciliation of Non-GAAP Financial Measures (unaudited) | ||||||||
(in thousands, except share and per share data) | ||||||||
Three Months Ended September 30, 2019 | ||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
|||||
GAAP | ($16,930) | ($13,099) | ($13,790) | ($0.25) | ||||
Non-GAAP Adjustments: | ||||||||
Amortization of intangible assets (a) | $1,255 | $1,255 | $1,255 | |||||
Stock-based compensation - Research & Development (b) | $491 | $491 | $491 | |||||
Stock-based compensation - Selling, General & Admin. (b) | $1,684 | $1,684 | $1,684 | |||||
Unrealized gain on fair value of warrants (c) | — | ($3,202) | ($3,202) | |||||
Adjusted | ($13,500) | ($12,871) | ($13,562) | ($0.25) | ||||
Three Months Ended September 30, 2018 | ||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
|||||
GAAP | ($24,732) | ($20,558) | ($20,558) | ($0.44) | ||||
Non-GAAP Adjustments: | ||||||||
Amortization of intangible asset (a) | $1,876 | $1,876 | $1,876 | |||||
Stock-based compensation - Research & Development (b) | $467 | $467 | $467 | |||||
Stock-based compensation - Selling, General & Admin. (b) | $1,649 | $1,649 | $1,649 | |||||
Unrealized gain on fair value of warrants (c) | — | ($7,131) | ($7,131) | |||||
Non-cash interest and debt extinguishment expense (d) | — | $1,488 | $1,488 | |||||
Adjusted | ($20,740) | ($22,209) | ($22,209) | ($0.47) | ||||
STRONGBRIDGE BIOPHARMA plc | |||||||||||||||||
Reconciliation of Non-GAAP Financial Measures (unaudited) | |||||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||
Nine Months Ended September 30, 2019 | |||||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
||||||||||||||
GAAP | ($50,458 | ) | ($38,703 | ) | ($40,471 | ) | ($0.75 | ) | |||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets (a) | $3,766 | $3,766 | $3,766 | ||||||||||||||
Stock-based compensation - Research & Development (b) | $1,595 | $1,595 | $1,595 | ||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $5,475 | $5,475 | $5,475 | ||||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($10,079 | ) | ($10,079 | ) | ||||||||||||
Adjusted | ($39,622 | ) | ($37,946 | ) | ($39,714 | ) | ($0.73 | ) | |||||||||
Nine Months Ended September 30, 2018 | |||||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
||||||||||||||
GAAP | ($59,534 | ) | ($52,204 | ) | ($52,205 | ) | ($1.14 | ) | |||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible asset (a) | $5,517 | $5,517 | $5,517 | ||||||||||||||
Stock-based compensation - Research & Development (b) | $1,339 | $1,339 | $1,339 | ||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $4,450 | $4,450 | $4,450 | ||||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($16,448 | ) | ($16,448 | ) | ||||||||||||
Non-cash interest and debt extinguishment expense (d) | — | $4,150 | $4,150 | ||||||||||||||
Adjusted | ($48,228 | ) | ($53,196 | ) | ($53,197 | ) | ($1.16 | ) | |||||||||
- The effects of amortization of the intangible assets and charges related to the impairment of the intangible assets are excluded because these charges are non-cash, and we believe such exclusion facilitates investors’ ability to more accurately compare our operating results to those of our peer companies.
- The effects of non-cash employee stock-based compensation are excluded because of varying available valuation methodologies and subjective assumptions. We believe this is a useful measure for investors because such exclusion facilitates comparison to peer companies who also provide similar non-GAAP disclosures and is reflective of how management internally manages the business.
- The unrealized gain on fair value of warrants are excluded due to the nature of this charge, which is non-cash and related primarily to the effect of changes in the company’s stock price at a point in time. We believe such exclusion facilitates investors’ ability to more accurately compare our operating results to those of our peer companies.
- The effects of non-cash interest charges are excluded. We believe such exclusion facilitates an understanding of the effects of the debt service obligations on the Company’s liquidity and comparisons to peer group companies and is reflective of how management internally manages the business.
Source: Strongbridge Biopharma plc