Strongbridge Biopharma plc Reports Second Quarter 2019 Financial Results and Provides Corporate Update
~ KEVEYIS®(dichlorphenamide) Second Quarter 2019 Revenue of
~ Company on Track to Meet Full-Year 2019 KEVEYIS® Revenue Guidance of
~ Enrollment in Phase 3 LOGICS Study for RECORLEV™ (levoketoconazole) Progressing with Top-Line Data Anticipated at the End of the First Quarter 2020 ~
“We are encouraged by the quarter-over-quarter revenue growth achieved with KEVEYIS® (dichlorphenamide) during the second quarter of 2019. These results reflect the progress the Company has made in more fully addressing the unmet needs of the primary periodic paralysis community,” said
Second Quarter 2019 and Recent Corporate & Financial Highlights
Rare Neuromuscular Franchise: KEVEYIS® (dichlorphenamide)
- Achieved KEVEYIS net product sales of $6.1 million during the second quarter of 2019, a 42 percent increase compared to $4.3 million during the second quarter of 2018.
- Reiterated full-year 2019 revenue guidance for KEVEYIS of $18 to
$20 million ; based upon current assumptions, the Company anticipates a positive KEVEYIS contribution margin by the end of the first quarter of 2020. - In May, Strongbridge presented long-term efficacy results for KEVEYIS at the 71st
American Academy of Neurology Annual Meeting. The results demonstrated that long-term treatment with KEVEYIS is efficacious and provides durable reduction in attack frequency and severity in patients with primary periodic paralysis.
Rare Endocrine Franchise: RECORLEV™ (levoketoconazole)
- Top-line data from the Phase 3 LOGICS study anticipated at the end of the first quarter of 2020; these data will support a New Drug Application (NDA) submission to the
U.S. Food and Drug Administration projected at the end of the third quarter of 2020. - In April, Strongbridge presented secondary endpoint results from the Phase 3 SONICS study demonstrating meaningful improvements in the clinical signs and symptoms of Cushing’s syndrome at the 2019
American Association of Clinical Endocrinologists Annual Scientific andClinical Congress .
Corporate:
- In July, Strongbridge was added to the U.S. broad-market Russell 3000® and Microcap® Indexes.
- In June, Strongbridge announced that it strengthened its senior leadership team with the promotion of
Scott Wilhoit to chief commercial officer and the appointment of Marcy Nanus to vice president of corporate affairs. - Strongbridge had
$86.2 million of cash and cash equivalents and no debt outstanding as ofJune 30, 2019 . The Company believes the combination of existing cash resources, along with anticipated KEVEYIS revenues and payments fromNovo Nordisk , are sufficient to fund operations as currently planned at least through the first quarter of 2021.
Second Quarter 2019 Financial Results
For the three months ended June 30, 2019, basic net loss attributable to ordinary shareholders on a GAAP basis was
For the three months ended
The Company recorded net revenues from sales of KEVEYIS of
Selling, general and administrative expenses were
Research and development expenses were
Year-to-Date
For the six months ended June 30, 2019, basic net loss attributable to ordinary shareholders on a GAAP basis was
For the six months ended
The Company recorded net revenues from sales of KEVEYIS of
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, 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
+1 610-263-2252
[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) | |||||||
June 30 | December 31, | ||||||
2019 | 2018 | ||||||
( in thousands) | |||||||
Consolidated Balance Sheet Data: | |||||||
Cash and cash equivalents | $ | 86,167 | $ | 122,490 | |||
Total assets | 135,156 | 170,285 | |||||
Total liabilities | 43,867 | 57,330 | |||||
Total stockholders’ equity | 91,289 | 112,955 |
STRONGBRIDGE BIOPHARMA plc | |||||||||||||||
Consolidated Statement of Operations (unaudited) | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Consolidated Statement of Operations Data: | |||||||||||||||
Revenues: | |||||||||||||||
Net product sales | $ | 6,073 | $ | 4,296 | $ | 10,406 | $ | 8,166 | |||||||
Royalty revenues | 6 | - | 16 | - | |||||||||||
Total revenues | 6,079 | 4,296 | 10,422 | 8,166 | |||||||||||
Cost and expenses: | |||||||||||||||
Cost of sales (excluding amortization of intangible assets) | $ | 1,022 | $ | 753 | $ | 1,835 | $ | 1,420 | |||||||
Selling, general and administrative | 12,182 | 15,210 | 24,282 | 27,572 | |||||||||||
Research and development | 8,739 | 5,453 | 15,322 | 10,334 | |||||||||||
Amortization of intangible assets | 1,255 | 1,872 | 2,511 | 3,641 | |||||||||||
Total cost and expenses | 23,198 | 23,288 | 43,950 | 42,967 | |||||||||||
Operating loss | (17,119 | ) | (18,992 | ) | (33,528 | ) | (34,801 | ) | |||||||
Other income, net | |||||||||||||||
Income from field services agreement | 1,725 | — | 3,741 | — | |||||||||||
Expense from field services agreement | (1,758 | ) | — | (3,987 | ) | — | |||||||||
Unrealized gain on fair value of warrants | 8,697 | 19,017 | 6,877 | 9,317 | |||||||||||
Interest expense | — | (3,289 | ) | — | (6,163 | ) | |||||||||
Loss on extinguishment of debt | — | — | — | (500 | ) | ||||||||||
Other income, net | 608 | 342 | 1,293 | 502 | |||||||||||
Total income, net | 9,272 | 16,070 | 7,924 | 3,156 | |||||||||||
Loss before income taxes | (7,847 | ) | (2,922 | ) | (25,604 | ) | (31,645 | ) | |||||||
Income tax expense | (400 | ) | (1 | ) | (1,077 | ) | (1 | ) | |||||||
Net loss | (8,247 | ) | (2,923 | ) | (26,681 | ) | (31,646 | ) | |||||||
Net loss attributable to ordinary shareholders: | |||||||||||||||
Basic | $ | (8,247 | ) | $ | (2,923 | ) | $ | (26,681 | ) | $ | (31,646 | ) | |||
Diluted | $ | (16,944 | ) | $ | (21,940 | ) | $ | (33,558 | ) | $ | (40,963 | ) | |||
Net loss per share attributable to ordinary shareholders: | |||||||||||||||
Basic | $ | (0.15 | ) | $ | (0.06 | ) | $ | (0.49 | ) | $ | (0.69 | ) | |||
Diluted | $ | (0.30 | ) | $ | (0.43 | ) | $ | (0.60 | ) | $ | (0.81 | ) | |||
Weighted-average shares used in computing net income (loss) per share attributable to ordinary shareholders: | |||||||||||||||
Basic | 54,175,731 | 45,829,600 | 54,165,439 | 45,728,793 | |||||||||||
Diluted | 55,781,078 | 50,437,716 | 56,262,936 | 50,363,801 |
STRONGBRIDGE BIOPHARMA plc | ||||||||||||||||
Reconciliation of Non-GAAP Financial Measures (unaudited) | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Three Months Ended June 30, 2019 | ||||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
|||||||||||||
GAAP | ($17,119 | ) | ($7,847 | ) | ($8,247 | ) | ($0.15 | ) | ||||||||
Non-GAAP Adjustments: | ||||||||||||||||
Amortization of intangible assets (a) | $1,255 | $1,255 | $1,255 | |||||||||||||
Stock-based compensation - Research & Development (b) | $592 | $592 | $592 | |||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $1,981 | $1,981 | $1,981 | |||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($8,697 | ) | ($8,697 | ) | |||||||||||
Adjusted | ($13,291 | ) | ($12,716 | ) | ($13,116 | ) | ($0.24 | ) | ||||||||
Three Months Ended June 30, 2018 | ||||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
|||||||||||||
GAAP | ($18,992 | ) | ($2,922 | ) | ($2,923 | ) | ($0.06 | ) | ||||||||
Non-GAAP Adjustments: | ||||||||||||||||
Amortization of intangible asset (a) | $1,872 | $1,872 | $1,872 | |||||||||||||
Stock-based compensation - Research & Development (b) | $463 | $463 | $463 | |||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $1,521 | $1,521 | $1,521 | |||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($19,017 | ) | ($19,017 | ) | |||||||||||
Non-cash interest expense (d) | — | $1,430 | $1,430 | |||||||||||||
Adjusted | ($15,136 | ) | ($16,653 | ) | ($16,654 | ) | ($0.36 | ) |
STRONGBRIDGE BIOPHARMA plc | ||||||||||||||||
Reconciliation of Non-GAAP Financial Measures (unaudited) | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Six Months Ended June 30, 2019 | ||||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
|||||||||||||
GAAP | ($33,528 | ) | ($25,604 | ) | ($26,681 | ) | ($0.49 | ) | ||||||||
Non-GAAP Adjustments: | ||||||||||||||||
Amortization of intangible assets (a) | $2,511 | $2,511 | $2,511 | |||||||||||||
Stock-based compensation - Research & Development (b) | $1,104 | $1,104 | $1,104 | |||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $3,792 | $3,792 | $3,792 | |||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($6,877 | ) | ($6,877 | ) | |||||||||||
Adjusted | ($26,121 | ) | ($25,074 | ) | ($26,151 | ) | ($0.48 | ) | ||||||||
Six Months Ended June 30, 2018 | ||||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
|||||||||||||
GAAP | ($34,801 | ) | ($31,645 | ) | ($31,646 | ) | ($0.69 | ) | ||||||||
Non-GAAP Adjustments: | ||||||||||||||||
Amortization of intangible asset (a) | $3,641 | $3,641 | $3,641 | |||||||||||||
Stock-based compensation - Research & Development (b) | $871 | $871 | $871 | |||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $2,801 | $2,801 | $2,801 | |||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($9,317 | ) | ($9,317 | ) | |||||||||||
Non-cash interest and debt extinguishment expense (d) | — | $2,662 | $2,662 | |||||||||||||
Adjusted | ($27,488 | ) | ($30,987 | ) | ($30,988 | ) | ($0.68 | ) |
- 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