Strongbridge Biopharma plc Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Corporate Update
~ KEVEYIS® (dichlorphenamide) Full-Year 2019 Revenue of
~ Full-Year 2020 KEVEYIS®(dichlorphenamide) Revenue Guidance of Approximately
~ Phase 3 LOGICS Study of RECORLEV® (levoketoconazole) has Achieved Approximately 85 Percent Target Enrollment To-Date ~
~ Company Anticipates Reporting Top-Line LOGICS Results at the End of Second Quarter or During the Third Quarter 2020 ~
~ Strongbridge to Host Conference Call Today at 8:30 am ET; Accompanying Slides will be Available at
“We are pleased with the continued revenue growth of KEVEYIS® (dichlorphenamide) in 2019, which resulted in a positive and growing contribution margin for the Company. We believe that this revenue growth can be attributed to both a steady flow of referrals from physicians that resulted in new patient starts and improved retention rates, and we expect this growth to continue in 2020,” said John
Corporate & Financial Highlights
Rare Neuromuscular Franchise: KEVEYIS® (dichlorphenamide)
- Achieved KEVEYIS net product sales of
$5.6 million during the fourth quarter of 2019, a 27 percent increase compared to$4.4 million during the fourth quarter of 2018. - Full-year 2019 net revenues from sales of KEVEYIS totaled
$21.7 million , compared to full-year net revenues of$16.8 million in 2018, a 29 percent increase. - Full-year 2020 revenue guidance for KEVEYIS of
$26 to$27 million ; the Company continues to anticipate a positive and growing KEVEYIS contribution margin in 2020.
Rare Endocrine Franchise: RECORLEV® (levoketoconazole)
- Enrollment in the Phase 3 LOGICS study of RECORLEV in endogenous Cushing’s syndrome is approximately 85 percent complete; the Company projects that all of the remaining patients required to complete enrollment are currently in the titration and maintenance phase.
- Based upon current observations, the Company believes that it will report top-line results from the LOGICS study at the end of the second quarter or during the 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 had
$78 million of cash, cash equivalents and marketable securities, and no debt outstanding as ofDecember 31, 2019 . - As previously announced, the Company has further extended its cash runway guidance by an additional three months, and now believes it can fund operations as currently planned through the third quarter of 2021, at least one-year following anticipated receipt of LOGICS top-line results.
Fourth Quarter 2019 Financial Results
For the three months ended
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 twelve months ended
For the twelve months ended
Net revenues were
Selling, general and administrative expenses were
Research and development expenses were
Select Consolidated Balance Sheet Information (unaudited) | ||||||||
(in thousands, except share and per share data) | ||||||||
2019 |
2018 | |||||||
Consolidated Balance Sheet Data: | ||||||||
Cash and cash equivalents | $ | 57,032 | $ | 122,490 | ||||
Marketable securities | 21,072 | — | ||||||
Total assets | 117,638 | 170,285 | ||||||
Total liabilities | 45,447 | 57,330 | ||||||
Total stockholders’ equity | 72,191 | 112,955 |
Consolidated Statements of Operations and Comprehensive (Loss) Income (unaudited) | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
Three Months Ended |
Year Ended |
||||||||||||||
2019 |
2018 |
2019 |
2018 | ||||||||||||
Consolidated Statement of Operations Data: | |||||||||||||||
Revenues: | |||||||||||||||
Net product sales | $ | 5,593 | $ | 4,514 | $ | 21,676 | $ | 18,027 | |||||||
Royalty revenues | 13 | - | 36 | - | |||||||||||
Total revenues | 5,606 | 4,514 | 21,712 | 18,027 | |||||||||||
Cost and expenses: | |||||||||||||||
Cost of sales (excluding amortization of intangible assets) | $ | 986 | $ | 1,125 | $ | 3,822 | $ | 3,986 | |||||||
Selling, general and administrative | 11,970 | 16,199 | 49,058 | 63,336 | |||||||||||
Research and development | 8,029 | 7,909 | 30,903 | 25,441 | |||||||||||
Amortization of intangible assets | 1,256 | 1,670 | 5,022 | 7,187 | |||||||||||
Total cost and expenses | 22,241 | 26,903 | 88,805 | 99,950 | |||||||||||
Operating loss | (16,635 | ) | (22,389 | ) | (67,093 | ) | (81,923 | ) | |||||||
Other income, net | |||||||||||||||
Income from field services agreement | 7,150 | — | 12,616 | — | |||||||||||
Expense from field services agreement | (993 | ) | — | (6,652 | ) | — | |||||||||
Unrealized gain (loss) on fair value of warrants | 1,307 | (111 | ) | 11,386 | 16,337 | ||||||||||
Interest expense | — | (2,965 | ) | — | (12,515 | ) | |||||||||
Gain on sale of subsidiary | — | 130,832 | — | 130,832 | |||||||||||
Loss on extinguishment of debt | — | (21,049 | ) | — | (21,549 | ) | |||||||||
Other income, net | 191 | 273 | 2,060 | 1,205 | |||||||||||
Total income, net | 7,655 | 106,980 | 19,410 | 114,310 | |||||||||||
(Loss) income before income taxes | (8,980 | ) | 84,591 | (47,683 | ) | 32,387 | |||||||||
Income tax expense | — | (535 | ) | (1,768 | ) | (536 | ) | ||||||||
Net (loss) income | (8,980 | ) | 84,056 | (49,451 | ) | 31,851 | |||||||||
Other comprehensive income | |||||||||||||||
Unrealized gain on marketable securities | 3 | — | 3 | — | |||||||||||
Comprehensive (loss) income | (8,977 | ) | 84,056 | (49,448 | ) | 31,851 | |||||||||
Net (loss) income attributable to ordinary shareholders: | |||||||||||||||
Basic | $ | (8,980 | ) | $ | 84,056 | $ | (49,451 | ) | $ | 31,851 | |||||
Diluted | $ | (8,980 | ) | $ | 84,167 | $ | (60,837 | ) | $ | 15,514 | |||||
Net (loss) income per share attributable to ordinary shareholders: | |||||||||||||||
Basic | $ | (0.17 | ) | $ | 1.73 | $ | (0.91 | ) | $ | 0.69 | |||||
Diluted | $ | (0.17 | ) | $ | 1.64 | $ | (1.10 | ) | $ | 0.31 | |||||
Weighted-average shares used in computing net loss per share attributable to ordinary shareholders: | |||||||||||||||
Basic | 54,205,852 | 48,696,269 | 54,182,499 | 46,297,088 | |||||||||||
Diluted | 54,205,852 | 51,373,590 | 55,383,030 | 49,724,503 |
Reconciliation of Non-GAAP Financial Measures (unaudited) | |||||||||||
(in thousands, except share and per share data) | |||||||||||
Three Months Ended |
|||||||||||
Operating loss |
Loss before income taxes | Net loss attributable to ordinary shareholders | Net loss per share attributable to ordinary shareholders |
||||||||
GAAP | ( |
) | ( |
) | ( |
) | ( |
) | |||
Non-GAAP Adjustments: | |||||||||||
Amortization of intangible assets (a) | |||||||||||
Stock-based compensation - Research & Development (b) | |||||||||||
Stock-based compensation - Selling, General & Admin. (b) | |||||||||||
Unrealized gain on fair value of warrants (c) | — | ( |
) | ( |
) | ||||||
Gain on settlement of field services agreement (d) | — | ( |
) | ( |
) | ||||||
Adjusted | ( |
) | ( |
) | ( |
) | ( |
) | |||
Three Months Ended |
|||||||||||
Operating loss |
Loss before income taxes | Net loss attributable to ordinary shareholders | Net loss per share attributable to ordinary shareholders | ||||||||
GAAP | ( |
) | |||||||||
Non-GAAP Adjustments: | |||||||||||
Amortization of intangible asset (a) | |||||||||||
Stock-based compensation - Research & Development (b) | |||||||||||
Stock-based compensation - Selling, General & Admin. (b) | |||||||||||
Unrealized loss on fair value of warrants (c) | — | ||||||||||
Loss on extinguishment of debt (f) | — | ||||||||||
Gain on sale of subsidiary (g) | — | (130,832 | ) | (130,832 | ) | ||||||
Adjusted | ( |
) | ( |
) | ( |
) | ( |
) |
Reconciliation of Non-GAAP Financial Measures (unaudited) | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
Twelve Months Ended |
|||||||||||||||
Operating loss | Loss before income taxes | Net loss attributable to ordinary shareholders | Net loss per share attributable to ordinary shareholders | ||||||||||||
GAAP | ( |
) | ( |
) | ( |
) | ( |
) | |||||||
Non-GAAP Adjustments: | |||||||||||||||
Amortization of intangible assets (a) | |||||||||||||||
Stock-based compensation - Research & Development (b) | |||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | |||||||||||||||
Unrealized gain on fair value of warrants (c) | — | ( |
) | ( |
) | ||||||||||
Gain on settlement of field services agreement (d) | — | ( |
) | ( |
) | ||||||||||
Adjusted | ( |
) | ( |
) | ( |
) | ( |
) | |||||||
Twelve Months Ended |
|||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders | ||||||||||||
GAAP | ( |
) | |||||||||||||
Non-GAAP Adjustments: | |||||||||||||||
Amortization of intangible asset (a) | |||||||||||||||
Stock-based compensation - Research & Development (b) | |||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | |||||||||||||||
Unrealized gain on fair value of warrants (c) | — | ( |
) | ( |
) | ||||||||||
Non-cash interest expense (e) | — | ||||||||||||||
Loss on extinguishment of debt (f) | — | ||||||||||||||
Gain on sale of subsidiary (g) | — | ( |
) | ( |
) | ||||||||||
Adjusted | ( |
) | ( |
) | ( |
) | ( |
) |
- 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 (loss) 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 gain on settlement of field services agreement is excluded due to the non-recurring nature of this gain. We believe such exclusion facilitates investors’ ability to more accurately compare our operating results to those of our peer companies and is reflective of how management internally manages the business.
- 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.
- The loss on extinguishment of debt is excluded due to the non-recurring nature of this charge. We believe such exclusion facilitates investors’ ability to more accurately compare our operating results to those of our peer companies and is reflective of how management internally manages the business.
- The gain on sale of subsidiary is excluded due to the non-recurring nature of this gain. We believe such exclusion facilitates investors’ ability to more accurately compare our operating results to those of our peer companies and is reflective of how management internally manages the business.
Conference Call Details
Strongbridge will host a conference call on Tuesday, February 25 at 8:30 a.m. ET; accompanying slides will be available at
About
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
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.
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 Company’s 2020 revenue guidance, expected cash runway, future cash balances, 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 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:
Investor Relations
Solebury Trout
+1 617-221-9660
[email protected]
Corporate and Media Relations
Elixir Health Public Relations
+1 862-596-1304
[email protected]
Source: Strongbridge Biopharma plc