Strongbridge Biopharma plc Reports Fourth Quarter and Full-Year 2018 Financial Results
~ RECORLEV™ (levoketoconazole) Phase 3 Clinical Program and Type C FDA Meeting in First Quarter Progressing as Planned ~
~
~ KEVEYIS®(dichlorphenamide) Full-Year 2018 Revenue of
~ Full-Year 2019 KEVEYIS® (dichlorphenamide) Revenue Guidance of
~ Company to Host Conference Call Today at
“Strongbridge remains focused on its strategy of identifying, developing, and commercializing important treatments for rare diseases by continuing to build therapeutically‑aligned franchises. We had three major accomplishments in 2018 – positive results from SONICS, the purchase, launch and sale of MACRILEN™ (macimorelin), and the continued revenue growth of KEVEYIS® (dichlorphenamide),” said
Corporate & Financial Highlights
Rare Endocrine Franchise: RECORLEV™ (levoketoconazole)
- Detailed initial results from the pivotal Phase 3 SONICS study of RECORLEV for the treatment of endogenous Cushing’s syndrome were presented in October at the
European NeuroEndocrine Association annual meeting and new data were presented at the AnnualEuropean Network for the Study of Adrenal Tumors meeting in November showing that levoketoconazole, the active ingredient in RECORLEV, has a favorable efficacy, safety, and tolerability profile, reinforcing the potential for RECORLEV to play an important role in medical therapy, including consideration as a first-line treatment. - Results from additional SONICS analyses will be presented at the International Pituitary Congress, the Endocrine Society’s annual meeting in March, and at the
American Association of Clinical Endocrinologists meeting in April. - A Type C meeting with the
FDA is progressing as planned in the first quarter of 2019 to seek guidance on the regulatory pathway forward to obtain marketing approval for RECORLEV for the treatment of endogenous Cushing's syndrome. - One-year safety data from SONICS are expected in the first half of 2019 and receipt of top-line results from the confirmatory Phase 3 LOGICS study remain on track for the fourth quarter of 2019.
Rare Endocrine Franchise: MACRILEN™ (macimorelin)
- In
December 2018 , Strongbridge completed a transaction withNovo Nordisk to sell the Company’s rights to MACRILEN in the U.S. andCanada ; highlights include:- Strongbridge received
$145 million upfront cash payment fromNovo Nordisk ; - Strongbridge will receive royalties on MACRILEN sales through 2027;
Novo Nordisk will fund Strongbridge’s 23-person rare endocrine commercial field organization over three years to promote MACRILEN in the U.S.;- In addition,
Novo Nordisk purchased 5.2 million ordinary shares of Strongbridge at a purchase price of$7.00 per share, resulting in gross proceeds of$36.7 million .
- Strongbridge received
Rare Neuromuscular Franchise: KEVEYIS® (dichlorphenamide)
- Achieved KEVEYIS net product sales of $4.4 million during the fourth quarter of 2018, a 47 percent increase compared to
$3.0 million during the fourth quarter of 2017. - Full-year 2018 net revenues from sales of KEVEYIS totaled
$16.8 million , compared to full-year net revenues of$7.0 million in 2017, a 140 percent increase. - 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.
Corporate:
- Strongbridge had
$122.5 million of cash and cash equivalents and no debt outstanding as ofDecember 31, 2018 .
Fourth Quarter 2018 Financial Results
For the three months ended December 31, 2018, basic net income attributable to ordinary shareholders on a GAAP basis was
For the three months ended December 31, 2018, non-GAAP basic net loss attributable to ordinary shareholders was
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
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 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 potential for RECORLEV as a first-line treatment, discussions with regulators regarding the approval process for RECORLEV, the release of additional planned analyses of the SONICS study, Strongbridge’s strategy, plans, status and results of SONICS and other 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, 2017 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 Media Relations
Elixir Health Public Relations
+1 862-596-1304
[email protected]
Investor Relations
U.S.:
Solebury Trout
Marcy Nanus
+1 646-378-2927
[email protected]
First House
+47 913 10 458
[email protected]
Suite 200
Tel. +1 610-254-9200
Fax. +1 215-355-7389
STRONGBRIDGE BIOPHARMA plc | ||||||||
Select Consolidated Balance Sheet Information (unaudited) | ||||||||
(in thousands, except share and per share data) | ||||||||
December 31, | December 31, | |||||||
2018 | 2017 | |||||||
( in thousands) | ||||||||
Consolidated Balance Sheet Data: | ||||||||
Cash and cash equivalents | $ | 122,490 | $ | 57,510 | ||||
Total assets | 170,285 | 103,925 | ||||||
Long-term debt, net | — | 37,794 | ||||||
Total liabilities | 57,330 | 115,839 | ||||||
Total stockholders’ equity (deficit) | 112,955 | (11,914 | ) | |||||
STRONGBRIDGE BIOPHARMA plc | ||||||||||||||||
Consolidated Statement of Operations (unaudited) | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Consolidated Statement of Operations Data: | ||||||||||||||||
Revenues: | ||||||||||||||||
Net product sales | $ | 4,514 | $ | 2,984 | $ | 18,027 | $ | 7,046 | ||||||||
Total revenues | 4,514 | 2,984 | 18,027 | 7,046 | ||||||||||||
Cost and expenses: | ||||||||||||||||
Cost of sales (excluding amortization of intangible assets) | $ | 1,125 | $ | 515 | $ | 3,986 | $ | 1,483 | ||||||||
Selling, general and administrative | 16,199 | 10,224 | 63,336 | 36,292 | ||||||||||||
Research and development | 7,909 | 5,155 | 25,441 | 17,268 | ||||||||||||
Amortization of intangible assets | 1,670 | 1,255 | 7,187 | 5,022 | ||||||||||||
Impairment of intangible asset | — | — | — | 20,723 | ||||||||||||
Total cost and expenses | 26,903 | 17,149 | 99,950 | 80,788 | ||||||||||||
Operating loss | (22,389 | ) | (14,165 | ) | (81,923 | ) | (73,742 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Unrealized gain (loss) on fair value of warrants | (111 | ) | (2,024 | ) | 16,337 | (30,218 | ) | |||||||||
Interest expense | (2,965 | ) | (1,475 | ) | (12,515 | ) | (4,313 | ) | ||||||||
Foreign exchange loss | (25 | ) | (5 | ) | (47 | ) | (41 | ) | ||||||||
Gain on sale of subsidiary | 130,832 | — | 130,832 | — | ||||||||||||
Loss on extinguishment of debt | (21,049 | ) | — | (21,549 | ) | (3,545 | ) | |||||||||
Other income, net | 298 | 41 | 1,252 | 147 | ||||||||||||
Total other income (expense), net | 106,980 | (3,463 | ) | 114,310 | (37,970 | ) | ||||||||||
Loss before income taxes | 84,591 | (17,628 | ) | 32,387 | (111,712 | ) | ||||||||||
Income tax (expense) benefit | (535 | ) | (1,119 | ) | (536 | ) | (1,771 | ) | ||||||||
Net income (loss) | 84,056 | (18,747 | ) | 31,851 | (113,483 | ) | ||||||||||
Net income (loss) attributable to ordinary shareholders: | ||||||||||||||||
Basic | $ | 84,056 | $ | (18,747 | ) | $ | 31,851 | $ | (113,483 | ) | ||||||
Diluted | $ | 84,167 | $ | (18,747 | ) | $ | 15,514 | $ | (113,483 | ) | ||||||
Net income (loss) per share attributable to ordinary shareholders: | ||||||||||||||||
Basic | $ | 1.73 | $ | (0.47 | ) | $ | 0.69 | $ | (3.11 | ) | ||||||
Diluted | $ | 1.64 | $ | (0.47 | ) | $ | 0.31 | $ | (3.11 | ) | ||||||
Weighted-average shares used in computing net income (loss) per share attributable to ordinary shareholders: | ||||||||||||||||
Basic | 48,696,269 | 39,753,550 | 46,297,088 | 36,544,825 | ||||||||||||
Diluted | 51,373,590 | 39,753,550 | 49,724,503 | 36,544,825 | ||||||||||||
STRONGBRIDGE BIOPHARMA plc | |||||||||||||||||||||
Reconciliation of Non-GAAP Financial Measures (unaudited) | |||||||||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||||||
Three Months Ended December 31, 2018 | |||||||||||||||||||||
Operating loss | Loss before income taxes | Net loss attributable to ordinary shareholders | Net loss per share attributable to ordinary shareholders | ||||||||||||||||||
GAAP | ($22,389 | ) | $84,591 | $84,056 | $1.73 | ||||||||||||||||
Non-GAAP Adjustments: | |||||||||||||||||||||
Amortization of intangible assets (a) | $1,670 | $1,670 | $1,670 | $0.03 | |||||||||||||||||
Stock-based compensation - Research & Development (b) | $456 | $456 | $456 | $0.01 | |||||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $1,562 | $1,562 | $1,562 | $0.03 | |||||||||||||||||
Unrealized loss on fair value of warrants (c) | — | $111 | $111 | $0.00 | |||||||||||||||||
Loss on extinguishment of debt (f) | — | $21,049 | $21,049 | $0.43 | |||||||||||||||||
Gain on sale of subsidiary (g) | — | (130,832 | ) | ($130,832 | ) | ($2.69 | ) | ||||||||||||||
Adjusted | ($18,701 | ) | ($21,393 | ) | ($21,928 | ) | ($0.46 | ) | |||||||||||||
Three Months Ended December 31, 2017 | |||||||||||||||||||||
Operating loss | Loss before income taxes | Net loss attributable to ordinary shareholders | Net loss per share attributable to ordinary shareholders | ||||||||||||||||||
GAAP | ($14,165 | ) | ($17,628 | ) | ($18,747 | ) | ($0.47 | ) | |||||||||||||
Non-GAAP Adjustments: | |||||||||||||||||||||
Amortization of intangible asset (a) | $1,255 | $1,255 | $1,255 | $0.03 | |||||||||||||||||
Stock-based compensation - Research & Development (b) | $318 | $318 | $318 | $0.01 | |||||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $986 | $986 | $986 | $0.02 | |||||||||||||||||
Unrealized loss on fair value of warrants (c) | — | $2,024 | $2,024 | $0.05 | |||||||||||||||||
Non-cash interest expense (d) | — | $599 | $599 | $0.02 | |||||||||||||||||
Non-cash income tax expense (e) | — | — | $1,247 | $0.03 | |||||||||||||||||
Adjusted | ($11,606 | ) | ($12,446 | ) | ($12,318 | ) | ($0.31 | ) | |||||||||||||
STRONGBRIDGE BIOPHARMA plc | |||||||||||||||||||||
Reconciliation of Non-GAAP Financial Measures | |||||||||||||||||||||
(Unaudited, in thousands, except share and per share data) | |||||||||||||||||||||
Twelve Months Ended December 31, 2018 | |||||||||||||||||||||
Operating loss | Loss before income taxes | Net loss attributable to ordinary shareholders | Net loss per share attributable to ordinary shareholders | ||||||||||||||||||
GAAP | ($81,923 | ) | $32,387 | $31,851 | $0.69 | ||||||||||||||||
Non-GAAP Adjustments: | |||||||||||||||||||||
Amortization of intangible assets (a) | $7,187 | $7,187 | $7,187 | $0.16 | |||||||||||||||||
Stock-based compensation - Research & Development (b) | $1,795 | $1,795 | $1,795 | $0.04 | |||||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $6,012 | $6,012 | $6,012 | $0.13 | |||||||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($16,337 | ) | ($16,337 | ) | ($0.35 | ) | ||||||||||||||
Non-cash interest expense (d) | — | $1,393 | $1,393 | $0.03 | |||||||||||||||||
Loss on extinguishment of debt (f) | — | 21,549 | 21,549 | $0.47 | |||||||||||||||||
Gain on sale of subsidiary (g) | — | (130,832 | ) | (130,832 | ) | ($2.83 | ) | ||||||||||||||
Adjusted | ($66,929 | ) | ($76,846 | ) | ($77,382 | ) | ($1.66 | ) | |||||||||||||
Twelve Months Ended December 31, 2017 | |||||||||||||||||||||
Operating loss | Loss before income taxes | Net loss attributable to ordinary shareholders | Net loss per share attributable to ordinary shareholders | ||||||||||||||||||
GAAP | ($73,742 | ) | ($111,712 | ) | ($113,483 | ) | ($3.11 | ) | |||||||||||||
Non-GAAP Adjustments: | |||||||||||||||||||||
Amortization of intangible asset (a) | $5,022 | $5,022 | $5,022 | $0.14 | |||||||||||||||||
Impairment of intangible asset (a) | $20,723 | $20,723 | $20,723 | $0.57 | |||||||||||||||||
Stock-based compensation - Research & Development (b) | $1,140 | $1,140 | $1,140 | $0.03 | |||||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $4,027 | $4,027 | $4,027 | $0.11 | |||||||||||||||||
Unrealized loss on fair value of warrants (c) | — | $30,218 | $30,218 | $0.83 | |||||||||||||||||
Non-cash interest expense (d) | — | $1,378 | $1,378 | $0.04 | |||||||||||||||||
Non-cash income tax expense (e) | — | — | $1,644 | $0.04 | |||||||||||||||||
Adjusted | ($42,830 | ) | ($49,204 | ) | ($49,331 | ) | ($1.35 | ) | |||||||||||||
(a) 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.
(b) 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.
(c) The unrealized gain or 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.
(d) 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.
(e) The effect of non-cash tax expense or benefit related to valuation allowance adjustments of the deferred income tax asset is excluded because of its non-recurring nature. We believe such exclusion facilitates investor’s ability to more accurately compare our operating results to those of our peer companies.
(f) 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.
(g) 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.
Source: Strongbridge Biopharma plc