Strongbridge Biopharma plc Reports Second Quarter 2018 Financial Results and Provides Corporate Update
~ Statistically Significant Positive Top-line Clinical Results Reported from SONICS Phase 3 Study of RECORLEV™ (levoketoconazole) in Endogenous Cushing's Syndrome ~
~ Rare Endocrine Franchise Expands with the U.S. Launch of MACRILEN™ (macimorelin) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) ~
~ Patent Issued in United States for Extended-release veldoreotide Formulation, Providing Patent Protection Until 2037 ~
~ KEVEYIS® (dichlorphenamide) Achieves
Second Quarter 2018 And Recent Highlights:
Rare Endocrine Franchise:
- Earlier today, Strongbridge reported statistically significant positive top-line clinical results from the SONICS Phase 3 study of RECORLEV™ (levoketoconazole) in endogenous Cushing's syndrome.
- Launched MACRILEN™ (macimorelin) in
the United States at the end of July. MACRILEN is the Company’s second rare disease commercial product and the first and onlyFDA -approved oral drug indicated for the diagnosis of adult growth hormone deficiency (AGHD), a condition often treated by the same endocrinologists who diagnose and treat Cushing’s syndrome. - Patent issued for veldoreotide, a next-generation somatostatin analog (SSA), with claims covering an extended-release formulation and a method of manufacturing the formulation, strengthening the Company’s intellectual property portfolio. The patent is scheduled to expire in
February 2037 .
Rare Neuromuscular Franchise:
- Achieved KEVEYIS net product sales of $4.3 million in the second quarter of 2018, a 187 percent increase compared to $1.5 million in the second quarter of 2017.
- Full-year 2018 KEVEYIS revenue guidance remains
$18 –$20 million .
“We have achieved several value-creating milestones across our rare disease portfolio over the last several months, including the compelling RECORLEV Phase 3 clinical trial results announced earlier today,” said
Second Quarter 2018 Financial Results
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Selling, general and administrative expenses were
Year-to-Date
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The Company recorded net revenues from sales of KEVEYIS, which was launched in
Research and development expenses were
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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
About MACRILEN
MACRILEN® (macimorelin) is a prescription oral solution that is used to test for adult growth hormone deficiency (AGHD). In clinical studies, the most common side effects of MACRILEN were changed sense of taste, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, excessive sweating, sore nose and throat, and decreased heart rate. These are not all of the possible side effects that you may experience with MACRILEN. Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects to Strongbridge at 1-855-324-8912, or to the FDA at 1-800-
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 demand for MACRILEN, our ability to achieve positive cash flows from operating activities, Strongbridge’s strategy, plans, future financial position, anticipated investments, costs and results, outcomes of product development efforts, status and results of clinical trials, intellectual property portfolio 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, the emergence of unexpected adverse events following regulatory approval and use of the product by patients, and risks related to our ability to access funds under our credit facility. 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
Contacts:
Corporate and Media Relations
Elixir Health Public Relations
+1 862-596-1304
[email protected]
Investor Relations
U.S.:
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) | |||||||
June 30, | December 31, | ||||||
2018 | 2017 | ||||||
( in thousands) | |||||||
Consolidated Balance Sheet Data: | |||||||
Cash and cash equivalents | $ | 85,514 | $ | 57,510 | |||
Total assets | 156,212 | 103,925 | |||||
Long-term debt, net | 77,572 | 37,794 | |||||
Total liabilities | 147,349 | 115,839 | |||||
Total stockholders’ equity (deficit) | 8,863 | (11,914 | ) | ||||
STRONGBRIDGE BIOPHARMA plc | |||||||||||||||
Consolidated Statement of Operations and Comprehensive Loss (unaudited) | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Consolidated Statement of Operations Data: | |||||||||||||||
Revenues: | |||||||||||||||
Net product sales | $ | 4,296 | $ | 1,529 | $ | 8,166 | $ | 1,529 | |||||||
Total revenues | 4,296 | 1,529 | 8,166 | 1,529 | |||||||||||
Cost and expenses: | |||||||||||||||
Cost of sales (excluding amortization of intangible assets) | $ | 753 | $ | 377 | $ | 1,420 | $ | 377 | |||||||
Selling, general and administrative | 15,210 | 10,142 | 27,572 | 17,584 | |||||||||||
Research and development | 5,453 | 4,128 | 10,334 | 7,609 | |||||||||||
Amortization of intangible assets | 1,872 | 1,255 | 3,641 | 2,511 | |||||||||||
Total cost and expenses | 23,288 | 15,902 | 42,967 | 28,081 | |||||||||||
Operating loss | (18,992 | ) | (14,373 | ) | (34,801 | ) | (26,552 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Unrealized gain (loss) on fair value of warrants | 19,017 | (15,219 | ) | 9,317 | (30,147 | ) | |||||||||
Interest expense | (3,289 | ) | (737 | ) | (6,163 | ) | (1,474 | ) | |||||||
Foreign exchange gain (loss) | 13 | (14 | ) | (7 | ) | (25 | ) | ||||||||
Loss on early extinguishment of debt | — | — | (500 | ) | — | ||||||||||
Other income, net | 329 | 60 | 509 | 25 | |||||||||||
Total other income (expense), net | 16,070 | (15,910 | ) | 3,156 | (31,621 | ) | |||||||||
Loss before income taxes | (2,922 | ) | (30,283 | ) | (31,645 | ) | (58,173 | ) | |||||||
Income tax (expense) benefit | (1 | ) | 92 | (1 | ) | (1,502 | ) | ||||||||
Net loss | (2,923 | ) | (30,191 | ) | (31,646 | ) | (59,675 | ) | |||||||
Net loss attributable to ordinary shareholders: | |||||||||||||||
Basic | $ | (2,923 | ) | $ | (30,191 | ) | $ | (31,646 | ) | $ | (59,675 | ) | |||
Diluted | $ | (21,940 | ) | $ | (30,191 | ) | $ | (40,963 | ) | $ | (59,675 | ) | |||
Net loss per share attributable to ordinary shareholders: | |||||||||||||||
Basic | $ | (0.06 | ) | $ | (0.86 | ) | $ | (0.69 | ) | $ | (1.69 | ) | |||
Diluted | $ | (0.43 | ) | $ | (0.86 | ) | $ | (0.81 | ) | $ | (1.69 | ) | |||
Weighted-average shares used in computing net loss per share attributable to ordinary shareholders: |
|||||||||||||||
Basic | 45,829,600 | 35,335,026 | 45,728,793 | 35,335,026 | |||||||||||
Diluted | 50,437,716 | 35,335,026 | 50,363,801 | 35,335,026 | |||||||||||
STRONGBRIDGE BIOPHARMA plc | ||||||||||||||||||||
Reconciliation of Non-GAAP Financial Measures (unaudited) | ||||||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||||||
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 assets (a) | $1,872 | $1,872 | $1,872 | $0.04 | ||||||||||||||||
Stock-based compensation - Research & Development (b) | $463 | $463 | $463 | $0.01 | ||||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $1,521 | $1,521 | $1,521 | $0.03 | ||||||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($19,017 | ) | ($19,017 | ) | ($0.41 | ) | |||||||||||||
Non-cash interest and debt extinguishment expenses (d) | — | $1,430 | $1,430 | $0.03 | ||||||||||||||||
Adjusted | ($15,136 | ) | ($16,653 | ) | ($16,654 | ) | ($0.36 | ) | ||||||||||||
Three Months Ended June 30, 2017 | ||||||||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
|||||||||||||||||
GAAP | ($14,373 | ) | ($30,283 | ) | ($30,191 | ) | ($0.86 | ) | ||||||||||||
Non-GAAP Adjustments: | ||||||||||||||||||||
Amortization of intangible asset (a) | $1,255 | $1,255 | $1,255 | $0.04 | ||||||||||||||||
Stock-based compensation - Research & Development (b) | $281 | $281 | $281 | $0.01 | ||||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $1,082 | $1,082 | $1,082 | $0.03 | ||||||||||||||||
Unrealized loss on fair value of warrants (c) | — | $15,219 | $15,219 | $0.43 | ||||||||||||||||
Non-cash interest expense (d) | — | $270 | $270 | $0.01 | ||||||||||||||||
Non-cash income tax benefit (e) | — | — | ($92 | ) | $0.00 | |||||||||||||||
Adjusted | ($11,755 | ) | ($12,176 | ) | ($12,176 | ) | (0.34 | ) | ||||||||||||
STRONGBRIDGE BIOPHARMA plc | ||||||||||||||||||||
Reconciliation of Non-GAAP Financial Measures | ||||||||||||||||||||
(Unaudited, in thousands, except share and per share data) | ||||||||||||||||||||
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 assets (a) | $3,641 | $3,641 | $3,641 | $0.08 | ||||||||||||||||
Stock-based compensation - Research & Development (b) | $871 | $871 | $871 | $0.02 | ||||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $2,801 | $2,801 | $2,801 | $0.06 | ||||||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($9,317 | ) | ($9,317 | ) | ($0.20 | ) | |||||||||||||
Non-cash interest and debt extinguishment expenses (d) | — | $2,662 | $2,662 | $0.06 | ||||||||||||||||
Adjusted | ($27,488 | ) | ($30,987 | ) | ($30,988 | ) | ($0.67 | ) | ||||||||||||
Six Months Ended June 30, 2017 | ||||||||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
|||||||||||||||||
GAAP | ($26,552 | ) | ($58,173 | ) | ($59,675 | ) | ($1.69 | ) | ||||||||||||
Non-GAAP Adjustments: | ||||||||||||||||||||
Amortization of intangible asset (a) | $2,511 | $2,511 | $2,511 | $0.07 | ||||||||||||||||
Stock-based compensation - Research & Development (b) | $498 | $498 | $498 | $0.01 | ||||||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $2,035 | $2,035 | $2,035 | $0.06 | ||||||||||||||||
Unrealized loss on fair value of warrants (c) | — | $30,147 | $30,147 | $0.85 | ||||||||||||||||
Non-cash interest expense (d) | — | $712 | $712 | $0.02 | ||||||||||||||||
Non-cash income tax expense (e) | — | — | $1,247 | $0.04 | ||||||||||||||||
Adjusted | ($21,508 | ) | ($22,270 | ) | ($22,525 | ) | ($0.64 | ) | ||||||||||||
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 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.
- The effects of non-cash interest and debt extinguishment 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 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.
Source: Strongbridge Biopharma plc