Strongbridge Biopharma plc Reports Third Quarter 2018 Financial Results and Provides Corporate Update
~ Financial Position to be Significantly Strengthened in Fourth Quarter 2018 by
~ Third Quarter 2018 Revenue of
~ Presented Positive Results from the SONICS Study at the
~ Strongbridge to Host Conference Call Today at 9:15 a.m. ET to Discuss the Transaction Details and Third Quarter Financial Results and Corporate Highlights ~
Third Quarter 2018 And Recent Corporate Highlights:
Rare Endocrine Franchise:
- Earlier today, Strongbridge announced in a separate press release that the Company entered into an agreement with
Novo Nordisk to sell the U.S. and Canadian rights to MACRILEN™ (macimorelin) for an upfront payment of$145 million plus tiered royalties on net sales. Strongbridge’s current MACRILEN field organization will continue to promote the product in the U.S. under an up to three-year agreement withNovo Nordisk . In addition,Novo Nordisk agreed to purchase approximately 5.2 million ordinary shares of the Company at a purchase price of$7.00 per share, resulting in gross proceeds of approximately$36.7 million . These transactions are expected to close inDecember 2018 . - Following the commercial launch of MACRILEN at the end of July, the Company achieved initial net product sales of $1.1 million in the third quarter of 2018.
- Detailed initial results from SONICS, presented at the 18th Annual Congress of the
European Neuroendocrine Association , showed that: 1) RECORLEV™ (levoketoconazole) achieved statistically significant and clinically meaningful improvements in key secondary endpoints of cardiovascular risk biomarkers; 2) normalized mUFC initially in 81 percent of patients with Cushing’s syndrome who advanced into the maintenance phase; and 3) nearly half of patients who completed the six-month maintenance phase achieved a 50 percent or more decrease or normalization in mUFC regardless of a dose increase. - Ongoing evaluation of the clinical data from the pivotal Phase 3 SONICS study of RECORLEV for the treatment of endogenous Cushing’s syndrome continues to instill confidence in RECORLEV’s potential to play an important role in individualized medical therapy, including consideration as a first-line treatment. Results from further SONICS analyses are planned for the
International Congress of Endocrinology inDecember 2018 and for publication in a peer-reviewed journal in the first half of 2019. - The Company will amend the clinical trial protocol for the ongoing Phase 3 LOGICS study to expand the randomized-patient target from 35 to 54 patients. The increase in randomized study participants will bolster the body of evidence for RECORLEV by including a larger patient population from this double-blind, placebo controlled, randomized withdrawal trial. Top-line results from the expanded LOGICS study are expected in the fourth quarter of 2019. The Company plans to conduct a Type C meeting with
FDA in the first quarter of 2019 to discuss the path forward for the NDA filing for RECORLEV.
Rare Neuromuscular Franchise:
- Achieved KEVEYIS® (dichlorphenamide) net product sales of $4.2 million in the third quarter of 2018, a 66 percent increase compared to $2.5 million in the third quarter of 2017.
- Full-year 2018 KEVEYIS revenue guidance revised to
$16 –$17 million from$18 –$20 million .
Corporate:
- Strongbridge had
$67.4 million of cash and cash equivalents and$88.3 million in outstanding debt as ofSeptember 30, 2018 . - After giving effect to the anticipated net proceeds upon closing of the transactions separately announced today with
Novo Nordisk and the anticipated repayment in full of outstanding debt, the Company’s pro forma cash and cash equivalents as ofSeptember 30, 2018 was approximately$148 million .
“We are pleased with the transactions announced earlier today with
Third Quarter 2018 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 nine months ended
For the nine 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 Wednesday, October 31 at 9:15 a.m. ET. To access the live call, dial 844-285-7153 (domestic) or 478-219-0180 (international) with conference ID 9775249. The conference call will also be audio webcast from the Company’s website at www.strongbridgebio.com under the “Investor/Webcasts and Presentations” section. A replay of the call will be made available for one week following the conference call. To hear a replay of the call, dial 855-859-2056 (domestic) or 404-537-3406 (international) with conference ID 9775249.
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 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 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, and risks related to our ability to repay 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 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) | |||||||||
September 30, | December 31, | ||||||||
2018 | 2017 | ||||||||
(in thousands) | |||||||||
Consolidated Balance Sheet Data: | |||||||||
Cash and cash equivalents | $ | 67,383 | $ | 57,510 | |||||
Total assets | 140,849 | 103,925 | |||||||
Long-term debt, net | 79,061 | 37,794 | |||||||
Total liabilities | 147,105 | 115,839 | |||||||
Total stockholders’ deficit | (6,256 | ) | (11,914 | ) | |||||
STRONGBRIDGE BIOPHARMA plc | ||||||||||||||||
Consolidated Statement of Operations and Comprehensive Loss (unaudited) | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Consolidated Statement of Operations Data: | ||||||||||||||||
Revenues: | ||||||||||||||||
Net product sales | $ | 5,347 | $ | 2,533 | $ | 13,513 | $ | 4,062 | ||||||||
Total revenues | 5,347 | 2,533 | 13,513 | 4,062 | ||||||||||||
Cost and expenses: | ||||||||||||||||
Cost of sales (excluding amortization of intangible assets) | $ | 1,441 | $ | 591 | $ | 2,861 | $ | 968 | ||||||||
Selling, general and administrative | 19,564 | 8,484 | 47,137 | 26,068 | ||||||||||||
Research and development | 7,198 | 4,504 | 17,532 | 12,113 | ||||||||||||
Amortization of intangible assets | 1,876 | 1,256 | 5,517 | 3,767 | ||||||||||||
Impairment of intangible asset | — | 20,723 | — | 20,723 | ||||||||||||
Total cost and expenses | 30,079 | 35,558 | 73,047 | 63,639 | ||||||||||||
Operating loss | (24,732 | ) | (33,025 | ) | (59,534 | ) | (59,577 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Unrealized gain (loss) on fair value of warrants | 7,131 | 1,953 | 16,448 | (28,194 | ) | |||||||||||
Interest expense | (3,387 | ) | (1,364 | ) | (9,550 | ) | (2,838 | ) | ||||||||
Foreign exchange loss | (15 | ) | (11 | ) | (22 | ) | (36 | ) | ||||||||
Loss on extinguishment of debt | — | (3,545 | ) | (500 | ) | (3,545 | ) | |||||||||
Other income, net | 445 | 82 | 954 | 107 | ||||||||||||
Total other income (expense), net | 4,174 | (2,885 | ) | 7,330 | (34,506 | ) | ||||||||||
Loss before income taxes | (20,558 | ) | (35,910 | ) | (52,204 | ) | (94,083 | ) | ||||||||
Income tax benefit (expense) | — | 850 | (1 | ) | (652 | ) | ||||||||||
Net loss | (20,558 | ) | (35,060 | ) | (52,205 | ) | (94,735 | ) | ||||||||
Net loss attributable to ordinary shareholders: | ||||||||||||||||
Basic | $ | (20,558 | ) | $ | (35,060 | ) | $ | (52,205 | ) | $ | (94,735 | ) | ||||
Diluted | $ | (27,690 | ) | $ | (35,060 | ) | $ | (68,653 | ) | $ | (94,735 | ) | ||||
Net loss per share attributable to ordinary shareholders: | ||||||||||||||||
Basic | $ | (0.44 | ) | $ | (0.98 | ) | $ | (1.14 | ) | $ | (2.67 | ) | ||||
Diluted | $ | (0.55 | ) | $ | (0.98 | ) | $ | (1.37 | ) | $ | (2.67 | ) | ||||
Weighted-average shares used in computing net loss per share attributable to ordinary shareholders: | ||||||||||||||||
Basic | 46,978,472 | 35,716,247 | 45,916,177 | 35,463,496 | ||||||||||||
Diluted | 50,317,423 | 35,716,247 | 49,985,483 | 35,463,496 | ||||||||||||
STRONGBRIDGE BIOPHARMA plc | ||||||||||||||||
Reconciliation of Non-GAAP Financial Measures (unaudited) | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
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 | $0.04 | ||||||||||||
Stock-based compensation - Research & Development (b) | $468 | $468 | $468 | $0.01 | ||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $1,649 | $1,649 | $1,649 | $0.04 | ||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($7,131 | ) | ($7,131 | ) | ($0.15 | ) | |||||||||
Non-cash interest and debt extinguishment expenses (d) | — | $1,488 | $1,488 | $0.03 | ||||||||||||
Adjusted | ($20,739 | ) | ($22,208 | ) | ($22,208 | ) | ($0.47 | ) | ||||||||
Three Months Ended September 30, 2017 | ||||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
|||||||||||||
GAAP | ($33,025 | ) | ($35,910 | ) | ($35,060 | ) | ($0.98 | ) | ||||||||
Non-GAAP Adjustments: | ||||||||||||||||
Amortization of intangible asset (a) | $1,256 | $1,256 | $1,256 | $0.04 | ||||||||||||
Impairment of intangible asset (a) | $20,723 | $20,723 | $20,723 | $0.58 | ||||||||||||
Stock-based compensation - Research & Development (b) | $324 | $324 | $324 | $0.01 | ||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $1,007 | $1,007 | $1,007 | $0.03 | ||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($1,953 | ) | ($1,953 | ) | ($0.05 | ) | |||||||||
Non-cash interest expense (d) | — | $1,501 | $1,501 | $0.04 | ||||||||||||
Non-cash income tax benefit (e) | — | — | ($850 | ) | ($0.02 | ) | ||||||||||
Adjusted | ($9,715 | ) | ($13,052 | ) | ($13,052 | ) | ($0.35 | ) | ||||||||
STRONGBRIDGE BIOPHARMA plc | |||||||||||||||||
Reconciliation of Non-GAAP Financial Measures | |||||||||||||||||
(Unaudited, in thousands, except share and per share data) | |||||||||||||||||
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 | $0.12 | |||||||||||||
Stock-based compensation - Research & Development (b) | $1,339 | $1,339 | $1,339 | $0.03 | |||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $4,450 | $4,450 | $4,450 | $0.10 | |||||||||||||
Unrealized gain on fair value of warrants (c) | — | ($16,448 | ) | ($16,448 | ) | ($0.36 | ) | ||||||||||
Non-cash interest and debt extinguishment expenses (d) | — | $4,150 | $4,150 | $0.09 | |||||||||||||
Adjusted | ($48,228 | ) | ($53,196 | ) | ($53,197 | ) | ($1.16 | ) | |||||||||
Nine Months Ended September 30, 2017 | |||||||||||||||||
Operating loss |
Loss before income taxes |
Net loss attributable to ordinary shareholders |
Net loss per share attributable to ordinary shareholders |
||||||||||||||
GAAP | ($59,577 | ) | ($94,083 | ) | ($94,735 | ) | ($2.67 | ) | |||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible asset (a) | $3,767 | $3,767 | $3,767 | $0.11 | |||||||||||||
Impairment of intangible asset (a) | $20,723 | $20,723 | $20,723 | $0.58 | |||||||||||||
Stock-based compensation - Research & Development (b) | $822 | $822 | $822 | $0.02 | |||||||||||||
Stock-based compensation - Selling, General & Admin. (b) | $3,041 | $3,041 | $3,041 | $0.09 | |||||||||||||
Unrealized loss on fair value of warrants (c) | — | $28,194 | $28,194 | $0.80 | |||||||||||||
Non-cash interest expense (d) | — | $2,213 | $2,213 | $0.06 | |||||||||||||
Non-cash income tax expense (e) | — | — | $397 | $0.01 | |||||||||||||
Adjusted | ($31,224 | ) | ($35,323 | ) | ($35,578 | ) | ($1.00 | ) | |||||||||
(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 the Company believes 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. The Company believes 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. The Company believes 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 and debt extinguishment charges are excluded. The Company believes 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. The Company believes such exclusion facilitates investor’s ability to more accurately compare our operating results to those of our peer companies.
Source: Strongbridge Biopharma plc