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Strongbridge Biopharma plc Reports First Quarter 2021 Financial Results and Provides Corporate Update

~ Reports KEVEYIS® (dichlorphenamide) First Quarter 2021 Revenue of $8.4 Million, a 25 Percent Increase Compared to $6.7 Million of Revenue During First Quarter of 2020 ~

~ Reiterates Full-Year 2021 KEVEYIS® (dichlorphenamide) Revenue Guidance of Approximately $34 Million to $36 Million ~

~ Awaiting Day 74 Letter from U.S. Food & Drug Administration (FDA) for the Company’s New Drug Application (NDA) Submission for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome ~

~ Receives Notification from United States Patent and Trademark Office that it has Entered a Notice of Allowance Covering a Method of Treating Patients with Cushing’s Syndrome with RECORLEV® (levoketoconazole) ~

~ Strongbridge to Host Conference Call Today at 8:30 am ET ~

DUBLIN, Ireland and TREVOSE, Pa., May 12, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today reported financial results for the first quarter of 2021 and provided a corporate update.

“We delivered strong financial results in the first quarter with 25 percent quarter-over-quarter revenue growth achieved with KEVEYIS® (dichlorphenamide) versus the first quarter last year, providing a strong foundation as we enter the second quarter. Looking ahead, Strongbridge remains focused on driving continued revenue growth for KEVEYIS and leveraging our operational and commercial expertise to further accelerate the growth of Strongbridge’s rare disease portfolio,” said John H. Johnson, chief executive officer of Strongbridge Biopharma.

Johnson added, “Strongbridge is currently awaiting notification from the U.S. Food and Drug Administration (FDA) regarding filing of the Company’s New Drug Application (NDA) for RECORLEV® (levoketoconazole) for the treatment of endogenous Cushing’s syndrome. We look forward to receiving the official Day 74 letter shortly and sharing an update thereafter, as well as the potential opportunity to bring a new therapeutic option to the Cushing's syndrome community.”

Corporate & Financial Highlights

Rare Neuromuscular Franchise: KEVEYIS® (dichlorphenamide)

  • The Company achieved KEVEYIS net product sales of $8.4 million for the first quarter ended March 31, 2021, representing a 25 percent increase over first quarter 2020 revenue of $6.7 million. Sales momentum continued in April with KEVEYIS delivering the highest month of net product sales since its launch by the Company in 2017.
    • First quarter performance is attributed to the growth in patients on drug, resulting from new patient starts combined with improved discontinuation rates for existing patients on therapy.
  • In April, a case report concerning a patient with Andersen-Tawil Syndrome switching from acetazolamide to KEVEYIS was presented at the American Academy of Neurology (AAN) virtual meeting. This case report was also recently published in the peer-reviewed journal Neuromuscular Disorders.

Rare Endocrine Franchise: RECORLEV® (levoketoconazole)

  • Strongbridge is currently awaiting filing notification via the Day 74 letter from the FDA regarding the Company’s NDA submission for RECORLEV for the treatment of endogenous Cushing’s syndrome.
  • The United States Patent and Trademark Office (USPTO) has entered a Notice of Allowance for U.S. Patent Application 17/010,387 covering a method of treating Cushing’s syndrome patients with RECORLEV who also take metformin for Type 2 diabetes.
    • This Notice of Allowance concludes the substantive examination of the patent application and is expected to result in the issuance of a U.S. patent after administrative processes are completed.
    • The term of the U.S. patent scheduled to issue from this application will expire in September 2040.
  • Strongbridge continues to prepare for the potential commercial launch of RECORLEV in the first quarter of 2022.
  • In April, a diabetes subgroup analysis from the Phase 3 SONICS study of RECORLEV was published in the peer-reviewed journal, Frontiers in Endocrinology.
  • In March, interim safety and efficacy results, including new data analyses from the Phase 3 LOGICS study, were presented via poster at the Endocrine Society’s (ENDO) 2021 virtual annual meeting.

Corporate Updates

  • Strongbridge reports approximately $73.9 million of cash and cash equivalents as of March 31, 2021.
  • Assuming the availability and full draw-down of the remaining $10 million from its debt facility, the Company believes that it can fund operations as currently planned into, and potentially beyond, the first quarter of 2023.
  • Strongbridge has been recognized as a 2021 Great Place to Work®-Certified company. Great Place to Work® is a global authority on workplace culture, employee experience and the leadership behaviors proven to deliver market-leading revenue and increased innovation.

First Quarter 2021 Financial Results
The Company’s net revenues from sales of KEVEYIS increased $1.7 million, or 25 percent, to $8.4 million for the three months ended March 31, 2021 compared to $6.7 million for the three months ended March 31, 2020. The Company recorded cost of sales of $0.4 million for the three months ended March 31, 2021, compared to cost of sales of $1.0 million for the same period in 2020. Cost of sales decreased due to changes in the assumptions underlying the allocation between the purchase price of our inventory and our supply agreement. Gross margins were 95 percent for three months ended March 31, 2021, compared to gross margins of 85 percent for the same period in 2020.

Selling, general and administrative expenses were $10.9 million for the three months ended March 31, 2021, compared to $10.4 million for the same period in 2020. The increase during the current period was primarily due to an increase in our non-cash stock compensation expense.

Research and development expenses were $5.8 million for the three months ended March 31, 2021, compared to $7.6 million for the same period in 2020. The decrease was primarily due to decreases in costs associated with our LOGICS and OPTICS trials, offset by increases in regulatory costs associated with our NDA submission.

For the three months ended March 31, 2021, basic net loss attributable to ordinary shareholders on a GAAP basis was ($11.8 million), or ($0.18) per share, compared to a basic net loss attributable to ordinary shareholders of ($12.7) million, or ($0.23) per share, for the same period in 2020. Net loss for the three months ended March 31, 2021 was lower than the same period in 2020 due to the increase in KEVEYIS revenue of $1.7 million, the improvement in gross margin and the reduction in research and development expenses. Those decreases were offset by $0.8 million of interest expense recorded in the three months ended March 31, 2021, and a $1.4 million change in the revaluation of the fair value of our liability classified warrants due to the increase in the Company’s stock price in 2021 compared to 2020.

For the three months ended March 31, 2021, non-GAAP basic net loss attributable to ordinary shareholders was ($7.2 million), or ($0.11) per share, compared to a non-GAAP basic net loss attributable to ordinary shareholders of ($10.3 million), or ($0.19) per share, for the same period in 2020. The decrease in non-GAAP net loss during the three months ended March 31, 2021 was primarily due to an increase in KEVEYIS revenue of $1.7 million and improvement in gross margin. In addition, research and development expenses decreased during the three months ended March 31, 2021 compared to the same period in 2020 offset by cash interest expense in the three months ended March 31, 2021.


STRONGBRIDGE BIOPHARMA plc 
Select Consolidated Balance Sheet Information (unaudited) 
(in thousands, except share and per share data) 
       
 March 31, December 31, 
 2021 2020 
Consolidated Balance Sheet Data:      
Cash and cash equivalents$73,898 $87,522 
Total assets 108,050  121,100 
Long-term debt, net 17,399  17,114 
Total liabilities 52,203  55,495 
Total shareholders’ equity 55,847  65,605 


STRONGBRIDGE BIOPHARMA plc
Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(in thousands, except share and per share data)
       
 Three Months Ended March 31, 
 2021  2020  
   
   
Total revenues$8,382  $6,674  
       
Cost and expenses:      
Cost of sales (excluding amortization of intangible asset) 411   969  
Selling, general and administrative 10,946   10,403  
Research and development 5,839   7,552  
Amortization of intangible asset 1,256   1,256  
Total cost and expenses 18,452   20,180  
Operating loss (10,070)  (13,506) 
Other (expense) income, net:      
Interest expense (782)    
Unrealized (loss) gain on fair value of warrants (774)  580  
Other (expense) income, net (188)  228  
Total other (expense) income, net (1,744)  808  
Loss before income taxes (11,814)  (12,698) 
Income tax expense      
Net loss$(11,814) $(12,698) 
Other comprehensive loss:      
Unrealized loss on marketable securities    3  
Comprehensive loss$(11,814) $(12,695) 
       
Net loss attributable to ordinary shareholders:      
Basic$(11,814) $(12,698) 
Diluted$(11,814) $(13,278) 
Net loss per share attributable to ordinary shareholders:      
Basic$(0.18) $(0.23) 
Diluted$(0.18) $(0.24) 
Weighted-average shares used in computing net loss per share
attributable to ordinary shareholders:
      
Basic 67,375,383   54,231,024  
Diluted 67,375,383   54,444,681  


By: GlobenewsWire - 12 May 2021
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STRONGBRIDGE BIOPHARMA plc 
Reconciliation of Non-GAAP Financial Measures (unaudited) 
(in thousands, except share and per share data) 
                  
                  
       Three Months Ended March 31, 2021 
       Operating
loss
  Loss before
income taxes
  Net loss
attributable to
ordinary
shareholders
  Net loss per
share
attributable to
ordinary
shareholders
 
                  
GAAP    $(10,070) $(11,814) $(11,814) $(0.18) 
                     
 Non-GAAP Adjustments:                    
                                                  
 Amortization of intangible asset (a) $1,256  $1,256  $1,256     
 Stock-based compensation - Selling, General & Admin. (b)$1,719  $1,719  $1,719     
 Stock-based compensation - Research & Development (b)$558  $558  $558     
 Unrealized loss on fair value of warrants (c) -  $774  $774     
 Non-cash interest expense (d)   -  $286  $286     
                  
Adjusted    $(6,537) $(7,221) $(7,221) $(0.11)