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SI-BONE, Inc. Reports Third Quarter 2020 Financial Results and 2020 Revenue Guidance

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SANTA CLARA, Calif. , Nov. 02, 2020 (GLOBE NEWSWIRE) -- SI-BONE, Inc. (NASDAQ:SIBN), a medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, today reported financial results for the quarter ended September 30, 2020.

Recent Highlights

  • Worldwide revenue of $20.4 million for the third quarter 2020, representing a 26% increase over the corresponding period in 2019
  • U.S. revenue of $18.9 million for the third quarter 2020, representing a 27% increase over the corresponding period in 2019
  • Surpassed 50,000 iFuse procedures performed by more than 2,200 surgeons worldwide
  • Obtained exclusive iFuse coverage policy by Medica, one of the three largest commercial payers in the state of Minnesota, with an estimated 1.1 million covered lives, effective August 19, 2020
  • Introduced a portable, radiation-free, haptics based computer simulator for surgeon training, enabling the training of over 100 surgeons in their offices
  • Completed a second follow-on offering in October 2020, with net proceeds of $71.9 million after deducting underwriting discounts and commissions

"Our team executed remarkably well during the quarter, supported by the fact that approximately 80% of our procedures are performed in an outpatient or ASC setting, where patients are currently more receptive to treatment," said Jeff Dunn, President, Chief Executive Officer and Chairman of SI-BONE. "As the market and innovation leader for minimally invasive SI joint fusion, we believe our strong balance sheet and recent favorable reimbursement coverage decisions will enable us to capture this multi-billion dollar market as we enter 2021."

Third Quarter 2020 Financial Results

Revenue was $20.4 million in the third quarter 2020, a 26% increase from $16.2 million in the corresponding  period in 2019. U.S. revenue for the third quarter 2020 was $18.9 million, a 27% increase from $14.9 million in the corresponding period in 2019 primarily driven by growth of domestic case volumes. International revenue for the third quarter 2020 was $1.4 million, a 9% increase from $1.3 million in the corresponding period in 2019.

Gross margin was 87% for the third quarter 2020, as compared to 90% in the corresponding period in 2019. The decrease was primarily due to increased write-downs of iFuse-related inventory as a result of the more rapid than anticipated adoption of iFuse-3D.  Gross margin was also impacted by higher cost of operations to support the growth of the business. 

Operating expenses increased 5% to $26.5 million in the third quarter 2020, as compared to $25.1 million in the corresponding period in 2019. The increase was primarily driven by higher sales and marketing and research and development expenses, mainly from increased sales hiring and new product development costs.  The increase was partly offset by a reduction in general and administrative expenses in the third quarter of 2020, primarily due to the accrual of estimated settlement costs of the TCPA class action lawsuit of $2.5 million in the third quarter 2019. 

Operating loss was $8.7 million in the third quarter 2020, as compared to an operating loss of $10.6 million in the corresponding period in 2019.

Net loss was $9.5 million, or $0.33 per diluted share for the third quarter 2020, as compared to a net loss of $11.3 million, or $0.46 per diluted share in the corresponding period in 2019.

Cash and marketable securities were $132.0 million and long-term borrowings were $39.4 million as of September 30, 2020. With the completion of the follow-on offering in October 2020, the Company added net proceeds of $71.9 million to its balance sheet.

2020 Revenue Guidance

As previously reported on Form 8-K filed on October 8, 2020, SI-BONE expects full year 2020 revenue to be in the range of $73.0-$74.0 million, representing growth of approximately 8%-10% over 2019 revenue. SI-BONE remains cautious in the fourth quarter based upon the potential impact of COVID-19 on its business. The COVID-19 pandemic is a highly fluid situation and poses a continued risk to SI-BONE's financial position and operating results.

Webcast and Conference Call Information

SI-BONE will host a conference call to discuss the third quarter 2020 financial results after market close on Monday, November 2, 2020 at 4:30 P.M. Eastern Time. The conference call can be accessed live over the phone (866) 470-1968 for domestic callers or (409) 217-8248 for international callers, using conference ID: 6728555. The webcast can be accessed at https://investor.si-bone.com

About SI-BONE, Inc.

SI-BONE is a medical device company that pioneered minimally invasive surgery of the SI joint with the iFuse Implant System. Studies have shown that the SI joint can be a source of pain in 15% to 30% of chronic low back pain. The iFuse Implant™, commercially available since 2009, is the only SI joint fusion device supported by multiple prospective clinical studies, including two randomized controlled trials, showing improved pain, patient function and quality of life resulting from treatment. There are over 85 peer-reviewed publications demonstrating the safety, durable effectiveness, and biomechanical and economic benefits unique to the iFuse Implant (www.si-bone.com/results). This body of evidence has enabled multiple government and private insurance payors to establish coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The iFuse Implant System is also intended for sacroiliac fusion to augment stabilization and immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. In addition, the iFuse Implant System is intended for sacroiliac fusion in acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit.

For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2020 SI-BONE, Inc. All Rights Reserved. 11022020

Forward Looking Statements

The statements in this press release regarding expectations of future events or results, including SI-BONE's  expectations of continued growth and financial outlook, contained in this press release are "forward-looking" statements. These forward-looking statements are based on SI-BONE's current expectations and inherently involve significant risks and uncertainties. These risks include the impact the COVID-19 pandemic will have on the ability and desire of patients and physicians to undergo procedures using the iFuse Implant System, the duration of the COVID-19 pandemic, whether the COVID-19 pandemic will recur in the future, and SI-BONE's ability to increase demand for iFuse, and obtain favorable coverage and reimbursement determinations from third-party payors. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these and other risks and uncertainties, many of which are described in the company's most recent filings on Form 10-K and Form 10-Q, and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov), especially under the caption "Risk Factors". SI-BONE does not undertake any obligation to update forward-looking statements and expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.

Investor Contact
Matt Bacso, CFA
investors@SI-BONE.com 

 
 
SI-BONE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(unaudited)
 
    Three Months Ended
September 30,
  Nine Months Ended
September 30,
    2020   2019   2020   2019
Revenue   $ 20,373     $ 16,182     $ 51,243     $ 47,490  
Cost of goods sold   2,578     1,630     6,627     4,744  
Gross profit   17,795     14,552     44,616     42,746  
Gross margin   87 %   90 %   87 %   90 %
                                 
Operating expenses:                                
Sales and marketing   18,772     16,443     53,808     48,985  
Research and development   2,778     1,874     7,033     5,503  
General and administrative   4,920     6,816     14,471     15,776  
Total operating expenses   26,470     25,133     75,312     70,264  
                 
Loss from operations   (8,675 )   (10,581 )   (30,696 )   (27,518 )
Interest and other income (expense), net:                
Interest income   192     612     1,019     2,051  
Interest expense   (1,102 )   (1,243 )   (5,016 )   (3,706 )
Other income (expense), net   111     (94 )   (25 )   (132 )
Net loss   $ (9,474 )   $ (11,306 )   $ (34,718 )   $ (29,305 )
                 
Net loss per share, basic and diluted   $ (0.33 )   $ (0.46 )   $ (1.23 )   $ (1.19 )
Weighted-average number of common shares used to
compute basic and diluted net loss per share
  28,713,418     24,803,452     28,155,561     24,596,788  
                         


SI-BONE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
 
    September 30,   December 31,
    2020   2019
ASSETS        
Current assets:        
Cash and cash equivalents   $ 55,996     $ 10,435  
Short-term investments   76,024     81,345  
Accounts receivable, net   11,417     11,720  
Inventory   5,071     5,452  
Prepaid expenses and other current assets   1,014     2,510  
Total current assets   149,522     111,462  
Long-term investments       1,278  
Property and equipment, net   4,479     3,954  
Other non-current assets   314     315  
TOTAL ASSETS   $ 154,315     $ 117,009  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY                
Current liabilities:        
Accounts payable   $ 3,102     $ 2,811  
Accrued liabilities and other   8,719     11,605  
Current portion of long-term borrowings       4,358  
Total current liabilities   11,821     18,774  
Long-term borrowings   39,368     34,865  
Other long-term liabilities   1,095     362  
TOTAL LIABILITIES   52,284     54,001  
         
Stockholders' Equity:        
Common stock and additional paid-in capital   331,899     258,124  
Accumulated other comprehensive income   430     464  
Accumulated deficit   (230,298 )   (195,580 )
TOTAL STOCKHOLDERS' EQUITY   102,031     63,008  
   TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY   $ 154,315     $ 117,009  

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