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 March 31, 2020.
Recent Highlights
- Revenue of $16.8 million for the first quarter 2020,
representing a 12% increase over the corresponding period in
2019
- U.S. revenue of $15.3 million for the first quarter 2020,
representing a 14% increase over the corresponding period in
2019
- Received FDA 510(k) clearance for an expanded indication for
the iFuse Implant System to support the Company's trauma
program
- Obtained positive coverage by Health Alliance Plan, a
commercial payor in Michigan
“Our SI-BONE team has shown tremendous efforts
and strength through these difficult times. I am incredibly proud
to be part of this team and believe that we will come out of this
period even stronger as a company," said Jeffrey Dunn, President,
CEO and Chairman. “The underlying fundamentals of our business
remain strong. Through mid-March, we saw record procedure volumes
resulting from the significant investments we made across our
commercial organization to develop this market, and we are taking a
very disciplined and thoughtful approach to financial decisions and
capital allocation priorities.”
First Quarter 2020 Financial
Results
Revenue was $16.8 million in the first quarter
2020, a 12% increase from $15.0 million in the corresponding prior
period in 2019. U.S. revenue for the first quarter 2020 was
$15.3 million, a 14% increase from $13.5 million in the
corresponding prior period in 2019 primarily driven by growth of
domestic case volumes. Our international revenue was $1.5 million
in the first quarter 2020, flat compared to the corresponding
period in 2019. Though our total revenue increased as discussed
above, it was partly impacted by lower than anticipated case
volumes specifically in the second half of March 2020 due to the
effects of COVID-19.
Gross margin was 89% for the first quarter 2020,
as compared to 90% in the corresponding prior period in 2019. The
change in gross margin was due to higher cost of operations to
support the growth of the business.
Operating expenses were $26.8 million in the
first quarter 2020, as compared to $22.3 million in the
corresponding prior period in 2019, an increase of 20%. The
increase in operating expense was primarily driven by higher
employee related costs due to higher headcount mainly from sales
hiring, surgeon training and stock-based compensation.
Operating loss was $11.9 million in the first
quarter 2020, as compared to $8.8 million in the corresponding
prior period in 2019.
Net loss was $12.8 million, or $0.47 per diluted
share for the first quarter 2020, as compared to $9.3 million, or
$0.38 per diluted share in the corresponding prior period in
2019.
Cash and marketable securities were $146.2
million as of March 31, 2020. This includes a follow-on offering,
completed during the first quarter of 2020, which raised net
proceeds of $63.4 million after deducting the underwriting
discounts and commissions.
2020 Guidance
As previously reported on Form 8-K filed on
April 2, 2020, due to the evolving environment and continued
uncertainties from the impact of COVID-19, SI-BONE has withdrawn
its previously announced guidance for the full year 2020. The
COVID-19 pandemic is a highly fluid situation and it is not
currently possible for the Company to reasonably estimate the
impact it may have on financial and operating results.
ESG
As SI-BONE progresses through its second full
year as a public company, the Company has worked to improve overall
corporate disclosure. In response to the evolving shareholder
interest in Environmental, Social and Governance (ESG) topics,
SI-BONE anticipates updating its related disclosures during the
second quarter of 2020.
Webcast and Conference Call
Information
SI-BONE will host a conference call to discuss
the first quarter 2020 financial results after market close on
Monday, May 4, 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: 7919778. 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 80 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.
Forward Looking Statements
The first quarter 2020 financial results and
statements in this press release regarding expectations of future
events or results, as well as SI-BONE's expectations set forth
under the caption "2020 Financial Guidance" are "forward-looking"
statements. These forward-looking statements are based on SI-BONE's
current expectations and inherently involve significant risks and
uncertainties and, in the case of its first quarter 2020 financial
results, are subject to quarter-end closing adjustments. 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, expand
geographically, 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 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 ContactLynn Lewis or
Carrie Mendivilinvestors@SI-BONE.com
SI-BONE, INC. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS(In
thousands, except share and per share amounts)
(unaudited)
|
Three Months Ended March 31, |
|
2020 |
|
2019 |
Revenue |
$ |
16,821 |
|
|
$ |
14,991 |
|
Cost of goods sold |
1,932 |
|
|
1,526 |
|
Gross profit |
14,889 |
|
|
13,465 |
|
Gross margin |
89 |
% |
|
90 |
% |
|
|
|
|
Operating expenses: |
|
|
|
Sales and marketing |
19,281 |
|
|
15,815 |
|
Research and development |
2,090 |
|
|
1,683 |
|
General and administrative |
5,400 |
|
|
4,766 |
|
Total operating expenses |
26,771 |
|
|
22,264 |
|
|
|
|
|
Loss from operations |
(11,882 |
) |
|
(8,799 |
) |
Interest and other income
(expense), net: |
|
|
|
Interest income |
498 |
|
|
744 |
|
Interest expense |
(1,231 |
) |
|
(1,230 |
) |
Other expense, net |
(157 |
) |
|
(60 |
) |
Net loss |
$ |
(12,772 |
) |
|
$ |
(9,345 |
) |
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.47 |
) |
|
$ |
(0.38 |
) |
Weighted-average number of
common shares used to compute basic and diluted net loss per
share |
27,252,409 |
|
|
24,390,648 |
|
SI-BONE, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS(in
thousands)(unaudited)
|
March 31, |
|
December 31, |
|
2020 |
|
2019 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
67,568 |
|
|
$ |
10,435 |
|
Short-term investments |
77,373 |
|
|
81,345 |
|
Accounts receivable, net |
9,361 |
|
|
11,720 |
|
Inventory |
5,726 |
|
|
5,452 |
|
Prepaid expenses and other current assets |
1,936 |
|
|
2,510 |
|
Total current assets |
161,964 |
|
|
111,462 |
|
Long-term investments |
1,274 |
|
|
1,278 |
|
Property and equipment,
net |
4,269 |
|
|
3,954 |
|
Other non-current assets |
312 |
|
|
315 |
|
TOTAL ASSETS |
$ |
167,819 |
|
|
$ |
117,009 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,577 |
|
|
$ |
2,811 |
|
Accrued liabilities and other |
9,284 |
|
|
11,605 |
|
Current portion of long-term borrowings |
8,731 |
|
|
4,358 |
|
Total current liabilities |
20,592 |
|
|
18,774 |
|
Long-term borrowings |
30,557 |
|
|
34,865 |
|
Other long-term
liabilities |
400 |
|
|
362 |
|
TOTAL LIABILITIES |
51,549 |
|
|
54,001 |
|
|
|
|
|
Stockholders' Equity: |
|
|
|
Common stock and additional paid-in capital |
323,925 |
|
|
258,124 |
|
Accumulated other comprehensive income |
697 |
|
|
464 |
|
Accumulated deficit |
(208,352 |
) |
|
(195,580 |
) |
TOTAL STOCKHOLDERS' EQUITY |
116,270 |
|
|
63,008 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ |
167,819 |
|
|
$ |
117,009 |
|
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