SI-BONE, Inc. Reports Third Quarter 2019 Financial Results and Updates Full-Year 2019 Revenue Guidance
November 11 2019 - 3:05PM
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,
2019.
Recent Highlights
- Revenue of $16.2 million for the third quarter 2019,
representing a 21% increase over third quarter 2018
- U.S. revenue of $14.9 million for the third quarter 2019,
representing a 22% increase over third quarter 2018
- Published five-year prospective study results on 103 patients
treated with iFuse Implant System, showing continued durability of
clinical response and positive radiographic outcomes
- Obtained positive coverage from Wellmark Blue Cross Blue Shield
for 1.5 million members in South Dakota and Iowa and transitioned
Health New England to exclusive iFuse coverage for minimally
invasive SI joint fusion
- Announced the Medicare physician payment increase of 27% for
minimally invasive SI joint fusion
“We continue to focus on accelerating our growth
by hiring sales people, training surgeons, and launching new
products like Bedrock,” said Jeffrey Dunn, President, Chief
Executive Officer, and Chairman. “In addition, we are working to
influence positive reimbursement coverage by the remaining large
payors in the U.S. with the publication of our five-year
prospective clinical data. We are also pleased with the
decision by Medicare to increase the surgeon payment from $720 to
$915 effective January 1, 2020, recognizing the greater work effort
and intensity involved in performing minimally invasive SI joint
fusion.”
Third Quarter 2019 Financial
Results
Revenue was $16.2 million in the third quarter
2019, a 21% increase from $13.4 million in the corresponding prior
year period. U.S. revenue for the third quarter 2019 was $14.9
million, an increase of 22% from the corresponding prior year
period primarily driven by growth of domestic case volumes. Our
international revenue was $1.3 million in the third quarter
2019.
Gross margin was 90% for the third quarter 2019,
as compared to 91% in the corresponding prior year period. The
change in gross margin was due to an increase in personnel in
operations to support the growth of the business.
Operating expenses were $25.1 million in the
third quarter 2019, as compared to $15.2 million in the
corresponding prior year period, an increase of 65%. The
increase in operating expense was primarily driven by increased
sales hiring, surgeon training, new public company costs,
stock-based compensation and litigation expenses.
Operating loss was $10.6 million in the third
quarter 2019, as compared to $3.0 million in the corresponding
prior year period.
Net loss was $11.3 million, or $0.46 per diluted
share for the third quarter 2019, as compared to $4.8 million, or
$1.29 per diluted share in the corresponding prior year period.
Cash and marketable securities were $101.5
million as of September 30, 2019.
2019 Financial Guidance
SI-BONE now expects full year 2019 revenue to be
in the range of $65.5 million to $66.5 million, representing growth
of 18% to 20% over full year 2018 revenue. This compares to the
Company’s previously full year 2019 total revenue guidance of $65.0
million to $66.5 million.
Webcast and Conference Call
Information
SI-BONE will host a conference call to discuss
the third quarter 2019 financial results after market close on
Monday, November 11, 2019 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: 8881559. 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 RCTs, showing improved pain, patient
function and quality of life resulting from treatment. There are
over 75 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
immobilization and stabilization of the sacroiliac joint in
skeletally mature patients undergoing sacropelvic fixation as part
of a lumbar or thoracolumbar fusion.
There are potential risks associated with the
iFuse Implant System. It may not be appropriate for all
patients and all patients may not benefit. Rx Only. For
indications, risks, and safety information visit:
www.si-bone.com/risks.
SI-BONE and iFuse Implant System are registered
trademarks of SI-BONE, Inc. iFuse Implant is a trademark of
SI-BONE, Inc. ©2019 SI-BONE, Inc. All Rights Reserved.
Forward Looking Statements
The statements in this press release regarding
SI-BONE’s continued growth and financial outlook are
“forward-looking” statements. These forward-looking statements are
based on SI-BONE’s current expectations and inherently involve
significant risks and uncertainties. These statements and risks
include SI-BONE’s ability to expand its sales and marketing
capabilities and increase surgeon demand for iFuse, increase
revenue through new products, obtain favorable coverage and
reimbursement determinations from third-party payors, and fulfill
its projections about 2019 full year revenue. Actual results and
the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of the risks and
uncertainties, which are described in SI-BONE’s filings on Form
10-K and Form 10-Q and SI-BONE’s other filings with the Securities
and Exchange Commission (SEC) available at the SEC’s Internet site
(www.sec.gov). 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.
Investor Contact:Lynn 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 September 30, |
|
Nine Months Ended September 30, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenue |
|
$ |
16,182 |
|
|
$ |
13,381 |
|
|
$ |
47,490 |
|
|
$ |
39,756 |
|
Cost of goods sold |
|
1,630 |
|
|
1,221 |
|
|
4,744 |
|
|
3,451 |
|
Gross profit |
|
14,552 |
|
|
12,160 |
|
|
42,746 |
|
|
36,305 |
|
Gross margin |
|
90 |
% |
|
91 |
% |
|
90 |
% |
|
91 |
% |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Sales and marketing |
|
16,443 |
|
|
10,605 |
|
|
48,985 |
|
|
31,890 |
|
Research and development |
|
1,874 |
|
|
1,373 |
|
|
5,503 |
|
|
3,875 |
|
General and administrative |
|
6,816 |
|
|
3,226 |
|
|
15,776 |
|
|
8,198 |
|
Total operating expenses |
|
25,133 |
|
|
15,204 |
|
|
70,264 |
|
|
43,963 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(10,581 |
) |
|
(3,044 |
) |
|
(27,518 |
) |
|
(7,658 |
) |
Interest and other income
(expense), net: |
|
|
|
|
|
|
|
|
Interest income |
|
612 |
|
|
69 |
|
|
2,051 |
|
|
199 |
|
Interest expense |
|
(1,243 |
) |
|
(1,282 |
) |
|
(3,706 |
) |
|
(3,826 |
) |
Other expense, net |
|
(94 |
) |
|
(535 |
) |
|
(132 |
) |
|
(855 |
) |
Net loss |
|
$ |
(11,306 |
) |
|
$ |
(4,792 |
) |
|
$ |
(29,305 |
) |
|
$ |
(12,140 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.46 |
) |
|
$ |
(1.29 |
) |
|
$ |
(1.19 |
) |
|
$ |
(3.34 |
) |
Weighted-average number of
common shares used to compute basic and diluted net loss per
share |
|
24,803,452 |
|
|
3,712,876 |
|
|
24,596,788 |
|
|
3,638,905 |
|
SI-BONE, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(in
thousands)(unaudited)
|
|
September 30, |
|
December 31, |
|
|
2019 |
|
2018 |
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
12,614 |
|
|
$ |
25,120 |
|
Short-term investments |
|
83,609 |
|
|
97,103 |
|
Accounts receivable, net |
|
9,918 |
|
|
8,486 |
|
Inventory |
|
4,953 |
|
|
3,343 |
|
Prepaid expenses and other current assets |
|
1,619 |
|
|
1,990 |
|
Total current assets |
|
112,713 |
|
|
136,042 |
|
Long-term investments |
|
5,273 |
|
|
— |
|
Property and equipment,
net |
|
3,025 |
|
|
2,154 |
|
Other non-current assets |
|
305 |
|
|
325 |
|
TOTAL ASSETS |
|
$ |
121,316 |
|
|
$ |
138,521 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
2,623 |
|
|
$ |
2,146 |
|
Accrued liabilities and other |
|
10,211 |
|
|
6,860 |
|
Total current liabilities |
|
12,834 |
|
|
9,006 |
|
Long-term borrowings |
|
39,158 |
|
|
38,963 |
|
Other long-term
liabilities |
|
363 |
|
|
360 |
|
TOTAL LIABILITIES |
|
52,355 |
|
|
48,329 |
|
|
|
|
|
|
Stockholders' Equity: |
|
|
|
|
Common stock and additional paid-in capital |
|
254,968 |
|
|
246,930 |
|
Accumulated other comprehensive income |
|
475 |
|
|
439 |
|
Accumulated deficit |
|
(186,482 |
) |
|
(157,177 |
) |
TOTAL STOCKHOLDERS' EQUITY |
|
68,961 |
|
|
90,192 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ |
121,316 |
|
|
$ |
138,521 |
|
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