SI-BONE, Inc. (Nasdaq:SIBN), a medical device company that
pioneered the minimally invasive surgical treatment of the
sacroiliac joint with the iFuse Implant System, today reported
financial results for the three months and full year ended December
31, 2018.
Recent Highlights
- Revenues of $55.4 million for 2018, representing a 15% increase
over 2017
- Revenues of $15.6 million for the fourth quarter of 2018,
representing a 13% increase over fourth quarter 2017
- FDA clearance of the iFuse Bedrock technique for use in adult
deformity patients with sacroiliac joint dysfunction
- Exclusive payer coverage policies from BlueCross BlueShield of
Arizona, CareFirst BlueCross BlueShield, Premera Blue Cross, and
Excellus BlueCross BlueShield
- Non-exclusive payer policy changed to exclusive coverage of
iFuse by Highmark Blue Cross Blue Shield based upon the eviCore
iFuse exclusive guidelines
- Publication in Journal of Bone and Joint Surgery of 2-year
results from iMIA, a European multi-center level 1 randomized
controlled trial comparing sacroiliac joint fusion with the iFuse
Implant System to conservative care
“Our fourth quarter 2018 accomplishments and first quarter 2019
announcements reflect the ongoing strength of our business building
robust clinical data and expanding our reimbursement coverage,”
said Jeffrey Dunn, President, Chief Executive Officer, and
Chairman. “During the fourth quarter of 2018, we also executed on
our commitment to expand into adjacent markets with the recent
clearance of the iFuse Bedrock technique for use in adult deformity
procedures. We are entering 2019 in a strong competitive position
and are continuing to strengthen our position as the market leader
in sacro-pelvic solutions. We remain confident that our focus on
clinical data, education and innovation will continue to position
the company for long term success.”
Fourth Quarter 2018 Financial ResultsRevenue
was $15.6 million for the fourth quarter of 2018, a 13% increase
from $13.8 million in the prior year period. U.S. revenue was
$14.5 million, an increase of 16% from the prior year period, and
international revenue was $1.1 million. The increase
primarily was driven by higher domestic case volumes from improved
U.S. reimbursement coverage.
Gross margin was 91% for the fourth quarter of 2018, consistent
with the prior year period.
Operating expenses were $18.5 million for the fourth quarter of
2018, as compared to $14.2 million in the prior year period, an
increase of 31%. The increase in operating expense primarily
was due to increased investment in field operations to take
advantage of improved payer coverage as well as higher general and
administrative spending for public company related costs.
Operating loss was $4.3 million in the fourth quarter of 2018,
as compared to $1.6 million in the prior year period.
Net loss was $5.3 million, or $(0.26) per diluted share for the
fourth quarter of 2018, as compared to $4.9 million, or $(1.39) per
diluted share in the prior year period.
Non-GAAP net loss per share was $(0.22) for the three months
ended December 31, 2018. The non-GAAP net loss calculation assumes
the inclusion of IPO shares and conversion of preferred stock and
warrants outstanding into common stock for the entire period. The
non-GAAP shares used to compute basic and diluted net loss per
share were the 24,450,757 shares outstanding at December 31,
2018.
2018 Financial ResultsRevenue was $55.4 million
for 2018, a 15% increase from $48.0 million in the prior year
period. U.S. revenue was $50.1 million, an increase of 16%
from the prior year period, and international revenue was $5.2
million, a 13% increase from the prior year period. The
increase primarily was driven by higher domestic and international
case volumes.
Gross margin was 91% for the full year of 2018, as compared to
89% in the prior year period. The higher gross margin
primarily was the result of cost management activities during the
first half of 2018.
Operating expenses were $62.5 million for the full year of 2018,
as compared to $60.2 million in the prior year period, an increase
of 4%. The increase in operating expense primarily was due to
increased investment in field operations in the second half of the
year to take advantage of improved payer coverage.
Operating loss was $12.0 million in full year 2018, as compared
to $17.4 million in the prior year period.
Net loss was $17.5 million, or $(2.20) per diluted share for
full year 2018, as compared to $23.0 million, or $(6.65) per
diluted share in the prior year period.
Non-GAAP net loss per share was $(0.71) for the year ended
December 31, 2018. The non-GAAP net loss calculation assumes the
inclusion of IPO shares and conversion of preferred stock and
warrants outstanding into common stock for the entire period. The
non-GAAP shares used to compute basic and diluted net loss per
share were the 24,450,757 shares outstanding at December 31,
2018.
Cash, cash equivalents and short-term investments were $122.2
million as of December 31, 2018.
2019 Financial GuidanceSI-BONE expects full
year 2019 revenue to be in a range of $65.0 million to $66.5
million, representing growth of 17-20% over full year 2018
revenue.
Webcast and Conference Call InformationSI-BONE
will host a conference call to discuss the fourth quarter and full
year 2018 financial results after market close on Thursday, March
7, 2018 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:
5682385. The webcast can be accessed at
http://investor.SI-BONE.com.
About SI-BONE, Inc.SI-BONE is a medical device
company that pioneered the iFuse Implant System, a minimally
invasive surgical system for fusion of the sacroiliac joint to
treat sacroiliac joint dysfunction. The SI joint is believed
to be the last major joint to have a clinically proven surgical
treatment. The iFuse Implant, commercially available since
2009, is believed to be the only SI joint fusion device supported
by multiple prospective clinical studies showing improved pain,
patient function and quality of life resulting from
treatment. There are more than 65 peer-reviewed publications
supporting the safety, effectiveness, and biomechanical and
economic benefits unique to the iFuse Implant. This body of
evidence has enabled multiple government and private payors to
establish coverage of the SI joint fusion procedure exclusively
when performed with the iFuse Implant System.
Forward Looking StatementsThe 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 our sales and marketing capabilities and increase
demand for iFuse, expand geographically, and obtain favorable
coverage and reimbursement determinations from third-party payors,
SI-BONE’s projections about 2019 full year revenue. Actual
results and the timing of events could different materially from
those anticipated in such forward-looking statements as a result of
the risks and uncertainties, which are described in the company’s
filings on Form S-1, 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). 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.
Use of Non-GAAP Financial MeasuresThis press
release includes the financial measure of non-GAAP net loss per
share, which differs from financial measures calculated in
accordance with U.S. generally accepted accounting principles
(“GAAP”). The non-GAAP net loss calculation assumes the inclusion
of IPO shares and conversion of preferred stock and warrants
outstanding into common stock for the entire period. The non-GAAP
shares used to compute basic and diluted net loss per share were
the 24,450,757 shares outstanding at December 31, 2018. The
non-GAAP net loss calculation is presented because the Company
believes it is a useful indicator of its operating performance this
year due to the IPO. The Company believes this measure is useful to
investors as supplemental information because it is frequently used
by analysts, investors and other interested parties to evaluate
companies in its industry. The Company believes non-GAAP net loss
per share is useful to its management and investors as a measure of
comparative operating performance for the periods ended December
31, 2018. Non-GAAP net loss per share is a non-GAAP financial
measure and should not be considered as an alternative to, or
superior to, net loss per share as a measure of financial
performance, or any other performance measure derived in accordance
with GAAP, and it should not be construed to imply that the
Company’s future results will be unaffected by unusual or
non-recurring items. Management compensates for these limitations
by primarily relying on the Company’s GAAP results in addition to
using non-GAAP net loss per share on a supplemental basis. The
Company’s definition of this measure is not necessarily comparable
to other similarly titled captions of other companies due to
different methods of calculation.
Investor Contact:Lynn Lewis or Carrie
Mendivilinvestors@SI-BONE.com
SI-BONE, Inc.Condensed Consolidated Statements of Operations(in
thousands, except percentages and per share data)(unaudited)
|
|
Three Months Ended |
|
Year ended |
|
|
December 31, |
|
December 31, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenue |
|
$ |
15,624 |
|
|
$ |
13,769 |
|
|
$ |
55,380 |
|
|
$ |
47,983 |
|
Cost of goods sold |
|
1,382 |
|
|
1,218 |
|
|
4,833 |
|
|
5,112 |
|
Gross
profit |
|
14,242 |
|
|
12,551 |
|
|
50,547 |
|
|
42,871 |
|
Gross
margin |
|
91 |
% |
|
91 |
% |
|
91 |
% |
|
89 |
% |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Sales and
marketing |
|
12,607 |
|
|
10,659 |
|
|
44,497 |
|
|
41,646 |
|
Research
and development |
|
1,501 |
|
|
1,279 |
|
|
5,376 |
|
|
5,513 |
|
General
and administrative |
|
4,441 |
|
|
2,254 |
|
|
12,639 |
|
|
13,062 |
|
Total operating
expenses |
|
18,549 |
|
|
14,192 |
|
|
62,512 |
|
|
60,221 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(4,307 |
) |
|
(1,641 |
) |
|
(11,965 |
) |
|
(17,350 |
) |
Interest
and other income (expense), net |
|
(1,004 |
) |
|
(3,263 |
) |
|
(5,488 |
) |
|
(5,689 |
) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,311 |
) |
|
$ |
(4,904 |
) |
|
$ |
(17,453 |
) |
|
$ |
(23,039 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(1.39 |
) |
|
$ |
(2.20 |
) |
|
$ |
(6.65 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average number
of common shares used to |
|
|
|
|
|
|
|
|
compute
basic and diluted net loss per share |
|
20,593,028 |
|
|
3,522,202 |
|
|
7,950,284 |
|
|
3,467,096 |
|
|
|
|
|
|
|
|
|
|
SI-BONE, Inc.Condensed Consolidated Balance Sheets(in
thousands)(unaudited)
|
|
December 31, |
|
|
2018 |
|
2017 |
ASSETS |
|
|
|
|
CURRENT ASSETS |
|
|
|
|
Cash and
cash equivalents |
|
$ |
25,120 |
|
|
$ |
22,408 |
|
Short-term investments |
|
97,103 |
|
|
— |
|
Accounts
receivable, net |
|
8,486 |
|
|
7,416 |
|
Inventory |
|
3,343 |
|
|
2,553 |
|
Prepaid
expenses and other current assets |
|
1,990 |
|
|
1,252 |
|
Total
current assets |
|
136,042 |
|
|
33,629 |
|
Property
and equipment, net |
|
2,154 |
|
|
1,896 |
|
Other
non-current assets |
|
325 |
|
|
309 |
|
TOTAL
ASSETS |
|
$ |
138,521 |
|
|
$ |
35,834 |
|
|
|
|
|
|
LIABILITIES, REDEEMABLE
CONVERTIBLE PREFERRED STOCK |
|
|
|
|
AND
STOCKHOLDERS' EQUITY (DEFICIT) |
|
|
|
|
CURRENT
LIABILITIES |
|
|
|
|
Accounts
payable |
|
$ |
2,146 |
|
|
$ |
1,814 |
|
Accrued
liabilities and other |
|
6,860 |
|
|
5,724 |
|
Total
current liabilities |
|
9,006 |
|
|
7,538 |
|
Redeemable convertible preferred stock warrants |
|
— |
|
|
422 |
|
Long-term
borrowings |
|
38,963 |
|
|
38,704 |
|
Other
long-term borrowings |
|
360 |
|
|
— |
|
TOTAL
LIABILITIES |
|
48,329 |
|
|
46,664 |
|
|
|
|
|
|
Redeemable convertible preferred stock |
|
— |
|
|
118,548 |
|
|
|
|
|
|
TOTAL
STOCKHOLDERS' EQUITY (DEFICIT) |
|
90,192 |
|
|
(129,378 |
) |
|
|
|
|
|
TOTAL
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK |
|
|
|
|
AND
STOCKHOLDERS' EQUITY (DEFICIT) |
|
$ |
138,521 |
|
|
$ |
35,834 |
|
|
|
|
|
|
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