Dextera Surgical Inc. (Nasdaq:DXTR) today announced financial
results for its fiscal fourth quarter and full year ended June 30,
2016. The Company’s conference call at 4:30 p.m. Eastern Time to
provide a business update and review financial results will also
feature Dr. Joel Dunning, a cardiothoracic surgeon at James Cook
University Hospital, Department of Cardiothoracic Surgery in
Middlesbrough, U.K., who will provide a clinical perspective on
Dextera’s MicroCutter surgical stapler and take related questions.
“Over the course of fiscal 2016, with new leadership in place,
we have made significant strides to improve the clinical
performance of our innovative MicroCutter surgical stapler, as well
as driving early adoption by key opinion leaders and executing an
effective market awareness program,” said Julian Nikolchev,
president and CEO of Dextera Surgical Inc. “With the recent FDA
510(k) clearance, we are beginning our evaluation of the
MicroCutter 5/80, that deploys both blue and white cartridges, in
selected centers in the U.S. and Europe through initial market
preference testing and a newly initiated MATCH registry designed to
collect hemostasis and ease-of-use data on our stapler.”
“We look forward to expanding our commercial efforts in the
fourth quarter of calendar 2016 while advancing our new development
program with Intuitive Surgical, Inc. Fiscal 2017 promises to be a
pivotal and milestone-driven year for the company,” continued Mr.
Nikolchev.
Recent Highlights and Accomplishments:
- Received 510(k) clearance to market the blue cartridge reload
with the MicroCutter 5/80 intended for transection and resection in
multiple open or minimally invasive urologic, thoracic and
pediatric surgical procedures, as well as application for
transection, resection, and/or creation of anastomoses in the small
and large intestine, and the transection of the appendix.
- Initiated a post-market surveillance registry, the
MicroCutter-Assisted Thoracic Surgery Hemostasis (MATCH) registry
to evaluate the hemostasis and ease-of-use for the MicroCutter
5/80. This is a prospective, open-label, multi-center registry and
Dextera Surgical plans to enroll up to 120 patients requiring
surgical stapling during a lobectomy or segmentectomy at leading
centers in the U.S. and Europe.
- Announced a first-of-its kind use of the MicroCutter 5/80 in a
laparoscopic duodenal atresia repair in a newborn. Leading
pediatric surgeon Oliver Muensterer, M.D., Ph.D., professor
and chairman of Pediatric Surgery, University Medical
Center of the Johannes Gutenberg University, Mainz,
Germany performed the challenging laparoscopic repair, known as
duodenoduodenostomy.
- Successfully completed a six-month feasibility evaluation of
the MicroCutter technology as part of an ongoing license agreement
with Intuitive Surgical.
- Entered into a joint development program with Intuitive
Surgical to develop a surgical stapler and cartridge for use with
Intuitive’s da Vinci® Surgical System. Under the terms of the joint
development program, Intuitive Surgical will be responsible for the
development of the stapler and Dextera Surgical will be responsible
for development of the stapler cartridge. Dextera Surgical will
receive financial support for the development of the cartridge and
tooling for manufacturing as well as a unit-based royalty on
commercial sales once the product is on the market.
- Appointed Mark Soberman, M.D., MBA, FACS, to the position of
medical director to expand the presence of the MicroCutter 5/80 in
minimally-invasive and robotic-assisted surgery by working with key
opinion leaders around the world. Dr. Soberman is a practicing
thoracic surgeon who also serves as medical director of the
Oncology Service Line and chief physician executive, Monocacy
Health Partners at Frederick Regional Health System in Frederick,
Maryland.
- Initiated new branding, changing the company’s name to Dextera
Surgical Inc. to reflect the MicroCutter surgical stapling
technology portfolio and broadening the company’s focus beyond its
anastomotic product lines originally introduced for use in cardiac
surgery.
- Reported positive results for the Multicenter Assessment of
Grafts in Coronaries (MAGIC) Study, a long-term post-market
evaluation of the C-Port® Distal Anastomosis System demonstrating
that the C-Port device is safe and effective when used to create
the distal anastomosis in CABG surgery, with equivalent patency
rates to hand-sewn grafts at 12 months. Data were presented at the
Annual Meeting of the American Association for Thoracic
Surgery (AATS) by Husam Balkhy, M.D., associate professor
of Surgery and director of Robotic and Minimally Invasive Cardiac
Surgery at The University of Chicago’s Medicine & Biological
Sciences Division.
Fiscal 2016 Fourth Quarter and Full Year Ended June 30,
2016, Financial Results
Total product sales were $0.7 million for both the fiscal 2016
and fiscal 2015 fourth quarters. Total license and royalty revenue
for the fiscal 2016 fourth quarter was $63,000 compared with
$17,000 in royalty revenue for the fiscal 2015 fourth quarter.
Total revenue was approximately $0.7 million for both the fiscal
2016 and fiscal 2015 fourth quarters.
Total operating costs and expenses for the fiscal 2016 fourth
quarter were $4.9 million, compared with $4.5 million for the same
period of fiscal 2015. Cost of product sales was approximately $1.1
million for the fiscal 2016 fourth quarter, compared with $0.9
million for the fiscal 2015 fourth quarter. Research and
development expenses were approximately $1.6 million for the fiscal
2016 fourth quarter, compared with $1.8 million for the fiscal 2015
fourth quarter. Selling, general and administrative expenses were
$2.2 million for the fiscal 2016 fourth quarter, compared with $1.8
million for the fiscal 2015 fourth quarter.
The net loss for the fiscal 2016 fourth quarter was
approximately $4.3 million, or $0.48 per share, compared with a net
loss of approximately $3.9 million, or $0.43 per share, for the
fiscal 2015 fourth quarter.
Total revenue was approximately $4.1 million for the fiscal year
ended June 30, 2016, compared with $3.0 million for the fiscal year
ended June 30, 2015. Total operating costs and expenses for fiscal
2016 were approximately $19.7 million, compared with approximately
$21.8 million for fiscal 2015. Net loss for fiscal year ended June
30, 2016, was approximately $16.0 million, or $1.80 per share,
compared with a net loss of $19.2 million, or $2.16 per share for
fiscal 2015.
Cash, cash equivalents and investments as of June 30, 2016, were
approximately $12.7 million, compared with approximately $16.5
million at March 31, 2016. As of June 30, 2016, there were
approximately 8.9 million shares of common stock outstanding and
191,474 shares of Series A convertible preferred stock outstanding.
Calendar Year 2016 Milestones
Management’s key objectives during the remainder of calendar
2016 continue to be as follows:
- Increase clinical adoption of the MicroCutter in Germany and
the U.K.;
- Demonstrate clinical adoption for Video-Assisted Thoracic
Surgery (VATS) by a select group of centers in both the EU and the
U.S.;
- Complete initial evaluation cases with the MicroCutter 5/80 in
the third quarter of calendar 2016, with a selective launch
targeted for the fourth quarter of calendar 2016;
- By the end of the calendar year, establish an improved
MicroCutter supply chain using the most appropriate technologies;
and
- Finally, by the end of the year, announce Dextera Surgical’s
product pipeline.
Conference Call DetailsTo access the live
conference call today at 4:30 p.m. Eastern Time via phone, please
dial 877-797-0722 from the United States and Canada or 615-247-0191
internationally. The conference ID is 54847839. Please dial in
approximately 10 minutes prior to the start of the call. A
telephone replay will be available beginning approximately four
hours after the call through August 16, 2016, and may be accessed
by dialing 855-859-2056 from the United States and Canada or
404-537-3406 internationally. The replay passcode is 54847839.
To access the live and subsequently archived webcast of the
conference call, go to the Investor Relations section of the
company’s website at ir.dexterasurgical.com. Please connect
to the website at least 15 minutes prior to the presentation to
allow for any necessary software downloads.
The webcast is also being distributed through the Thomson
StreetEvents Network. Institutional investors can access the call
via Thomson StreetEvents at www.streetevents.com, a
password-protected event management site.
About Dextera Surgical
Dextera Surgical designs and manufactures proprietary
stapling devices for minimally invasive surgical
procedures. In the U.S., surgical staplers are routinely used
in more than one million minimally invasive laparoscopic,
video-assisted or robotic-assisted surgical procedures
annually.
The company's signature proprietary technology, the MicroCutter
5/80 Stapler, is the world's first and only five-millimeter
surgical stapler that articulates to 80 degrees in each direction.
As the smallest-profile articulating stapler available today, the
MicroCutter 5/80 Stapler may reduce the amount of dissection and
tissue handling required to position the stapler in confined
spaces, enabling access to difficult-to-reach anatomy. The
cartridge-based device's small size and wide articulation range are
designed to enhance the surgeon's access and visualization at the
surgical site and to mitigate limitations on the advancement of
minimally invasive surgical approaches created by larger stapling
devices.
Dextera Surgical also markets the only automated
anastomosis devices for coronary artery bypass graft (CABG)
surgery on the market today: the C-Port® Distal
Anastomosis Systems and PAS-Port® Proximal Anastomosis
System. These products, sold by Dextera Surgical
under the Cardica brand name, have demonstrated long-term
reliable clinical performance for more than a decade.
Forward-Looking StatementsThe statements in
this press release regarding Dextera Surgical’s beliefs as to the
timing of development of its enhanced MicroCutter device are
"forward-looking statements." There are a number of important
factors that could cause Dextera Surgical’s results to differ
materially from those indicated by these forward-looking
statements, including: that Dextera Surgical may not be successful
in its efforts to make the improvements necessary to its enhanced
MicroCutter device due to unanticipated technical or other
difficulties; risks inherent in obtaining regulatory approvals; as
well as other risks detailed from time to time in Dextera
Surgical’s reports filed with the U.S. Securities and Exchange
Commission, including its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2016, under the caption “Risk
Factors.” Dextera Surgical expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein. You are encouraged to
read Dextera Surgical’s reports filed with the U.S. Securities and
Exchange Commission, available at www.sec.gov.
Dextera Surgical
Inc. |
|
|
|
|
Consolidated Statements of Operations |
|
(amounts in thousands except per share
amounts) |
|
|
|
|
|
|
Three months ended |
|
Twelve months ended |
|
|
|
|
June 30, |
|
June 30, |
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
(unaudited) |
|
(unaudited) |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
660 |
|
|
$ |
684 |
|
|
$ |
2,538 |
|
|
$ |
2,922 |
|
|
License and development
revenue |
|
48 |
|
|
|
- |
|
|
|
1,460 |
|
|
|
- |
|
|
Royalty
revenue |
|
|
15 |
|
|
|
17 |
|
|
|
66 |
|
|
|
68 |
|
|
|
Total |
|
|
723 |
|
|
|
701 |
|
|
|
4,064 |
|
|
|
2,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
costs and expenses |
|
|
|
|
|
|
|
|
Cost of product
sales |
|
|
1,093 |
|
|
|
851 |
|
|
|
3,916 |
|
|
|
4,235 |
|
|
Research and
development |
|
1,577 |
|
|
|
1,817 |
|
|
|
6,390 |
|
|
|
7,341 |
|
|
Selling, general and
administrative |
|
2,211 |
|
|
|
1,793 |
|
|
|
9,353 |
|
|
|
10,197 |
|
|
|
Total
operating costs and expenses |
|
4,881 |
|
|
|
4,461 |
|
|
|
19,659 |
|
|
|
21,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(4,158 |
) |
|
|
(3,760 |
) |
|
|
(15,595 |
) |
|
|
(18,783 |
) |
|
Interest
and other income |
|
17 |
|
|
|
25 |
|
|
|
67 |
|
|
|
51 |
|
|
Interest
expense |
|
|
(128 |
) |
|
|
(116 |
) |
|
|
(497 |
) |
|
|
(450 |
) |
|
Net loss |
|
|
$ |
(4,269 |
) |
|
$ |
(3,851 |
) |
|
$ |
(16,025 |
) |
|
$ |
(19,182 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$ |
(0.48 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.80 |
) |
|
$ |
(2.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per
share |
|
8,928 |
|
|
|
8,896 |
|
|
|
8,910 |
|
|
|
8,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheets |
|
(amounts in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
June 30, |
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
Assets |
|
|
(unaudited) |
|
|
Cash, cash equivalents
and investments |
$ |
12,716 |
|
|
$ |
25,206 |
|
|
|
Accounts
receivable |
|
|
313 |
|
|
|
424 |
|
|
|
Inventories |
|
|
1,061 |
|
|
|
1,391 |
|
|
|
Other assets |
|
|
1,600 |
|
|
|
2,273 |
|
|
|
|
Total assets |
|
$ |
15,690 |
|
|
$ |
29,294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and stockholders' equity |
|
|
|
|
|
Accounts payable and
other liabilities |
$ |
2,245 |
|
|
$ |
1,849 |
|
|
|
Deferred
revenue |
|
|
3,068 |
|
|
|
2,528 |
|
|
|
Long term debt |
|
|
3,124 |
|
|
|
2,828 |
|
|
|
Total stockholders'
equity |
|
7,253 |
|
|
|
22,089 |
|
|
|
|
Total
liabilities and stockholders' equity |
$ |
15,690 |
|
|
$ |
29,294 |
|
|
|
|
|
|
|
|
|
|
|
Contact:
Bob Newell
Vice President, Finance and Chief Financial Officer
(650) 331-7133
investors@dexterasurgical.com
Media:
Kelly Morrison
+1 (224) 240-1481
kelly@kellyamorrison.com