Cardica Reports Fiscal 2016 Second Quarter Financial Results and Business Progress
February 04 2016 - 4:05PM
Cardica, Inc. (Nasdaq:CRDC) today announced financial results for
its fiscal second quarter ended December 31, 2015. Cardica’s
management will hold a conference call at 4:30 p.m. Eastern Time to
discuss the financial results and provide an update on the
company’s business.
“We made significant commercial, operational and development
progress over the course of the last several months including our
recent agreement with Intuitive Surgical and 510(k) U.S. market
clearance for our Microcutter XCHANGE® 30 with the white cartridge
for indications in thoracic, pediatric and urologic surgeries
including vascular tissue,” said Julian Nikolchev, president and
CEO of Cardica. “In addition to our focus on video assisted
thoracic surgery (VATS), in the EU, we are now developing
relationships with a select group of key opinion leaders in the
U.S. in the fields of thoracic and pediatric surgery to build deep
relationships within high volume and academic centers, focusing on
procedures where the MicroCutter may truly be enabling for less
invasive techniques.”
Mr. Nikolchev continued, “In parallel with our controlled
commercial outreach focusing on clinical adoption, we continue to
make progress in the development of our MicroCutter Generation 4
surgical stapler for use in a wider range of tissue thicknesses. We
have completed initial burst pressure and tissue thickness testing
of the device, with positive results, and continue to develop the
supply chain for this device.”
Recent Highlights and Accomplishments
- Received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to use the MicroCutter XCHANGE 30 surgical
stapling device with a white cartridge for the transection and
resection in open or minimally invasive thoracic, pediatric and
urologic surgical procedures including vascular tissue. This
clearance complements the existing indications for use of the
MicroCutter XCHANGE 30 in surgical procedures in the small and
large intestine and in the appendix.
- Amended the license agreement with Intuitive Surgical to
include an agreement providing for the evaluation and potential
development of a surgical stapling cartridge for use with Intuitive
Surgical’s da Vinci® Surgical Systems. Under the terms of the
amendment, Intuitive Surgical paid Cardica $2 million to extend its
rights to improvements in Cardica’s stapling technology and certain
patents from August 2013 until August 2018 and to provide for a
feasibility evaluation period of up to six months. The feasibility
evaluation allows Intuitive Surgical to test and evaluate Cardica’s
MicroCutter XCHANGE technology, and upon completion, Intuitive
Surgical will have the option to initiate a joint development
program for an 8 millimeter in diameter surgical stapling cartridge
for use with the da Vinci Surgical System. Cardica may receive
further funding for development of the cartridge and tooling as
well as a unit-based royalty on commercial sales.
- The company’s MicroCutter XCHANGE 30 was featured in a
presentation by Joel Dunning, M.D., cardiothoracic surgeon at James
Cook University Hospital, Department of Cardiothoracic Surgery in
Middlesbrough, U.K., at The Society of Thoracic Surgeons and
American Association for Thoracic Surgery’s Tech Conference
(STS/AATS Tech-Con) during the “Lung Surgery of the Future” program
track.
Fiscal 2016 Second Quarter and First Six Months Ended
December 31, 2015, Financial ResultsTotal product sales
were $0.7 million for the fiscal 2016 second quarter, compared with
approximately $0.6 million for the fiscal 2015 second quarter.
Product sales in the fiscal 2016 second quarter were negatively
impacted by Cardica’s voluntary market withdrawal of the blue
cartridge in November 2015. Total revenue was approximately $0.7
million for both the fiscal 2016 and fiscal 2015 second
quarters.
Cost of product sales was approximately $0.9 million for both
the fiscal 2016 and fiscal 2015 second quarters. Research and
development expenses were approximately $1.6 million for the second
quarter of fiscal 2016, compared with $1.8 million for the second
quarter of fiscal 2015. Selling, general and administrative
expenses were $2.2 million for the fiscal 2016 second quarter,
compared with $3.2 million for the fiscal 2015 second
quarter.
The net loss for the fiscal 2016 second quarter was
approximately $4.0 million, or $0.05 per share, compared with a net
loss of approximately $5.4 million, or $0.06 per share, for the
fiscal 2015 second quarter.
Total revenue was approximately $1.4 million for the first six
months of fiscal 2016, compared with $1.7 million for the same
period of fiscal 2015. Total operating costs and expenses for the
six months ended December 31, 2015, were approximately $10.0
million, compared with approximately $12.0 million for the six
months ended December 31, 2014. Net loss for the six months ended
December 31, 2015, was approximately $8.7 million, or $0.10 per
share, compared with a net loss of $10.5 million, or $0.12 per
share for the same period of fiscal 2015.
Cash, cash equivalents and investments as of December 31, 2015
were approximately $18.5 million, which does not include the $2
million from the signing of the license agreement with Intuitive
Surgical. This compares with approximately $21.9 million at
September 30, 2015. As of December 31, 2015, there were
approximately 89 million shares of common stock outstanding and
191,474 shares of Series A convertible preferred stock outstanding.
This is a change from 89.1 million shares.
Conference Call DetailsTo access the live
conference call today at 4:30 p.m. Eastern Time via phone, please
dial 800-901-5241 from the United States and Canada or 617-786-2963
internationally. The conference ID is 61547195. 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 February 11, 2016, and may be accessed
by dialing 888-286-8010 from the United States and Canada or
617-801-6888 internationally. The replay passcode is 80216818.
To access the live and subsequently archived webcast of the
conference call, go to the Investor Relations section of the
company’s website at www.cardica.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 CardicaCardica designs and
manufactures proprietary stapling and anastomotic devices for
cardiac and minimally invasive surgical procedures. Cardica's
technology portfolio is intended to reduce operating time and
facilitate minimally invasive and robot-assisted surgeries.
Cardica’s MicroCutter XCHANGE® 30, that includes a cartridge-based
articulating surgical stapling device with a five-millimeter shaft
diameter and staples, is manufactured and cleared for use in the
United States 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. The MicroCutter XCHANGE 30 white
cartridge staple has application in vascular tissue. In
addition, Cardica manufactures and markets its automated
anastomosis systems, the C-Port® Distal Anastomosis Systems and
PAS-Port® Proximal Anastomosis System for coronary artery bypass
graft (CABG) surgery, and has shipped over 57,500 units throughout
the world.
Forward-Looking StatementsThe statements in
this press release regarding Cardica’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 Cardica’s results to differ materially from those indicated
by these forward-looking statements, including: that Cardica 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
Cardica’s reports filed with the U.S. Securities and Exchange
Commission, including its Quarterly Report on Form 10-Q for the
quarter ended September 30, 2015, under the caption “Risk
Factors,” filed on November 12, 2015. Cardica 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 Cardica’s reports filed with the U.S.
Securities and Exchange Commission, available at
www.sec.gov.
| Cardica,
Inc. |
| Consolidated Statements
of Operations |
| (amounts in thousands
except per share amounts) |
| |
|
| |
Three months ended |
|
Six months ended |
| |
December 31, |
|
December 31, |
| |
2015 |
|
2014 |
|
2015 |
|
2014 |
| |
(unaudited) |
|
(unaudited) |
| Revenue |
|
|
|
|
|
|
|
| Product sales, net |
$ |
683 |
|
|
$ |
639 |
|
|
$ |
1,420 |
|
|
$ |
1,690 |
|
| Royalty revenue |
|
17 |
|
|
|
18 |
|
|
|
35 |
|
|
|
35 |
|
| Total |
|
700 |
|
|
|
657 |
|
|
|
1,455 |
|
|
|
1,725 |
|
| |
|
|
|
|
|
|
|
| Operating costs and
expenses |
|
|
|
|
|
|
|
| Cost of product sales |
|
889 |
|
|
|
944 |
|
|
|
1,912 |
|
|
|
2,577 |
|
| Research and development |
|
1,630 |
|
|
|
1,848 |
|
|
|
3,246 |
|
|
|
3,584 |
|
| Selling, general and
administrative |
|
2,161 |
|
|
|
3,205 |
|
|
|
4,818 |
|
|
|
5,863 |
|
| Total operating costs and
expenses |
|
4,680 |
|
|
|
5,997 |
|
|
|
9,976 |
|
|
|
12,024 |
|
| |
|
|
|
|
|
|
|
| Loss from
operations |
|
(3,980 |
) |
|
|
(5,340 |
) |
|
|
(8,521 |
) |
|
|
(10,299 |
) |
| Interest and other
income |
|
16 |
|
|
|
10 |
|
|
|
35 |
|
|
|
14 |
|
| Interest expense |
|
(123 |
) |
|
|
(112 |
) |
|
|
(243 |
) |
|
|
(222 |
) |
| Net loss |
$ |
(4,087 |
) |
|
$ |
(5,442 |
) |
|
$ |
(8,729 |
) |
|
$ |
(10,507 |
) |
| |
|
|
|
|
|
- |
|
|
|
- |
|
| Basic
and diluted net loss per share |
$ |
(0.05 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.12 |
) |
| |
|
|
|
|
|
|
|
| Shares
used in computing basic and diluted net loss per share |
|
89,018 |
|
|
|
88,955 |
|
|
|
88,991 |
|
|
|
88,950 |
|
| |
|
|
|
|
|
|
|
| |
|
|
|
|
|
| Consolidated Balance
Sheets |
|
|
| (amounts in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
December 31, |
|
June 30, |
|
|
| |
2015 |
|
2015 |
|
|
| Assets |
(unaudited) |
|
|
| Cash, cash equivalents and
investments |
$ |
18,480 |
|
|
$ |
25,206 |
|
|
|
| Accounts receivable |
|
533 |
|
|
|
424 |
|
|
|
| Inventories |
|
1,018 |
|
|
|
1,391 |
|
|
|
| Other assets |
|
1,777 |
|
|
|
2,273 |
|
|
|
| Total assets |
$ |
21,808 |
|
|
$ |
29,294 |
|
|
|
| |
|
|
|
|
|
| |
|
|
|
|
|
| Liabilities and
stockholders' equity |
|
|
|
|
|
| Accounts payable and other
liabilities |
$ |
2,555 |
|
|
$ |
1,849 |
|
|
|
| Deferred revenue |
|
2,528 |
|
|
|
2,528 |
|
|
|
| Long term debt |
|
2,971 |
|
|
|
2,828 |
|
|
|
| Total stockholders' equity |
|
13,754 |
|
|
|
22,089 |
|
|
|
| Total liabilities and stockholders'
equity |
$ |
21,808 |
|
|
$ |
29,294 |
|
|
|
| |
|
|
|
|
|
Contact:
Bob Newell
Vice President, Finance and Chief Financial Officer
(650) 331-7133
investors@cardica.com