Cardica, Inc. (Nasdaq:CRDC) today announced financial results for
its fiscal third quarter ended March 31, 2016. 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.
“Over the last several months, working with key opinion leaders,
we gained approval from the value analysis committees at several
top-tier U.S. hospitals to sell the MicroCutter® XCHANGE 30 into
these institutions,” said Julian Nikolchev, president and CEO of
Cardica. “As we move toward our planned launch of the MicroCutter
XCHANGE 30 Generation 4 device later this calendar year, we are
working in parallel to complete testing and move into humans while
readying our manufacturing capabilities by working to secure a
stable and scalable supply chain.”
Recent Highlights and Accomplishments
- Robert J. Cerfolio, M.D. at the University of Alabama at
Birmingham's Comprehensive Cancer Center completed the first U.S.
cases using the company’s MicroCutter XCHANGE 30 surgical stapler
successfully during a number of recent robotically-assisted cancer
surgeries to remove portions of the lung, including both lobectomy
and segmentectomy procedures; and
- Received a medical device license issued by Health Canada to
market the MicroCutter XCHANGE 30 stapling device for surgical
procedures in the small and large intestine and in the
appendix.
Fiscal 2016 Third Quarter and First Nine Months Ended
March 31, 2016, Financial ResultsTotal product sales were
$0.5 million for both the fiscal 2016 and fiscal 2015 third
quarters. Total license and royalty revenue for the fiscal 2016
third quarter was $1.4 million, compared with approximately $0.02
million for the fiscal 2015 third quarter. Cardica amended its
license agreement with Intuitive Surgical, resulting in the receipt
of $2.0 million to extend Intuitive’s 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. Cardica recognized $1.4 million in
license revenue in the fiscal 2016 third quarter from its agreement
extension with Intuitive Surgical, with the remaining portion of
the $2.0 million to be recognized in subsequent quarters. Total
revenue was approximately $1.9 million for the fiscal 2016 third
quarter, compared with $0.6 million for the same period of fiscal
2015.
Total operating costs and expenses for the fiscal 2016 third
quarter were $4.8 million, compared with $5.3 million for the same
period of fiscal 2015. Cost of product sales was approximately $0.9
million for the fiscal 2016 third quarter, compared with $0.8
million for the fiscal 2015 third quarter. Research and development
expenses were approximately $1.6 million for the fiscal 2016 third
quarter, compared with $1.9 million for the fiscal 2015 third
quarter. Selling, general and administrative expenses were $2.3
million for the fiscal 2016 third quarter, compared with $2.5
million for the fiscal 2015 third quarter.
The net loss for the fiscal 2016 third quarter was approximately
$3.0 million, or $0.34 per share, compared with a net loss of
approximately $4.8 million, or $0.54 per share, for the fiscal 2015
third quarter. On February 17, 2016, Cardica announced a
one-for-ten reverse stock split of its common stock, resulting in
the number of common shares outstanding decreasing from 89.0
million to 8.9 million shares.
Total revenue was approximately $3.3 million for the first nine
months of fiscal 2016, compared with $2.3 million for the same
period of fiscal 2015. Total operating costs and expenses for the
nine months ended March 31, 2016, were approximately $14.8 million,
compared with approximately $17.3 million for the nine months ended
March 31, 2015. Net loss for the nine months ended March 31, 2016,
was approximately $11.8 million, or $1.32 per share, compared with
a net loss of $15.3 million, or $1.72 per share for the same period
of fiscal 2015.
Cash, cash equivalents and investments as of March 31, 2016,
were approximately $16.5 million, compared with approximately $18.5
million at December 31, 2015. As of March 31, 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 calendar 2016 continue to be
as follows:
- Increase clinical adoption of the MicroCutter XCHANGE 30 in
Germany and the UK
- For both the EU and the US, demonstrate clinical adoption for
Video-Assisted Thoracic Surgery (VATS) by a select group of centers
by the third quarter of calendar 2016
- Complete the Intuitive Surgical evaluation phase by the end of
June 2016
- Complete the first evaluation cases with the Generation 4
device in the third quarter of calendar 2016, with a selective
launch targeted for the fourth quarter of calendar 2016
- By the end of the year, establish an improved supply chain
using the most appropriate technologies
- Finally, by the end of the year announce Cardica’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 97363213. 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 May 12, 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 97363213.
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 58,250 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 December 31, 2015, under the caption “Risk
Factors,” filed on February 10, 2016. 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 |
|
Nine months ended |
|
|
March 31, |
|
March 31, |
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
(unaudited) |
Revenue |
|
|
|
|
|
|
|
|
Product sales, net |
$ |
458 |
|
|
$ |
548 |
|
|
$ |
1,878 |
|
|
$ |
2,238 |
|
License and Royalty
revenue |
|
1,428 |
|
|
|
16 |
|
|
|
1,463 |
|
|
|
51 |
|
|
Total |
|
1,886 |
|
|
|
564 |
|
|
|
3,341 |
|
|
|
2,289 |
|
|
|
|
|
|
|
|
|
|
Operating
costs and expenses |
|
|
|
|
|
|
|
Cost of product
sales |
|
911 |
|
|
|
807 |
|
|
|
2,823 |
|
|
|
3,384 |
|
Research and
development |
|
1,567 |
|
|
|
1,940 |
|
|
|
4,813 |
|
|
|
5,524 |
|
Selling, general and
administrative |
|
2,324 |
|
|
|
2,541 |
|
|
|
7,142 |
|
|
|
8,404 |
|
|
Total operating costs
and expenses |
|
4,802 |
|
|
|
5,288 |
|
|
|
14,778 |
|
|
|
17,312 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(2,916 |
) |
|
|
(4,724 |
) |
|
|
(11,437 |
) |
|
|
(15,023 |
) |
Interest
and other income |
|
14 |
|
|
|
12 |
|
|
|
49 |
|
|
|
26 |
|
Interest
expense |
|
(125 |
) |
|
|
(112 |
) |
|
|
(368 |
) |
|
|
(334 |
) |
Net loss |
|
$ |
(3,027 |
) |
|
$ |
(4,824 |
) |
|
$ |
(11,756 |
) |
|
$ |
(15,331 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$ |
(0.34 |
) |
|
$ |
(0.54 |
) |
|
$ |
(1.32 |
) |
|
$ |
(1.72 |
) |
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per
share |
|
8,916 |
|
|
|
8,896 |
|
|
|
8,905 |
|
|
|
8,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheets |
|
(amounts in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
June 30, |
|
|
|
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
Assets |
|
(unaudited) |
|
|
Cash, cash equivalents
and investments |
$ |
16,549 |
|
|
$ |
25,206 |
|
|
|
Accounts
receivable |
|
422 |
|
|
|
424 |
|
|
|
Inventories |
|
1,150 |
|
|
|
1,391 |
|
|
|
Other assets |
|
1,765 |
|
|
|
2,273 |
|
|
|
|
Total assets |
$ |
19,886 |
|
|
$ |
29,294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and stockholders' equity |
|
|
|
|
|
Accounts payable and
other liabilities |
$ |
2,567 |
|
|
$ |
1,849 |
|
|
|
Deferred revenue |
|
3,115 |
|
|
|
2,528 |
|
|
|
Long term debt |
|
3,046 |
|
|
|
2,828 |
|
|
|
Total stockholders'
equity |
|
11,158 |
|
|
|
22,089 |
|
|
|
|
Total liabilities and
stockholders' equity |
$ |
19,886 |
|
|
$ |
29,294 |
|
|
|
|
|
|
|
|
|
|
Contact:
Bob Newell
Vice President, Finance and Chief Financial Officer
(650) 331-7133
investors@cardica.com