-- Shipping Resumes for MicroCutter 5/80™
Stapler and Reloads --
Dextera Surgical Inc. (Nasdaq: DXTR), a company developing and
commercializing the MicroCutter 5/80™ Stapler, today announced
financial results for its fiscal fourth quarter and full year ended
June 30, 2017. Management will hold a conference call at 4:30 p.m.
Eastern Time to discuss financial results and provide an update on
the company’s business.
“We have identified and addressed the cause for the premature
lock out of the MicroCutter 5/80 surgical stapler announced on July
6th, and after extensive in-house testing of the modification, we
resumed shipping to our customers,” said Julian Nikolchev,
president and CEO of Dextera Surgical Inc. “Simultaneously, after
appropriate testing, we have implemented production changes for the
reloads, allowing us to resume shipping, with expectations of
fulfilling all backorders before the end of the quarter. We are
excited to have the MicroCutter 5/80 back in the hands of surgeons
to help enable less invasive surgical procedures.”
Recent Highlights and Accomplishments:
- Implemented a solution for the
premature lockout of the MicroCutter 5/80 Stapler and resumed
shipping the stapler.
- Implemented product changes for the
reloads and shipped reloads to customers, eliminating a significant
portion of the backorder.
- Completed an underwritten public equity
offering of 8,000 shares of the company’s Series B convertible
preferred stock and related warrants resulting in net proceeds to
Dextera Surgical of $6.7 million.
- The MicroCutter 5/80 was highlighted
for its ability to help enable less invasive video-assisted
thoracic surgery (VATS) in three sessions during the 25th European
Conference on General Thoracic Surgery (ESTS).
- Filed a 510(k) with the U.S. Food and
Drug Administration to expand the indications for use of the
MicroCutter 5/80 to include liver, pancreas, kidney and spleen
surgery.
- The roles of the MicroCutter 5/80 and
Dextera’s C-Port® Distal and PAS-Port® Proximal Anastomosis Systems
were highlighted in a variety of less invasive surgical procedures
at the 14th Annual International Society for Minimally Invasive
Cardiothoracic Surgery (ISMICS) meeting in Rome, Italy.
Fiscal 2017 Fourth Quarter Financial Results
Total product sales were approximately $1.0 million for the
fiscal 2017 fourth quarter compared with $0.7 million for the same
quarter of fiscal 2016. MicroCutter sales were approximately
$359,000 in the fiscal 2017 fourth quarter with $75,000 in
backorders compared to $516,000 of sales in the third quarter of
fiscal 2017. The sequential decrease in MicroCutter product sales
is due to a backorder for the blue reload cartridges for a portion
of the fourth quarter and a shipping hold at the end of the fourth
quarter of fiscal 2017. Total revenue was approximately $1.1
million for the fiscal 2017 fourth quarter compared with
approximately $0.7 million for the fiscal 2016 fourth quarter.
Total operating costs and expenses for the fiscal 2017 fourth
quarter were $4.0 million, compared with $4.8 million for the same
period of fiscal 2016. Cost of product sales was approximately $1.0
million for the fourth quarter of fiscal 2017 compared with $1.1
million for the same period of 2016. Research and development
expenses were $1.4 million for the fiscal 2017 fourth quarter,
compared with $1.5 million for the fiscal 2016 fourth quarter.
Selling, general and administrative expenses were $1.5 million for
the fiscal 2017 fourth quarter compared with $2.2 million for the
comparable period of fiscal 2016. Total Operating cost and expenses
in the fourth quarter included a reversal of accrued incentive
compensation expense of approximately $0.5 million.
The net loss for the fiscal 2017 fourth quarter before the
deemed preferred stock dividend was approximately $3.1 million.
Additionally, net loss applicable to common stockholders included a
deemed (non-cash) preferred stock dividend of $4.0 million,
representing the value of beneficial conversion rights embedded in
the preferred shares issued in the company’s recently completed
convertible preferred stock public offering. This amount was
determined as the difference between fair value of common stock
into which preferred shares are convertible and the proceeds of the
financing allocated to the preferred shares. The total net loss
attributable to common stockholders for the fiscal 2017 fourth
quarter was $7.0 million, or $0.40 per share. Net loss attributable
to common stockholders for the fiscal 2016 fourth quarter was
approximately $4.2 million, or $0.47 per share.
Cash, cash equivalents and investments, as of June 30, 2017,
were approximately $6.0 million, compared with approximately $2.5
million at March 31, 2017. This includes $6.7 million in net
proceeds raised through a public equity offering in May 2017. As of
June 30, 2017, there were approximately 40.3 million shares of
common stock outstanding, which includes the conversion of all
previously outstanding Series A convertible preferred stock and all
but 273 shares of the Series B convertible preferred stock.
Milestones
Management’s key objectives in the near term are as follows:
- Execute a strategic partnership with B.
Braun by the end of the third quarter of calendar year 2017;
- Continue optimizing supply chain and
establish production capacity of 120 MicroCutters per week by the
end of the calendar year 2017;
- Complete enrollment of patients in the
MATCH Registry Trial by the end of the third quarter of calendar
2017;
- Expand MicroCutter 5/80 indication for
use in the U.S. to include liver, pancreas, kidney and spleen
surgery by the end of calendar year 2017;
- Demonstrate success in Spain with the
B. Braun collaboration throughout calendar year 2017;
- Continue advancement of co-development
project with Intuitive Surgical to develop new robotic stapler
based on MicroCutter technology; and
- Evaluate and execute initiatives to
reduce cost structure and improve long-term gross margins.
Conference Call Details
To access the live conference call on August 8, 2017, at 4:30
p.m. Eastern Time via phone, please dial 844-419-1785 from the
United States and Canada or 216-562-0472. The conference ID is
61373128. 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 15, 2017,
and may be accessed by dialing 855-859-2056 from the United States
and Canada or 404-537-3406 internationally. The replay passcode is
61373128.
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.
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 Statements
The statements in this press release regarding Dextera
Surgical’s expectations that it will fulfill all backorders before
the end of August, and its management objectives under the caption
“Milestones,” 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 the 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, 2017, 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, 2017 2016 2017
2016 (unaudited) (unaudited) Revenue Product
sales, net $ 952 $ 651 $ 3,051 $ 2,529 License and development
revenue 82 48 302 1,460 Royalty revenue 16 15
70 66 Total 1,050 714 3,423
4,055 Operating costs and expenses Cost of product sales
1,034 1,074 3,798 3,897 Research and development 1,386 1,514 6,565
6,327 Selling, general and administrative 1,547
2,246 7,657 9,388 Total
operating costs and expenses 3,967 4,834
18,020 19,612 Loss from
operations (2,917 ) (4,120 ) (14,597 ) (15,557 ) Interest and other
income 3 18 15 67 Interest expense (142 ) (129 )
(549 ) (497 ) Net loss before income tax benefit
(3,056 ) (4,231 ) (15,131 ) (15,987 ) Income tax benefit -
- - - Net loss $
(3,056 ) $ (4,231 ) $ (15,131 ) $ (15,987 ) Preferred stock deemed
dividend (3,980 ) - (3,980 ) -
Net loss attributable to common stockholders $ (7,036 ) $
(4,231 ) $ (19,111 ) $ (15,987 ) Basic and diluted
net loss per share attributable to common stockholders $ (0.40 ) $
(0.47 ) $ (1.71 ) $ (1.79 ) Shares used in computing basic
and diluted net loss per share attributable to common stockholders
17,794 8,928 11,144
8,910 Consolidated Balance Sheets
(amounts in thousands) June 30, June 30, 2017
2016 Assets (unaudited) Cash, cash equivalents and
investments $ 6,010 $ 12,716 Accounts receivable 608 313
Inventories 1,311 1,063 Other assets 942 1,600
Total assets $ 8,871 $ 15,692
Liabilities and stockholders' equity Accounts payable and other
liabilities $ 2,294 $ 2,218 Deferred revenue 2,902 3,068 Long term
debt 3,473 3,124 Total stockholders' equity 202
7,282 Total liabilities and stockholders' equity
(deficit) $ 8,871 $ 15,692
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Dextera SurgicalBob Newell, 650-331-7133Vice President, Finance
and Chief Financial Officerinvestors@dexterasurgical.com