Amedica Releases First and Second Quarter 2017 Preliminary
Unaudited Earnings Report and Business Update
SALT LAKE CITY, UT-(Marketwired - Sep 22, 2017) - Amedica
Corporation (NASDAQ: AMDA), a company that develops and
commercializes silicon nitride for biomedical applications, today
announced its preliminary earnings report for the first and second
quarters ended March 31, 2017 and June 30, 2017, respectively, and
provided a business update related to its business strategy and
certain recent developments.
2017 Q1 PRELIMINARY EARNINGS REPORT - UNAUDITED
Amedica reported preliminary unaudited revenue of $2.6 million
for the first quarter of 2017 as compared to revenue of $4.2
million for the first quarter of 2016. Preliminary unaudited GAAP
net loss for the first quarter of 2017 was $0.07 per share,
compared to net loss of $0.30 per share in the first quarter of
2016. The company's cash and cash equivalents were $6.9 million at
March 31, 2017, a decrease of $1.0 million from March 31, 2016.
2017 Q2 PRELIMINARY EARNINGS REPORT - UNAUDITED
Amedica reported preliminary unaudited revenue of $3.2 million
for the second quarter of 2017 and $5.8 million for the six month
period ending June 30, 2017, as compared to revenue of $4.0 million
for the second quarter of 2016 and $8.2 million for the six month
period ending June 30, 2016. Preliminary unaudited GAAP net loss
for the second quarter of 2017 was $0.05 per share, compared to net
loss of $0.40 per share in the second quarter of 2016. For the six
month period ended June 30, 2017, the company reported preliminary
unaudited GAAP net loss of $0.12 per share, compared to a net loss
of $0.71 per share in for the six month period ending June 30,
2016. The company's cash and cash equivalents were $3.5 million at
June 30, 2017, a decrease of $1.7 million from June 30, 2016.
BUSINESS UPDATE AND RELATED DEVELOPMENTS
Unaudited Financial Update
As of September 1, 2017, the company has approximately $2.4
million of term debt payable to Hercules, down from $24.3 million
of total debt owing in July 2015. The Hercules debt, being
currently amortized, will retire by January 2018, or sooner. The
company also has $2.7 million of debt payable to North Stadium
Investments, without prepayment penalties, back-end fees, debt
covenants, or other restrictions. The North Stadium Investments
debt is currently being amortized and will retire by July 28, 2018,
or sooner.
Commercialization Report
The Alpha launch of Amedica's Taurus™ Pedicle Screw System, a
spine fixation product line that received FDA clearance in November
2016, has now shifted to the Beta launch phase with the release of
additional sets to the field. Over 125 new surgeries have been
performed with the system generating over $750,000 in new revenue
year-to-date. The company plans to release additional sets in the
fourth quarter of 2017 to provide increased access to the system to
meet new surgeon demand.
In August 2017, the company continued a trend of month-on-month
increasing sales of the Taurus system and had its highest monthly
revenue year to date. The August sales were led by high demand for
the Taurus and Preference pedicle screw systems. Other
commercialization highlights include:
- 38% increase in surgeons users since the end of 2016.
- 14% increase in sales agents representing our products versus
end of 2016, with many of these agents in parts of the United
States that presently had no representation of the company's
products.
- A new Area Vice President for the Southeast region has been
hired. His 20+ years of spine sales experience is consistent with
the experience of other AVP and VP leadership team members.
Research and Development
Recent Research and Development Highlights:
- During 2017, Amedica's R&D group has published 15
peer-reviewed journal articles and 7 scientific proceedings on
various aspects of silicon nitride. 5 additional manuscripts are in
preparation or are at various stages of submission and peer
review.
- There have been a total of 19 presentations made at scientific
conferences to date. More recently, a presentation entitled,
"Osteoinductive Properties of Silicon Nitride, Alumina, and
Titanium," given at the ORS Midwest Musculoskeletal Workshop at
Washington University Medical School in July won the "Best Poster"
Award.
- The company has completed an initial friction and wear test of
polished silicon nitride against native cartilage. Preliminary data
show that silicon nitride is at least non-inferior in its friction
and wear performance as compared to typical cobalt chrome alloys
that are currently used in this application.
- Initial characterization and cell adhesion studies on silicon
nitride, PEEK, and titanium performed under the company's
multi-year agreement with Texas A&M University's School of
Dentistry are consistent with prior independent studies showing
favorable ionic, hydrophilic, and surface texture properties of
silicon nitride.
- Scientific data from the University of Rochester show
resistance of silicon nitride to infection with
Methicillin-Resistant Staphylococcal Aureus (MRSA), a major
pathogen of concern in health care systems. These data, accepted
for publication, are consistent with a number of internal and
independent studies that have shown similar antimicrobial
properties of silicon nitride against a variety of bacterial
species, including those implicated in dental infections.
Clinical and Regulatory
As previously announced, in December 2016, Amedica re-filed an
application with the FDA with a modified porous (cancellous
structured ceramic) cervical implant. After a 510(k) pre-submission
meeting, the company remains on track to file a 510k submission
with a modified porous (cancellous structured ceramic) cervical
implant in October 2017 based on FDA feedback.
In July 2017, Amedica's Quality Management System was audited by
its notified body (BSI) and was certified to the ISO 13485:2016
standard.
Participation at Ladenburg Thalmann 2017 Healthcare Conference
The Company also announced that Dr. Bal will make a presentation at
the Ladenburg Thalmann 2017 Healthcare Conference on Tuesday,
September 26, 2017, at 10:30 a.m. Eastern time in New York, NY.
A webcast of the presentation will be available during the
presentation in the Investors section of the company's website at
http://wsw.com/webcast/ladenburg3/amda/, and will be archived and
available at that site for 14 days.
Nasdaq Listing Status The company has received notice from The
NASDAQ Stock Market LLC ("NASDAQ") indicating that a NASDAQ
Hearings Panel (the "Panel") had granted the company's request to
extend the stay of the suspension of trading in the company's
common stock pending the company's scheduled hearing on October 12,
2017 before the Panel and a final determination regarding the
company's listing status.
At the October 12, 2017 hearing, the company will present its
plan to evidence compliance with NASDAQ's listing requirements. The
company is diligently working to evidence compliance with NASDAQ's
listing requirements as soon as possible; however, there can be no
assurance that the Panel will grant the company's request for
continued listing and a further stay of suspension. The delisting
of the company's common stock from the NASDAQ Capital Market could
have a material adverse effect on the company's business and on the
trading of its common stock.
Strategic Direction
"Our focus at Amedica is three-fold. First, we are focused on
product sales, i.e., increasing revenue so that the company is
self-sustaining. Second, we will continue engagement with a number
of major, external partners, developing biomedical applications of
silicon nitride outside spinal implants. Third, we will continue to
strengthen our leadership position in the science and data related
to silicon nitride and its biomedical applications," said B. Sonny
Bal, MD, MBA, JD, PhD; Chairman and CEO of Amedica.
Amedica continues to add new U.S surgeons to their customer base
while remaining engaged with revenue opportunities in Brazil,
Europe, and Australia, all markets where its silicon nitride
implants are approved for commercialization.
About Amedica Corporation
Amedica is focused on the development and application of spinal
interbody implants made with medical-grade silicon nitride ceramic.
Amedica markets spinal fusion products and is developing implants
for other biomedical applications, such as wear- and
corrosion-resistant hip and knee bearings, and dental implants. The
Company's products are manufactured in its ISO 13485 certified
manufacturing facility, and it has a partnership with Kyocera, one
of the world's largest ceramic manufacturers. Amedica's FDA-cleared
and CE-marked spine products are currently marketed in the U.S. and
select markets in Europe and South America through its distributor
network, and OEM and private label partnerships.
For more information on Amedica or its silicon nitride material
platform, please visit www.amedica.com.
Forward-Looking Statements
This press release contains statements that constitute
forward-looking statements within the meaning of the Securities Act
of 1933 and the Securities Exchange Act of 1934, as amended by the
Private Securities Litigation Reform Act of 1995. Such statements,
which include statements regarding preliminary unaudited financial
results, anticipated future revenues, FDA clearance of our
products, addition of new surgeon users, and, results of clinical
studies are subject to risks and uncertainties that could cause
actual results to differ materially from those contemplated within
this press release. A discussion of those risks and uncertainties
can be found in Amedica's Risk Factors disclosure in its Annual
Report on Form 10-K, filed with the Securities and Exchange
Commission (SEC) on September 20, 2017, and in Amedica's other
filings with the SEC. Amedica disclaims any obligation to update
any forward-looking statements.
Contacts: Amedica IR 801-839-3502 IR@amedica.com
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