CORRECTION - Amedica Releases 2016 Preliminary Unaudited
Earnings Report and Business Update
SALT LAKE CITY, UT-(Marketwired - Jun 9, 2017) - In the news
release, "Amedica Releases 2016 Preliminary Earnings Report and
Business Update," issued earlier today by Amedica Corporation
(NASDAQ: AMDA), we are advised by the company that the this press
release has been amended to reflect an increase in preliminary
revenue, an increase in fourth quarter 2015 net loss per share, an
adjustment to the decrease in cash and equivalents, and, to reflect
that certain financial data in the Business Update and Related
Developments section are unaudited. There have been numerous
material changes to this release. Complete corrected text
follows.
SALT LAKE CITY, UT - June 8, 2017 - Amedica Corporation (NASDAQ:
AMDA), a company that develops and commercializes silicon nitride
for biomedical applications, today announced its preliminary
unaudited earnings report for the fourth quarter and fiscal year
ended December 31, 2016 and provided a business update related to
its business strategy and certain recent developments.
2016 PRELIMINARY EARNINGS REPORT - UNAUDITED
Amedica reported preliminary revenue of $3.7 million for the
fourth quarter of 2016 and $15.2 million for the full year.
Preliminary GAAP net loss for the fourth quarter of 2016 was $0.16
per share, compared to net loss of $0.57 per share in the fourth
quarter of 2015. For the full year, the company reported
preliminary GAAP net loss of $1.19 per share, compared to a net
loss of $5.50 per share in 2015. The company's cash and cash
equivalents were $6.9 million at December 31, 2016, a decrease of
$4.6 million from December 31, 2015.
Amedica continues to consider any potential impairment in
relation to certain of its long-lived assets. Once this exercise is
completed, the Company will promptly complete its Annual Report on
Form 10-K for the fiscal year ended December 31, 2016 and file it
with the SEC. Upon filing of the annual report the Company also
expects to promptly file its quarterly report on Form 10-Q for the
first quarter ended March 31, 2017.
BUSINESS UPDATE AND RELATED DEVELOPMENTS
Unaudited Financial Update
The company has reduced its total debt to approximately $4
million, down from $24.3 million in July 2015 and from $36 million
in late 2014. All debt will retire by January 2018, or sooner.
Absent new financing, Amedica expects to be compliant with its debt
covenants under the Hercules loan through July 2017. The company's
monthly cash burn rate has decreased from $2.8 million in 2014 to
$1.3 million per month. Exclusive of principal and interest
payments on the debt, the monthly operating cash burn rate is
approximately $500,000. Staff count is now 35, compared to 56 last
year, and greater than 100 in late 2014, as the company continues
to focus on cost controls in-line with its October 2016
reorganization.
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 completed over 60 surgeries, generating a total of
$450,000 in new revenue (unaudited) with 10 new surgeons trialing
the system for the first time. The company expects the Beta launch
in mid-summer as additional instrument sets become available for
new surgeon users.
Amedica continues to promote its Valeo ® line of silicon nitride
spine implants with the addition of new surgeon users and
distributors. With solid material science data supporting its
silicon nitride, the company is now focused on clinical studies.
The company has been successful in entering purchasing agreements
for its products with multiple national and regional hospital
groups. These purchasing agreements should lead to increased usage
of the company's products at those hospitals, resulting in
increased revenue.
Other commercialization highlights include:
- 12% increase in surgeons users since the end of 2016.
- 10% increase in sales agents representing our products versus
end of 2016, with a focus on improved management leading to
increased productivity.
- Multi-center clinical study initiated with long-term surgeon
users of silicon nitride to examine results in a retrospective
cohort of more than 1,000 patients.
- Two new spine industry executives hired for Area Vice President
and Vice President of Market Development positions; both with 20+
years of experience in the U.S. spine market.
Research and Development
Recent Research and Development Highlights:
- Since the beginning of 2017, Amedica's R&D group has
published 10 peer-reviewed journal articles and 7 scientific
proceedings on various aspects of silicon nitride. 7 additional
manuscripts are in preparation or are at various stages of
submission and peer review.
- 4 additional patents awarded related to silicon nitride and
other ceramic materials processes since 2015.
- Already this year there have been 13 presentations made at
scientific conferences including the American Academy of
Orthopaedic Surgeons (AAOS), the Orthopedic Research Society (ORS),
the Society for Biomaterials (SFB), and the Association of Bone and
Joint Surgeons (ABJS), among others.
- A recently-completed University of Rochester study re-confirmed
that silicon nitride is resistant to bacteria, and has osteogenic
properties.
- As previously announced, Amedica completed five million cycle
(Mc) wear testing of silicon nitride femoral heads in comparison to
the industry-standard zirconia-toughened alumina (ZTA). Silicon
nitride produced less wear, and less oxidative damage to the
polyethylene than ZTA. Testing is continuing through 12 million
cycles. Additional testing of the corrosion resistance of silicon
nitride femoral heads is in progress toward a regulatory
filing.
- The company is testing the friction and wear behavior of
polished silicon nitride against native cartilage. If successful,
this project will open hemi-arthroplasty applications in several
anatomic joint reconstructions, where native cartilage is partially
preserved.
- In large-animal testing, 12-week data have shown greater bone
formation within porous silicon nitride than porous titanium. A
separate large-animal spine fusion model with Amedica's silicon
nitride spacers showed greater bone formation than PEEK at the
six-month study end-point.
- The company entered a multi-year agreement with Texas A&M
University's School of Dentistry to evaluate silicon nitride in
maxillofacial surgery, where osteogenic and antimicrobial
properties are highly desirable. This partnership is expected to
yield funding from the U.S. National Institute of Health (NIH) and
the Small Business Innovative Research (SBIR) programs to continue
support for Amedica's R&D efforts.
Clinical and Regulatory
Results from Amedica's CASCADE clinical trial showing effective
spine fusion with porous silicon nitride without added bone graft
are now published in the European Spine Journal. A similar trial
(SNAP) compared silicon nitride to PEEK in lumbar fusion;
preliminary data from the SNAP trial are consistent with previous
observations that silicon nitride shows enhanced and earlier spine
fusion than PEEK.
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 is
using FDA feedback to prepare a 510k submission to be filed in
October 2017.
In 2017, Amedica's Quality and Regulatory systems were audited
exhaustively by the U.S. FDA and ANVISA - Brazil's equivalent to
the FDA - and the company is fully compliant with these regulatory
bodies.
Strategic Direction
"Going forward, we are focused on growing spine sales, first and
foremost, while pursuing a robust R&D program with academic and
industry leaders, to assure leadership in medical ceramic
technology," said Dr. Bal, Chairman and CEO of Amedica. In addition
to adding new U.S. surgeons, Amedica is aggressively targeting
revenue opportunities in Brazil, Europe, and Australia, all markets
where its silicon nitride implants are approved for sale. With
recent submission of favorable clinical data to the Japan PMDA, the
company expects approval in that market as well.
In addition to the ceramic femoral head development for the hip
replacement market, Amedica has fabricated and tested a silicon
nitride dental implant with FDA pre-submission, and expects FDA
feedback in June 2017. A metal-ceramic brazing project with a
global ceramics manufacturer is underway, targeting the total knee
market, and composite devices in the spine market.
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 March 23, 2016, and in Amedica's other filings
with the SEC. Amedica disclaims any obligation to update any
forward-looking statements.
Contact Information
Contacts: Amedica IR 801-839-3502 IR@amedica.com
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