Amedica Corporation Reports Second Quarter 2016 Financial
Results
Year-to-Date Operational Cash Burn Improved by 55%
Year-Over-Year
SALT LAKE CITY, UT-(Marketwired - Aug 11, 2016) - Amedica
Corporation (NASDAQ: AMDA), a company that develops and
commercializes silicon nitride ceramics as a biomaterial platform,
today announced financial results for the second quarter ended June
30, 2016.
Recent Company Highlights
- Decreased year-to-date operational cash burn by 55%
- Completed $12.7 million public offering and reduced total debt
principal balance to $10 million
- Submitted response to FDA in support of its application seeking
clearance to commercialize its composite cervical interbody fusion
device
- Featured unique silicon nitride attributes in several leading
industry events and publications
- Signed an additional joint development agreement with an
implant designer and distributor of dental technologies
"Despite the decrease in commercial sales this quarter, we are
confident with our commercial sales strategy targeted at adding new
surgeons and distributors and expanding our sales into new
territories," said Dr. Sonny Bal, Chairman and Chief Executive
Officer. "We expect that the solid foundation of scientific and
clinical data that we have now built will also help expand spine
sales and further strengthen our balance sheet."
"In the product pipeline, we have added a new OEM partner with
whom we're exploring the application of our silicon nitride ceramic
for use in dental implants; this announcement comes after recent
evidence that silicon nitride is effective against bacteria that
cause gingivitis. We believe that our silicon nitride ceramic is
the best-characterized biomaterial available and offers a
compelling set of advantages for a variety of medical applications.
Even as we explore mid-term opportunities with external partners,
we will remain focused on driving our commercial sales," added Dr.
Bal.
Second Quarter 2016 Financial Results
Total product revenue was $4.0 million in the second quarter of
2016 as compared to $4.8 million in the same period of 2015, a
decrease of $0.8 million, or 16%. This decrease was due to lower
private label sales during the quarter and weaker than expected
commercial sales in a key geographic region during the
implementation of the Company's commercial sales expansion
strategy. We expect that our commercial sales expansion strategy
will be substantially completed during the third quarter with
benefits expected to be realized during the fourth quarter of 2016
and into 2017. The decrease in revenue for the second quarter 2016
was also attributable, in part, to continued market pricing
pressure and hospital vendor consolidation.
Cost of revenue decreased $0.3 million, or 25%, as compared to
the same period in 2015. The decrease in cost of revenue was
primarily due to the decline in product sales. Excluding the impact
of excess or obsolete inventory for both periods, second quarter
2016 gross margins ended at 83% of total sales, as compared to 78%
during the prior year period. The increase in gross margins as a
percentage of sales is primarily attributable to lower private
label sales, which have lower gross margins, and to a lesser
extent, the impact of the medical device excise tax moratorium.
Operating expenses decreased $0.5 million, or 8%, as compared to
the same period in 2015. This decline in operating expenses is
primarily due to a decrease of $0.3 million in commissions as a
result of decreased sales and a $0.2 million decrease in personnel
related expenses.
Net loss for the second quarter 2016 was $5.1 million, compared
to a net loss of $5.9 million in the prior-year period. The
reduction in net loss was primarily the result of improved gross
profit and decreases in operating costs and other expenses during
the quarter.
Adjusted EBITDA, which is defined as earnings before deductions
for interest, taxes, depreciation, amortization, non-cash stock
compensation expense, change in fair value of derivative
liabilities, offering costs, loss on extinguishment of derivative
liabilities and loss on extinguishment of debt for the second
quarter 2016 was a loss of $1.9 million, compared to a loss of $2.0
million for the second quarter 2015.
Cash and cash equivalents totaled $5.2 million as of June 30,
2016. Operating cash burn decreased to $2.4 million for the six
months ended June 30, 2016 as compared to $5.3 million the prior
year period, or 55%. Total principal debt obligations were $12.1
million as of June 30, 2016, a decrease of $12.2 million from June
30, 2015.
Conference Call
The Company will hold an investor conference call to discuss the
financial results on Thursday August 11, 2016 at 5:00 PM Eastern
Time. The Company invites all interested parties to join the call
by dialing Toll Free 877-524-8416, any time after 4:50 p.m. Eastern
Time on August 11th. The Conference ID number is 13642503.
International callers should dial 412-902-1028. For those who are
not available to listen to the live webcast, a digital replay will
be archived on the investor relations section of the Amedica
website under News/Events.
Non-GAAP Financial Measures
This press release includes the following "non-GAAP financial
measures" as defined by the Securities and Exchange Commission
(SEC): Adjusted EBITDA and Gross Margin Before deducting the
Provision for Excess and Obsolete Inventory. These measures may be
different from non-GAAP financial measures used by other companies.
The presentation of this financial information, which is not
prepared under any comprehensive set of accounting rules or
principles, is not intended to be considered in isolation of, or as
a substitute for, the financial information prepared and presented
in accordance with generally accepted accounting principles (GAAP).
For a reconciliation of these non-GAAP financial measures to the
nearest comparable GAAP measure, see "Reconciliation of Non-GAAP
Financial Measures" included in this press release.
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. Forward-looking
statements contained in this press release include the intent,
belief or current expectations of Amedica and members of its
management team with respect to Amedica's future business
operations as well as the assumptions upon which such statements
are based. Forward-looking statements include specifically, but are
not limited to, Amedica's ability to accelerate the adoption of
silicon nitride, strengthen its balance sheet, expand spine sales,
complete the commercial sales expansion strategy during the third
quarter with benefits expected to be realized during the fourth
quarter of 2016 and into 2017, as well as other references to its
market opportunities, growth, future products, market acceptance of
its products, sales and financial results and such statements are
subject to risks and uncertainties such as the timing and success
of new product introductions, physician acceptance, endorsement,
and use of Amedica's products, regulatory matters, competitor
activities, changes in and adoption of reimbursement rates,
potential product recalls, effects of global economic conditions
and changes in foreign currency exchange rates. Additional factors
that could cause actual results to differ materially from those
contemplated within this press release can also 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.
Amedica Corporation
|
|
Condensed Consolidated Balance Sheets - Unaudited
|
|
(in thousands, except share and per share data)
|
|
|
|
|
|
June 30, 2016
|
|
|
December 31, 2015
|
|
Assets
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
5,155
|
|
|
$
|
11,485
|
|
|
Trade accounts receivable, net of allowance of $26 and $49,
respectively
|
|
|
1,950
|
|
|
|
2,660
|
|
|
Prepaid expenses and other current assets
|
|
|
531
|
|
|
|
229
|
|
|
Inventories, net
|
|
|
8,144
|
|
|
|
9,131
|
|
Total current assets
|
|
|
15,780
|
|
|
|
23,505
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
2,090
|
|
|
|
2,472
|
|
Intangible assets, net
|
|
|
3,437
|
|
|
|
3,687
|
|
Goodwill
|
|
|
6,163
|
|
|
|
6,163
|
|
Other long-term assets
|
|
|
35
|
|
|
|
35
|
|
Total assets
|
|
$
|
27,505
|
|
|
$
|
35,862
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,960
|
|
|
$
|
643
|
|
|
Accrued liabilities
|
|
|
3,469
|
|
|
|
3,421
|
|
|
Current portion of lease liability
|
|
|
19
|
|
|
|
-
|
|
|
Current portion of long-term debt
|
|
|
10,681
|
|
|
|
16,365
|
|
Total current liabilities
|
|
|
16,129
|
|
|
|
20,429
|
|
|
|
|
|
|
|
|
|
|
Deferred rent
|
|
|
376
|
|
|
|
432
|
|
Long-term debt
|
|
|
469
|
|
|
|
-
|
|
Lease liability, net of current portion
|
|
|
38
|
|
|
|
-
|
|
Other long-term liabilities
|
|
|
166
|
|
|
|
171
|
|
Derivative liabilities
|
|
|
574
|
|
|
|
598
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
|
Common stock, $0.01 par value; 250,000,000 shares authorized;
13,306,001 and 10,886,248 shares issued and outstanding at June 30,
2016 and December 31, 2015, respectively
|
|
|
133
|
|
|
|
109
|
|
|
Additional paid-in capital
|
|
|
214,609
|
|
|
|
210,660
|
|
|
Accumulated deficit
|
|
|
(204,989
|
)
|
|
|
(196,537
|
)
|
Total stockholders' equity
|
|
|
9,753
|
|
|
|
14,232
|
|
Total liabilities and stockholders' equity
|
|
$
|
27,505
|
|
|
$
|
35,862
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amedica Corporation
|
|
Condensed Consolidated Statements of Operations and
Comprehensive Loss - Unaudited
|
|
(in thousands, except share and per share data)
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
Product revenue
|
|
$
|
4,023
|
|
|
$
|
4,780
|
|
|
$
|
8,196
|
|
|
$
|
9,523
|
|
Costs of revenue
|
|
|
1,017
|
|
|
|
1,363
|
|
|
|
1,910
|
|
|
|
2,885
|
|
Gross profit
|
|
|
3,006
|
|
|
|
3,417
|
|
|
|
6,286
|
|
|
|
6,638
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,553
|
|
|
|
1,553
|
|
|
|
3,161
|
|
|
|
3,396
|
|
|
General and administrative
|
|
|
1,360
|
|
|
|
1,334
|
|
|
|
2,922
|
|
|
|
3,361
|
|
|
Sales and marketing
|
|
|
2,594
|
|
|
|
3,126
|
|
|
|
5,188
|
|
|
|
6,483
|
|
Total operating expenses
|
|
|
5,507
|
|
|
|
6,013
|
|
|
|
11,271
|
|
|
|
13,240
|
|
Loss from operations
|
|
|
(2,501
|
)
|
|
|
(2,596
|
)
|
|
|
(4,985
|
)
|
|
|
(6,602
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
(2,353
|
)
|
|
|
(1,134
|
)
|
|
|
(3,253
|
)
|
|
|
(2,234
|
)
|
|
Loss on extinguishment of debt
|
|
|
(244
|
)
|
|
|
-
|
|
|
|
(244
|
)
|
|
|
(79
|
)
|
|
Change in fair value of derivative liabilities
|
|
|
35
|
|
|
|
(923
|
)
|
|
|
24
|
|
|
|
(1,100
|
)
|
|
Loss on extinguishment of derivative liabilities
|
|
|
-
|
|
|
|
(1,245
|
)
|
|
|
-
|
|
|
|
(1,261
|
)
|
|
Other expense
|
|
|
(1
|
)
|
|
|
(35
|
)
|
|
|
6
|
|
|
|
(38
|
)
|
Total other income (expense)
|
|
|
(2,563
|
)
|
|
|
(3,337
|
)
|
|
|
(3,467
|
)
|
|
|
(4,712
|
)
|
Net loss before income taxes
|
|
|
(5,064
|
)
|
|
|
(5,933
|
)
|
|
|
(8,452
|
)
|
|
|
(11,314
|
)
|
Provision for income taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Net comprehensive loss
|
|
|
(5,064
|
)
|
|
|
(5,933
|
)
|
|
|
(8,452
|
)
|
|
|
(11,314
|
)
|
Other comprehensive loss, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
$
|
(5,064
|
)
|
|
$
|
(5,933
|
)
|
|
$
|
(8,452
|
)
|
|
$
|
(11,314
|
)
|
Net loss per share attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.40
|
)
|
|
$
|
(1.64
|
)
|
|
$
|
(0.71
|
)
|
|
$
|
(4.16
|
)
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
12,761,814
|
|
|
|
3,622,491
|
|
|
|
11,981,865
|
|
|
|
2,717,688
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amedica Corporation
|
|
Condensed Consolidated Statements of Cash Flows - Unaudited
|
|
(in thousands)
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
2016
|
|
|
2015
|
|
Cash flow from operating activities
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,452
|
)
|
|
$
|
(11,314
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
Depreciation expense
|
|
|
772
|
|
|
|
841
|
|
|
Amortization of intangible assets
|
|
|
250
|
|
|
|
250
|
|
|
Amortization of lease incentive for tenant improvements
|
|
|
10
|
|
|
|
10
|
|
|
Non cash interest expense
|
|
|
2,365
|
|
|
|
1,130
|
|
|
Loss on extinguishment of debt
|
|
|
244
|
|
|
|
79
|
|
|
Stock based compensation
|
|
|
145
|
|
|
|
704
|
|
|
Change in fair value of derivative liabilities
|
|
|
(24
|
)
|
|
|
1,100
|
|
|
Loss on extinguishment of derivative liabilities
|
|
|
-
|
|
|
|
1,261
|
|
|
(Gain) loss on disposal of equipment
|
|
|
(7
|
)
|
|
|
4
|
|
|
Provision for inventory reserve
|
|
|
696
|
|
|
|
625
|
|
|
Bad debt recovery
|
|
|
-
|
|
|
|
(7
|
)
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
Trade accounts receivable
|
|
|
711
|
|
|
|
11
|
|
|
|
Prepaid expenses and other current assets
|
|
|
(219
|
)
|
|
|
(289
|
)
|
|
|
Inventories
|
|
|
296
|
|
|
|
556
|
|
|
|
Accounts payable and accrued liabilities
|
|
|
834
|
|
|
|
(284
|
)
|
Net cash used in operating activities
|
|
$
|
(2,379
|
)
|
|
$
|
(5,323
|
)
|
Cash flows from investing activities
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
(350
|
)
|
|
|
(417
|
)
|
Proceeds from sale of property and equipment
|
|
|
23
|
|
|
|
7
|
|
Net cash used in investing activities
|
|
$
|
(327
|
)
|
|
$
|
(410
|
)
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
Proceeds from the exercise of warrants
|
|
|
1
|
|
|
|
-
|
|
Payments on long-term debt
|
|
|
(3,424
|
)
|
|
|
-
|
|
Issuance costs paid for debt
|
|
|
(198
|
)
|
|
|
-
|
|
Payments for capital lease
|
|
|
(3
|
)
|
|
|
-
|
|
Purchase of treasury stock
|
|
|
-
|
|
|
|
(120
|
)
|
Net cash used in financing activities
|
|
$
|
(3,624
|
)
|
|
$
|
(120
|
)
|
Net decrease in cash and cash equivalents
|
|
|
(6,330
|
)
|
|
|
(5,853
|
)
|
Cash and cash equivalents at beginning of period
|
|
|
11,485
|
|
|
|
18,247
|
|
Cash and cash equivalents at end of period
|
|
$
|
5,155
|
|
|
$
|
12,394
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of Non-GAAP Financial Measures:
To supplement our consolidated statements of operations and
comprehensive net loss which are presented in accordance with GAAP,
we use certain non-GAAP measures of components of financial
performance. Although not measures of financial performance under
GAAP, "Adjusted EBITDA" and "Gross Margin Before deducting the
Provision for Excess and Obsolete Inventory" are provided for the
use of investors in understanding our operating results and are not
prepared in accordance with, nor do they serve as alternatives to
GAAP measures, and may be materially different from similar
measures used by other companies. We define "Adjusted EBITDA" as
our earnings before deductions for interest, taxes, depreciation,
amortization, stock-based compensation, change in fair value of
derivative liabilities, and loss on extinguishment of debt. We
define "Gross Margin Before Deducting the Provision for Excess and
Obsolete Inventory" as our gross margin before deducting the
provision for excess and obsolete inventory. While not a substitute
for information prepared in accordance with GAAP, management
believes that this information is helpful for investors to more
easily understand our operating financial performance. Management
also believes these measures may better enable an investor to form
views of our potential financial performance in the future. These
measures have limitations as analytical tools, and investors should
not consider these measures in isolation or as a substitute for
analysis of our results prepared in accordance with GAAP.
Below is a reconciliation of Adjusted EBITDA to Net Loss for
each of the periods presented (in thousands - unaudited):
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
Net Loss
|
|
|
(5,064
|
)
|
|
|
(5,933
|
)
|
|
|
(8,452
|
)
|
|
|
(11,314
|
)
|
Interest expense, net
|
|
|
2,353
|
|
|
|
1,134
|
|
|
|
3,253
|
|
|
|
2,234
|
|
Income tax expense
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Depreciation
|
|
|
383
|
|
|
|
414
|
|
|
|
772
|
|
|
|
841
|
|
Amortization
|
|
|
125
|
|
|
|
125
|
|
|
|
250
|
|
|
|
250
|
|
Stock-based compensation
|
|
|
57
|
|
|
|
82
|
|
|
|
145
|
|
|
|
704
|
|
Change in fair value of derivative liabilities
|
|
|
(35
|
)
|
|
|
923
|
|
|
|
(24
|
)
|
|
|
1,100
|
|
Loss on extinguishment of derivative liabilities
|
|
|
-
|
|
|
|
1,245
|
|
|
|
-
|
|
|
|
1,261
|
|
Loss on extinguishment of debt
|
|
|
244
|
|
|
|
-
|
|
|
|
244
|
|
|
|
79
|
|
Adjusted EBITDA
|
|
$
|
(1,937
|
)
|
|
$
|
(2,010
|
)
|
|
$
|
(3,812
|
)
|
|
$
|
(4,845
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Below is a reconciliation of Gross Profit and Margin to Gross
Profit and Margin Before deducting the Provision for Excess and
Obsolete Inventory for each of the periods presented (in thousands
- unaudited):
|
|
Three Months Ended June 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
|
Gross Profit
|
|
Gross Margin
|
|
|
Gross Profit
|
|
Gross Margin
|
|
Gross profit and margin
|
|
$
|
3,006
|
|
75
|
%
|
|
$
|
3,417
|
|
71
|
%
|
Provision for excess and obsolete inventory
|
|
$
|
323
|
|
8
|
%
|
|
$
|
326
|
|
7
|
%
|
Gross profit and margin, excluding provision for excess and
obsolete inventory
|
|
$
|
3,329
|
|
83
|
%
|
|
$
|
3,743
|
|
78
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
About Amedica Corporation
Amedica is focused on the development and application of
medical-grade silicon nitride ceramics. Amedica markets spinal
fusion products and is developing a new generation of wear- and
corrosion-resistant implant components for hip and knee
arthroplasty. The Company manufactures its products in its ISO
13485 certified manufacturing facility and through its partnership
with Kyocera, the world's largest ceramic manufacturer. Amedica's
spine products are FDA-cleared, CE-marked, and are currently
marketed in the U.S. and select markets in Europe and South America
through its distributor network and its growing OEM
partnerships.
For more information on Amedica or its silicon nitride material
platform, please visit www.amedica.com.
Contact Information
- Contact:Mike HoustonVP,
Commercialization801-839-3534ir@amedica.com
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