SAN DIEGO, Aug. 10, 2015 /PRNewswire/ -- Organovo
Holdings, Inc. (NYSE MKT: ONVO) ("Organovo" or the "Company"),
a three-dimensional biology company focused on delivering
scientific and medical breakthroughs using its 3D bioprinting
technology, today reported its financial results for the first
quarter of fiscal 2016 ended June 30, 2015.
Recent Corporate Highlights Included:
- Celebrated the successful launch of its exVive3DTM
Human Liver Tissue, with an announcement of the launch results
showing approximately $2 million in
total contract bookings as of June 9,
2015.
- Presented data on the Company's in vitro
three-dimensional kidney tissue at the 2015 Experimental Biology
conference in Boston,
Massachusetts, demonstrating fully human kidney proximal
tubular tissues were generated that were three-dimensional, and
consisted of multiple tissue-relevant cell types arranged to
recapitulate the renal tubular/interstitial interface. This
breakthrough result demonstrated a proof of concept that kidney is
on the way to becoming another core commercial tissue for
Organovo.
- Announced a partnership with L'Oreal USA, wherein L'Oreal's U.S.-based global
Technology Incubator and Organovo will leverage Organovo's
proprietary NovoGen Bioprinting Platform and L'Oreal's expertise in
skin engineering to develop 3D printed skin tissues for product
evaluation and other areas of advanced research, marking the
first-ever application of Organovo's groundbreaking technology
within the beauty industry.
- Raised $46 million through the
sale of approximately 10.8 million shares of common stock in an
underwritten secondary offering focused primarily on institutional
investors. Jefferies LLC and Piper
Jaffray & Co. acted as joint book-running managers for
this offering.
- Announced the hiring of Paul Gallant as the Company's
General Manager of the in vitro tissue service and product
business. Mr. Gallant brings more than 20 years of management
and R&D experience in the drug discovery industry, where he
most recently served as chief operating officer for DiscoveRx, a
global scientific product and services company. The Company
plans to draw upon Mr. Gallant's experience in advancing new
technology platforms in collaboration with pharmaceutical
companies, contract research organizations and academic
institutions to assist it with developing and executing strategies
for capturing market share and otherwise growing its in
vitro business.
Keith Murphy, Organovo's
President and Chief Executive Officer commented "We are very
pleased to have had a successful launch and have a diverse set of
customers for our exVive3D Liver, including top 25 global pharma
companies, additional public pharmaceutical companies from small to
large cap, and private venture backed companies. We have
continued to expand the data demonstrating the predictive power and
comparability to native human biology provided by the exVive3D
Liver, and we continue to gain penetration and awareness of the
technology through our marketing, sales, and R&D efforts.
As importantly, we have put ourselves in position to further expand
capacity, develop new tissue and disease model opportunities, and
drive liver and kidney tissue revenue growth faster."
Financial Summary
A summary of the Company's financial results for the first
quarter of fiscal 2016 ended June 30, 2015 follows, but
is not intended to replace the full financial disclosure enclosed
in the Company's Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on August 10,
2015. Please refer to that document for additional
information.
Financial Condition, Liquidity and Capital
Resources
During the quarter ended June 30,
2015, the Company raised net proceeds of
approximately $43.2 million through the sale of 10.8
million shares of its common stock in an underwritten secondary
offering.
The Company had cash and cash equivalents of $86.0
million and an accumulated deficit of $130.8 million,
with negative cash flows from operations of $6.3 million
for the quarter ended June 30, 2015. Total current
assets of $87.0 million and current liabilities
of $5.2 million resulted in working capital of $81.8
million at June 30, 2015, versus the
prior year's first quarter total current assets of $45.7
million and current liabilities of $3.1 million, which
resulted in working capital of $42.6 million. At
March 31, 2015, we had total current
assets of approximately $51.3 million
and current liabilities of approximately $4.8 million, resulting in working capital of
$46.5 million.
Net cash used in investing activities was
approximately $1.1 million and $0.2 million for
the quarters ended June 30, 2015 and
2014, respectively. The majority of net cash used in
investing activities to date has been for the purchases of
laboratory equipment related to the Company's launch of its first
commercial product and expanded research capabilities.
Net cash provided by financing activities was
approximately $43.3 million and $0.3 million for the quarters ended
June 30, 2015 and 2014,
respectively.
Revenues
For the three months ended June 30,
2015, total revenue of $306,000 was $207,000, or approximately 209%, higher than
total revenue for the three months ended June 30, 2014. Product and service revenue of
$209,000 for the first quarter of
fiscal 2016 versus $0 in the first
quarter of fiscal 2015 represented revenue from the initial
shipments of the Company's exVive3D Human Liver Tissue product and
from exVive3D Human Liver Tissue research services. The Company
announced the commercial launch of its exVive3DHuman Liver Tissue
in November 2014. The majority of
revenues for the first quarter of fiscal 2016 were derived from
research service agreements related to the exVive3D Human Liver
Tissue, whereas revenues for the first quarter of fiscal 2015 were
derived mainly from existing collaborations and from research
funded by grants.
Operating and Other Expenses
Operating expenses increased approximately $2.3 million, or 35%, from approximately
$6.5 million for the three months
ended June 30, 2014 to $8.8 million for the three months ended
June 30, 2015. Of this increase,
$0.9 million related to increased
selling, general and administrative expenses, while the remaining
$1.4 million related to increased
investment in research and development. These increases can be
attributed to the Company's continued implementation of its
business plan, including hiring additional staff to support its
research and development initiatives, incremental investments
associated with strategic growth and commercialization project
initiatives associated with the commercial launch of its exVive3D
Human Liver Tissue in November 2014,
expenses related to operating as a publicly traded corporation,
expansion of its facilities, and increased stock compensation
expense relative to employees and certain consulting services.
More specifically, research and development expenses increased
50% from approximately $2.8 million
for the three months ended June 30,
2014 to $4.2 million for the
three months ended June 30, 2015, as
the Company increased its research staff to support its obligations
under existing collaborative research agreements and to expand its
product development team and activities commensurate with launching
commercial research services associated with the commercial launch
of the Company's first product in the third quarter of fiscal
2015. Full-time research and development staffing increased
from thirty-six full-time employees as of June 30, 2014 to fifty-four full-time employees
as of June 30, 2015, resulting in an
increase in staffing expense of approximately $0.7 million, an increase in stock-based
compensation of $0.1 million, an
increase in lab supply costs of $0.3
million and an increase in facility costs of approximately
$0.2 million.
Selling, general and administrative expenses for the three
months ended June 30, 2015 were
approximately $4.6 million, an
increase of $0.9 million, or 24%,
over expenses in the same period of the previous year of
approximately $3.7 million. This
increase was primarily related to an increase in staffing expense
of $0.8 million due to an increase in
administrative headcount from fourteen full-time employees to
thirty-two full-time employees to provide strategic infrastructure
in developing collaborative relationships and preparation for
commercialization of research-derived product introductions as well
as an increase in stock-based compensation of $0.1 million due to additional grants.
Other expense was less than $0.1
million for the three months ended June 30, 2015 and 2014, respectively, and
consisted primarily of losses related to revaluation of warrant
derivative liabilities. The majority of the underlying warrants to
which derivative liability may apply have been exercised or
converted to equity instruments in previous years, significantly
lessening the impact of subsequent changes in our stock price.
Conference Call
The Company will host a conference call at 5:00 p.m.
ET to discuss the financial results for the first quarter of
fiscal 2016 ended June 30, 2015. If you would like to
participate in the call, please dial-in approximately 10
minutes prior to the start time, and ask to join the Organovo
Holdings, Inc. conference call. Participants will be required
to state their name and company upon entering the call. The
dial-in info is as follows:
Participant dial in
(toll free):
|
1-888-317-6003
|
Participant
international dial in:
|
1-412-317-6061
|
EE TF -
Canada
|
1-866-284-3684
|
You will need to provide the Participant Elite Entry Number:
4892967
A replay will be made available one hour following the live call
and remain available for 30 days. To access the replay, the dial-in
info is as follows:
US Toll
Free:
|
1-877-344-7529
|
International
Toll:
|
1-412-317-0088
|
Canada Toll
Free:
|
855-669-9658
|
Replay Access
Code:
|
10070773
|
To access the replay using an international dial-in number,
please select the link below.
https://services.choruscall.com/ccforms/replay.html
About Organovo Holdings, Inc.
Organovo designs and creates functional, three-dimensional
human tissues for use in medical research and therapeutic
applications. The Company develops 3D human disease models
through internal development and in collaboration with
pharmaceutical and academic partners. Organovo's 3D human
tissues have the potential to accelerate the drug discovery
process, enabling treatments to be developed faster and at lower
cost. The Company recently launched its initial product of
the planned exVive3D portfolio offering, the
exVive3D Human Liver Tissue for use in toxicology and other
preclinical drug testing. Additional products are in
development, with the anticipated release of the
exVive3D Human Kidney Tissue scheduled for the latter half of
calendar year 2016. The Company also actively conducts early
research on specific tissues for therapeutic use in direct surgical
applications. In addition to numerous scientific
publications, the Company's technology has been featured
in The Wall Street Journal, Time Magazine, The Economist,
and numerous other media outlets. Organovo is changing
the shape of medical research and practice. Learn more
at www.organovo.com.
Total Contract Bookings
Total contract bookings represents the total value of contracts
the Company has entered into for research services related to its
exVive3D Human Liver Tissue as of the end of the applicable
period. Where contracts involve research relating to
additional tissue types, only that portion of the total contract
applicable to the exVive Human Liver Tissue is included. The
Company's contracts typically require the Company to provide
services over a four to six month period, though contracts may in
some cases require services over a longer timeframe. In
addition, the Company's customers may opt out of having the Company
perform all of the services contemplated by the contract or
otherwise terminate the contract early. As a result, the
revenues represented by any contract included in the total contract
bookings may be recognized by the Company over several quarters as
the Company completes the research services required by the
contract, or not at all, if the customer elects to opt out or
otherwise terminate the contract early. Total contract
bookings is an operational measure that should be considered in
addition to the Company's results prepared in accordance with U.S.
generally accepted accounting principles ("GAAP"). This
operational measure should not be considered as a substitute for,
or superior to, GAAP results. The Company believes total
contract bookings is a relevant and useful operational measure for
the Company and its investors because it provides information
regarding the Company's commercialization efforts and customer
uptake of the Company's liver tissue product. The Company
does not intend to update total contract bookings on a quarterly
basis, but may update total contract bookings on an annual
basis.
Safe Harbor Statement
Any statements contained in this press release that do not
describe historical facts constitute forward-looking statements as
that term is defined in the Private Securities Litigation Reform
Act of 1995. Any forward-looking statements contained herein
are based on current expectations, but are subject to a number of
risks and uncertainties. The factors that could cause the
Company's actual future results to differ materially from current
expectations include, but are not limited to, risks and
uncertainties relating to the Company's ability to develop, market
and sell products and services based on its technology; the
expected benefits and efficacy of the Company's products, services
and technology; the market acceptance of the Company's products and
services; the Company's business, research, product development,
regulatory approval, marketing and distribution plans and
strategies; and the Company's ability to successfully complete the
contracts and recognize the revenue represented by the contracts
included in its previously reported total contract bookings.
These and other factors are identified and described in more detail
in the Company's filings with the SEC, including its Annual
Report on Form 10-K filed with the SEC on June 9,
2015 and its Quarterly Report on Form 10-Q filed with the SEC on
August 10, 2015. You should not
place undue reliance on these forward-looking statements, which
speak only as of the date that they were made. These
cautionary statements should be considered with any written or oral
forward-looking statements that the Company may issue in the
future. Except as required by applicable law, including the
securities laws of the United States, the Company does
not intend to update any of the forward-looking statements to
conform these statements to reflect actual results, later events or
circumstances or to reflect the occurrence of unanticipated
events.
Sign up for email updates and connect with us
on Twitter (@Organovo).
Investor Relations Contacts: Barry
Michaels, Chief Financial Officer, phone (858) 224-1000,
ext. 3 or IR@organovo.com, or Gerry
Amato, Amato & Partners, LLC,
admin@amatoandpartners.com
Organovo Holdings,
Inc.
|
Condensed
Consolidated Balance Sheets
|
(in thousands
except for share data)
|
|
|
|
|
|
|
|
|
|
June 30,
2015
|
|
|
March 31,
2015
|
|
|
|
(Unaudited)
|
|
|
(Audited)
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
Assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
86,000
|
|
|
$
|
50,142
|
|
Accounts
receivable
|
|
|
132
|
|
|
|
—
|
|
Inventory
|
|
|
69
|
|
|
|
66
|
|
Prepaid expenses and
other current assets
|
|
|
795
|
|
|
|
1,054
|
|
Total current
assets
|
|
|
86,996
|
|
|
|
51,262
|
|
Fixed assets,
net
|
|
|
3,381
|
|
|
|
2,042
|
|
Restricted
cash
|
|
|
79
|
|
|
|
79
|
|
Other assets,
net
|
|
|
107
|
|
|
|
106
|
|
Total
assets
|
|
$
|
90,563
|
|
|
$
|
53,489
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,030
|
|
|
$
|
1,387
|
|
Accrued
expenses
|
|
|
1,646
|
|
|
|
2,257
|
|
Deferred
rent
|
|
|
1,088
|
|
|
|
759
|
|
Deferred
revenue
|
|
|
1,433
|
|
|
|
227
|
|
Capital lease
obligation
|
|
|
2
|
|
|
|
5
|
|
Warrant
liabilities
|
|
|
26
|
|
|
|
126
|
|
Total current
liabilities
|
|
|
5,225
|
|
|
|
4,761
|
|
Deferred revenue, net
of current portion
|
|
|
19
|
|
|
|
32
|
|
Capital lease
obligation, net of current portion
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
$
|
5,244
|
|
|
$
|
4,793
|
|
Commitments and
Contingencies (Note 4)
|
|
|
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
|
|
|
|
|
Common stock, $0.001
par value; 150,000,000 shares authorized, 92,426,404 and 81,536,724 shares issued and
outstanding at June 30, 2015
and March 31, 2015, respectively
|
|
|
92
|
|
|
|
82
|
|
Additional paid-in
capital
|
|
|
216,013
|
|
|
|
170,909
|
|
Accumulated
deficit
|
|
|
(130,786)
|
|
|
|
(122,295)
|
|
Total stockholders'
equity
|
|
|
85,319
|
|
|
|
48,696
|
|
Total Liabilities
and Stockholders' Equity
|
|
$
|
90,563
|
|
|
$
|
53,489
|
|
Organovo Holdings,
Inc.
|
Unaudited
Condensed Consolidated Statements of Operations
|
(in thousands
except share and per share data)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
Three Months
Ended
|
|
|
|
June 30,
2015
|
|
|
June 30,
2014
|
|
Revenues
|
|
|
|
|
|
|
|
|
Product and
service
|
|
$
|
209
|
|
|
$
|
-
|
|
Collaborations
|
|
|
14
|
|
|
|
69
|
|
Grants
|
|
|
83
|
|
|
|
30
|
|
Total
Revenues
|
|
|
306
|
|
|
|
99
|
|
Selling, general, and
administrative expenses
|
|
|
4,622
|
|
|
|
3,695
|
|
Research and
development expenses
|
|
|
4,142
|
|
|
|
2,814
|
|
Loss from
Operations
|
|
|
(8,458)
|
|
|
|
(6,410)
|
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
|
Change in fair value
of warrant liabilities
|
|
|
(38)
|
|
|
|
(30)
|
|
Interest
expense
|
|
|
(3)
|
|
|
|
-
|
|
Interest
income
|
|
|
8
|
|
|
|
7
|
|
Total Other Income
(Expense)
|
|
|
(33)
|
|
|
|
(23)
|
|
Net
Loss
|
|
$
|
(8,491)
|
|
|
$
|
(6,433)
|
|
Net loss per common
share—basic and diluted
|
|
$
|
(0.10)
|
|
|
$
|
(0.08)
|
|
Weighted average
shares used in computing net
loss per
common share—basic and diluted
|
|
|
82,993,966
|
|
|
|
78,241,373
|
|
Organovo Holdings,
Inc.
|
Unaudited
Condensed Consolidated Statements of Cash Flows
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
Three Months
Ended
|
|
|
|
June 30,
2015
|
|
|
June 30,
2014
|
|
Cash Flows From
Operating Activities
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,491)
|
|
|
$
|
(6,433)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
135
|
|
|
|
96
|
|
Change in fair value
of warrant liabilities
|
|
|
38
|
|
|
|
30
|
|
Stock-based
compensation
|
|
|
1,780
|
|
|
|
1,537
|
|
Amortization of
warrants issued for services
|
|
|
(95)
|
|
|
|
141
|
|
Increase (decrease) in
cash resulting from changes in:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(132)
|
|
|
|
(60)
|
|
Inventory
|
|
|
(3)
|
|
|
|
(8)
|
|
Prepaid expenses and
other assets
|
|
|
256
|
|
|
|
117
|
|
Accounts
payable
|
|
|
(357)
|
|
|
|
513
|
|
Accrued
expenses
|
|
|
(611)
|
|
|
|
460
|
|
Deferred
rent
|
|
|
(8)
|
|
|
|
112
|
|
Deferred
revenue
|
|
|
1,193
|
|
|
|
130
|
|
Net cash used in
operating activities
|
|
|
(6,295)
|
|
|
|
(3,365)
|
|
Cash Flows From
Investing Activities
|
|
|
|
|
|
|
|
|
Purchases of fixed
assets
|
|
|
(1,135)
|
|
|
|
(238)
|
|
Net cash used in
investing activities
|
|
|
(1,135)
|
|
|
|
(238)
|
|
Cash Flows From
Financing Activities
|
|
|
|
|
|
|
|
|
Proceeds from issuance
of common stock and exercise of warrants, net
|
|
|
43,214
|
|
|
|
224
|
|
Proceeds from exercise
of stock options
|
|
|
77
|
|
|
|
111
|
|
Principal payments on
capital lease obligations
|
|
|
(3)
|
|
|
|
(2)
|
|
Net cash provided
by financing activities
|
|
|
43,288
|
|
|
|
333
|
|
Net Increase
(Decrease) in Cash and Cash Equivalents
|
|
|
35,858
|
|
|
|
(3,270)
|
|
Cash and Cash
Equivalents at Beginning of Period
|
|
|
50,142
|
|
|
|
48,167
|
|
Cash and Cash
Equivalents at End of Period
|
|
$
|
86,000
|
|
|
$
|
44,897
|
|
Supplemental
Disclosure of Cash Flow Information:
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
—
|
|
|
$
|
—
|
|
Income
Taxes
|
|
$
|
(3)
|
|
|
$
|
—
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/organovo-reports-first-quarter-fiscal-2016-financial-results-and-corporate-highlights-300126322.html
SOURCE Organovo Holdings, Inc.