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Investor Contact: Press Contact: Steve Kunszabo Jessica Yingling Organovo Holdings, Inc. Little Dog Communications +1 (858) 224-1092 +1 (858) 480-2411 skunszabo@organovo.com jessica@litldog.com ORGANOVO ANNOUNCES FISCAL

Key Takeaway: Investor Contact: Press Contact: Steve Kunszabo Jessica Yingling Organovo Holdings, Inc. Little Dog Communications +1 (858) 224-1092 +1 (858) 480-2411 skunszabo@organovo.com jessica@litldog.com ORGANOVO ANNOUNCES FISCAL FOURTH-QUARTER and FULL-YEAR 2017 RESULTS; COMPAN

Full Press Release Details

Investor Contact: Press Contact:
Steve Kunszabo Jessica Yingling
Organovo Holdings, Inc. Little Dog Communications
+1 (858) 224-1092 +1 (858) 480-2411
skunszabo@organovo.com jessica@litldog.com
ORGANOVO ANNOUNCES FISCAL FOURTH-QUARTER and FULL-YEAR 2017 RESULTS; COMPANY ISSUES FULL-YEAR FISCAL 2018 OUTLOOK
SAN DIEGO - June 7, 2017 - Organovo Holdings, Inc. (NASDAQ:ONVO) ("Organovo") today reported financial results for the fiscal fourth quarter of 2017 and issued its full-year fiscal 2018 outlook. Organovo reported fiscal fourth-quarter total revenue of $0.8 million, which consisted largely of product and service revenue(1). Total revenue increased 48 percent versus the comparable period of fiscal 2016. Net loss was $10.7 million, or $0.10 per share, for the fiscal fourth quarter of 2017, as compared to $8.4 million, or $0.09 per share, for the fiscal fourth quarter of 2016.
"Fiscal 2017 was a year of significant commercial progress for Organovo, as we grew total revenue 185% and achieved many important scientific targets," said Taylor J. Crouch, CEO, Organovo. "We issued our outlook today for fiscal 2018 total revenue, which represents a robust increase in sales led by growth in tissue research services. In addition to our established work in the toxicology space, we're seeing strong customer demand for compound screening in disease models, including key areas such as liver fibrosis and non-alcoholic steatohepatitis ("NASH"). With 30% of the developed world now living with progressive fatty liver disease, I believe our work and capabilities will become critical to understanding the effects of new drugs in realistically modeled patient populations."
Crouch continued, "I've joined Organovo during a transformational time in its history. The leading indicators of broader customer acceptance are taking shape. A key component of customer adoption remains the breadth of our ongoing validation work. I'm excited to share that we've now studied 46 compounds and accurately characterized the safety profile in a high percentage of the cases based on clinical correlation. It's important to remember that these cases included preclinical misses and approved drugs where cell and animal models did not provide an adequate safety signal. We'll not only focus on growing our library of core validation work over the long-term, but as we shared last quarter, we'll continue supporting immediate customer needs related to optimized utilization and new applications."
Crouch concluded, "As we look ahead to fiscal 2018, our core business infrastructure is at a sufficient level to support anticipated customer demand and revenue producing opportunities. We're focused on a precise set of goals to enable our rapid growth. First, we expect to capitalize on future adoption of our liver and kidney tissue research services. Ongoing validation work and business development execution with new customers will be the cornerstones for achieving this objective, while also moving existing clients quickly to repeat orders on the path to routine use of our solutions. Second, we plan to advance our liver therapeutic tissue through preclinical studies with the goal of locking down our final tissue design and conducting successful animal disease model studies over the next 12 months. With each incremental success against these objectives, we're changing how drugs are developed and ultimately impacting patient outcomes where critical unmet needs exist."
Full-Year Fiscal 2017 Organovo Business Highlights
For the full year, the Company reported total revenue of $4.2 million, which was up 185% from the year-ago period. Total revenue included $3.2 million of product and service revenue and $1.0 million of revenue related to collaborations(2). Organovo reported fiscal 2017 net loss of $38.4 million, or $0.39 per share, as compared to net loss of $38.6 million, or $0.43 per share, for fiscal 2016.
Fourth-Quarter Organovo Business Highlights
Liquidity & Capital Resources
Fiscal-Year 2018 Outlook
The Company issued its full-year fiscal 2018 outlook for total revenue and negative Adjusted EBITDA(4). The Company expects:
Fiscal-Year 2018 Outlook (June 2017)
Fiscal-Year 2018 Total Revenue $6.0 million - $8.5 million
Fiscal-Year 2018 Negative Adjusted EBITDA $29.0 million - $31.0 million
A reconciliation of non-GAAP negative Adjusted EBITDA, as forecasted for fiscal 2018, to the closest corresponding GAAP measure, net loss, is not available without unreasonable efforts on a forward-looking basis due to the high variability and low visibility of certain charges that may impact our GAAP results on a forward-looking basis, such as the measures and effects of share-based compensation.
Definitions & Supplemental Financial Measures
Organovo Holdings, Inc.
Supplemental Reconciliation of GAAP Net Income to Adjusted EBITDA
(in thousands)
Twelve Months Ended Twelve Months Ended
March 31, 2017 March 31, 2016
GAAP net loss $ (38,447) $ (38,575)
Interest expense - -
Interest income (198) (88)
Income taxes 23 3
Depreciation and amortization 1,149 815
Share-based compensation 7,392 8,556
CEO transition costs 281 -
Adjusted EBITDA $ (29,800) $ (29,289)
Conference Call Information
As previously announced, the Company will host a conference call to discuss its results at 5:00 p.m. ET on Wednesday, June 7, 2017. Callers should dial (888) 317-6003 (U.S. only) or (412) 317-6061 (from outside the U.S.) to access the call. The conference call ID is 7936733. The conference call will also be simultaneously webcast on Organovo's Investor Relations webpage at www.organovo.com. A replay of the conference call will be available beginning Wednesday, June 7, 2017 through Wednesday, June 14, 2017 at Organovo's Investor Relations webpage. Callers can also dial (877) 344-7529 (U.S. only) or (412) 317-0088, Access Code 10104415, for an audio replay of the conference call.
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 tissue models through internal development and in collaboration with pharmaceutical, academic and other 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's ExVive Human Liver and Kidney Tissues are used in toxicology and other preclinical drug testing. 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, Forbes, and numerous other media outlets. Organovo is changing the shape of life science research and transforming medical care. Learn more at www.organovo.com.
Forward-Looking Statements
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 Company's ability to successfully complete
studies and provide the technical information required to support market acceptance of its products, services and technology, on a timely basis or at all; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies, including its use of third party distributors; 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 and secure additional contracted collaborative relationships; the final results of the Company's preclinical studies may be different from the Company's studies or interim preclinical data results and may not support further clinical development of its therapeutic tissues; the Company may not successfully complete the required preclinical and clinical trials required to obtain regulatory approval for its therapeutic tissues on a timely basis or at all; and the Company's ability to meet its fiscal year 2018 outlook. 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 7, 2017. 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.
Organovo Holdings, Inc.
Consolidated Statements of Operations and Other Comprehensive Loss
(in thousands except per share data)
Three Months Ended Three Months Ended Twelve Months Ended Twelve Months Ended
March 31, 2017 March 31, 2016 March 31, 2017 March 31, 2016
Revenues
Products and services $ 771 $ 117 $ 3,167 $ 806
Collaborations 21 $ 427 1,022 486
Grants 20 $ 4 41 191
Total Revenues 812 548 4,230 1,483
Cost of revenues 183 - 956 -
Research and development expenses 5,533 4,542 19,545 18,008
Selling, general, and administrative expenses 5,784 4,438 22,304 22,118
Total Costs and Expenses 11,500 8,980 42,805 40,126
Loss from Operations (10,688 ) (8,432 ) (38,575 ) (38,643 )
Other Income (Expense)
Change in fair value of warrant liabilities 8 10 4 (17 )
Loss on disposal of fixed assets (51 ) - (51 ) -
Interest expense - - - -
Interest income 74 50 198 88
Total Other Income (Expense) 31 60 151 71
Income Tax Expense - - (23 ) (3 )
Net Loss $ (10,657 ) $ (8,372 ) $ (38,447 ) $ (38,575 )
Net loss per common share-basic and diluted $ (0.10 ) $ (0.09 ) $ (0.39 ) $ (0.43 )
Weighted average shares used in computing net loss per common share-basic and diluted 104,385,617 92,402,668 97,763,032 90,057,356
Comprehensive Loss:
Net Loss $ (10,657 ) $ (8,372 ) $ (38,447 ) $ (38,575 )
Currency Translation Adjustment (1 ) - (11 ) -
Comprehensive Loss $ (10,658 ) $ (8,372 ) $ (38,458 ) $ (38,575 )
Organovo Holdings, Inc.
Consolidated Balance Sheets
(in thousands except per share data)
March 31, 2017 March 31, 2016
Assets
Current Assets
Cash and cash equivalents $ 62,751 $ 62,091
Accounts receivable 647 259
Inventory, net 550 334
Prepaid expenses and other current assets 1,144 968
Total current assets 65,092 63,652
Fixed assets, net 3,840 3,711
Restricted cash 127 79
Other assets, net 121 134
Total assets $ 69,180 $ 67,576
Liabilities and Stockholders' Equity
Current Liabilities
Accounts payable $ 1,171 $ 787
Accrued expenses 4,101 2,450
Deferred rent 157 139
Deferred revenue 582 1,110
Warrant liabilities - 4
Total current liabilities 6,011 4,490
Deferred revenue, net of current portion 58 -
Deferred rent, net of current portion 749 905
Total liabilities $ 6,818 $ 5,395
Commitments and Contingencies (Note 6)
Stockholders' Equity
Common stock, $0.001 par value; 150,000,000 shares authorized, 104,551,466 and 92,391,989 shares issued and outstanding at March 31, 2017 and March 31, 2016, respectively 104 92
Additional paid-in capital 261,586 222,959
Accumulated deficit (199,317 ) (160,870 )
Accumulated other comprehensive income (loss) (11 ) -
Total stockholders' equity 62,362 62,181
Total Liabilities and Stockholders' Equity $ 69,180 $ 67,576
Organovo Holdings, Inc.
Consolidated Statements of Cash Flows (in thousands)
Year Ended Year Ended
March 31, 2017 March 31, 2016
Cash Flows From Operating Activities
Net loss $ (38,447 ) $ (38,575 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of warrants issued for services - (92 )
Depreciation and amortization 1,149 815
Loss on disposal of fixed assets 56 -
Change in fair value of warrant liabilities (4 ) 17
Stock-based compensation 7,392 8,556
Increase (decrease) in cash resulting from changes in:
Accounts receivable (388 ) (259 )
Inventory (216 ) (268 )
Prepaid expenses and other assets (154 ) 83
Accounts payable 384 (600 )
Accrued expenses 1,651 193
Deferred rent (138 ) (89 )
Deferred revenue (470 ) 851
Net cash used in operating activities (29,185 ) (29,368 )
Cash Flows From Investing Activities
Deposits released from restriction (restricted cash deposits) (48 ) -
Purchases of fixed assets (1,354 ) (2,114 )
Proceeds from disposals of fixed assets 11 14
Purchases of intangible assets - (35 )
Net cash used in investing activities (1,391 ) (2,135 )
Cash Flows From Financing Activities
Proceeds from issuance of common stock and exercise of warrants, net 30,665 43,137
Proceeds from exercise of stock options 582 320
Principal payments on capital lease obligations - (5 )
Net cash provided by financing activities 31,247 43,452
Effect of currency exchange rate changes on cash and cash equivalents (11 ) -
Net Increase (Decrease) in Cash and Cash Equivalents 660 11,949
Cash and Cash Equivalents at Beginning of Period 62,091 50,142
Cash and Cash Equivalents at End of Period $ 62,751 $ 62,091
Supplemental Disclosure of Cash Flow Information:
Income Taxes $ 23 $ 3
Last updated: Jun 7, 2017