onvo-8k_20180208.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549 

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

 

Date of Report (Date of earliest event reported): February 8, 2018

 

ORGANOVO HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

 

Commission File Number: 001-35996

 

Delaware 

 

27-1488943

(State or other jurisdiction

of incorporation)

 

(I.R.S. Employer

Identification No.)

 

6275 Nancy Ridge Dr.,

San Diego, California 92121

(Address of principal executive offices, including zip code)

 

(858) 224-1000

(Registrant’s telephone number, including area code)

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 


 


 

Item 2.02 Results of Operations and Financial Condition

On February 8, 2018, Organovo Holdings, Inc. (the “Company”) issued a press release announcing financial results for the third quarter of its fiscal year, which period ended December 31, 2017.  A copy of the press release is attached hereto as Exhibit 99.1.

The information furnished in this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934 or otherwise subject to the liabilities of that Section and shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission (the “SEC”).

Item 9.01 Financial Statements and Exhibits
(d)

Exhibit No.

 

Exhibits

99.1

 

Press Release, dated February 8, 2018.



 


 

Exhibit Index

Exhibit

No.

 

Description

99.1

 

Press Release, dated February 8, 2018.

 


 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

ORGANOVO HOLDINGS, INC.

 

 

 

 

Date: February 8, 2018

/s/ Taylor Crouch  

 

Taylor Crouch

 

Chief Executive Officer and President

 

 

 

 

onvo-ex991_6.htm

EXHIBIT 99.1

 

 

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 THIRD-QUARTER 2018 RESULTS; COMPANY UPDATES FULL-YEAR FISCAL 2018 OUTLOOK

SAN DIEGO – February 8, 2018 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today reported financial results for the fiscal third quarter of 2018 and updated its full-year fiscal 2018 outlook.  The Company reported fiscal third-quarter total revenue of $1.2 million.  Total revenue was unchanged from the prior-year period and decreased 15 percent versus the fiscal second quarter of 2018.  Net loss was $7.8 million, or $0.07 per share, for the fiscal third quarter of 2018, as compared to $9.6 million, or $0.09 per share, for the fiscal third quarter of 2017.  Negative Adjusted EBITDA(1) for the third quarter was $5.2 million, as compared to $7.3 million for the prior-year period.

“Our liver therapeutic tissue program continues to make excellent progress in achieving critical regulatory and scientific milestones,” said Taylor J. Crouch, CEO, Organovo.  “With the U.S. Food and Drug Administration (“FDA”) recently granting orphan designation for our NovoTissues® treatment of Alpha-1 antitrypsin deficiency (“A1AT”), our path to commercializing this novel therapeutic comes with significant developmental and economic incentives.  With few alternative therapies and a high annual cost of care, patient need is great in treating this rare, debilitating liver disease.  We’ve also begun new studies in a second therapeutic indication within the category of inborn errors of metabolism, Fumarylacetoacetate Hydrolase (“FAH”) deficiency, and look forward to reporting proof-of-principle data in the coming months.”

Crouch continued, “In our commercial segment, we continue to shift our R&D and business development efforts to high-value liver disease modeling services.  We’re seeing meaningful

 


early uptake as we transition away from routine toxicology projects, with nearly all of our service revenue in the fiscal third quarter representing disease modeling studies.  With approximately 250 global programs pursuing treatments in the areas of non-alcoholic fatty liver disease (“NAFLD”) and non-alcoholic steatohepatitis (NASH”), we believe being a pioneer in this area translates into the best path forward for boosting our revenue growth.  Sophisticated clients are already partnering with us in a multi-faceted approach to develop custom tissue models, allowing us to target the entire drug discovery and development spectrum.  We continue to expect deeper engagement from our customers over the next several months.       

Crouch concluded, “We have the ability to monetize our platform in many ways, including the provision of primary human cells for research applications, compound screening in disease models, licensing agreements that capitalize on our technology, and the ongoing development of novel therapeutics.  We’ll continue to direct our resources at all of these opportunities as we focus on long-term value creation.”  

Third-Quarter Organovo Business Highlights

Revenue

 

Total revenue was $1.2 million, unchanged from the year-ago period.  Higher grant revenue related to the Company’s National Institutes of Health (“NIH”) project offset lower revenue from collaborative agreements.      

 

Product and service revenue was $0.8 million, up 19 percent from the prior-year period, largely driven by an increase in liver disease modeling studies and sales from human cell and tissue products.

Operating Expenses

 

Cost of revenues was $0.2 million, a decrease of 9 percent from the prior-year period, reflecting a greater contribution from higher-margin primary human cell and tissue products.   

 


 

Research and development costs decreased 20 percent year-over-year to $4.0 million, primarily due to lower employee and lab supply costs related to the Company’s organizational restructuring and prioritization of R&D projects.

 

Selling, general and administrative expenses decreased 12 percent from the prior-year period to $4.9 million, reflecting lower employee and non-cash stock-based compensation expenses, which offset $0.8 million in severance and other costs related to the Company’s organizational restructuring.

Liquidity & Capital Resources

 

The Company ended the fiscal third quarter with a cash and cash equivalents balance of $47.3 million.

 

During the fiscal third quarter, the Company generated net proceeds of approximately $3.1 million from the issuance of 2.3 million shares of common stock in at-the-market (“ATM”) offerings at a weighted average price of $1.42 per share.  Through January 31, 2018, the Company generated additional net proceeds of approximately $2.1 million from the issuance of 1.5 million shares of common stock in ATM offerings at a weighted average price of $1.40.    

 

Working capital was $46.0 million to end the fiscal third quarter compared to $67.5 million in the prior-year quarter.

Fiscal-Year 2018 Outlook

The Company updated its full-year fiscal 2018 outlook for total revenue and negative Adjusted EBITDA.  The Company now expects:  

 

Total revenue of between $4.5 million and $5.2 million for fiscal-year 2018.  Fiscal 2017 total revenue was $4.2 million.  

 

Negative Adjusted EBITDA of between $25.0 million and $26.0 million for fiscal-year 2018.  Fiscal 2017 negative Adjusted EBITDA was $29.8 million.  The Company’s continued improvement in negative Adjusted EBITDA will be largely driven by reduced

 


 

operating costs as the result of its organizational restructuring and a more rigorous focus on its existing commercial opportunities and therapeutics research program.

 

 

 

Fiscal-Year 2018 Outlook

(November 2017)

Fiscal-Year 2018 Outlook

(February 2018)

Fiscal-Year 2018

Total Revenue

$4.5 million - $6.5 million

$4.5 million - $5.2 million

Fiscal-Year 2018 Negative Adjusted EBITDA

$26.0 million - $28.0 million

$25.0 million - $26.0 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 stock-based compensation.

Definitions & Supplemental Financial Measures

(1)

In addition to disclosing financial results that are determined in accordance with U.S. GAAP, the Company provides Adjusted EBITDA which is a non-GAAP financial measure, as a supplemental measure to help investors evaluate the Company's fundamental operational performance.  Adjusted EBITDA represents earnings before interest, income taxes, depreciation and amortization, stock-based compensation expenses and restructuring/CEO transition costs.  Adjusted EBITDA does not represent, and should not be considered in isolation from, as a substitute for, or as superior to, U.S. GAAP measurements such as net income or loss.  By eliminating interest, income taxes, depreciation and amortization, stock-based compensation expenses and restructuring/CEO transition costs, the Company believes the result is a useful measure across time in evaluating its fundamental core operating performance.  Management also uses Adjusted EBITDA to manage the business, including in preparing its annual operating budget, financial projections and compensation

 


plans.  The Company believes that Adjusted EBITDA is also useful to investors because similar measures are frequently used by securities analysts, investors and other interested parties in their evaluation of companies in similar industries.  However, there is no standardized measurement of Adjusted EBITDA, and Adjusted EBITDA as the Company presents it may not be comparable with similarly titled non-GAAP financial measures used by other companies.  Since Adjusted EBITDA does not account for certain expenses, its utility as a measure of the Company's operating performance has material limitations.  Due to these limitations, investors should not view Adjusted EBITDA in isolation, but should also consider other measurements, such as net income or loss and revenues, to measure the Company’s operating performance.  Please refer to the schedule below for a reconciliation of consolidated GAAP net income to Adjusted EBITDA for the fiscal quarters ended December 31, 2017 and 2016.

 

Organovo Holdings, Inc.

Supplemental Reconciliation of GAAP Net Income to Adjusted EBITDA

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Three Months Ended

 

 

 

 

December 31, 2017

 

December 31, 2016

 

 

 

 

 

 

 

 

 

GAAP net loss

$

(7,791)

$

(9,581)

 

 

Interest expense

 

-

 

-

 

 

Interest income

 

(118)

 

(50)

 

 

Income taxes

 

-

 

1

 

 

Depreciation and amortization

 

315

 

322

 

 

Stock-based compensation

 

1,250

 

2,018

 

 

 

 

 

 

 

 

 

Restructuring/CEO transition

 

1,130

 

-

 

 

 

 

 

 

 

 

 

Adjusted EBITDA

$

(5,214)

$

(7,290)

 

Conference Call Information

As previously announced, the Company will host a conference call to discuss its results at 5:00 p.m. ET on Thursday, February 8, 2018.  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 2242366.  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 Thursday, February 8, 2018 through Thursday, February 15, 2018 at Organovo’s Investor Relations webpage.  Callers can also dial (877) 344-7529 (U.S. only) or (412) 317-0088, Access Code 10115734, for an audio replay of the conference call.

About Organovo Holdings, Inc.

Organovo is developing and commercializing a platform technology to produce and study living tissues that emulate key aspects of human biology and disease for use in drug discovery, clinical development, and therapeutic applications.  The Company develops tissue systems through internal research programs and in collaboration with pharmaceutical, academic and other partners.  Organovo's living tissues have the potential to transform the drug discovery process, enabling treatments to be developed more effectively and with greater relevance to performance in human trials and commercialization.  The Company’s ExViveTM Liver and Kidney Tissues are used in high-value drug profiling, including compound screening in disease models, toxicology, target and marker discovery/validation, and other drug testing.  The Company is also advancing a preclinical program to develop its NovoTissues® liver therapeutic tissues for critical unmet medical needs, including certain life-threatening pediatric diseases.  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.  Forward-looking statements include, but are not limited to, statements regarding the potential for one or more customer’s electing to move toward framework agreements involving annual budgets, revenue commitments, and/or dedicated research plans, statements regarding customer demand for and acceptance of our disease modeling services and statements regarding the potential benefits and therapeutic uses of the Company’s therapeutic liver tissue, including the benefits of an orphan designation.  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 execute framework agreements involving multi-year commitments and routine use on a timely basis, or at all; 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 recognize deferred revenue; 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; the Company’s ability to control the costs and to achieve the expected operational benefits and long-term cost savings of its restructuring plan; 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 Quarterly Report on Form 10-Q filed with the SEC on February 8, 2018 and 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.

Unaudited Condensed Consolidated Statements of Operations and

 

 

 

 

Three Months Ended

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Nine Months Ended

 

 

 

December 31, 2017

 

 

December 31, 2016

 

 

December 31, 2017

 

 

December 31, 2016

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Products and services

 

$

832

 

 

$

699

 

 

$

2,722

 

 

$

2,396

 

Collaborations and licenses

 

 

61

 

 

 

443

 

 

 

367

 

 

 

1,001

 

Grants

 

 

260

 

 

 

9

 

 

 

409

 

 

 

21

 

Total Revenues

 

 

1,153

 

 

 

1,151

 

 

 

3,498

 

 

 

3,418

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenues

 

 

192

 

 

 

212

 

 

 

747

 

 

 

773

 

Research and development expenses

 

 

4,005

 

 

 

5,024

 

 

 

13,982

 

 

 

14,012

 

Selling, general, and administrative expenses

 

 

4,865

 

 

 

5,546

 

 

 

16,457

 

 

 

16,520

 

Total costs and expenses

 

 

9,062

 

 

 

10,782

 

 

 

31,186

 

 

 

31,305

 

Loss from Operations

 

 

(7,909

)

 

 

(9,631

)

 

 

(27,688

)

 

 

(27,887

)

Other Income (Expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of warrant liabilities

 

 

 

 

 

1

 

 

 

 

 

 

(4

)

Interest expense

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

118

 

 

 

50

 

 

 

334

 

 

 

124

 

Total Other Income (Expense)

 

 

118

 

 

 

51

 

 

 

334

 

 

 

120

 

Income Tax Expense

 

 

 

 

 

(1

)

 

 

 

 

 

(23

)

Net Loss

 

$

(7,791

)

 

$

(9,581

)

 

$

(27,354

)

 

$

(27,790

)

Currency Translation Adjustment

 

$

(2

)

 

$

(3

)

 

$

(2

)

 

$

(10

)

Comprehensive Loss

 

$

(7,793

)

 

$

(9,584

)

 

$

(27,356

)

 

$

(27,800

)

Net loss per common share—basic and diluted

 

$

(0.07

)

 

$

(0.09

)

 

$

(0.26

)

 

$

(0.29

)

Weighted average shares used in computing net

   loss per common share—basic and diluted

 

 

107,345,623

 

 

 

101,174,734

 

 

 

106,107,721

 

 

 

95,595,640

 

 

 

 


Organovo Holdings, Inc.

Consolidated Balance Sheets

 

 

 

 

December 31, 2017

 

 

March 31, 2017

 

 

 

(Unaudited)

 

 

(Audited)

 

Assets

 

 

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

47,338

 

 

 

62,751

 

Accounts receivable

 

 

1,174

 

 

 

647

 

Grant receivable

 

 

260

 

 

 

-

 

Inventory, net

 

 

605

 

 

 

550

 

Prepaid expenses and other current assets

 

 

891

 

 

 

1,144

 

Total current assets

 

 

50,268

 

 

 

65,092

 

Fixed assets, net

 

 

2,978

 

 

 

3,840

 

Restricted cash

 

 

127

 

 

 

127

 

Other assets, net

 

 

181

 

 

 

121

 

Total assets

 

$

53,554

 

 

$

69,180

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

452

 

 

$

1,171

 

Accrued expenses

 

 

2,808

 

 

 

4,101

 

Deferred revenue

 

 

857

 

 

 

582

 

Deferred rent

 

 

180

 

 

 

157

 

Total current liabilities

 

 

4,297

 

 

 

6,011

 

Deferred revenue, net of current portion

 

 

43

 

 

 

58

 

Deferred rent, net of current portion

 

 

613

 

 

 

749

 

Total liabilities

 

 

4,953

 

 

 

6,818

 

Commitments and Contingencies (Note 3)

 

 

 

 

 

 

 

 

Stockholders’ Equity

 

 

 

 

 

 

 

 

Common stock, $0.001 par value; 150,000,000 shares authorized,

   109,322,626 and 104,551,466 shares issued and outstanding at

   December 31, 2017 and March 31, 2017, respectively

 

 

109

 

 

 

104

 

Additional paid-in capital

 

 

275,176

 

 

 

261,586

 

Accumulated deficit

 

 

(226,671

)

 

 

(199,317

)

Accumulated other comprehensive income (loss)

 

 

(13

)

 

 

(11

)

Total stockholders’ equity

 

 

48,601

 

 

 

62,362

 

Total Liabilities and Stockholders’ Equity

 

$

53,554

 

 

$

69,180

 

 

 


Organovo Holdings, Inc.

Unaudited Consolidated Statements of Cash Flows

 

 

 

 

Nine Months Ended

 

 

Nine Months Ended

 

 

 

12/31/2017

 

 

12/31/2016

 

Cash Flows From Operating Activities

 

 

 

 

 

 

 

 

Net loss

 

$

(27,354

)

 

$

(27,790

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

962

 

 

 

824

 

Change in fair value of warrant liabilities

 

 

 

 

 

4

 

Stock-based compensation

 

 

5,600

 

 

 

5,540

 

Increase (decrease) in cash resulting from changes in:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(527

)

 

 

(771

)

Grants receivable

 

 

(260

)

 

 

 

Inventory

 

 

(55

)

 

 

6

 

Prepaid expenses and other assets

 

 

253

 

 

 

400

 

Accounts payable

 

 

(719

)

 

 

(65

)

Accrued expenses

 

 

(1,293

)

 

 

486

 

Deferred rent

 

 

(113

)

 

 

(103

)

Deferred revenue

 

 

260

 

 

 

(490

)

Net cash used in operating activities

 

 

(23,246

)

 

 

(21,959

)

Cash Flows From Investing Activities

 

 

 

 

 

 

 

 

Restricted cash deposits

 

 

 

 

 

(48

)

Purchases of fixed assets

 

 

(90

)

 

 

(1,061

)

Purchases of intangible assets

 

 

(70

)

 

 

 

Net cash used in investing activities

 

 

(160

)

 

 

(1,109

)

Cash Flows From Financing Activities

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock and exercise of warrants, net

 

 

7,169

 

 

 

30,401

 

Proceeds from exercise of stock options

 

 

826

 

 

 

582

 

Net cash provided by financing activities

 

 

7,995

 

 

 

30,983

 

Effect of currency exchange rate changes on cash and cash equivalents

 

 

(2

)

 

 

(10

)

Net Increase (Decrease) in Cash and Cash Equivalents

 

 

(15,413

)

 

 

7,905

 

Cash and Cash Equivalents at Beginning of Period

 

 

62,751

 

 

 

62,091

 

Cash and Cash Equivalents at End of Period

 

$

47,338

 

 

$

69,996

 

Supplemental Disclosure of Cash Flow Information:

 

 

 

 

 

 

 

 

Interest paid

 

$

 

 

$

 

Income taxes paid

 

$

 

 

$

23