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8-K - FORM 8-K - ORGANOVO HOLDINGS, INC.d441056d8k.htm

Exhibit 99.1

For Immediate Release

ORGANOVO REPORTS Q3 2012 FINANCIAL RESULTS, PROVIDES BUSINESS UPDATE

SAN DIEGO, CA – November 16, 2012 – Organovo Holdings, Inc. (OTCQX: ONVO) (“Organovo”) a three-dimensional biology company focused on delivering breakthrough 3-D bioprinting technology, has reported on its financial results for the three and nine month period ended September 30, 2012.

Third Quarter Corporate Highlights

 

   

National Institutes of Health three dimensional liver research grant revenue

 

   

Receipt of two issued patents, including Company’s first assigned patent

 

   

Move to new, larger research and headquarters facility

 

   

Appointment of additional independent director to serve as Audit Committee Chairman

Third quarter 2012 revenues increased by $237,300 or approximately 102% over the same period in 2011, commensurate with the Company’s continued delivery against collaborative research agreements and the initiation of research activities within the scope of a grant from the National Institutes of Health (“NIH”). Collaborative research agreement revenues contributed $141,800 or 60% of the revenue increase while grant revenues contributed $95,500.

Cash receipts related to the reported revenues partially offset the Company’s operating expenses and strengthened our balance sheet. During the quarter the balance sheet was additionally strengthened through the receipt of approximately $1.7 million in capital from warrant and stock option exercises. The Company had approximately $7.7 million cash on hand at the end of the quarter. While the Company reported net earnings of approximately $38.5 million for the quarter, investors should note those earnings were primarily the result of a non-cash adjustment resulting from the change in fair value of our warrant liabilities. The warrant liability is volatile in nature and is driven primarily by changes in the price of our Common stock, absent material changes in the number of warrants outstanding. Investors should anticipate swings in that fair value will continue to impact reported earnings and losses.

On July 9, 2012, Organovo announced the receipt of two issued patents. The patents consisted of the issuance in the United States of a patent to which the Company owns the exclusive license from the University of Missouri, and the issuance in the United Kingdom of the Company’s first assigned patent.

On July 9, 2012 Organovo announced the appointment of James T. Glover, former CFO of Beckman Coulter and Anadys Pharmaceuticals, to its Board of Directors. Mr. Glover has been affirmed as an independent director by the Organovo Board of Directors, and the Company expects to recruit additional independent directors in the future to meet the Board independence requirements of both NASDAQ and NYSE.

On July 17, 2012, Organovo announced the commencement of operations at its new, larger facility in San Diego, California. The increased capacity will facilitate execution of planned research, product development, and commercial initiatives. The new facility has three times the laboratory space and approximately four times the cleanroom space of our prior facility and is expected to provide adequate capacity for our immediate and near-term needs including product manufacturing. At September 30,


2012, the Company employed twenty-six full-time employees and six part-time employees, including twenty-four individuals in research and development, an increase over second quarter employment by four full-time and two part-time employees.

“Organovo has continued to execute its business plan and has grown substantially in 2012,” stated Keith Murphy, chief executive officer of Organovo. “As a result we are better positioned to deliver on 3D bioprinted liver, new tissue-based disease models, and future partnership opportunities. We believe all of these efforts will continue to grow shareholder value over the long term.”

Financial Results

For the third quarter 2012 total revenues of approximately $469,200 were $237,300 or 102% above the approximately $232,000 in revenues for the same period in 2011. Collaborative research revenues for the third quarter of approximately $373,800 increased $141,800 or 61% over the same period of prior year revenues of approximately $232,000. Grant revenue for the three months ended September 30, 2012 of approximately $95,500 increased approximately $95,500 over the same period of prior year. No grant revenue was received in the prior year third quarter.

Operating expenses increased approximately $3,232,500 or 378% in the three months ended September 30, 2012 over the same period in 2011, from approximately $854,400 in 2011 to $4,086,900 in 2012. Most significantly, relative to the same period in the prior year, the Company invested in infrastructure and outside services to support its transition from private ownership to a publicly owned and traded corporation. As expected in such transition, incremental initiatives were established in investor outreach, corporate governance, and SEC financial reporting. Non-payroll related incremental public company expenses incurred in the three month period ended September 30, 2012 were approximately $308,200. There were no such expenses incurred in the same period, prior year, due to our status as a private company. . Moreover, the Company invested in building its executive, research, and development staff, and in expanding the number of independent board directors. As a result payroll related expenses, for the three months ended September 30, 2012, increased by approximately $676,800 or 236% over the same period in 2011. Similarly, stock-based compensation expenses increased approximately $1,277,200, fees to our non-employee board members were initiated, raising period expenses by $32,900 and we moved into a new, larger facility to accommodate our growing administrative and research staff. Facility related expenses increased approximately of $97,500 over the same period in 2011, as a result of that move.

The approximate $42,278,500 increase in other income (expense) for the three month period ending September 30, 2012 over the same period of the prior year, was primarily related to the change in fair value of warrant liabilities for the three months ended September 30, 2012 of approximately $42,252,400. During the Private Placement in the first quarter of 2012 we issued warrants to purchase 6,099,195 shares of our common stock to the placement agent and warrants to purchase 15,247,987 of our common stock to investors in the Private Placement. The warrants issued to the placement agent and Private Placement investors were determined to be derivative liabilities as a result of the anti-dilution provisions in the warrant agreements that may result in an adjustment to the warrant exercise price. We will revalue the derivative liability on each balance sheet date and will do so until the securities to which the derivatives liabilities relate are exercised or expire. The third quarter of 2012 also included a loss on disposal of fixed assets of approximately $158,400 which occurred in relation to moving to our new facility. Other expenses for the three months ended September 30, 2011 of approximately $182,800 related primarily to interest recorded on convertible notes payable.

About Organovo Holdings, Inc.

Organovo is a three-dimensional biology company focused on delivering breakthrough bioprinting


technology and creating tissue on demand for research and medical applications. The Company’s NovoGen three-dimensional bioprinting technology is a platform that works across all tissue and cell types. Organovo’s NovoGen MMX Bioprinter was selected as one of the “Best Inventions of 2010” by TIME Magazine. Organovo is helping pharmaceutical partners develop human biological disease models in three dimensions that enable therapeutic drug discovery and development. Organovo’s bioprinting technology can also be developed to create surgical tissues direct therapy. Organovo leads the way in solving complex medical research problems and building the future of medicine. For more information, please visit http://www.organovo.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may 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 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 based on its technology; the expected benefits and efficacy of the Company’s products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including, our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.

 

Investor Contact:

  

Media Contact:

Barry Michaels    Mike Renard
Chief Financial Officer    Exec. VP, Commercial Operations
858-224-1003    858-224-1006
or    mrenard@organovo.com
Gerry Amato   
Booke and Company   
Investor Relations   
admin@bookeandco.com   


Organovo Holdings Inc.

(A development stage company)

Condensed Consolidated Balance Sheets

 

     September 30,
2012
    December 31,
2011
 
     (Unaudited)     (Audited)  

Assets

    

Current Assets

    

Cash and cash equivalents

   $ 7,675,918      $ 339,607   

Grants receivable

     95,477        —     

Inventory

     312,182        291,881   

Deferred financing costs

     —          318,843   

Prepaid expenses and other current assets

     144,515        79,874   
  

 

 

   

 

 

 

Total current assets

     8,228,092        1,030,205   

Fixed Assets—Net

     605,920        278,208   

Restricted Cash

     88,321        —     

Other Assets

     120,890        100,419   
  

 

 

   

 

 

 

Total assets

   $ 9,043,223      $ 1,408,832   
  

 

 

   

 

 

 

Liabilities and Stockholders’ Deficit

    

Current Liabilities

    

Accounts payable

   $ 61,347      $ 657,560   

Accrued expenses

     830,033        437,837   

Deferred revenue

     75,000        152,500   

Capital lease obligation, current portion

     9,845        —     

Accrued interest payable

     —          24,018   

Convertible notes payable, current portion

     —          703,833   
  

 

 

   

 

 

 

Total current liabilities

     976,225        1,975,748   

Capital lease obligation, net current portion

     19,712        —     

Warrant Liabilities

     35,471,527        1,266,869   
  

 

 

   

 

 

 

Total liabilities

   $ 36,467,464      $ 3,242,617   

Commitments and Contingencies

    

Stockholders’ Deficit

    

Common stock, $0.001 par value; 150,000,000 shares authorized, 43,772,483 and 22,445,254 issued and outstanding at September 30, 2012 and December 31, 2011, respectively

     46,969        22,445   

Additional paid-in capital

     13,208,039        4,835,326   

Deficit accumulated during the development stage

     (40,679,249     (6,691,556
  

 

 

   

 

 

 

Total stockholders’ deficit

     (27,424,241     (1,833,785
  

 

 

   

 

 

 

Total Liabilities and Stockholders’ Deficit

   $ 9,043,223      $ 1,408,832   
  

 

 

   

 

 

 


Organovo Holdings, Inc.

(A development stage company)

Unaudited Condensed Consolidated Statements of Operations

 

     Three Months Ended
September 30, 2012
    Three Months Ended
September 30, 2011
    Nine Months Ended
September 30, 2012
    Nine Months Ended
September 30, 2011
    Period from
April 19, 2007
(Inception)
through
September 30,
2012
 

Revenues

          

Product

   $ —        $ —        $ —        $ 100,000      $ 223,500   

Collaborations

     373,761        231,974        752,736        449,213        1,515,824   

Grants

     95,477        —          95,477        56,925        759,589   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Revenues

     469,238        231,974        848,213        606,138        2,498,913   

Cost of product revenue

     —          —          —          50,584        133,607   

Selling, general, and administrative expenses

     2,981,481        550,157        4,939,403        1,129,597        7,605,440   

Research and development expenses

     1,105,456        304,251        2,305,311        1,013,981        5,503,699   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss from Operations

     (3,617,699     (622,434     (6,396,501     (1,588,024     (10,743,833
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other Income (Expense)

          

Fair value of warrant liabilities in excess of proceeds received

     —          —          (19,019,422     —          (19,019,422

Change in fair value of warrant liabilities

     42,252,357        —          (5,190,637     —          (5,197,206

Financing transaction costs in excess of proceeds received

     —          —          (2,129,500     —          (2,129,500

Loss on disposal of fixed assets

     (158,366     —          (158,366     —          (158,366

Interest expense

     (203     (182,320     (1,087,656     (294,245     (3,406,098

Interest income

     1,358        —          3,342        —          5,348   

Other income (expense)

     596        (488     (8,953     (2,038     (30,172
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Other Income (Expense)

     42,095,742        (182,808     (27,591,192     (296,283     (29,935,416
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net Loss

   $ 38,478,043      $ (805,242   $ (33,987,693   $ (1,884,307   $ (40,679,249
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) per common share—basic

   $ 0.87      $ (0.07   $ (0.86   $ (0.16  

Net income (loss) per common share—diluted

   $ 0.69      $ (0.07   $ (0.86   $ (0.16  

Weighted average shares used in computing net income (loss) per common share—basic

     44,099,554        12,262,691        39,349,681        11,537,879     

Weighted average shares used in computing net income (loss) per common share—diluted

     55,849,360        12,262,691        39,349,681        11,537,879     


Organovo Holdings, Inc.

(A development stage company)

Unaudited Condensed Consolidated Statements of Cash Flows

 

     Nine Months Ended
September 30, 2012
    Nine Months Ended
September 30, 2011
    Period from
April 19, 2007
(Inception)
through
September
30, 2012
 

Cash Flows From Operating Activities

      

Net loss

   $ (33,987,693   $ (1,884,307   $ (40,679,249

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

      

Amortization of deferred financing costs

     318,843        —          438,296   

Loss on disposal of fixed assets

     158,366        —          158,366   

Depreciation and amortization

     116,828        49,929        273,156   

Amortization of debt discount

     896,167        97,565        2,083,735   

Interest accrued on convertible notes payable

     11,616        196,680        495,392   

Fair value of warrant liabilities in excess of proceeds

     19,019,422        —          19,019,422   

Change in fair value of warrant liabilities

     5,190,637        —          5,197,206   

Stock-based compensation

     1,284,529        2,596        1,301,478   

Amortization of warrants issued for services

     36,054        —          36,054   

Warrants issued in connection with exchange agreement

     —          —          527,629   

Increase (decrease) in cash resulting from changes in:

         —     

Accounts receivable

     —          —          —     

Grants receivable

     (95,477 )     59,744        (95,477 )

Inventory

     (327,993     (212,395     (619,874

Prepaid expenses and other assets

     (53,490     1,044        (146,496

Accounts payable

     (596,213     374,973        61,347   

Accrued expenses

     392,196        260,031        830,033   

Deferred revenue

     (77,500 )     95,075        75,000   
  

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

     (7,713,708     (959,065     (11,043,982
  

 

 

   

 

 

   

 

 

 

Cash Flows From Investing Activities

      

Restricted cash deposits

     (88,321     —          (88,321

Purchases of fixed assets

     (255,750     (16,290     (682,573

Purchases of intangible assets

     —          (65,000     (95,000
  

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

     (344,071     (81,290     (865,894
  

 

 

   

 

 

   

 

 

 

Cash Flows From Financing Activities

      

Proceeds from issuance of convertible notes payable

     —          1,042,500        4,630,000   

Proceeds from issuance of common stock and warrants

     15,491,075        —          15,491,075   

Proceeds from exercise of stock options

     17,925        —          17,925   

Proceeds from issuance of related party notes payable

     —          225,000        250,000   

Principal payments on capital lease obligations

     (4,663     —          (4,663

Repayment of related party notes payable

     —          (250,000     (250,000

Repayment of convertible notes and interest payable

     (110,247     —          (110,247

Deferred financing costs

     —          (205,984     (438,296
  

 

 

   

 

 

   

 

 

 

Net cash provided by financing activities

     15,394,090        811,516        19,585,794   
  

 

 

   

 

 

   

 

 

 

Net Increase (Decrease) in Cash and Cash Equivalents

     7,336,311        (228,839     7,675,918   

Cash and Cash Equivalents at Beginning of Period

     339,607        285,308        —     
  

 

 

   

 

 

   

 

 

 

Cash and Cash Equivalents at End of Period

   $ 7,675,918      $ 56,469      $ 7,675,918