Revenues for three months ended September 30, 2012 and 2011 were approximately $390,000 and $320,000 respectively. Revenues were attributable to providing technology services to Fiocruz to assist it in implementing the Company’s technology for a future Phase 1 clinical trial of yellow fever.
Research and development expense for the three months ended September 30, 2012 was approximately $1,178,000 compared to $1,457,000 for the three months ended September 30, 2011, a difference of $279,000. This decrease primarily relates to a research project (“Project 1”) that the Company entered in December 2010 with FhCMB to evaluate gene expression and protein production. Work on this project terminated, and there was no expense for the three months ended September 30, 2012 which resulted in a decrease in the expense from the comparable period for September 30, 2011 of approximately $264,000. The focus of that project was to determine feasibility and relative priority, for business development purposes, of several protein therapeutic candidates that are representative of market classes of products. For example, two market classes are monoclonal antibodies and plasma-derived proteins. The Company entered into an additional project with FhCMB (“Project 2”) which was completed during the year ended June 30, 2012. This also resulted in a decrease in expenses of approximately $211,000 for the three months ended September 30, 2012 as compared to the three months ended September 30, 2011. This project was to evaluate the mechanism of immune-potentiating activity of LicKM, which is a thermostable bacterial enzyme used as a carrier molecule for vaccine antigens. There was an additional decrease in expense by approximately $76,000 for the expenses incurred with the Technology Transfer Agreement (“TTA”) with FhCMB. The estimated amount incurred with the agreement over the service period was more during the three months ended September 30, 2011 than the comparable period in 2012. Increases in research and development expense were approximately $95,000 for outside services to a related party to perform laboratory feasibility analyses of gene expression and protein purification and also preparation of research samples. There were expenses that increased during the three months ended September 30, 2012 by approximately $70,000 for FhCMB to service the yellow fever vaccine contract with Fiocruz using iBio’s technology. In addition, share-based compensation expense for options issued to employees and to consultants increased by approximately $147,000 during the three months ended September 30, 2012 as compared to the three months ended September 30, 2011. Non-employee options are revalued each reporting period using the Black-Scholes option pricing model. The stock price is a component in the Black-Scholes calculation, which is used to compute fair market value. Changes in the Company’s closing stock price can result in fluctuations in share-based compensation results between reported periods.
General and administrative expense for the three months ended September 30, 2012 was approximately $1,023,000 compared to $1,189,000 for the three months ended September 30, 2011, a decrease of $166,000. The decrease is primarily attributed to reduced professional fees of approximately $139,000 and an increase in share-based compensation expense of approximately $1,000.
The Company is required to account for the August 2008 Warrants (“August 2008 Warrants”) as derivative liabilities. The Company is required to mark to market in each reporting period, the value of the embedded derivative. The derivative liabilities are revalued at the end of each reporting period. The periodic change in value of the derivative liabilities is recorded as either non-cash derivative income (if the value of the embedded derivative and the August Warrants decrease) or as non-cash derivative expense (if the value of the embedded derivative and the August 2008 Warrants increase). If the stock price increases, the derivative liability will generally increase and if the stock price decreases, the derivative financial liability will generally decrease. The Company recorded non-cash expense and non-cash income of approximately $241,000 and $2,704,000, for the three months ended September 30, 2012 and 2011, respectively. The calculation of this derivative financial liability is affected by factors which are subject to significant fluctuations and are not under the Company’s control. Therefore, the resulting effect upon our net income or loss is subject to significant fluctuations and will continue to be subject to significant fluctuations until the warrants either expire in August 2013 or are exercised prior to that date.
Net (loss) income per share
Based upon the above, the net (loss) income for the three months ended September 30, 2012 and 2011 was approximately $(2,051,000) and $383,000, or $(0.04) and $0.01 per share, respectively.
Liquidity and Capital Resources
The Company has incurred losses and negative cash flows from operations since the spinoff from its Former Parent in August 2008. As of September 30, 2012, the Company had an accumulated deficit of approximately $33,389,000 and cash used in operating activities for the three months ended September 30, 2012 and 2011 approximated $1,290,000 and $1,228,000, respectively. The Company has historically financed its activities primarily through the sale of common stock and warrants. Through September 30, 2012, the Company has dedicated most of its financial resources to investing in its iBioLaunch™ platform, advancing intellectual property, product candidate development, and general and administrative activities.
These matters raise questions about the Company’s ability to continue as a going concern. These financial statements were prepared under the assumption that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of that uncertainty.
In addition, the Company estimates that the cash on hand as of September 30, 2012 of approximately $4,276,000 will be adequate to fund its operations until the end of the second calendar quarter of 2013. The Company plans to fund its further development and commercialization through licensing and partnering arrangements, which may include milestone receipts and royalties and/or the sale of equity securities or debt. The Company cannot be certain that such funding will be available on acceptable terms or available at all. To the extent that the Company raises additional funds by issuing equity securities, its stockholders may experience dilution. Further, if additional funds are raised through the issuance of equity or debt, such instruments may have powers, designations, preferences or rights senior to its currently outstanding securities. If the Company is unable to raise funds when required or on acceptable terms, it may have to: a) significantly delay, scale back, or discontinue the product application and/or commercialization of its technologies; b) seek collaborators for product candidates on terms that are less favorable than might otherwise be available; or c) relinquish or otherwise dispose of rights to technologies, product candidates, or products that it would otherwise seek to develop or commercialize itself; and d) possibly cease operations.
On July 26, 2011, the Company filed with the SEC a Registration Statement on Form S-3 under the Securities Act, which was declared effective by the SEC on July 28, 2011. This Registration Statement allows the Company, from time to time, to offer and sell shares of common stock, preferred stock, warrants, purchase its securities and/or debt securities, up to a maximum aggregate amount of $100 million of such securities. The Company raised gross proceeds of $10 million in January 2012 under this Registration Statement.
For the three months ended September 30, 2012 and 2011, the Company had net cash used in operating activities of approximately $1,290,000 and $1,228,000, respectively. The net cash used in operating activities for the three months ended September 2012 primarily resulted from the loss from operations of $2,051,000, adjusted for the effects of non-cash activity from the change in fair value of derivative instrument liability of $241,000, stock-based compensation expense of $454,000, depreciation and amortization of $82,000 and changes in operating assets and liabilities of $16,000. Included in the changes in operating assets are net decreases in prepaid expenses, other receivable and other current assets of $440,000, which primarily resulted from the reduction of the prepaid expense recorded for the TTA of $500,000, and an increase in accounts receivable of $39,000. Included in changes in operating liabilities was a decrease in accounts payable of $427,000 relating to timing of payments made to vendors and an increase in accrued expense of $10,000. The net cash used in operating activities for the three months ended September 30, 2011 resulted from net income from operations of approximately $383,000, adjusted for the effects of non-cash activity related to change in fair value of derivative instrument liability of $2,704,000, stock-based compensation expense of $306,000, depreciation and amortization of $80,000 and changes in operating assets and liabilities of $707,000. Included in the changes in operating assets were net decreases in prepaid expenses, other receivable and other currents assets of $427,000, which primarily resulted from the reduction of the prepaid expense recorded for the TTA of $576,000, and decrease in accounts receivable of $24,000. Included in changes in operating liabilities was an increase in accrued expense of $171,000, which primarily resulted from the expense recorded for a project with FhCMB of $131,000, and an increase in accounts payable of $85,000.
For the three months ended September 30, 2012 and 2011, net cash used in investing activities was approximately $58,000 and $92,000, respectively, which was from additions for intangible assets.
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COMMITMENTS AND CONTINGENCIES
Please refer to Note I in our Annual Report on Form 10-K for the year ended June 30, 2012, under the heading Commitments and Contingencies.
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Item 3 | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide this information under this item.
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Item 4 | CONTROLS AND PROCEDURES |
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(a) Evaluation of Disclosure Controls and Procedures |
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| As of September 30, 2012, the end of the period covered by this report, our management, including our Chief Executive Officer and our Chief Financial Officer, reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended). Such disclosure controls and procedures are designed to ensure that material information we must disclose in this report is recorded, processed, summarized and filed or submitted on a timely basis. Based upon that evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures were effective as of September 30, 2012. |
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(b) Changes in Internal Control over Financial Reporting |
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| There were no changes in our internal control over financial reporting during the first quarter of fiscal 2013 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting. |
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PART II | OTHER INFORMATION |
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Item 1 | LEGAL PROCEEDINGS |
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We are not currently a party to any material legal proceedings. |
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Item 1A | RISK FACTORS |
The risks described in Item 1A, Risk Factors, in our Annual Report on Form 10-K for the year ended June 30, 2012, could materially and adversely affect our business, financial condition and results of operations. The risk factors discussed in that Form 10-K do not identify all risks that we face because our business operations could also be affected by additional factors that are not presently known to us or that we currently consider to be immaterial to our operations.
We could become non-compliant with exchange listing standards
On November 4, 2011, the Company received notice from NYSE Amex LLC (the “Exchange”) that the Company was below certain of the Exchange’s continued listing standards. The Exchange indicated that its review of the Company’s Form 10-K for the year ended June 30, 2011, indicated that the Company was not in compliance with Section 1003(a)(iv), which applies if a listed company has sustained losses that are so substantial in relation to its overall operations or its existing financial resources, or its financial condition has become so impaired that it appears questionable, in the opinion of the Exchange, as to whether the company will be able to continue operations and/or meet its obligations as they mature.
The Company was afforded the opportunity to submit a plan of compliance to the Exchange by November 28, 2011 that would demonstrate the Company’s ability to regain compliance with Section 1003(a)(iv) of the Company Guide by January 25, 2012.
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The Company provided the Exchange with a satisfactory plan by November 28, 2011, to show that it would be able to return to compliance with Section 1003(a)(iv) of the Company Guide by January 25, 2012. Based upon subsequent submissions by the Company to the Exchange on January 27, 2012, the Exchange confirmed that the listing deficiency was resolved. Although the previous listing deficiency was resolved, we cannot provide assurance that we will not be out of compliance in the future. Any such non-compliance could cause our common stock to no longer be listed on the Exchange, which could affect the market price and liquidity of our common stock.
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Item 2 | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
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None. | |
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Item 3 | DEFAULTS UPON SENIOR SECURITIES |
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None. | |
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Item 4. | MINE SAFETY DISCLOSURES |
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Not applicable. | |
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Item 5 | OTHER INFORMATION |
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None. | |
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Item 6 | EXHIBITS |
Exhibit Number
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31.1 | Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 by Chief Executive Officer. |
31.2 | Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 by Chief Financial Officer. |
32.1 | Certification of periodic financial report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 by Chief Executive Officer. |
32.2 | Certification of periodic financial report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 by Chief Financial Officer. |
101.INS | XBRL Instance Document ‡ |
101.SCH | XBRL Taxonomy Extension Schema Document‡ |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF | XBRL Extension Definition |
101.LAB | XBRL Taxonomy Extension Label Linkbase Document‡ |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document‡ |
‡ Pursuant to applicable securities laws and regulations, the Registrant is deemed to have complied with the reporting obligation relating to the submission of interactive data files in such exhibits and is not subject to liability under any anti-fraud provisions of the federal securities laws as long as the Registrant has made a good faith attempt to comply with the submission requirements and promptly amends the interactive data files after becoming aware that the interactive data files fail to comply with the submission requirements. These interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under these sections.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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| | iBio, Inc. |
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Date: | November 14, 2012 | By: | /s/ Robert B. Kay |
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| | Robert B. Kay, |
| | Chief Executive Officer |
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Date: | November 14, 2012 | By: | /s/ Douglas Beck, CPA |
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| | Douglas Beck, CPA |
| | Chief Financial Officer |
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