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| PBIO > SEC Filings for PBIO > Form 10-Q on 15-Aug-2012 | All Recent SEC Filings |
15-Aug-2012
Quarterly Report
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. In some cases, forward-looking statements are identified by terms such as "may", "will", "should", "could", "would", "expects", "plans", "anticipates", "believes", "estimates", "projects", "predicts", "potential", and similar expressions intended to identify forward-looking statements. Such statements include, without limitation, statements regarding:
- our need for, and our ability to raise additional equity or debt financing
on acceptable terms, if at all;
- our belief that we have sufficient liquidity to finance normal operations
until the end of August 2012;
- our need to take additional cost reduction measures, cease operations or
sell our operating assets, if we are unable to obtain sufficient additional
financing in the future;
- the amount of cash necessary to operate our business;
- the amount of grant revenue and anticipated uses of grant revenue in future
periods;
- our plans and expectations with respect to our pressure cycling technology
(PCT) operations;
- the potential applications for PCT;
- the expected expenses, benefits and results from our research and
development efforts;
- the expected benefits and results from our collaboration efforts, strategic
alliances and joint ventures;
- the expected increase in number of PCT units installed and the increase in
revenues from sale of consumable products and extended service contracts;
- the potential size of the market for biological sample preparation;
- general economic conditions; and
- the anticipated future financial performance and business operations of our
Company.
These forward-looking statements are only predictions and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this Report. Except as otherwise required by law, we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this Report to reflect any change in our expectations or any change in events, conditions, or circumstances on which any of our forward-looking statements are based or to conform to actual results. We qualify all of our forward-looking statements by these cautionary statements. You should read this section in combination with the section entitled Management's Discussion and Analysis of Financial Condition and Results of Operations for the year ended December 31, 2011 included in our Annual Report on Form 10-K for the year ended December 31, 2011.
Factors that could cause or contribute to differences in our future financial and operating results include those discussed in the risk factors set forth in Item 1 of our Annual Report on Form 10-K for the year ended December 31, 2011, as well as those discussed elsewhere in this Report. The risks described in our Form 10-K and this Report are not the only risks that we face. Additional risks not presently known to us or that we do not currently consider significant may also have an adverse effect on us. If any of the risks actually occur, our business, results of operations, cash flows or financial condition could suffer.
As of August 2, 2012, we had available cash of approximately $100,000. We require additional capital to fund our operations and cannot ensure that additional capital will be available on acceptable terms or at all.
We have experienced negative cash flows from operations from our pressure cycling technology business since we commenced our pressure cycling technology operations. As of August 2, 2012, we had available cash of approximately $100,000 which, based on current projections, will be sufficient to fund normal operations until the end of August 2012. We need substantial additional capital to fund our operations in periods beyond August 2012. If we are unable to raise sufficient funds from equity or debt financings or other sources of financing, we may need to cease our business operations.
We failed to meet applicable NASDAQ Stock Market requirements and as a result we delisted our stock from The NASDAQ Capital Market, which could adversely affect the market liquidity of our common stock and harm our businesses.
Until April 5, 2012, our common stock was traded on The NASDAQ Capital Market. As a result of our stockholders' equity falling below the minimum $2.5 million requirement and the bid price of our common stock remaining below the minimum $1.00 per share requirement for continued inclusion on The NASDAQ Capital Market, on April 5, 2012, our common stock was delisted from The NASDAQ Capital Market and on April 5, 2012 our common stock began trading on the OTCQB Marketplace under the ticker symbol PBIO. We continue to file periodic reports with the Securities and Exchange Commission in accordance with the requirements of Section 12(g) of the Securities Exchange Act of 1934, as amended.
Our delisting from The NASDAQ Capital Market and commencement of trading on the OTCQB Marketplace may result in a reduction in some or all of the following, each of which could have a material adverse effect on our shareholders:
• the liquidity of our shares of common stock;
• the market price of our shares of common stock;
• our ability to obtain financing for the continuation of our operations;
• the number of institutional and other investors that will consider investing in our shares of common stock;
• the number of market markers in our shares of common stock;
• the availability of information concerning the trading prices and volume of our shares of common stock;
• and the number of broker-dealers willing to execute trades in our shares of common stock.
Furthermore, as a result of our delisting, our shares of common stock are subject to the so-called "penny stock" rules. The SEC has adopted regulations that define a penny stock to be any equity security that has a market price per share of less than $5.00, subject to certain exceptions, such as any securities listed on a national securities exchange. For any transaction involving a penny stock, unless exempt, the rules impose additional sales practice requirements on broker-dealers, subject to certain exceptions. As a result of being a penny stock, a broker-dealer may find it more difficult to trade our shares of common stock and an investor may find it more difficult to acquire or dispose of our shares of common stock on the secondary market. Investors in penny stocks should be prepared for the possibility that they may lose their whole investment.
We have identified a material weakness in our internal control over financial reporting that could result in a material misstatement of our financial statements.
Our management is responsible for maintaining disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports to the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. Our management assessed the effectiveness of the design and operation of our disclosure controls and procedures as of June 30, 2012 and concluded that the material weaknesses identified in our Annual Report on Form 10-K for the year ended December 31, 2011 relating to the lack of sufficient segregation of duties and lack of sufficiency of personnel have not been fully remediated due to our limited financial resources, and therefore our disclosure controls and procedures were not effective as of June 30, 2012.
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting that creates a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. While we have performed additional substantive procedures to ensure that our consolidated financial statements as of and for the three month period ended June 30, 2012, are fairly stated in all material respects in accordance with GAAP, the completion of our remediation efforts are largely dependent upon our securing additional financing to cover the costs of implementing the changes required. If we are unsuccessful in securing such funds, remediation efforts may be adversely affected in a material manner. If our efforts are insufficient to remediate our material weaknesses, our financial statements may contain material misstatements. Any failure on our part to remediate the material weaknesses successfully may affect the results of the periodic management evaluations on the effectiveness of our internal control over financial reporting and disclosure controls and procedures that we must include in our periodic reports. A material weakness could also cause investors to lose confidence in our reported financial information.
We cannot give any assurance that the measures we are taking to remediate the identified material weaknesses will be effective. We also cannot assure that other material weaknesses will not arise as a result of our failure to maintain adequate disclosure controls and procedures or circumvention of those controls and procedures. Additionally, even if we succeed in improving our controls and procedures, those controls and procedures may not be adequate enough to prevent irregularities, identify irregularities or facilitate a fair presentation of our financial statements or reports we file with the SEC.
We have developed instruments which utilize our unique and proprietary pressure cycling technology ("PCT"), which we sell along with associated consumables and services to life sciences companies, academic institutions and government agencies. PCT represents the core of our products and has enabled our customers to perform biological sample preparation and enzymatic digestion in unique ways that were previously unavailable. The enabling capability of our PCT products allows us to continue to increase the number of applications for our platform beyond current uses, which include genomic and proteomic sample preparation, pathogen inactivation, the control of chemical and enzymatic reactions, immunodiagnostics, and protein purification. Additionally, we are pursuing business opportunities to leverage our products and PCT into new markets beyond our current focus of PCT-enhanced enzymatic digestion products designed specifically for the mass spectrometry marketplace, as well as sample preparation products for biomarker discovery, soil and plant biology, forensics, histology, and counter-bioterror applications.
PCT uses internally developed instrumentation that is capable of cycling pressure between ambient and ultra-high levels at controlled temperatures to rapidly and repeatedly control the interactions of bio-molecules. Our instrument, the Barocycler®, and our internally developed consumables product line, which includes PULSE® (Pressure Used to Lyse Samples for Extraction) Tubes as well as application specific kits (which include consumable products and reagents) together make up the PCT Sample Preparation System.
We have experienced negative cash flows from operations with respect to our pressure cycling technology business since our inception. As of June 30, 2012, we did not have adequate working capital resources to satisfy our current liabilities and as a result we have substantial doubt about our ability to continue as a going concern. Based on our current projections, including equity financing completed subsequent to June 30, 2012, we believe our current cash resources will enable us to extend our cash resources to fund normal operations until the end of August 2012. Please see Note 6, Subsequent Events.
We need substantial additional capital to fund normal operations in periods beyond the end of August 2012. If we are able to obtain additional capital or otherwise increase our revenues, we may increase spending in specific research and development applications and engineering projects and may hire additional sales personnel or invest in targeted marketing programs. In the event that we are unable to obtain financing on acceptable terms, or at all, we will likely be required to cease our operations, pursue a plan to sell our operating assets, or otherwise modify our business strategy, which could materially harm our future business prospects.
We hold 14 United States and 10 foreign patents covering multiple applications of PCT in the life sciences field. Our pressure cycling technology employs a unique approach that we believe has the potential for broad use in a number of established and emerging life sciences areas, including;
- sample preparation for genomic, proteomic, and small molecule studies;
- pathogen inactivation;
- protein purification;
- control of chemical (particularly enzymatic) reactions; and
- Immunodiagnostics (clinical laboratory testing).
Since we began operations as Pressure BioSciences in February 2005, we have installed 224 Barocycler instruments, of which 142 currently remain installed. Our customers include researchers at academic laboratories, government agencies, biotechnology, pharmaceutical and other life sciences companies in the United States, and six foreign distribution partners.
We reported a number of accomplishments in the second quarter of 2012.
· Registered Direct Offering with Ironridge BioPharma for $500,000. We completed a registered direct offering with Ironridge BioPharma Co. to purchase $500,000 in shares of Series E Convertible Preferred Stock of the Company.
· Distribution Agreement with Yinzhou Police Equipment & Technology Co., Ltd. ("Yinzhou"). We entered into an exclusive distributor agreement for our PCT product line and a non-exclusive agreement for our patent-pending, mechanical homogenization device, the Shredder SG3, and associated consumables. This agreement allows Yinzhou to market and sell PBI products into the forensics marketplace in China only.
· Distribution Agreement with BMN MSI, Ltd. ("BMN"). For Vietnam, Cambodia, and Laos, we entered into an exclusive distribution agreement with BMN for our PCT product line and a non-exclusive agreement for the Shredder SG3 homogenization device and associated consumables.
· Distribution Agreement with iScience Technology ("iScience"). For Australia and New Zealand, we entered into an exclusive distribution agreement with iScience for our PCT product line and a non-exclusive agreement for the Shredder SG3 homogenization device and associated consumables.
· Co-Development, Co-Marketing, and Co-Selling Agreement with LEAP Technologies, Inc. ("LEAP"). Under the Agreement, we plan to develop a next generation sample preparation system by combining our PCT platform with LEAP's proprietary robotics and lab automation equipment. The companies share an industry focus in proteomics sample preparation, primarily in mass spectrometry. PBI and LEAP believe that by combining the best attributes of both technology platforms, they can develop a sample preparation system superior in quality and robustness to current methods.
· Expanded strategic technology license and supply agreements with Target Discovery, Inc. ("TDI"). In April 2012, we signed expanded strategic technology license and supply agreements (the "Agreements") with TDI. Under these agreements, TDI now has the right to use PBI's PCT Platform for their planned entry into the clinical diagnostics testing market. The planned commercial diagnostic services will initially target what the companies believe are critical, unmet needs in treatment selection guidance for ovarian cancer. Until now, PBI's PCT Platform has been available on a "research-use-only" basis.
RESULTS OF OPERATIONS
Three Months Ended June 30, 2012 and 2011
Revenue
We recognized revenue of $324,908 for the three months ended June 30, 2012 as compared to $190,686 during the three months ended June 30, 2011. This increase is due to an increase in grant revenue and the sale of a Barocycler HUB instrument system and its accessories.
PCT Products, Services, Other. Revenue from the sale of PCT products and services increased 18% to $224,384 for the three months ended June 30, 2012 as compared to $190,686 during the three months ended June 30, 2011. We expanded into Asia through sales to new distributors. Revenue increased from the sale of a Barocycler HUB instrument system and its accessories. The Barocycler HUB system became available for sale in late 2011. Sales of consumables of $22,255 were recorded for the three months ended June 30, 2012 compared to $20,295 during the same period in the prior year. Our domestic and foreign installations of PCT systems are set forth in the table below.
For the Three Months Ended
June 30,
2012 2011
Domestic 5 6
International 3 1
Total PCT System Installations 8 7
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Grant Revenue. During the three months ended June 30, 2012, we recorded $100,524 of grant revenue. We continue to work on a Phase II grant received from the Department of Defense, or DOD, to fund the development of a PCT-based system to improve the processing of pathogenic organisms. We completed all billable work by the end of April 2012 on the Phase I grant received from the National Institutes of Health, or NIH, to help fund the development of a high pressure-based system to improve the processing of cancer and other samples. Both grants were awarded in the second half of 2011. During the three months ended June 30, 2011, we did not have any active grants.
Cost of PCT Products and Services
The cost of PCT products and services was $109,203 for the three months ended June 30, 2012 compared to $78,296 for the comparable period in 2011. Our gross profit margin on PCT products and services decreased to 51% for the three months ended June 30, 2012, as compared to 59% for the prior period. The decrease is from favorable pricing given to distributors on instrument sales.
Research and Development
Research and development expenditures were $256,307 during the three months ended June 30, 2012 as compared to $263,809 in the same period in 2011. Our work on research and development projects remained steady during both periods. Work on the NIH grant ended in April 2012.
Research and development expense recognized in the three months ended June 30, 2012 and 2011 included $3,508 and $3,737 of non-cash, stock-based compensation expense, respectively.
Selling and Marketing
Selling and marketing expenses decreased to $168,173 for the three months ended June 30, 2012 from $242,544 for the comparable period in 2011. This decrease was primarily due to employee related savings from a smaller headcount offset by tradeshow and travel related expenses.
During the three months ended June 30, 2012 and 2011, selling and marketing expense included $3,669 and $2,728 of non-cash, stock-based compensation expense, respectively.
General and Administrative
General and administrative costs totaled $474,015 for the three months ended June 30, 2012 as compared to $448,314 for the comparable period in 2011. We increased our investor relations efforts in the current period while the prior period included legal fees incurred in connection with investor matters.
During the three months ended June 30, 2012 and 2011, general and administrative expense included $4,045 and $5,737 of non-cash, stock-based compensation expense, respectively.
Operating Loss
Our operating loss was $682,790 for the three months ended June 30, 2012 as compared to $842,277 for the comparable period in 2011. The decreased operating loss resulted primarily for the reasons noted above.
Other Income (Expense), Net
Interest (Expense) Income
Interest expense totaled $4,214 for the three months ended June 30, 2012 as compared to interest income of $75 for the three months ended June 30, 2011. We recorded $4,216 of interest expense for the three months ended June 30, 2012 related to a promissory note.
Change in Fair Value of Warrant Derivative Liability
During the three months ended June 30, 2012, we recorded non-cash income of $177,312 for warrant revaluation in our consolidated statements of operations due to a decrease in the fair value of the warrant liability related to warrants issued in our Series C private placement and Series D registered direct offering. This decrease in fair value was primarily due to a lower stock price at quarter-end and time remaining on warrants.
Net Loss
During the three months ended June 30, 2012, we recorded a net loss to common shareholders of $1,089,666 or $(0.11) per share, as compared to a net loss to common shareholders of $1,172,541 or $(0.41) per share in the three months ended June 30, 2011. The decrease in net loss per share is primarily due to a significant increase in the number of outstanding shares of common stock resulting from the issuance of shares of common stock upon conversion of convertible preferred stock. We also recorded a deemed dividend of $185,544 in connection with the Series C Warrants exchange. See Note 3 of the Notes to Consolidated Condensed Financial Statements under the "Computation of Loss per Share" heading.
Six Months Ended June 30, 2012 and 2011
Revenue
We recognized revenue of $630,569 for the six months ended June 30, 2012 as compared to $371,329 during the six months ended June 30, 2011. This increase is due to an increase in grant revenue and the sale of a Barocycler HUB instrument system and its accessories.
PCT Products, Services, Other. Revenue from the sale of PCT products and services was $389,156 for the six months ended June 30, 2012 as compared to $371,329 during the six months ended June 30, 2011. We sold to new distributors in the Asia Pacific region. Revenue increased from the sale of a Barocycler HUB instrument system and its accessories. The Barocycler HUB system became available for sale in late 2011. We had fewer active Barocycler leases during the first half of 2012 due to expirations. Sales of consumables of $38,876 were recorded for the six months ended June 30, 2012 compared to $39,026 during the same period in the prior year. Our domestic and foreign installations of PCT systems are set forth in the table below.
For the Six Months Ended
June 30,
2012 2011
Domestic 10 14
International 5 3
Total PCT System Installations 15 17
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Grant Revenue. During the six months ended June 30, 2012, we recorded $241,413 of grant revenue. We continue to work on a Phase II grant received from the Department of Defense, or DOD, to fund the development of a PCT-based system to improve the processing of pathogenic organisms. We completed all billable work by the end of April 2012 on the Phase I grant received from the National Institutes of Health, or NIH, to help fund the development of a high pressure-based system to improve the processing of cancer and other samples. Both grants were awarded in the second half of 2011. During the six months ended June 30, 2011, we did not have any active grants.
Cost of PCT Products and Services
The cost of PCT products and services was $187,397 for the six months ended June 30, 2012 compared to $157,225 for the comparable period in 2011. Our gross profit margin on PCT products and services decreased to 52% for the six months ended June 30, 2012, as compared to 58% for the prior period. The decrease in gross margin was primarily the result of discounted sales to distributors and changes in product mix with growth in sales of lower gross margin product offerings.
Research and Development
Research and development expenditures were $527,918 during the six months ended June 30, 2012 as compared to $482,774 in the same period in 2011. We capitalized approximately $50,000 of engineering expenses to Inventory as overhead as a one-time implementation charge.
Research and development expense recognized in the six months ended June 30, 2012 and 2011 included $6,125 and $25,342 of non-cash, stock-based compensation expense, respectively. This decrease is due to expense adjustments for fully vested options included in the first half of 2011, which did not occur in the same period in 2012.
Selling and Marketing
Selling and marketing expenses decreased to $406,265 for the six months ended June 30, 2012 from $546,383 for the comparable period in 2011. This decrease was primarily due to employee related savings from a smaller headcount offset by tradeshow and travel related expenses.
During the six months ended June 30, 2012 and 2011, selling and marketing expense included $6,783 and $33,739 of non-cash, stock-based compensation expense, respectively. This decrease is due to expense adjustments for fully vested options included in the first half of 2011, which did not occur in the same period in 2012.
General and Administrative
General and administrative costs totaled $1,156,361 for the six months ended June 30, 2012 as compared to $860,843 for the comparable period in 2011. We increased our investor relations efforts in the current period. We also incurred increased audit fees relating to accounting matters and legal fees in connection with our completed private placements and amendments to our Registration Statement on Form S-1 originally filed in December 2011.
During the six months ended June 30, 2012 and 2011, general and administrative expense included $7,182 and $22,087 of non-cash, stock-based compensation expense, respectively. This decrease is due to expense adjustments for fully vested options included in the first half of 2011, which did not occur in the same period in 2012.
Operating Loss
Our operating loss was $1,647,372 for the six months ended June 30, 2012 as compared to $1,675,896 for the comparable period in 2011. The decreased operating loss resulted primarily for the reasons noted above.
Other Income (Expense), Net
Interest (Expense) Income
Interest expense totaled $60,527 for the six months ended June 30, 2012 as compared to interest income of $329 for the six months ended June 30, 2011. We recorded $14,386 of interest expense for the six months ended June 30, 2012 related to our short-term loans and promissory note. We also amortized approximately $46,000 of imputed interest against the debt discount on these short-term loans relating to warrants issued with these loans.
Change in Fair Value of Warrant Derivative Liability
During the six months ended June 30, 2012, we recorded non-cash income of $135,300 for warrant revaluation in our consolidated statements of operations due to a decrease in the fair value of the warrant liability related to warrants . . .
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