Form 10-K for AMARANTUS BIOSCIENCE HOLDINGS, INC.
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.
This Annual Report on Form 10-K (including the section regarding Management's Discussion and Analysis or Plan of Operation) contains forward-looking statements regarding our business, financial condition, results of operations and prospects. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements as denoted in this Annual Report on Form 10-K. Additionally, statements concerning future matters are forward-looking statements.
Although forward-looking statements in this Annual Report on Form 10-K reflect the good faith judgment of our Management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation, those specifically addressed under the heading "Risks Factors" below, as well as those discussed elsewhere in this Annual Report on Form 10-K. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Annual Report on Form 10-K.
The following discussion should be read in conjunction with our consolidated financial statements and notes thereto included elsewhere herein.
We are a California-based biopharmaceutical company founded in January 2008. We own or have exclusive licenses or options to various product candidates in the biopharmaceutical and diagnostic areas of the healthcare industry. We are developing our diagnostic product candidates in the field of neurology, and our therapeutic product candidates in the areas of neurology, psychiatry, ophthalmology and regenerative medicine. Our business model is to develop our product candidates through various de-risking milestones that we believe will be accretive to shareholder value, and will position them to be strategically partnered with pharmaceutical companies, diagnostic companies and/or other stakeholders in order to more efficiently achieve regulatory approval and commercialization.
Principal Products in Development
Our focus is currently in the areas of diagnostic, therapeutics, and drug
discovery. During 2014, we had the following products at various stages of
Area and candidate Application Status
LymPro Test � Diagnostic blood test for Available for
Alzheimer's disease Investigational Use Only
Eltoprazine � Parkinson's disease Phase 2a trial completed;
levodopa-induced Phase 2b program trial
dyskinesia ("PD LID") design FDA review
completed; IND underway
� Adult Attention Pre-clinical
Disorder ("Adult ADHD")
MANF Retinitis pigmentosa (RP) Orphan drug designation
granted by FDA
PhenoGuard� Drug discovery platform 88 cell lines available
for discovery of other
In addition to development and clinical areas for the above candidates, our efforts during 2014, and continuing into 2015, have been to license or acquire rights to intellectual properties and in-process research and development to advance development in these candidates, as well as other candidates in the areas of neurology, psychiatry, ophthalmology and regenerative medicine. We also entered into various sponsored research amongst these areas.
Critical Accounting Policies
Principles of Consolidation - The Consolidated Financial Statements include the accounts of Amarantus Bioscience Holdings, Inc. and its subsidiaries. All significant intercompany accounts and transactions have been eliminated.
Use of Estimates - The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America ("GAAP") requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Significant estimates include the fair value of derivatives, the fair value of stock-based compensation and warrants, the carrying value of intangible assets (patents and licenses), valuation allowance against deferred tax assets, and related disclosure of contingent assets and liabilities. Actual results could differ from those estimates.
Certain Significant Risks and Uncertainties - We participate in a global, dynamic, and highly competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company's future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies and industry standards; regulatory approval and market acceptance of the Company's products; development of the necessary manufacturing capabilities and the Company's ability to obtain adequate resources of necessary materials; development of sales channels; certain strategic relationships; litigation or claims against the Company based on intellectual property, patent, product, regulatory, or other factors; and the Company's ability to attract and retain employees and other resources necessary to support its growth.
Intangible Assets - Intangible assets or certain rights to use certain intangible assets in our research and development activities are capitalized as assets in cases where we have determined that those assets have an identifiable alternative future use in accordance with GAAP. In certain cases, we may conclude certain assets have indeterminate useful lives in which case they are considered to have indefinite lives. We have determined that the useful lives of assets which can be reasonable estimated and amortized to expense over such useful lives range between 9.5 years and 18.5 years.
Research and Development Expenditures - Research and development expenses consist of personnel costs, including salaries, benefits and stock-based compensation, materials and supplies, licenses and fees, and overhead allocations consisting of various administrative and facilities related costs. Research and development activities consist primarily of three main categories:
research, clinical development, and biotechnology development. Research costs typically consist of preclinical and toxicology costs. Clinical development costs include costs for clinical studies and trials. Biotechnology development costs consist of costs incurred for product formulation and analysis. Research and development costs are charged to expense when incurred.
Fair Value of Financial Instruments - The fair value of certain of financial instruments, including cash and cash equivalents, accrued compensation, and other accrued liabilities, approximate cost because of their short maturities. The fair value of certain financial assets and liabilities are measured on a recurring basis. A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at fair value which is not equivalent to cost will be classified and disclosed in one of the following three categories:
� Level 1- Quoted prices (unadjusted) in active markets for identical assets and liabilities.
� Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
� Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
Stock-Based Compensation - Stock-based compensation is measured at the grant date based on the fair value of the award. The fair value of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period, which is generally the vesting period. The expense recognized for the portion of the award that is expected to vest has been reduced by an estimated forfeiture rate. The forfeiture rate is determined at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
Grant-date fair value is determined using the Black-Scholes option pricing model, which requires the use of the following assumptions:
Expected Term - The expected term represents the period that options are expected to be outstanding based on the simplified method, which is the half-life from vesting to the end of its contractual term.
Expected Volatility - Stock price volatility is computed over expected terms based on the historical common stock trading price for our stock.
Risk-Free Interest Rate - The risk-free interest rate is estimated based upon the implied yield available on U.S. Treasury zero-coupon issues with an equivalent remaining term.
Expected Dividend - Cash dividends have never been declared or paid on common shares and there are no plans to do so in the foreseeable future such that the expected dividend yield is assumed to be zero.
The fair value of stock options granted to nonemployees is recognized as stock-based compensation expense over the period in which the related services are received.
Preferred Stock - Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares, which include preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company's control, are classified as temporary equity until such time as the conditions are removed or lapse.
Convertible Financial Instruments - We bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments if certain criteria are met. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. An exception to this rule is when the host instrument is deemed to be conventional, as that term is described under applicable GAAP.
When it has been determined that the embedded conversion options should not be bifurcated from their host instruments, discounts are recorded for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the debt transaction and the effective conversion price embedded in the debt. Deemed dividends are also recorded, when present, for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred shares.
Common Stock Purchase Warrants and Derivative Financial Instruments - Common stock purchase warrants and other derivative financial instruments are classified as equity if the contracts (1) require physical settlement or net-share settlement or (2) give the issuer a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). Contracts which (1) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the control of the Company), (2) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement), or (3) that contain reset provisions that do not qualify for the scope exception, are classified as assets or liabilities. Classification of its common stock purchase warrants and other derivatives is assessed at each reporting date to determine whether a change in classification between assets and liabilities is required.
Debt Discounts - Debt discounts under these arrangements are amortized to interest expense using the interest method over the earlier of the term of the related debt or their earliest date of redemption.
Income Taxes - Income taxes are accounted for using the liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided, if necessary, to reduce deferred tax assets to their estimated realizable value.
All available positive and negative evidence is considered, including operating results, ongoing tax planning, and forecasts of future taxable income on a jurisdiction-by-jurisdiction basis is evaluated regarding the ability to recover deferred income tax assets. In the event we determine we will be able to realize any deferred income tax assets in the future in excess of their net recorded amount, we would adjust the valuation allowance which would reduce our provision for income taxes. Conversely, in the event that all or part of net deferred tax assets are determined not to be realizable in the future, an adjustment to the valuation allowance would be charged to earnings in the period such determination is made.
The effect of uncertain income tax positions is recognized only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50% likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs.
Interest and penalties related to uncertain tax positions are recorded in the provision for income tax expense on the consolidated statements of operations.
Recently Issued Accounting Pronouncements
Accounting Standards Update (ASU) No. 2014-10, Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation removes all incremental financial reporting requirements for development stage entities, including the removal of reporting of the cumulative results of operations and cash flows for the period from inception to the end of the current period. The ASU is effective for the first annual period beginning after December 15, 2014. Early adoption is permitted, and we adopted this change during 2014.
ASU No. 2014-12, Compensation - stock requires that a performance target which affects vesting and could be achieved after the requisite service period should be treated as a performance condition that affects vesting, rather than a condition that affects the grant-date fair value. The ASU is effective for the first annual period beginning after December 15, 2015 and interim periods within those years for all entities. Early adoption is permitted. We are evaluating the effect of this FASB issuance, if any, on our financial statements. We have decided not to early adopt at this time.
ASU No. 2014-15, Presentation of Financial Statements- Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. The amendments in this ASU are effective for the first annual period ending after December 15, 2016 and interim periods within those years for all entities. Early adoption is permitted. We are evaluating the effect of this FASB issuance, if any, on our financial statements. We have decided not to early adopt at this time.
ASU 2014-16, Derivatives and Hedging (Topic 815): Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share Is More Akin to Debt or to Equity. The amendments in this ASU are effective for the first annual period ending after December 15, 2015 and interim periods within those years. Early adoption is permitted. We are evaluating the effect of this FASB issuance, if any, on our financial statements. We have decided not to early adopt at this time.
Results of Operations
Comparison of Years Ended December 31, 2014 and 2013
(in thousands, except share and per share data)
Net Sales - We did not recognize any revenue in either of the two years ended December 31, 2014 or 2013.
We do not expect to receive any revenues from the commercialization of our product candidates for at least the next several years in the case of Eltoprazine and MANF and until the second half of 2015 in the case of LymPro. To obtain revenues from sales of our product candidates, we must succeed, either alone or with third parties, in developing, obtaining regulatory approval for, manufacturing and marketing drugs with commercial potential.
The following table summarizes our research and development expenses for the years ended December 31, 2014 and 2013:
2014 2013 $ Change % Change Research and development $ 13,762 $ 2,089 $ 11,673 559 %
During the year ended December 31, 2014, our research and development costs consisted primarily of start-up clinical expenses. Research and development expense increased in 2014 as compared to 2013 primarily due to expensed in-process research and development associated with intellectual property and technology acquired in the Regenicin transaction, and to a lesser extent, increases in consulting, stock based compensation, and preclinical research study costs.
The following table summarizes our general and administrative expenses for the years ended December 31, 2014 and 2013:
2014 2013 $ Change % Change General and administrative $ 7,592 $ 3,622 $ 3,970 110 %
General and administrative expenses increased primarily due to increased patent related legal costs, investor and public relations services, other outside services and stock based compensation.
The following table summarizes our other income (expense) for the years ended December 31, 2014 and 2013:
2014 2013 $ Change Change
Interest expense $ (813 ) $ (2,631 ) $ 1,818 69 %
Loss on issuance of common stock $ (260 ) $ (352 ) $ 92 ) 26 %
Loss on issuance of debt $ - $ (6,709 ) $ 6,709 100 %
Loss on extinguishment of convertible
debt (1,250 ) - (1,250 ) (100 )%
Loss on issuance of warrants $ (3,867 ) $ - $ (3,867 ) (100 )%
Other expense $ (50 ) $ - $ (50 ) (100 )%
Change in fair value of warrants and
derivative liabilities $ 317 $ 271 $ 46 17 %
Total other expense $ (5,923 ) $ (9,421 ) $ 3,498 37 %
Net loss attributable to common
stockholders $ (28,152 ) $ (15,170 ) $ 12,982 86 %
Basic and diluted net loss per common
share $ (0.04 ) $ (0.03 ) $ .01 33 %
The decline in interest expense was attributable to the retirement of debt, primarily during the first half of 2014 and primarily retired through conversion to common stock.
The decline in loss incurred upon the issuance of common stock was attributable to the reduction of stock issued for services from in 2014 from 2013.
We incurred a loss on conversion of debt of $1,250 for the year ended December 31, 2014 as a result of retiring debt, primarily our 8% senior convertible debentures, through conversion to common stock. The loss occurred as a result of the fair value of our stock on the date of conversion being above the fair value of the debt at conversion.
We incurred a loss on the issuance of warrants of $3,867 for the year ended December 31, 2014 as a result of our warrant exchange program in which existing warrant holders could receive new warrants if they exercised existing warrants. The fair value of the new warrants was determined to be greater than the fair value of the exchanged warrants, resulting in a loss on issuance.
We incurred a loss on investment of $50 in 2014 and no loss was recorded in 2013.
The change in the fair value of warrants and derivative liabilities was minimal, primarily to lower balances of the warrant and derivative liabilities in 2014 as compared to 2013. The derivative liability was associated with the 8% senior convertible debentures, which were retired primarily in the first quarter of 2014. At December 31, 2014, the balance of the warrant and derivative liability was $0.
Liquidity and Capital Resources
(in thousands except per share and per share data)
As of December 31, 2014, the Company had total current assets of $412 consisting of $214 in cash and cash equivalents and $198 in prepaid expenses and other current assets. As of December 31, 2014, the Company had current liabilities in the amount of $6,329, consisting of:
Accounts payable $ 5,903
Accrued liabilities $ 149
Accrued interest $ 25
Related party liabilities and accrued interest $ 252
The table below sets forth selected cash flow data for the periods presented
Net cash used in operating activities $ (11,331 ) $ (3,473 )
Net cash used in investing activities (1,535 ) (70 )
Net cash provided by financing activities 12,047 4,419
Net (decrease) increase in cash and cash equivalents $ (819 ) $ 876
Since inception, the Company has financed cash flow requirements primarily through the issuance of stock or debt.
During 2014, we augmented our ability to raise operating cash through two significant equity agreements:
Lincoln Park Capital
In March 2014, we entered into an agreement with Lincoln Park Capital Fund LLC ("LPC") for an equity financing agreement. LPC is obligated to purchase up to $20,000 of the Company's common stock from time to time over a 30 month period, in amounts up to $500 per sale as directed by the Company and subject to certain requirements, restrictions and limitations. There are no upper limits to the price LPC may pay to purchase our common stock and the purchase price is based on prevailing market prices of our stock at the time of sales without any fixed discount, We control the timing and amount of any sales to LPC In addition, we may direct LPC to purchase additional amounts as accelerated purchases the closing price of our stock is not below certain threshold price. We filed a registration statement with the SEC covering the shares issuable to LPC. As of December 31, 3104, we had approximately $17,300 available to us under the agreement.
Through March 25, 2015, the Company has sold an additional 37,445,801 shares of common stock for gross proceeds of $2,767 under its agreement with LPC.
Series E Convertible Preferred Stock
On November 7, 2014, the Company entered into securities purchase agreements pursuant to which the Company issued 4,500 shares of Series E Convertible Preferred Stock ("Series E Preferred Stock") which has a stated value of $1,000 per share of Series E Preferred Stock and pays quarterly 12% cumulative dividends per annum. Dividends are payable by the Company in cash or at the Company's option, in shares of common stock if certain conditions are met. Series E shares are entitled to three years of dividends even if converted up to three years following the issuance date. Each share of Series E Preferred Stock is convertible into shares of common stock by dividing the stated value per share by the then effective conversion price. The conversion price for the Series E is initially $0.08 per share, subject to adjustment under certain conditions, but in no event prior to six months from issuance. Series E Preferred stockholders have the right to vote on all matters submitted to the Company's shareholders and the Series E Preferred Stock is entitled to such number of votes on an as-converted basis. Series E Preferred Stock also has a liquidation preference equal to the stated value and accrued and unpaid dividends.
Through March 31, 2015, the Company has sold a total of 7,779 shares of Series E for gross proceeds of $7,000.
The proceeds received by the Company through sales of common stock to LPC and sales of Series E convertible preferred stock were used for product development, commercialization, strategic acquisitions, and general corporate purposes.
The success of our business plan during the next 12 months and beyond is contingent upon us generating sufficient revenue to cover our costs of operations, or upon us obtaining additional financing. We believe our current capital resources are not sufficient to support our operations. We intend to continue our research efforts and to finance operations through debt and/or equity financings. We will seek additional debt and/or equity financing through private or public offerings or through a business combination or strategic partnership. There can be no assurance that such additional financing will be available to us on acceptable terms or at all. Similarly, there can be no assurance that we will be able to generate sufficient sales to cover the costs of our business operations.
Our financial statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Because we believe our current capital resources are not sufficient to support our operations and there can be no assurance that we will be successful in obtaining additional financing on favorable terms, or at all there is substantial doubt about our ability to continue as a going concern. We will, however, seek additional debt and/or equity financing through private or public offerings or through a business . . .
Sentiment: Strong Buy
Watch out for him, he is slick! Lesson learned already! I'm on the sidelines just waiting! Best to you!
Amarantus BioScience Opens Investigational New Drug (IND) Application With the U.S. Food and Drug Administration Allowing the Start of a Phase 2b Program of Eltoprazine in Parkinson's Disease Levodopa-Induced Dyskinesia
Sentiment: Strong Buy
Medican Enterprises Inc. (MDCN), announced today that the 67,000 square foot facility located, in Phoenix Arizona, it is acquiring has received zoning approval and is now zone compliant for the operation of legal #$%$ businesses.
“With the zoning approval in hand, this commercial transaction now meets our criteria and we are moving rapidly to finalize the due diligence process,” commented Ken Williams, CEO of Medican Enterprises. “Located just minutes from Hwy 60 and the I-17 and featuring excellent visibility in a high traffic center, this unique property represents the type of asset we are looking for.”
The transaction is planned for closure by the end of the first quarter of 2015.
Amarantus to Present Positive Alzheimer's Disease Biomarker Data on the LymPro Test(R) at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders
SAN FRANCISCO and GENEVA, Feb. 23, 2015 (GLOBE NEWSWIRE) -- Amarantus BioSciences Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing diagnostics in neurology, and therapeutic products with the potential for orphan drug designation in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that its abstract titled, "The LymPro® Assay: A Biomarker For Alzheimer's Disease Using Blood Samples From Clinically Diagnosed Alzheimer's Disease And Cognitively Intact Subjects," was accepted for poster presentation at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PDTM 2015) being held March 18-22, 2015, in Nice, France.
The poster will highlight the positive data analysis of whole blood samples from 140 subjects (71 Alzheimer's disease and 69 age matched controls) using the company's LymPro Test blood-based assay for Alzheimer's disease (AD). The LymPro Test measures lymphocyte proliferation in response to a mitogenic stimulus and quantifies the extent to which lymphocytes have entered the cell division cycle. Cell cycle dysregulation in neurons is a key pathology in AD, that results in neuronal death and cognitive decline. In the LymPro test, lymphocyte measurements are used as a surrogate for this neuronal cell dysfunction. The analysis demonstrates that, in combination with standard of care clinical measurements, LymPro can give physicians greater confidence that an Alzheimer's diagnosis is truly accurate.
"We are very pleased to have this confirmatory LymPro abstract accepted for a poster session at one of the premiere scientific congresses focused on neurological disorders," said Gerald E. Commissiong, President & CEO of Amarantus BioSciences Holdings, Inc. "We believe the LymPro Test is an important leading Alzheimer's biomarker assay and is a key diagnostic asset for advancing robust therapeutic clinical studies in Alzheimer's disease. This conference will provide important exposure as we continue building a significant customer base for blood-based biomarker services in Alzheimer's disease, with the ultimate shared goal of improving the current standard of care used to treat AD."
The poster data to be presented at AD/PD 2015 by Louis Kirby, Corporate Advisor and Medical Director of Amarantus Diagnostics, confirms the consistent and accurate ability of the LymPro Test to distinguish univariate and multivariate combination indicators of lymphocyte proliferation AD biomarkers from controls. Additionally, the analysis corroborates two previous peer-reviewed publications in which data from the Company's recently completed LP-002 clinical study established the LymPro Test as an advantageous diagnostic that can serve as the first step in a multistep diagnostic process for early identification of Alzheimer's disease.
Sentiment: Strong Buy